Bayer bid fails; Cipla, patients get HC boost

In a victory for generic drugmakers and patient bodies, the Delhi High Court has rejected an attempt by multinational pharma company Bayer Corporation to link patent status with regulatory approval of generics.

Patent linkage is a system in which the Drugs Controller General of India (DCGI) refuses to grant marketing approval to a generic drug if the original drug is patented.

This is known to be against public health as it delays the entry of low cost generics and also makes the drug regulator don the robes of the patent office.

This particular case concerns the kidney cancer drug sorefenib tosylate, which is sold by Bayer at Rs 2,85,000 for 120 tablets, covering a month’s dosage.

In November 2008, Bayer had filed a writ petition before the Delhi HC, against the Union of India, DCGI and generic drugmaker Cipla, seeking an order that the DCGI consider the patent status of sorefenib tosylate before granting a marketing approval to any generic company and refuse the marketing approval to generic versions while its patent is in force.

The HC granted an injunction and stopped DCGI from granting approval to Cipla’s version of sorefenib tosylate until the final order was passed in this matter.

The HC has now held that Bayer’s petition was an attempt to tweak public policy, and has imposed a cost of Rs 6.75 lakh on the MNC, which is to be paid to Union of India and Cipla.

According to an official from Cipla, patent linkage is part of a MNC campaign to block the entry of generics into the market.

“Bayer’s attempt to introduce a policy change has been quashed. This is a major victory for us,” says Y K Sapru, chairperson of Cancer Patients Aid Association (CPAA), the Mumbai-based NGO, which intervened in the case filed by Bayer against the DCGI,
Legal experts say India does not have a patent linkage system and the patent system and drug regulatory systems are two separate mechanisms.

According to Anand Grover, counsel for CPAA, early entry of generics is possible through mechanisms like compulsory licensing within the Patent Act itself, or where there is a belief that a patent has been wrongly granted.

“Moreover, Bayer cannot use the DCGI, which is a government agency, to enforce its private rights,” says Grover.

According to Shamnad Basheer, who is the ministry of human resources’ chair in intellectual property law at the National University of Judicial Sciences, the DCGI does not have patent expertise and the two issues of patents and regulatory approval should not be mixed.