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P.T. Jyothi Datta

Mumbai, Aug 5 The Madras High Court will bring in more clarity on whether or not to reward incremental innovation on a know substance, when it delivers its judgment on a case regarding Novartis’ cancer drug Glivec, expected on Monday.

Last year, Novartis had filed multiple writs at the court challenging the rejection of its Glivec patent application by the Patent Controller’s office in January 2006. The Swiss drug-maker also contested the constitutional consideration based on which the Patent Controller’s office rejected the patent application on Glivec.

This was, among other things, Section 3 (d) of the Patents Act 1970 as amended by the Patents (Amendment) Act 2005.

This parameter does not at present recognise incremental developments on a known substance, unless it significantly improves the efficacy of the substance.

The aim of Section 3 (d) was to prevent drug companies from prolonging the life and patent monopoly it had on a drug.

The court’s judgment will have ramifications not just for Novartis and drug Glivec but on medicines used to treat other illnesses – which is why cancer and AIDS-related patient organisations will be watching the developments closely.

The judgment is generating much interest among pharmaceutical companies of all hues also because it seeks to iron out wrinkles as the relatively young product-patent regime gets implemented on the ground.

India began honouring product patents from January 2005.

In the pharmaceutical sector, this meant that drugs with patent applications in India after 1995 were protected, granting them monopoly by keeping generic copies at bay.

But this had patient advocacy groups concerned, as they felt access to new drugs could get strangled in the process.

However, in earlier interactions with the media and shareholders, Novartis has maintained that the case regarding Section 3 (d) was to seek clarity on rewarding innovation.

Medical progress occurs through incremental innovation, the company had said, and Section 3(d) excluded important developments in the form of incremental innovation, denying patients in India new and better medicines.

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Glivec case: Madras HC judgment likely today

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