New Delhi: The Delhi high court has dismissed an appeal by multinational drug firm Bayer Corp. and its Indian arm Bayer Polychem (India) Ltd seeking to restrain India’s drug regulator from granting Cipla Ltd permission to market a copycat version of Bayer’s anti-cancer drug.
The court’s action is significant as it involves the rejection of Bayer’s request for a link between the patent status of a drug and regulatory clearance—a link not enforced in most countries, including the US.
A division bench of the court comprising chief justice A.P. Shah and justice S. Muralidhar upheld the judgement delivered by justice S.Ravindra Bhat on 18 August 2009, rejecting Bayer’s attempt to block the Drug Controller General of India (DCGI) from allowing Cipla to market its generic version of Nexavar. Bhat had also vacated an interim order of 7 November 2008, staying the approval given by DCGI to Cipla’s application for generic Nexavar and imposed a penalty of Rs6.75 lakh on Bayer, saying the “speculative” petition had delayed approval of generic drugs in the Indian market.
A lawyer who works for an activist patient heath group said the case reflected the evolving patent regime in India.
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“In India we have introduced certain laws and not others, so multinational companies are trying to bring in patent linkage and data exclusivity. This judgement is very important from that point of view” said Anand Grover, counsel for Cancer Patients Aid Association (CPAA) and director, Lawyers Collective. He added that Bayer would most likely appeal the Supreme Court.
“Bayer HealthCare (the holding company) intends to defend the patent vigorously,” said Aloke Pradhan, vice-president, corporate communications, Bayer Group (India).
“This judgement is good for us. We will be able to grant drug marketing approvals without worrying about patent status,” said DCGI Surinder Singh. He added that his office’s stand is that the regulator’s job is to grant marketing approvals to drugs and that it does not have the expertise to interpret patents. “Patent issues should be resolved either in court or with the patent office.” In its submission, Bayer had also said that Cipla’s generic drug would be a “spurious drug” under section 17B of the Drugs and Cosmetics Act 1940. This too was rejected by the court, which “upheld India’s international position that generic drugs are not spurious drugs”,?said Pratibha M. Singh, patent lawyer for Cipla.
The genesis of this case goes back to 2008 when Bayer Corp. filed a writ petition before the Delhi high court against the Union of India, DCGI and Cipla seeking an order that DCGI consider the patent status of Sorafenib Tosylate (brand name Nexavar), and refuse the approval to any generic version of the drug.
“DCGI is not the authority and does not have the statutory power to verify the patent status of a drug and grant marketing approvals based on that. The law itself extends certain rights to the patent holder and it is up to him to defend his patent,” said Srividhya Ragavan, professor of law at University of Oklahoma, College of Law, who specializes in intellectual property law in developing countries.
According to Ragavan, Bayer is asking for a third party, in this case DCGI, to guard its patent, which would amount to a TRIPS-plus agreement which India is not required to follow. TRIPS refers to the World Trade Organization’s agreement on intellectual property. A TRIPS-plus agreement goes beyond the requirements of WTO. “Even in the US, the drug regulator has no right to link patent status and drug approval and there is no reason why we should link it in India,” added Ragavan.
Graphic by Paras Jain / Mint