BUSINESS
In INITIAL RULING, judge weighs in favor of patients’ immediate interest THE ROCHE lung cancer drug Tarceva is
Intellectual Property Appellate Board. Responding to Cipla’s allegations, the under patent protection in 50 countries Roche legal team claimed that the discovworldwide, including the U.S., Japan, and ery of erlotinib appears obvious only in the largest countries in Europe. But Justice retrospect, once the drug has actually been S. Ravindra Bhat wasn’t swayed in Januinvented and proven to work. Although ary when Roche came to the High Court of erlotinib is related to gefitinib—both drugs Delhi to ask for an injunction stopping the are quinazoline derivatives—the two comIndian drug company Cipla from making pounds have numerits version of the ous differences in drug. He refused to their structures. In grant it. any case, the Roche At first glance, HN team argued, India’s the case seems to be O assistant controller as clear-cut as they O N general of patents come. In 2005, India O O has dealt with the N began to implement notion that both a new intellectual Erlotinib drugs are derivatives property protection of quinazoline and regime that grants decided that erlotinib is novel. owners of patented pharmaceuticals excluJustice Bhat carefully weighed the sive rights to market their products in Inarguments presented by both Roche dia. Roche was granted a patent for Tarceva and Cipla in his 59-page decision (http:// in October 2007. courtnic.nic.in/dhcorder/dhcqrydisp_ Roche appeared in court claiming that j.asp?pn=1031&yr=2008). He observed that Cipla’s December 2007 introduction of a although Roche filed a total of 27 Tarceva similar drug branded as Erlocip was a patpatents in India, only two were granted. On ent violation and demanding that Cipla be the other hand, the judge noted that the forced to halt sales. Cipla’s action marks Office of the Controller of Patents has the the first time that an Indian company has view that, when sold a copy of a dealing with patented pharmaCl pharmaceuticals, ceutical under the F even a small new intellectual modification to property regime. HN a given structure A reading of O O N “can bring great the judgment N revolutions in the shows that the CH3O world.” Cipla legal team N It will take had prepared its Gefitinib time for the Inresponse well. dian agencies that Among their arprotect intellectual property to reach a figuments, Cipla lawyers claimed that Tarcenal decision on whether the Tarceva patent va, known generically as erlotinib, is not is valid, the judge stated. In the meantime, truly a novel invention but rather a derivabecause the Roche drug is more expensive tive of an AstraZeneca drug, gefitinib, that than Cipla’s, “it is plain that a large number failed to earn patent protection in India. of patients would be deprived of access to Although Roche was granted a patent for a life-saving drug if injunction is granted,” erlotinib, Cipla predicts that the patent will Bhat said. He decided that denying access be revoked when it is reviewed by India’s WWW.C E N- ONLI NE .ORG
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INDIAN CASE TESTS NEW PATENT LAW
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.—JEAN-FRANÇOIS TREMBLAY
