In a verdict that brings cheer to public health interest, the Delhi High Court on Tuesday dismissed Bayer’s appeal to introduce the patent linkage system in India. The judgement passed by a Division Bench comprising of Chief Justice A.P. Shah and Justice Muralidhar, upheld the decision passed by Justice Ravindra Bhat who had earlier rejected Bayer’s appeal.

In 2008, Bayer had filed a writ petition against the DCGI (Drug Controller General of India) and Cipla, stating that the Drug Controller must consider the patent status of its drug, Sorafenib Tosylate, before allowing marketing approval to generic versions.

‘Patent Linkage’ is a system whereby the drug controller of a country refuses to grant, or delays marketing approval for a generic drug if a patent for that drug is already in existence. This system is believed to be derogatory to consumer rights and general health policies since it delays the entry of cheaper and possibly life-saving medicines.

A standard monthly dose of Sorafenib, used to treat renal cancer, is 120 tablets. Those manufactured by Bayer costs around Rs. 2.85 lakh ($ 6,100), while the generic Cipla drug is touted to cost about half of that price.

Earlier, Senior Counsel Shanti Bhushan had argued on behalf of Bayer that granting marketing approval to the generic version of the drug would result in the violation of the rights of the patent holder. Justice Bhat had adopted a contrary view and had agreed with Senior Counsel Arun Jaitley, who was appearing for Cipla. Jaitley had argued that there cannot be a simple combined reading of the Patent Act and the Drugs and Cosmetics Act. The court had imposed a cost of Rs. 6.75 lakh ($ 14,500) on Bayer, stating that Bayer’s petition was a tactic to introduce public polices in a country through court judgements.

After a battery of counsels had addressed arguments in this matter, the Bench had reserved its judgment on December 1, 2009. Senior Counsels Shanti Bhushan, Additional Solicitor General A.S. Chandiok, Abhishek Manu Singhvi and Anand Grover had appeared for Bayer, Union of India, Cipla and the Cancer Patients Aid Association (CPAA) respectively. Briefing Bhushan, were Remfry & Sagar and PM Associates. Batting for the respondents were Singh & Singh (Cipla), Lawyers Collective (CPAA) and lawyers Sandeep Phogat and Jayant K. Mehta for Indian Pharmaceuticals.

The Division Bench, however found no reason to reverse the judgment of Justice Bhat. Stating that the decision to introduce a Patent Linkage system is the prerogative of the Government they 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."

Pratibha M. Singh, the counsel briefing Dr. Singhvi for Bayer, told Bar & Bench, “India does not follow a system of patent linkage and the countries that follow a system of patent linkage have proper safeguards and specific statutory provisions. Patent Linkage is a Trips Plus provision and we only comply with Trips.”