ipminds- IPlog from India

We have Moved!

2007-07-09T13:43:00.000+05:30

Glaxo's patent on AIDS drug opposed by INP+ in India

2006-04-25T18:04:00.000+05:30

Glaxo's patent on AIDS drug opposed by INP+ in India The World Trade Review: "Intellectual Property Rights (TRIPs), 16-30 April 2006 Mumbai: People living with HIV/AIDS are taking on drug major GlaxoSmithKline's efforts to patent its AIDS-medicine Combivir in India. The Manipur Network of Positive People (MNP+), under the aegis of the Indian Network of People Living with HIV/AIDS (INP+) has filed a pre-grant opposition to GSK's patent application at the Indian Patent office in Kolkata. The pre-grant opposition has been filed for the patient organisations by Lawyers' Collective. Combivir is the backbone of AIDS therapy and is used in the first-line of treatment, Mr Loon Gangte, a HIV-positive person with INP+, told Business Line. GSK's patent application is being opposed on technical and health grounds, he said. Combivir is a fixed-dose combination of two existing AIDS drugs - zidovudine and lamivudine, technically that is not a new invention, Mr Gangte said. GSK officials were not available for comment. A pre-grant opposition allows people to oppose patent applications filed by a company. A decision on the patent is given after the Patent Controller's office hears arguments from different stakeholders. Only recently, the Patent Office in Chennai had rejected Novartis' patent on cancer drug Glivec. Generic or copycat versions of Combivir are available in India from drug-makers such as Cipla, Ranbaxy, Aurobindo, Emcure and Strides. They are priced at about Rs 1,100 per patient, per month. These drug-makers supply to patients to other developing countries too, he said. GSK's Combivir is not available in the local market, said Ms Priti Radhakrishnan of Lawyers' Collective. But international aid organisation Medecins Sans Frontieres (MSF) purchases it at about $237 per patient per year compared to the cheapest generic at $182, said Ms Leena Menghaney with Campaign for Access to Essential Medicines and MSF. Generic competition has brought down the price on Combivir-clones. If GSK gets a patent, it becomes a monopoly and could control the price, Mr Gangte said. Though the present product-patent regime in India may allow Combivir-clones to sell provided they pay a royalty to GSK, there is a risk of a price increase. There is no clarity in the law on the royalty to be paid. Either way a price increase is on the cards, he said. Previous Page Next Page Top of the Page"

Overview of Chinese Patent Litigation System

2006-04-24T16:18:00.000+05:30

An informative overview of Chinese Patent Litigation System "Patent Litigation in Chinese Courts" by J. Benjamin Bai, Helen Cheng and Peter Wang from JONES DAY appired on Mondaq.com A must read....

State of Innovation in Global Pharma Industry

2006-03-22T19:59:00.000+05:30

An article appierd in Forbs Magzine, the state of innovation in Global Pharma Industry as ..........But right now, big drug companies are suffering from an innovation drought. Aitken says that there were only 30 new medicines launched in key markets in 2005, well off the peak of the 1990s. A more encouraging sign: There are 2,300 experimental drugs being tested in humans. In the late stages of human testing, IMS counts 96 cancer drugs, 51 heart treatments, 37 antivirals and 28 potential medicines for arthritis or pain. However, more and more drugs are being developed by biotech--though Aitken argues that this is less of a problem than people think."

TRIPS & Convention on Biological Diversity (CBD) Alaince worries Western Pharma/ Biotech Companies

2006-01-11T16:21:00.000+05:30

TRIPS & Convention on Biological Diversity (CBD) Alaince worries Western Pharma/ Biotech Companies

Tuesday, January 10, 2006 By Stephanie Weinberg

U.S. biotech firms representing a variety of industries are working to ward off efforts by India, Brazil and other developing countries that want to amend World Trade Organization rules to require patent holders to disclose the origin of their patents and share benefits when those patents are based on genetic plant material or traditional knowledge from developing countries. Failure to meet these new rules would result in the loss of patents if these changes to WTO rules were approved.

The firms expect to create an education campaign this spring to build opposition among other WTO members to demands from India and Brazil, and argue that developing countries could actually be disadvantaged by such rules. In addition, the group hopes to find allies within India's biotech industry, which also could be disadvantaged by the new requirements, they said. This could include Indian companies making patented health care and personal grooming products based on ayurveda, or Hindu traditional medicine.

The U.S. biotech firms have been brought together under the recently formed American BioIndustry Alliance, which includes pharmaceutical companies Merck, Pfizer, Bristol Myers-Squibb and Eli Lilly, as well as General Electric and Procter & Gamble. The membership of companies not strictly in pharmaceuticals shows the issue is important to firms beyond the drug industry, industry sources said. Procter & Gamble, for example, is chiefly interested in how new WTO rules requiring benefits sharing and disclosure of origin could adversely affect its skin care products, an industry source said.

The goal of the group is to prevent such requirements from being incorporated into the WTO Agreement on Trade-Related Aspects on Intellectual Property Rights, as demanded chiefly by Brazil, India and Peru. At the December 13-18 WTO ministerial in Hong Kong, those countries successfully negotiated language into the final ministerial text that calls for the WTO director general to intensify his consultations on all outstanding implementation issues, including the relationship between TRIPS and the Convention on Biological Diversity, which covers the use of biological materials.

Paragraph 39 also calls for the WTO General Council to review progress and "take any appropriate action" no later than July 31, 2006 on the implementation issues. Implementation refers to issues during the Uruguay Round that developing countries argue were not effectively implemented, but the only two issues specifically highlighted in paragraph 39 are the traditional knowledge and genetic material issue, and the European Union's demands for protections for foods with geographic names or indications such as Parma ham. Some fear the EU may ultimately support talks on negotiating new rules on the use of traditional knowledge and genetic material if this also allows the GIs issue to move.

U.S. firms would have preferred to see language calling for open-ended consultations rather than a date indicating some decision could be made by this summer, sources said. However, one industry source said open-ended language was too much to expect given the push by Brazil and India for an endorsement of talks on amending WTO rules to be included in the ministerial text. At the same time, the source acknowledged it would be better to have more than six months to consult with other WTO members and potential allies in India as a way to counter the current demands from India, Brazil and Peru.

The July 31 date corresponds to deadlines for members to submit comprehensive draft schedules of commitments in agriculture and industrial market access, although this depends on members meeting a separate deadline agreed in Hong Kong to establish specific negotiating terms or modalities in those areas by April 30. Still, it is conceivable that Brazil and India could use the deadline on these schedules as leverage to win concessions on the TRIPS issue.

However, U.S. industry sources indicated they are hopeful of softening the position of India, which in Hong Kong indicated to the U.S. that its position was based on domestic political reasons, and that its biotechnology and pharmaceutical industry had not raised its voice on the issue, sources said. The ruling party in India shares power with several minority parties, including the Communists, who support introducing WTO requirements for benefits sharing and origin disclosure.

As a result, industry sources said it could be possible to get India to lower its demands if industry groups in that country announced their opposition to rules that would threaten to invalidate a patent if a patent holder failed to share benefits or disclose the origin of related traditional knowledge or genetic material. These sources indicated U.S. groups would reach out to potential supporters in India in the hopes of changing the dynamics there.

Such a scenario, however, is unlikely with Brazil, which is seen as more interested in advocating fundamental changes to TRIPS, sources said.

The alliance will argue to developing countries that creating a mandatory patent disclosure obligation would make it less likely that industry would invest in bio-prospecting in developing countries, which would add to uncertainty in the bio-industry and make it less likely that genetic resource inventions would become commercially viable. This would go against the interest of countries rich in traditional knowledge and genetic material, since these countries would not get to share in any benefits unless products appear on the market.

Determining where genetic material comes from can also be complicated, and is another reason why linking patents to disclosure or benefit sharing would be a bad idea, the alliance argues. For example, questions could be raised about the origin of bio-materials found in the Brooklyn Botanical Garden. Another possible complication could occur if a company disclosed that the country of origin for its material was India, but it turned out the same material could be found in, for example, China. This could lead to conflicts over how benefits should be shared among various countries.

U.S. firms and the U.S. government have advocated a contractual system for sharing benefits, and have urged members to reject a linkage between patents and benefit sharing, these sources said.

Finally, the alliance argues the goals that would need to be captured in an international regime on access and benefit sharing related to genetic resource inventions go beyond the expertise of the WTO TRIPS Council. It argues the better forum for an agreement would be under the Convention on Biological Diversity, which the U.S. has not ratified. There is also no dispute settlement mechanism under the CBD.

Stephanie Weinberg Trade Policy Advisor Oxfam America

Evaluation of EU Rules on Databases

2005-12-15T18:17:00.000+05:30

Interesting development on database protection tracked by BLOG@IP::JUR EXTERNAL LINKRAPID Database: '[...] The European Commission has published an evaluation of the protection EU law gives to databases. EU law protects databases by copyright if they are sufficiently creative. Other databases, especially those that are compilations of information or commonplace data, such as telephone directories, music charts or football match listings, may benefit from a new form of protection introduced by the 1996 Database Directive. This protection is known as the 'sui generis' database right, i.e. a specific property right for databases that is unrelated to other forms of protection such as copyright. The evaluation focuses on whether the introduction of this right led to an increase in the European database industry's rate of growth and in database production. It also looks at whether the scope of the right targets those areas where Europe needs to encourage innovation. Stakeholders are invited to comment on the evaluation by 12 March 2006. [...]' The evaluation paper is available EXTERNAL LINKhere. Policy options discussed therein are: * Option 1: Repeal the whole Directive; * Option 2: Withdraw the 'sui generis' right; * Option 3: Amend the 'sui generis' provisions; and * Option 4: Maintaining the status quo. '[...] Before deciding on its future policy approach with respect to the 'sui generis' protection for 'non-original' databases, the Commission services deem it appropriate to further consult stakeholders on the four policy options outlined above. Stakeholder consultation should also provide further evidence on the economic impact of 'sui generis' protection in stimulating the production of European databases. Stakeholders are invited to submit their observations by 12 March 2006.'"

Unveiling your masterpiece: Find out how to keep an eye on the competition before showing the world your sales and marketing strategies.

2005-12-15T12:50:00.000+05:30

An interesting article on importance of Competitor Intelligence by Richard G Ensman. Worth reading ... enjoy

WTO upholds cheaper drugs waiver

2005-12-14T18:40:00.000+05:30

It is a great win for humanity as well as opportunities for pharma companies from developing countries like India, in Generic Market producing Life Saving Drugs. The agreement will extend a 2003 temporary rule World Trade Organization (WTO) members have agreed to uphold a rule that allows poor countries to import cheaper copies of patented medicines. Its general council has agreed to make permanent a 2003 waiver that allows poorer nations to import generic drugs to treat serious diseases such as Aids. The measure would become permanent by 1 December 2007, the WTO said. The current waiver remains until then. WTO boss Pascal Lamy said the agreement showed the body's humanitarian concern. 'Landmark' US Trade Representative Rob Portman added that America was fully behind the move. 'This is a landmark achievement that we hope will help developing countries devastated by HIV/Aids and other public health crises,' he said. The European Union (EU) has also backed the change. 'The EU has worked hard for this outcome and welcomes that others have moved to make this possible,' said EU Trade Commissioner Peter Mandelson. And for the UK, Trade Secretary Alan Johnson said 'this announcement should be an important step in making drugs available in poor countries. 'The lack of access to essential medicines in developing countries is one of the biggest health issues - and one of the gravest injustices - in the world.' Under the rule, poorer nations will be allowed to import the generic drugs for humanitarian reasons and not for commercial purposes. Some of the larger developing countries, like India, hope that they will be able to sell antiretroviral Aids drugs to Africa under the deal. "

Patent for 1.4 lakh medicines soon - Newindpress.com

2005-11-14T11:12:00.000+05:30

Including Claims in Provisional Patent Applications?

2005-11-14T00:05:00.000+05:30

Patently-O: Patent Law Blog: Including Claims in Provisional Patent Applications?: "Including Claims in Provisional Patent Applications? Curtsy-Patently-O: Patent Law Blog: Including Claims in Provisional Patent Applications? An ongoing debate amongst some patent attorneys is whether to include claims in provisional applications. According to the rules of practice, claims are not required in the provisional application. (MPEP 601). However, there are a few good reasons for including claims in the application. In the wake of Phillips v. AWH, it has become even more important to ensure that a patent?s specification accurately describes the meaning of the associated claim terms. This task is all but impossible in the absence of any claim terms to describe. Thus, it is important to draft at least a few model claims with the provisional application. Some practitioners, such as Russ Krajec, have advocated drafting the claims but then deleting them from the application before filing. Russ argues that claims in the provisional can only hurt the applicant. I disagree. The claims can be helpful in ensuring adequate disclosure and enablement ? this is especially true in cases where the provisional is rushed through on a very short deadline and/or low budget. The claims, as part of the specification, can easily tie together loose ends that may have been created in the rush. As Todd Mayover aptly points-out, including claims in the provisional creates a clear record associating those claims with the earliest filing date or priority date. It is also unlikely that patent attorneys would seriously stick to the practice of initially drafting claims that will eventually be deleted ? this is especially true in the fast-paced area of provisional applications. One newfound fear is that including claims in the provisional leaves the patentee open to Festo-type prosecution history estoppel. However, we have no evidence that presenting new claims in a subsequent nonprovisional would create any such estoppel ? especially since the nonprovisional is newly-filed rather than simply an amended version. An astute Patently-O reader provided the following comment: I include at least one extremely broad, never likely obtainable claim in a provisional. First under US law, it is true that a provisional need not include one in order to be considered valid. But foreign courts can say otherwise and render the US provisional (if serving as a priority document) invalid in a foreign court. Not including a provisional claim is only useful if you are absolutely certain that you won't go foreign. I hear the arguments related to the effect of narrowing by amendment as creating PHE. In the post-Festo world, you can at least explain the amendment so as to overcome the presumption of PHE. Let's face it, if you are relying on the DOE to win your case anyway and the case rests on whether you started broad and narrowed by amendment, you are fighting a likely unwinnable battle. In the last 10 years or so, how many DOE cases has the Fed. Circuit actually upheld? Not too many. No U.S. practitioner has been able to cite a case, rule, regulation, expanded Board of Appeals decision, etc. from a foreign court that has categorically said, "A U.S. provisional application serving as a priority document [to this foreign application] that does not include at least one claim is nonetheless considered a permissible priority document." Why take the chance of not including a claim in a provisional if there is a likelihood that the foreign counterpart could get knocked out. Another reason to the include at least a broad claim is that most foreign laws have strict adherence to the rule that the broadest initially presented claim will set the claim scope for the application. So if you present a very broad claim initially, you can amend narrower. But if you present a narrower claim first then realize that you can go broader, you cannot amend to go broader. It is for this reason you can include a "claim" that says something like, "I claim, the product comprising any feature described, either individually or in combination with any feature, in any configuration." or a "process to [...] comprising any process described, in any order, using any modality, ..."

How to Write a Patent Application-Deconstruction and Rebuilding Approach

2005-11-14T00:02:00.000+05:30

Anything Under the Sun Made By Man: How to Write a Patent Application ? Deconstruction and Rebuilding Approach: "How to Write a Patent Application ? Deconstruction and Rebuilding Approach Curtsey --Anything Under the Sun Made By Man: ? There are several different styles of patent applications, each being a certain response to a specific business situation and prosecution strategy. I use a deconstruction and rebuilding approach, detailed below, for applications where the prior art is reasonably well known, a product is reasonably well known or anticipated, and thus the claims can be well tailored. For example, if the inventor knows the art very well and has worked at or near the top of the field for a period of time, I have reasonable confidence that they can distinguish their invention and the prior art. Also, if I have a reliable search done using a draft set of claims, we may be confident enough in the prior art to know what would reasonably be allowed by the Patent Office. The method for drafting the patent application is quite simple: deconstruct the invention down to the claims, then rebuild the description to match the claims. This method results in an application that is very tight and fully supports each element of the claims very well, but it might not have much fat or excess that could be used as backup claims if the original claim set must be significantly altered. These applicati"

US again threatns to suspend patent rights on health hazard grounds..

2005-11-11T12:30:00.000+05:30

Apprehension about offering the stringent Product Patent protection to Pharma inventions during the TRIPs negotiations are turning the to be true. Even in developed world, companies holding the key patented medicine were reluctant to offer the medicines to the needy people at the time of community health crises and in order to avoid any catastrophy might govts like US has literally threat to them suspend/ revoke their patent rights over the life saving medicine. Perhaps, most of developing countries are not strong enough to compel any such patent holder to make available the life saving drugs to the public on reasonable prices. We have to ensure that natural human lives are always placed above the profit making motives of legal entities. IPBiz: Washington Post on Tamiflu: U.S. bullies IP owners: "Monday, November 07, 2005 Washington Post on Tamiflu: U.S. bullies IP owners But the U.S. isn't a model of respect for intellectual property, either. Panicked by its own lateness, the Bush administration has bullied Roche into opening a new production operation in the United States; if Roche had refused, the administration was ready to break the patent. Sen. Chuck Schumer has gone further, denouncing Roche for elevating profits above health and demanding that the firm license its technology to other drugmakers or face legislation compelling it to do so. Coming on top of similar bullying four years ago of Bayer, the maker of an anti-anthrax drug, this browbeating sends a clear signal: If you make a drug that turns out to be really important, don't expect patent laws to protect you. <-- by Sebastian Mallaby In the earlier CIPRO confrontation, the 'bullying' pertained to negotiation over price, and there was a related fear that such price negotiation could carry over into a prescription plan for Medicare. See 'Where have you gone, Richard K. Lyon,' Intellectual Property Today, Oct. 2001.

Patent Analysis

2005-09-17T07:12:00.000+05:30

Patent Data, Analysis & Visualisation by Juan C. Dürsteler Patents are extremely important when configuring the business strategy of technological companies. There are more and more tools that allow you to download and analyse patents in one way or another. Visualisation is a key tool for the analysis and detection of opportunities that is still used shyly. One of the less usual applications of information visualisation is patent visualisation. In fact visualising patent information is just a part of text or document visualisation. In the end, a patent is just text with a certain structure and with a specific objective. Patents encompass several aspects that have, nonetheless, great importance.: * they are a way to protect intellectual property rights o our own rights, allowing us to produce without being copied with inpunity o the other's rights, preventing us of using alien developments. For these reasons patents constitute a very important source of information about the competitors. This makes them the main tool for technological and business intelligence. On the other hand, knowing which patents are enforced in the market is vital before deciding to make a new development or product, with the important investment it means, that could be finally blocked by an existing patent. Many patent offices already allow to freely download abstracts and complete text of their patents. Among them the USPTO from United States or the EPO from Europe, and many others you can find, for example, in the PatentLawLinks.com list. In particular Esp@cenet, the download service of the European Patent Office has become a very popular source of information in this field. Based on the many possibilities of search that all this offers, there have been appearing in the market different systems allowing you to search, download and analyse patents automatically. Many of them are present in the Patent Information Users Group (PIUG) vendors list. Although downloading, classificating, clustering and finding the relationship between patents of similar contents has become quite widespread, even making use of text mining tools, the visualisation of those resuts is not so usual. Anacubis, patent division of the i2 inc group, has some visualisation demos that use i2 inc Analyst's Notebook visualisation tool. Unfortunately some problem with the demo has prevented me from executing it properly, so I can't report on it. Spore.inc provides two main types of visualisations: Patent matrix diagram. Diagrams that represent the substance and hierachical relationships of the claims of a patent. This way, reading and understanding of a patent's claims is much easier. Source: Diagram as can be seen at Spore Inc website. Spore diagram. It produces graphs of patent groups that allow you to see how are they related, identifying trends and detecting development opportunities related to "gaps" in some areas of the patent scope of a product portfolio. Source: Diagram as can be seen at Spore Inc website. But maybe Mathéo Software represents one of the easiest to use systems (you can download a free demo) that incorporates four main types of visualisation that can be produced with many combinations of the different variables that identify a patent. We'll focus on MatheoPatent 6.1. This program allows you to launch a search on different sources according to keywords, inventors, etc. With the downloaded results you can get the following types of visualisation. MatheoPatent 6.1 MatheoPatLista2.gif (182879 bytes) MatheoPatPDate.gif (68024 bytes) Table: Presentation in form of a table where you can see the results of the search. To the left, a list of inventors with their nationalities and number of patents granted. To the right, the list of patents. Below lies the summary of particular patent of the list. Source: Screenshot by the author of the program in execution. Click on the image to enlarge it. Bar chart: Here you can see a bar chart of the number of patents present per year. MatheoPatent allows you to select different variables (inventor, family, date, etc) building bar charts accordingly. Source: Screenshot by the author of the program in execution. Click on the image to enlarge it. MatheoMatrix1.gif (146436 bytes) MatheoGrafo1.gif (82098 bytes) Matrix: By crossing the different variables MatheoPatent allows you to select (inventor, family, date, etc), you can obtain this matrix chart. In this particular case we cross inventors against inventors. The coloured squares in the diagonal indicate the patents of a particular inventor. Big squares indicate groups of inventors acting together. If they are out of the diagonal it means that some inventors or groups participate in patents with other groups. It's possible to cross other variables to detect different patterns Source: Screenshot by the author of the program in execution. Click on the image to enlarge it. Networks: In this case we represent the relationships between inventors and companies by means of a force directed graph where dragging a company you can drag also the inventors related to it as if they were linked by rubber bands. Again we can select different variables to see the networking between them. Source: Screenshot by the author of the program in execution. Click on the image to enlarge it. ¿Do you remember ThemeScape and newsmaps? (see number 93). Finally this technology, renamed as Aureka!, has become the patent visualisation of MicroPatent. This way, this extraordinary form of visualisation has seen its incorporation to the world of patents. Let's recall that ThemeScape allows you to represent a document corpus as a topographic map where the "mountains" are associated with frequent terms (predominant "themes") that are as close as their concepts are similar. Aureka! The patent version of ThemeScape represents as a topographic map the explored document space. Dots depict particular documents (patents) . The closer they are, the most related the patent topics. You can access the documents by clicking on them. Fuente: Image of Aureka! as can be seen at MicroPatent's website in Internet. Patent visualisation is just one more within the possibilities of text mining. Nevertheless, as anyone working in R+D knows, detecting the patents that can prevent us to follow a research line or finding a "hole" where there's nothing patented can be fundamental for the business strategy of a company. Visualisation is vital to open a way through the web of legal text, [sometimes obscure] claims, and the large amount of data that represent the world of patents. We are still an a very preliminar stage in this field. Links of this issue: http://www.uspto.gov/ United States Patent Office (USPTO) http://www.european-patent-office.org/ European Patent Office (EPO) http://www.patentlawlinks.com/patoff.htm PatentLawLinks website http://ep.espacenet.com/ Espacenet EPO download center http://www.piug.org/ Patent Information Users Group web site. http://www.piug.org/vendor.html Patent Information Users Group vendors list. http://www.anacubis.com/ Anacubis website http://www.i2inc.com/Products/Analysts_Notebook/default.asp i2 inc. Analyst's Notebook http://www.sporeusa.com/home/ Spore website http://www.matheo-software.com/ Mathéo Software website http://www.infovis.net/printMag.php?num=93〈=2 Num 93 Two years later http://www.micropatent.com/ Micro Patent website

Patent Analysis: Data Analysis & Result Visualisation

2005-09-17T07:08:00.000+05:30

Patent Analysis
by Juan C. Dürsteler

One of the less usual applications of information visualisation is patent visualisation. In fact visualising patent information is just a part of text or document visualisation. In the end, a patent is just text with a certain structure and with a specific objective.
Patents encompass several aspects that have, nonetheless, great importance.:

they are a way to protect intellectual property rights

our own rights, allowing us to produce without being copied with inpunity

the other's rights, preventing us of using alien developments.

For these reasons patents constitute a very important source of information about the competitors. This makes them the main tool for technological and business intelligence. On the other hand, knowing which patents are enforced in the market is vital before deciding to make a new development or product, with the important investment it means, that could be finally blocked by an existing patent.
Many patent offices already allow to freely download abstracts and complete text of their patents. Among them the USPTO from United States or the EPO from Europe, and many others you can find, for example, in the PatentLawLinks.com list. In particular Esp@cenet, the download service of the European Patent Office has become a very popular source of information in this field.
Based on the many possibilities of search that all this offers, there have been appearing in the market different systems allowing you to search, download and analyse patents automatically. Many of them are present in the Patent Information Users Group (PIUG) vendors list. Although downloading, classificating, clustering and finding the relationship between patents of similar contents has become quite widespread, even making use of text mining tools, the visualisation of those resuts is not so usual.
Anacubis, patent division of the i2 inc group, has some visualisation demos that use i2 inc Analyst's Notebook visualisation tool. Unfortunately some problem with the demo has prevented me from executing it properly, so I can't report on it.
Spore.inc provides two main types of visualisations:
(image placeholder)
(image placeholder)

Spore Inc
Spore Inc

But maybe Mathéo Software represents one of the easiest to use systems (you can download a free demo) that incorporates four main types of visualisation that can be produced with many combinations of the different variables that identify a patent. We'll focus on MatheoPatent 6.1. This program allows you to launch a search on different sources according to keywords, inventors, etc. With the downloaded results you can get the following types of visualisation.

¿Do you remember ThemeScape and newsmaps? (see number 93). Finally this technology, renamed as Aureka!, has become the patent visualisation of MicroPatent. This way, this extraordinary form of visualisation has seen its incorporation to the world of patents. Let's recall that ThemeScape allows you to represent a document corpus as a topographic map where the "mountains" are associated with frequent terms (predominant "themes") that are as close as their concepts are similar.
(image placeholder)
(image placeholder)

MicroPatent

Patent visualisation is just one more within the possibilities of text mining. Nevertheless, as anyone working in R+D knows, detecting the patents that can prevent us to follow a research line or finding a "hole" where there's nothing patented can be fundamental for the business strategy of a company. Visualisation is vital to open a way through the web of legal text, [sometimes obscure] claims, and the large amount of data that represent the world of patents. We are still an a very preliminar stage in this field.
Links of this issue:
http://www.uspto.gov/

http://www.european-patent-office.org/

http://www.patentlawlinks.com/patoff.htm

http://ep.espacenet.com/

http://www.piug.org/

http://www.piug.org/vendor.html

http://www.anacubis.com/

http://www.i2inc.com/Products/Analysts_Notebook/default.asp

http://www.sporeusa.com/home/

http://www.matheo-software.com/

http://www.infovis.net/printMag.php?num=93〈=2

http://www.micropatent.com/

LawMemeVindicated by DNA

2005-08-23T15:34:00.000+05:30

Vindicated by DNA Posted by Rebecca Bolin on Monday, August 01 @ 16:09:32 EDT News A friend volunteering for the Innocence Project at Cardozo School of Law sent me this article (typo of Cardoza seems to be AP's) about a man released from prison following a DNA test after serving eighteen years of a wrongful rape conviction. The Innocence Project write-up has some different details than the AP version. My friend was really happy about this. "Isn't this great?!" My feelings are more mixed. It's rather sobering that this can happen in the first place and that a few little mistakes can cost a man with small children so much of his life. I wonder how the victim feels, even if she honestly thought that was the right guy. So, I suppose it's great that science finally showed the truth, but those eighteen years are still lost.

Six Easy Steps to Highly Effective Patent Searching

2005-08-23T14:26:00.000+05:30

Six Easy Steps to Highly Effective Patent Searching You can speed up your design cycle time by mining patents for information. Here, a skilled patent attorney shares his secrets to faster and better searches. Craig Fieschko -- Design News, June 6, 2005 A patent is often described as a monopoly (generally limited to 17-20 years) granted to the inventor of a new and useful machine, process, or other invention in exchange for the inventor's complete written description of how to make and use the invention in a patent application. These details can be highly useful to design engineers, who can use patents to learn how others have approached similar problems, what design strategies have and have not worked in the past, and to get a handle on what is state-of-the-art in their field. But with almost 7 million U.S. patents covering virtually every field of technology, it can be a lot like trying to find a needle in a haystack to locate the patents that are most relevant to your design problem. In this article, I share some of the basic search strategies I use as a patent lawyer (and former engineer) to sift through the clutter. This article assumes that you're using the search engines of the U.S. Patent and Trademark Office (USPTO). First a Few Basics on Patent Searching Some of my favorite patent-searching resources on the Web are listed in the sidebar, and the following discussion will assume that you're using the search engine of the United States Patent and Trademark Office (USPTO), the government agency that administers the U.S. patent system. While you can simply enter a string of terms into the search engine and obtain all the patents or published applications that contain these terms, the USPTO's search engines, like most patent search engines, helpfully allow "fielded" searching. Terms can be entered in certain fields, such as Title, Abstract, Assignee (Owner), etc., to locate patents or published patent applications having the entered terms in the specified fields (in the specified sections of the patents or applications). The USPTO also allows strings of fielded search terms to be connected with Boolean terms such as AND, OR, and ANDNOT, and parentheses can be used to order the connected terms (see a sample search on page 80). Additionally, the ends of search terms can be truncated and the "wildcard" symbol $ can be substituted to search for variants of the term. For example, "circuit$" will search for the terms circuit, circuits, circuitry, etc. (Note that a term may not be truncated to less than four characters.) Search terms can also be combined in strings by using quotation marks. For example, entering the term "circuit board" (in quotes) will search for the adjacent words "circuit" and "board," in that order. It might seem that a good way of locating relevant patents is to search in the Abstract (ABST) and/or Title (TTL) fields. Unfortunately, this is rarely the case. Titles are usually vaguely worded because patent attorneys fear the potential ramifications of a specifically worded title. The same is true of most Abstracts, which poorly represent the contents of their documents. So it's no surprise, then, that an Abstract and/or Title search should never be regarded as complete and accurate. A Specification (SPEC) search, which extends to the detailed bodies of the patents or applications, is far more complete. Nevertheless, if a search strategy results in a very large number of hits, it may be preferable to begin a search by limiting it to the Title (TTL) or Abstract (ABST) fields. Other useful search fields include the Assignee (AN) field, which may list the owner of the patent, and/or the Inventor (IN) field. You may be able to find relevant patents by searching for those that name a company and/or inventor who has expertise in your field of interest. Nevertheless, while the use of fields, Boolean connectors, and wildcards can help you locate relevant patents and applications faster, many people still find it difficult to generate relevant search results. All patents and patent applications are assigned "class numbers" by the USPTO codes that classify the patent or application into one or more very particular fields of technology, similar to the Dewey Decimal System. So if you can identify the classes of your problem or technology of interest, and then use the USPTO search engines to search documents in these classes, you'll often find relevant documents much faster. To identify U.S. classes for particular fields of technology, you can access the Manual of U.S. Patent Classification at www.uspto.gov/web/classification/. Unfortunately, most users find the manual confusing and difficult to use, and it usually takes significant experience before one can quickly and accurately locate the appropriate class(es) relating to a technology in question. By following the six easy steps I have outlined on page 80, you can bypass the manual almost entirely (or at least minimize its use) and get superior search results immediately. Now What? Once you're done, you can then use the search results in your research and design efforts. In some cases, you may even be able to adopt a patented invention as an "off-the-shelf" solution. You're usually free to use matter described in a patent so long as: (1) The matter is not secured by this (or another) patent (i.e., the matter is not defined by the "claims" set forth at the end of a patent); or (2) Even if the matter is covered by the claims, if the patent's expired. Usually, patents have terms lasting 20 years from their patent application filing date, or 20 years from the date of patent issuance, whichever date is later. Both of these dates are shown on the first page of a patent. However, patents can (and often do) expire earlier for failure to pay periodic maintenance fees to the USPTO. You can check this out at the USPTO website at https://ramps.uspto.gov/eram/. Nevertheless, if you have questions about whether and how you can use certain matter, you really should get the assistance of a patent attorney. As the old saying goes, "anyone who serves as his own attorney has a fool for a client." Craig Fieschko has a BSME and MSME and worked for several years as an R&D engineer. He is a registered patent attorney at the DeWitt Ross & Stevens law firm, and he also teaches intellectual property law at the University of Wisconsin Law School. Request a more detailed version of the article by contacting Fieschko at cf@dewittross.com, or at (608) 828-0722. Step-by-Step Guide to Patent Searching In this example, we look for patents related to handheld, ultrasonic surgical cutting tools On the USPTO's "Advanced Search" page, different fields are searchable by typing in a field code followed by a forward slash. The USPTO also provides a "Quick Search" page (not shown here), where a limited number of fields can be chosen from drop-down boxes. Clicking "Search" will return the patent numbers and titles (or published patent applications) that match the specified terms in the specified fields. You can access the full text of a selected item by clicking on the document number or title. Once you access the full text of a patent or application, you can get an "Image Copy" of the actual document (with drawings, etc.) either by using the "Add to Cart" option and paying to have it sent to you. On the front page of a patent are relevant patent classes at the headings "U.S. Cl." (U.S. Classification), listing the classes of the patent [51] and [52], and "Field of Search," or related classes reviewed by the USPTO when granting the patent [58]. The USPTO Manual of Classification can be searched by entering terms of interest (at right) and then reviewing the resulting classes. Alternatively, you can enter a particular class (at left) and then review its description to see if it’s relevant (see figure below). This is the "Class Schedule" resulting from entry of Class 604/22 in Figure (5), showing a description of Class 604/22 and its surrounding classes. Clicking the icon to the left of each class number will return a list of all patents in the class. 1. IDENTIFY A FEW STARTING PATENTS Use fielded searching in the USPTO Issued Patent search engine (not the Published Application search engine) to locate one or more "starting patents" that have strong relevance to your technology of interest. You only need one (or a handful) of starting patents. See figures above, showing an exemplary search for a handheld, ultrasonic surgical cutting tool. 2. FIND UPSTREAM PATENTS "Upstream patents" are prior patents that the USPTO regarded to be technologically relevant to the starting patents. These are listed on the first pages of the starting patents under the heading "References Cited;" see the list in Figure 4 under "U.S. Patent Documents," or in Figure 3, where the patent numbers of the upstream patents are provided as links, which allow you to quickly access their texts. Review the upstream patents and add any that are relevant to your list of starting patents. Note that only a few upstream patents are usually relevant to what you're looking for; the remainder were cited by the USPTO because they're relevant to some subcomponent or small feature of the starting patents. 3. FIND DOWNSTREAM PATENTS "Downstream patents" are later patents having USPTO citations to the starting patents because the USPTO regarded the starting patents to be technologically relevant. If you're viewing the text of a patent, you can access downstream patents by clicking the "Referenced By" link. Alternatively, you can access the search engine query box and search in the Cited References (REF) field by entering "REF/" followed by the patent number of a starting patent. Review the downstream patents, and if any are relevant, add them to your list of starting patents. 4. ITERATE A search for further upstream and downstream patents—by returning to the second step above—can often prove fruitful. By following this process, you're effectively building the "family tree" for the starting patents by locating patents cited in, or citing to, the growing list of starting patents. 5. IDENTIFY COMMON CLASSES Look at your collected starting patents and identify which classes are cited most frequently on the first page. You can then get a list of all patents in a particular class by accessing the search engine query box and searching in the U.S. Classification (CCL) field. Then review these patents and save those that are of interest (and add them to your starting patents and return to the second step above, if desired). It may also be helpful to now access the Manual of Classification and look at the descriptions of your classes of interest, as well as adjacent classes, to verify that the classes seem relevant to the technology you're seeking. 6. SEARCH ON CLASSES Take your classes of interest (as well as any search strings you used for fielded searching, etc.) and search for relevant published patent applications in the USPTO Patent Application search engine. To reduce frustration, note that some fields in the USPTO Patent Search Engine are different from those in the USPTO Patent Application Search Engine, and some seemingly identical fields behave differently (with the USPTO's "Help" link providing tips for usage). Patent Lawyer Craig Fieschko's Bookmarked Sites USPTO www.uspto.gov The USPTO provides a database of issued patents, and a separate database of published patent applications. (Since it generally takes over 18 months for an application to reach issuance, published applications provide a preview of soon-to-come patents). The site allows users to search the full texts of patents from 1976 onward and patent applications from 2001 onward, and limited searching of earlier patents. Drawback: While the full texts of patents and applications are available, image copies are only printable/downloadable one page at a time unless you pay for e-mail or postal delivery of image copies. Freepatentsonline www.freepatentsonline.com Pat2PDF www.pat2pdf.org These two websites compile full PDF image copies of U.S. patents for free, making them far easier to print and download (and Freepatentsonline allows searching as well). Or, access www.pat2pdf.com (not affiliated with the .org site) to pay for full PDF's of both U.S. and European patents. Freshpatents www.freshpatents.com Enter a search query, and you'll be sent regular updates of corresponding newly published U.S. patent applications. European Patent Office http://ep.espacenet.com The EPO's esp@cenet patent database allows free access to the patents of most major patenting countries, though searching is crude and image copies are printable/downloadable only one page at a time. However, by accessing "Online Public File Inspection" at http://my.epoline.org/portal/public under the Products and Services menu, you can download full PDF copies of European patents, provided you have the publication/application number. Delphion www.delphion.com One of the oldest and most powerful patent search engines, Delphion allows multiple databases (basically, all those noted above, and more) to be searched simultaneously. Disadvantage: Formerly free, now it's pay to play.

European Commission Proposes New I/P Directive

2005-08-22T17:32:00.000+05:30

I/P Updates: European Commission Proposes New I/P Directive: "European Commission Proposes New I/P Directive On 12 July 2005, the European Commission proposed a new directive on 'criminal measures aimed at ensuring the enforcement of intellectual property rights.' Under the proposed directive, all intentional infringements of an intellectual property right on a commercial scale, and attempting, aiding or abetting and inciting such infringements are treated as criminal offences. The proposal for a framework decision also sets a threshold for criminal penalties including at least four years' imprisonment if the offence involves a criminal organisation or if it jeopardises public health and safety. The applicable fine must be at least EUR 100 000 to EUR 300 000 for cases involving criminal organisations or posing a risk to public health and safety. However, the proposal allows Member States to apply tougher penalties. According to the press release by the EC, 'the Commission hopes that this clear political signal reflecting the determination to combat piracy and counterfeiting will be supported by concerted, long-term information campaigns by national and regional authorities and other interested parties to raise awareness, not only among key players in the fight against counterfeiting and piracy but also amongst the wider public as a whole.' Click here for a primer on European Union law."

Patent Searching an Effective Tool for Competitive Intelligence

2005-07-20T18:05:00.000+05:30

Patent Searching an Effective Tool for Competitive Intelligence Article by Vinod Singh A lot of valuable information is now available of the industries in different databases in the web. Among all those patents the most important and easily available. Patent searching can give insights into the state of the art across any technical field. It can provide a platform to monitor the competitors activities by revealing which companies are involved in a field of technology of your interest. Patent searching data can also reveal the technological road map to a particular invention, the science or logic behind the invention, and its intended application. However the legal nature of patents makes them an uncompromisingly formal style. They are written in a language sometimes so abstruse that it does more to obscure the nature of the invention than to elucidate it. Also the millions of patents exited are distributed across different databases and in each case coded and grouped according to one of several classification systems. The family patent information is also varied from various databases. The skilled patent search requires in-depth knowledge of an array of software tools, search commands, searching techniques and classification systems. That’s why patent searching is an expert's job. In the recent few years the demand for a professional patent searcher has increased. Main benefits of free-access Web databases are that they provide a low-cost means of doing initial background searches. The problem is that they suffer serious drawbacks for more crucial searches. For example: free databases generally come from the patent issuing authorities (usually national patent offices) so their content is restricted to those patents granted by that particular authority. There is no universal structure, so the same fields may not necessarily be searchable across different databases. There is no 'added value' - such as readable abstracts in plain English, which has given patent information-provider Thomson Derwent its enviable reputation. There are rarely any patent analysis technologies. And they do not provide the option of sophisticated, command driven, Boolean searches as offered by powerful tools from host companies such as Dialog, Delphion, Questel-Orbit, MicoPat and STN - which also allow parallel searches across several (commercial and free) databases at once. More importantly, a quick and easy search on a free site is extremely unlikely to uncover 'stealth patents' or "hidden patents"- one of the latest IP protection tricks. The authors of these patents deliberately choose obfuscating keywords and try to have their patents inappropriately classified in order that others' searches do not throw them up. Whereas commercial patent database providers provide access to patent collections throughout the world, along with value-added patent information, various analytical tools and other technologies. A number of these commercial providers have recently released innovative new functionalities alongside the search function Why Conduct a Patent Search? 1. Patent searches are conducted for many purposes. Among them are to: 1. Determine if a particular invention is unique 2. Identify potential features for new product 3. Identify other possible uses for a new product 4. Determine independent inventors or companies currently or historically obtaining patents in a particular area 5. Find the patent(s) for a particular invention 6. Determine the state of the art in a particular area 7. Identify patents in a specific field for generating citation maps (a tool in determining the relative importance/value of a specific invention 8. Study the rate of innovation in a particular area 9. Determine the patent portfolio of a specific company 10. Determine if an invention infringes upon the intellectual property rights of others 11. Learn about an industry or a specific company 12. Search for potential solutions to design or safety problems 13. Identify potential licensees 14. To identify additional reference materials (journal articles, books, product literature) of use to those working in this area. Patents often list printed reference materials. 15. Identify inventors working in a certain field. Patent search Procedure: 1. The Steps 1. Search the web to get the up to date information about the area of work and select the specific keywords describing the area of interest and identify the control patents. To start with by searching for any specific patents be aware of in this area, patents of companies work in this field, patents invented by inventors in this field, etc. This step is called "shoot from the tip". 2. Try a few relevant words in the word search engine and see what turns up. If turned up any patents in the "shoot from the hip" step above, examine them for possible search words. Record the search words on a page in a project notebook and add other words as they come to mind or encounter them in other patents. Usually the word list becomes separated into groups of words covering different aspects of the invention. 3. Access the Classification Index. In paper it is about the size of a small town phone book. Look up your topic and you will find a class number. The area you are interested in may have several class numbers (for example marine propulsion and propellers (impellers) are in two different classes). 4. Access the Manual of Classification (in paper it is a large 3 volume set of ring binders). Turn to or click to the class you are interested in and identify the specific subclass's best relating to your topic. You may need some assistance in understanding the hierarchial listing of subclasses. Many are subclasses of subclasses. 5. Access the Classification Definitions. It used to be on microfiche, but now you can access it online. Look up the specific class and subclass under study. Make sure you are really hunting for items resembling the definition of this class/subclass. Often additional hints are given for other places to look, including classes no longer existing. 6. Keep cycling through the three tools (Classification Index, Manual of Classification and Classification Definitions) until you identify the appropriate classes and subclasses. 7. Search the database to identify patents in the classes/subclasses identified. 8. Examine the ABSTRACT & IMAGE of these patents to identify those resembling your device. Make copies of the drawings, abstract and description of patents closely resembling your invention and of inventions serving the same purpose. After completing Steps 1 to 7, examine the patents for: 1. Companies frequently appearing as assignees (patents assigned to them). Search for other patents assigned to these companies in an attempt to identify more patents in the area of interest. 2. Inventors frequently appearing on the patents (both independents and those working for companies). Search for other patents listing these individuals as inventors in an attempt to identify more patents in the area of interest. 3. Look for words and combinations of words in the patents of interest. Sort the words into groups. Some will describe one aspect of the invention and some will describe another. Record the search words on the list started earlier. Search for other patents containing these words in an attempt to identify more patents in the area of interest. Be aware of what portion of the patent you are searching (some search abstract only, front page only, full texts). 4. Examine the patents cited as reference by the patents of interest to see if some of them are of interest as well. 5. Examine the class and subclass info of the patents of interest in an attempt to identify other classes and subclasses that may contain patents of interest. Search these new classes/subclasses for additional patents of interest. 9. Keep cycling through steps 1 to 8 over and over until no more patents of interest are identified. Conclusion The patent search has become an effective tool for the mining of the patent data, which help in the competitive analysis. A throughout knowledge of the different patent database, their classification system is required for a in depth patent search. Patent search is crucial for the patentability, validity, infringement analysis etc. Thus a skilled patent search professional must know the various search procedures, databases limitations and technical tools and software to reveal a good search result.

Intellectual property as an economic asset: key issues in valuation

2005-07-16T19:20:00.000+05:30

Intellectual property as an economic asset: key issues in valuation and exploitation Background and Issues http://academy.epo.org/schedule/2005/e02/background_report.pdf

2005-07-16T19:16:00.000+05:30

Best resources in intellectual property and asset management 

http://www.ipambestpractices.com/Info/BPLibraryIndex.html
Intellectual Property Best Practices Library:  Summaries

http://www.ipmenu.com/
IP Menu – Global Intellectual Property

http://www.providersedge.com/docs/km_articles/Managing_Knowledge_for_Advantage_-_Technologies.pdf
Managing Knowledge for Advantage: Content & Collaboration Technologies

http://www.kmmag.com/articles/default.asp?ArticleID=655
Making Knowledge Pay
Companies find that their intellectual processes and assets, if
properly packaged and sold, can yield surprising top-line revenues

http://www.internetcapital.com/news/partners/061702b.html
Delphion to Deliver Enterprise Software for Generating Corporate Value
from Intellectual Assets

2005-05-14T17:41:00.000+05:30

Open Source isn't just for code anymore... What do fashion, yoga, and libraries have in common? All are dealing with the issues of "intellectual property" and "open source." The fashion industry has a long history of valuing creativity and accepting the sharing and "remixing" of fashion ideas. Meanwhile, a teacher of the 5000 year old practice of yoga has copyrighted his methods and poses and is being opposed by an "open source yoga" movement. And, at the recent O'reilly Emerging Technology Conference, the theme was "Remix your world" and included Lawrence Lessig speaking about copyright, and Cory Doctorow spelling out the dangers of Digital Rights Management, and a fascinating presentation by Clay Shirky on Ontologies. Read on... * Ready to Share On January 29, 2005, the Norman Lear Center held a landmark event on fashion and the ownership of creativity. The event had an incredible variety of participants including John Seely Brown (former Chief Scientist of Xerox Corporation), musician and producer T Bone Burnett, Danger Mouse (creator of the Grey Album), and Siva Vaidhyanathan (Professor of Culture and Communication at New York University). More than any other industry, fashion treats a far larger portion of its creative output as a commons - shared resources that can be freely reused and transformed by other creators. Ready to Share is funded in part by a generous gift from the Center for the Public Domain. For lots more information see the press coverage and press releases page. For a quick overview of the issues, see the opinion piece, Control of creativity? Fashion's secret By David Bollier and Laurie Racine. Christian Science Monitor, September 09, 2003. * Bikram goes to the mat, By Hilary E. MacGregor. Los Angles Times, March 21, 2005. After he sued an Orange County yoga studio for copyright and trademark infringement in 2002, a small group of yogis went on the counterattack. Taking a page from the "open source" movement in the computer software world, they called themselves "Open Source Yoga Unity." * O'Reilly Emerging Technology Conference, March 2005, San Diego, Ca. o press coverage o Doctorow: All Complex Ecosystems Have Parasites by Cory Doctorow, For the O'Reilly Emerging Technology Conference. San Diego, California, 16 March 2005. Likewise, DRM has exacted a punishing toll wherever it has come into play, costing us innovation, free speech, research and the public's rights in copyright. And likewise, DRM has not stopped infringement: today, infringement is more widespread than ever. All those costs borne by society in the name of protecting artists and stopping infringement, and not a penny put into an artist's pocket, not a single DRM-restricted file that can't be downloaded for free and without encumbrance from a P2P network. o Lessig: Re:MixMe. Audio (MP3) of presentation by Lawrence Lessig, Professor of Law, Stanford Law School, Thursday, March 17. o Shirky: Ontology is Overrated: Links, Tags, and Post-hoc Metadata. Abstract of presentation by Clay Shirky, Wednesday, March 16. Ontology, far from being an ideal high-order tool, is a 300-year-old hack, now nearing the end of its useful life. The problem ontology solves is not how to organize ideas but how to organize things--the Library of Congress's classification scheme exists not because concepts require consistent hierarchical placement, but because books do.

Pillsbury Winthrop Shaw Pittman LLP - United States - Claim Construction: The Dictionary/Specification Dichotomy (20/04/2005) from Mondaq

2005-04-30T10:49:00.000+05:30

Pillsbury Winthrop Shaw Pittman LLP - United States - Claim Construction: The Dictionary/Specification Dichotomy (20/04/2005) from Mondaq: "20 April 2005 Article by John R. Wetherell, Ph.D. and Michelle Mehok Companies understand that in order to protect their technology from competitors, the company must have a strong patent portfolio. However, achieving this goal is requiring greater levels of drafting sophistication and strategy. It has become increasingly clear, by the recent case ruling in Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., just how important it is to have a well drafted patent document that has clearly defined claim terms. At issue in the Merck case was the meaning of the apparently simple term "about" in the claims and what the patentee asserted was the meaning of this term as defined in the specification. The Federal Circuit’s ruling on the legally operative meaning of this term emphasizes the critical need for the patentee to exercise caution in drafting patent applications where a term in the claim is redefined from its common meaning. Numerous court decisions have held that claim construction requires terms used in the claims to be given their "ordinary", "accustomed", or "dictionary" meaning unless the patentee has chosen to otherwise clearly define the terms in the patent specification or prosecution history. It is well settled that a patentee can act as his own lexicographer by choosing his own definition of a term and using it as he wishes so long as he remains consistent in its use and makes the meaning clear. The law provides the patentee with this opportunity because the public may not be schooled in the terminology of the technical art or there may be more than one way to interpret the structure or concept that is being claimed. However, the lexicographer privilege has recently come under criticism by some courts that have viewed it as imposing on the interpreter of the claims the burden of determining, through study of the patent’s specification or prosecution history, whether the patent gives an unconventional meaning to a term that otherwise has an established meaning. Most recently, courts have questioned what sources should be consulted during the claim construction process to determine the legally operative meaning of the words in a claim. In a recent decision, the Federal Circuit reversed an August 2003 district court ruling thereby invalidating Merck’s patent on Fosamax, an osteoporosis treatment that was Merck's second-best-selling drug. In a statement to the press after the verdict, Merck said that it disagreed with the court's ruling "and is considering its options, including a request for reconsideration by the court of appeals." Thus, Merck is considering asking the Supreme Court to review the ruling. It is doubtful that the Supreme Court would do so, because it rarely accepts patent cases. The district court held that Merck had acted as its own lexicographer and in the specification had redefined the ordinary meaning of the term "about". Merck had taken the position that it acted as its own lexicographer and that the claim term "about 70 mg of alendronate monosodium trihydrate on an alendronic acid base" should mean exactly 70 mg of alendronic acid. Ordinarily, of course, the term "about" would mean "approximately", but the district court sided with Merck and ruled that the term "about" meant "exactly". Relying on this latter construction of the term "about", the district court found the prior art cited against the patent to be insufficient to invalidate the patent based on anticipation or obviousness. Teva’s allegations that the claims at issue were invalid was based on (1) anticipation by a July 1996 Lunar News article and (2) obviousness in light of an April 1996 Lunar News article combined with the July 1996 article. However, the district court found the patent valid and infringed by Teva’s Abbreviated New Drug Application ("ANDA"), effectively delaying Teva’s FDA approval of the ANDA until the Merck patent expires. On appeal, the Federal Circuit addressed claim construction and obviousness. The Federal Circuit opined that when construing a claim term, the court must first consider the intrinsic evidence, starting with the language of the claims. "General claim terms should be construed consistently with their ordinary and customary meanings, as determined by those of ordinary skill in the art." In this regard, the specification is reviewed to determine whether the patentee acted as his own lexicographer of a term that already has an ordinary meaning. However, any "statement in the specification must have sufficient clarity to put one reasonably skilled in the art on notice that the inventor intended to redefine the claims term." Merck’s position was that the following passage from the specification redefined "about" to mean "exactly": Because of the mixed nomenclature currently in use by those or [sic] ordinary skill in the art, reference to a specific weight or percentage of bisphosphonate compound in the present invention is on an active weight basis unless otherwise indicated herein. For example, the phrase "about 70 mg of a bone resorption inhibiting bisphosphonate selected from the group consisting of alendronate, pharmaceutically acceptable salts thereof, and mixtures thereof, on an alendronic acid active weight basis" means that the amount of the bisphosphonate compound selected is calculated based on 70 mg of alendronic acid. The Federal Circuit disagreed and held Merck’s definition of "about" is ambiguous in that this passage was not clear enough to put one of skill in the art on notice that the ordinary meaning of "about" was redefined. The term "about" was amenable to two interpretations. The Federal Circuit stated that, under Merck’s construction, the phase "about 70 (or 35) mg" means that one should administer approximately 70 (or 35) mg of the derivative compound, such that the end result would be that the patient received exactly 70 (or 35) mg of active compound. In other words, the phrase "about 70 (or 35) mg" modifies the quantity of the derivative compound rather than the resulting active compound. However, according to Teva, the phrase could also be construed to mean that "about 70 (or 35) mg" refers to the amount of resulting active compound rather than the amount of the derivative compound administered. The term "about" would then serve to modify the quantity of the active compound in a way consistent with its ordinary meaning of "approximately". Given that the passage was agreeable to both interpretations, the Federal Circuit held that Merck did not clearly set out its own definition of "about". The Federal Circuit further decided the invention was obvious in light of earlier published articles. In short, the Federal Circuit opined that the district court clearly erred in not (1) distinguishing the claimed invention from the two Lunar News articles, (2) ascertaining the required motivation to combine references to achieve the claimed invention which clearly suggested the dosages described in the articles, (3) determining the probative value of the articles, and (4) weighing the secondary considerations or Merck’s commercial success. Judge Rader wrote a dissent in which he made two specific points: (i) that the majority erred in its analysis of the lexicographer doctrine and (ii) that the majority should have given some deference to the lower court's decision. The Merck decision warns the patentee to be clear when defining claim terms. It is hoped that another case pending before the Federal Circuit will provide additional clarification regarding the process of defining terms used in the claims. In Phillips v. AWH Corp., which was heard en banc on February 8, 2005, the Federal Circuit prudently chose to re-examine and consider seven issues: (1) how and to what extent various types of evidence, particularly the specification and dictionaries, serve the public notice function of patent claims; (2) how the specification should be used to interpret claims without impermissibly importing limitations into the claims; (3) how and to what extent various types of evidence, particularly the specification and dictionaries, should be used for claim construction; (4) whether the two approaches (dictionary and specification) should be treated as complementary methodologies such that there is a dual restriction on claim scope, and a patentee must satisfy both limiting methodologies in order to establish the claim coverage it seeks; (5) when, if ever, should claim language be narrowly construed for the sole purpose of avoiding invalidity under, e.g., 35 U.S.C. §§ 102, 103 and 112; (6) what role should prosecution history and expert testimony by one of ordinary skill in the art play in determining the meaning of the disputed claim terms; and (7) what deference, if any, the Federal Circuit should give to a district court's claim construction. Thus, this decision is expected to provide additional guidance on the proper approach to construing patent claims. In light of the fact that it is not uncommon for the patentee to use a word to mean something different than its dictionary definition and because a patent’s specification can be ambiguous, it is advisable that the patentee and his counsel work closely together to clearly define claim terms having technical, scientific, or multiple meanings. The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Responding to Restriction Requirements

2005-04-20T15:04:00.000+05:30

Anything Under the Sun Made By Man: Responding to Restriction Requirements: "Responding to Restriction Requirements I recently had a three way restriction requirement from the US PTO on an application. The examiner had restricted the invention three ways: 1. An apparatus with features possibly usable outside the client’s business. 2. A special instance of the apparatus directly relating to a product being developed by the client. 3. A method for using either invention 1 or 2. The business situation of the client is this: they are in the process of developing a technology that could be widely deployed in 3-5 years. Right now, any potential infringers/licensees are very small players and do not pose a business threat. The client is feverishly working to deploy some product and prove that it works. If their trials are successful, the market is much bigger than they can supply right now. They may raise capital and expand to meet the market, or they may license the technology to one or more existing players in the market. The question is: how to respond to the restriction? My suggestion is to elect the first invention, the one which does not necessarily directed at the client’s product. Rather than filing divisional applications right away, I would wait and file a divisional on the method claim, then file a divisional on the invention directed specifically at the client’s product. There are several reasons for this. Looking at the invention directed specifically at an embodiment like the client’s product, if we pursue it now, we will get a patent based on today’s understanding of what we think is the important features of the invention. We would rather make that definition as far into the development cycle as possible. There is always the possibility that technology or market considerations may cause certain parts to be more important than we can see at this point. This is one reason why I want to do this embodiment last. Another reason is that there are no potential infringers that need to be dealt with immediately. If we did have a patent issue protecting the client’s product, we would do little with it, except hang a plaque on the wall. Having a patent issue on invention #1, the apparatus outside the client’s business, the client will have a bargaining chip or a potential licensing stream outside the core business. The client could negotiate such a patent away without losing coverage on the core product. Looking at the method inventions, the potential infringers may be customers who buy the product. However, because the product is not widely deployed and thoroughly shaken out, there may be some changes to the methods that we may wish to make to the application with a continuation-in-part application. Taking all of this into consideration, I suggest taking the generic invention first, the methods second, and the actual client device third. I also suggest doing them as serially as possible, filing a divisional as late as possible and on paper, and keeping the application alive. There are a couple situations that may change the strategy. The first is if the client feels like the product has matured and stabilized and that there is a potential licensee. In such a case, I would suggest pursuing the product invention as quickly as possible. Another situation is if another player in the market looks like they will infringe. In that case, I suggest beginning to tailor the claims to match the potentially infringing product so that a licensing deal can be reached quickly and amicably, or so the infringer be shut down fast. Because we have no knowledge of the merits of the case from the examiner, we cannot use the merits as a basis for evaluating one invention over the other in the restriction requirement. In summary, the business considerations of the client, including their ultimate potential business strategies, can be the key to deciding which step to take in this case. The patent attorney who does not have the ability to appreciate the client’s business interests and operate with those in mind does his client a gross disservice.

Anything Under the Sun Made By Man: Vagueness in the Written Description

2005-04-20T13:13:00.000+05:30

Anything Under the Sun Made By Man: Vagueness in the Written Description: "April 07, 2005 Vagueness in the Written Description One of the biggest challenges in writing the written description is that it is almost impossible to guess how the invention might be used over the next twenty years, which is the life of the patent. Especially in developing technologies, what makes sense today may be turned on its ear by changes in technology or the market. However, reading that crystal ball is essential for good patent protection. There are a number of cases where limitations from the specification are read into the claims by the courts. In the Phillips v. AWH Corporation case before the Federal Circuit, the lower courts read a limitation into a claim because the drafter described ‘the’ advantage of the invention had a special feature. The drafter seemed to me to be describing only ‘an’ advantage of a particular embodiment. However, the applied the feature to all the claims. If the drafter had used ‘an advantage’ rather than ‘the advantage’, it is likely that the case would not be in front of an en banc Federal Circuit and would have been settled a long time ago. The best way to deal with this situation is to eliminate any mandatory language from the written description. Use terms like ‘may’ and ‘could’ rather than ‘must’ and ‘should.’ Give every alternative embodiment that can be imagined, and especially examples at the outlying extremes of the invention. Many times, the inventors see their specific embodiment as the most logical and rational of the possibilities. What is an optimal embodiment today may be obsolete in three years. I see the invention as a combination of several elements, regardless of the embodiment. When writing the written description, I try to take each element to its logical extreme and cover every possibility for that element. After going through each element in as much detail as possible with as many examples as possible, the entire field of various embodiments should be covered. Remember, the purpose of the written description is not only to support the claims, but to give as much breadth and scope to the claims as possible. Additionally, a broad written description effectively keeps other inventors from attempting to patent a close invention, one that may turn out to be even better than the inventor’s optimized embodiment of today.

Prism Legal Consulting, Inc.

2005-04-18T16:42:00.000+05:30

Prism Legal Consulting, Inc.: "Outsourced Legal Services print Introduction and Explanation Outsourced Legal Services print Introduction and Explanation List of Outsourced Legal Services Outsourced Legal Services - Background This list of selected legal outsourcing activity was compiled and is maintained by Joy London, author of the blog excited utterances and Ron Friedmann, President of Prism Legal Consulting, Inc and author of the blog Strategic Legal Technology. We have observed with interest a recent trend by US law firms and law departments to outsource some legal work overseas. As bloggers, we have informally tracked legal offshoring activity and wanted to consolidate our observations in a single list. We hope that readers will offer updates, corrections, and comments as appropriate. The primary focus of our list is offshore outsourcing by US firms and corporations of certain substantive and administrative legal functions, specifically # Document drafting by lawyers # Legal research # IP legal work, substantive or administrative # Review of discovery documents # Paralegal services # Administrative and secretarial support services, excluding digital dictation The list does not include offshore litigation support coding or vendor-provided technology services. Nor does it include offshore vendors whose business does not focus primarily on the legal market. A secondary focus of the list is selected outsourcing by US law firms or vendors within the United States. The inclusion criteria are loose but exclude outsourcing to US-based vendors of technology support, legal research, and copy/mail-room services. This type of outsourcing has occurred for years and is thus of less interest to us. Our list is neither complete nor comprehensive. We assembled it based on web research, articles we have read, and people we have met. Each entry includes a source, either a web site or article. For web sites, we list the URL; for articles, we provide a citation. We checked URLs at the time we assembled the list. Where the source is an article, we have no way to track possible changes since the publication date. We welcome comments, suggestions, and corrections from readers. We reserve the right to post reader comments at excited utterances and/or Strategic Legal Technology unless requested otherwise. If we receive corrections and/or suggestions for new entries, we will include them in periodic updates to the list. List of Outsourced Legal Services Organization Organization Type Services Location Source | Notes Date Added Accenture Corporation Law dept. support (contracts) Mauritius Corporate Legal Times, Sep 2004, reports company has set up owned and operated office in Mauritius for company legal work. Mar 05 Andrew Corp Corporation Law dept. support (patents) NZ See Outsourcing Reaches Corporate Counsel, The Recorder, 8/25/04 Mar 05 General Electric Corporation Law dept. support (contracts) India See Outsourcing Reaches Corporate Counsel, The Recorder, 8/25/04 Mar 05 General Mills Corporation Patent work NZ and Australia See Corporate Legal Times article, July 2003 Mar 05 Microsoft Corporation Patent work India See Briefed in Bangalore American Lawyer, Nov 2004 Mar 05 Baker & McKenzie Law Firm Network ops & doc production Philippines See http://www.lwk.co.uk/ViewItem.asp?id=16509 Mar 05 Bickel & Brewer Law Firm Litigation Support India See also Briefed in Bangalore American Lawyer, Nov 2004 Mar 05 Orrick Herrington Law Firm Tech, finance, admin US (Wheeling, WV) See http://www.orrick.com/offices/goc/ Mar 05 Atlas Legal Research Vendor Legal research India See Briefed in Bangalore American Lawyer, Nov 2004 Mar 05 CBF Group Vendor Secretarial & admin support US (Fargo, ND) Mar 05 Docuserve Vendor Reception, telephone & fax services, mail-room, printing & reprographics & hospitality functions Scotland See http://news.scotsman.com/index.cfm?id=199662005 Mar 05 Evalueserve Vendor IP work & market research India Mar 05 Intellevate LLC Vendor Paralegal, docketing, technical research, proofreading, bookkeeping India See http://www.practicesource.com/ale/blog/pivot/entry.php?uid=standard-532 Mar 05 Intercom India Vendor Legal transcription, legal coding India See http://www.globallawreview.com/outsourcing.html#Annexure Mar 05 Law Abroad Vendor Legal work S. Africa and UK Not clear if operational yet (see http://www.lawabroad.com/outsourcing.php) Mar 05 Lawwave Vendor Legal research, IP analytics, doc review, back office India See also India Abroad article Jan 04 Mar 05 Lexadigm Vendor Legal research India Mar 05 http://www.lexwerx.com/ Vendor Legal research India Specializes in insurance and re-insurance; has a UK office Mar 05 Manthan Services Vendor Case management, legal transcription, data digitization & archiving India See http://www.globallawreview.com/outsourcing.html#Annexure Mar 05 Mindcrest Vendor Legal process outsourcing, legal research & business research services India See http://www.globallawreview.com/outsourcing.html#Annexure Mar 05 http://www.officetiger.com/ Vendor Document processing, legal research, professional support, finance & accounting services India See http://www.hildebrandt.com/Documents.aspx?Doc_ID=1802 Mar 05 QuisLex Vendor Legal support services India Web site does not specify services Mar 05

law.com - Article

2005-04-18T16:35:00.000+05:30

law.com - Article: "Briefed in Bangalore Briefed in Bangalore Legal services are moving offshore -- will India's lawyers help reshape the U.S. legal market? Helen Coster The American Lawyer 11-01-2004 In recent months Microsoft Corp. began using Indian professionals to search for prior art -- written information about an invention -- in preparation for filing patent applications. Other Fortune 500 companies, such as Oracle Corp., have considered it. And law firms, which often follow the lead of their clients on new initiatives, are finally catching on. Outsourcing may be a dirty word in this year's presidential campaign. But in the real world -- where costs and competitiveness matter -- lawyers, like other professionals, have started to recognize the value of tapping into the highly educated, English-speaking Indian workforce to carry out tasks that would typically be performed by junior-level employees. Several outsourcing companies are courting the U.S. legal market, using Indian lawyers, scientists, and other trained professionals in cities like Hyderabad, Bangalore, and Noida. There are a few different emerging models. Vendors like Lexadigm Solutions and Lawwave.com rely exclusively on Indian lawyers to conduct low-level legal work and analysis. Others, like OfficeTiger, use a mix of lawyers and trained professionals to handle legal and nonlegal tasks such as managing conflicts databases and document management and review. A few vendors specialize. Intellevate has hired an Indian staff of lawyers and Ph.D.s to conduct patent research and other IP work. The company has a dedicated team devoted just to Microsoft's patent work. Smaller law firms are taking advantage of the range of services offered by these companies. Document review is the most popular task to outsource. In most cases a vendor scans and uploads the documents onto a secure Intranet site. Lawyers in India access the documents, identify responsive and privileged documents, and, when complete, upload their findings back onto the Intranet. The process varies slightly for lawyers who outsource IP prosecution work, rather than just discovery. "A large company will send us an invention description," says Intellevate chief executive Leon Steinberg, who oversees 72 Indian employees and offices in Bangalore and Noida, a suburb of New Delhi. "We would have a computer science expert, or some other kind of trained specialist, do research and determine whether the invention can be patented. They use proprietary databases and online tools to conduct research. Then they post their search result on a Web site that only our client can access." Some law firms and legal departments have opened their own offices staffed by Indian employees, rather than outsourcing their work to a third-party vendor. This is called offshoring. In 2001 General Electric Co. established a legal team in Gurgaon, India, with lawyers and paralegals who draft documents like contracts. Bickel & Brewer, a 34-lawyer Dallas litigation firm, opened a facility in Hyderabad, India, in 1995. Several hundred Indian employees -- both lawyers and nonlawyers -- scan, code, index, and abstract documents. Bickel & Brewer's offshore practice has been so successful, says partner William Brewer, that the firm spun it off as a standalone company. While cost might be the most obvious incentive for outsourcing legal work to India, lawyers cite a number of other motivating factors. One is the 9-to-13-hour time difference between the United States and India, which gives U.S. lawyers the sense of operating on a 24-hour-basis. "When I go home at six I can have them do the grunt work, research, and proofreading that I would otherwise have other people do," says Solan Schwab, a New York-based solo practitioner who outsources research projects like analyzing state-by-state insurance regulations with QuisLex, which has 12 lawyers in Hyderabad. "Then when I come in in the morning, I receive a beautiful e-mail with research done exactly how I like it." Schwab sees outsourcing as the answer to the age-old dilemma facing solo practitioners: an erratic work flow that doesn't justify the overhead of a full-time staff. He estimates that by outsourcing legal work, he spends about one-third to one-half of what he would spend on hiring a full-time associate. He adds that because he has the manpower to take on new business, he has been able to generate about $50,000-$60,000 in new revenue. "I usually bill the clients a certain hourly rate and pay these folks a portion of that rate." Schwab says that the markup depends on whether the client is an individual or a corporation. Even with the occasional markup, lawyers say that the financial incentive of outsourcing legal work is the factor that most impresses their clients. "None of my clients have opposed it because it saves them money," says Noah Henry Simpson, of five-lawyer Simpson, Woolley, McConachie of Dallas. "It probably saves them at least half of what they would usually pay." Vendors charge an hourly rate or on a per-project basis. Lexadigm charges $60 per lawyer per hour, Atlas Legal Research charges $80, and OfficeTiger will not disclose its fees. (London's Allen & Overy is currently outsourcing word processing to 74 OfficeTiger employees, a practice that the firm says saves "a seven-figure sum.") Quislex gives clients the option of being billed by the hour or project. Intellevate offers three pricing mechanisms: a seat license, which can range from $1,200 to $4,500 per month; a straight hourly rate, which varies from $12 to $65 per hour based on experience; and a flat fee for a particular activity, such as $390 for seven hours of prior arts searching. The lure of inexpensive labor, however, isn't enough to convince many lawyers that outsourcing legal work to India is a good idea. Their primary concern is security, and how to deal with issues of attorney-client privilege. "If I'm one firm and I'm outsourcing work in India, then I don't know that another firm isn't using the same lawyers," says G. Hopkins Guy, an IP partner in the Silicon Valley office of Orrick, Herrington & Sutcliffe. Proponents of outsourcing explain that outsourcing work to India is no different from outsourcing scanning and coding of litigation documents to a vendor or legal work to a temporary lawyer. But Guy and others are not convinced. "We need to tightly manage conflicts," he says. "I've heard of instances where just by sending documents out to a place like Kinko's, lawyers have had problems with conflicts." Guy adds that while Orrick routinely uses outside vendors to do document imaging and processing, he prefers that those vendors be located fairly close to his office and within easy access to manage the quality of the end product. Orrick also hires temporary, or contract, lawyers. The difference, says Guy, is the hands-on way that Orrick manages and integrates these lawyers. "We'll put a group of contract attorneys with Orrick lawyers in a room with eight computer terminals," Guy says. "[While reviewing documents] someone will often have a question, like 'I see this here. Is this important?' and they can ask a supervising attorney. But if I have a contract attorney who is by himself, in India, what do they do with that question? Maybe he can send an e-mail and get a reply a day later. But quite naturally you would think that they would say it's not important and move on. And I want that question immediately answered. That's why I don't see outsourcing of this type working." Many lawyers feel uncomfortable with the idea of outsourcing work to professionals whom they've never trained, let alone met, yet whose work reflects the quality of the firm. "I would be concerned about the absence of quality assurance," says Matthew Powers, the head of patent litigation in the Silicon Valley office of New York's Weil, Gotshal & Manges. "If you ship work to India and there's a problem and the judge says, 'How did this happen?' and you say, 'I don't know,' then there's an abdication of responsibility." Powers says that he'd be nervous to rely on legal research completed by someone he doesn't know. "We invest a lot of time in training and managing our people to ensure that we get a high-quality work product. I'd rather find efficiencies in other forms." Other lawyers question the wisdom of outsourcing, citing the time needed to review the work done by Indian professionals or to manage the flow of information. Oracle, for example, decided it wanted its patent professionals closer to the business units. Yet proponents of outsourcing say that the practice becomes increasingly efficient with time. H. Wynne James III, a partner in 250-lawyer Louisville, Ky.-based Stites & Harbison, is realistic about the management required to outsource legal work to India. His firm has outsourced legal research and pieces of M&A transaction and is currently considering forming an alliance with outsourcing vendors and Indian firms. "If I think that I am going to get a high quality from the first day, I'm kidding myself," he says. "I think that this is not without its real challenges. One is efficiently managing Indians and American lawyers in the same engagement. I think that the internal mechanics of a lot of firms are not structured to handle that very well." Lawyers were reluctant to use temporary lawyers when the service started nearly two decades ago. Small firms were the first to embrace the concept. Today, they are present in firms of all sizes. But as some lawyers have found, this kind of universal acceptance doesn't happen overnight. As James says, "One of my partners said, 'I thought you were crazy when I thought you meant Indiana.'" THE INSIDE SCOOP ON LEGAL OUTSOURCERS Company Web site Personnel Most popular outsourcing requests: Atlas Legal Research atlaslegal.com 3 lawyers in Bangalore legal research and brief writing Intellevate intellevate.com 72 employees in Bangalore and New Delhi patent proofreading, prior arts searches, and paralegal functions Lawwave.com lawwave.com 8 lawyers working on an as-needed basis in Chennai document review and legal research Lexadigm Solutions lexadigm.com 6 lawyers in Gurgaon research memos, briefs, and surveys of state law OfficeTiger officetiger.com Declined to say how many lawyers and nonlawyers in Chennai word processing and legal research Quislex quislex.com 11 lawyers in Hyderabad research and document review The 2004 Global 100 Database is now available in an electronic spreadsheet. These definitive rankings of the world's largest international law firms can be sorted, searched and imported into an active database. The rankings include gross revenue for FY 2003, number of lawyers, average revenue per lawyer, profit per equity partner, number of countries in which the firm has offices, percentage of lawyers outside the firm's home country, key marketing contacts and more.

Bloglines | My Feeds

2005-04-18T15:50:00.000+05:30

It is proper to limit the scope of the claims according to the specification By Dennis Crouch PatentlyOImage022Rhodia Chimie v. PPG Industries Inc., (Fed. Cir. 2005) By Baltazar Gomez, Ph.D. Rhodia is an international chemical company and the assignee of U.S. Pat. No. 6,013,234 ("the '234 patent"). The patent discloses and claims certain essentially spheroidal precipitated silica particulates. Rhodia markets “Micropearl” which is a silica particulate covered by the patent. PPG also makes three silica products, namely, Hi-Sil SC60M, SC72 and SC72C. Rhodia alleges that these products infringe claim 1 of the '234 patent. The district court granted summary judgment for noninfringement in favor of PPG. On appeal, Rhodia argued that the district court erred in interpreting claim 1. The CAFC, however, affirmed the district court’s construction. Claim 1 of the '234 patent partly reads as follows: Dry, dust-free and non-dusting, solid and homogeneous atomized precipitated silica particulates essentially spheroidal in geometrical configuration… (emphasis added) In addition, the specification included examples tested both for flowability and dusting properties. Flowablity tests were performed by a pour test which compared the flowability of Micropearl with the prior art. The dusting tests were measured by the German DIN 53 583 standard (the "DIN test"). During the district court’s claim construction hearing, PPG asserted that the phrase "dust-free and non-dusting" should be interpreted literally to mean "no dust cloud whatsoever." Conversely, Rhodia argued that such a meaning was improper in view of the results of the pour test that showed production of some dust. Accordingly, Rhodia advocated construing "dust-free and non-dusting" to mean "very low dust." The district court was concerned, however, that Rhodia's proposed definition of the phrase was relative and that such a definition would not meet the statutory requirement that the claims particularly point out and distinctly claim the invention. Thus, to resolve the perceived ambiguity of the phrase, the district court adopted a construction based upon the only meaningful guidance provided in the patent, namely the DIN test. On appeal, Rhodia argued that the DIN test was not the only means by which to assess the amount of dust produced by the invention. Rhodia asserted that the pour test could also be used to determine the level of dustiness, and therefore, it is inappropriate for the district court to limit the phrase "dust-free and non-dusting" to the DIN test. Further, Rhodia cited statements made during prosecution of the ‘234 patent explaining that the pour test could be used to show the non-dusting and free-flowing properties of the ‘234 patent. In affirming the district court's construing of "dust-free and non-dusting", CAFC noted that although the pour test may also provide evidence of dustiness, the results of the pour tests presented in the '234 patent were only identified as evidence of the products' flowability. The CAFC further noted that there is no language in either the claims or the written description that taught the application of the pour test to determine the level of dustiness. Finally, CAFC stated that Rhodia's statements made during prosecution cannot serve to fill such a gap. Thus, the CAFC concluded that the district court did not erred in limiting the scope of the claims by defining the phrase "dust-free and non-dusting" to the only disclosure in the patent. Note: Dr. Baltazar Gomez is a scientific advisor at McDonnell Boehnen Hulbert & Berghoff LLP in Chicago. Dr. Gomez obtained his PhD in biochemistry from the University of Texas and researched retrovirology as a PostDoc at Cornell University. File Attachment: Chimie v. PPG.pdf (98 KB)

Pierce Law IP News Blog | All the IP News that's fit to blog.

2005-04-18T15:48:00.000+05:30

Pierce Law IP News Blog | All the IP News that's fit to blog.: "The Next Time You Want to do the 'Tree Pose,' it Might Be Wise to Check First With the Copyright Office Submitted by Carey on Sat, 04/09/2005 - 6:48pm. * In a decision announced on April Fools, U.S. District Judge Phyllis Hamilton handed down a mixed ruling, denying summary judgment to both the plaintiffs and defendant, in a copyright case that is starting to 'heat up.' Bikram Yoga, a form of Hatha yoga which its founder, Bikram Choudhury, has modified and shortened to 26 principal poses (or asanas) and 2 breath exercises (called pranayama), done in a room with a heated temperature of 105 degrees. Open Source Yoga Unity(OSYU), had challeneged the copyrights and trademarks that Mr. Choudhury holds in his form of yoga. The website for OSYU claims that the group was formed in part to 'provide a common voice, and the pooling of resources, to oppose the litigious position Bikram Choudhury is taking against the Yoga community by his attempted enforcement of copyright protection.'"

PATENTS & TRADEMARKS > FACTS & MYTHS

2005-04-12T20:01:00.000+05:30

PATENTS & TRADEMARKS > FACTS & MYTHS PATENTS MAKE PEOPLE RICH There is no guarantee that an invention, design, or plant that is patented will sell. In fact, most patents do not generate income for their owners. (See sidebar) Fact U.S. PATENTS ARE ENFORCEABLE ONLY IN THE UNITED STATES A U.S. patent is only enforceable in the United States. Myth PATENTS CAN BE ISSUED FOR REALLY GOOD IDEAS Patents are not issued for great ideas or mere suggestions. Patents are granted to people who (claim to) "invent or discover any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof"—to quote the essence of the U.S. statute governing patents. Myth YOU MUST PATENT YOUR INVENTION A patent provides protection for your intellectual property, but when you are deciding if you should apply for a patent you should keep in mind that: 1) it takes work and it can be expensive to obtain a patent, and 2) patents protect your invention for a limited term, but they also disclose your information. Disseminating information while protecting inventors is one of the reasons patent offices exist. If you have invented something you think you can profit from but still want to keep the important details secret, you may opt not to get a patent. Myth A PATENT MEANS THE INVENTION WORKS The government does not get involved in testing or verifying submitted inventions to see if they work.

I/P Updates: A Three-Layered Patenting Strategy - News and Information for Intellectual Property Practitioners

2005-02-06T15:06:00.000+05:30

I/P Updates: A Three-Layered Patenting Strategy - News and Information for Intellectual Property Practitioners: "A Three-Layered Patenting Strategy When Russell Krajec developes a patent strategy for a client with an emerging technology, he looks at 'three specific layers of coverage' from both the technology and business aspects of a client. As discussed in his artcle for Law.com, the first layer describes the basic underpinnings of the new technology and usually covers the first embodiments of the technology. The second layer is the 'tool' layer, covering the tools required to use the technology, and the third layer is the 'application' layer, detailing new uses and application of the technology."

Twenty Steps for Pricing a Patent - News and Information for Intellectual Property Practitioners

2004-12-15T12:40:00.000+05:30

I/P Updates: Twenty Steps for Pricing a Patent - News and Information for Intellectual Property Practitioners: "Twenty Steps for Pricing a Patent The ability to appraise patents can be important for GAAP financial reporting purposes under FASB nos. 141 and 142, especially for auditors and valuators in high-tech industries in which there are lots of business combinations. Here are the '20 Steps for Pricing a Patent' according to J. Timothy Cromley, CPA, an accredited senior appraiser with the Valuation Advisory Services Group of JPMorgan Chase & Co: 1. Check whether the patent is in force. 2. Identify the business context. 3. Gather information including file history, business plans, licenses, etc. 4. Assemble a valuation team with expertise in patent law, an understanding of monopolies, business valuation skills, and a background in the technology of the patent 5. Read the patent or carefully interview an independent patent attorney who has. 6. Investigate the patent's claim scope. 7. Talk with a patent attorney. 8. Inquire about the patent's validity. 9. Inquire into blocking patents. 10. Investigate foreign patent protection. 11. Consider synergies among patents 12. Consider the remaining life of the patent. 13. Analyze any prior royalties paid for the patent. 14. Inquire into any actual or threatened litigation involving the patent. 15. Identify the next-best alternative technologies. 16. Estimate a demand curve for the patented item. 17. . Determine the patented product's point of profit maximization. 18. Consider the applicability of traditional valuation approaches. 19. Do an income-approach valuation. 20. Write the patent valuation report."

Anchen files ANDA for Wellbutrin XL (buproprion)

2004-11-22T00:19:00.000+05:30

Anchen files ANDA for Wellbutrin XL (buproprion) Anchen files ANDA for Wellbutrin XL (buproprion) By Lawrence B. Ebert Taiwan-based generic company Anchen Pharmaceuticals has submitted an abbreviated new drug application (ANDA) to the FDA for Biovail's Wellbutrin XL (once daily dose of bupropion for depression). Litigation over bupropion has been extensive. Current issues are NOT about the drug itself (the composition of which is off patent) but about the formulations for controlled delivery of the drug. The Excel and Impax decisions of the Court of Appeals for the Federal Circuit have involved interpretation of the foreseeability prong of the US Supreme Court decision in Festo (535 US 722 (2002)). Wellbutrin is a drug used to treat depression, but the underlying chemical is also used for smoking cessation (marketed as ZYBAN). Of depression, the chemical is different from Paxil, Prozac and Zoloft, and as a result, Wellbutrin can often successfully treat people with depression whose condition has not improved from taking these other drugs. Although the chemical of Wellbutrin and Zyban has been off patent as a composition of matter for a long time, in 1995 Glaxo received a patent for the extended release formula of Wellbutrin SR. In 1999, generic drug manufacturer Andrx filed two ANDAs with the FDA seeking to sell generic versions of extended release Wellbutrin and Zyban. Andrx argued that because its generic used a different method of extended release, that it did not infringe on Glaxo's patent. Four other generic manufacturers followed Andrx's lead, and several have received tentative approval to manufacture and market their generic versions. In February of 2002, the US District Court for the Southern District of Florida ruled that Andrx did not violate Glaxo’s patent and therefore should be allowed to manufacture and market its generics. On appeal, however, the Federal Circuit Court of Appeals held that the district court in Florida erred in its construction of the patent infringement claims. Glaxo owns U.S. Patent No. 5,427,798 (the ’798 patent) directed to controlled sustained release tablets containing bupropion hydrochloride. Pharmacologically, bupropion (m-chloro--t-butylaminopropiophenone) is a monocyclic aminoketone antidepressant. See U.S. Patent No. 4,393,078 (issued July 12, 1983) (the ’078 patent). These compounds treat depression and inebriation. In addition, they facilitate the cessation of smoking by producing neural stimulation in mammalian systems. See ’798 patent, col. 1, ll. 5-10; ’078 patent, col. 1, ll. 29-39; U.S. Patent No. 3,819,706 (issued June 23, 1974). To avoid the need for multiple dosages with the attendant fluctuations in plasma bupropion concentrations, Glaxo invented a sustained release formulation of the compound. While bupropion hydrochloride itself was separately patented, Glaxo obtained the ’798 patent to protect its sustained release formulation of the drug. Glaxo markets this patented sustained release formulation as Wellbutrin®SR for treatment of depression and as Zyban® for smoking cessation. The key ingredient for achieving sustained release in this invention is hydroxypropyl methylcellulose (HPMC), which is a partly O-methylated and O-(2-hydroxypropylated) cellulose. In oral preparations, HPMC extends drug release by transforming into a gel that swells upon ingestion. The hydrogel state of HPMC releases bupropion hydrochloride from an ingested tablet over a period of time. The ’798 patent claims a sustained release tablet containing an admixture of bupropion hydrochloride and HPMC. However, many of the claims as originally filed did not recite HPMC as a limitation. During prosecution on the merits in the United States Patent and Trademark Office (Patent Office), the examiner rejected the claims that did not recite HPMC for lack of enablement under 35 U.S.C. § 112, 1. Glaxo amended those claims to overcome the rejection. The first independent claim of the ’798 patent states: 1. A controlled release tablet comprising 25 to 500 mg of bupropion hydrochloride and hydroxypropyl methylcellulose, the amount of hydroxypropyl methylcellulose to one part bupropion hydrochloride being 0.19 to 1.1 and said tablet having a surface to volume ratio of 3:1 to 25:1 cm-1 and said tablet having a shelf life of at least one year at 59deg to 77deg F. and 35 to 60% relative humidity, said tablet releasing between about 20 and 60 percent of bupropion hydrochloride in water in 1 hour, between about 50 and 90 percent in 4 hours and not less than about 75 percent less in 8 hours.

The WTO angle and TRIPS

2004-11-22T00:18:00.000+05:30

The WTO angle and TRIPS: "The WTO angle and TRIPS By Lawrence B. Ebert Of the Ballmer quote: 'Someday, for all countries that are entering the [World Trade Organization], somebody will come and look for money owing to the rights for that intellectual property.' Section 5, Article 27, paragraph 1 of TRIPS recites: 1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. (5) Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. Paragraphs 2 and 3 don't say anything about business method or software patents. [http://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm#5] David Berlind writes: Given the significant overlap between the members of the WTO and the European Union [EU], I'm having a tough time imagining how, if Europe can't uphold patents on software, the WTO can. One poster observed that the EU could take the position that business methods/software are not a 'field of technology' or perhaps even 'inventions.' Further, if the USA did even try to get WTO to force a change in the EPC, the EU would counter-attack with TRIPS complaints about various aspects of the US patent system which currently favour US-based inventors. --> Mutually assured standoff. Berlind also wrote of the WTO remark: 'the easiest way to get rid of a potential customer forever is to sue them. Especially when that customer is a government. Governments usually have pretty big budgets.' Within the US, patent holders have sued customers. Go back to the days of the Selden patent on the automobile. One of the advertising slogans for licensed cars was 'Don't buy a lawsuit.' Henry Ford said that this tactic by the Selden patent holder (ALM) launched Ford's business. In the pharma business today, many claims on drugs are written such that patients, doctors, and pharmacists could be sued for use of competitor's infringing drugs. For example, this could have happened with omeprazole. But, of course, it didn't. In the area of copyright, there have been some exemplary suits brought by the RIAA against consumer-infringers, but this is tricky business. A different website gives a different example. http://www.linuxworld.com.au/index.php/id;1874419189;fp;4;fpid;1 -->Up to now, not many users have faced such threats. When asked for an example of a user actually getting sued over intellectual property rights, Microsoft spokesmen go back four years. In 2000, Allan Konrad, a computer scientist, sued three dozen corporations, including General Motors, Ford Motor, The Boeing Co., Daimler Chrysler, United Air Lines and Eastman Kodak. Konrad held three patents and ownership to the mechanism of Web-based delivery of information. He went after corporations serving Web information from back-end databases. 'Microsoft worked to get IBM, Sun and AOL, whose products were also implicated, to step in collectively on behalf of our customers. We hired one law firm to defend them, paid the cost of that. The outcome was very positive, the infringement claims were thrown out,' said David Kaefer, director of business development at Microsoft. <--"

Navigating the patent maze: Nap Hal - Comments Addressed

2004-11-13T19:55:00.000+05:30

Navigating the patent maze: Nap Hal - Comments Addressed: "Nap Hal - Comments Addressed An interested reader commented on the post in which I expressed approval for the decision of the Indian Government to not oppose the European Patent, now owned by Monsanto, that used Nap Hal. The reader raised several points that I would like to address. I also hope that it evokes more discussion on this topic area. (Sidebar - there are currently 5 parties opposing this patent, including Greepeace and the European Flour Milling Association) The reader raises several points. The first point, quoted below, speaks to whether the patent claims are in violation of the European Patent Convention. The Patent in question explicitly claims a wheat variety, and so is squarely in violation of the European Patent Convention.?? The short answer is that the patent in question (EP 0 445 929) does not claim any plant varieties. The claims are directed to soft-milling wheat with particular characteristecs, flour prepared from that wheat, dough or batter prepared from the flour, edible products made from the dough or batter, and biscuits made from the flour. The second point of the reader is that 'the disclosure of the patent shows that the genetic traits which are key to the patent (double null allele in glu-D1 gene) were wholly derived from the landrace developed in India, namely, Nap Hal.' I'm not sure what the reader's objection is other than the landrace came from India. In fact, the landrace was obtained from a public germplasm bank. The accession was placed prior to the Convention on Biological Diversity, so that treaty does not control the situation. Until the CBD, typically there were no restrictions on accessions or, in the case of the CGIAR the restrictions regarding intellectual protection placed on germplasm held in FAO Trust were limited to the variety itself and did not extend to derivatives (such as the wheat claimed in the Monsanto"

REFUSING TO SUPPLY IN CHEAP JURISDICTIONS MAY BE OKAY, SAYS AG

2004-10-30T17:55:00.000+05:30

IPKat - fishing for IP stories for YOU: "Friday, October 29, 2004 REFUSING TO SUPPLY IN CHEAP JURISDICTIONS MAY BE OKAY, SAYS AG Yesterday in Case C-53/03 Synetairismos Farmakopoion Aitolias & Akarnanias (Syfait) and Others v Glaxosmithkline AEVE Advocate General Francis Jacobs gave his Opinion as to whether a drug company may plead the threat of parallel trade as an excuse for limiting the amount of IMIGRAN, LAMICTAL and SEREVENTIT it sends to pharma wholesalers in 'cheapo' regimes. In his conclusion he recommends that the European Court of Justice rule as follows: '(1) A pharmaceutical undertaking holding a dominant position does not necessarily abuse that position by refusing to meet in full the orders sent to it by pharmaceutical wholesalers only by reason of the fact that it aims thereby to limit parallel trade. (2) Such a refusal is capable of objective justification, and thus of not constituting an abuse, where the price differential giving rise to the parallel trade is the result of State intervention in the Member State of export to fix the price there at a level lower than that which prevails elsewhere in the Community, given the combined circumstances of the European pharmaceutical sector at the current stage of its development, and in particular: �- the pervasive and diverse State intervention in the pricing of pharmaceutical products, which is responsible for price differentials between the Member States; �- the regulation by the Community and the Member States of the distribution of pharmaceutical products, which establishes nationally demarcated obligations upon pharmaceutical undertakings and wholesalers to ensure the availability of adequate stocks of those products; �- the potentially negative consequences of parallel trade for competition, the common market, "

The Use of Exculpatory Opinions in Defending Against A Charge of Willful Infringement (12/05/04) from Mondaq

2004-10-22T08:36:00.000+05:30

McDermott Will & Emery - United States - The Use of Exculpatory Opinions in Defending Against A Charge of Willful Infringement (12/05/04) from Mondaq: The exercise of intellectual property rights has become a mainstay of business over the last 10 years. Indeed, business models are proliferating where obtaining patents for the purpose of licensing and enforcement are the sole activity of the enterprise. Even among those entities that routinely engage in R&D or the manufacture and sale of products, more and more are investing in the acquisition of IP rights, and many have realized that enforcement of those rights against competitors is an effective tool in protecting markets and/or generating revenue. As a consequence, corporate executives and general counsels are likely to face, at least once in their careers, a charge that their companies are infringing upon another entity’s intellectual property rights. Especially threatening is the receipt of a notice that your company’s products infringe patents held by another. The threat is worrisome for a variety of reasons. First, the threat is often leveled at a company’s core technology, changes to which are almost never trivial. Second, patent infringement carries with it the very real threat of devastating injunctive relief. Finally, damages in such cases, while nominally calculated in terms of a reasonable royalty or lost profits, may, at the discretion of the court, be enhanced up to three times for so-called willful infringement. In order to navigate this minefield and defend themselves against claims of willfulness, many companies engage counsel in order to obtain advice as to whether their actions violate valid patent rights of some third party and/or how to avoid such violations by design arounds. This article, addresses defenses to a charge of willfulness, and in particular, some of the issues which may arise when relying on opinions of counsel as a defense to a patent owner’s claim of willful infringement. The "Totality of the Circumstances" Test When considering whether an infringer acted in bad faith, thereby supporting an increased damage award, courts look at a "totality of the circumstances," including (1) whether the infringer copied the invention of another; (2) whether the infringer, when it knew of the other’s patent, investigated the scope of the patent and formed a good-faith belief that it was either not infringed, invalid or both; (3) whether the infringer mounted a substantial (albeit unsuccessful) challenge in the issues of validity and infringement; (4) the closeness and complexity of the legal and factual issues presented; (5) whether the infringer engaged in good faith efforts to design around the patent; and (6) the infringer’s behavior in the litigation. 1 Because there are few situations where sufficient evidence of actual copying or litigation conduct egregious enough to find willfulness are present, the primary focus for courts when considering willful infringement claims is usually on whether an alleged infringer has formed a good-faith belief that its conduct was justified. In the seminal case, Underwater Devices, Inc. v. Morrison-Knudsen Co.,2 the U.S. Court of Appeals for the Federal Circuit imposed as affirmative duty on a potential infringer to exercise due care to determine whether or not its activities are infringing. This duty includes obtaining competent legal advice from counsel before initiating possibly infringing activity. The requirements for an opinion of counsel as evidence of good-faith in defense to a charge of willful infringement has led to several problems relating to waiver of the attorney-client privilege with respect to such opinions, and often to matters beyond the scope of the opinions. Following Underwater Devices, in Kloster Speedsteel AB v. Crucible Inc.,3 the Federal Circuit found that silence by the accused infringer on whether it obtained legal advice relating to infringement could warrant an adverse inference that the accused infringer either had not obtained an opinion (as required by Underwater Devices) or that the opinion was adverse. The Court followed its Kloster Speedsteel decision with its holding that the failure of an infringer to introduce an exculpatory opinion of counsel at trial could lead to an adverse inference instruction to the jury. Fromson v. Western Litho Plate & Supply Co.4 Thus, although the test for determining willful infringement ostensibly requires a multifaceted review of the totality of circumstances, the Federal Circuit jurisprudence has, for many years, imposed an opinion requirement. In the view of many, the opinion of counsel "requirement," coupled with the adverse inference, has led to a serious erosion of attorneyclient privilege. Waiver of the Attorney-Client Privilege Under the present state of the law, in addition to the affirmative duty to seek and obtain advice-of-counsel, if a company finds itself in a lawsuit facing a charge of willful infringement it is all but required to disclose the legal advice it received relating to infringement and/or validity. In other words, by merely raising the willful infringement claim, a patent owner presents the accused infringer with the Hobson’s choice of either waiving its attorney- client communications or confronting an adverse inference instruction on the issue of willfulness. Most choose waiver. The "choice" mandated by the Federal Circuit authority requires considerations not found in any other area of law. The most obvious is the effect and scope of the privilege waiver resulting from reliance on an opinion of counsel. There is no question that reliance on opinions of counsel as evidence of goodfaith results in a waiver of privileged communications. The thorny question facing accused infringers is just how broad a waiver results. Accused infringers agonize over this question and district courts have found the task of line drawing to be a daunting one. The uncertainty on this issue is well illustrated by the following quote from a court struggling to fairly decide the issue: "In few, if any, areas of the law has the tail taken to wagging the dog as vigorously as in the privilege waiver disputes endemic to patent infringement cases. Defendants often rely upon an advice-ofcounsel defense when confronting the threat of enhanced damages for willful infringement. The consequent waiver of privileges and protections that the adviceof- counsel defense entails, however, is now the basis of innumerable disputes like the one at bar, distracting the court and the parties from addressing the fundamental questions of infringement and validity. It seems that a whole subspecialty of opinion practice has developed as part of infringement defense strategy. Litigation resources are heavily invested in delaying the moment when an accused infringer must choose between relying on advice-of-counsel or maintaining typical privileges, or in seeking bifurcation on the issue of willfulness, or in trying to control the scope of waiver, once the advice-ofcounsel route is taken." Rhodia Chimie, et al. v. PPG Industries, Inc. 5 Scope of Waiver It is long settled that if an accused infringer chooses to rely on an advice-of-counsel defense, it waives privilege with respect to the communications transmitting the reliance opinion. Thorn EMI North America, Inc. v. Micron Tech.6 Materials considered by reliance counsel in rendering the opinion, but not communicated to the accused infringer, are typically protected as work product and are not discoverable. EMI No. Am. See also, Dunhall Pharm., Inc. v. Discus Dental, Inc.;7 and Steelcase, Inc. v. Haworth, Inc.;8 Even when a work product waiver occurs it is not unlimited in time but ends once a lawsuit is filed.9 However, some courts have extended the waiver to include all communications between the client and counsel, in some instances including trial counsel. Haney v. Timesavers, Inc.10 (Broad waiver found where "document logs show that a number of documents were sent from the [defendant’s trial counsel] to the [reliance opinion counsel] and to others concerning infringement and validity…as a result, [trial counsel] has provided opinions to advise [defendants]);" FMT Corp. v. Nissei ASB Co.;11 Electro Scientific12 (Trial counsel implied that communications with reliance opinion counsel were substantial.); Matsushita Elec. Corp. v. Loral Corp.13 (Defendant patentowner’s defense of good faith litigation was based on opinion given by trial counsel.); Carl Zeiss Jena GmbH v. Bio-Rad Labs. Inc.14 (Written and oral reliance opinion were given by trial counsel.); Fonar Corporation, et al. v. Johnson and Johnson15 (Various outside lawyers’ authored opinion signed by in-house counsel.). While the scope of the waiver in any given case cannot be accurately predicted, the cases provide some guidance that will help counsel limit the potential scope of the waiver. First, where practical, opinion counsel should be separate from trial counsel. Broad waivers, including trial counsel’s work product, have been found where trial counsel also rendered an opinion regarding the infringement or validity matters at issue. While the different counsel can be members of the same law firm, the risk of a broad waiver is mitigated if they are not. Second, opinion counsel and trial counsel should not communicate on the substance of the opinions lest it be inferred that trial counsel influenced opinion counsel. Broad waivers have resulted where trial counsel and opinion counsel share information and theories. Though opinion counsel may be able to bring trial counsel "up to speed" more quickly, it must be remembered that opinion counsel was engaged to provide objective advice on issues of infringement and validity. Trial counsel’s view on whether opinion counsel was articulate and appropriately analytical is only marginally relevant to trying the substantive defenses of the particular action. In preparing an opinion memo, the opinion writer typically has no more than a commercial validity search report and/or a relatively abbreviated consultation with a person knowledgeable about the accused device or method. When this is compared to the resources typically available to defense counsel, it is no wonder that different prior art and different or additional reasons for asserting non-infringement are likely to percolate up. As long as the opinion was competent as delivered and was relied upon in good faith by the client, the Underwater Devices criteria are met. Third, avoid any appearance of "opinion shopping." Don’t engage counsel to prepare an opinion and then stop the process in favor of a new counsel without good cause to do so. Are the Winds of Change Blowing? Based upon recent actions, the Federal Circuit appears to be keenly aware that these scopes of waiver issues—sequela to the duty to obtain an opinion and the negative inference imposed if the opinion is not produced to the plaintiff—need to be reviewed and addressed. Recently, the Court sua sponte decided to review en banc certain issues regarding exculpatory opinions, waiver and the adverse inferences. In Knorr-Bremse Systeme Fuer Nutzfahrzeuge GMBH v. Dana Corp., et al.,16 the Court asked for amicus submissions on the following questions: (1) Is the adverse inference appropriate when an accused infringer invokes the attorney-client privilege and/or work-product doctrine with regard to willful infringement? (2) Is it appropriate to draw an adverse inference with respect to willful infringement when the accused infringer has not obtained legal advice? (3) Should the existence of a substantial defense to infringement be sufficient to defeat liability for willful infringement even where no legal advice has been obtained? At least 14 amicus briefs were submitted. With near unanimity, the amici answered the Court’s questions as follows: (1) The adverse inference is inappropriate when a defendant invokes the attorney-client privilege and/or work-product doctrine with regard to willful infringement. (2) It is not appropriate to draw an adverse inference even when a defendant has not secured legal advice. (3) The existence of a substantial defense to infringement should be sufficient to defeat a willfulness claim regardless of whether legal advice was sought and obtained. Some parties went even further, asking the Court to simply abolish the Underwater Device rule. As of this writing, oral argument has been completed and the patent bar eagerly awaits guidance from the en banc Federal Circuit. Given the Court’s request and the overwhelming call for change, it appears that some Federal Circuit guidance on these issues may soon be forthcoming. However, until that happens, it is important to understand the opinion "requirement" and the attendant attorney-client privilege waiver virtually inherent in presenting a defense to a charge of willful infringement. Paul Devinsky Stephen J. Akerley Paul Devinsky, a Washington, D.C. based-partner, concentrates his practice on patent, trademark and copyright litigation, counseling and prosecution and on trade secret litigation. Stephen J. Akerley, a partner in Silicon Valley, focuses his practice on high-profile patent, trade secret, trademark and copyright cases as well as technology-related commercial disputes. Footnotes 1 See, e.g., Anjimoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338 (Fed. Cir. 2000); SRI Int’l Inc. v. Advanced Tech. Labs. Inc., 127 F.3d 1462 (Fed. Cir. 1997); Gustafson, Inc. v. Intersystems Indus. Prods., Inc. 897 F.2d 508, 510 (Fed. Cir. 1990) ("Willfulness is determined from the totality of the circumstances...."); and Bott v. Four Star Corp., 807 F.2d 1567, 1572 (Fed. Cir. 1985). 2 717 F.2d 1380, 1389-90 (Fed. Cir. 1983). 3 793 F.2d 1565, 1580 (Fed. Cir. 1986). 4 853 F.2d 1568, 1572-73 (Fed. Cir. 1988). 5 Civil Action No. 01-389-KAJ, Memorandum Opinion, October 8, 2003. 6 837 F. Supp. 616 (D. Del. 1993). 7 994 F. Supp. 1202, 1205-06 (C.D. Cal. 1998). 8 954 F.Supp. 1195 (W.D. Mich. 1997). 9 Dunhall, supra. 101995 U.S. Dist. LEXIS 15222, *8-9 (D. Ore. 1995). 111992 U.S. Dist. LEXIS 21500, *7, 24 U.S.P.Q.2D (BNA) 1073 (N.D. Ga. 1992) 12175 at F.R.D. 539, 540 (N.D. Cal. 1997). 131995 U.S. Dist. LEXIS 12880, *1-4 (S.D.N.Y. 1996). 142000 U.S. Dist. LEXIS 10044 *1. 15227 U.S.P.Q. (BNA) 886, 887 (D. Mass. 1985). 16Case Nos. 01-1357, - 1376, 02-1221, - 1256 (Fed. Cir.); on appeal from the U.S. District Ct for the Eastern District of Virginia (Case No. 00-CV-803).

LEX ORBIS - India - Data Exclusivity � The Indian Perspective (21/09/04) from Mondaq

2004-10-22T08:32:00.000+05:30

LEX ORBIS - India - Data Exclusivity � The Indian Perspective (21/09/04) from Mondaq: by Manisha Singh Nair, Under Special 301 of the U.S. Trade Act of 1974 India has been put on the ‘PRIORITY WATCH LIST’ of USTR (United States Trade Representative) for failing to provide an adequate level of protection or enforcement and market access for persons relying on Intellectual Property protection. The absence of ‘data exclusivity’ legislation inter alia forms the reason for India’s inclusion in the list. Special 301’ is a part of the U.S. Trade Law that requires the USTR to identify countries that deny adequate protection for Intellectual Property Rights or that deny fair equitable market access for the U.S. persons who rely on IP protection. PRIORITY WATCH LIST’ are the countries or trading partners that have very serious problems in terms of scope and/or impact on U.S. commerce requiring the focus of increased bilateral attention on the problem areas. The Government of India has constituted a High level Inter-ministerial committee to consider steps to be taken in the context of the provisions of Article 39.3 of the TRIPS agreement for the protection of undisclosed information. As the Indian government caves in to the economic coercion of the U.S. government backed by the omnipotent Pharmaceutical lobby of U.S this paper attempts to analyze what India stands to lose or gain and what alternative we have to come out of this conundrum victoriously. There are several burning questions that come to the forefront with regard to the issue of data exclusivity – does Article 39.3 of the TRIPS agreement mandate ‘data exclusivity’ or mere ‘data protection’? should the developing countries like India adopt measure of data protection other than data exclusivity? would data exclusivity sound death knell for the India pharmaceutical industry with a strong generic base? what would be the ramifications of such legislation on Indian Population more than half of which lives under abject poverty? It is imperative to find answers to these questions, as we have to reconcile the apparently opposing mandates of public health and strong IP protection. The predicament before the developing countries like India is how to strike a fine balance between public health and the demand of increased IP protection. Before attempting to analyze these issues it is important to understand the meaning of ‘data exclusivity, its genesis, impact on drugs and the reasons for conferment of this privilege. Data exclusivity –meaning, genesis and impact Data exclusivity is generally defined in United States as a period of exclusive marketing rights granted to a new drug application (NDA) upon obtaining marketing approval by the regulatory authority if certain statutory requirements are met. The regulatory bodies require the pharmaceutical companies to submit extensive data establishing the safety and efficacy of a new drug before approving it for sale. This data arises out of many years of research and clinical trials and is the most expensive part of drug development. It is estimated that the total cost of drug development and marketing is approximately $500 in industrialized countries. Data exclusivity laws prevent the regulatory bodies from accessing the originators data when considering an application for a generic competitor seeking approval to sell an equivalent competing product. Thus in the countries where data exclusivity is granted the regulatory authorities can take up the applications for generic versions only after the expiry of data exclusivity period. In the alternative the competitor is required to generate his own marketing approval data. The period of data exclusivity is provided by the national legislation of a country and as such there is no uniform period. Data Exclusivity legislation was for the first time enacted by United States of America in the year 1984.The 1984 Drug Price Competition and Patent Term Restoration Act popularly known as Waxman-Hatch Act provides for there different terms of marketing exclusivity depending on the type of drug. Each type of exclusivity has specific requirements and results in various lengths of time for which the applicant is granted the exclusive marketing rights. Three main Types of exclusivity are Orphan, Waxman-Hatch and Pediatric granted for 7years, 5years and 3 years respectively from the date of approval of the drug. Exclusivity for the first time approval of a new chemical entity in the US is for a period of 5 years. Interestingly data exclusivity provision is seen in US as balancing the interests of innovator or pioneer drug firm that bear the research and development and the interests of the generic drug industry that can increase competition and lower the cost of the drug The reasons for granting exclusivity in United States have been enumerated as- to achieve balance between the pioneer drug industry and the generic drug industry Costly clinical trials that established the safety and effectiveness of the drug would not need to be repeated in order for a generic drug to enter the market place. Once information has been established about a drug, there is no requirement for a second sponsor to prove the safety and efficacy a second time. exclusivity is an incentive to a new drug development in particular in the absence of patent protection. unnecessary death of and suffering to the animals due to duplication of tests could be avoided. Side effects to the human subjects due to repetitive trials can be obviated. European Community adopted data exclusivity in the year 1987 vide the Directive 65/65 EE (amended 87/21/EEC). The period of data exclusivity in European community varies from 6 to 10 year. Data exclusivity arose in the European Community during the time when there was no patent for biotech products in order to protect the biotech industries and afforded the biotech products some form of market protection. U.K., Sweden, Netherlands, Germany, Italy, France and Belgium grant 10 years data exclusivity. More than half of the members of European union provide 6 years of data exclusivity. In Japan, the data exclusivity period varies from 4 years (for medicinal products with new indications, formulations, dosages, or compositions with related prescriptions) to 6 years (for drugs containing a new chemical entity or medicinal composition, or requiring a new route of administration) to 10 years (for orphan drugs or new drugs requiring pharmaco-epidemiological study). In New Zealand the protection period is 5 years. There is no data exclusivity period for data relating to new uses or formulations of old active ingredients Data exclusivity is primarily granted for pecuniary reason that is to enable the initial registrant to recover investment made by him in obtaining the marketing approval. In the absence of data exclusivity period, generic drugs could be introduced onto the market on the basis of bioequivalence tests without the having to replicate the time consuming and expensive clinical trials that are used to establish safety and efficacy of the product. The duplication of the tests would be inefficient use of the resources. Bioequivalence means-‘the absence of a significant difference in the rate and extent to which an active ingredient or active moiety becomes available at the site of drug action when administered at the same molar dose under similar conditions’ If bioequivalence is established, the products will have the same clinical effect and safety profile, and are considered to be therapeutically equivalent and interchangeable. TRIPS Agreement As a part of the Uruguay Round of the World Trade Organization (WTO) multilateral negotiations a new and rigorous treaty on intellectual property rights- the TRIPS was established in 1994. Beginning on the 1st of January 1995, the Agreement on Trade Related Aspects of Intellectual Property Rights administered by WIPO became the standard for protecting IPRs in those nations seeking to engage in international trade and enhance their prospects for economic growth. Thus the members of WTO are obliged to adhere to and provide for the minimum protection prescribed by the TRIPS. Accordingly, member countries are required to amend their laws to bring them in conformity with the substantive standards laid down by TRIPS. Failure to do so within the conceded time would certainly lead to referral of the matter to the Dispute Settlement Body of WTO. An affirmative finding of the Body and non-compliance may culminate into trade retaliations by the member nations. Developing countries where product patent was not being granted at the time of adoption of TRIPS were given time till 1st January 2005 to bring their patent law in line with TRIPS. India being one of them is legally bound to make the requisite amendments in its domestic patent law by the said date. However there are certain controversial and unsettled provisions in TRIPS, which have triggered considerable deliberations and debate in the international fora. The scope, meaning and the manner of their implementation remain nebulous. Article 39.3 dealing with data protection is one such provision. Article 39.3 runs thus: 3. Members when requiring as a condition of approving marketing of pharmaceutical or of agricultural chemical product which utilize new chemical entities, the submission of undisclosed test or other data, the originator of which involves considerable efforts shall protect such data against disclosure, expect where necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use" Thus, if in respect of pharmaceutical or agricultural chemical products which utilize a ‘new chemical entity’, the regulatory authority of a country requires submission of ‘undisclosed clinical and test data’ for granting marketing approval it is under obligation – protect the data against ‘unfair commercial use’ protect the data against ‘disclosure’ expect where it is necessary to protect the public or unless steps are taken to ensure that the data are protected against ‘unfair commercial use’. The diclosure is permitted only in two circumstances- Where it is necessary to protect the public Where the data is protected from unfair commercial use As it is evident from the language of the Article, latitude is given to the individual members to take such steps as they deem fit for protecting data against ‘unfair commercial use’. The purpose of Article 39.3 can be inferred from paragraph 1 of the same article that is to ‘ensure effective protection against unfair competition’. Article 39.1 provides- 39.1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 below with data submitted to governments or governmental agencies in accordance with paragraph below. Unfortunately the agreement refrains from defining the practices that would constitute ‘unfair commercial use’, thus allowing the several interpretations to creep in. The term ‘unfair competition’ has been defined in article 10bis of Paris Convention but that does not aid in identifying the practices that would fall within the gamut of the ‘unfair commercial use. Reference may also be made here of the WIPO model provision on protection against unfair competition (1996). Article 6 of the model provisions lays down the acts that would amount to unfair competition in respect of Secret Information. It reads as follows: Article6 (1) -Any act or practice, in the course of industrial or commercial activities, that results in the disclosure, acquisition or use by others of secret information without the consent of the person lawfully in control of that information (hereinafter referred to as "the rightful holder") and in a manner contrary to honest commercial practices shall constitute an act of unfair competition. Two points emerge from this general principle: Firstly the disclosure, acquisition or use of the secret information must be without the consent of person lawfully in control of that information. Secondly it must be in a manner contrary to the ‘honest commercial practices’. Applying it to pharmaceutical products utilizing new chemical entity, when the undisclosed data is submitted to the drug Regulatory authority, it becomes the trustee of that data and the originator remains the person lawfully in control of the data or ‘the rightful holder’. The authority thus not being the ‘rightful holder’ cannot use the data for any purpose other than for which it is submitted without the consent of the ‘rightful holder’. The sole purpose for which the data is submitted by the originator is to enable the authority to evaluate the data for ascertaining the safety and efficacy of the drug before granting marketing approval. Therefore the regulatory authority should not be allowed to rely on that data without the consent of the originator for testing the safety and efficacy of the subsequent applications. Further where considerable cost is incurred by the originator in order to earn reward for his investment, it would be unjust to deprive him of the legitimate and reasonable profits by allowing the other persons to avoid the cost of undertaking the similar procedure and rolling out the same drug at much lower price. Thus compelling a person to suffer loss would tantamount to acting in a manner contrary to honest commercial practices. The model also provides some examples of unfair competition in respect of secret information. It provides that disclosure, acquisition or use of secret information by others without the consent of the rightful holder may, in particular, result from (i) industrial or commercial espionage; (ii) breach of contract; (iii) breach of confidence; (iv) inducement to commit any of the acts referred to in items (i) to (iii); (v) Acquisition of secret information by a third party who knew, or was grossly negligent in failing to know, that an act referred to in items (i) to (iv) was involved in the acquisition. [Article 6(2)] This list is however inclusive and not exhaustive in nature and can very well include use of data to grant approval for those drugs for which it was not meant. Information is regarded as secret if - (i) It is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; (ii) It has commercial value because it is secret; and (iii) It has been subject to reasonable steps under the circumstances by the rightful holder to keep it secret. Article 6(4) of the said model correspond with Article 39.3 of the TRIPS agreement and is full of the same ambiguities as the latter. The model also deliberately refrains to define unfair commercial use. Article 39.3 of TRIPS has bifurcated member nations into two camps viz: - One consisting of developed countries reading ‘data exclusivity’ into Article 39.3.The most vociferous advocates include United States of America and European Union. The second Group consisting of Developing countries who subscribe to the view that data protection does not extend to granting ‘data exclusivity’ as data exclusivity invariably leads to market exclusivity, which is not envisaged by Article 39.3. Opponents of data exclusivity rely on the negotiating history of TRIPS to refute the contention that TRIPS mandates ‘data exclusivity’. The United States and European Union had made the proposal to the GATT signatories to adopt explicit language that would obligate members to Guarantee data secrecy and exclusivity for "a reasonable period" except upon compensating the initial registrant for the "reasonable value" of any use that offered a "commercial or competitive benefit" to any other person, including the government. However the proposal was rejected by the negotiators who finally adopted the present provision. An insight into the background of the Article 39.3 would make it amply clear that the interpretation forwarded by the developed countries does not withstand scrutiny. Moreover, an author argues that if the intention had been to have such exclusive marketing rights, this term, which is used in Article 70.9 of TRIPS, would have been used here too. Therefore, she avers, that a reasonable interpretation would be that the obligation on the authorities would be to keep the test data secret and to prohibit others from accessing this test data for unfair commercial use, such as sale to rival firms and this substantive obligation would exclude use by the authorities without disclosure of the data (Jayashree Watal, 2000). It is evident from bare reading, that Article 39.3 does not per se mandate data exclusivity. However many countries recognize marketing approval data as ‘trade secret’ of the drug developer and hence justify the data exclusivity laws. Proponents of this view give cogent reasons for regarding ‘clinical and test data’ as trade secret. The reasons forwarded are- Protection in form of confidentiality obligation, granted to the data is consistent with the treatment of the data as trade secret. Article, 39 falls in section 7 of the Part II of the TRIPS Agreement, which is concerned with Trade secrets and the Drug Marketing approval provided in Paragraph 3 is just a subset of the trade secret. Article 1.2 of the TRIPS Agreement labels the subject matter protected by Section 7 as a category of ‘intellectual property Article 1.2 reads thus: For the purposes of this agreement, the term "Intellectual Property" refers to all the categories of intellectual property that are subject to Sections 1 to 7 of Part II Therefore it is argued that prohibition on unfair commercial use when considered in the backdrop of trade secret principles does require data exclusivity (Aaron Xavier Felmeth, 2004). Should India adopt measure of data protection other than data exclusivity? Developed countries traditionally take the view that strengthening IPR protection fosters economic growth in developing countries by facilitating international investment while simultaneously rewarding domestic innovation. By contrast developing countries see IPR protection as impeding the flow of knowledge by increasing cost and decreasing access to new technology. Developed countries argue that IPRs therefore slows economic development and decrease social welfare, at least in short term (Gary Smith, 1999). This argument against IPRs becomes all the more vehement in respect of Pharmaceutical products, as patented drugs are costly and unaffordable for the poor population. Moreover developing countries do not have the economic resources to provide health insurance cover to the people. Data exclusivity protection is often charged of being a superfluous or sui generis form of protection. Many arguments are advanced against data exclusivity, which can be summed as follows- Undermines genuine innovation as it encourages originator companies to focus their activities in changes in the product rather than focus on developing new innovative and beneficial product. All the TRIPS members to 20 years have uniformly extended the product patent period. Patents are increasingly being granted for new uses, indications, dosages and change in formulations. Data exclusivity period is granted without originator having to demonstrate any of the basic principles of novelty or inventiveness. Data exclusivity leads to ever greening of patents. Hypothetical example is often cited-suppose X Company applies for marketing approval of its drug in 17th year of patent, assuming data exclusivity period to be of 5 years, the total period of protection will increase to 22 years. Thus it could keep the generic drug producers out of the market for longer duration. Poor consumers of medicines would suffer as a result of lack of competition in the market. The battle lines over data exclusivity are predictably drawn between net exporters and net importers of intellectual property. The developing countries including India are reluctant in granting exclusive marketing privileges to affluent foreign drug companies for the fear that it would escalate the prices of drugs. On the other hand the developed countries fail to see any incentive to market such drugs in India in the without adequate recompense in form of data exclusivity. Many sections of Indian Society fear that the data exclusivity will cause slew of problems for the consumers in India, would give excessive benefits and protection to the MNC pharmaceutical companies, deprive people of the generic equivalents, prices of the drugs would become exorbitant as a result a large chunk of the population will have to go without even the essential drugs. Before we consider the ill effects of data exclusivity we must bear in mind that India is different from the other developing countries in various aspects. India has a well-developed Pharmaceutical industry, which has already notched up a large share in US generic market. Unlike other countries India has excellent outsourcing opportunities for clinical trials, R&D and technical services. In addition, fleet of highly trained scientists makes India an attractive destination for research projects. More than 15 percent of the scientists engaged in pharmaceutical R & D in US are of Indian origin. Empirical evidence suggests that a stronger intellectual property protection would facilitate the flow of FDI in the developing countries. A study conducted by Mansfield indicated that effective intellectual property rights protection could be an important factor in securing foreign direct investment and technology transfer, especially in high technology industries. The findings indicate that, in relatively high-technology industries like chemicals, pharmaceuticals, machinery, and electrical equipment, a country's system of intellectual property protection often has a significant effect on the amount and kinds of technology transfer and direct investment to that country by Japanese and German, as well as U.S. firms (Edwin Mansfield, 1995). Some of the international researches clearly indicate that a close relationship exists between level of Intellectual property protection and R & D expenditures. It was found that foreign R & D expenditures by Research based pharmaceutical firms was concentrated in Western Europe where patents are adequately protected and the R &D expenditures decreased by 6.6 percent over a period 1977 to 1987 in Latin America where the protection is relatively very poor (Rapp and Rozek, 1990) According to a US representative protection of test data is key to company decisions on location of clinical trials. According to the U.S. National Institutes of Health (NIH), lack of data exclusivity in India is the primary reason why India only ranks 9th (compared to China which ranks 2nd), in funding given by the NIH outside of the U.S. U.S. pharmaceutical companies spent $30 billion on R&D in2001. Pharmaceutical industry is a research and development intensive industry. Indian Pharmaceutical companies on an average allocate only 2 percent of their sales for R&D activities (only some allocate 6 percent). The growth of this highly competitive, technology-based industry is not possible without substantial investment. Most of the Indian companies do not have the requisite financial resources to conduct extensive researches for bringing out novel drugs. If data exclusivity legislation is enacted in India it would provide the necessary incentive to the originators to market their drugs in India without the fear of generic manufacturers and other multinational drug manufacturers free riding on their data. The benefits that would flow would be numerous. The Data Exclusivity laws would set the environment that would Afford the opportunity to the Indian Research based pharmaceutical companies to bag important research projects form top pharmaceutical companies of US and European countries. Increase the diffusion of knowledge and technology. Indian pharmaceutical industry needs to be aware and in possession of latest technologies used in developed countries in order to acquire a cutting edge in this sector. India is lagging behind in developing technology for the latest drug delivery system. Create demand for Indian scientists in the domestic research organizations and thus would be effective in checking brain drain from India. Most of the talented Indian scientist migrate to the greener pastures in US, UK and other European countries. These scientists would have less incentive to emigrate if their creative work was adequately protected in India. The research organizations once equipped with the structural resources can conduct researches that are specific to the diseases prevalent in India. Diseases such as tuberculosis, malaria, leprosy, plague and dengue fever continue to pose serious problems in India and take millions of lives each year. It is unlikely that such researches would be undertaken by the research firms located in developed countries. Facilitate the entry of new drugs in the market particularly those that are not protected by patent. Employment opportunity in the pharmaceutical sector would increase manifold. Bring about scientific and technological integration. More over if the Indian Pharmaceutical Industry has to give strong competition to countries like China and Israel we must create an environment, which allures the foreign firms to invest in India rather than to these countries. In china, the period of data exclusivity is 6 years and a data exclusivity law is already in the offing in Israel. China in September 2002 PRC Drug Administration Implementing Regulations introduced a new data exclusivity right. Under this law, the government (that is the SFDA) has an obligation to "protect against [the] unfair commercial use by any other person the undisclosed clinical data and other data … submitted by a manufacturer or marketer in obtaining the approval of manufacturing or marketing a drug containing new ingredients. During this six year period, any person who relies on data which is subject to the exclusive right shall be refused marketing approval unless the data relied upon is generated by himself or on his behalf. Data Exclusivity and pharmaceutical industry in India The Indian pharmaceutical industry is one of the most advanced among those of the developing countries. The ranking of the industry in the global market is fourth in volume (eight percent share in world market) and thirteenth in terms of value (1 percent share in the world market). The industry exports products worth rupees 141 billion to over 65 countries. The annual turn over is rupees 226 billion. Besides all the above, India has the largest number of US Food and Drug Administration (FDA) approved manufacturing facilities outside US. The number of Drug Master Files (DMFs) filed with the US FDA is twenty six percent higher then Spain, Italy, China and Israel. The Indian pharmaceutical industry has availed tremendous advantage of the absence of product patent regime in the past. By using the copycat technique of reverse engineering, it has succeeded in bringing out generic versions of almost every new drug developed in the other parts of the globe within 5 to 6 years of its introduction in the market. At present there are over 60,000 generic brands in 60 therapeutic categories in the market. The generic pharmaceutical companies of India offer cheap alternative for expensive branded drugs. Bristol-Myers Squibb (BMS) an American firm sells stavudin treatments for $3,400/year in US and $55/year in Africa, Cipla an Indian firm can sell the same drug for $40/year. Similarly Cipla and Ranbaxy laboratories can provide a daily dose of three antiretroviral for $244 and $292 per patient per year. A similar treatment from major US Pharmaceutical costs at least $562 per year. National Sector units like Ranbaxy, Dr. Reddy’s laboratories, CIPLA, Sun Pharmaceuticals, Wokhardt, Zydus Cadila and others have come out with original research on development of new drugs, delivery system and even new molecules, acquiring patents in countries US and others. The products of Indian manufactures are accepted on the WHO list of essential drugs and also approved by the regulatory authorities in EU and US. The pharmaceutical industry is not unanimous on the issue of grant of data exclusivity in India. There are two Trade associations representing the Pharmaceutical industry - Organization of Pharmaceutical Producers of India (OPPI) and the Indian Drug Manufacturers’ Association (IDMA). OPPI has requested the government to amend Schedule Y of the Drug and Cosmetic Act to include provisions for Data Exclusivity for period of 4 or 6 years from the date of marketing approval whereas IDMA opposes data exclusivity legislation in India. IDMA attributes the growth of the Indian pharmaceutical industry to the Indian Patent Act of 1970 or in the other words to the absence of product patent regime. OPPI is of the view that the discovery, development and bringing to market a new drug the originator requires to conduct extensive chemical, pharmacological and clinical research and testing and generate data for submission to the Drug Regulatory Authority for marketing approval of the new drug. This activity takes 8-10 years of painstaking efforts. The data generated in such work is proprietary to the originator and needs to be protected OPPI is composed of both the national as well as multinational firms. Most of the leading pharmaceutical companies are its members.foreg- Aventis Pharma ltd, Novartis India ltd, Pfizer ltd, Eli Lily &Co. (Ind) Pvt., Workhardt ltd, Johnson &Johnson ltd, Merck Ltd, Glaxo Smith Kline etc. IDMA represents the national sectors of the of the Indian Manufacturers. It has a membership of 500 Indian large, medium and small companies. Members include: Ajanta Pharma Ltd, Cadila Health Care Ltd, Cadila Pharmaceuticals Ltd, Dabur India Ltd, Dr. Reddy’s Laboratories, Lupin laboratories, Merrill Pharmaceuticals etc. Unlike Indian Pharmaceutical industry, generic industry of US strongly advocates strengthening of the Intellectual property regime by accepting the data exclusivity laws. Once the period of exclusivity is over the generic drug producers can prove bioequivalence on the basis of the clinical and test data submitted to the regulatory body. Thus the interest of consumers can be balanced with that of the intellectual property holders. Impact of data exclusivity on access to health care "The Hatch –Waxman period of data exclusivity works in this country because the people in US have Health insurance that pays for essential drugs and because we have a safety care net to assure that the poorest in our society are not left without medical care and treatment. But to impose such a system on a country without a safety net, depriving millions of people of life of life saving drugs is irresponsible and even unethical. In developing countries we must do every thing in our power to make affordable drugs for the life threatening diseases available now"- Henry Waxman In India, however the drugs, which are put in the Indian essential drug list, are not patented and the prices of these drugs will not be affected by strong patent protection. Moreover the product patent would only apply to new drugs, which would make a very insignificant percentage of the total market. The empirical data is not clear whether data exclusivity definitely has adverse impact on the prices of drugs. The multinational Pharmaceutical companies practice the policy of differential pricing that is to say that the prices of the drugs vary from country to country depending on the purchasing capacities of the consumers. Differential pricing policy provides a mechanism, which ensures that the consumers in the developing countries are not excessively burdened with the high prices of the drugs. The flexibilities, which are inherent in Trips like compulsory licensing under Article under Article 31 or the parallel importing from other countries can always be used as a tool for making the drugs more affordable in cases of emergencies and on the grounds permitted by the TRIPS agreement. Compulsory Licensing is "an authorization given by a National authority to a person, without or against the consent of the title-holder, for the exploitation of a subject matter protected by a patent or other intellectual property rights": (Correa, 1999) An author divides the middle income countries like China, Argentina, India etc the consumers of medicines can very well be bifurcated into two groups viz: - rich and the poor. On humanitarian and social grounds the poor people can be exempted from paying the additional cost of a patented product but the rich, must contribute to the cost of research and development that goes towards creating a patented product. So he is opines the Rich cannot be allowed to reap unjust advantage by free riding on the clinical and test data produced by the originator (Arvind Subramanian, 2001). Benefits of granting data exclusivity to the Pharmaceutical products utilizing new chemical entities would certainly outnumber the drawbacks Intellectual Property protection encourages innovation, which is a key factor that contributes to improved health care, through promoting both development of new medicines and economic growth generally. (Nozek and Tully, 1999) Therefore the Indian Government must expedite the enactment of the data exclusivity legislation in India.

PatentCafe Streamlines Claims Test/Claims Chart Development (06/05/04) from Mondaq

2004-10-22T08:14:00.000+05:30

patent cafe .com (cafezine) - United States - PatentCafe Streamlines Claims Test/Claims Chart Development (06/05/04) from Mondaq: "patent cafe .com (cafezine) United States: PatentCafe Streamlines Claims Test/Claims Chart Development Web-based Claims Charting Breaks Long Tradition of Hand Comparison 06 May 2004 Article by Andy Gibbs Not long after patent attorneys, R&D researchers or patent drafters being comparison of inventions or patents, the focus converges on the patent claims. The process of comparing claims is cumbersome, time consuming, and when relevant patents remain elusive to traditional Boolean search engines, frustrating. Nevertheless, claims comparison remains the critically important core to patentability searches, invalidity searches, infringement studies, and even in testing proposed claims prior to filing new applications. Litigation: Infringement Analysis: In instances of infringement litigation, the Rules of Practice often require the parties (Claimant, as well as Adverse Party) to submit a clear outline of the infringed claims of the patent. Of course, this applies to trial preparation as well as Markman hearings. The Adverse Party's Obligations typically include the serving on all parties an Adverse Party's Claim Chart. The Adverse Party's Claim Chart usually includes separately, with respect to each claim in Claimant's Claim Chart, the identification of all items of prior art that anticipate the claim or render it obvious. For each item of prior art, a position must be made as to whether it anticipates the claim or renders it obvious. If a combination of prior art references makes a claim obvious, that combination must be identified. The prior art must be identified as specifically as possible, including: (a) prior art patents must be identified by their number, country of origin, and date of issue; and (b) identify where, specifically, within each item of prior art each element of the claim is found. Assessing Patentability: Patent searches result in a stack of prior art patents deemed to be relevant to the present invention. Thumbing through a stack of papers is an inefficient method of quickly assembling the most important prior art, especially when extracting the claims for comparison to the present invention are in paper form, making compilation in an opinion document requires re-typing. Yet again, a digital means to evaluate and assemble comparative claims from a variety of patents would not only streamline the claims charting process, but in reality short-circuit the fatigue that creeps in after digesting the dozens of patents relevant to the present case. Drafting New Patent Claims: In some circles, Festo established a new standard of application writing – that is, draft a high volume of independent and dependent claims so that, in the event of disallowance of a particular claims as written, the claim can be deleted (rather than amended) and there will be another more appropriate claim in the set upon which to rely. More appropriately, had the robust claims analysis tools been readily available, the proposed claims could be tested against all prior art and amended prior to application filing. The specification can then be amended as appropriately to support the amended claims. First Web-Based Claims Charting System: In all of the above instances, and more not specifically addressed, development of a Claims Chart is a reasonable and appropriate method of capturing and evaluating claims of one patent with many others. PatentCafe’s Claims Charting system incorporates its advanced Semantic patent search tools that extract claims directly from the most relevant patent returned in the concept-based search results. Input to the Claims Test / Claims Chart system can be a valid patent number, text of claims copied and pasted into the text box, or the full text of a proposed claims set for a new application. Prior Art Claims are then generated by mining the ICO Global Patent Database using the company’s advanced Latent Semantic Analysis search technology. The more relevant patents (and claims) are presented at the top of the results set for immediate claims comparison to the baseline patent of set of patent claims. The system then takes those claims and immediately builds a Claims Chart online, allowing the side-by-side comparison of claims from a Baseline Patent or proposed claims, against the claims of one or more patents of interest. Output is in PDF format, creating a document that presents the claims of a pair of patents on opposing sides of the page. PDF claims Charts are created "on the fly", creating Claims Charts in a mater of minutes. (sample: http://www.iamcafe.com/papers/ClaimsTest_PDF.pdf Notes, comments and annotations, along with "copy and paste" text from any source are integrated into the claims chart document, appended to the end of the claims test document. The claims Chart utility is included in PatentCafe’s Infringement Litigation Suite http://www.iamcafe.com/Index.asp?option=Litigation, and is available separately as a stand-alone solution for patent or claims drafters or patent researchers. The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Detectability and Software Patents

2004-10-16T21:09:00.000+05:30

Bloglines | My Blogs: "Detectability and Software Patents By krajec on Patents in Business Some software ideas suffer from a unique problem: detectability. When an embodiment of an idea is expressed in a language that is compiled and distributed as executable code, how can that idea be detected? If it cannot be detected, there is no way to know if someone infringes. There are many ways patents may be used. In some cases, patents merely buttress a resume, an advertising brochure, or a marketing message. These patents sometimes can also deter other competitors from entering the market and act as a deterrent effect. Enforceable patents that protect the foundational technologies of a company should be detectable. In other words, the patent owner should be able to detect when a competitor is unlawfully copying his idea and take measures to enforce the patent. Some of the most creative and ingenious ideas fall into the first category. For example, a very clever and improved sorting algorithm used deep in the bowels of a software application may be tremendously novel, useful, and non-obvious, but it makes little business sense to patent that technology. The sorting algorithm is best protected as a trade secret, even if the executable code is widely distributed under a license. A competitor may use a completely different sort algorithm to achieve the same result, even if the competitor�s algorithm is much more cumbersome. Patents of the second category typically focus on the overall function of a software application, relate to interfaces used by the application, or define data structures. In each case, clear and immediate detection of infringement is possible. Patents covering this second category are much better suited to licensing or infringement enforcement. For the Patent Office, it may be enough that an invention is novel, useful, and non-obvious, but for "

No Progress on Bio/TK Disclosure for Patents -from I/P UPdates

2004-09-30T16:51:00.000+05:30

I/P Updates: TRIPS: No Progress on Bio/TK Disclosure for Patents - News and Information for Intellectual Property Practitioners: "TRIPS: No Progress on Bio/TK Disclosure for Patents According to an article in BRIDGES Trade BioRes, Vol. 4 No. 17 23 September, 2004 , the Council for Trade-related Aspects of Intellectual Property Rights (TRIPS) considered a proposal by Brazil, India, Pakistan, Peru, Thailand, and Venezuela on September 21, 2004 suggesting a checklist of issues to be covered in negotiations on biodiversity, traditional knowledge and folklore. The proposal elaborates on possible disclosure requirements in patent applications relating to the source and country of origin of a biological resource and/or traditional knowledge used in an invention. The US and Japan again voiced their opposition to using the checklist. No substantive progress was made and the meeting closed after one day rather than the scheduled two. The next TRIPS Council is reportedly scheduled for December 1-2. posted at 1:58 PM "

IP leveraging--- A Strategy Article from Mckinsey

2004-09-30T16:47:00.000+05:30

The McKinsey Quarterly: Intellectual property: Partnering for profit: " Intellectual property: Partnering for profit Patents and proprietary processes represent an untapped source of revenue for many companies. McKinsey research shows that in lots of cases, companies could earn 5 to 10 percent of their operating income from the sale or licensing of intellectual property, yet most earn less than one-tenth that. Too often, they don't know what they have, what it is worth, or what other industries could do with it. The solution is to build a network of outside specialists who can identify the best market for each asset and use their industry contacts and experience to negotiate a sale. The authors describe the five kinds of specialists needed, their likely terms of engagement, and the keys to managing the network. The take-away Most companies' attempts to make money out of their intellectual property suffer from the mistaken belief that it is an easy source of revenue. But capturing the full value of these assets requires systematic effort, a well-managed network of outside partners, and active senior-management support. "

Accounting intangible patent portfolio

2004-09-15T06:31:00.000+05:30

Intangibles Intangible Property is property that has value but cannot be seen or touched. Generally, you can either amortize or depreciate intangible property.You must amortize certain intangible property over 15 years if you meet the following conditions: You acquired the property after 8/10/93, (after 7/25/91, if elected) You use the property in connection with a business or for the production of income If you meet these conditions, amortize the following intangibles: Patents and copyrights Customer or subscription lists, location contracts, and insurance expirations Designs and patterns Franchises Agreements not to compete If you created any of the intangibles listed in item (1) through (3), you can amortize them only if you created them in connection with the acquisition of assets constituting a trade or business or a substantial part of a trade or business.For more information on amortizing these and other intangibles, refer to Amortization in Publication 535, Business Expenses. Generally, you can depreciate any of these intangibles acquired before August 11, 1993, or that do not qualify for amortization. However, they must have a determinable useful life. Agreements not to compete, lists, contracts, and expirations are sometimes confused with goodwill, which is not depreciable. Therefore, you must be able to determine their value separately from the value of any goodwill that goes with the business. If you can depreciate the cost of a patent or copyright, you can use the straight line method over the useful life. The useful life of a patent or copyright is the lesser of the life granted to it by the government or the remaining life. If it becomes valueless before the end of its useful life, you can deduct in that year any of its remaining cost or other basis. Straight Line MethodGenerally, if you can depreciate intangible property, you use the straight line method of depreciation. It lets you deduct the same amount of depreciation each year. To figure your deduction, first determine the adjustment basis, salvage value, and estimated useful life of your property. Subtract the salvage value, if any, from the adjusted basis. The balance is the total depreciation you can take over the useful life of the property. Divide the balance by the number of years in the useful life. This gives you your yearly depreciation deduction. Unless there is a big change in adjusted basis or useful life, this amount will stay the same throughout the time you depreciate the property. If, in the first year, you use the property for less than a full year, you must prorate your depreciation deduction for the number of months in use. Example: In April, Frank bought a patent for $5,100. It was not acquired in connection with the acquisition of any part of a trade or business. He depreciates the patent under the straight line method, using a 17-year useful life and no salvage value. He divides the $5,100 basis by 17 years ($5,100/17=$300) to get his yearly depreciation deduction. Because he only used the patent for 9 months during the year, he multiplies $300 by 9/12 to get his deduction of $225. Next year, Frank can deduct $300 for the full year. Intangible Property That Can Never Be DepreciatedThe following are two types of intangible property that you can never depreciate. Goodwill Trademark or trade name Goodwill is the value of a trade or business based on expected continued customer patronage due to its name, reputation, or any other factor. You can never depreciate goodwill because its useful life cannot be determined. However, if you acquired a business after August 10, 1993 (after July 25, 1991, if elected), and part of the price included goodwill, you may be able to amortize the cost of the goodwill over 15 years. For more information, refer to Amortization in Publication 535, Business Expenses. Trademark, trade name or franchise is a section 197 intangible. In general, you cannot depreciate the cost of a trademark, trade name or franchise. However, you may be able to amortize over 15 years the cost of a trademark, trade name or franchise you acquired after August 10, 1993 (after July 25, 1991, if elected). You must amortize its purchase or renewal cost, other than certain contingent payments that you can deduct currently. For more information, refer to Other Expenses in Publication 535, Business Expenses. If you buy a trademark, trade name, or franchise you can deduct the amount you pay or incur as a business expense only if your payments are part of a series of payments that are: Contingent on productivity, use, or disposition of the item Payable at least annually for the entire term of the transfer agreement, and Substantially equal in amount (or payable under a fixed formula). When determining the term of the transfer agreement, include all renewal options and any other period for which you and the transferor reasonably expect the agreement to be renewed. The tax treatment of goodwill, a covenant not to compete and a consulting agreement can be summarized as follows: Buyer Seller Goodwill Amortize 15 years Capital asset Covenant not to compete Amortize 15 years Ordinary income Consulting agreement Deduct as incurred Ordinary income Additional Resources Publication 535, Business Expenses Publication 946, How to Depreciate Property IRS Code Section 197 From: Crouch, Dennis [mailto:crouch@mbhb.com] Sent: Tuesday, September 14, 2004 3:59 PMTo: PatentLawPractice@yahoogroups.comSubject: RE: [PatentLawPractice] Use of patents I agree, you need more info before he gets the ax. It is likely that the IRS and accounting rules relating to patents do not follow any logic. In terms of being in use, you should also include inventions that have not even been written up as patent applications -- these would be considered trade secrets. -- Dennis -----Original Message-----From: Pyle, Jeffrey [mailto:jpyle@wmalaw.com] Sent: Tuesday, September 14, 2004 2:53 PMTo: PatentLawPractice@yahoogroups.comSubject: RE: [PatentLawPractice] Use of patents You never know…I wouldn’t be surprised if the IRS is sufficiently obtuse about patents to realize there’s even an issue. Or, they might not care, and just assume that for accounting purposes only the “in use” patents can get amortized since you can’t value the patent that are not “in use.” I guess I’d just get a second opinion from another accountant on this narrow issue. -----Original Message-----From: N. Stephan Kinsella [mailto:kinsella@ao-inc.com] Sent: Tuesday, September 14, 2004 2:49 PMTo: PatentLawPractice@yahoogroups.comSubject: [PatentLawPractice] Use of patents An accountant who was trying to decide how to amortize the costs of our patent portfolio for tax or auditing purposes wanted to know how many of our patents "were being used", were "in use". I told him that patents and apps in our portfolio have a variety of classifications: pending, published, allowed, issued, abandoned. But that I don't know what it means for a patent to be "in use". He replied that he assumed "in use" means an issued patent, since "when it issues you start selling product and getting licensing revenue." I cannot believe this is correct. Not all patents cover the owner's products or even competitors' products. And of course not all of them are licensed. It is not even always objectively clear (or at least, the owners don't always have an up to date chart showing which patents do, and do not, "cover" the owner's products; or are generating licensing revenue). I cannot believe IRS or relevant accounting rules require such records to be kept. It seems to me that any issued patent that you own is "in use" since it sits there as potential ammunition or asset, at the ver least. Moreover, it seems to me that at least published apps are also "in use" in a sense given that their claims are published and putting competitors on notice for possible back royalties in the event of a future issuance. My guess is this guy is an idiot. My question is, should I fire our accounting firm?

So you want to monitor a patent%3F %7C IP News Blog

2004-08-20T11:49:00.000+05:30

So you want to monitor a patent%3F %7C IP News Blog: "So you want to monitor a patent%3F%0D%0ASubmitted by Carey on Thu%2C 07%2F29%2F2004 - 3%3A35pm. 35 U.S.C. %7C Invention %7C IP News %0D%0AThe folks at Varchars have come up with a neat little perl hack that allows you to keep track of a patent at the USPTO. Set this up as a cronjob%2C and you have an automatic and easy way to keep track of applications as they pass through the patent process. Very neat. Thanks to ResearchBuzz for the link."

ANDA filing doesn't constitute Willful patent infringement

2004-08-16T00:47:00.000+05:30

"Glaxo Group Limited v. Apotex, Inc., 2004 U.S. App. LEXIS 15489 (Fed. Cir., July 27, 2004) Apotex, Inc. ('Apotex') appeals the judgment of the United States District Court for the Northern District of Illinois, which found that Apotex's filing of an Abbreviated New Drug Application ('ANDA') for a generic version of the antibiotic CEFTIN willfully infringed U.S. Patent No. 4,562,181 (the ''181 patent') and U.S. Patent No. 4,820,833 (the ''833 patent') owned by Glaxo Group Limited and SmithKline Beecham Corp. (collectively 'Glaxo'). The Federal Circuit affirmed the district court's determination that Apotex's ANDA infringes both the '181 and '833 patents pursuant to 35 U.S.C. � 271(e)(2), and also affirmed that the patents at issue are not invalid. The Federal Circuit, however, reversed the district court's finding that Apotex's ANDA filing constituted willful infringement. The Federal Circuit held that the mere filing of an ANDA cannot constitute an act of willful infringement compensable by attorney's fees under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Federal Circuit explained that 35 U.S.C. � 271(e)(2) and 35 U.S.C. � 271(e)(4) create only an 'artificial' act of infringement for a 'very limited and technical purpose that relates only to certain drug applications.' This purpose is to permit patent holders to bring suit against generic companies despite the fact that the generic companies have not yet infringed the patents at issue. The Federal Circuit eloquently wrapped up its analysis by saying: '[t]he district court therefore erred in hanging a finding of willfulness on such a special-purpose peg.'"

WAR FOR DRUGS........

2004-08-16T00:32:00.000+05:30

Drug Wars: six lawyers discussing genrics Vs big Pharma drug war In our roundtable, pharma lawyers dissect the changes in Hatch-Waxman, the costs of patent litigation, and the blurring line between generic and branded drug companies. IP Law & Business/August 2004 "

Profiting from Patents--anyway-whether ethical or ....

2004-08-16T00:17:00.000+05:30

"Submarine Patents Sunk: One of the frequent criticisms I hear of the U.S. patent system in particular is the existence of 'submarine' patents. This term refers to patents that issue very long after their filing. So a company or organization that has been happily proceeding along a path of commercialization of their product is blind-sided by a patent issuance, the existance of which was secret. For several reasons, the number of submarine patents is diminishing: the U.S. now has a patent term of 20 years counted from the date of filing, and for the most part, patent applications are published 18 months after filing. Because these changes only took place in 1995 (patent term) and 2000 (publication), a few submarine patents have been lurking stealthily along, grandfathered in under the old rules. The most prolific user of the old U.S. patent system has to be Jerome Lemelson. Patent applications he filed in the mid-1950s and that were granted between 1978 and 1994 are now being asserted against manufacturers of bar code readers and machine vision systems. While this strategy has netted Lemelson and the Lemelson Foundation as much as $1 billion in royalty payments, the gold mine is being shut down. A U.S. District Court recently ruled that 14 patents of Lemelson's are invalid because 'Lemelson's delay in securing the asserted patent claims is unexplained and unreasonable'. While this is good news for the manufacturers, it is not the end of the story as the Lemelson Foundation is expected to appeal the decision. In the opinion of yours truly, Lemelson Foundation is going to be sunk for good on this one. In the last few years, the Federal Circuit Appeals Court has not looked favorably on delays initiated by the patent applicant. "

Who lost it.... plant breeder or farmer or we

2004-08-16T00:12:00.000+05:30

Navigating the patent maze: Court Decisions: "Schmeiser v Monsanto By this time, most of you have heard that 'Monsanto won' over Percy Schmeiser in the Canadian Supreme Court. Actually, Mr Schmeiser was found to have infringed Monsanto's patent but no damages were assessed. It was a close decision and a momentous one for two main reasons. Several commentators have written about how genetically-engineered plants are essentially, if not expressly, protectable because of the gene introduced. In another blog entry, I will discuss that issue. For this entry, however, I raise the possibility that the Court has defined 'use' of a patented invention in such a way that that there may now be an exemption for basic science research in Canada. Monsanto Canada Inc v Schmeiser 2004 SCC 34. In particular, the court defined 'use' as utilization with a view to production or advantage. The use then that interferes with the rights granted to the patent owner is infinging. Amazingly, the Court characterized deprivation of their rights when 'another person, without licence or permission, uses the invention to further a business interest.' Does this imply that a use that is not commercial or furthering a business interest is non-infringing? Would a research use in the confines of a non-profit or educational institute be non-infringing? There are several ways that the Canadian Courts can go. For example, the Canadians, like their southern neighbor counterpart court, may say that essentially all uses have a business purpose, even universities who may 'use' in furtherance of their business of education and money raising. Or, they may hold that that commercial use is not the only use that can be infringing. The Canadian Supreme Court hints that the latter route is appropriate when they write 'Even in the absence of commercial exploitation, the patent holder is entitled to protection." In Schmeiser's case, Mr Schmeiser contended that he didn't use the patented gene, which conferred resistance to roundup, because he didn't spray the canola crop with the herbicide. But, the court still found 'use' of the invention because Mr Schmeiser's business was growing canola, and he grew canola containing the patented seeds. Furthermore, he had the advantage of the stand-by use, meaning that he could have sprayed Roundup (tm) or could have sold the seed to other farmers who didn't want to pay the fee to Monsanto. Where does this leave those who may use a patented invention in the context of research? Without clarification of this issue by the Canadian courts, I wouldn't assume that there is now a research exemption. That said, despite what is likely a huge amount of infringment of patents in university settings, very rarely are universities and scientists there ever stopped from using a patented invention. For more on this subject, I refer you to this article: "Accessing other people's technology for non-profit researchAJARE.pdf Australian Journal of Agricultural and Resource Economics 46:3 389-416 (September 2002).

The Invent Blog: Software Patents

2004-08-03T00:47:00.000+05:30

The Invent Blog: Software Patents: "EU software patents a reality Via Bill Heinze, The European Council approved the Software Patents Directive which will now be sent back to the European Parliament for another vote in the Fall where reversing the Council's vote may be difficult. The Community Patent Regulation, on the other hand, died when Spain demanded all 20 translations of the claims be considered legally binding and ministers would not compromise by leaving the issue for courts to decide. For still more, see http://zdnet.com.com/2100-1104-5215020.html and http://www.siliconvalley.com/mld/siliconvalley/news/editorial/8695760.htm"

Vote on Software patent directives in EU EurActiv.com Portal - News nr 1507687

2004-08-03T00:42:00.000+05:30

Tension grows as Council prepares to vote on software patents directive Background:On 20 February 2002, the Commission presented a proposal for a Directive on the Patentability of computer-implemented inventions. These are defined as inventions "involving the use of a computer, computer network or other programmable apparatus". Currently, patents for computer-implemented inventions are granted by the European Patent Office (EPO), but are not enforceable in all Member States because of diverging legislation. The Commission argues that the directive would provide more certainty for businesses, encouraging them to innovate and profit from their work. At the same time, it said its objective was to avoid stifling competition in the internal market and to favour small businesses. To achieve this, the Commission argued patents should be awarded only to inventions "which make a 'technical contribution'- in other words which contribute to the "state of the art" in the technical field concerned". Computer programmes as such, it said, would not fall under the proposal. Issues:The Irish presidency has tabled a compromise deal on the software patents directive which is scheduled to be voted on by EU ministers at the 18 May Competitiveness Council. According to the Council press service, Germany (abstaining), Belgium (opposed) and Denmark (unpronounced as of yet) are the only countries who have not accepted the compromise. Because there is so ittle opposition among the Member States, the Irish presidency is considering tabling the text without debate. But the draft is already stirring much criticism from anti-patent campaigners. They claim that the amendments introduced by Parliament in September last year have been scrapped almost entirely. And MEPs themselves have expressed dismay at the Council's choices. If approved by EU ministers, the Irish compromise will have to return to Parliament for a second reading as not all of the MEPs' amendments were taken on board. The directive was voted on by Parliament on 24 September 2003 (see EurActiv, 25 September 2003). MEPs introduced numerous amendments, reflecting concerns by critics from diverse backgrounds who claimed the Commission proposal would introduce a US-style regime under which large companies can acquire unlimited software patents to protect them from competition. MEPs in particular insisted that the directive should not lead to "any drift towards the patentability of unpatentable methods such as trivial procedures and business methods". To them, the technical contribution referred to in the Commission proposal has to offer an "inventive step" defined as something "new, non-obvious, and susceptible of industrial application". They recommended applying a test in order to verify this. In addition, they claimed that a mathematical algorithm in itself should not be patentable unless it its used to solve a technical problem. The Parliament was also wary not to damage provisions of an existing directive (91/250/EEC on the legal protection of computer programmes) under which rights holders are forced to disclose information to ensure interoperability with other applications. Positions:MEPs from all major political parties have expressed discontent at the Irish presidency compromise for ignoring the Parliament's position. MEP Arlene MC Carthy (PES, UK), the Parliament's rapporteur on the dossier, told EurActiv she is not surprised at the Council's position: "Member States have been heavily lobbied by industry. The Parliament's vote was clear - we do not want software per se to be patented. We want strict interpretations and criteria for genuine inventions. The Council Common Position is not the final word. The new Parliament will have a second reading and I expect there to be some tough talking and negotiations". Speaking to EurActiv, a spokesperson at the Irish Department of Enterprise, Trade and Employment said the compromise merely reflected the position of Member States' experts at the Council's Working Party on Intellectual Property (Patents). The spokesperson indicated the second reading in the Parliament would provide another opportunity for MEPs to move away from the Council's common position. European Industry Association for Information Systems, Communication Technologies and Consumer Electronics (EICTA) says it is "quite satisfied" with the Irish compromise text. Speaking to EurActiv, it expressed satisfaction at the removal of a proposal from the Luxembourg delegation concerning Article 6a on interoperability. This, EICTA said, would have rendered it "impossible" for European companies to develop and protect innovations that depend on data communications. To EICTA, the Irish compromise would implement the status quo of the European Patents Office "with clarification and tightening", as adovated by the industry association. The Foundation for a Free Information Infrastructure (FFII) is leading a campaign against the directive. It says the compromise agreement clinched by the Irish Presidency discards all the Parliament amendments aimed at limiting patentability. It says that the rejection of the Luxembourg delegation's attempt to ensure interoperability leaves the door open to unlimited patentability of computer programmes, data structures and process descriptions. Major European companies including Nokia, Philips, Siemens, Ericsson and Daimler Chrysler have issued a joint statement on 13 April 2004. They call for all EU ministers to support the text proposed by the Irish Presidency: "We commend the Irish Presidency for presenting a balanced text which preserves the incentives for European innovation (...) while responding to the European Parliament’s call for limitations to ensure that patentability does not extend into non-technical areas or unduly hinder interoperability in our increasingly networked society," the statement reads. Internal Commissioner Frits Bolkestein is strongly opposed to the Parliament's amendments which he thinks are "unacceptable". He threatened to withdraw the proposal altogether and go another route: "If I may be blunt (...) the process of renegotiation of the European Patent Convention would not require any contribution from this Parliament," Bolkestein told MEPs before they voted on the text in September last year. Next steps: The EU Council of ministers will vote on the directive on 18 May The Parliament will examine the text for a second reading after the June elections, probably under the Dutch presidency Links: Official documents: EUR-Lex: Proposal for a Directive on the patentability of computer-implemented inventions, COM(2002) 92 final, [FR] [DE] (20 Feb. 2002) PreLex: Proposal for a Directive on the patentability of computer-implemented inventions [FR] [DE] Parliament OEIL: Patent law: patentability of computer-implemented inventions [FR] Parliament: Texts Adopted - European Parliament legislative resolution on the proposal for a directive on the patentability of computer-implemented inventions [FR] [DE] (24 Sept. 2003) Parliament: Press release - Patentability of computerised inventions [FR] [DE] (24 Sept. 2003) Parliament: Report on the proposal for a Directive on the patentability of computer-implemented inventions, Arlene MC CARTHY (PES, UK) [FR] [DE] (18 June 2003) Commission: Proposal for a Directive on the patentability of computer-implemented inventions - frequently asked questions [FR] [DE] Commission press release: Patents: Commission proposes rules for inventions using software [FR] [DE] Cordis: Proposal for a Directive on the patentability of computer-implemented inventions EU Actors' positions: Foundation for a Free Information Infrastructure (FFII): Software patents in Europe FFII: EU Council plans to scrap parliamentary vote without discussion (7 May 2004) FFII: EU Council 2004/01/29 "Presidency Compromise Proposal" on Software Patents (5 May 2004) European Industry Association for Information Systems, Communication Technologies and Consumer Electronics (EICTA): Proposal for a Directive on the patentability of computer-implemented Inventions - EICTA Response on the Irish Presidency Consolidated Text (24 Mar. 2004) EICTA: Industry Calls on Council to Correct Damage Done by the European Parliament -- European R&D Will Be Jeopardised If CII Patents Are Eliminated (26 Nov. 2003) EICTA: Analysis of Amendments adopted by the European Parliament at the First Reading (23 Oct. 2003) Nokia, Ericsson, Daimler Chryseler & others: Joint statement on the proposed directive on patentability of computer-implemented inventions (13 Apr. 2004) Campaign for creativity: The Software Patents Directive [FR] Electronic Frontier Finland: Open Letter by Linus Torvalds and Alan Cox to the European Parliament (21 September 2003) EuroLinux: Petition for a Software Patent Free Europe Research in Europe: An Open Letter to the European Parliament Concerning the Proposed Directive on the Patentability of Computer-Implemented Inventions Research in Europe: A Critique of the Rapporteur’s Explanatory Statement accompanying the JURI Report to the European Parliament on the proposed Directive on the Patentability of Computer-Implemented Inventions

Software Patents in EU

2004-08-03T00:38:00.000+05:30

The Invent Blog: Software Patents: "Software patents in Europe Arnoud Engelfriet e-mailed me to some links on his site about software patents in Europe: Examples of granted European business method patents The patentability of business methods at the European Patent Office Software patents under the European Patent Convention

Patently Obvious: MBHB Patent Law Blog: Patent Explosion

2004-08-03T00:29:00.000+05:30

Patently Obvious: MBHB Patent Law Blog: Patent Explosion: "Aug 02, 2004 Patent Explosion The past twenty years has seen increadible increases in the number of patents both applied for and issued. In her most recent paper (PDF), Berkeley professor and empirical whiz, Bronwyn Hall, examines patenting data and arrives at some interesting conclusions. 1) Although patenting has increased in most technological fields, the explosive growth is largely accounted for by electrical and computing fields. 2) The explosion is drivin, for the most part, by U.S. firms, with some contribution from Asia and Europe. 3) Patenting has become a critical signal of viability for new entrants in many industries. Professor Hall's data shows that in most industries, increases in patenting were drivin by new entrants. However, patenting increases in electrical and computing industries were accomplished by a shift in patenting by industry stalwarts. The figures reveal the following interesting fact: although the jump in patent applications within the U.S. occurred in all technology classes, when we look by broad industry class, we find that it occurred only in firms that are in the electrical, computing and instruments industries. That is, the increase in chemicals, mechanical and other technologies appears to have been driven by increasing patenting activity by firms that were not traditionally in these industries. This result is consistent with the view that there has been a major strategic shift in patenting in the electrical/computing industries, but not in other industries. UPDATE: Professor Hall provided a correction to my original interpretation of her results. She interprets her results as showing 'that patents held by new entrants in the electrical and computing industries became more valuable post-1985 than those"

India: the big outsourcing hub of patent ideas

2004-07-30T19:37:00.000+05:30

this is how the world is changing around us... India: the big outsourcing hub of patent ideas - The Economic Times: India: the big outsourcing hub of patent ideas NONA WALIA TIMES NEWS NETWORK[ SUNDAY, JANUARY 04, 2004 01:04:38 AM ] NEW DELHI: Sample this - the Intel team in Bangalore is developing microprocessor chips for high-speed broadband wireless technology, to be launched in 2006; at GE's John F Welch Technology Centre in Bangalore, engineers are developing new ideas for aircraft engines, transport system and plastics. Be it Bangalore, Hyderabad, Chennai, Gurgaon, a 'weighty' amount of intellectual property is being created for US companies here. Indian units of Cisco Systems, Intel, IBM , Texas Instruments, GE have filed 1,000 patent applications with the US Patent Office. Texas Instruments has 225 US patents awarded to its Indian operation. It's the Year of the Idea, and the newest and busiest hub for innovations and intellectual property is India. Indians are parenting patents like never before in 200 R&D labs. (Can India become the R&D backyard for global MNCs?) "India is the new hub for patents, and soon, the world will be outsourcing R&D from India," says P Gopalakrishnan, director, IBM India Research Lab, IIT. Here's a list of patents passed in India: a moulded toothbrush with flexible bristles; a process for preparing a cell culture composition; a safety device for motorised two-wheelers with shock absorption; a process for isolation and purification of protein P17 for HIV. Intel, Bangalore has photographs of company engineers who have applied for patents hanging on the wall of fame. "We're making innovations in Bangalore, like we would in the Silicon Valley," says Siddhartha Das, Intel Technology India Pvt Ltd. "Our 1,400 engineers are constantly innovating chip hardware design, communication technologies. Now, we even have a well-developed Intellectual Property strategic program. In 2003, we made 125 invention disclosures and several patent filings from India," he says. There's even a BPO for patents - Evaluserve in Gurgaon. "We file patents for Fortune 500 companies across the world. But even Indian companies are waking up to the Big Idea. More and more companies are inviting us to evaluate innovations and file patents," says Ashish Gupta, COO, Evaluserve. "Indians want to be creators of intellectual property and not just own it."

How about it??

2004-07-29T01:18:00.000+05:30

Patently Obvious: MBHB Patent Law Blog: "ANDA Filing is not per se willful patent infringement Glaxo v. Apotex (Fed. Cir. July 27, 2004) Apotex appealed the district court judgment, which found that Apotex's filing of an Abbreviated New Drug Application (ANDA) for a generic version of the antibiotic Ceftin� willfully infringed Glaxo and SmithKline Beecham's patents. (U.S. Patents 4,562,181 and 4,820,833). On appeal, the Federal Circuit (GAJARSA) affirmed the infringement holding, but refersed the the district court's finding of willful infringement. We hold that the mere filing of an ANDA cannot constitute an act of willful infringement compensable by attorney�s fees under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. Because, the ANDA filing did not constitute an 'exceptional case,' the willfulness holding was reversed In dissent, DYK argued that the case was moot and thus should not be decided. The questions of infringement and invalidity are moot since, as the parties conceded at oral argument, there are no past damages being sought for infringement, and the patents have expired. I dissent from the majority�s decision to address the issues of infringement and invalidity in the absence of a live case or controversy."

Segway Inventor to speak at Inventors Conference

2004-07-29T01:15:00.000+05:30

Patently Obvious: MBHB Patent Law Blog: Segway Inventor to speak at Inventors Conference: "Segway Inventor to speak at Inventors Conference The USPTO has announced that Dean Kamen, one of the world�s best known and most successful inventors, will be the keynote speaker at the opening session of the USPTO�s annual Independent Inventors Conference in Concord, N.H. on Friday, August 20. Dean Kamen is Chairman of Segway LLC, an inventor and a physicist. 'His inventions include a portable dialysis machine and the Segway� Human Transporter.' Registration is available online. "

Ousourcing Patent Serches

2004-07-28T01:01:00.000+05:30

Publishing Technology News: "Wednesday, March 10 Quality Assured Patents The US government has approved a bill that allows outsourcing of prior art searches as part of the patent examination process - sounds like a good idea? I don't think so. The bill stipulates that the maximum that can be paid for searches is $500 and that small companies should be favored when placing the searches (US companies/nationals only need apply). So we're likely to have a raft of new patents granted whilst the patent examiners figure out who can do decent searches and the quality is likely to be even more erratic than it has been to date. Rather than go through all this, why not just require that patent attorneys ensure, to the best of their determination, that patent applications are novel? I do not believe this happens at the moment; doing so would greatly reduce the burden placed on patent examiners and shift some of the costs of the search filtering onto those applying for patents. "

IQ matters!

2004-07-28T00:59:00.000+05:30

The Bell Curve revisited

Driving back and forth to Nashua, NH yesterday I listened to The Bell Curve as an abridged book on tape (picked it up for $5 in a used bookstore in San Diego). This book created quite a stir in 1994 because of its discussion of average IQ differences among races but I had never read it. It turns out that even if you leave out all the controversial stuff about race the book is potentially very relevant to our times.

The Bell Curve starts out by talking about how we live in an era where people get sorted by cognitive ability into socioeconomic classes. In 14th century England if you were a peasant with a high IQ or a noble with a low IQ it didn't affect your life, reproductive potential, or income very much. In our more meritocratic and vastly more sophisticated economy a smart kid from a lower middle class might make it to the top of a big company (cf. Jack Welch, who paid himself $680 million as CEO of GE) or at least into a $300,000/year job as a radiologist. For the authors of the Bell Curve the increasing disparity in income in the U.S. is primarly due to the fact that employees with high IQs are worth a lot more than employees with low IQs. They note that we have an incredibly complex legal system and criminal justice system. So you'd expect people with poor cognitive ability to fail to figure out what is a crime, which crimes are actually likely to be punished, etc., and end up in jail. (A Google search brought up a report on juvenile justice in North Carolina; the average offender had an IQ of 79.) If they stay out of jail through dumb (literally) luck, there is no way that they are ever going to be able to start a small business; the legal and administrative hoops through which one must jump in order to employ even one other person are impenetrable obstacles to those with below-average intelligence.

The trend that the decade-old Bell Curve book misses is telecom and outsourcing. The authors assume that an American with high IQ will have a higher income and better standard of living than an American with low IQ. That's the sorting function of an advanced economy. They don't get into the question of whether it is sustainable that an American with low IQ should have a higher income than someone in India or China with a high IQ. Statistically, due to their sheer hugeness, you'd have to expect that there are more really smart people in India and China than the total population of the U.S. If the sorting-by-IQ process were efficient across international borders you'd expect that an American with an IQ of 100 should be making less than an Indian with an IQ of 120. Given that a lot of brilliant well-educated people in India are getting paid less than $5,000 per year, this is a bit worrisome those of us here who are fat, dumb, and happy. [Imagine that you were running a company. Would you rather employ a local high school graduate with an IQ of 90 or an Indian college grad with an IQ of 130 via Internet link?]

For us oldsters, one unexpected piece of cheerful news from this book is that younger Americans are getting genetically dumber every year. Even if you ignore the racial and immigrant angles of the book that created so much controversy back in 1994 it is hard to argue with the authors' assertion that smart women tend to choose higher education and careers rather than cranking out lots of babies. As a middle-aged (40) guy whose own cognitive abilities are beginning to fade due to neuron death I felt sure that there would be no place me for in the America of 2050. Our population is predicted to reach 450 million or so, i.e., the same as India had back when we were kids and our mothers told us about this starving and overpopulated country. An individual person's labor in India has negligible economic value--the American firm Office Tiger gets 1500 applicants, many of whom are very well qualified, on a good day in Chennai. It would seem that no enterprise would need an old guy's skills in a country of 450 million; why bother when there are so many energetic young people around? And how would we be able to afford a house or apartment if there are 450 million smart young people out there earning big bucks and putting pressure on real estate prices? But if the book is right most of those young people will be dumb as bricks.

[Update: The Sunday New York Times has a long article in the Business section "Hourly Pay in U.S. Not Keeping Pace With Price Rises" about how American workers in jobs that don't require high IQs are losing ground compared to the middle class and compared to inflation. Raw labor isn't worth very much right now.]

# Posted by Philip Greenspun on 7/16/04; 4:18:31 PM - Comments [20] Trackback [1]

Software patent---- for whoes benefit

2004-07-28T00:49:00.000+05:30

Will Software Patents Destroy The U.S. Software Industry? :: Manageability ::

There's a pretty disturbing thread going on a TheServerSide. It was supposed to be a discussion about Hibernate, unfortunately its degenerated into an extremely heated and personal shouting match between the Ward Mullins (CTO of ThoughtInc) and Gavin King (co-author of Hibernate). Apparently, Ward is taking the playbook out of SCO, and playing the Patent FUD game. That is, if you're not a commercial entity, then the software you're distributing hasn't been cleared by the lawyers and it just might be possible that you might be violating someone's intellectual property (i.e. IP). Software Patents is now a weapon of choice to spread Fear, Uncertainty and Disinformation against a competitor. It doesn't matter that your patents will hold up in the court of law, it doesn't matter if you can extract compensation, what seems to matter is that you can make customers of a competitor think twice. It's an extremely bad situation, where business is won, rather than competing on merits, but on mudslinging.

In fact the trend looks like it's turning for the worse as evidence by two recent articles from CNET. Overture's business strategy to leverage its patent portfolio. Pinpoint, a company who's sole business model is suing other companies for patent infringement. We are now seeing the horrible consequences of the US patent office misguided policies to allow the patenting of software and business practices and to compound it with turning the office into a money making business rather than a public trust. The US software industry could eventually consist mostly of intellectual property lawyers trying to untangle the patent mess. The reality is, the rampant approval of questionable software patents has made it impossible for any software written to avoid infringing on an existing patent.

The only reason why we don't see even more rampant lawsuits is that its simply not worth it to sue someone without deep pockets. That however doesn't prevent companies for making unsubstantiated threats. So far things have remain relatively sane, that's because the bigger companies don't risk suing each other, afterall they all have something to lose. However, what happens if you've got companies with nothing to loose, that is companies whose sole business is not making software but rather suing companies. They aren't worried about a counter suit, you can't sue a lawyer for suing you.

The future looks pretty grim, it doesn't help that a lot of companies are already outsourcing IT work outside the US, maybe that's just the only place to legally do innovative software development. U.S. Software firms for all intents and purpose would end up as subsidiaries of law firms. The consolation maybe that you can still make a living programming only using "standards". Just make sure you don't innovate, that's something you either have to clear with the lawyers or done offshore!

Outsourcing Knowledge Processing

2004-07-28T00:40:00.000+05:30

India is putting more values yo it BPO service chain and a concept of Knowledge Process Outsourcing is coined specially for the advantage india. Here is an article pointing such changes in favor of india. Outsourcing Business: Evalueserve provides services for patent writing, evaluating and assessing the commercial potential for law firms and entrepreneurs. Its market research services are aimed at top-rung financial services companies, to which it provides analysis of investment opportunities and business plans. Another major product is multilingual services--Evalueserve trains and qualifies employees to communicate in Chinese, Spanish, German, Japanese and Italian, among other languages. That skill set has opened market opportunities in Europe and elsewhere, especially with global corporations. Experts say these new trends are significant, and they will continue to grow over time. "Activities considered for 'offshoring' have moved up in value and begun to touch core functions, such as highly analytical processes," says Stefan Spohr, a principal in the financial institutions group of A.T. Kearney, a global management consulting firm in Chicago. "More complex customer services are substituting simple data processing and call center activities." Spohr adds that the higher-end functions being performed offshore these days include information research, financial portfolio analysis, customer data mining, statutory reporting and inbound insurance sales, among others. . . . Cutting costs is not the only reason why outsourcing such tasks makes sense for its clients; its also about higher quality of work, says Aggarwal. "Among the more unusual emerging developments is that business process offshoring is not merely a way to reduce cost by migrating core functions," adds Spohr of A.T. Kearney. "It is also a strategic initiative to take advantage of technological advances and the human capital available offshore to fundamentally restructure an organization's operating model." Evalueserve's model works on a mixed system where anywhere between 50 percent and 80 percent of the work is handled out of an Indian facility, while the rest is done at the client's location. For example, a patent filing assignment from a U.S. corporation may involve the Indian staff writing the patent in English or say, Japanese, and evaluating its commercial potential. But the client or its law firm would do the actual filing in the United States. Us coders carp about outsourcing/offshoring all the time. Among other things, we always think it's witty to suggest outsourcing CEO's, managers, and other business positions. Well, there ya go. Yay capatalism!

New rules of US patent practice

2004-07-27T19:43:00.000+05:30

New Rules for US patent Practice this is quite an Interesting artice by William F. Heinze mailto:Bill.Heinze@tkhr.com Effective December 28, 2001, the U.S. Patent and Trademark Office has changed its Rules of Practice in Patent Cases with regard to claiming the benefit of prior-filed applications. The changes were made in order to implement provisions of the American Inventors Protection Act of 1999 for eighteen-month publication of patent applications. Here is a brief analysis of these changes announced in the Federal Register Notice of December 28, 2001.

Indiatimes Email - the most evolved email service

2004-07-27T19:36:00.000+05:30

Indiatimes Email - the most evolved email service

Necessity's Progeny -- Nipper's Patent Law Blog: Caselaw

2004-07-15T16:15:00.000+05:30

this link offers a good information on a latest case.. have a look over it,.... Necessity's Progeny -- Nipper's Patent Law Blog: Caselaw 06038004L.jpg is a good website for a comprehensive web search.

Patent Examiner Training-USA

2004-07-15T15:52:00.000+05:30

I found it Interesting ...... well with the wide spreading globalization .. perhaps we would see the day of globl IP Agent Necessity's Progeny -- Nipper's Patent Law Blog: Patent Examiner Training: "Patent Examiner Training"

Necessity's Progeny -- Nipper's Patent Law Blog

2004-07-15T15:46:00.000+05:30

Necessity's Progeny -- Nipper's Patent Law Blog

hi all

2004-07-15T15:39:00.000+05:30

NEW ALZHERIMER'S TREATMENT METHODS PATENTED NEW ALZHEIMER'S TREATMENT METHODS PATENTED Elan Corporation and Wyeth Pharmaceuticals' joint venture, Neuralab Limited, has been issued three patents for its research on immunotherapeutic approaches to the treatment of Alzheimer's disease. U.S. Patent Number 6,750,324, entitled "Humanized and chimeric N-terminal amyloid beta-antibodies," claims pharmaceutical compositions comprising an antibody that specifically binds to a region within the beta amyloid molecule. According to the abstract of the invention: The invention provides improved agents and methods for treatment of diseases associated with amyloid deposits [i.e. a protein aggregation] of A.beta. in the brain of a patient. Such methods entail administering agents that induce a beneficial immunogenic response against the amyloid deposit. The methods are useful for prophylactic and therapeutic treatment of Alzheimer's disease. Preferred agents including N-terminal fragments of A.beta. and antibodies binding to the same. U.S. Patent Numbers 6,743,427 and 6,761,888, entitled "Prevention and treatment of amyloidogenic disease" and "Passive immunization treatment of Alzheimer's disease" respectively, claim methods of prophylactically or therapeutically treating Alzheimer's disease, including the administration of a pharmaceutical composition comprising an antibody that specifically binds to a region within the beta amyloid molecule. In layman's terms, a patient is injected with an antibody (from Wikipedia: "An antibody is a protein complex used by the immune system to identify and neutralize foreign objects like bacteria and viruses.") that binds to a specific region within the amyloid molecule within the brain. Once the antibody binds the amyloid molecule, the patient's own immune system can attack and destroy the amyloid deposit and/or bind with precursor proteins and block the production of the amyloid deposits.