SSRN Paper:Compulsory Licences on Pharmaceutical Patents in India

Mr. Sandeep Rathod (patent lawyer and Head of Litigation at Mylan Laboratories) recently uploaded a paper on SSRN titled, ‘Compulsory Licences on Pharmaceutical Patents in India’. The paper which argues against the notion that the Bayer case opened the floodgates for compulsory licensing in India (discussed on GoT here) is based on empirical evidence and an excellent repository of the compulsory licence applications which have been filed in India so far.

While reading the paper, I realised the gaps in my own research on compulsory licensing in the Indian context. My article (which has now finally been published by the JIPLP) missed many of the lesser known compulsory licence applications documented by Mr. Rathod in his paper.

I would encourage you to read the paper and share your thoughts. The working draft of the article is available open access at SSRN:




24 (India) Season 2 & the Access to Medicines debate in India (*Contains Spoilers*)

24 season 2

I spent yesterday binge-watching Anil Kapoor’s 24. 24 (India) TV series is a crime-suspense thriller and based on the US show of the same name. The wait for Season 2 has been long and my excitement knew no bounds when Season 2 finally premiered this July.

Being an IP enthusiast, I was delighted to find that 24 contained a pop culture reference to the long-standing debate on access to medicines in India (Warning: Spoilers ahead!)

There is a scene in Episode 3 (13:53 to 19:23) where it is revealed to us that Aditya Singhania is dating Dr. Devyani whose father is a scientist/heads a pharmaceutical company in India. In a meeting with pharmaceutical companies, Aditya Singhania talks of a proposed health bill which aims to subsidize medicines and make them accessible to the poor and rich alike in the country. The pharma companies are critical of this bill; they argue that it would adversely affect their profits since they have invested heavily in marketing, R & D and in patents. Both sides spar, with pharmaceutical companies arguing that diseases like small pox were eradicated because their life-saving drugs drugs reached every person and that this was proof that the companies already price drugs at affordable costs; the Prime Minister offers that it was ‘because’ the government did not ‘allow’ such drugs to be priced highly that the medicines were accessible to every person leading to successful eradication of life-threatening diseases. While this debate can very well be a chicken-and-egg situation, it captures the essence of the debate on ‘access to medicines’.

Up until a year ago, I could never fully understand the hullabaloo over access to medicines since I lacked the understanding of the subtle issues involved in this debate. This changed when I had the opportunity to provide research assistance to Prof. Feroz Ali Khader for his book, ‘The Access Regime:Patent Law Reforms for Affordable Medicines’. For those who do not yet grasp the fine points of this debate, I present below the issues in a nutshell:

Until 2005, India did not provide for patent protection on pharmaceutical products (based on the recommendations of the Ayyangar Committee report which recognized that it was important for the Indian government to ensure that medicines remain accessible to the citizens). Since there were no patents on pharmaceutical products, generic drug companies in India could reverse-engineer the product and supply them at lost-cost in India in abroad, thereby earning India the title of the ‘pharmacy of the world’. It was only after signing the TRIPS Agreement that India had an international obligation to amend its patent laws to include patent protection for pharmaceutical products. While pharmaceutical products can now be patented in India, India has not shied away from using the “TRIPS flexibilities” (Article 1 of TRIPS states that WTO members are free to determine the manner of implementation of the provisions of the Agreement)  to ensure access to certain life-saving medicines in the country.

Some of these flexibilities are:

  1. Section 3(d) of the Patents Act, 1970 which increases the threshold of patentability of pharmaceutical products in order to prevent ever-greening of patents (the constitutionality of section 3(d) was at issue in the famous Novartis v. UOI).
  2. Section 84 of the Patents Act which provides for issuance of “market-initiated” compulsory licences ((section 84 compulsory licences are different from compulsory licences issued on the ground of national emergency (section 92))- Section 84 allows interested persons to apply for compulsory licences on patented products on the grounds of non-affordability, non-accessibility or non-working of the product in India. Section 84 was the bone of contention in Bayer v UOI.
  3. The process of pre-grant opposition (section 25(1)) which allows any person to oppose a patent application on certain specified grounds.

India has faced a lot of flak by pharmaceutical companies (known as the Big Pharma in the US) for using the TRIPS flexibilities. From the pharmaceutical companies’ perspective, this is detrimental to innovation because commercial exploitation of their inventions (e.g. through patent licensing) allows companies to re-coup their R&D costs and use the money in further R&D to further develop medicines. It is important to note that R&D costs in developing pharmaceuticals can be quite significant given that only few in the many drugs developed are effective and/or get marketing approval. Health advocates, on the other hand, feel that pharmaceutical companies inflate their R&D costs to make neat profits at the expense of public health. This encapsulates the debate on access to medicines.

Interestingly, 24 Season 2 is based on bio-warfare and it would be interesting to see whether this reference was merely incidental to the plot or is part of a bigger sub-plot. In any case, 24 is one of the better TV shows to come out of India in the recent past and definitely worth a watch.

[The show premieres every Saturday and Sunday on Viacom 18, and those without access to TV can stream it online (LEGALLY <yay>) for free on Voot (the digital arm of Viacom 18).]