Roche plea on cancer drug patent dismissed

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Recently the division bench of Delhi High Court allowed domestic drug major Cipla to sell its generic version of the lung cancer drug Erlotinib, dismissing an appeal filed by F Hoffmann-La Roche (Roche) and OSI Pharmaceuticals Inc (OSI).

Roche was awarded a product patent for the drug, which it has sold under the brand name Tarceva in India since 2006. Cipla launched its generic version, Erlocip, in India, challenging the monopoly rights of Roche. In January 2008, Roche and OSI filed an infringement suit in Delhi High Court seeking an interim injunction to restrain Cipla from manufacturing, offering for sale, selling and exporting Erlocip, and from infringing the patent with respect to Tarceva. Cipla submitted to the court that no injunction should be granted till its post-grant opposition, filed in the Delhi patent office, was heard and decided upon, as Cipla had also filed a counter-claim and a written statement seeking the revocation of the patent granted to Roche.

Delhi High Court passed an order in favour of Cipla in 2008, thereby declining Roche’s appeal for the grant of an interim injunction. However, Roche challenged the order at the division bench of Delhi High Court by filing an appeal.

Upholding the theory of public interest, the court dismissed the appeal and imposed costs of Rs500,000 (US$10,500) on Roche. The court affirmed that general public access to life-saving drugs in India is a matter of great significance. The court stated that it could not be unmindful of the general access to life-saving products, and of the possibility that such access would be denied if an injunction was granted. If the court believed that public interest in granting an injunction in favour of the plaintiff during the pendency of an infringement action was outweighed by the public interest of ensuring easy and affordable access to a life-saving drug, the balance would tilt in favour of the latter.

The court found that in this case, irreparable injury would be caused to the public if the injunction was granted, as they would be deprived of the defendant’s product. Several unknown individuals who are not parties to the suit and who would be deprived of the life-saving drug would not be able to be compensated in monetary terms for the damage that would be caused to them if the injunction were granted.

The judgment is significant, as this is one of the first test cases of India’s product patent regime, in place since January 2005. For this reason the case is being keenly watched by patent experts, global and Indian drug companies and consumer interest groups. According to reports, nearly 160,000 people in India are estimated to be suffering from lung cancer. Cipla’s generic version costs about Rs1,600 for a tablet, one-third the price of Roche’s product, which costs over Rs4,500 per tablet.

The update of court judgments is compiled by Bhasin & Co, Advocates, a corporate law firm based in New Delhi. The authors can be contacted at lbhasin@bhasinco.in, lbhasin@vsnl.com or lbhasin@gmail.com. Readers should not act on the basis of this information without seeking professional legal advice.