Onbrez case: Delhi High Court reserves decision on Novartis-Cipla patent dispute

By Vikas Dandekar

MUMBAI: A division bench of the Delhi High Court has reserved its decision on a high-profile patent case that pitted Swiss drug maker Novartis against Cipla over its respiratory drug brand Onbrez.

Last year, Cipla launched copies of indacaterol, the generic name of Onbrez, under its own brand name in the Indian market, while simultaneously calling for revocation of five of Novartis’ patents.

Novartis filed an injunction plea against Cipla, alleging infringement of its patent rights. In January this year, Cipla was restrained from selling copies of the drug, following which both companies filed cross appeals in the Delhi High Court.

On Monday, Cipla lawyers Abhishek Singhvi and Pratibha Singh argued that Novartis ought to grant a licence for making the product to ensure its sufficient availability in India at an affordable price. Cipla had priced Unibrez, its versions of the drug, at Rs 130 per pack of ten tablets, compared with Rs 677 for Onbrez.

Novartis imports the product, which makes it unaffordable to local patients, Cipla’s lawyers said, while highlighting the fact that it was not produced here, one of the key grounds to keep a drug’s patents valid.

According to a patent lawyer who is tracking the case closely, Novartis’ lawyer Gopal Subramaniam said the company had made sufficient quantities of the drug available in India and that no shortage of it has been reported.

He further reasoned that the patents for Onbrez were held valid in India and Cipla violated the provisions of patenting laws by launching its own brand prior to seeking a voluntary licence from the innovator. Novartis, subject to conclusion of discussions, may agree to give distribution rights for the product to Cipla, much on the lines of its existing terms with Lupin, he said. Cipla and Novartis refused to comment on the case.

Experts said Cipla’s contention to dispute the patent was primarily based on grounds of affordability and local manufacturing