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Delhi High Court Bars Cipla From Selling Novartis’ Respiratory Drug

The drugmakers were contesting a patent infringement case.

General views of drugs (Photographer: JB Reed/Bloomberg News)
General views of drugs (Photographer: JB Reed/Bloomberg News)

The Delhi High Court on Thursday barred Cipla Ltd. from manufacturing and selling a generic version of Swiss drugmaker Novartis AG’s respiratory drug Onbrez in India.

In doing so, the 2-judge bench of justices Badar Durrez Ahmed and Sanjeev Sachdev upheld an earlier order of the high court in January 2015 that restrained Cipla from making and selling Indacaterol – the generic name of Onbrez – until Cipla got compulsory licence for it.

Cipla challenged the order before the 2-judge bench, saying permission to make and sell the drug was in larger public interest as Novartis’ drug was too expensive and made available only to government hospitals because of which is was not easily available to the public.

Responding to the plea, the Delhi High Court said on Thursday, “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. On the other hand, the respondents have established a prima facie case in that that patent is valid and, therefore, there is no credible challenge to the validity of the patent,” the bench said.

In 2014, Cipla launched Indacaterol under its own brand name at one-fifth of the original price. Novartis, which held the patent for the drug, moved the high court for infringement, saying it had partnered with Cipla’s Indian rival Lupin Ltd. to sell the drug in India.

The judges said they could not arrive at a definite conclusion on whether “the extent of imports is not sufficient for meeting the demands of chronic obstructive pulmonary disease (COPD) patients in India”.

There are drugs available in the Indian market, besides Indacaterol, which deal with the management of COPD, the bench pointed out.

Noting that Indacaterol does not fall in the category of a life saving drug, such as a cancer medicine, the bench in its 27-page judgement declined Cipla's contention that public interest may be a factor in considering the grant of an injunction.