New Delhi: In a judgement cheered by public health advocates, the Delhi high court refused to restrain Indian drug maker Cipla Ltd from selling cheaper copies of a patented lung cancer drug, quashing a plea from its patent holder, Swiss drug maker F. Hoffman La Roche.
The ruling stated that irreparable damages would accrue to the patients who will have their lives cut short if a cheaper version of the drug was denied to them. The litigation was being seen as a test case on how strictly the Indian courts will read the patent law and rights granted under it versus the wider public health concerns in a situation when a patent had already been granted.
As part of the verdict, delivered on Wednesday by justice Ravinder Bhatt, Cipla has been allowed to manufacture and sell copies of the drug, erlotinib, sold as Tarceva by the Swiss company in India. Cipla has also been instructed by the court to maintain “faithful accounts” of earnings from the drug in case there is an adverse ruling later and damages need to be paid.
Cautious step: A file photo of Cipla’s Kurkumbh plant. The firm has been instructed by the Delhi high court to maintain ‘faithful accounts’ of earnings from the lung cancer drug in case there is an adverse ruling later.
Cipla’s chairman Yusuf Hameid said it was “a boon for cancer patients in India who need affordable drugs”.
Hailing the ruling as “excellent news”, Cancer Patient Aid Association president Y.K. Sapru said “the human approach, the fact that harm to patients was recognized in the ruling, is a welcome move.”
Roche got a patent for erlotinib in February 2007 and, later that year, ignoring the patent, Cipla announced that it was going to sell the drug under the label Erlocip at Rs1,600 per tablet, or one-third of Roche’s price. Roche then sued Cipla for allegedly infringing on its patent.
Cipla’s move, seen as being risky by some, hinged on the argument that Roche’s patent was invalid as the drug was a tweaked version of an older drug and that its prices were out of reach for most Indian patients. Roche was contesting it as “plain and simple indemnity” case, as its counsel Abhiskeh Singhvi said during the hearings, and wanted its rights to be protected as per the patent law. While the injunction has been denied, the hearing on the revocation of patent— filed for by Cipla—will go on.
Girish Telang, managing director of Roche’s Indian arm, Roche Scientific Co. (India) Pvt. Ltd, expressed disappointment at the ruling. “It is a disappointment because we have a patent and patent should be respected. That has not come by with the refusal of the injunction,” he said, while declining to say if Roche will appeal.
According to a report by the Indian Council of Medical Research, at least 90,000 men and 79,000 women are diagnosed each year in India with cancer of the lungs and bronchitis. Sapru estimates that at any point of time, there would be more than 100,000 patients with lung cancer in India.
Another expert dealing closely with the Roche litigation, who did not want to be identified, said: “What was the use of amending the Patent Act in 2005 if the patent is not to be respected? A benchmark for pricing is not fixed by the patent office when a patent is given, so why is that a valid ground now?” Moreover, added the expert, this was an infringement lawsuit and not a writ petition where issues of public interest are considered thoroughly.