October 2017: Dueling narratives on compulsory licensing emerge from the WTO TRIPS Council

The October 2017 meeting of the WTO TRIPS Council witnessed heated discussions on compulsory licensing within the context of IP and the Public Interest. As reported earlier by Knowledge Ecology International, on 31 May 2017, Brazil, China, Fiji, India, and South Africa requested the TRIPS Council to hold discussions on IP and the Public Interest; in their submission, these group of countries noted,

More than 20 years after the adoption of the TRIPS Agreement, there is a need for discussion in the TRIPS Council on the relationship between IP and the public interest and to broaden the understanding of how the IP system can be more responsive to public interest considerations and to broaden the understanding of how the IP system can be more responsive to public interest considerations. While this issue is very pertinent for developing countries, it has also been a topic of significant policy debate even in developed countries. During the course of the meetings of the Council for TRIPS in this year and later, WTO Members could exchange views and experiences on measures
within the IP system that they have adopted to promote the public interest, including but not limited to compulsory licensing, patentability criteria, IP and competition, and Bolar exception. (Source: IP/C/W/630)

Compulsory licensing was the focus of discussions at the TRIPS Council in 13-14 June 2017 and 19-20 October 2017. At the October 2017 meeting, South Africa, on behalf of Brazil, China, India, and South Africa, underscored 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.”

South Africa, on behalf of the co-sponsors highlighted 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 royalty. (In the case of Wisconsin Alumni Research Foundation v. Apple, Inc., Case: 3:14-cv-00062-wmc, W.D. Wis., June 6, 2017). 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. (Source: WTO TRIPS Council (October 2017): South Africa highlights examples of compulsory licensing in Germany, Malaysia, and the US)

The United States of America rejected South Africa’s description (on behalf of Brazil, China, India and South Africa) of the compulsory license obtained by Apple on patents owned by the Wisconsin Alumni Research Foundation (WARF).

The United States asserted,

  • Second, as a point of clarification, the delegate of South Africa, representing also Brazil, China, and India, mischaracterized a recent US court judgment. The delegate claimed that the outcome is a compulsory licence. This is not correct. The judgment is, in fact, an example of a court awarding equitable relief in a case of patent infringement. This is standard practice in the United States and in other jurisdictions.
  • Such remedies are fully consistent with the rule of law, and most certainly are not the equivalent of a governmental mechanism for favoring national industries by granting compulsory licences to domestic competitors of foreign innovative companies. (Source: IP/C/M/87/Add.1)

In response to Brazil, China, India, and South Africa citing the issuance of a compulsory license on an HIV drug, raltegravir,in Germany, the European Union responded,

From the outset, the EU has also been at the forefront of the debate on TRIPS and access to medicines. In the WTO, the EU has played an active role with the aim of bringing together the almost in-reconcilable positions of the opposing sides including on the latest LDC waiver…EU has also consistently supported the use, where necessary and justified, of the flexibilities provided under the TRIPS Agreement and the Doha Declaration with the objective of ensuring effective access to medicines for the relevant populations…The quoting of the example for the issuing of compulsory licences in line with Article 31 of TRIPS, among others a case in Germany has been mentioned, actually reassures that the system works and is not as burdensome as often claimed by some. (Source: IP/C/M/87/Add.1)