The Supreme Court of India has directed the Intellectual Property Appellate Board (IPAB) to hear the Novartis matter on November 3 2008. During the recent patent row involving the cancer drug Glivec (imatinib mesylate) of Swiss pharma major Novartis, the constitution of IPAB came under scrutiny due to its reviews of the Indian patent office's decisions. The Supreme Court ordered the appointment of Dr PC Chakraborty, deputy controller general of patents and designs in the Kolkata office as the new technical member for hearing the Gleevec appeal. This was in response to the concerns expressed by Novartis over the existing member S Chandrasekharan, since he was the patent controller who rejected Novertis' beta patent. The IPAB is the board of appeals for intellectual property matters and consists of a chairman, one judicial member and one technical member.
The Supreme Court directed the IPAB to list the matter for hearing on November 3 to decide on the further course of action and hear the matter on a day-to-day basis. The need to have a technical member stems from the complicated issues involved in a patent dispute which necessitate intensive examination of chemical compounds against the criteria of patentability.
Earlier, the central government had been asked by the Madras High Court to hear an appeal from Novartis against the rejection of the Glivec patent without the technical member. Against the verdict, Natco Pharma, who had challenged the Glivec patent, filed a special leave petition in the Supreme Court seeking the appointment of a technical member. Natco had secured an interim stay order on the High Court verdict. The litigation is an offshoot of India's first patent proceeding after the new amendment came into force, laying out the contentious Section 3(d). The Madras High court decided that section 3(d) was well within the constitutional scheme and there was no need to detail any explanation to it, as it would create further complications.
According to section 116(2) of the Patents Act, 1970, which deals with the qualification of the technical member; such a person must have held the post of controller or exercised the functions of controller for a period of five years at least; or functioned as a registered patent agent for at least ten years and must possess a degree in engineering or technology or a masters degree in science.
Novartis had previously got exclusive marketing rights for the pharmaceutical, driving out the generic manufacturers, who approached the judiciary against it because as soon as the exclusive marketing rights were granted, the cost of one month's dosage of the drug shot up more than ten times.
The ruling and the subsequent appointment of the technical member has far-reaching significance for the Indian pharma industry. With this, all decks seem to have been finally cleared for the review of the rejection of Novartis' patent.
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