Is the Compulsory Licensing Mechanism Guaranteed by TRIPS the Best Remedy to Improve Access to Biological Therapies Worldwide?

Abstract

A compulsory licence is an authorisation under the state administration to use intellectual property rights by third parties, subject to payment of remuneration, regardless of the patent holder's objection. In the Polish legal system, the institution of a compulsory licence is regulated by: the Paris Convention for the Protection of Industrial Property Rights (20 March 1883), the Agreement on Trade-Related Aspects of Intellectual Property Rights (15 April 1994), Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on the granting of compulsory licences for patents relating to the manufacture of pharmaceutical products for export to countries with public health problems and the Industrial Property Law Act (30 June 2000). The basic research thesis of my paper was based on the assumption that a compulsory licence does not meet the objective of providing access to biologics. The regulations governing this institution need to be changed, fi rst of all towards the regranting of a compulsory licence with the proper meaning of balancing the interests of the public (society) and private (patent holder).