Supreme Court admits Bayer patent-linkage plea

The Supreme Court has admitted a special leave petition filed by Bayer seeking introduction of patent linkage system in India.

Bayer appealed to the apex court after the division bench of the Delhi High Court dismissed the German firm’s appeal on the issue on February 9.

Following the dismissal, a Bayer spokesperson had said the company was disappointed about and disagreed with the court’s decision, and would consider its legal options.

In August, 2009, a single-judge bench of the Delhi High Court had rejected Bayer’s attempt to bring patent linkage —  a system that can delay the entry of low-cost generic drugs into the market by making the drugs controller general of India (DCGI) act like patent police and refuse marketing approval to generics if the innovators hold a patent in India.

The case dates back to 2008, when Bayer had filed a writ petition before the Delhi High Court against the Union of India, the DCGI and Mumbai-based drugmaker Cipla seeking an order that the DCGI should consider the patent status of its drug sorafenib tosylate (brand name Nexavar) and refuse marketing approval to any generic version.

Sorafenib tosylate is used to treat renal cancer and is sold by Bayer at Rs 2.85 lakh for 120 tablets, for a month’s dosage
Going by patent experts, patent linkage is beyond the ambit of the Trade Related Aspects of Intellectual Property Rights (Trips) agreement of the World Trade Organisation, which India is a signatory to.

“Nowhere in Trips is there a reference to an obligation to link patent protection and drug registration,” says an international patent law expert.

According to Anuradha Salhotra, managing partner at intellectual property law firm Lall, Lahiri & Salhotra, the DCGI should not be asked to look into the patent status of drugs as the DCGI and Patent Office are two completely different entities having separate expertise.

Experts say patent linkage undermines public health safeguards such as Bolar exception and compulsory licensing, which are key to the Indian Patent Act. Bolar exception allows marketing approval of a generic when a patent is in place so that the generic can be introduced as soon as the patent expires. A compulsory license, on the other hand, is issued if patented drugs are unavailable or unaffordable.

“Patent linkage could block marketing approval of generics, thereby rendering compulsory licenses useless and neutralise Bolar exception,” says BK Keayla, convenor, National Working Group on Patent Laws.