CHENNAI: Shutting down the patenting of chemical derivatives on the ground that a derivative shall be deemed to be the original substance is tantamount to a "fatwa" on incremental innovation, pharmaceutical major Novartis AG told the Madras High Court.

When a batch of petitions filed by Novartis AG against the rejection of its patent application for beta crystalline form of imatinib mesylate came up for hearing before a Division Bench comprising Justices R. Balasubramanian and Prabha Sridevan on Friday, senior counsel Soli Sorabjee said the deeming provision inhibited patenting of the derivative, which was new and involved inventive step and industrial application.

The company had challenged the rejection order dated January 25, 2006 as well as Section 3 (d) of the Patents Act, 1970 as amended by Patents (Amendment) Act 2005.

"Vague, nebulous"

Describing the explanation to the provision as being "vague, nebulous and undefined," Mr. Sorabjee said it required the derivative to differ significantly from the original substance containing enhanced efficacy. He said it was the most offending provision, as there were no guidelines, criteria or standard to ascertain as to what constituted "significance" in property. "Where does the insignificance end and significance begin," he asked, adding: "Section 3 (d) amounts to an embargo on patenting new chemical entities."

Not TRIPS-compatible

Pointing out that India was a signatory of TRIPS Agreement, he said the impugned provision was not TRIPS-compatible.

Shanthi Bhushan, who also represented the company, said the impugned provision would limit innovative research in the country. If molecules are shut out, then nothing can be patented and there cannot be any new substance, he said. To say that a derivative will not be considered an invention will inhibit innovative research, he added. According to Mr. Bhushan, the TRIPS contemplated that incremental innovation, by which one would come out with certain compound/product, should be regarded a different product.

Writ appeals

As for objections to converting the writ petitions into writ appeals, the senior advocate said it was a question of nomenclature. "Unless there is a special procedure which is mandatory, the nomenclature is immaterial, more so when the court has jurisdiction."

Lodging "strong objections" to converting the petitions into writ appeals, senior counsel for Cipla Arvind Dattar said though the forum was the High Court, the jurisdiction was totally different. The move was "fraught with grave danger," he said, adding that the appellate jurisdiction of the court could not be converted into the extraordinary original jurisdiction.

At the end of the day, when the arguments were still inconclusive, the judges decided to hear the petitions challenging Section 3 (d) of the Act on February 22 and 23. They will hear the matters relating to the conversion of the writ petitions into writ appeals on March 2.

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