Delhi HC bars Cipla from selling copy of Novartis respiratory drug

The Delhi High Court has barred generic drugmaker Ciplafrom making or selling a cheaper copy of Novartis AG’s respiratory drug Onbrez domestically, citing infringement of patents held by the Swiss company.

Cipla, India’s fourth-largest generic drugmaker by revenue, had launched its copy of Onbrez in New Delhi in October last year at a fifth of the original drug’s price, citing urgent unmet need in India.

But Novartis last month challenged the Cipla move in the Delhi High Court. Onbrez, chemically called indacaterol, is used to treat chronic obstructive pulmonary disease in adults, and patents covering the drug expire only in 2020.

Foreign drugmakers in India have been frustrated by a series of decisions on patents and pricing in the recent past, with New Delhi looking to improve access to cheap medicines in country where a majority of people live on less than $2 a day.

Market access and patent protection for US drugs are expected to feature when Prime Minister Narendra Modi hosts President Barack Obama later this month for annual Republic Day celebrations.

The Delhi court, in its order passed on Friday, observed Cipla did not provide any figures about the “inadequacy or shortfall in the supply” of the drug, while Novartis claimed it had enough stocks to meet demand and could supply more if needed.

The court did not agree with Cipla’s proposal that it be allowed to make the patented drug, citing public interest, without compensating Novartis for its innovation, according to the court documents seen by Reuters.

The Delhi High Court, however, said that Cipla could file for a compulsory licence if Novartis was not able to meet the demand. If granted, that would in effect breaks patent rights, making a cheaper version of the drug possible.

Later in the day, Cipla moved the Delhi High Court challenging its order temporarily.

The matter was mentioned before a bench of Justices Badar Durrez Ahmed and Sanjeev Sachdeva who directed that the plea be listed before the appropriate bench on Wednesday.

The petition which has been settled by senior advocate Pratibha Singh was mentioned before the bench by advocate Bitika Sharma.

Cipla has challenged the high court’s single judge order of January 9, passed on a plea of Switzerland-based Novartis AG which holds a patent for the Indacaterol maleate salt as well as the manufacturing process for the drug.