Novartis to continue Indian patent fight

Novartis CEO Daniel Vasella on Tuesday at the company's annual general meeting said that the drug maker plans to continue a lawsuit challenging a section of India's Patents Act that aims to restrict certain kinds of patents, despite criticism from some HIV/AIDS advocacy groups and shareholders, Reuters reports (Cage, Reuters, 3/6).

A court in Chennai, India, last month heard arguments in the case. Some HIV/AIDS advocacy groups are calling on Novartis to drop its legal challenge, saying that if the company wins the case it could restrict access to antiretroviral drugs for millions of people worldwide. Novartis brought a civil lawsuit against the Indian government after the country in January 2006 rejected the company's attempt to patent a new version of its leukemia drug Gleevec on the basis that the drug is a new formulation of an existing drug. India's patent law, which went into effect in January 2005, allows patents for products that are new inventions developed after 1995, when India joined the World Trade Organization, or for an updated drug that exhibits improved efficacy. Although some Indian drug companies and groups say that Gleevec is a new formulation of a drug developed before 1995, Novartis says that it is an improved drug. Decisions concerning patents on some newer HIV/AIDS drugs in India have not been announced. If Novartis wins the case, it could potentially set a precedent for other pharmaceutical companies seeking patent protection for drugs, including antiretrovirals, some HIV/AIDS advocates have said. The court has been asked to clarify regulations on patents for new versions of existing drugs whose original patents have expired. According to Medecins Sans Frontieres, most of the roughly 9,000 pending patent applications would be affected by this ongoing case. MSF, which relies on India for about 80% of the AIDS drugs it uses to provide 80,000 people worldwide with access to treatment, in a statement said that if India is "made to change its law, many of these medicines could become patented, making them off-limits to the generic competition that has proved to bring prices down" (Kaiser Daily HIV/AIDS Report, 2/16).

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"We don't want popularity awards, we want to serve our patients and remain competitive," Vasella said Tuesday at the meeting, adding that India has a growing middle class that can afford to pay for patented medications. "There are two markets within one country," he said, adding, "We are only concerned with protection of intellectual property in India." Novartis has said that intellectual property laws are crucial to encouraging investments in new drugs and that it is important for India to recognize the role of patents in drug development (Reuters, 3/6). Some advocates on Tuesday at the meeting planned to call on Novartis to withdraw the lawsuit, the nongovernmental organization Erklaerung von Bern said, Dow Jones reports. Novartis' lawsuit is "endangering access to affordable generics in developing countries," EVB said. According to Dow Jones, EVB and Oxfam plan to ask shareholders to back their efforts aimed at encouraging Novartis officials to drop the case (Greil, Dow Jones, 3/6). According to Christian Captier, MSF's Switzerland director, if "Novartis were to win this case, it would probably strengthen the inequalities up to creating a medical apartheid." A verdict in the case, which closed on Monday, is expected in about one month and can be appealed by either side to the Indian Supreme Court (Reuters, 3/6). In related news, Reuters India on Monday examined the effects the Novartis case might have for people living with HIV/AIDS in Africa. According to Reuters India, about 300,000 people worldwide have signed a petition calling on Novartis to withdraw the case (Clarke, Reuter India, 3/5).