Mumbai: The Delhi high court on Tuesday dismissed a November petition by Bayer Corp. and Bayer Polychem (India) Ltd seeking to restrain India’s drug regulator from granting local pharma firm Cipla Ltd permission to sell a generic version of Bayer’s patented anti-cancer medication Nexavar.
It also vacated an interim order passed in November that stayed the approval given by the Drug Controller General of India (DCGI) to Cipla’s generic drug application for the cancer drug.
The court also imposed a Rs6.75 lakh penalty on the petitioners, both of which are group companies of German multinational Bayer AG, saying the “speculative” petition had delayed the approval of generic drugs in the domestic market.
In a court order to be released on Wednesday, justice Ravindra Bhatt observed that the petitioner tried to tweak public policy by seeking a stay on the drug approval system and said that unpatented (generic drugs) are not spurious, as Bayer had suggested in its petition.
A Bayer group spokesman said in a statement on Tuesday that the company was disappointed and would consider its legal options.
“Bayer HealthCare had received marketing authorization for Nexavar from the DCGI in August 2007 for the treatment of advanced kidney cancer and liver cancer. Bayer was granted a patent for Nexavar and its active ingredient sorafenib tosylate in India on March 28 2008,” the company said.
Cipla’s joint managing director Amar Lulla said: “It is a very reasonable and clear judgement, which will go a long way in addressing access of poor patients to life-saving medicines.”
“At this stage, it is clear that a dismissal of the writ petition along with the imposition of costs clearly indicates that the judge wasn’t really pleased with Bayer’s attempt to use the courts to do something that was clearly beyond the scope of the existing law,” said Shamnad Basheer, a professor in intellectual property law at the National University of Juridical Sciences, Kolkata.
Y.K. Sapru, chairperson of Cancer Patients Aid Association, who had intervened in the case filed by Bayer Corp. against the DCGI, said: “We are very glad that the court has recognized the aspect of access to drugs and has rejected Bayer’s attempt to introduce a policy change with adverse public health consequences through the court.”
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 for the generic version of a drug covered by a patent.
Such approval would rather have been granted only after the generic manufacturer established in a court of law that the patent is either invalid or that there is no infringement since the patent claims do not cover the generic drug in question.
In its response to the Bayer petition, the DCGI had earlier said that the government had presented an affidavit in the court. A key concern expressed in it was that such a linkage would affect the performance of the department as its key responsibility is to ensure the quality of a drug before stamping its approval for domestic consumption.
“I hope foreign companies will learn out of this decision and appreciate concerns of Indian people and its government,” said Dilip G. Shah, secretary general, Indian Pharmaceutical Alliance, a industry lobby of Indian drug companies.