Indian Case Tests New Patent Law

THE ROCHE lung cancer drug Tarceva is under patent protection in 50 countries worldwide, including the U.S., Japan, and the largest countries in Europe. But Justice S. Ravindra Bhat wasn't swayed in January when Roche came to the High Court of Delhi to ask for an injunction stopping the Indian drug company Cipla from making its version of the drug. He refused to grant it.

At first glance, the case seems to be as clear-cut as they come. In 2005, India began to implement a new intellectual property protection regime that grants owners of patented pharmaceuticals exclusive rights to market their products in India. Roche was granted a patent for Tarceva in October 2007.

Roche appeared in court claiming that Cipla's December 2007 introduction of a similar drug branded as Erlocip was a patent violation and demanding that Cipla be forced to halt sales. Cipla's action marks the first time that an Indian company has sold a copy of a patented pharmaceutical under the new intellectual property regime.

A reading of the judgment shows that the Cipla legal team had prepared its response well. Among their arguments, Cipla lawyers claimed that Tarceva, known generically as erlotinib, is not truly a novel invention but rather a derivative of an AstraZeneca drug, gefitinib, that failed to earn patent protection in India. Although Roche was granted a patent for erlotinib, Cipla predicts that the patent will be revoked when it is reviewed by India's Intellectual Property Appellate Board.

Responding to Cipla's allegations, the Roche legal team claimed that the discovery of erlotinib appears obvious only in retrospect, once the drug has actually been invented and proven to work. Although erlotinib is related to gefitinib—both drugs are quinazoline derivatives—the two compounds have numerous differences in their structures. In any case, the Roche team argued, India's assistant controller general of patents has dealt with the notion that both drugs are derivatives of quinazoline and decided that erlotinib is novel.

Justice Bhat carefully weighed the arguments presented by both Roche and Cipla in his 59-page decision (http://courtnic.nic.in/dhcorder/dhcqrydisp_j.asp?pn=1031&yr=2008). He observed that although Roche filed a total of 27 Tarceva patents in India, only two were granted. On the other hand, the judge noted that the Office of the Controller of Patents has the view that, when dealing with pharmaceuticals, even a small modification to a given structure "can bring great revolutions in the world."

It will take time for the Indian agencies that protect intellectual property to reach a final decision on whether the Tarceva patent is valid, the judge stated. In the meantime, because the Roche drug is more expensive than Cipla's, "it is plain that a large number of patients would be deprived of access to a life-saving drug if injunction is granted," Bhat said. He decided that denying access to Cipla's drug would "shorten the lives of several unknown persons who are not parties to this suit."

The Cipla-Roche case is a landmark in India's new patent regime. Both companies are determined to pursue the proceedings, even though both expect that the fight will continue for several years. "The court has decided on the preliminary injunction issue only," says Lester B. Davis, a Roche spokesman. "Roche will continue legal actions in line with the patent laws of India."

Despite the broad implications of the case for innovative pharmaceutical firms, Roche is not receiving funding from any industry association to help defray its legal costs, Davis notes. "Where its patent is violated, Roche will take action through appropriate legal means according to the laws of those countries," he says.

In a phone interview, Yusuf K. Hamied, the chairman of Cipla, told C&EN that he is mostly concerned about the welfare of Indian cancer patients. He noted that if Cipla wins the case, all of India's generic drug producers will be able to produce versions of Tarceva.