Ranbaxy fights Pfizer on generic drugs but wants strong home law on patents

By Rohan George
Published: Monday 30 April 2007

Indian drug manufacturer Ranbaxy is contesting us multinational Pfizer in 17 countries. It is filing for the right to manufacture generic versions of the world's bestselling drug Lipitor and a combination drug Caduet, in the us. But it hasn't really struck a blow for the generic pharma industry: Ranbaxy remains a supporter of product patents and incremental innovations at home.

At the crux of the dispute is Pfizer's designs on a patent extension by combining Lipitor with another drug: Norvasc. Ranbaxy senses a weakness in Pfizer's case and is questioning the us multinational's rights in several countries. It has also filed applications to market, and make generic versions of Caduet. Pfizer is contesting these applications (See box: Items of contest).Shamnad Basheer of George Washington University Law School, however, believes that the Caduet patent will be invalidated since it does not really represent any "inventiveness". "The litigation can have a bearing on the Novartis dispute in India on the generic blood cancer drug, Gleevec," he said. (see 'Patent Puzzle', Down To Earth, February 28, 2007). Basheer believes that Caduet will not be patentable if it's a sum of the properties of Lipitor and Norvasc. "But Lipitor's patent has to end for a generic to come out," he notes. Duplicity Its battles against Pfizer notwithstanding, Ranbaxy has often supported a strong product patent regime. In its deposition before the Mashelkar Committee for Drug Regulatory Systems in India it stated, that "incremental innovations in terms of developing new forms, new derivatives and new delivery systems of existing drugs should be granted patents provided they are new, involve an inventive step and have commercial utility".

Ranbaxy's spokespersons affirm this. They told Down To Earth, "We have a strategy to use r&d capabilities for generics andlitigate against patents which we consider weak. We are committed to developing drugs, affordable to all. We respect patents but when non-infringing products are developed such efforts must be rewarded.
Common corporate According to M D Nair, a consultant to the industry, Ranbaxy is adopting normal corporate strategies. But the company's growing clout has not been salutary for the generic industry, which comprises a variety of interests, from smaller generic manufacturers such as Natco or Hetero to larger multinationals such as Ranbaxy and Nicholas Piramal with research facilities for incremental innovations. And as K M Gopakumar of the Centre for Trade and Development--a Delhi-based research body--points out, "While smaller companies need an intellectual property system that supports access to cheaper generics, emerging Indian pharma majors would prefer a system that allows them to use their r&d capabilities to their advantage." Support for incremental innovations and product patents would strengthen this advantage.

Ranbaxy, in fact, is the only company whose comments feature in the Mashelkar committee report, pointing to a trend of lobby-savvy Indian pharma majors getting their view across.

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