IPR Policy: A reality check
K M Gopakumar,
June 5, 2016
National Intellectual Property Rights Policy (IPR Policy) has generated
unprecedented responses within and outside India. According to news
reports, the US Department of Commerce is assessing India’s IP policy.
The commerce minister also made it clear that the adoption of the
policy is an attempt to clear India’s stand prior the prime minister’s
US visit. It is very clear that the IPR policy would figure prominently
in the US India bilateral discussions in the coming week.
Though the IPR policy contains measures on various IPR rights, it
predominantly focuses on measures related to patents. The Indian Patents
Act 1970 denied product patent protection to pharmaceuticals, which
in turn played a key role in building self-sufficiency in the medicine
While introducing the product patent protection to pharmaceutical
inventions, India incorporated many public interest safeguards in
the Patents Act to address concerns of unaffordable prices of patented
As a result, the Patents Act effectively prevents multiple patenting
of known a molecule, a common practice of pharmaceutical Multinational
Corporations (MNCs) to extend the patent monopoly over the molecule.
Similarly, Patents Act also allows generic companies to seek licence
from the patent office to produce patented medicines (compulsory licence)
under various grounds, including if the patented medicine is not available
at an affordable price.
Therefore, India’s Patents Act is viewed as a model patent law by
many developing countries. Patents laws of Philippines and Argentina
contain similar provisions against obtaining of patents on known a
Similarly, South Africa and Brazil are expected to incorporate certain
provisions of the Indian Patents Act. The Indian generic industry
with sufficient manufacturing capability has played an important role
in lowering the prices of HIV/AIDS medicines. This public interest
safeguards pose obvious threat to the pharmaceutical MNCs, as their
business model relies heavily on patent monopoly.
Use of safeguards
Sensing this threat, pharmaceutical MNCs target the public interest
safeguards in the Patents Act and also attempt to obstruct the use
of these safeguards by the Indian pharmaceutical companies.
The legality of these safeguards cannot be challenged at the World
Trade Organisation (WTO) Dispute Mechanism because the Trade-Related
Aspects of Intellectual Property Rights (TRIPS) Agreement unequivocally
allows the use of such safeguards.
The WTO Ministerial Conference in 2001 adopted the Doha Declaration
on the TRIPS Agreement and public Health, which states: “We agree
that the TRIPS Agreement does not and should not prevent members from
taking measures to protect public health. Accordingly, while reiterating
our commitment to the TRIPS Agreement. … we reaffirm the right of
WTO members to use, to the full, the provisions in the TRIPS Agreement,
which provide flexibility for this purpose.” Hence, the pharmaceutical
MNCs are left with no option but to seek the help of the US government,
which hosts most of the MNCs headquarters, to exert bilateral pressures
on India against the use of safeguards. In 2013, after the issuance
of compulsory licence and Supreme Court’s rejection of Novartis’ patent
application, a campaign was launched against the Indian IP regime,
especially on provisions of the Patents Act.
In 2012, the Indian patent office granted a compulsory licence to
an Indian company to produce and sell an anti-cancer medicine Sorafenibat
Rs 8,800 per month against the patent owner’s price of $5000 per month.
The US instead of challenging the India patent law, it exerted bilateral
pressure on India against the use of safeguards in the Patents Act.
The submission of US India Business Council creates reasonable doubts
that these pressures are working, and India is accommodating the demands
of the industry including an oral assurance against the use of compulsory
The IP policy contains the following seven objectives: IPR awareness,
generation of IPRs, legal and legislative framework, administration
and management, commercialisation of IPR enforcement and adjudication,
and human development.
The policy contains concrete measures under each of these objectives.
Even though it talks about the balance approach to IP, the policy
measures substantially promote IP without any balance.
The policy advocates for an increased awareness and generation of
IP. The policy without looking at the limitation of IP, states in
its vision statement: “An India where creativity and innovation are
stimulated by intellectual property for the benefit of all. …Knowledge
owned is transformed into knowledge shared”. The IP Policy also proposes
to change the approach of the patent office to make it conducive to
generate more patents.
In reality, India’s development needs technology acquisition and come
abreast with the developed nations in various sectors like agriculture,
environment-friendly technologies, and manufacturing. Therefore, India
needs a patent law with robust safeguards and limit the grant of patents
only to genuine inventions. India’s own experiences of achieving self-sufficiency
in manufacturing of medicines and food production through green revolution
shows that patents are barrier rather than facilitating for technology
transfer and dissemination.
Ideally, the policy should have focused on the effective implementation
of the Patents Act, including the use of public interest safeguards.
However, there is nothing in the policy to further the implementation
of the public interest safeguards in the Patents Act.
The policy totally ignores the various bottlenecks in the implementation
of the safeguards. Often, pharmaceutical MNCs backed with their financial
resources use multiple litigations against the Indian generic companies
to deter them from using such safeguards. The policy should have looked
at the experiences of using the public interest safeguards, since
the introduction of product patent protection and suggested measures
to increase their use.
Thus the approach of the policy does not address the development needs
of India and aims to accommodate the interest of pharmaceutical MNCs
instead. However, it is a slippery slope for India. The pharmaceutical
MNCs along with other 16 associations wrote to the US president and
US lawmakers that “India just released its long-awaited National Intellectual
Property Rights Policy, which falls far short of industry expectations”.
Government of India should understand that the demands from pharmaceutical
MNCs if implemented would compromise the health security of India
as well as millions of people living in other developing countries
who are dependent on affordable generic medicines from India. Further,
it is only the pharmaceutical MNCs that are complaining against the
Indian Patent Act. Other industries like aircraft manufactures such
as Boeing went on record to express their satisfaction on Indian Patents
It’s high time that India should stop tending to the expectations
of the US on IP protection, which caters needs of their business and
focus towards the implementation of public interest safeguards envisaged
in the Patents Act in order to fulfill India’s socio-economic needs.
It is also high time to stop dancing to the US’ IP tune.
(The author is a lawyer specialising in Intellectual Property
Rights and legal adviser, Third World Network)