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Our Bureau

Mumbai, Nov. 3 The review of the rejected patent on Novartis’ cancer-drug Glivec is set to be heard by the Intellectual Property Appellate Board (IPAB) on a ‘day to day’ basis, starting November 17. Novartis’ patent application on Glivec had been rejected by the Indian Patent Office in January 2006.

The hearings of the appeals made by Novartis and Natco would be heard by the IPAB in the first week from the scheduled date, followed by the Cancer Patients Aid Association, Cipla and Hetero in the following week, a lawyer handling the case told Business Line.

These were directions from IPAB that convened on Monday as directed by the Supreme Court. The board comprised Mr Z.S. Negi (Judicial Member) and Dr P.C. Chakraborty (Special Technical Member).

The appointment of the technical member on the IPAB had got caught in litigation, as Novartis was unhappy with the earlier appointment of Mr S. Chandrasekaran as the technical hand. The reason for Novartis’ concern was because Mr Chandrasekaran, was the former Patent Controller under whom Novartis’ patent on Glivec had been rejected in the first place.

Novartis’ Glivec has been at the centre of litigation since late 2003, when it was the first pharmaceutical company to be granted Exclusive Marketing Rights in the country, in the run-up to the product patent regime that came into effect in January 2005.

Subsequently, after its patent application was rejected in 2006, Novartis approached the Madras High Court, challenging separately the rejection of its application and contesting the parameters that lead to the rejection, including Section 3 (d) of the Patents Act 1970 as amended by the Patents (Amendment) Act 2005. (The parameter does not recognise incremental developments on a known substance, unless it significantly improves the efficacy of the substance.)

In August 2007, the Madras High Court dismissed Novartis’ writ petition challenging the constitutionality of Section 3(d).

With the constitution issue settled, the hearing on Glivec’s patent rejection later shifted to the newly-operationalised IPAB in April last year, following a notification on the issue from the Centre.

More Stories on : IPR | Regulatory Bodies & Rulings | Pharmaceuticals

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