[Ip-health] National IPR Policy: A reality check

Mirza Alas mirzalas at gmail.com
Mon Jun 6 03:31:34 PDT 2016

*TWN Info Service on Health Issues (Jun16/03) 6 June 2016 Third World


*National IPR Policy: A reality check*

K M Gopakumar, June 5, 2016

*The 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 molecule.

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 licence.

* Seven objectives*

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

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 Act.

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)*

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