The amended Indian Patent Act was notified in January 2005 allowing grant of product patent in pharmaceutical industry under pressure from the World Trade Organization. A product patent entitles the inventor of a new molecule to have an exclusive marketing right for a period of 20 years in the country. Implication of granting such an absolute marketing right to a company with freedom to sell at any price is a serious matter considering the essentiality and life saving nature of these products. The amended Act, however, provided for certain key provisions relating to patentability of a product and opportunities for pre grant and post grant opposition to the affected parties. Probably, one of the most important clauses of the amended Act was the power provided to the Patent Controller to issue compulsory license. As per the Act, a compulsory license could be granted in case of a national emergency or in the event of non working of the patent for 3 years from the date of grant. These provisions were incorporated with the intention of preventing any misuse of the patent right by the owner of the patent. But, what India has been witnessing since 2005 is persistent attempts to misinterpret new patent rules by the MNCs by exploiting the inherent weakness of the Indian legal system. The decision of the Patent Controller or IPAB in a patent matter is invariably contested by MNCs and they move high courts and finally to Supreme Court. And high courts and the Supreme Court usually take several years for a final judgement.
Take the first patent case of Glivec, the cancer drug of Novartis. Application for the patent of beta crystalline version of imatinib mesylate, the chemical used in the drug, 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 is yet to deliver the judgement. Now, in March 2012, the Patent Controller granted the first compulsory license to Natco for Bayer's patented cancer drug, Nexaver, as it was highly priced and not easily accessible to patients. Bayer had obtained the patent for the drug in March 2008. As expected, Bayer challenged the Patent Controller's decision to grant CL to Natco in IPAB. The appeal was rejected by IPAB on grounds that Bayer has not taken any steps in revising the marketing strategy and cut the price of the product in three years. The Bayer has now approached the Madras High Court challenging IPAB's rejection. It should take several months if not years for the Madras High Court to decide on this case. Apart from these two cases, there are more than 20 other major cases pertaining to grant of patent held up in various courts of the country after January 2005. What is disturbing the patient community and the generic companies is the injustice they have to suffer on account of the inordinate delays in deciding the patent disputes by the judiciary. And the MNCs, on the other hand, is able to sell their products at exorbitant prices despite having a vigilant and pro active patent authority in the country.