[Ip-health] Statement of Organizations and Individuals : Proposed IP Policy and PM's Visit to US

K.M. Gopakumar kumargopakm at gmail.com
Tue Sep 23 05:05:46 PDT 2014

*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] <#148a1af55822bde0__ftn1>.

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] <#148a1af55822bde0__ftn2>  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:*


Dr. Nityanand, Eminent Scientist, Former Director Central Drug Research

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

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


[1] <#148a1af55822bde0__ftnref1>

[2] <#148a1af55822bde0__ftnref2>

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