NEW DELHI: Swiss pharmaceutical giant Novartis has filed a suit in the high court of Chennai in south India contesting the rejection of its patent application concerning its anti-cancer drug Glivec.
A division bench of the court is hearing the issue, a decision on which will have a major impact on the generic medicine industry, which will in turn impact health care not only in India but most of the developing and underdeveloped countries.
Novartis is not merely challenging the patent office's decision, it is questioning the constitutional validity of a major provision in the Patents Act of the country. The company contends that section 3(d) in the act is unconstitutional and a breach of international trade law. This section stipulates that modifications of already-known medicines cannot be patented unless such modifications make the drugs significantly more effective.
It is aimed at preventing a practice in pharmaceutical industry whereby a patent holder continues to apply for patents for minor modifications of existing drugs to extend their hold on the original patent beyond the original period of patent.
Novartis had invented Glivec prior to 1995, but it has filed for a new patent for the chrystalline form of Imatinib mesylate (Glivec's active ingredient), after 1995. This was rejected by the Indian patents office in January 2006 and the company is appealing against this decision in the high court.
The generic form of Glivec is currently distributed to thousands of patients in India, at a fraction of the price charged by Novartis.
Watchdog groups, including Medicines sans Frontiers, say generic competition has dramatically reduced the cost of AIDS drugs. Several of these groups have launched a petition against Novartis. These groups said India's ability to manufacture low cost generic versions of newer medicines would be threatened if Novartis' claim is entertained by the court.
A spokesperson for Medicines sans Frontiers said a court ruling will not just have consequences for Glivec, but the whole market is at stake.
In Washington, activists from non-governmental groups tried Monday to deliver a golden miniature coffin at a Novartis office but were turned away.
The activists said the action symbolized the "fatal consequence" of Novartis' filing the appeal and it is on behalf of people dependent on India for generic medications.
A major AIDS and human rights activists group in the U.S. said people with HIV around the world depend on India for generic equivalents of antiretrovirals. Generic Indian antiretrovirals are reportedly used for about half of all HIV treatment in poor countries.
In the Indian capital of New Delhi activists marched in protest.
The court hearing is expected to continue on 15 February.
