[Ip-health] Indian CSO Letter: Concerns regarding proposed US-India MoU on Intellectual Property Rights

Malini Aisola malini.aisola at gmail.com
Sat Feb 22 00:25:35 PST 2020


Shri Piyush Goyal
Hon’ble Minister, Ministry of Commerce and Industry
Udyog Bhawan
New Delhi-110011

22 February 2020

Dear Goyal ji,

US -India Memorandum of Understanding on Intellectual Property Rights

We are writing to you on learning from media reports about the proposed
US-India Memorandum of Understanding (MoU) on Intellectual Property Rights
(IP) for the exchange of knowledge and training of officials working in
offices undertaking IP management in India. This is a matter of serious
concern because the United States has been pressing India to make changes
in its IP legislations, rules and procedures through the annual United
States Trade Representative (USTR) Special 301 reports and is also
interested in getting Indian IP management officials to opt for a stronger
IP regime.

As you are aware, India has been the target of USTR since the country chose
to make use of all the flexibilities available in the TRIPS Agreement in
its implementing legislations. India’s IP laws especially the Patents Act,
Copyrights Act and Protection of Plant Varieties and Farmers Rights Act
contain robust public interest safeguards against the abuse of IP
monopolies. The provisions in the Patents Act are considered as model law
for other countries because these provisions curb the patenting of known
molecules and provide effective remedies to prevent abuse of a patent
monopoly through compulsory licensing. These public health provisions in
the Patents Act are crucial for ensuring affordable generic medicines for
the people. The United States has been opposing public health safeguards in
the Patents Act. Unable to change the substantive provisions of the Patents
Act, 1970, the US is trying to use indirect methods such as training Indian
patent examiners to dissuade them from implementing the public health
safeguards in Indian patent law. Any accommodation of a demand from the US
to directly change laws or indirectly impact the implementation of the
public interest provisions should be rejected outright.

A strong IP regime favouring the patent holder will create changes in the
form of extending the term of protection through the establishment of
linkage between patent and drug registration procedures; expanding the
scope of protectable subject matter through the IP officials implementing a
liberal interpretation and granting approval for broader IP protection;
increased penalties for violations; facilitating enforcement; and
expediting litigation to block local inventors and innovators from
commercializing their products within domestic markets. Through such a
bilateral arrangement, the aim of the United States would also be to get
Indian IP management organizations to strengthen enforcement and
adjudicatory mechanisms for combating IPR infringements through the
introduction of specialized commercial courts to achieve a higher level of
monopoly for US multinationals operating in the Indian market, for
medicines, seeds, electronic designs and products of new and emerging
technologies involving biotech, new materials and software.

We also gather from the news reports that the MoU is going to provide for
training of Indian IP officials in the US by the United States Patent and
Trademark Office (USPTO).  These trainings by the USPTO do not appreciate
that the patentability standards in India and the US are different. In
fact, Indian patent law has higher and stricter patentability standards as
compared to US patent laws. We apprehend that such trainings of Indian
patent examiners as were part of the MoU in 2006, could be a factor behind
the poor or non-implementation of the strict standards of patentability in
the Indian patent law. Some recent studies show that despite
anti-evergreening provisions, Section 3 of the Patents Act, the Indian
Patent Office granted a large number of patents on minor modifications of
existing medicines as against novel and inventive chemical entities. One
study[1] showed that 72% of patents granted on pharmaceuticals are on
marginal improvements on existing drugs. This is indicative of an alarming
trend of granting low-quality patents that enable evergreening. Therefore,
we caution that such trainings lead to the harmonisation of the Indian
Patents Act with the US Patent Act and undermine the legislative intent
behind our Patents Act.

Past experience also informs us that enhanced bilateral engagement with the
US on IP, led Indian IP management officials to accommodate the demands of
the United States without informing the Parliament or public. For instance,
the Indian Patents Office amended the Guidelines for Examining the Computer
Related Inventions multiple times to provide patents on software, which
goes against the Patents Act. The US-India Chamber of Commerce submission
to USTR Special 301 Report in 2016 stated that government allowed the US
industry to train Indian IP officials. Further the same submission also
stated that Indian government provided secret verbal assurances that India
would not use compulsory license provisions for commercial purposes. This
clearly shows that intensified bilateral engagement with the US resulted in
the undermining the implementation of the India’s Patents Act.

We also have concerns regarding the abrupt and unilateral decision for
DPIIT to initiate a review of existing IP legislations in India. We urge
that a review of IP laws should be in accordance with the needs of the
country such as to increase the disclosure standard in patent applications
and to seek mandatory disclosure of INN in pharmaceutical patent
applications. We therefore request for a more transparent process in this
regard.

Against this background we request you:

·      To reject US demands to influence the implementation of India’s IP
legislations.
·      To reject any demand to provide ‘TRIPS-plus’ protection on patent
rights through changes in IP administrative processes.
·      To halt the unilateral move of the DPIIT to review India’s IP
legislations to make changes to tilt the balance towards rights of IP
holders
·      To make public the contents of MoU prior to its finalisation

Sincerely,

All India Drug Action Network (AIDAN)
National Working Group on Patent Laws and WTO
Campaign for Access to Medicines and Devices–India
Third World Network (India)
Drug Action Forum, Karnataka (DAF-K)

Copy to:

Dr. Harsh Vardhan, Hon’ble Minister, Ministry of Health and Family Welfare
Smt. Preeti Sudan, Secretary, Ministry of Health and Family Welfare
Shri D. V. Sadananda Gowda, Hon’ble Minister, Ministry of Chemicals and
Fertilizers
Shri Mansukh Mandaviya, Hon’ble Minister of State, Ministry of Chemicals
and Fertilizers
Dr. P. D. Vaghela, Secretary, DOP, Ministry of Chemicals and Fertilizers
Smt. Shubhra Singh, Chairperson, NPPA, Ministry of Chemicals and Fertilizers
Dr. Subrahmanyam Jaishankar, Hon’ble Minister, Ministry of External Affairs
Shri Harsh Vardhan Shringla, Foreign Secretary, Ministry of External Affairs
Dr. Guruprasad Mohapatra, Secretary, Department for Promotion of Industry
and Internal Trade, Ministry of Commerce and Industry
Dr. Anup Wadhawan, Commerce Secretary, Ministry of Commerce and Industry
Dr. P K Mishra, Principal Secretary to Prime Minister, PMO
Shri P. K. Sinha, Principal Advisor to Prime Minister, PMO

________________________________

[1] “Pharmaceutical Patent Grants in India: How our safeguards against
evergreening have failed, and why the system must be reformed”, Dr. Feroz
Ali, Dr. Sudarsan Rajagopal, Dr. Venkata S. Raman & Roshan John,
https://accessibsa.org/media/2018/04/Pharmaceutical-Patent-Grants-in-India.pdf


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