[Ip-health] WTO TRIPS Council (October 2017): Brazil documents the compulsory licensing of raltegravir in Germany

Thiru Balasubramaniam thiru at keionline.org
Sat Oct 21 00:57:21 PDT 2017


https://www.keionline.org/node/2886

WTO TRIPS Council (October 2017): Brazil documents the compulsory licensing
of raltegravir in Germany


Submitted by thiru on 21. October 2017 - 9:49

On Friday, 20 October 2017, Brazil delivered the following statement during
TRIPS Council discussions on compulsory licensing. Brazil zeroed in a
recent compulsory licensing case in Germany involving raltagravir, an
antiretroviral.

Madam Chair, we have previously described the process that led to the
single compulsory license issued by Brazil, as well as the results achieved
by it. More recently, developments in countries from different regions have
generated increased interest on the matter. As an example, last July the
Bundesgerichtshof, Germany’s highest civil court, decided to uphold the
decision of a lower court to grant a provisional compulsory patent license
on Raltegravir, an antiretroviral drug ingredient. The producer of that
medicine was facing legal threats from the owner of the Raltegravir patent,
in spite of distributing the drug in Europe for some years. In the course
of judicial proceedings, it requested a compulsory license based on Section
24 (1) of the German Patent Pact. Section 24 (1) of the German Patent Act
lists two conditions for the grant of a compulsory license, namely, that
the license seeker has, within a reasonable period of time, unsuccessfully
attempted to obtain permission from the owner of the patent and, second,
that the public interest calls for the grant of a compulsory license. Based
on it, it was decided to grant a provisional compulsory license, allowing
the company to continue to distribute the medicine containing Raltegravir
in the country.

The Court understood that there is a concrete need of certain HIV patient
group for a treatment containing Raltegravir. The use of alternative
compounds would entail severe risks of adverse effects and a loss of
therapy quality, in particular for infants and pregnant women.

The full text of the intervention is reproduced below.

IP and Public Interest

Support S. Africa

In the last session, Brazil, China, Fiji, India and South Africa circulated
document IP/C/W/630, with the goal of expanding the discussions on a very
important topic for the multilateral trade system. There is a continuous
need of increasing knowledge regarding those aspects and the exploration of
possible solutions for developing as well as for developed countries.
Indeed, for all Member States.

In the first session in which the issue was discussed, some delegations
claimed that the document did not take into account the benefits of
protecting IP and focused only on compulsory licenses.

As we have stated before, we do not see those issues as mutually exclusive.
On the contrary: Brazil understands that the balance reached by the TRIPS
Agreement allows for ways to address their public health challenges while
maintaining intellectual property systems that incentivize the investment
and research necessary to develop innovative new medicines. This is clearly
provided in two of the pillars of the Agreement, namely, Articles 7 and 8,
which contain the objectives and principles of intellectual property
protection under the treaty. In our view, a balanced intellectual property
system, with built-in flexibilities as well as complementary policies and
incentives, is the best way to promote innovation in all fields of
technology, including the health sciences. In short: a balanced
intellectual property system is a much stronger intellectual property
system.

The recent entry into force of the Protocol of Amendment to the TRIPS
Agreement demonstrates the need to have mechanisms that ensure adequate
remuneration to intellectual property rights holders while allowing
Governments to adopt measures necessary to protect the public interest. The
Preamble of the TRIPS Agreement advocates this view, as it recognizes “the
underlying public policy objectives of national systems for the protection
of intellectual property, including developmental and technological
objectives”.

Madam Chair, we have previously described the process that led to the
single compulsory license issued by Brazil, as well as the results achieved
by it. More recently, developments in countries from different regions have
generated increased interest on the matter. As an example, last July the
Bundesgerichtshof, Germany’s highest civil court, decided to uphold the
decision of a lower court to grant a provisional compulsory patent license
on Raltegravir, an antiretroviral drug ingredient. The producer of that
medicine was facing legal threats from the owner of the Raltegravir patent,
in spite of distributing the drug in Europe for some years. In the course
of judicial proceedings, it requested a compulsory license based on Section
24 (1) of the German Patent Pact.

Section 24 (1) of the German Patent Act lists two conditions for the grant
of a compulsory license, namely, that the license seeker has, within a
reasonable period of time, unsuccessfully attempted to obtain permission
from the owner of the patent and, second, that the public interest calls
for the grant of a compulsory license. Based on it, it was decided to grant
a provisional compulsory license, allowing the company to continue to
distribute the medicine containing Raltegravir in the country.

The Court understood that there is a concrete need of certain HIV patient
group for a treatment containing Raltegravir. The use of alternative
compounds would entail severe risks of adverse effects and a loss of
therapy quality, in particular for infants and pregnant women.

This decision, in Brazil’s view, is a good example of how the intellectual
property system provides the basis for advancing the public interest
without prejudicing the innovative efforts by companies. It also shows that
this should not be a polarizing issue, as it is of interest to all Member
States of this organization.

Madam Chair, during the June session of the Council we heard comments to
the effect that access to medicines also depend on factors outside the IP
system. While this is undoubtedly a complex phenomenon that requires a
broad range of actions, the mandate of this Council does not include tax
systems or the physical infrastructure of countries, but intellectual
property. Let us focus on this issue and its concrete effects in a positive
and constructive way, enabling a rich exchange of views and experiences
that enhances the mutual understanding of the matter.

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



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