The Hindu Business Line - Court Ruling Allows Cipla to Market Generic Cancer Drug


Mumbai, Feb. 9

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

Bayer had urged the regulatory the Drug Controller General of India (DCGI) to not give marketing approval to Cipla's generic version of the same drug.


 In what is referred to as "patent linkage" in pharmaceutical circles, Bayer had initially approached the Delhi High Court seeking to link the patent status of an innovative drug to the marketing approval given by the DCGI to generic versions of the same medicine.

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 aDivision Bench of the court. And on Tuesday, the two-judge Bench ruled against Bayer concurring with the earlier, single-judge, decision.

"Bayer is disappointed about and disagrees with the court's decision and will consider its legal options in this regard," a spokesperson told Business Line. The directive outlines the role of the DCGI and also clears the way for Cipla to launch its drug in the market, an industry-watcher said. Cipla, though, did not comment if it was ready to launch the drug.

In its judgement, the Court said that Bayer's argument would mean that instead of testing the validity of a patent, the DCGI will begin with the presumption that the patent granted in respect of the drug for which marketing approval is sought has been validly granted.

This would block generic manufacturers who could have made the drug at affordable prices, subject to infringement suits by the patent holder, the Court observed.

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.


Source: The Hindu Business Line