In a landmark case that has sparked a heated debate about patent linkage in India, Delhi's high court today threw out Bayer's petition to block Indian generics maker Cipla from gaining regulatory approval for its version of Bayer's patented kidney cancer drug Nexavar (sorefenib tosylate). The Germany-based Bayer and its Indian subsidiary brought the claim against the Drug Controller General of India, the Indian government and Cipla back in November when drug regulator DCGI approved Cipla's generic sorefenib tosylate, Soranib.
Bayer received DCGI approval for Nexavar in August of 2007 and was awarded an Indian patent in March 2008. Under India's patent laws, the company is allowed exclusive marketing rights for 20 years. An approval for Cipla's copycat would infringe on that patent, the German drugmaker argued. Delhi's high court blocked Cipla's approval until a decision could be reached. The suit sparked debate over India's patent laws and accusations that Bayer was trying to change public policy. Those opposed to patent linkage argued that--given the country's 20-year exclusivity policy--a decision in Bayer's favor would prevent many Indian drugmakers from bringing drugs to the market.
But, according to the high court, Bayer had no business bringing the case in the first place as drug regulation is not tied to patent rights. Bayer was also slapped with nearly $14 million in legal fees to be paid to Cipla and the Indian government for delaying the approval of generics. According to the Economic Times, in a 31-page report, the court ruled that it cannot "conclude that unpatented drugs are spurious drugs." And went on to say, "This court is constrained to observe that the present litigation was what may be categorised as speculative foray, and attempt to 'tweak'' public policies through court mandated regimes." The ruling permits generic drugmakers to bring products to the market, but at the risk of facing patent lawsuits.
While multinational companies may not appreciate the outcome, the decision--which will likely have a far-reaching impact--is seen as a win for Indian pharma. "I hope foreign companies will learn out of this decision and appreciate concerns of Indian people and its government," said Dilip G. Shah, secretary general, Indian Pharmaceutical Alliance (as quoted by LiveMint).
Bayer is still locked in a separate battle with Cipla over intellectual property rights for Nexavar and says it "intends to defend the patent vigorously."