In a landmark judgment on Tuesday, the Delhi High Court dismissed Bayer Corporation's Writ Petition to sanction the patent linkage system in India through a court direction.

Holding that unpatented (generic) drugs are not spurious drugs, Justice Ravindra Bhat held that this petition was an attempt to tweak public policy. While dismissing the petition, the Court also held that this is a vexatious and luxury litigation which should be discouraged and imposed cost of approximately Rs 6 lakh to be paid by Bayer Corporation to Respondents - Union of India and the Cipla Ltd.

Patent linkage is a system in which the Drug Controller refuses to grant or delay 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.

Hailing the High Court order, 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, said, "We are very glad that the Court has recognized the aspect of access to drugs and has rejected Bayer's attempt to introduce a policy change with adverse public health consequences through the court."

Bayer Corporation had filed a Writ Petition before the Delhi High Court against Union of India, the Drug Controller General of India 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 pharmaceutical company and refuse marketing approval to any generic company. Sorefenib tosylate is used to treat kidney cancer and is sold by Bayer at Rs 2,85,000 for 120 tablets for a month dosage.

On November 7 last year, the Delhi High Court had granted an interim injunction to Bayer stopping the DCGI from granting marketing approval to the generic company (Cipla) until a final order is passed in this matter.

CPAA had filed an intervention application to be added as a party, which was allowed by the Delhi High Court. It was pointed out by CPAA that due to the stay in this case, the DCGI is not accepting the applications for marketing approval from any generic companies on any drug. The Court had then clarified that the stay would operate only with respect to the drug in question in the matter, i.e. sorefenib tosylate.

Anand Grover, counsel for CPAA and project director of Lawyers Collective HIV/AIDS Unit, said, "We welcome the High Court's judgment. In India, we do not have a patent linkage system. The patent system and the drug regulatory system are two separate and independent mechanisms and this is Parliament's intent. If introduced, the patent linkage system would have seriously impacted the early entry of generic drugs into the market. Such early entry 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 we are now seeing an increase in the number of patents being granted to drugs, which we believe are being wrongly granted. Moreover, a patentee cannot use the DCGI, a government agency, to enforce its private rights. This was an attempt to introduce a TRIPS-plus requirement in India, which has been rejected."

CPAA had urged that the introduction of patent linkages in India would have adverse public health consequences. It had argued that despite the fact that the Legislature has kept the patent and regulatory systems separate, Bayer is attempting to link the two independent and separate systems and introduce a policy change through the Court.

Kiran Hukku, director, Cancer Patients Aid Association, New Delhi, said "With this rejection, we can hope to have early access to cheaper, generic medicines. This will benefit our patients."