Immaterialgüter- und Wettbewerbsrecht

Compulsory Licensing of Patented Pharmaceuticals: A Cross-National Study of Developing Countries

This work is to offer lessons for developing countries of how to use compulsory licensing to meet their national interests, by adopting a comparative approach between international law (TRIPS) and domestic patent laws (India, Brazil and Thailand), and a cross-national study of these jurisdictions.

Last Update: 10.08.18

It is far from true that developing countries are homogeneous. On the other hand, the developing world is more heterogeneous. Although India, Brazil and Thailand represented as fascinating examples of using compulsory licences for medicines in the field of patent law, their approaches widely differed.
The similarities of these countries are as follow: (1) they are considered as emerging economies, rich elites which excluded them from differential pricing for least-developed countries, such as Sub-Saharan countries; (2) they possess gigantic population and adequate purchasing powers, which make them profitable markets for the pharmaceutical industry, and therefore (3) their uses of compulsory licences have captured the global attention.
-    Preliminary findings:
    In general, India has, undoubtedly, the broadest and most comprehensive compulsory licensing grounds of all the world’s patent systems. While there is little doubt that India’s compulsory licensing regime is a tool to promote its pharmaceutical industry rather than a safe vale for public interest, this legal regime is found to serve the health policies in Brazil and Thailand.
    When it comes to the procedural grant, Brazil seems to be the least TRIPS compliant, whereas India is the most TRIPS compatible, albeit excessively. It is evident that Brazil overlooked prior-negotiation in its patent legislations, India even rejected an application on this threshold. In the meanwhile, Thailand complied with TRIPS sufficiently but uncreatively.
    In the eyes of the law, Brazil and Thailand adopt a simpler process which enables a fast grant. Their legal proceedings comprise three main stages: filing the application, the decision-making process, and appeal.
    Indian rules prove more troublesome by contrast. The procedure allows the patentee’s unlimited oppositions and unnecessarily complicated. Therefore, the total time to grant a compulsory licence under Indian patent law seems to be longer than those under Brazil and Thailand’s.
    Government uses: Brazil and Thailand’ relevant Ministers holds power de jure and de facto, so that there would be almost no room for the patent holder to bargain in the decision-making process. By contrast, India tends towards a more market-driven environment, even in the situation which entails the public authority. Indian law lends the decisive role to the Patent Controller, while the relevant Ministries’ responsibility is of less significance.
    Developing countries should shift the attention from government uses to market-initiated licences, letting the market decide whether or not a compulsory licence is needed. In this way, the involvement of political factor will less likely happen and hence, central debates will be more about legal issues rather than political matters.


Doctoral Student

Vu Van Anh Le

Doctoral Supervisor

Dr. Mark Hyland

Fields of Research

Immaterialgüter- und Wettbewerbsrecht zwischen Markt und Regulierung

Main Areas of Research

Rechtliche und ökonomische Rahmenbedingungen der Pharmaindustrie