In my last post, I had reported on the pharma and IP Roundtable that was scheduled to be organized by and at NLU Jodhpur under the dynamic and able leadership of Assistant Professor Yogesh Pai, for whose mind and breadth of knowledge I have deep regard and great respect. Thanks to him, I had the opportunity to not just attend, but to also share my views on the subject with an august gathering of thought-leaders from diverse backgrounds.
Since all presentations and podcasts of all the sessions are expected to be available at http://www.nlujodhpur.ac.in/ip_events.php, I shall only capture only the gist of the presentations in this post.
This roundtable was held in almost the immediate aftermath of the Bayer Compulsory Licensing Order. Naturally, the roundtable was abuzz with talk about the order. In fact, this probably was the first roundtable of IP practitioners, academicians and policy analysts to come together after the pronouncement of the CL Order. This is one of the reasons, among several others, that it was a fantastic success.
In the first session on March 17th, the inaugural presentation was that of Dr.Malathi Lakshmikumaran, who shared her views on patentability of isolated substances from living and non-living organisms. This was followed by a very crisp, engaging and interesting presentation by Essenese Obhan of Obhan and Associates on nature and variety of challenges available against a patent under the Act, and attendant issues. Essenese pointed out, among other things, that the post-grant opposition system is redundant, which I concur with.
Next was a riveting presentation by Adarsh Ramanujan of Lakshmikumaran on Section 3(d) and the Novartis case, where he spoke at length about his take on the provision and whether the Novartis case was the best case for the pharma patent debate.
Prof.Madhukar Sinha of the Centre for WTO Studies of IIFT then presented an extremely interesting point of view on how cost-sharing model may not be the best of alternatives to data exclusivity since it could actually end up spiking transaction costs even in a model with limited complications.
Following this, Prof.Shamnad Basheer of NUJS presented his views on interim injunctions in the pharmaceutical sector, and was of the opinion that expedited trials are a better option in the limited context of pharma patent litigation.
In the afternoon session, Mr.Anand Grover, Senior Advocate and one of the founding members of the Lawyers’ Collective, shared his views on how FTAs, particularly the EU FTA with their TRIPS-plus obligations could have an adverse effect on access to medicines in India.
The last presentation of the day was by Shashank Kumar whose talk revolved around unilateralism in international law, with specific reference to EU Regulation 1383 on cross-border measures and in-transit seizure of goods. He pointed out that the “manufacturing fiction” of the EU regulation on in-transit seizure, despite being interpreted by the ECJ in favour of the consignor of the in-transit goods, is slowly finding its way in other treaties.
The first presentation of the second day i.e. March 18th, was by Prof. Sudip Chaudhuri of IIM Calcutta whose primary thrust was that the initial optimism associated with the Indian pharmaceutical industry’s success is slowly giving way to disappointment, since the Indian industry has not lived up to what was expected of it in terms of indigenous research. Further, Prof.Chaudhuri was of the view that the re-introduction of the product patent regime was responsible for the downturn in the Indian pharma sector’s fortunes and for price-rise. According to him, the product patent regime is taking India back to the pre-1970 product regime days when India depended on pharma imports by originator companies and was characterized by absence of self-reliance in the Indian pharma sector.
Following this, Mr.Dilip Shah, Secretary General of the Indian Pharmaceutical Alliance critiqued the National Pharmaceutical Pricing Policy of 2011 for not adopting an evidence-based approach to fix drug prices. According to him, the NPPA’s policy would lead to a minimum loss of INR300 crores, which according to him, could be invested in boosting indigenous R&D efforts.
After Mr.Shah, I spoke on the interface between IP and Competition Law. The specific topics that were part of my presentation were:
1. Legality of Patent Pools under the Competition Act 2002, specifically under Section 3(3), defenses to presumption of anti-competitiveness of patent pools.
2. Alternatives to the compulsory licensing model to sustain competition between originator drug and generic companies.
The penultimate presentation of the day was by Prof.Amit Shovon Ray of JNU on the importance of public-funded research in critical areas of public interest such as the pharmaceutical sector. He pointed out that as opposed to USD 34 billion invested by private US players in the US pharma sector for research, the National Institutes of Health (NIH) of the US had invested USD 28 billion. This, according to him, is the approach that India must adopt too.
The last presentation was by Mr.M.R.Santhosh of CENTAD on the skewed focus of drug companies on research in non-communicable diseases with waning efforts in the area of bulk drugs for communicable diseases.
Each of the presentations only added to my understanding of the role of IP, its relevance for innovation and its implications on public health. As mentioned, most or all of them will soon be made available by NLU Jodhpur on its website along with podcasts of the proceedings of the roundtable.