[Ip-health] WTO TRIPS Council (October 2017):India asks EU, Malaysia to share details of their respective compulsory licenses

Thiru Balasubramaniam thiru at keionline.org
Tue Oct 24 09:44:43 PDT 2017


https://www.keionline.org/node/2887

WTO TRIPS Council (October 2017):India asks EU, Malaysia to share details
of their respective compulsory licenses


Submitted by thiru on 24. October 2017 - 9:54

On Friday, 20 October 2017, India delivered the following intervention on
compulsory licensing. India briefly recounted the experiences of Brazil,
South Africa, and Thailand in using compulsory licensing to secure access
to ARVs.

"Madam Chair, during the 1980s and 1990s the antiretroviral medicines used
to treat HIV/AIDS were priced beyond the reach of most people who needed
them in developing countries. Countries like Brazil, Thailand, South Africa
and others have used flexibilities under the TRIPS Agreement, including
compulsory licenses to bring down the price by increasing the supply of
generic ARV medicines for a fraction of the price of the patented
equivalents. Indian generic companies, especially CIPLA played an important
role by announcing in early 2001 that that triple therapy could be
manufactured for less than a dollar a day from the price of standard triple
therapy from $US 10,000 per patient/year. Indian generic companies made ARV
medicines accessible to all those who needed the drugs but had previously
not been able to afford them."

India provided a précis of compulsory licensing and government use
provisions in the United States noting that

"[t]he Bayh-Dole Act offers the federal government “march-in rights,” and
28 U.S.C. Section 1498 provides the U.S. government with broad ability to
use inventions patented by others. Compulsory licenses have also been
awarded as a remedy for antitrust violations and a court may decline to
award an injunction in favor of a prevailing patent owner during
infringement litigation, an outcome that some observers believe is akin to
the grant of a compulsory license."

India reaffirmed the findings of the United Nations High-Level Panel Report
on Access to Medicines in relation to compulsory licensing noting that many
governments were wary of employing TRIPS flexibilities including compulsory
licensing for fear of "undue political and economic pressure from states
and corporations". India stressed that "political and economic pressure
placed on governments to forgo the use of TRIPS flexibilities violate[d]
the integrity and legitimacy of the system of legal duties and rights
created by the TRIPS agreement and as reaffirmed by the Doha Declaration."

India concluded its remarks by requesting the European Union and Malaysia
to provide details on the compulsory licenses issued by Germany and
Malaysia.

The full text of the intervention is reproduced below.

Agenda Item 13: Intellectual Property and the Public Interest: Follow-up
discussion on Compulsory Licensing

Madam Chair, I would like to support the statements made by South Africa
and Brazil. During the last meeting of the Council for TRIPS, many Members,
including India, shared their experiences on the use of Compulsory
Licensing (CL). We have shared details of provisions in our national law
regarding Compulsory Licensing, including the one compulsory license issued
by India so far, i.e., in March 2012, Indian generic manufacturer NATCO
Pharma was granted compulsory License to manufacture Bayer’s drug Sorafenib
Tosylate (Nexavar) used for the treatment of Kidney and Liver cancer. Since
the last meeting of the Council for TRIPS, Compulsory Licenses were issued
by Germany and Malaysia. I would like to thank the delegations of South
Africa and Brazil for providing details about the two CLs.

TRIPS Agreement attempts to strike an appropriate balance between the
interests of rights holders and users. TRIPS Agreement also recognizes that
the principles of IP protection are based on underlying public policy
objectives. In furtherance of the objectives and principles of TRIPS
enshrined in Articles 7 and 8, a number of safeguards or flexibilities have
become an integral part of the TRIPS framework. These flexibilities have
been clarified and enhanced by the 2001 Doha Declaration on TRIPS and
Public Health that WTO members have the flexibility to interpret and
implement the TRIPS provisions in a manner supportive of their right to
protect public health.

Madam Chair, Article 31 provides members complete freedom to decide the
grounds for issue of compulsory license. The Doha Declaration on the TRIPS
Agreement and Public Health has also duly confirmed what was already
implicit in the TRIPS Agreement – that WTO Members have the freedom to
determine the grounds upon which compulsory licenses are granted.

Madam Chair, during the 1980s and 1990s the antiretroviral medicines used
to treat HIV/AIDS were priced beyond the reach of most people who needed
them in developing countries. Countries like Brazil, Thailand, South Africa
and others have used flexibilities under the TRIPS Agreement, including
compulsory licenses to bring down the price by increasing the supply of
generic ARV medicines for a fraction of the price of the patented
equivalents. Indian generic companies, especially CIPLA played an important
role by announcing in early 2001 that that triple therapy could be
manufactured for less than a dollar a day from the price of standard triple
therapy from $US 10,000 per patient/year. Indian generic companies made ARV
medicines accessible to all those who needed the drugs but had previously
not been able to afford them.

Madam Chair, now, I would like to provide brief details of the Compulsory
Licensing provisions in a developed Member, the United States. According to
United States Congressional Research Service Article “Compulsory Licensing
of Patented Inventions” dated 14 January 2014, the law in the United States
permits for the issuance of compulsory licenses in a number of
circumstances, and also allows for circumstances that are arguably akin to
a compulsory license. The Atomic Energy Act, Clean Air Act, the Federal
Insecticide, Fungicide and Rodenticide Act and Plant Variety Protection Act
provide for compulsory licensing. Atomic Energy Act allows for compulsory
license if the invention or discovery covered by the patent is of primary
importance in the production and utilization of special nuclear material or
atomic energy; Clean Air Act contains a similar provision relating to
devices for reducing air pollution; and Plant Variety Protection act,
Section 44-‘Public Interest in Wide Usage’ provides for compulsory
licensing of seed-bearing plant that are protected by plant variety
certificate, a patent-like instrument granted by Department of Agriculture.
The Bayh-Dole Act offers the federal government “march-in rights,” and 28
U.S.C. Section 1498 provides the U.S. government with broad ability to use
inventions patented by others. Compulsory licenses have also been awarded
as a remedy for antitrust violations and a court may decline to award an
injunction in favor of a prevailing patent owner during infringement
litigation, an outcome that some observers believe is akin to the grant of
a compulsory license.

September 2016 report of the UNSG’s High-Level Panel (HLP) states that many
governments have not used the flexibilities available under the TRIPS
Agreement, including compulsory licenses for various reasons, ranging from
capacity constraints to undue political and economic pressure from states
and corporations, both express and implied.

Madam Chair, political and economic pressure placed on governments to forgo
the use of TRIPS flexibilities violates the integrity and legitimacy of the
system of legal duties and rights created by the TRIPS agreement and as
reaffirmed by the Doha Declaration.

I conclude by quoting the recommendations in the HLP report on Compulsory
Licenses. “Governments should adopt and implement legislation that
facilitates the issuance of compulsory licenses. Such legislation must be
designed to effectuate quick, fair, predictable and implementable
compulsory licenses for legitimate public health needs, and particularly
with regards to essential medicines. The use of compulsory licensing must
be based on the provisions found in the Doha Declaration and the grounds
for the issuance of compulsory licenses left to the discretion of
governments”.

I would request the delegations of European Union and Malaysia to provide
details on the CL issued by Germany and Malaysia respectively. We look
forward to listening from other delegations on their experiences on using
this important TRIPS flexibility, compulsory licensing.


-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org



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