Delhi High Court quashes Cipla’s appeal, says it can’t market generics of Novartis’ Onbrez


NEW DELHI: The Delhi High Court has decided to uphold an earlier decision to stop Indian drug giant CiplaBSE -0.06 % from selling copies of Swiss pharmaceutical firm Novartis’ patented respiratory drug ‘Onbrez’. The decision is yet another setback for Cipla, which has been locked in a high-profile legal battle against NovartisBSE -0.42 % since 2014 over whether it can provide its version of the drug to cater to what it claims is an unmet need.

Onbrez, Novartis’ brand of the chemical drug indacaterol, is used to treat chronic obstructive pulmonary disease (COPD). Indian drug maker Lupin LtdBSE 0.13 % imports and markets Onbrez here through a 2012 agreement with Novartis.

A division bench comprising Justices Badar Durrez Ahmed and Sanjeev Sachdeva on Thursday dismissed Cipla’s appeal to an earlier ruling at the Delhi High Court on several grounds. For instance, the court said it can’t make a definitive conclusion that Novartis’ imports of Onbrez were insufficient to meet the demands COPD patients from the data that was submitted by Cipla and Novartis during the hearings.

The division bench’s judgment further observed that indacaterol did not fall into the category of a life-saving drug and that there were several other drugs available in India for the management of COPD patients.

In January 2015, the Delhi court had blocked Cipla from making or selling generics of Onbrez, stating it infringed on Novartis’ patent. The court had said the Indian drug maker could not sell its copies unless it secured a compulsory licence to do so.

Justice Manmohan Singh, who had delivered the judgment back then, said that Cipla didn’t provide any clear evidence or figures about “the inadequacy or shortfall in the supply” of the drug. The judge added that Novartis had assured it had stocks ready in advance for almost two months in order to meet the demand situation and was further agreeable to accelerate the supplies “as soon as the demand arises”.

Novartis’ patent reportedly expires in 2020.

Cipla appealed the judgment soon after on grounds that there was an unmet need for the drug in India. It had claimed that Novartis was not importing sufficient quantities of Onbrez into India to cater to all COPD patients and not working its patent, according to the Delhi High Court’s latest judgment.

The Indian drug giant had claimed that only 4,000 patients were getting access to the drug as against 1.5 crore COPD patients–a figure that Novartis had contested.

Cipla had also claimed that a reason for Onbrez being inaccessible to patients here was its “exorbitant” price. According to the judgment, Cipla had claimed that 10 tablets of Onbrez costed Rs677 as opposed to its own drug priced at Rs130–less than a fifth of the price.

Cipla launched its generic in 2014 under the brand name ‘Unibrez’ before changing it to ‘Indaflo’ to satisfy a separate trademark infringement suit that Novartis had initiated against it.