Compulsory Licensing and Legal Issues in the Pharmaceutical Sector
As the awareness and adoption of patents grows across the globe, we look to evaluate the consequences to society as a result of protection through patents. We will look at both sides objectively – the side of the inventor who has been granted exclusive rights to his/her invention and the other side – whether patents can deny basic social rights such as health to society.
As we move further, we will look to understand a global framework (TRIPS) that provides guidelines on intellectual property regulations, the issue of compulsory licenses used by governments to circumvent patent protection and critically analyze specific cases where issuing compulsory licenses may be the need of the hour.
What is TRIPS?
TRIPS or …show more content…
E.g. in 2001, in light of grave consequences of a possible anthrax attack on its population, the US government reached an agreement with Bayer to procure Bayer’s Cipro anthrax antibiotic at little more than half of its normal price.
Note: Compulsory licensing was not an outcome of the Doha declaration. There are instances of compulsory licensing prior to Doha declaration. For e.g. in January 1992, BTG-Israel filed an application in the Israeli Patent Office for a compulsory license to manufacture BTG's Bio-Hep-B under Biogen's Israeli patent which license, upon approval, would enable BTG to produce the vaccine in Israel and likely to export the vaccine to countries in which neither Biogen nor others have been granted a blocking patent.
Compulsory licensing is supported by:
Berne Convention (1886) – Article 11b (2) and Article 13(1) of the Berne Convention for the Protection of Literary and Artistic Works provide legal basis for compulsory licensing. Member states are free to determine the conditions under which certain exclusive rights may be exercised in their national laws. The convention also provides which minimum requirements are to be set when compulsory licenses are applied without taking away the patent owner’s right to fair compensation.