Section 3 (d) of the Indian Patent Act

The section 3 (d) of the Indian Patent Act, which was introduced in 2005, states that, for a new form of an existing substance to be patentable, it should show an ‘enhanced efficacy’. This section prevents pharmaceutical companies from evergreening and monopolising their drugs by merely making physico-chemical changes in their patented drug formulae without actually increasing the drug’s therapeutic ability. The Indian pharmaceutical industry has been a major producer and supplier of low cost generic medicines, not only for the Indian consumers but also for many developing nations like it-self, especially the African nations. The section 3 (d) protects the interests of billions of poor, who depend on low-cost generic drugs, from frivolous patent claims by Multinational Pharmaceutical companies in the name of innovation.

The provision of the Section 3 (d) recognizes incremental innovations as a basis for patentability of the drug. The Supreme Court upheld the decision of Intellectual Property Appellate Board rejecting the patent claimed by Novartis for its cancer-therapy drug Glivec on the basis that it was only a ‘beta-crystalline’ form of the cancer Drug Imatinib, was already known before Glivec’s development and thus it was a mere discovery of a new form of a known substance. Novartis had petitioned that its claim stood valid according to article 27 of TRIPS agreement according to which patents are available for inventions provided they are new, involve an inventive step and are capable of industrial applications. Thus, the section 3 (d) of the Indian Patent Act has raised the benchmark of inventiveness and what can actually fall under the category of innovation by introducing the criteria of ‘efficacy’. It intends to balance patent protection by pharmaceutical companies with the obligations of the government and the civil society to provide access to affordable healthcare to the common man at large.