Chennai, March 27 (PTI): Stoutly defending the rejection of a patent application from Switzerland-based pharma major Novartis, the Centre today said the decision was not just an administrative process but a quasi-judicial function.

"All parties get adequate opportunities to appeal against the reasoned order," Additional Solicitor General V T Gopalan told a division bench of the Madras High Court comprising Justices R Balasubramanian and Prabha Sridevan.

The judges were hearing a petition filed by Novartis to challenge the rejection of its application for patenting the beta crystalline form of Imatinib Messylate, a drug for cancer.

Rejecting the allegation that the amendment to the Patents Act was an excessive delegation of unbridled power, Gopalan contended that section 3D of the law itself provided for adequate safeguards and the act had sufficient guidelines on patenting.

On the argument that the section was not compliant with TRIPS, he said it would not offend the fundamental right to equality. "The courts have uniformly held that no direction could be issued to Parliament on what legislation must be brought and in what manner," he said.

Indian courts should only be concerned with the law passed by Parliament and not whether it was TRIPS-compliant. There were instances when Parliament, in its wisdom, chose not to make any law to give effect to international treaties and nobody could compel Parliament in this regard, he said.

Stating that Novartis had not claimed any "efficiency" in its application for a patent, Gopalan contended that the firm was required to show the drug was efficient and it had to be tested in the laboratory before it was administered to humans.

Even when Novartis was asked to furnish details of trial runs, the firm did not oblige, he said.

When a medicine is produced and a patent is sought for it, the manufacturer has to demonstrate the properties of its product and its results and efficiency. "If efficiency has been proved in clinical tests, let them (Novartis) place the results before the authorities," Gopalan said.

He furnished a letter from the House of Representatives addressed to Novartis, which said the Indian generic drug field was robust and supplied nearly two-thirds of anti- retroviral drugs to developing countries at affordable costs.

Novartis should not have challenged the constitutional validity of the legislation that provides for public health safeguards, he said.

Appearing on behalf of Indian pharmaceutical giant Ranbaxy, advocate Lakshmi Kumaran contended that if the amendment to the Act violated TRIPS, other members could initiate conciliation proceedings or seek dispute resolution in Geneva.

Alleging that by merely changing the form of a compound, Novartis was preventing people from getting access to drugs for some years, Kumaran said the objective of section 3d was to prevent "evergreening".

Merely because the firm refuses to understand the terms "efficiency and enhancement", it wants the law to be struck down, he claimed.

When words are ambiguous, courts should interpret and not merely strike down. Non-compliance with TRIPS would not automatically mean that the provision is arbitrary, he said.

"The forum to decide whether it is TRIPS-compliant or not is in Geneva and not this court," he said.

The arguments will continue tomorrow.