The symposium had brought together prominent multi-disciplinary experts, legal practitioners, academicians, policy specialists, representatives from the pharmaceutical industry and non-profit organizations. The symposium was spread in over five technical sessions focusing on different aspects of the issues posed by the IP-pharmaceuticals law and policy interface. Given the recent approval of India’s first compulsory license, an open session had also been held on this issue, which generated quite an intense debate.
The first session focused on the contemporary challenges to the intellectual property regime for pharmaceuticals.
Dr. Malathi Lakshmikumaran (Director, Lakshmikumaran & Sridharan Attorneys, New Delhi) made a presentation on patent law issues in pharma-biotech in the post-2005 scenario, including various provisions of the Patent Act, 1970 affecting patent protection for biotechnology and voiced the need for clear policy and uniform decision making by the patent offices.
Mr. Essenese Obhan (Founding Partner, Obhan & Associates, New Delhi) focused on procedural challenges in opposition and revocation proceedings, the lack of clarity in appeals against pre-grant opposition orders, bar on counters-rejoinders in opposition proceedings and the need for having post-grant opposition at all. He also discussed problems in the formulation of standard of skills possessed by ‘Person Skilled in the Art’.
The third speaker was Mr. Adarsh Ramanujan (Associate, Lushmikumaran & Sridharan Attorneys, New Delhi), who discussed the Novartis case and emphasized the need to settle issues regarding defining efficacy, its relation with inventive step, evidence required to prove ‘efficacy’ and other related aspects of section 3(d) and also whether Novartis was the right case to test this provision.
The session concluded with Mr. Madhukar Sinha’s presentation (Professor, Centre for WTO Studies, IIFT, New Delhi) on justifying price control to combat the skewed increase in rate of inflation of drug prices, the role of data exclusivity as another kind of monopoly and the practicality of Cost sharing models due to unavailability of reliable data and cost breakups etc.
The second session focused on the ‘Working through Remedies and Exceptions to Patent Rights.’
Moderating an open session on compulsory licenses (CL), Yogesh Pai (Asst. Prof. of Law & Coordinator- Ministry of HRD Chair on IPR, NLU, Jodhpur) introduced the CL provisions under the Indian patent law and the grounds for CL as invoked in the recent Bayer/NATCO decision. Delegates agreed that Section 84 is a viable option and clear policy should be formulated for its utilization. While many doubts were raised concerning the effectiveness of the CL framework due to certain open-ended provisions, the Bayer/NATCO decision was overall appreciated for its correct judicial determination. Some speaker delegates discussed the economic aspects of the CL mechanism, while others noticed an increasing paradigm shift towards the ‘liability rule’ from that of an ‘exclusivity’ rule, which is a welcome sign considering the possible unequal benefits arising out of the present patent system. Speakers also debated whether ‘working’ necessitates local manufacturing. Delegates discussed the requirement of local manufacturing, which they said could ensure transfer of technology, while being TRIPs-compatible.
Prof. Shamnad Basheer (Ministry of HRD Chair on IPR, NUJS, Kolkata) then made a presentation on patent enforcement, especially on injunctions, the evolution of the test to establish a prima facie case necessary for granting of interim injunctions, the inconclusive nature of the position with regard to whether merely showing a triable issue is required or a strong probability of winning the case needs to be shown etc. He suggested doing away with the interim injunction stage to directly proceed to trial. He also mooted an idea for specialized courts for patent cases to cater to its growing legal and technological specificity, including at the appellate levels.
The third Session dealt with ‘Trade and International Intellectual Property’.
The session, chaired by Prof. Madhukar Sinha of the IIFT, New Delhi, started with a presentation by Mr. Anand Grover (Senior Advocate, Supreme Court of India; Director, Lawyers Collective and the UN Special Rapporteur to the Right to Health) on the necessity of affordable medicines to secure the right to health and the adverse effect of FTAs vis-à-vis TRIPS flexibilities. He pointed out that south-south road map is essential to avail the flexibilities and should include all stakeholders in treaty negotiations. This session provoked discussions on treaty making in the international economic law space and raised many fundamental issues concerning the competence to the executive to agree to international treaties without prior Parliamentary approval.
This was followed by a presentation on in-transit seizure of generic drugs by Mr. Shashank P. Kumar (Consultant, New Delhi), who warned ‘border measures against goods in transit’, contained in many FTAs, are not compatible with WTO and TRIPS. However, considering the recent decision of the ECJ on this issue, he expressed hope that a remedy within the European domestic legal framework may settle the matter.
Towards the end of the first day consensus emerged that developing countries today have a better and nuanced understanding of the international IP regime and this progress is expected to continue. The session ended with the apt statement by Mr. Grover “March Separately, but Strike Together!”.
The second day began with the fourth session covering ‘Market Environment, Price Regulation and Competition in Indian Pharmaceutical Industry’ chaired by Prof. Shamnad Baheer of NUJS, Kolkata.
Mr. Dilip Shah (Secretary General, Indian Pharmaceutical Alliance, Mumbai) presented an informed critique of the National Pharmaceutical Pricing Policy, 2011. He stated that the present policy of cost price fixation system is not responsive to market changes and suffers from rampant conceptual ambiguities and lack of evidence based examination. He emphasized that policy should be based on substantive evidence, validated data and should take into account profitability of the industry.
Prof. Sudip Chaudhari (IIM, Kolkata) noted a steep rise in the drug prices after introduction of TRIPS. He noted that Indian companies have not been able to develop the skill required to innovate. User friendly compulsory licensing system, price control for consumer access and limits on data protection was suggested. He reiterated that it may be achieved through South-South collaboration. He also emphasized on the increasing consolidation in the Indian pharmaceutical industry and its implications in the long run.
Mr. J. Sai Deepak (Associate, Saikrishna Associates, New Delhi) argued that patent pools can attract Section 3 (3) of Competition Act, 2002. He also discussed the available defenses to the same. His presentation suggested alternatives to the compulsory licensing model to sustain competition between originator drug and generic companies.
Fifth and final session dealt with ‘Pharmaceutical Innovation: Intellectual Property and Beyond’.
The Session was chaired by Mr. Anand Grover, Senior Advocate and Director of Lawyers Collective. This session was initiated by Prof. Amit Shovon Ray (JNU, New Delhi). He emphasized the need of greater and effective linkage of public research and pharmaceutical industry. Some delegates concurred on the point that public –private partnership can be effective in dealing with many R&D problems. The efficiency of such model, however, was questioned. He also discussed on technical capacities in the Indian public funded institutions and issues concerning the proposed Indian Bayh Dole.
The session ended with a presentation by Mr. Santosh M R., (Associate Fellow, Centad, New Delhi). According to the speaker numerous communicable and non-communicable diseases are being neglected in our country today. He felt the need for increased government funding in public health sector, control on the exit and entry of capital and brownfield investments. He emphasized on the need for generic industry to develop more bulk drugs targeting the epidemiological needs of the country. In the event of failure of the patent system to generate incentives for R&D in neglected diseases, participants noted the relevance and effectiveness of alternative models to IP system, such as India’s Open Source Drug Discovery (OSDD) launched by the CSIR. The Session concluded with an open ended debate as to whether the IP system prohibits access to medicines.
The roundtable symposium concluded with a vote of thanks by Mr. Yogesh Pai (Coordinator- MHRD IPR Chair, NLU, Jodhpur) and distribution of mementoes to the speakers. As a follow-up, he invited speakers to collaborate for sharing thoughts for collective law and policy making in the Indian IP context and was hopeful that the brainstorming discussions held during the two-day roundtable would be useful in this regard.
Presentations and other details regarding the symposium are available here. The Spicy IP team thanks Monika (IV year student), NLU, Jodhpur for providing this concise and succinct report of this informative event that certainly provided a great deal of subject of thought for IP enthusiasts and left the delegates craving more.