Early this month India revoked yet another drug patent granted to a multinational, Boehringer Ingelheim, for its respiratory drug, Spiriva at a time when the US is putting pressure on Indian government for not providing adequate patent protection to multinational drug companies. The patent office revoked the nine year marketing exclusivity granted to German based Boehringer in 2012 on a post grant opposition filed by Cipla in 2013 on the ground that drug is not a new invention. In its decision, the patent office came to the conclusion that Boehringer failed to establish any technical advancement or any economic significance for the compound. The product also fails to demonstrate any new therapeutic efficacy and therefore cannot fulfil the requirement of a patentable invention under Section 3(d) of the Patents Act. Last January the Patent office revoked yet another patent granted to Abbott for its drug, Humira, under Section 3(d). In this case, the Patent office was directed by Delhi High Court to review its decision of granting patent to Abbott while disposing of an appeal from Glenmark. The Indian company had argued that its pre-grant opposition, filed in September 2008, was not considered by the controller of patents before granting patent to Abbott in 2009. Withdrawing the patent, the patent office in its January order stated that product is lacking inventive step and the description of the invention is insufficient and ambiguous.
The Section 3(d) was incorporated in the amended Patent Act with the objective of blocking the pharmaceutical companies’ attempt to claim patent right for incremental innovation involving new forms of a known molecule with no significantly enhanced efficacy. And MNCs have been constantly trying to circumvent this provision ever since the Patent Act was amended in 2005. The government does not want pharmaceutical companies to unjustifiably profiteer from a product without incurring any significant research costs. A 15-year market exclusivity for any incremental innovation cannot be justified as powerful pharma companies charge any price on such products by promoting them at the cost of patients. Granting patent protection for pharmaceutical substances involving only incremental innovation is against the public interest as such research does not involve any huge expenditure or timeline unlike in the case of a new molecule. Considering the increasing number of objections to grant of patents and patent related litigations in various courts, it is important for the Patent office to be extremely vigilant about judging such innovations so that attempts of evergreening are effectively prevented.