[Ip-health] Don't Trade Our Lives Away: India’s National IPR Policy - Leaked Final Draft - Is it really the finest?
zack.struver at keionline.org
Mon Oct 12 13:55:22 PDT 2015
India’s National IPR Policy - Leaked Final Draft - Is it really the finest?
Posted on October 12, 2015 by donttradeourlivesaway
Amitabh Kant, Ministry of Commerce, India, recently announced the release
of a national intellectual property rights (IPR) policy in next two months,
which in his words “will be one of the finest in the world
Yet, in light of its potential influence on access to medicines, it might
also be one of the deadliest in the world.
Despite the short commenting period, the previous draft
received series of statements/critiques/analysis from industry, trade
associations, academicians, legal agencies and civil society globally.
However, none of these comments were ever made public by the “IPR Think
assigned with drafting the policy. This is despite several requests and
RTIs. DIPP (Department of Intellectual Property & Promotion) and the Think
Tank kept passing the responsibility to each other.
In light of increasing transparency around IP policy making in India, the
leaked final version of the revised policy can be seen here
Page 29 of the original document is missing.
The purpose of bringing out this IPR policy was to address the rising
from the US, backed by its multinational pharmaceutical industry. This
issue has been extensively covered on this blog before
On a positive note, the policy emphasizes that any attempt to treat
generics as counterfeit should be resisted and explicitly excludes
pharmaceuticals from being granted low-barrier utility models. Reaffirming
India’s will to continue using flexibilities under the TRIPS agreement, the
policy also does not recognize TRIPS plus provisions such as patent
linkage. It thus ignores a recent proposal in the Health Ministry to
introduce such provisions which would make the Indian drug regulatory
authority (CDSCO), the patent police for big pharmaceutical companies
against local manufacturers.
However, the policy overall lays stress on the enforcement of IPR, and
therefore the adoption of this policy would present a serious threat to the
affordability of health products. Overzealous use of enforcement measures,
including injunctions, could undermine key TRIPS flexibilities and have a
chilling effect on generic competition. The policy does not take into
consideration the changing legal scenario in the US which incorporates a
more cautious approach to granting of injunctions against direct
competitors in public interest. In fact, it does not address the growing
number of ex-parte injunctions against APIs (Active Pharmaceutical
Ingredient) and formulation producers from the Delhi High Court in
violation of Supreme Court guidelines.
The policy contains several measures for a stronger enforcement of IPRs
including special courts for patent cases and a taxpayer-funded “Task
Force”. These provisions go beyond the WTO’s TRIPS agreement and bear the
risk of excessive enforcement of IP. The experience of special patent
courts in other countries has not always worked in public interest. In
addition, the public will end up subsidizing a task force that will enforce
private IP rights, undermining consumer rights and other constitutional
Furthermore, the draft places emphasis on the usage and commercialization
of IP as driver for innovation, which is especially doubtful in the case of
medicines. Not only did patents lead to stratospheric drug prices
in the last years, hindering millions of getting access to the treatments
they need, but the system also produces little innovation
especially for diseases that primarily affect the marginalized and the
poor. By counting on this approach to innovation, instead of increased
efforts in public research, many public problems in India will remain
neglected. A pharmaceutical R&D system that manages IP in public interest
and delinks from high medicine prices could pave the way for India to
contribute to public health solutions adapted to its needs and should thus
be envisaged by a “fine IPR policy”.
Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428
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