Cipla Ltd. Asks Government To Revoke Five Patents Held By Novartis AG

October 30, 2014

By Riley McDermid, BioSpace.com Breaking News Staff

Generic drugmaker Cipla is taking on biogiant Novartis , saying this week that it has asked the Indian government to revoke five patents Novartis holds on respiratory drug Onbrez, because the company has been depriving 99.9 percent of the patient population in India who need the drug.

"Cipla believes that it has the potential to manufacture adequate quantities of the drug and make the same available in the country," the company said in a statement.

Onbrez (indicaterol) is used as a therapy for chronic obstructive pulmonary disease (COPD), from which Cipla says more than 15 million Indians suffer.

Cipla takes particular issue with the fact that Novartis pledged in 2008 to make and distribute the drug locally, but instead has only imported around 54,000 annually—or about 1 percent of the amount needed for treatment.

India’s fourth-largest drugmaker by revenue said it had asked India’s Department of Industrial Policy & Promotion to cancel the patents. A senior official at the agency confirmed to Reuters that Cipla had made the filing under Section 66 of the Indian Patents Act.

That section has been controversial with international biotech firms, because it grants the Indian government the power to revoke a patent in the public interest. Patent holders are given a chance to defend their rights to the drug—which could mean a protracted legal battle is in the works between Cipla and Novartis.