The Delhi High Court refused a patent linkage to multinational pharma company Bayer’s for its cancer drug sorefenib tosylate, sold under the name Nexavar. This means there is no restriction on the drug controller to approve generic versions of patent drugs. Bayer holds the patent for sorenfenib, used to treat renal and liver cancers; 120 tablets, a month’s dose, cost Rs 2.85 lakh.
In October 2008, Bayer, petitioned the court to restrain the Drugs Controller General of India (DCGI) from giving license for a similar drug by Cipla called Soranib. Bayer claimed it would infringe its patent and approve spurious drugs. After a single judge bench rejected their plea in August 2009, Bayer appealed to a division bench, which too rejected Bayer’s petition.
The judges saw no reason to reverse the order that had called Bayer’s petition a “speculative foray and attempt to tweak public policies through court mandated regimes.” It held that the law does not deem spurious generic versions of patented drugs. Social activists argue patent linkage is against public health interest because it keeps affordable drugs out of the market.
Leena Menghaney of the non-profit Campaign for Access to Essential Medicines said Bayer’s petition was in any case pointless. “DCGI does not look into patents but only the efficacy of the drug and its safety,” she said. Cipla is yet to launch Soranib. Bayer said it got a patent for Nexavar in India in March 2008; Cipla opposed it in April 2009. “We disagree with the court’s decision and will consider our legal options,” said Aloke Pradhan of Bayer.