NEW DELHI: The Supreme Court is set to rule today on a patent challenge by Swiss pharmaceutical giant Novartis that activists say threatens access to cheap generic versions of life-saving drugs in poor nations.
Generic drug firms in India — long known as the “pharmacy to the developing world” — have been a major supplier of copycat medicines to treat diseases such as cancer, TB and AIDS for those who cannot afford expensive branded versions.
A Novartis win in the Supreme Court would “be dire for people in the developing world who depend on generic drugs made in this country. It could seriously curb access”, said Leena Menghaney, a lawyer with medical charity Medecins Sans Frontieres (MSF).
The landmark challenge — watched closely by global pharmaceutical firms — involves an updated version of Novartis’ blockbuster cancer drug Glivec, for which the company is seeking patent protection.
India’s patent office has refused protection, asserting that the amended form of Glivec was not vastly different from the earlier version.
The challenge strikes at the heart of India’s patent act, which restricts pharmaceutical companies from seeking fresh patents for making only small modifications to existing drugs — an industry practice known as “evergreening”. Novartis says the updated form of Glivec merits a patent, arguing that it is a significant improvement from the earlier version because it is more easily absorbed by the body.
But critics such as MSF describe the changes in Glivec — often hailed as a “silver bullet” for its breakthrough in treating a deadly form of leukaemia — as “an obvious, routine modification”.
A Novartis win would “set a dangerous precedent, severely weakening India’s legal norms against ‘evergreening’,” Menghaney said.
“You could have drug companies claiming one new drug and then patenting it over and over again for routine improvements,” she told AFP. The Novartis case is the most high-profile of several drug patent battles being waged in the country and is seen as having far-reaching implications in defining the extent of patent protection in India.
It is being watched closely by other global drug firms hoping to sell branded medicines in the country of 1.2 billion, whose growing affluence has created a highly lucrative market. AFP
