New Delhi: The Delhi High Court has passed an interim order that allows domestic drug maker Cipla to sell its version of the lung cancer treatment drug for which Swiss multinational Roche Scientific holds the India patent.
The court has yesterday accorded approval to Cipla to continue to market the drug, pending another hearing scheduled for 6 August.
In 1996, Roche had filed a patent application for the drug Tarceva in India, that the Drug Controller General of India had approved in 2005, allowing Roche to market the drug in India. In July 2007, two year after the company was allowed to market Tarceva, it was also granted the patent for the drug in India. However, in January 2008, Cipla launched a generic version of the drug, and later that month Roche filed an infringement lawsuit against the Indian pharmaceutical firm in the Delhi High Court. Yesterday ,the Delhi High Court allowed Cipla to carry on marketing the drug in India, pending another hearing scheduled for 6 August.
The generic name of the drug is at the centre of the lawsuit is Erlotnib, which Roche markets as Tarceva, and Cipla sells as Erlocip. The Delhi High court has asked Cipla to maintain records of Erlocip sales before the next hearing in August, and has admitted a counter-claim filed by Cipla it, which questions the validity of the Roche patent. It has given Roche four weeks to respond to the counter claim.
The case is of special interest to global and domestic drug makers and consumer interest groups, as it it the first test of India's new patent regime. India's new patent law came into effect on 1 January, 2005, and offers firms product patent protection against the earlier prevailing practice of process patent protection. The earlier law effectively allowed companies to make the same drug, albeit through different processes.
Cipla commenced marketing Erlocip at Rs1,600 per tablet in January this year, which is a third of the price patent-holder Roche sells to patients in India at Rs4,800 a tablet. Roche has been selling Tarceva in the country since 2006. Roche's argument in the infringement lawsuit is that the product patent accorded to it for Tarceva prevents competition from manufacturing copy-cat versions. Cipla has countered that argument by questioning the validity of the Indian patent, while saying that it was well within its rights by manufacturing and marketing Erlotnib under its brand name in the country.
Cipla's counsel said the high court's order takes cognisance of the life-threatening nature of cancer, and the life-saving properties of this drug; given the price difference, and the consequent affordability of the drug, the court would not like to see patients deprived of a lower priced alternative by granting a stay on the sales of the generic drug.
The high court's decision allows uninterrupted supply of a low-cost alternative for treating lung cancer, which around 160,000 Indians are estimated to be suffering from.