The decision today by India’s Supreme Court to deny Novartis a patent for its cancer drug Glivec® (imatinib mesylate) has been welcomed by Indian patient activists and generics manufacturers. However, it causes concern for the Swiss pharma company, along with Pfizer, Bayer and Roche, who are currently challenging patent decisions in India for their drugs Sutent, Nexavar and Pegasys respectively. The implications for pharma investment in R&D in India will also be worrying for the growing India CRO sector.
The Supreme Court ruled that the patent application was an example of “evergreening” – making a small alteration to an existing drug in order to gain additional patent protection. The compound is based on a drug originally patented in 1993, and its patent in the USA was granted an extension to expire in 2015. Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Limited, stated that “Novartis has never been granted an original patent for Glivec in India” and that the company “provides Glivec free of charge to 95% of patients prescribed the drug in India, currently more than 16,000 patients”.
The ruling also raises questions around global pharma’s willingness to invest in India, which has a massive population although many of them cannot afford conventional drug prices. Issues around protection of Intellectual Property have dogged India for many years, with pharma patenting only being introduced in 2005. Novartis has previously said it needs legal certainty if it is to plan further investment in drug research in India, and other companies will doubtless be considering this when distributing their global R&D investment.