CHENNAI: The provision governing the grant of patents for various products is bereft of guidelines, Habibulla Basha, senior counsel for pharmaceutical major Novartis AG, told the Madras High Court on Monday.

The provision left the decision to the whims and fancies of a drug controller, he said when petitions questioning the constitutional validity of Section 3(d) of the Patents (Amendments) Act 2005 came up for further hearing before a Division Bench comprising Justices R. Balasubramanian and Prabha Sridevan.

"Not an expert"

Pointing out that the official was not an expert, Mr. Basha said the provision was lacking in guidelines to determine what "mere" or "significantly" meant. The impugned order, turning down Novartis' patent application for beta crystalline form of imatinib mesylate, itself said the product had 30 per cent of enhancement in efficacy but added it did not amount to a significant increase in efficacy. Earlier, another senior counsel Shanti Bhushan said nothing could prevent the court from declaring Section 3(d) TRIPS-violative if the judges arrived at such a conclusion. "If the Government claimed that the patent provisions were TRIPS-compliant and if the court felt it was not so, then why should the court not make a declaration to that effect?" If the provision was not TRIPS-compliant, then the courts should not hesitate to say so one way or the other.

Yardstick for patents

Mr. Bhushan submitted that a minor or tiny improvement over the existing compounds need not be patented, and reiterated that three factors including inventive step and industrial application were the yardstick for patents. There was a confrontation between incremental and original research processes. Arguments will continue on Tuesday.

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