In a landmark judgment, a division bench of the Delhi High Court comprising chief justice AP Shah and justice Muralidhar has dismissed an appeal by Bayer Corporation, a multinational pharmaceutical company, seeking the introduction of patent linkage system in India.

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.

On the issue of introducing patent linkage in India, the Delhi High Court 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 appeal was filed against a judgment 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.

The Delhi High Court held that it found no ground 'to reverse the well reasoned judgment 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'.

In 2008, 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.

Meanwhile, NGOs and other public interest groups have welcomed the court verdict. "We are very glad that the Court has rejected Bayer's attempt to introduce a policy change, which would have adverse consequences for access to medicines, through the court. This decision will prevent delays in cancer patients getting access to less expensive, generic versions of patented drugs." said Y K Sapru, chairperson of Cancer Patients Aid Association (CPAA), who had intervened in the case filed by Bayer Corporation against the Drug Controller of General of India (DCGI).

CPAA, represented by Lawyers Collective HIV/AIDS Unit through Anand Grover as counsel, had filed an intervention application to be added as a party, which was allowed by the Delhi High Court. In a decision delivered on 18 August 2009, Justice Ravindra Bhat of the Delhi High Court rejected Bayer's writ petition holding that unpatented (generic) drugs are not spurious drugs.

Appearing for Bayer, Shanthi Bhushan had argued that patent linkage was in-built in the Indian law, and that granting marketing approval to generic versions of patented drugs would infringe the patent holder's rights. Pointing out the Patents Act, 1970 conferred limited negative rights against third parties, Anand Grover, counsel for CPAA, urged that the grant of marketing approval to a generic version of a patented drug by the DCGI would not violate any right of the patent holder.

Bayer had also urged that generic versions of patented drugs are 'spurious drugs' under the Drugs and Cosmetics Act, 1940 and therefore could not be granted marketing approval while the patent was in force. Grover pointed out from the Hathi Committee Report, the Parliamentary debates and other legislative history that the Drugs and Cosmetics Act, 1940 does cover generic versions of drugs within the ambit of 'spurious drugs'. At this, Bhushan conceded this issue and said that he would not argue this issue further.