The Hindu Business Line : Patent law should have guidelines to follow: Novartis

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Chennai March 5 A Division Bench of the Madras High Court, which has been hearing a writ petition from the Swiss pharmaceutical major Novartis AG, challenging rejection of its patent application for beta crystalline form of imatinib mesylate, on Monday posed a query to the senior counsel of the firm, Mr Soli Sorabjee whether or not would there be "absolute bar" for grant of patents for chemical derivatives if Section 3(d) of the amended Patents Act, 1970 were to go, as pleaded by the petitioner.

Mr Justice R. Balasubramanian and Ms Prabha Sridevan, also raised a point whether vesting some discretion with the authority would be objectionable.

Presenting his arguments, Mr Sorabjee said that the statute framed by the legislature on this subject should contain guidelines, which would help in the authority not acting arbitrarily. The present Section 3(d) vested with the authority unfettered powers, which might result in questionable decisions by the authority concerned. The section incorporated terms like `significantly' and `efficacy', which were not defined and were nebulous and vague.

The counsel contended that there had been various judgments of the apex court ruling that the laws should incorporate sufficient guidelines and had also declared some of the provisions as ultra vires of the Constitution.

He also elaborated how different statutes had been enacted to deal with marketing of drugs and issue of patents. In regard to marketing of drugs, the authority had no problem in following the law. Here in the case of patents, the latest amendment to Section 3(d) said that the section required a derivative to differ `significantly' from the original substance containing enhanced efficacy. This was perhaps the most vaguely drafted expression, as there were no guidelines, criteria or standard to ascertain as to what constituted `significance' in property. `Where does insignificance end and significance begin?', the counsel wondered.

The counsel told the Bench that the amended patent law must incorporate `in-built indication' of the various expressions used, to avoid `divergent exercise of powers' by the authority.

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