Procedural aspects of compulsory licensing under TRIPS
Wednesday 28. June 2017
4-6 p.m (CEST)
Sign-up & questions: Jakob.blak.wested@jur.ku.dk
Procedural aspects of compulsory licensing under TRIPS
This webinar on “TRIPS and the life sciences” will approach the question of compulsory licensing by looking at the technical and procedural requirements applied by national courts when evaluating a petition for a compulsory license.
The balancing of the instrumental application of patent rights as a motivator of innovation and the public interest in having access to these innovations form a controversial trajectory of discourse as old as modern patent law. Compulsory licenses are one of the means that has been applied throughout the history of patent law, to condition this complex intersection of interests. The TRIPS agreement is no exception and art 31 contains the provision for member states to grant CL. In 2013, the Indian authorities granted a compulsory license to Natco Pharmaceuticals for Bayers patented pharmaceutical product Carboxy Substituted Diphenyl Ureas, useful for the treatment of liver and kidney cancer. This decision raised several issues regarding the procedures and requirements to be met in order to grant a compulsory license. Furthermore, in January 2017 an amendment to TRIPS agreement entered into force allowing compulsory licensors to export their generic pharmaceuticals to least developed countries, further recalibrating the intersection of the monopoly power of the patent and public interest.
The rules and procedures governing CL have traditionally been conceived as an instrument to avoid abuse of patent rights. However, in the current competitive and globalized life science industry the protection of the patent holder has become an equally important and controversial aspect in the crafting of CL regimes. High R&D- and regulatory induced costs, long innovation cycles and significant national and public interests at stake illustrate some of the complexities making the crafting of CL regimes a wicked problem. The amendment to TRIPS that entered into force in January 2017 and extends the rights that may be granted by a compulsory license, stresses the importance of continuous dialogue as well as qualification of the debate by considering data as well as the broader context in which CL’s are to be integrated. Procedures for obtaining a CL form one aspect of this problem space that should be considered when considering the application, effect and consequences of CL regimes.
Timo Minssen, Professor of life science law at University of Copenhagen and research fellow Jakob Wested will organize and moderate the event.
About the Webinar series “Reinterpreting TRIPS in the life sciences”
The Centre for Information and Innovation Law (CIIL) at University of Copenhagen organize a series of webinars focusing on issues emerging from the interpretation of TRIPS in relation to the life sciences. The webinars aim to bring together scholars, industry and practitioners in constructive discussion on the pressing legal issues arising at this intersection.
Materials & Readings
- McManis, Charles R., and Jorge L. Contreras. "Compulsory Licensing of Intellectual Property: A Viable Policy Lever for Promoting Access to Critical Technologies?." (2014).
- Abbas, Muhammad Zaheer, and Shamreeza Riaz. "Compulsory licensing and access to medicines: TRIPS amendment allows export to least-developed countries." Journal of Intellectual Property Law & Practice (2017).
- Desai, Manisha A. "Compulsory licensing: Procedural requirements under the TRIPS agreement." Pharmaceuticals Policy and Law 18.1-4 (2016): 31-44.
- Reichman, Jerome H. "Comment: compulsory licensing of patented pharmaceutical inventions: evaluating the options." The Journal of Law, Medicine & Ethics 37.2 (2009): 247-263.
Presentations
- Introduction and program
- Manisha A. Desai, PhD, Eli Lilly: Compulsory Licenses – Procedural Requirements Under TRIPS
- Dr. Henning Grosse Ruse-Khan, University of Cambridge: The International Law Framework for Compulsory Licensing
- Wested, Jakob and Minssen, Timo, Procedural Aspects of Compulsory Licensing Under TRIPS: Report No. II of Webinar Series on Reinterpreting TRIPS in the Life Sciences (September 26, 2017)