As most of us know by now, Justice VR Krishna Iyer passed away on 6th December, 2014 at the age of 100. He had an illustrious career spanning as a lawyer, politician and Judge. He has served as a Judge of the Kerala High Court and the Supreme Court. He is perhaps most well-known for having been on the bench in the famous Maneka Gandhi judgment, whose interpretation of the Fundamental Right to Life under Art. 21 of the Constitution leaves an enduring mark.
In the domain of IPR, it is a little-known fact that he has left behind a legacy of sizeable magnitude- in the framing of S.3(d) of the Indian Patent Act.
Prior to India’s accession to the TRIPS Agreement, Indian Patent Law was based on the suggestions of the Ayyangar Committee Report- an insightful report drafted in 1959 by Justice Rajagopala Ayyangar (available here). It was framed in mind keeping India’s position as a newly independent country with fledgling industrial capabilities. The thrust of the report was to prioritise ‘access to all’ as much as possible especially in the fields of pharmaceutical and food-related patents. By not providing for product patents in pharmaceuticals, among other policies, India saw its generics industry grow and its drug prices plummet to one of the lowest in the word in the early 1990’s. However, after accession to the TRIPS Agreement, India was forced to make major changes in its patent policy, including the introduction of product patents for pharmaceuticals.
From a public health point of view, a particularly problematic aspect of granting product patents is ‘evergreening’- i.e. when owners of pharmaceutical patents extend the term of their patents by obtaining related patents on slightly modified forms of the same drug.
In 2004, the Department of Industrial Promotion and Policy (the DIPP) was responsible for drafting the Amendments that would make Indian law TRIPS-compliant. The initial amendment to S.3(d) read “ What are not inventions: (d) 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 employs at least one new reactant”. The only change to the original S.3(d) was the addition of the word ‘mere’.
Just one day before the amendments were introduced in the Parliament, the DIPP sent a note addressed to the Legislative Department suggesting a few more amendments to the Bill. Among these was the amendment to S.3(d) to make it read as it does now. The note credits none other than Justice VR Krishna Iyer to be the architect behind the provision. (The note is available here. The entire story behind S.3(d) is covered by Prashant Reddy in a spicyip post available here).
The rest, as they say, is history. S.3(d) now reads as follows:
“3(d) the 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 employs at least one new reactant.
Explanation.—For the purposes of this clause, 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.”
Therefore, Justice Krishna Iyer is the architect behind the enhancement of known efficacy standard. The interpretation of this standard then went on to be the crux of the controversy in the Novartis decision, with the Supreme Court restrictively interpreting efficacy to mean therapeutic efficacy in the case of pharmaceutical products.
In today’s world, it is perhaps unrealistic to expect Indian IPR policy to completely mirror the vision of Justice Ayyangar. Justice Krishna Iyer, who has always stood for social justice, did his part in adapting India’s patent law to the changing world without leaving its roots far behind.