Commerce and Industry Minister¹s Statement on IP Policy: Issues of ConcernStatement of Concerned Organisations and Individuals Monday, 22 September 2014 We the undersigned organisations and individuals understand that ahead of Prime Minister Narendra Modi’s scheduled visit to the United States, the government has decided to review India’s positions on intellectual property rights (IPRs). We are concerned that the government has chosen to undertake a Ministry-level exercise on India’s IPR policy, precisely on the eve of the scheduled visit of our Prime Minister to the US. It is our apprehension that the proposed exercise can become hostage to the pressures of the US government and companies. In her press briefing, the commerce and industry minister Ms. Nirmala Sitharaman has indicated that the government would roll out a revised policy on IPRs. She has also indicated that this policy will focus on boosting innovation and tone up the overall administration, besides setting up a think tank to strengthen the countrys patent regime. She has also said that, “India does not have an IPR policy. This is the first time we are coming out with an IPR policy. We are very strong in IPR and we certainly want to protect our interest. IPR policy issues have been hanging for quite a long time and the new policy will give direction in terms of protecting IPRs of India. With the US we have (certain) issues. India has become a brand in terms of pharma. Because India does not have any policy, developed nations are picking holes in India’s IPR laws”[1]. We would like to disagree with the Hon’ble Minister’s statement that India does not have an IPR policy. The current Indian IP legal regime represents the policy framework on IPRs which was adopted after considerable debate inside and outside Parliament. The strength of this IPR policy is well reflected in the successful establishment of the Indian pharmaceutical industry within a short period of three decades. Until 1995 the success was enabled by the Indian Patents Act, 1970 that limited patent protection to process innovations. After 1995 the success was ensured by the decision of Parliament to take full benefit of the transition period of 10 years available under the WTO Agreement on Trade-Related Aspects of Intellectual Property (TRIPS). India delayed the implementation of product patent and chose to limit the scope of patent protection through the introduction of Section 3 (d) of the Indian Patents Act. India also added article 3 (j) on biological processes not being inventions along with 3 (d) to protect its biotechnological innovations in the sector of agriculture and health. Section 3 (d) rejects patents that do not involve real innovation, an issue that foreign pharmaceutical companies are not in agreement with. Similarly, compulsory licensing provisions in the Indian Patents Act aim to ensure that patent holders do not abuse patents to develop monopolies and thereby charge exorbitant prices which would result in denial of access to medicine at affordable prices to the people of India. India’s IPR policy follows a TRIPS compliant framework. India chose to use the health safeguards available in the TRIPS Agreement, in order to protect the interests of Indian patients as well as millions of people living in other developing countries. Currently the law requires that patented inventions are available to the public at affordable prices as well as obligates the patent holders to work their patents in India. By making use of flexibilities in the TRIPS agreement the Indian Patents Act and policy reduce options to pharmaceutical companies, be they Indian or foreign, to profit from disease and suffering. The Indian law has stood the test of time and judicial scrutiny. It is also increasingly serving as model legislation for many developing countries including Brazil. We are also concerned about the implications of the Hon’ble Minister’s statement, linking innovation with strengthened IP protection. Globally, there is no conclusive proof that strengthened IP protection promotes innovation and we should be under no illusion that strong IP protection can boost innovative activities in India. Instead of seeking to strengthen IP protection, the government needs to enhance public investment in drug discovery and development research, to promote innovations that can lead to new drug discovery in India. We are concerned about the implications of the statement that the country’s IPR policy will “not be restrictive or regressive” but will “only give clarity and consistency without any overlap or contradictions …we don’t have a comprehensive IPR policy clearly spelling out our regime for the entire world to know. As a result we have had arbitration matters and court cases on many IPR matters. The lack of a clear policy is hurting us.”[2] We believe that the problem is not with the lack of clarity and consistency in the existing IPR policy but with the lack of its implementation by the political leadership. We also take this opportunity to express our concern on continued efforts of transnational corporations on linking strong IPR as a precondition to attracting foreign direct investment (FDI). There is no evidence to link IPR with inflow of FDI. We urge the government not to fall prey to such organised propaganda. While the US administration has been hostile towards India’s sovereign laws because they run contrary to the interests of US-based pharmaceutical companies, it has not prevented US-based pharmaceutical companies from operating in India. They are also able to patent products that are patentable under the Indian Act. The US continues to target India’s patent system and has amplified its pressure on India. For example, the Global Intellectual Property Centre of the US Chamber of Commerce accused India of harbouring the “weakest” IP environment among countries that it studied. Further, the US International Trade Commission (ITC) has initiated an investigation on India’s industrial policy, which primarily focused on India’s intellectual property regime and its impact on the US economy. Similarly, the United States Trade Representative (USTR) continues to make illegitimate threats (inconsistent with the principles of the multilateral decision making and dispute settlement processes of the WTO) of unilateral trade sanctions against India through the Special 301 process. It is to undertake an out–of-cycle review of India’s intellectual property protection and enforcement standards in the coming months. We would like to convey our serious concerns with regard to the unrelenting pressure mounted by the US to weaken public health safeguards in the Indian Patents Act. These pressures would further intensify through the mechanism of negotiations for a bilateral investment treaty. We understand that during the forthcoming visit to US by the Prime Minister, there will be tremendous pressure exerted to make modifications to India’s Patents Act such as the following: - Dilution of patentability criteria, including those enshrined in Section 3(d) of the Indian Patents Act; - Limitations to the use of compulsory licensing for access to patented medicines through generic production; - Prohibition of the use of pre- and post-grant oppositions that are currently being used to challenge fraudulent patent claims by foreign MNCs; - Strengthening of IP enforcement, so that the Indian judicial system would police and secure the patent rights of foreign entities; - Introduction of ‘data exclusivity’, thus extending patent monopolies and delaying the entry of generics; At this moment India needs an IP regime, especially a patent regime, which can facilitate technology catch-up and help her move forward in industrialisation. An IP regime that favours transnational companies would act contrary to the Prime Minister’s efforts to revive the manufacturing sector in India. The Government of India should not carry out any amendment to the Indian Patents Act to increase patent protection. We strongly urge the Government to proactively use the flexibilities in the Patents Act such as government use and compulsory license. In fact, smaller developing countries, with much less bargaining power, have issued more compulsory licenses than just the one that India has granted. We call upon the Prime Minister, during his visit to the US, not to make any legal or political commitments that compromise flexibilities in the Indian Patents Act for facilitating access to medicines and safeguarding public health, which is based on policies and principles approved by Indian Parliament and is fully consistent with international laws. Signed by Dr. Nityanand, Eminent Scientist, Former Director Central Drug Research Institute Mr. S P Shukla, Former GATT Ambassador and Secretary, Ministry of Health and Family Planning Prof. Muchkun Dubey, Chairperson Council for Social Development and Former Secretary, Ministry of External Affairs Mr. B L Das, Former GATT Ambassador Mr. Anand Grover, Former UN Special Rapporteur on the Right to Health, Director Lawyers Collective and Senior Advocate Dr. Biswajit Dhar, Professor, Centre for Economic Studies and Planning, School of Social Sciences, JNU Prof. Dinesh Abrol, Convener, National Working Group on Patent Laws Mr. K M Gopakumar, Third World Network - India Dr. Amit Sengupta, Jan Swasthya Abhiyan Ms. Leena Menghaney, Medicine Sans Frontier India Ms. Malini Asola, Oxfam India Ms. Ramya Sheshadri, Lawyers Collective Dr. Vandana Shiva, Research Foundation for Science Technology & Ecology (RFSTE) Mr. Amitava Guha, National Campaign Committee on Drug Policy Dr. T Sundararaman, Public Health Resource Network Mr. Suhas Kolhelkar, National Alliance of Peoples Movement Dr. Jashodara Dasgupta, Health Watch Forum Uttar Pradesh Dr. B Ekbal, Democratic Alliance for Knowledge Freedom Dr. Mira Shiva, All India Drug Action Network Mr. S Srinivasan, Low Cost Standard Therapeutics (LOCOST) Ms. Kajal Bhardwaj, Cancer Patients Group network Mr. Vikas Ahuja, Delhi Network of Positive People (DNP+) Mr. Loong Gangte, International Treatment Preparedness Coalition (ITPC) South Asia For further information, please contact: Dinesh Abrol Convener, National Working Group on Patent Laws E: dinesh.abrol@gmail Tel: 09868242691 K. M. Gopakumar Third World Network - India E: kmgkumar@gmail Tel: 09899976104 Amit Sengupta Jan Swasthya Abhiyan E: amit37064@gmail Tel: 09810611425 [1]business-standard/article/pti-stories/govt-to-come-out-with-ipr-policy-sitharaman-114090800852_1.html [2]indianexpress/article/business/economy/govt-signals-ipr-recast-ahead-of-modis-us-visit/2/
Posted on: Sun, 21 Sep 2014 19:13:56 +0000