The move is the latest in a series of high-profile patent battles between multinational pharmaceutical companies and Indian generic drug makers.
Cipla, India’s second biggest drug maker, said in January that it intended to sell copies of Tarceva (erlotinib) under the brand name Erlocip.
Roche, which obtained a patent in India for erlotinib in February 2006, sued Cipla for patent infringement and asked for an interlocutory interim injunction to stop Cipla making its version of the drug while the court was hearing the case.
On March 19 judge Ravindra Bhat of the Delhi High Court denied the request for an interim injunction. The division bench of the Delhi High Court will hear the appeal on April 22, according to the Times of India.
The judge first considered Cipla’s challenge to the validity of the patent. Cipla argued that the erlotinib patent is obvious, and, as a derivative of a known compound, does not pass the requirement for increased efficacy required by section 3(d) of India’s patent law. The judge described this as a “credible challenge” to the validity of the patent.
Having established that the defendant has a case, the judge then looked at the balance of convenience when considering whether or not to grant an injunction.
Roche claimed in court that one tablet of Tarceva costs Rs3,200 ($80), but Cipla provided evidence suggesting that the real price was Rs4,800 ($120) per tablet and that its own generic version cost only Rs1,600 ($40). The judge noted this, along with the fact that Roche does not make the drug in India, and stated:
“In this background the Court cannot be unmindful of the right of the general public to access life saving drugs which are available and for which such access would be denied if the injunction were granted”.
Campaigners for greater access to medicines in India have focused on this section of the decision, with some arguing that the judicial emphasis on price differential and availability means that other generics can follow Cipla’s example in making copies of patented drugs and avoid an interim injunction in court.
But Prathiba Singh, a lawyer acting for Cipla in the case, said that the judge “hasn’t done anything out of the ordinary” and pointed out that the judgment goes into great detail on Cipla’s challenge to the validity of the patent.
Singh also pointed out that the judge refers to the US Supreme Court decision in eBay v MercExchange, in which the Court rejected the Federal Circuit’s contention that injunctions should automatically be issued unless there are exceptional circumstances. It also mentions the Supreme Court’s decision in KSR v Teleflex, which deals, in part, with the issue of inventive step.
The judge asked Cipla to keep a record of the money it makes from selling its version of erlotinib so that damages can be calculated if the decision is different during a full trial.
The decision is available online here.
