Date:24/02/2007 URL: http://www.thehindu.com/2007/02/24/stories/2007022404551400.htm

National

"Innovative companies using derivatives to block entry of generic products"

Special Correspondent

CHENNAI: "Expensive and frivolous" litigation over generic drug products would not help the general public, Anand Grover, senior counsel for the Cancer Patients Aid Association, told the Madras High Court on Friday.

When writ petitions challenging the provision came up for hearing before a Division Bench comprising Justices R. Balasubramanian and Prabha Sridevan, the senior counsel said only generic applications had prevailed in such litigations in several countries. "World over, courts have shown judicial determination not to allow such proceedings," he said, adding, "innovative companies are using derivatives to block entry of generic products."

Pointing out that India supplied about 50 per cent of anti-retroviral drugs to developing nations at an affordable rate, Mr. Grover said a legislative policy had been made on patenting, and that the TRIPS Agreement itself permitted member-countries to have an independent patenting system. It is not constitutionally or legally possible to declare Section 3(d) of the Patents (Amendment) Act as void on the ground that it was violative of the WTO Agreement on TRIPS, he said.

Referring to a submission by Soli Sorabjee, senior counsel for Novartis, that terms such as "significantly" and "efficacy" found in Section 3(d) were not defined and that they were nebulous and vague, Mr. Grover said it was a settled position that if the terms were not defined, courts would fill the vacuum.

Senior counsel R. Thyagarajan, instructed by A. Ramesh, counsel for Cipla, Sun Pharmaceuticals and the Indian Pharmaceutical Alliance, said there was absolutely no inconsistency in Section 3(d) of the Patents (Amendment) Act and Article 27 of the TRIPS Agreement. The TRIPS provided for flexibility to member-nations, it was submitted.

Senior advocate K.M. Vijayan submitted that in case of conflicts between international treatises and domestic laws there could not be a plea of unconstitutionality. Reiterating that Section 3(d) dealt with all patient applications without discrimination, he said constitutionality of the provision could be tested only against the Constitution of India and not international treatises.

P.S. Raman, senior counsel for Natco Pharma, said the impugned Section was not pharma-centric and that it had an omnibus applicability. He said it should be an international dispute and not a private list in municipal court, and added that municipal laws would prevail in any case. He said it was not necessary for Parliament to define every word used in the legislation.