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

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

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

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

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

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.

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

WTO upholds cheaper drugs waiver

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. "