Hearing in the controversial Glivec patent case remained inconclusive in the Supreme Court with the Novartis' lawyer Gopal Subramaniam continuing his arguments in the court. The Supreme Court, which heard the case for three days from September 11 to 13, will resume hearing the case from September 18.
According to sources, the Novartis' lawyer Gopal Subramaniam has not concluded his arguments yet and will continue to argue on September 18 as well. This will be followed by arguments from Anand Grover, who represents the Cancer Patients Aids Association (CPAA), Rajeshwari Hariharan, who represents the generic pharma company Natco Ltd, representative of Cipla Ltd Harish Salve and Paras Kuhad, who is representing the government of India in this high-voltage case.
In this case, the Swiss pharma major Novartis is challenging Section 3(d) of India's Patents Act which prohibits 'evergreening' - the practice of multinational pharmaceutical companies to extend their patent terms by making small and trivial changes to existing molecules and thereby preventing manufacture of generic drugs.
The Supreme Court case, between Novartis and the government of India, is the final act in a legal battle that stretches back to six years over India's future capacity to produce low-cost generic medicines for its people, and for patients in other developing countries.
Novartis patented the molecule imatinib in 1993. After the signing of the WTO TRIPS agreement by India in 1995, Novartis filed another patent application on the mesylate salt form of imatinib in 1998 at the Indian patent office. In 2005 India amended its patent law to comply with the WTO TRIPS agreement but also included Section 3(d), an important health safeguard that does not allow companies to get patents on new forms of old drugs.
Novartis’ application was rejected by the Indian patent office on several grounds including that the application claimed a new form of an already existing medicine. The company then sued the Indian government, cancer patients and several generic companies in order to get its patent monopoly on imatinib mesylate by getting Section 3(d) knocked out of the patent law.
Simultaneously, Novartis pursued a separate appeal of the denial of its patent application on Glivec arguing that it met the standards of Indian law. When its administrative appeal failed, Novartis appealed again, this time to the Indian Supreme Court to try and change the interpretation of Section 3(d). |