Indian Court Hears Arguments In Case Against Country's Patents Act

A court in Chennai, India, on Thursday heard arguments from pharmaceutical company Novartis in a case challenging a section of India's Patents Act that aims to restrict certain kinds of patents, Reuters India reports (Cage, Reuters India, 2/15). 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 (Kaiser Daily HIV/AIDS Report, 1/30). "Internationally compatible patent laws would spur investment in biomedical [research and development] activities in India ... and help patients, the government and industry," Novartis executive Thomas Wellauer in a statement said, adding, "Only if patents are respected can research-based organizations continue making long-term, risky investments in new medicines for patients." 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" (Reuters India, 2/15).

Waxman Letter
Rep. Henry Waxman (D-Calif.) in a letter to Novartis CEO Daniel Vasella on Wednesday called on the pharmaceutical company to reconsider its lawsuit, saying it could have a negative effect on access to affordable drugs in developing countries, the AP/Forbes reports (AP/Forbes, 2/14). Waxman, chair of the House Committee on Oversight and Government Reform, said, "I do not dispute your right to apply for a patent or appeal a denial. I am concerned, however, that your attempt to influence domestic Indian law could have a severe impact on worldwide access to medicines." He added, "Because of the profound need for affordable medicines in the developing world, I ... urge you to reconsider Novartis' challenge of public health safeguards in India's patent law" (Waxman letter, 2/13). Novartis said that defending patent laws will help patients in the long term, according to the AP/Forbes. "History has shown that patents save lives by stimulating research, which leads to innovative medicines," the company said on its Web site (AP/Forbes, 2/14).

The Waxman letter is available online. Note: you must have Adobe Acrobat to view the letter.

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