The Delhi High Court on Friday directed the Drug Controller General of India to process the licence application of Cipla for production and sale of generic version of global pharma major Bayer Corporation’s liver and kidney cancer drug ‘Nexavar’

A division bench comprising Chief Justice A P Shah and Justice Manmohan directed Drug Controller General of India (DCGI) to take a decision over Cipla’s application.

“The government would process the application of Cipla and would pass an order accordingly,” said the court.

The court’s direction came over a petition filed by the German pharma major Bayer, challenging an order of a single bench, headed by Justice S Ravindra Bhatt, which rejected a plea to restrain DCGI from granting licence to Cipla to produce and sale ‘Soranib’

“We, prima facie agree with the order of the single judge,” the division bench said.

Meanwhile, the bench also said Cipla would have to take the court’s permission before launching Soranib -generic version of Nexavar.

The court, however, added that licence granted by the sectoral regulator would be the subject to its final decision on the case.

It also declined Bayer’s plea to restrain the sectoral regulator from taking any decision and directed all parties including Bayer, Cipla and the government to file their written submission in two weeks.

The court also rejected Bayer’s request to stay the cost of Rs 6.75 lakh imposed by Justice S Ravindra Bhatt for unnecessary litigating.

“We have a conscious decision... you would have to pay cost,” it said.

Meanwhile, the court has allowed Indian Pharmaceutical Alliance to intervene in the ongoing matter and directed it to file its submissions.

On August 18, Justice Bhatt had dismissed Bayer’s petition claiming exclusive patent right over the cancer drug. It has requested the court to direct the DCGI not to give Cipla the licence to manufacture, sell and distribute its generic version Soranib.

Justice Bhatt had also rejected the plea by Bayer that termed Soranib as “spurious” and asked to pay Rs 6.75 lakh for unnecessary litigation, of which Rs 2.25 lakh each to be paid to Cipla, DCGI and the Indian government.

The court has directed to list this matter on October 6 for next hearing.

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