Co-authored by Ms. Shristi Bansal, LexOrbis Associate and Mr. Vatsal Dhar, Fifth Year student of Symbiosis Law School, Noida.
The Supreme Court has admitted the plea of domestic pharma company Cipla Ltd. seeking the appointment of a scientific expert and challenging the order passed by the Delhi High Court which held Cipla Ltd. liable for infringing Swiss pharma giant Hoffmann-La Roche’s patent over the lung cancer drug erlotinib hydrochloride, manufactured under the name ‘Tarceva’.
Cipla contended that the High Court erred in holding that its product Erlocip was infringing the suit patent as the product was subject matter of a rejected patent application in India and had been in public domain.
In November last year, the Delhi High Court had noted that Erlocip-Cipla’s lung cancer medicine was a mere polymorphic form of the erlotinib hydrochloride compound, which may exist in several forms whereas Roche’s patent claim was not limited to any one such version. Roche had been granted a patent in India on Erlotinib in 2007 and the same is expected to expire in March 2016. Cipla’s drug Erlocip was launched in 2008 and was sued by Roche for patent infringement and even requested an injunction on same. However the interim injunction was refused by the court giving weight-age to public interest and need for cheap versions of life saving drugs in India considering the cost of Cipla’s drug being Rs. 1,600 per tablet i.e. almost one-third when compared to Roche’s drug Tarceva costing about Rs. 4,800 per tablet.[1]
This case is regarded as one of the very important case in a series of high profile patent battles between multinational pharmaceutical companies and Indian generic drug companies. One of the main issues raised in the litigation was the conflict of opinions between two schools of thought viz. ‘public interest’ versus ‘affordability’.One group, led by research companies, propounds that the main purpose of the Patents Act is to grant a statutory monopoly that will enable the patentee to exploit research in which one invests considerable time and money.
On the contrary, NGOs and generic drug companies argue that patent infringement cases involving life-saving drugs, practical realities must be taken into account. Thus affordability of the patented medicines is of paramount importance.
At present, the Supreme Court has also permitted High Court to continue hearing the matter, but restrained it from passing any final orders. The High Court is yet to consider certain aspects of the case inter alia the amount of compensation which has to be paid by Cipla to Roche for infringing its patent.
[1]Supreme Court agrees to hear Cipla’s plea against La Roche, Amit Anand Choudhary, The Times of India, Jan. 27, 2016, Available at:http://timesofindia.indiatimes.com/india/Supreme-Court- agrees-to-hear-Ciplas-plea-against-La-Roche/articleshow/50746320.cms.