[Ip-health] The Indian Patent Regime Is Accommodating Unreasonable Demands Of The US, But People Are Not Aware

Shailly shailly.17 at gmail.com
Sat Nov 4 11:26:01 PDT 2017

After four meetings of WG since its establishment, there are ample signs
that accommodation of US demands are being done at the cost of India’s
socio-economic interest.

K.M GOPAKUMAR <https://www.outlookindia.com/people/KM-Gopakumar/17486>

<https://www.outlookindia.com/people/KM-Gopakumar/17486>The fourth meeting
of India US annual High-Level Intellectual Property (IP) Working Group (WG)
took place as part of the USA India Trade Policy Forum (TPF), the annual
forum to discuss bilateral trade issues.

Unlike previous years there is no joint statement issued this year and
therefore there is no information about the outcomes of WG.  The three
joint statements issued in previous years show that Indian patent regime is
accommodating the unreasonable demands of US and undermining the public
interest and development orientation of the Indian Patents Act.  This has
resulted in the debasing of legislative intent of the patent act since it
is happening not through legislative amendment parliament and people are
not fully aware of it.

The WG was established in 2014 during Prime Minister Modi’s first visit to
the US. The decision to establish the WG astonished the IP Watchers because
it was a departure from India’s response to US demands on IP. Till then,
India had no bilateral engagement on IP with the US because US demands on
IP compromises the use of flexibilities in the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS) and pose a challenge to
access to medicines and technologies.

Since Indian Patents Act fully complies with the TRIPS Agreement there was
little chance for the US to obtain a remedy from WTO. Therefore many IP
watchers afraid that a bilateral engagement on IP would slow down if not
curtail the deployment of public interest safeguards in the Indian Patents

 However, some policymakers viewed that WG is an attempt to provide the way
out to the US government to ease the domestic pressure from a coalition of
industry associations lead by Pharmaceutical Research Manufacturers of
America (PhRMA). Therefore the working group is only talking shop and would
not lead to any adverse outcome for India's public interest-oriented
Patents Act. After four meetings of WG since its establishment, there is
ample signs accommodation of US demands at the cost of India’s
socio-economic interest.

In the first meeting of WG India raised concerns on the patenting of
traditional knowledge and access to medicines. On access to medicines, both
parties "reiterated the goal of ensuring the poorest populations in India
and the United States have access to quality healthcare and recognized the
important role that trade, intellectual property, and innovation policies
play in enhancing access to quality health and affordable medicines for the
public at large". However, no concrete measures were proposed or agreed.

 India has not raised any other concrete concerns related to patents.
However, India agreed to address the US concerns on patents such as the
pendency of patents and patenting of computer-related inventions.

Further, both parties also agreed to increase the interaction and
cooperation at the operational level between Indian Patent Office and the
US. Such operational-level cooperation may result in the functional
harmonization of the patent law, which would undermine the provisions
limiting the scope of patentability in the Indian Patents Act.

There is already an evidence prior to the establishment of WG that Indian
Patents Office granted patents on isolated genes, the pharmaceutical
substance in public domain and software, which is prohibited under the law.
The fear is that enhanced cooperation may lead to a functional
harmonization and neutralize the statutory prohibition against the
above-mentioned inventions.

 Patenting of computer-related inventions (CRI) is a case in point. The
Patents Act under Section 3 (k) excludes mathematical or business method or
a computer programme per se or algorithms from patent protection. The
exclusion with regard to computer programmes does not exclude a hardware
containing computer program such as embedded software. However, it clearly
excludes if the technical advancement of the hardware is solely based on
the software.

India developed three versions of the patent examination guidelines on
computer-related inventions (CRI) in 2015, 2016 and 2017. The 2015
guideline diluted the statutory prohibition and allowing patents on
computer programmes along with business models.  Due to the intervention of
civil society groups and experts, a revised Guideline was published in
2016, which restored the pre-2015 position with clear guidance to the

As per the joint statement of TPF 2016 "India has set up a Committee to
re-examine the guidelines on examination of CRI patent applications, and
expressed hope that a final decision would be taken soon in this regard
consistent with Indian law".  The new guideline published in 2017 removes
the specific examples and guidance given to the patent examiners in the
2016 guideline. As a result, the very purpose of the guideline is defeated
and the examiner is to exercise a great degree of discretion. This element
of discretion makes patent office vulnerable to undue influence.

Since 2014, Patents Office rejected at least two-pre grant opposition
including the blockbuster medicine on Hepatitis C and granted patents,
which were, rejected elsewhere.  In the case of Sofosbuvir, the Patents
Office rejected the patent in in 2015 January and reversed its decision in
2016. The Egyptian Patent Office rejected the patents citing the same
reasons on which Indian patents office rejected the patent in 2015.

Similarly, the patent office also rejected a compulsory license application
The US India Joint Business Council submission to US government reveals
that the Indian officials gave an oral assurance that India would not issue
any compulsory license. Further, the submission also states that the
Government partnered with USIBC to organize training for examiners and
invited USIBC to organize more such seminars.

Training of examiners by the industry, which is having the conflict of
interest, clearly goes against good governance norms.  Similarly, the
government also now allows the out of turn fast-track examination and grant
of patent applications in the name speedy decision. This push for
fast-track examination would result in the grant of the poor quality
patents becoming a rule rather an exception.

 Till date, the parliament has not been informed about the details of
outcomes WG or related engagements with the US. There is an urgent need for
the government to ensure transparency and accountability in this regard.
The government should not undermine the legislative intent behind Patents
Act without informing the parliament.

 (The writer is a legal advisor and senior researcher with the Third World


Shailly Gupta


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