Monday, April 21, 2008
Roche vs CIPLA: The Rhetoric of Patent Busting Roche, a multinational pharma company and CIPLA, a generic manufacturer from India. CIPLA brazenly defied Roche's patent over an anticancer drug, Tarceva and went ahead and introduced a generic version at 1/3rd the price. It claimed that the patent ought not have been granted in the first place. CIPLA's counsel, Arun Jaitley argued very persuasively in court that Roche's drug did not meet the requirements of section 3(d), a unique section introduced into India's patent regime in 2005 to prevent a phenomenon widely known as "evergreening".

Under section 3(d), derivatives of existing pharmaceutical substances would not merit patent protection, unless such derivative was more "efficacious" than the earlier existing pharma substance. The section was challenged by Novartis as being violative of TRIPS and of the Indian constitution

CIPLA also stressed that since the price differential between the patented drug and the generic version sold by CIPLA was extremely high, "public interest" demanded that no injunction be granted in favour of Roche. In a remarkably sophisticated and well researched judgment, Justice S Ravindra Bhat of the Delhi High Court ruled in favour of CIPLA.

The matter is now under appeal. Unless Roche is able to demonstrate empirically that CIPLA's lower prices for Tarceva (the lung cancer drug in issue) does not really translate to increased access to poor patients, it is difficult to see how Justice Bhat's order will be overturned in appeal.

The Rhetoric of ‘Patent Busting

The verdict on one of the most keenly watched patent litigations was finally out last month. In a carefully nuanced and remarkably well-researched judgment, Justice S. Ravindra Bhat of the Delhi High Court refused to injunct Cipla from selling generic versions of a patented anti-cancer drug