Drug firms, both Indian and multinational, are nervously awaiting April 1. The Supreme Court (SC) is set to pronounce its final verdict in the most controversial patent dispute. The dispute is whether an amended version of Novartis' blood cancer drug Glivec can be patented or not. The verdict would be a landmark for Novartis as well as other multinationals having interest in the Indian pharmaceutical market. CNBC-TV18's Archana Shukla reports.
It is one of the landmark patent cases in India. Novartis has been fighting to get a patent on Glivec since 2006. The Indian Patent Office had rejected its patent application based on the Amended Patent Acts of 2005.
At the heart of this case is Section 3(d), which was included in the Indian Patents Act in 2005. It denies patent to any new form of an already known substance or an already known compound unless it shows substantially enhanced efficacy.
Now, lawyers argue that Glivec, which is a beta crystalline form of an already known compound imatinib, is not patented under Section 3(D) of the Indian Patents Act. Section 3(D) was included in 2005 to avoid evergreening and to prevent an evergreening of patents by innovator firms by minor tweaks to the compound and to delay entry of generic products.
However, Novartis on its part argues that Glivec has shown 30 percent enhanced efficacy as against the original compound, which is imatinib. It is patented in 40 other countries. It is only India, which is not granted a patent to Glivec. The company says it is an invention and hence it should be given a patent under the Indian Patents Act too.
The other bone of contention is price. Glivec is costing over a lakh rupees for a month dosage while its other generic versions are available at one-tenth the cost.