Mumbai: The Delhi high court on Friday directed the Drug Controller General of India (DGCI) to go ahead with the process of granting a licence to Indian drug maker Cipla Ltd for producing a generic version of the anti-cancer medication sorafenib.
International drug maker Bayer Corp., which makes sorafenib under the brand name Nexavar, is fighting a legal battle against the grant of such a licence, saying it is a violation of its patent.
The court’s direction is in response to Bayer’s appeal challenging an 18 August order by a single bench that had rejected its plea to restrain the DGCI from processing Cipla’s application.
Friday’s interim order by a division bench headed by chief justice A.P. Shah also asked Cipla not to launch its product without the court’s permission. The court also directed Bayer, Cipla and the Indian government to file their written submissions within two weeks. It also allowed an application by the Indian Pharmaceutical Alliance, an industry lobby group, for making it a party in the case. The next hearing is on 8 October.
Bayer’s India spokesperson Alok Pradhan said the firm had no comments to offer at this time.
Bayer’s petition, which had named the DCGI as the prime respondent, had at the time sparked a public debate over patent protection and drug approval process, with implications that meant no drug approval could have been granted in India for the generic version of a drug covered by a patent.
(‘PTI’ contributed to this story.)