Indian Health Minister Asks Novartis to Stand Down On Gleevec Patent Fight
The Indian health minister Anbumani Ramadoss urged Novartis earlier this month to end its legal bid to win patent protection for its oncologic Gleevec, or he said the government may override existing patents for vitally necessary drugs by issuing licenses that allow Indian generic manufacturers to produce cheaper versions in the interest of public health.
However, Novartis has no plans to stand down in the matter. Novartis' Head of Corporate Services Thomas Wellauer told "The Pink Sheet" DAILY that the firm has a right to defend the merits of its appeal in the Indian courts. "I am surprised that a government official is questioning the right of an individual or a company to ask a judicial system for an opinion," Wellauer said.
For the time being, the health minister's comments amount to nothing more than empty threats for Novartis, since in order to issue a compulsory license to overrule a drug patent, an actual patent needs to exist.
The Indian Patent Office in January 2006 denied Novartis a patent for a beta-crystalline form of imatinib mesylate, reasoning that it did not show sufficient efficacy improvement over the original free base form of the drug (1"The Pink Sheet" DAILY, March 15, 2007).
Additionally, "there are generics on the market, so there is absolutely no reason to issue a compulsory license," Wellauer said. In addition, Novartis has maintained throughout the Gleevec patent suit that the company has no market for Gleevec in India, since it gives the majority of the drug away for free.
"If there is one country in the world where a compulsory license is bizarre, it's India because it didn't have a law that made substances patentable until 1995," Wellauer said.
India signed on to the WTO's Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement in June 2005, which instated product patents, and made "reverse engineering" and copying Western drugs illegal for products patented after 1995. The application for the original free base form of Gleevec was filed prior to 1995, and as mandated by section 3(d) of the Indian Patent Act of 2002, the beta-crystalline form of imatinib mesylate must show substantially more efficacy than the original free base formulation to receive patent protection (2"The Pink Sheet" DAILY, April 24, 2007).
Ramadoss' call for compulsory licensing, however, is a reaction to the growing concern that a court decision in favor of Novartis could create a difficult regulatory environment for India's generic drug manufactures, which make 67 percent of medicines exported to developing countries (3"The Pink Sheet" DAILY, March 16, 2007).
However, according to Shamnad Basheer, visiting associate professor of IP law at George Washington University Law School, "the health minister can't ask Novartis to withdraw its case. That's the court's decision."
"The health minister has nothing to do with the issuing of compulsory licenses," Basheer added. "Normally a private entity, like a generic drug company, has to request a compulsory license on some grounds, such as the price of the brand drug is too high, or that it is a public health emergency."
Additionally, given Thailand's recent experience with "compulsory licensing," the mere suggestion of such a possibility in India may make multinational pharmaceutical companies jittery about investing in the country. After Thailand's Ministry of Public Health issued compulsory licenses for three drugs- Bristol-Myers Squibb's Sustiva, Abbott's HIV drug Kaletra and Sanofi-Aventis' antiplatelet drug Plavix - Abbott announced in March it would no longer launch new products in Thailand.
-Turna Ray
This article is reprinted from "The Pink Sheet" DAILY – April 27, 2007
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