India Supreme Court to rule on ‘evergreening’ clause

The Swiss drug company Novartis has been involved in a long-running battle (since 2006) for an Indian patent for imatinib mesylate which is the leukaemia drug known as Glivec (Gleevec in the US). Glivec has shown success in turning deadly chronic myelogenous leukaemia into a manageable chronic disease for patients. Novartis developed a predecessor compound to imatinib mesylate in the early 1990s, which was not patented in India (because India did not grant drug patents at that time). However, this older compound was never marketed as a drug. Novartis says the current version of Glivec, which is currently patented in over 40 countries, is 30 per cent easier for the body to absorb than the older compound. Novartis alleges that the meaning of “efficacy” should be interpreted to include modifications which make a drug safer or easier to use, not just more effective in treating a disease.

With its arguments having been rejected below, Novartis has brought its final challenge before India’s highest court, with the hearing before Justices Aftab Alam and Ranajan Prakash Desai commencing on Tuesday. Even if Novartis is successful before the Supreme Court of India, generic versions of Glivec will still be able to be sold in India because they were marketed prior to 2005 and have protection under Indian patent law. While Novartis might not have much to gain directly from this case, the ruling is likely to be important because it may determine the limits of patentability of developed compounds in India.

The hearing is expected to last for at least two months.