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Academics, diplomats, scientists, lawyers, public health orgs issue open letter to PM on proposed IP Policy review


you-shall-not-passA variety of concerned stakeholders comprising of esteemed academicians, former diplomats, scientists, lawyers and public health organisations have written a sharp open letter to Narendra Modi’s government on the decision to review India’s position on IP laws ahead of his visit to the United States, strongly cautioning against coercion from the foreign state to align India’s IP laws with the interests of transnational corporations.

The letter begins by expressing concern at the timing of the review and disapprobation for statements made by the Commerce and Industry Minister, Nirmala Sitharaman, that India ‘does not have an IPR policy’ and that ‘because India does not have any policy, developed nations are picking holes in India’s IPR laws.’ They strongly disagree with this statement, pointing out instead, that India has a very developed and nuanced IPR policy as evidenced by the successful development of a thriving pharmaceutical sector in a period of 3 decades. This policy, they state, utilises the flexibilities provided by TRIPS for the purpose of protecting public health, and is absolutely TRIPS compliant, even if the US would have us believe otherwise.

They also expressed worry at the implications of the Minister’s statement that the new policy will “not be restrictive or regressive” but will “only give clarity and consistency without any overlap or contradictions” as signalling the entry of stronger IP protection to suit the interests of transnational pharmaceuticals.  They strongly oppose the linking of strong IP with innovation. Rather, they reiterate that 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.” Alternatively, they stress on the obligation of the government to enhance public investment in drug discovery and development research.

They also deny that the present IPR regime prevents FDI inflows in the pharmaceutical sector, pointing out instead, the robust presence of transnational pharmaceutical corporations in India. [Interestingly, see this post by Swaraj where he points out that FDI in pharma is at an all time high. See also this recent piece by Rod Hunter, Snr VP of PhRMA for a counterposition]

They end by underlining the “demand that the Government of India should not carry out any amendment to the Indian Patents Act to increase patent protection”  calling upon the “Prime Minister, during his visit to the US, not to make any legal or political commitment that compromises 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.”

In my opinion, the letter carries very sound and strong analysis. The timing of the decision to review India’s position on IP laws is indeed a cause for great concern. The US has had a history of pressurizing Indian governments to change our laws to better reflect corporate interests (see  these posts here, here and here). India is now looked up to as having an alternate vision of IP, one that integrates the goals of innovation and public health. I hope that the PM takes note of this timely caution to protect India’s core IP values at a time when the rest of the world looks to India to lead the resistance against the US’s corporate driven hegemony.

The complete letter including signatories is reproduced below.

(Thanks to Prof Yogesh Pai for sharing this with us.)

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Issues of concern : Proposed IP Policy and PM’s Visit to US

Statement of Organisations and Individuals

Tuesday, 23 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 about the timing that has been chosen to undertake a Ministry-level exercise on India’s IPR policy and apprehend the proposed exercise could become a hostage to the pressures of the US government and companies.

Commerce and industry minister Ms. Nirmala Sitharaman, in a press briefing on 8 September indicated that the government would roll out a revised policy on IPRs. She also indicated that this policy would focus on boosting innovation and tone up the overall administration, besides setting up a think tank to strengthen the country’s patent regime. She 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 clarify that the statement made by the minister that India does not have an IPR policy is not true. 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 reflected well in the successful establishment of the Indian pharmaceutical industry within three decades. Until 1995, its success was enabled by the Indian Patents Act, 1970, which limited patent protection to process innovations. After 1995, the success was ensured by Parliament’s decision 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 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 is TRIPS-compliant. India chose to use the health safeguards available in the TRIPS Agreement, to protect the interests of Indian patients as well as millions of people living in other developing countries. 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 diseases or those suffering from them. 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 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 worried about the implications of the statement by the minister that the country’s IPR policy will “not be restrictive or regressive” but will “only give clarity and consistency without any overlap or contradictions.”[2]  We believe that the problem is not with the lack of clarity and consistency in the existing IPR policy but rather with the lack of its implementation by the political leadership.

We are also of the view that the continued efforts by trans-national corporations on linking strong IPR as a precondition to attracting foreign direct investment (FDI) are misplaced. 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.

Meanwhile, 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 is 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 strong reservation on 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 modify India’s Patents Act in the following ways:

  • 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; and
  • Introduction of ‘data exclusivity’, thus extending patent monopolies and delaying the entry of generics.

India needs an IP regime, especially a patent regime, which can facilitate technology catch-up and that  aids industrialisation. An IP regime that favours transnational companies would act contrary to the Prime Minister’s efforts to revive the manufacturing sector in India.

We underline our demand that 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 commitment that compromises 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:

Individuals

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. Muchkund Dubey, President Council for Social Development, New Delhi and Former Foreign Secretary, Government of India

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.  B S Chimni, Centre for International Legal Studies, School of International Studies, JNU

Ms. Kajal Bhardwaj, Independent Lawyer (HIV, health and human rights)

Individuals signing on behalf of their organisations

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,Campaign for Affordable Trastuzumab

Ms. Malini Aisola, 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)

Mr. Vikas Ahuja, Delhi Network of Positive People (DNP+)

Mr. Loong Gangte, International Treatment Preparedness Coalition (ITPC) South Asia

Mr. Eldred Tellis, Director, Sankalp Rehabilitation Trust

Dr. Ashok Rau, The Freedom Foundation

Mr. Manoj Pardesi , National Coalition of PLHIV in India (NCPI+) and Network of Maharashtra by People Living with HIV/AIDS (NMP+)

Ms. Kausalya, Positive Women Network

 

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