`Process of grant or rejection of patent is a quasi-judicial function'

Special Correspondent

"Novartis' patent application does not claim any efficacy for its compound"

"Indian courts must be concerned with laws passed by Parliament"Patents Act operative even if it is not TRIPS-compliant

CHENNAI: The issue relating to rejection of the patent application of Novartis AG is not justiciable, and the matter does not call for a decision, the Union Government told the Madras High Court on Tuesday.

When a batch of petitions filed by Novartis against the refusal to patent its beta crystalline form of imatinib mesylate came up for hearing before a Division Bench, comprising Justices R. Balasubramanian and Prabha Sridevan, Additional Solicitor-General V.T. Gopalan said Indian courts must be concerned with the laws passed by Parliament. "They are not here to find out if the law is TRIPS-compliant or not."

Mr. Gopalan said courts had uniformly held that no mandamus could be issued to Parliament on what legislation should be brought in, and in what manner. The Patents (Amendment) Act 2005 was operative even if it was not TRIPS-compliant.

Describing the process of grant or rejection of patent to a product as a "quasi-judicial function," he said parties were afforded reasonable opportunity and that an appeal provision against the reasoned order too had been provided for under the Act.

Maintaining that the Act contemplated adequate guidelines, he said Section 3(d) itself had necessary safeguards to assess the efficacy of drugs submitted for patent.

Novartis' application did not claim any efficacy at all for its compound, Mr. Gopalan said. The company had failed to furnish details on trials and results even when it was asked to place them before the competent authority.

"When they make a medicine, which requires patent under the Act, they have to demonstrate the properties of that product. Let them place the results before the authorities and prove the efficacy," Mr. Gopalan said.

Senior counsel for Ranbaxy Lakshmi Kumaran said the TRIPS Agreement provided elbowroom for the member-nations to frame their own regulations to meet their rights and obligations. By merely changing the form, the petitioner was attempting to prevent people from getting access to life-saving drugs for a few more years.

As for the arguments that the terms found in the provision were ambiguous, counsel said it was the court's duty to interpret them keeping in mind the legislative intention. Courts cannot strike down legislations merely because the words were ambiguous.

Senior counsel for the Cancer Patients Aid Association Anand Grover said Section 3(d) dealt with the fundamental problem of ever-greening, and added, "salts are used to delay the generic entry."

Well-known terms

Senior counsel P.S. Raman, reiterating that the concept of "efficacy" and "significant enhancement" were not unknown to Novartis, said the terms were not only known in patent laws all over the world, but were also used as a tool to identify substances which were not new. Arguments will continue on Wednesday.

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