The controversial patent litigation over Glivec has come to almost to an end on last Monday with the Madras High Court rejecting Novartis' petition challenging the constitutional validity of the section 3 (d) of the Patent (amendment) Act, 2005. The Madras HC upheld the Patent Controller's decision in January 2006 of not granting patent protection to Glivec. The Swiss multinational in a press note, issued soon after the verdict, has stated that it would not move Supreme Court challenging the Madras HC decision. With this stand it is quite unlikely Novartis will pursue its other case, to be heard at Intellectual Property Appellate Board, over the rejection of Glivec patent by the Patent Controller. The company has already faced a defeat a few days ago when its plea for removal of S. Chandrasekaran from IPAB was rejected by the Madras High Court. Chandrasekaran was the head of the Indian Patent Office when it did not grant patent for Glivec in January 2006. Denial of patent to the drug is as per the Section 3 (d) of the amended Patent Act which does not recognize incremental innovation of known substances unless it significantly improves the efficacy of the substance. The objective of the Section is to prevent drug companies from unjustifiably prolonging the life of a patent by claiming new properties. The company's stand is that medical progress occurs through incremental innovation and section 3 (d) excluded important developments in the form of incremental innovation and thereby denying patients new and better medicines.
Definition of patentability of drugs in the Indian context is getting murkier with the increasing number of patent challenges on one side and the government's determination to redefine this most controversial aspect of the new patent law on the other. More than 20 cases pertaining to grant of patent are lying in various courts of the country after the amended Patent Act was notified in January 2005. A recent case is that of Wockhardt seeking patent for a new version of nadifloxacin filed in Bombay High Court. The company has challenged the rejection of its application for a patent for nadifloxacin by the Patent Controller early this year. While it is fine to allow the courts or IPAB to decide on patent disputes in pharmaceuticals for the time being, a proper definition of patentability is called for as it is a complex techno legal matter. The appointment of Mashelkar Committee by the government was primarily to look into the issue of patentability in drugs. But the report of the Committee has not been accepted by the government as it contained no concrete recommendations. The report was supposed to have resubmitted with some changes subsequently. That has not happened yet. Dr. Mashelkar, however, had made a significant observation in the report. Indian pharmaceutical industry is capable of incremental innovations only and therefore India should not limit patenting to new chemical entity or new medical entity. If this statement of one of India's top scientists is taken note of, government has to come out with a clear stand on patentability of drugs at the earliest.