New Delhi: Swiss drug maker F Hoffman-La Roche Ltd on Friday appealed in the Delhi high court against an order last month that had allowed copycat versions of its patented cancer drug, Tarceva, to continue in the market.
The move has signalled the Basel-headquartered company’s intention to go whole hog in enforcing its Tarceva patent, which it contends has been infringed by Indian pharmaceutical company Cipla Ltd.
Mumbai-based Cipla had said in January that it was going to sell copies of erlotinib, the chemical name for Tarceva, at one-third of Roche’s price. Roche Scientific Co. (India) Ltd, the company’s Indian arm, sells the drug at Rs4,800 per tablet.
Girish Telang, managing director of Roche Scientific, confirmed filing of the appeal as well as his company’s resolve in sticking to the the lawsuit.
Roche’s appeal will be heard on 22 April before a division bench comprising justices Manmohan Sarin and Manmohan. On 19 March, the single-judge bench of the same court had refused Roche’s plea for an injunction to restrain Cipla from selling the drug, saying it would cause irreparable damages to the patients who will have their lives cut short if a cheaper version of the drug was denied to them. The judge had, however, asked Cipla to maintain accounts of the earnings from erlotinib as the hearing on the revocation of the patent—filed by Cipla as it believes the drug is a tweaked version of an older drug that would not qualify for a patent here—will continue.
“Obviously, Roche has the right to appeal. We would hope that the division bench agrees with the original judgement, which we believe is a very well reasoned one,” said Chan Park, senior technical and policy adviser with public health advocates Lawyers’ Collective, adding, the last judgement had set a valuable legal precedent.
Roche’s legal counsels are tight-lipped on the arguments they will be presenting, but a source close to the lawsuit, who did not wish to be named, said that provisions that have not been specified in the Patent Act, 1970—such as lower prices—were considered in last month’s judgement.
“No benchmark for drug prices is fixed at the time of granting a patent, so should that be a valid ground now?” a legal expert from Roche’s side had asked when the injunction plea was quashed. Roche’s counsel Abhishek Singhvi had called it “a plain and simple indemnity case” during court hearings. Tarceva had received a patent from the Delhi Patent Office in February 2007.
One of the lawyers representing Cipla declined to comment until the legal team had a chance to go through the papers filed by Roche. “Our arguments remain the same, which we have extensively presented before the lower bench of the high court. Now, let the court take a view of the lower bench’s ruling,” said Amar Lulla, Cipla’s chief executive.
The litigation is being seen as a test case on how the Indian courts read the patent law and rights granted under it versus public health concerns, in a situation when a patent has already been granted.
Park dosn’t see these examples as an indication of greater aggression in protecting intellectual property by all innovator drug makers. “There is no clear trend overall. Novartis has been very aggressive in this front and Roche seems to be going that way too, but there are others such as GlaxoSmithKline, which have withdrawn certain patent applications, and Gilead Sciences that gave out multiple voluntary licences of its anti-AIDS drug.”
C.H. Unnikrishnan contributed to this story.