Delhi High Court upholds ruling barring Cipla from selling copies of Novartis drug


NEW DELHI: The Delhi High Court upheld an earlier decision to stop Indian drug maker CiplaBSE 0.18 % from selling copies of Onbrez, a respiratory drug for which Swiss pharmaceutical firm NovartisBSE 0.40 % holds the patent.

Cipla has been battling Novartis since 2014 over whether it can sell its version of Indacaterol, the generic version of the drug, to cater to what it says is an unmet need.

Indacaterol is used to treat chronic obstructive pulmonary disease (COPD). Indian drug maker Lupin Ltd imports and markets Onbrez through a 2012 agreement with Novartis.

A division bench comprising justices Badar Durrez Ahmed and Sanjeev Sachdeva on Thursday dismissed Cipla’s appeal against a 2015 ruling by Justice Manmohan Singh at the Delhi High Court that blocked it from making or selling the generic version of Onbrez.

Justice Singh had also restrained the company from making or selling any combinations using Indacaterol.

The 2015 order held that Cipla’s move infringed on Novartis’ patent. Justice Singh had said the Indian drug maker could not sell its copies unless it secured a compulsory licence to do so.
Novartis’ patent for Indacaterol in India expires in 2020, according to the company.

Cipla appealed against the judgement on the grounds that demand wasn’t being met and that Onbrez’s cost was “exorbitant.”

According to the judgment, Cipla had claimed that 10 tablets of Onbrez cost Rs 677 as opposed to its own drug priced at Rs 130.

“After considering the submissions advanced by the learned counsel for the parties and examining the relevant papers, we are of the view that the injunction granted by the learned single judge ought not to be disturbed,” said the division bench. ET has seen a copy of the judgement.

The court said it couldn’t be proven that supplies weren’t meeting demand. It also said Indacaterol wasn’t a life-saving drug and that there were several alternatives available.

“In any event, in the present case, we do not feel that the appellant has even made out a case that public service would be disserved by the grant of an injunction,” the court said. Novartis has established that its patent is valid, it said.

Novartis India’s country president, Jawed Zia, said the company commended the government’s steps to create an environment that fosters and promotes investments in innovation.