Has the Indian Patents Act succeeded in ensuring access to affordable medicine?

EVER SINCE the introduction of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) under the World Trade Organization (WTO), patents have critically impacted pharmaceutical products and the prices that patients have had to pay for them. 

For developing countries, the TRIPS Agreement meant one of the two things: either, it meant introduction of patents in pharmaceuticals, since in many countries, their patent laws did not cover pharmaceuticals, or two, it meant introducing product patents in pharmaceuticals, alongside the existing process patent regime in countries like India. Further, the TRIPS Agreement lacked clarity regarding any major remedy to address cases of abuse of patent monopoly, namely grant of compulsory licences, which was clarified six years after the commencement of implementation of the Agreement in the Doha Ministerial Conference of the WTO.

India’s law makers had developed a TRIPS-compliant patent regime with an eye to ensuring access to affordable medicines in the country. Though the TRIPS Agreement has strengthened the patent regime, there are several flexibilities in the Agreement that can be taken advantage of to ensure that patent holders do not enjoy a free run in India. The law makers included these flexibilities in India’s TRIPS-compliant patent law so that the domestic pharmaceutical companies could provide affordable generic medicines as they had done prior to the adoption of the TRIPS Agreement. 

The first of these flexibilities was the denial of patents on minor modifications of a patented product after its 20-year term of patent protection had lapsed using the provisions of Section 3(d) of the Patents Act, 1970. Second was the inclusion of provisions for the grant of compulsory licences if prices of a proprietary medicine was high and the patent holder was unwilling to produce the product in India. And third was the authorising of pre-grant opposition of patent applications, de facto a peer-review mechanism for filtering applications whose covered products/processes do not merit patent protection in India. We aim to discuss the first two flexibilities. 

Section 3(d): Preventing grant of patents on minor modifications

Section 3(d) seeks to prevent grant of patents on minor modifications of products that have already enjoyed patent protection, better known as “ever-greening”. Section 3(d) does not allow grant of patents on “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or following: employs at least one new reactant”. 

An explanation provided to this Section says the following: 

“salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.