The Madras High Court is set to give its verdict on Monday on Novartis? suit against the Government of India, challenging the provisions of a certain Section in the Indian Patent Act vis-?-vis the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement.
In favour or against, the verdict would assume significance globally as it would have a far-reaching impact over the availability of cheaper drugs across the world as India remains a global hub for cheaper generics.
Novartis had filed the suit with the high court, saying that Section 3(d) of Act was not compliant with the TRIPS agreement India signed in 2005. This followed the Chennai Patent Office?s decision on January 2006 to reject the company?s application for patents protection for cancer drug Glivec (imatinib mesylate). The patent office based its move on the provisions of the Section 3(d), saying that imatinib mesylate was a known substance and had gone off patents long back.
The provisions of the Section do not allow patenting of known products with trivial changes. Now, if the court?s decision is in favour of Novartis, multinational companies can claim patents for known drugs by making changes. Ranjit Shahani, vice-chairman & managing director, Novartis India , says, ?Without pharmaceutical research and development leading to innovative medicines, poor people will continue to suffer and die. Generic drugs would simply not exist without new, original medicines.?
Glivec, the bone of contention, is for treating chronic myeloid lukaemia and is priced at Rs 1,20,000 for a month?s use. But the generic versions manufactured by Indian companies like Ranbaxy, Cipla, Natco and Hetero Pharma are available for Rs 8,000.