Delhi High Court blocks Onbrez generic
The Delhi High Court has issued a interim injunction stopping Indian generic drug maker Cipla from selling copies of Novartis’s respiratory drug Onbrez (indacaterol) in the country.
Novartis sued Cipla for patent infringement after it launched its own indacaterol product, Unibrez, last October. Novartis also filed a case against Cipla citing trademark infringement, arguing that the ‘Unibrez’ name was “deceptively similar” to Onbrez.
Onbrez treats chronic obstructive pulmonary disease, a respiratory condition which, according to the court, affects more than 1% of India’s 1.2billion population.
The order, delivered on January 9, said that Cipla’s Unibrez drug, sold at 130 rupees ($2), was more than 80% cheaper than Novartis’s drug.
Cipla had sought to revoke Novartis’s compound patent 222346, due to expire in 2020, and four other patents protecting the drug. It argued that Onbrez was not available at a reasonable price.
The generic maker had added that as the Onbrez product was not being manufactured in India, Novartis was not meeting the demand of domestic patients. The patent should be “subject to compulsory licensing,” Cipla had said.
But the court found that there was never a shortfall of the product, and that Lupin, the drug’s distributor, said it has more of the drug in store than the amount demanded. The court ordered that Cipla stop making Onbrez generics, though it advised the company to file for a compulsory licence.
Cipla should “approach the compulsory licensing tribunal if the public interest [is] the sole reason for which the defendant intends to manufacture [the] patented product,” judge Manmohan Singh wrote in the judgment.
A spokesperson for Cipla told LSIPR: “We are disappointed with the order of the court.
“We will decide on the next course of action once we read the judgment. In the meantime the patients will continue to get the product till the old stocks last.”
He added: “We are, however, concerned that this judgment will deny patients access to the drugs they need.”
Novartis did not respond immediately to a request for comment.
