Cipla has asked the Indian government to forcibly revoke five patents covering Novartis’s lung disease drug Onbrez to pave the way for generic versions in the country, a move the Indian manufacturer says is needed to address a significant unmet need for the therapy.

The generics maker said it has already launched its version of Onbrez (indacaterol) in the Delhi market under the name Unibrez, and is seeking to distribute throughout India. The revocation bid is likely an attempt to preempt a patent infringement lawsuit and potential injunction, one observer said.

Cipla maintains there is urgent need of the therapy, and that Novartis hasn’t supplied nearly enough Onbrez to treat the at least 15 million Indian patients it says suffer from chronic obstructive pulmonary disease. Novartis manufactures Onbrez in Switzerland, and last year exported only enough product to treat less than 4,500 Indian patients, leaving a huge coverage gap that Cipla claims it can fill.

The case will likely be scrutinized by U.S. brandmakers, who contend the country has not done enough to protect pharmaceutical intellectual property rights. One key point of contention has been India’s compulsory licensing regime, by which the government may authorize generic versions of at least one brand drug before its patents expire under certain circumstances, such as a national emergency or unmet need.

In this case, Cipla is seeking the patent revocation not under compulsory licensing but under Section 66 of the Indian Patents Act, an arguably less onerous provision that has only been used twice to date, said Vince Suneja, a founding partner at TwoFour Insight Group, a U.S.-India life sciences advisory firm.

Suneja anticipates an uphill battle in Cipla’s bid, thanks in particular to a renewed commitment by India to IP protections in new trade dialogues with the U.S. and a promise for a new IP policy in the country. A court will most likely hear a patent infringement case on the matter, Suneja said.

Novartis has received no notice from the Indian government on the matter, the company said. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.