Court ruling allows Cipla to market generic cancer drug

Cipla Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 500087 | NSE: CIPLA

10 Feb 2010 Evaluate

In a major test of the five-year old product patent regime, the Delhi High Court dismissed an appeal by multinational drug-maker Bayer Corporation regarding its advanced renal cancer drug Nexavar.

In its judgment, the court said that the scheme of both the Patents Act and the Drugs and Cosmetics Act (DCA) are 'distinct and separate' and that the attempt by Bayer to establish a linkage cannot be 'countenanced'. 'Whether patent linkage should be introduced is an issue that requires a policy decision to be taken by the government. It is not for the court to determine if the Government should bring in a system of patent linkage,' the court said.

Bayer's initial writ petition, filed in November 2008, was dismissed in August 2009 by the Delhi High Court. Subsequently, in late August, Bayer filed an appeal to rehear the case before a Division Bench of the court. Yesterday, the two-judge Bench ruled against Bayer concurring with the earlier, single-judge, decision.

The directive outlines the role of the DCGI and also clears the way for Cipla to launch its drug in the market. Cipla, though, did not comment if it was ready to launch the drug. According to industry information, Bayer's Nexavar (Sorefenib tosylate) is sold at Rs 2,85,000 for 120 tablets for a month's dosage. Also, if the patent holder did not apply for a marketing approval, then the drug will be virtually unavailable in India till such time the patent holder decides it should be available, it noted.

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