The Supreme Court on last Monday put an end to the seven year old patent litigation pertaining to marketing of Glivec, the cancer drug of Novartis, in the Indian market. The SC upheld the Section 3(d) of the amended Indian Patent Act which prohibits attempt to evergreening of a drug patent by the inventor company by making some incremental changes to the original molecule. Novartis, the Swiss multinational, has been challenging the Section 3(d) of the Patent Act in the apex court to get the patent right to its imatinib mesylate. The main objective of Novartis to challenge first Patent Controller’s decision of denying the patent and subsequently to move court was to prevent manufacture and marketing of the cancer drug by any Indian drug company at a lower price. The Swiss company has been successful in achieving this goal as it could stop launching of the generic version of the drug in the market at least for seven years. Indian drug companies can now market generic versions of the drug which may cost just Rs.10,000 for a month’s course which is almost 92 per cent lower than the price of Rs.1.2 lakh at which Novartis is presently marketing in India. For the millions of poor patients of India and of developing countries, the SC verdict will prove to be a major relief.
Application for the patent of beta crystalline version of imatinib mesylate was rejected by the Patent Controller's office in January 2006. The company then moved Madras High Court challenging rejection. In August 2007, Madras HC rejected Novartis' petition challenging the constitutional validity of the Section 3(d) of the amended Patent Act. Madras HC then directed Novartis to appeal against Chennai Patent Office decision in IPAB. The case was subsequently heard by IPAB and rejected Novartis' appeal in July 2009. The company then moved the Supreme Court in the same year. After several adjournments and hearings of different parties, the apex court delivered this historic judgement now. With this verdict, Novartis has hardly any legal option left except moving a review petition of the order. That can only be a futile exercise and it cannot buy any more time. Reacting to the verdict, Novartis came out with an empty threat saying that SC verdict would discourage research in pharmaceutical sector in India. It is known to everyone that MNCs and large Indian drug companies have not brought out any new molecule in the country after 40 years of their operations and spending several thousands of crores of rupees in the name of drug research. Novartis may argue that it obtained patent for its cancer drug in 30 countries and therefore denial of patent right in India is not justified. The MNC should realize that the patent law for pharmaceutical products cannot be made applicable uniformly in all the countries as the socio economic conditions of the people vary quite vastly. In developed countries, cancer patients are relatively well placed and looked after by the government sponsored medical insurance schemes and that is not the case in India.