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

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

Thiru Balasubramaniam is the Geneva Representative of Knowledge Ecology International. Prior to his post as KEI’s Geneva Representative, Mr. Balasubramaniam worked at Health Action International in Colombo and at the World Health Organization in Geneva as a technical officer in the Department of Essential Drugs and Medicines Policy dealing with access to medicines and intellectual property. He began his career with CPTech working on issues related to health care and intellectual property. Mr. Balasubramaniam holds a B.A. in Economics and a Minor in European History from the University of Pennsylvania.