Utilizing TRIPS Flexibilities for Public Health Protection Through South-South Regional Frameworks
(2004; 110 pages) [Spanish] View the PDF document
Table of Contents
View the documentTHE SOUTH CENTRE
View the documentPREFACE
View the documentABBREVIATIONS
View the documentEXECUTIVE SUMMARY
Open this folder and view contentsI. INTRODUCTION
Close this folderII. INTELLECTUAL PROPERTY AND ACCESS TO ESSENTIAL MEDICINES IN DEVELOPING COUNTRIES
Close this folderII.1. An Overview of Public Health-related TRIPS Flexibilities
View the documentII.1.1 Compulsory Licensing
View the documentII.1.2 Parallel Imports and Exhaustion of Rights
View the documentII.1.3 Limitation on the Grant of New Use Pharmaceutical Patents
View the documentII.1.4 Research and the Early Working Exceptions
View the documentII.1.5 Limiting the Extent of Test Data Protection
View the documentII.1.6 Control of Anti-Competitive Practices and Abuse of Intellectual Property Rights
Open this folder and view contentsIII. CONSTRAINTS ON NATIONAL EFFORTS TO IMPLEMENT TRIPS FLEXIBILITIES FOR PUBLIC HEALTH PURPOSES
Open this folder and view contentsIV. OVERCOMING CONSTRAINTS IN THE USE OF TRIPS FLEXIBILITIES THROUGH SOUTH-SOUTH REGIONAL FRAMEWORKS
Open this folder and view contentsV. CONCLUSIONS AND RECOMMENDATIONS
View the documentBIBLIOGRAPHY
View the documentBACK COVER
 

II.1.1 Compulsory Licensing

A compulsory licence is a licence granted by an administrative or judicial body to a third party to exploit an invention without the authorization of the patent holder. This type of licence is commonly referred to as a non-voluntary licence connoting the lack of consent by the patent holder. The TRIPS rules on compulsory licensing are contained in article 31. The concept of compulsory licensing itself, however, has a long history. One of the earliest legal instruments to incorporate the concept was the United Kingdom (UK) Statute of Monopolies of 1623.11 At the international level, compulsory licences are recognized and provided for in the Paris Convention of 1883.12 Indeed, by 1994, when TRIPS was adopted, compulsory licensing provisions had become a typical feature of patent laws around the world.13

11 Correa (1999a), p. 1.

12 See article 5A(2) of the Paris Convention which provides that,

"Each country of the Union shall have the right to take legislative measures providing for the grant of compulsory licences to prevent abuses which might result from the exercise of the exclusive rights conferred by the patent, for example failure to work:"


13 Correa (1999a), p.2.


Article 31 of TRIPS lists detailed conditions which must be complied with when a WTO Member chooses to use compulsory licensing. These include the need to grant licences on a case-by-case basis, evidence of unsuccessful prior request for a voluntary license, non-exclusivity of the licence and the requirement for compensation. There are also conditions governing the termination of licences and restrictions on export and on assignment of licences to third parties. Notwithstanding these conditions, the Agreement still leaves considerable room for flexibility in legislating on compulsory licences.

Compulsory licensing as a policy mechanism can be used to address a number of situations including, among others:

• The high prices of medicines.
• Anti-competitive practices by pharmaceutical companies.
• Failure by pharmaceutical patent holders sufficiently to supply the market with needed medicines.
• Emergency public health situations.
• The need for establishing a pharmaceutical industrial base.

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