[Ip-health] WTO TRIPS Council (October 2017): South Africa highlights examples of compulsory licensing in Germany, Malaysia, and the US

Thiru Balasubramaniam thiru at keionline.org
Fri Oct 20 13:14:56 PDT 2017


https://www.keionline.org/node/2885

WTO TRIPS Council (October 2017): South Africa highlights examples of
compulsory licensing in Germany, Malaysia, and the US

Submitted by thiru on 20. October 2017 - 21:48

On 20 October 2017, South Africa delivered the following statement on
behalf of Brazil, China, India, and South Africa during the WTO TRIPS
Council's discussions on compulsory licensing. On 31 May 2017, these
delegations (along with Fiji) submitted a proposal to the TRIPS Council on
"Intellectual Property and the Public Interest" which would serve as an
overarching theme for the Council to address issues including access to
knowledge and access to medicines. The proponents of IP and the Public
Interest proposed compulsory licensing as the sub-theme for the June 2017
and October 2017 TRIPS Council sessions.

South Africa noted that "even though the use of compulsory licenses is
commonly referenced in respect health issues, compulsory licenses can also
be used in a variety of other situations as well."

South Africa, on behalf of the proponents recounted three recent
developments in the field of compulsory licensing:

On June 6, 2017, Judge William Martin Conley, a United States District
Judge of the Western District of Wisconsin, issued a compulsory license
allowing Apple Computers to use a patent it had infringed, owned by the
Wisconsin Alumni Research Foundation (WARF), in return for an ongoing
royally. This case follows a long line of cases that seem to suggest that
court decisions in the United States have allegedly responded to instances
of infringement of medical patents by denying injunctive relief, instead
granting monetary damages, often in the form of royalty payments, what
would in effect provide for compulsory licensing. Public interest is often
at the heart of such decisions.

On July 11, 2017, the German Federal Supreme Court announced that it had
affirmed the 2016 decision of the Federal Patent Court to issue a
compulsory license allowing Merck to continue selling its HIV drug,
Isentress. The Federal Court shared the assessment of the Federal Patent
Court that a public interest in the granting of a compulsory license was
credible.

On 20 September 2017, the Malaysian Department of Health announced that
Cabinet had authorized a government use compulsory license in respect
generics of the Hepatitis C medicine Sofosbuvir. The decision to initiate
the Rights of Government was made after the MOH efforts to include the drug
in the Medicine Patent Pool (MPP) and price negotiations with patent holder
were unsuccessful.

South Africa's statement is reproduced in full.

ITEM 13

Intellectual Property and the Public Interest: Continuation of the
discussion on compulsory licenses.

"Madam Chair,

This statement is read on behalf of Brazil, China, India and South Africa.
Following the circulation of IP/C/W/630, the co-sponsors introduced
“Intellectual Property and the Public Interest” as a topic for discussion.
During the initial discussions, the co-sponsors emphasized that WTO members
have the flexibility to design their national intellectual property (IP)
systems within the minimum standards set by the TRIPS Agreement, in
cognizance of a country’s economic, developmental and other objectives,
including public health. The TRIPS Agreement clearly recognizes that the
principles of IP protection are based on underlying public policy
objectives. Article 8 of TRIPS Agreement entitled “Principles” states that
WTO Members may, in formulating or amending their laws and regulations,
adopt measures necessary to protect public health and nutrition, and to
promote the public interest in sectors of vital importance to their
socio-economic and technological development, provided that such measures
are consistent with the provisions of this Agreement.

Article 8 (2) further states that appropriate measures may be needed to
prevent the abuse of IPRs by right holders, or to resort to practices which
unreasonably restrain trade or adversely affect the international transfer
of technology. The Trilateral Study of the WHO, WIPO and the WTO (2013)
point out that prices of medicines are a critical determinant of access to
medicines, especially in countries where the public sector is weak and poor
people purchase their treatment on the private market (2013:146). It posits
that in some developing countries, up to 80 percent to 90 percent of
medicines are purchased out-of-pocket, as opposed to being paid for by
national health insurance schemes or private insurance schemes (ibid).

In the last session of the TRIPS Council, the co-sponsors invited
delegations to share their experiences on the use of compulsory licenses
for accessing health and other technologies. Some delegations indicated
that the use of compulsory licenses can assist countries to uphold the
delicate balance achieved in the TRIPS Agreement, and noted that even
though the use of compulsory licenses is commonly referenced in respect
health issues, compulsory licenses can also be used in a variety of other
situations as well. Various delegations made reference to the entry into
force of the Protocol Amending the TRIPS Agreement, while the United
Nations Secretary General’s High-Level Panel Report on Access to Medicine
was widely quoted.

One delegation expressed the view that a balanced system of intellectual
property rights is one that takes account of legitimate interests of users
and right holders and endorsed the idea of intellectual property as a
fundamental right of every citizen. The right to health is a fundamental
part of our human rights and our understanding of a life of dignity and as
such the achievement of the highest attainable standard of health is the
right of every human being, without distinction of race, religion,
political belief, or economic or social condition. This is codified in the
1948 Universal Declaration of Human Rights. In the same vein, SDG Goal 3.
Target 3.b relating to support for research and development of vaccines and
medicines for the communicable and non-communicable diseases that primarily
affect developing countries, promotes access to affordable essential
medicines and vaccines, in accordance with the Doha Declaration on the
TRIPS Agreement and Public Health, which affirms the right of developing
countries to use to the full the provisions in the Agreement on
Trade-Related Aspects of Intellectual Property Rights regarding
flexibilities to protect public health, and, in particular, provide access
to medicines for all.

A common theme that emerged from discussions was how governments use
compulsory licenses to substantially reduce the price of essential
medicines while striking a balance between the interest of right holders
and users. It is however noteworthy that in specific areas, such as access
to antiretroviral therapy, where substantial progress has been made, and
where substantial price reductions for commonly used first-line ARVs have
been achieved, prices for second-line regimes remain much higher
(2013:150). The World Health Statistics point out that new health
technologies, such as medicines, vaccines and diagnostics are becoming
increasingly expensive (2017:19). As one of the co-sponsors pointed out,
pubic interest in the achievement of inclusive public health goals call on
the active participation of governments, pharmaceutical companies and
patient associations alike. As a result, a balanced intellectual property
system, through a combination of flexibilities, complementary policies and
incentives, guarantee sustainable public health outcomes that harness
innovation and promotes access to medicines and health technologies.

Given the continued interest that delegations have expressed in the topic
of compulsory licenses, the co-sponsors have decided to continue an
inclusive debate on compulsory licenses. Since the last TRIPS Council
meeting, several noteworthy developments have occurred in this area.

On June 6, 2017, Judge William Martin Conley, a United States District
Judge of the Western District of Wisconsin, issued a compulsory license
allowing Apple Computers to use a patent it had infringed, owned by the
Wisconsin Alumni Research Foundation (WARF), in return for an ongoing
royally. This case follows a long line of cases that seem to suggest that
court decisions in the United States have allegedly responded to instances
of infringement of medical patents by denying injunctive relief, instead
granting monetary damages, often in the form of royalty payments, what
would in effect provide for compulsory licensing. Public interest is often
at the heart of such decisions.

On July 11, 2017, the German Federal Supreme Court announced that it had
affirmed the 2016 decision of the Federal Patent Court to issue a
compulsory license allowing Merck to continue selling its HIV drug,
Isentress. The Federal Court shared the assessment of the Federal Patent
Court that a public interest in the granting of a compulsory license was
credible.

On 20 September 2017, the Malaysian Department of Health announced that
Cabinet had authorized a government use compulsory license in respect
generics of the Hepatitis C medicine Sofosbuvir. The decision to initiate
the Rights of Government was made after the MOH efforts to include the drug
in the Medicine Patent Pool (MPP) and price negotiations with patent holder
were unsuccessful.

On this basis, I would like to invite the co-sponsors and other delegations
to intervene on the issues taken up in this statement or any other matter
that may be raised in the context of compulsory licenses."

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



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