[Ip-health] KM Gopakumar in the Hindu Business Line: IP policy should drive research for self-sufficiency in pharma

Thiru Balasubramaniam thiru at keionline.org
Mon Feb 9 03:12:47 PST 2015


http://www.thehindubusinessline.com/features/pulse/ip-policy-should-drive-research-for-selfsufficiency-in-pharma/article6865914.ece

BY INVITATIONIP policy should drive research for self-sufficiency in pharma

KM GOPAKUMAR


Instead, the new draft proposes an IP maximalist agenda

The draft of the National IPR Policy envisages intellectual property as an
“integral part of India’s overall development policy”. It goes on to
suggest that “the idea of being a creator and innovator must capture the
imagination of our people to maximise the generation of all genres of IP
rights”.
*Competitive edge*

In reality, intellectual property rights (IPR) protection is a tool to
manage competition rather than incentivise research and creativity. And
there is adequate evidence to show that IP like patents cannot stimulate
research especially in areas like diseases disproportionately affecting
developing countries.

The proposed policy turns a blind eye to the real working of IP and is
anchored on the romantic notion of IP as a tool for creativity and research.

This erroneous understanding of IP directs the vision, objectives and
specific policy measures such as the massive campaign to convey the value
and benefit of IP, stimulation for IP creation that encourages IP
generation; review of existing laws, commercialisation of IP, introduction
of new IP laws such as trade secret protection, traditional knowledge, and
regulation of IP in public funded research (Bayh Dole model), creation of
special courts, etc.

Thus the proposed policy essentially proposes an IP maximalist agenda,
which would compromise India’s technological needs in manufacturing and
agriculture, even as it threatens the country’s self-sufficiency in
critical sectors like pharmaceuticals.

India needs to fill the technology gap to transform itself into an
industrialised economy.

The interesting thing about the technology is that, often, it cannot be
purchased from the market. The tried and tested pathway is emulation,
innovation and invention. A patent law and policy focusing heavily on
protection and enforcement of patent rights would act as barrier for
technology emulation. Therefore, a technology-dependent country like India
should need an IP regime, especially patent regime, to facilitate
technology emulation.
*Make in India*

The success of the Indian pharmaceutical industry is the best example of
this. The Indian Patents Act 1972 prohibited product patent protection to
pharmaceutical inventions and provided the legal freedom to emulate the new
medicine introduced in the developed country market.

Today, the Indian pharmaceutical industry not only meets more than 90 per
cent of the domestic needs, but also supplies affordable medicines to more
than 190 countries. Thus, the 1972 Act delivered on “Make in India” in the
pharmaceutical sector. The TRIPS Agreement reduced the policy space and
makes it difficult but not impossible to pursue the same strategy.
Therefore, India should adopt the same legal and policy approach on patent
and other IP with minimum changes to fulfil its international obligations
in order to replicate the success of the pharmaceutical industry in other
sectors such as bio technology.
*Strategic approach*

India changed its original version of the 1972 Act to comply with the WTO
TRIPS Agreement law but policy-makers adopted a strategy to use the
flexibilities in the TRIPS Agreement to curb the abuse of patent monopoly.
This approach succeeded in delivering access to new medicines using various
provisions in the Act such as pre-grant opposition or compulsory license.

The result: life-saving medicines are available at a fraction of the
patented medicine price. These safeguards have even forced the
pharmaceutical giants to grant voluntary licenses, which provide
manufacturing and marketing rights in selected countries, to Indian
pharmaceutical companies to control the competition. There is a need to
optimise use of the safeguards in the Patents Act by providing a set of
policy incentives such as tax break or production subsidy to the industry.

It is worrisome that instead of being firm about more use of patent law
flexibilities, the proposed policy cautiously says, “the policy space and
flexibilities available under the international instruments will continue
to be used judiciously”. The proposed policy needs major changes in its
approach to transform India from technological dependency to
self-sufficiency in critical areas like pharmaceuticals to achieve
socio-economic development.

*The author is Member, National Working Group on Patent Laws (NWGPL)*
(This article was published on February 6, 2015)



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