Sharmi Mahajan- Second Year
Public Interest Legal support and Research Centre (PILSARC) (New Delhi, India)
The Public Interest Legal Support and Research Centre (PILSARC) is a public interest law firm based in New Delhi, India. Set up in 1987, the centre supportssocial justice groups, NGOs, human rights institutions and marginalized communities by providing them with legal advice, research and litigation support in the formal legal system. Functioning as a pro bono organization, the centre engages in everything from legal matters concerning refugees and communal violence victims to aboriginal and women’s rights.
During my summer with PILSARC, I worked on a project concerning changes in the Indian patent regime, demanded by compliance with the World Trade Organization’s Trade Related Aspects of Intellectual Property Rights (TRIPS). My task was to document the changes in Indian patent law by reviewing the series of three(3)Patent Amendment Acts and trace the incremental changes made to the regime. Furthermore, I researched the various impacts and issues- social, economic and political- emerging from the changes in the patent regime. Primarily, I investigated the direct and indirect effects on the accessibility of affordable medicines to the Indian public. In order to understand more about TRIPS and the resulting compliance related changes, I first developed a general understanding of patent law and Indian patent legislation. Afterwards, I explored newspaper articles, foundation/organization reports and other relevant written sources to survey the reactions of industry members, government and other interested parties to these changes. Finally, I set up interviews with the convenor of the National Working Group on Patent Laws (NWGPL), Dr. Keayla, several academics from the Delhi Science Forum, the National Institute for Science, Technology and Development and DelhiUniversity. Another insightful interview involved speaking with Mr. Wakankar, who is the executive director of the Indian Drug Manufacturers Association. Thus, I was able to conduct my project and gather my research with the aid of many different sources and experts.
The main change brought about by the India Patent Amendments Actswas the extension of patentability to pharmaceutical and agro-chemical products. Patenting of pharmaceuticalsis particularly tricky, given the one to one correspondence between the structure of the molecule and the therapeutic effect. Assuch,strong monopolies are created by these patentsbecause one can not circumvent them by inventing around the patent. Prior to the 2005 Patent Amendment Act, only a process patent was in place. This is what contributed to a thriving Indian generic pharmaceutical industry, consisting of large, medium and small companies and manufacturing units. Against this backdrop, generic drugs were abundant and substantially cheaper than their brand named counter-parts, and were affordable for many of the poor. Furthermore, generic drugs were also available for export to other developing nations to help combat some of the ravaging diseasessuch as HIV/AIDS. Indeed, the impact on drug pricesis the main concern stemming from the changes in the patent regime. The Pan African Treatment Access Movement reveals that 51% of persons taking anti-retroviral drugs in developing countries rely on India’s form of 3-in-1 drugs.
One of the particularly interesting aspects of the project was the exploration of legal technicalities, loopholes and processes that were present in the changes brought about by the Patent Amendment Acts. Groups such as the Affordable Medicines Treatment Campaign, a platform of several different interested organizations, have quickly identified clauses that are vague, overly broad and go beyond what is required in TRIPS. As an example, sections 2 and 3 of the amended Patent Act include a broad definition of ‘invention’, which could possibly lead to frivolous claims, secondary patents and thereby increase the phenomenon of ‘ever greening’. The inclusion of the word ‘mere’ in front of new use, is confusing, and may also cause the extension of a life of a patent. Furthermore, the criteria of economic significance that can be satisfied to fulfill the requirements of inventive step is very contentious. The NWGPL hasargued, unsuccessfully, that the word ‘considerable’ be placed before the words ‘economic significance’. Another critical change is the new definition of a pharmaceutical entity which includes any new entity involving one or more inventive steps. Allowing for ‘any’ new entity as opposed to new chemical or medical entity in the definition results in a broader range of eligible products for patenting. Together, these changes create several avenues for unnecessary litigation. These inclusions would in turn decrease the supply of generic drugs available on the market. Several procedural changes in the licensing and opposition procedures are also noted as being cumbersome and unclear. For example, there is no set royalty rate that is to be paid under compulsory licensing procedures, and such a license is only available three years after the granting of a patent which is not required by TRIPS. The pre-grant opposition provisions have also been diluted and there has been a reversal of the burden of proof in infringement proceedings.
There have also been several positive aspects of the amendments. Most significant is the insertion of s.92A which allows for the compulsory license for export of patented pharmaceutical products in certain exceptional circumstances. Such a license will be available for manufacture and export to any country that does not have pharmaceutical manufacturing capacity for the product to deal with public health needs. Furthermore, that country is not required to issue a compulsory license for the product, but can indicate their allowance for importation of the product through notification or other means. Another positive clarification of the amendments indicates that Indian companies who are already producing drugs, and for which patent applications are pending in the mailbox, are able to continue this manufacture after payment of a royalty. Such clarifications and insertions are reflective of public health and affordability concerns.It is good to see that there are several hardworking and diligent members of Indian society, from industry, academia, government and the social justice sector, that are ensuring that the interests of the poor and the vulnerable are being championed. The efforts of these very dedicated and diligent groups and individuals go a long way in recognizing and shaping the content of health as a human right.
During my experience in India this summer, I was very fortunate to gain exposure to different areas of human rights law, international trade law, patent law and other health related legal matters. Furthermore, interactions with other interns and their projects at the firm gave meexposure to other human rights issues concerning refugees and communal violence for example. I also gained valuable skills in research, communication and project management which are great lawyering skills! The opportunity to understand human rights, political and public health issues from different perspectives is a great feature of the International Human Rights Program. I am certainly greatful to have had this enriching opportunity!