CHENNAI: The Madras High Court, hearing writ petitions relating to the rejection of a patent application from pharmaceutical major Novartis AG, posed a volley of questions concerning the core grounds of challenge on Monday.

Justice R. Balasubramanian sought to know how the Legislature could specify the derivative for which a patent application was made. It could only facilitate the Controller of Drugs to use his discretion either to grant or reject a patent plea, he said. Justice Prabha Sridevan said that 30 per cent of enhancement in efficacy, which might be sufficient for an anti-cancer drug, could not be laid down as a criterion for all patent-seeking products uniformly.

The writ petitions are against the rejection of an application to patent Novartis' beta crystalline form of imatinib mesylate, by an order dated January 25, 2006. By separate petitions, the company has questioned the constitutional validity of Section 3(d) of the Patents Act 1970 as amended by Patents (Amendment) Act 2005, as per which a patent-seeking product must differ significantly from the original substance in regard to efficacy.

Later, Mr. Justice Balasubramanian sought to know from senior counsel Shanti Bhushan as to what order could be passed by the court if it were convinced that the impugned provision of the Act was TRIPS-violative. To this, Mr. Bhushan, representing Novartis, said the provision could be declared not TRIPS-compliant. It will give the Government of India two options: either to amend the law further to make it TRIPS-compatible or prefer an appeal against the ruling. He also stated that if Section 3(d) of the amended Act were allowed to inhibit the grant of patents, then it would amount to taking away a right provided by the TRIPS.

Mr. Justice Balasubramanian also wondered if an individual could challenge a legislation on the ground that it was violative of the TRIPS, when the member-nations were entitled to take up such issues before a competent forum provided for under the TRIPS.

Earlier, senior counsel for Novartis, Soli Sorabjee, submitted that if India did not fulfil its TRIPS obligations, it would lead to erosion of the country's credibility globally. Though the original Ordinance sought to fulfil the avowed objective of complying with TRIPS commitments, the subsequent developments like the amendment and the reference to an expert committee gave a stamp of irrationality and arbitrariness to the legislation, he said.

Citing Supreme Court rulings, Mr. Sorabjee said it was the duty of courts to strike down arbitrary powers conferred on the Legislature and the Executive. He said the concept of efficacy was foreign to patent laws, and added that a safeguard was needed with regard to determining efficacy as an undefined expression in the explanation to the Act could be interpreted differently by different authorities. The arguments will continue on Tuesday.

Statutory appeals

A. Ramesh Kumar, counsel for Cipla, Sun Pharmaceuticals and the Indian Pharmaceutical Alliance, said the same Division Bench would hear the statutory appeals of Novartis from March 26.

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