The Supreme Court admitted a special leave petition (SLP) filed by Bayer Corporation seeking introduction of patent linkage system in India. Earlier on February 9, in a landmark judgement, the Delhi High Court had dismissed an appeal by Bayer Corporation on the same issue. Noted lawyer Shanti Bhushan will argue the case for Bayer in the Supreme Court. However, no date has been posted for hearing by the Supreme Court.
The appeal in the Delhi High Court was filed against a judgement delivered by Justice Ravindra Bhat on 18 August 2009, rejecting Bayer’s attempt to introduce the patent linkage system in India through a court direction. But, a division bench of the Delhi High Court comprising Chief Justice AP Shah and Justice Muralidhar dismissed the appeal on February 9.
The case dates back to 2008 when Bayer Corporation filed a Writ Petition before the Delhi High Court against Union of India, the DCGI and Cipla Ltd seeking an order that the DCGI should consider the patent status of its drug, Sorefenib tosylate, before granting a marketing approval to any generic versions of the drug and refuse marketing approval to any generic version. Sorefenib tosylate is used to treat renal cancer and is sold by Bayer at Rs 2, 85,000 for 120 tablets for a month dosage.
Patent linkage is a system in which the Drug Controller refuses to grant or delays a marketing approval to a generic drug manufacturer to manufacture and sell a drug, if the drug is already patented. Patent linkage is known to be against public health interests as it will delay the entry of cheap, generic medicines into the market and keep medicines out of reach of those who need them.
If introduced, the patent linkage system would have seriously impacted the early entry of generic drugs into the market. Such early entry of generic drugs is possible either through mechanisms such as compulsory licensing within the Patents Act itself, or where there is a bona fide belief that a patent has been wrongly granted. This is especially important as India is now witnessing an increase in the number of patents being granted to drugs by the Indian patent office.
On the issue of introducing patent linkage in India, the Delhi High Court had held, “This court cannot possibly read into the statute a provision that plainly does not exist. … The scheme of both the Patents Act and the Drugs and Cosmetics Act are distinct and separate and … the attempt by … Bayer to establish a linkage cannot be countenanced. Whether patent linkage should be introduced is an issue that requires a policy decision to be taken by the government. It is not for the court to determine if the government should bring in a system of patent linkage.”
The Delhi High Court held that it found no ground 'to reverse the well reasoned judgement of learned single Judge (Justice Ravindra Bhat) in which we fully concur'. In the decision under challenge, while rejecting Bayer’s writ petition, Justice Ravindra Bhat of the Delhi High Court had earlier held that the case was “what may be characterised as a speculative foray; an attempt to tweak ‘public policies’ through court mandated regimes”.