The Government is examining if it can move on Indian drug-maker Cipla’s demand for revocation of Swiss company Novartis’ patents on respiratory drug Onbrez.

Both the companies are now fighting a case over the drug in court.

“We are keenly watching the case launched by Novartis this week against Cipla for copying its patented medicine. It will give us leads on how to deal with Cipla’s demand that Novartis’ patent be revoked.

“But more importantly, our team is working on whether we could indeed move on revocation, with the case going on in court,” a Department of Industrial Policy and Promotion (DIPP) official told Business Line .

The Health Ministry has recommended to the DIPP — the nodal department for patent-related issues — that the patent be revoked and a compulsory licence issued to Cipla for producing a generic copy of the drug on the ground of “mischievous” intent (under Section 64 of the Indian Patents Act).

Inadequate grounds

The DIPP, however, wants to examine both the Sections under which the patent could be revoked and a compulsory licence granted.

“We have noted recommendations made by the Health Ministry, but we will go forward with our own investigations,” the official said.

A compulsory licence is a permission given by the Government to a local drug-maker to manufacture a copied version of a patented medicine under special circumstances which includes a national emergency.

Cipla launched a copy of Onbrez in New Delhi in October at a fifth of the price (without a compulsory licence from the Government) on the ground that its demand in India far out-stripped its availability.

It simultaneously submitted an application to the DIPP, urging it to grant it a compulsory licence and revoke five patents on the drug held by Novartis.

It argued that the Swiss company had not started manufacturing the drug in India over the last six years since it was given the patent and also imported it in very small quantities.

Compulsory licence

Novartis, this week, sued Cipla for infringing on its patents rights.

The company claims that there is enough supply of Onbrez and that Cipla’s claims of a shortage lack substance.

So far, India has granted just one compulsory licence, to Hyderabad-based Natco Pharma, for producing the generic version of Bayer’s cancer medicine in 2012.

It led to a huge outcry from pharma lobbies in the US and the EU and, since then, no such licence has been granted despite several applications from Indian pharma companies.