Info Service on WTO and Trade Issues (Sept14/11)
26 September 2014
Third World Network
concerned over timing of IP policy review in India
Published in SUNS #7881 dated 25 September 2014
Geneva, 24 Sep (Kanaga Raja) -- Ahead of Indian Prime Minister Narendra
Modi's visit to the United States, a number of civil society organisations
and prominent individuals in India have raised concerns over the timing
of a Ministry-level review of the country's intellectual property
rights (IPR) policy.
In a statement issued on 23 September, they warned that the proposed
exercise could become "hostage to pressures of the US government
Among the notable individuals that signed the statement are Dr Nityanand,
Eminent Scientist and former Director of the Central Drug Research
Institute; Mr S. P. Shukla, former Ambassador to GATT and Secretary,
Ministry of Health and Family Planning; Prof. Muchkund Dubey, President
of the Council for Social Development and former Foreign Secretary;
Mr B. L. Das, former Ambassador to GATT; Mr Anand Grover, former UN
Special Rapporteur on the Right to Health and Director of the Lawyers
Collective; Dr Biswajit Dhar, Professor at the Centre for Economic
Studies and Planning, JNU; Prof. B. S. Chimni, Centre for International
Legal Studies, JNU; and Ms Kajal Bhardwaj, an independent lawyer.
Among the organisations that signed the statement are the National
Working Group in Patent Laws, Third World Network-India, Campaign
for Affordable Trastuzumab, Oxfam-India, Lawyers Collective, Research
Foundation for Science, Technology & Ecology, National Campaign
Committee on Drug Policy, National Alliance of Peoples' Movement,
All India Drug Action Network, Delhi Network of Positive People, International
Treatment Preparedness Coalition South Asia, and Jan Swasthya Abhiyan.
In their statement, the CSOs and individuals noted that Commerce and
Industry Minister Ms. Nirmala Sitharaman, in a press briefing on 8
September, had indicated that the government would roll out a revised
policy on IPRs, and 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.
The statement also quoted the Minister as having 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
The CSOs said they 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, they said.
"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 [Rights] (TRIPS),"
said the statement.
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.
According to the statement, it also added article 3 (j) on biological
processes not being inventions to protect its bio-technological 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
The groups underlined that India's IPR policy is TRIPS-compliant,
and that 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," the statement stressed.
The CSOs are concerned about the implications of the Minister's statement,
linking innovation with strengthened IP protection.
Globally, they argued, 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
"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.' 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."
The CSOs were also of the view that the continued efforts by transnational
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," said the statement.
Meanwhile, the statement noted, 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, said the CSOs, 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,"
said the CSOs.
The groups understand that during the forthcoming visit to the 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
* 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 catchup 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," said the statement.
"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."
The CSOs called 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 the Indian Parliament and is fully consistent with international