Academic journal article Marquette Intellectual Property Law Review

Ancillary Orders of Compulsory Licensing and Their Compatibility with the TRIPs Agreement

Academic journal article Marquette Intellectual Property Law Review

Ancillary Orders of Compulsory Licensing and Their Compatibility with the TRIPs Agreement

Article excerpt

I. INTRODUCTION II. CONDITIONS FOR COMPULSORY LICENSING TO BE EFFECTIVE III. ANCILLARY ORDERS TO ENSURE THE EFFECTIVENESS OF      COMPULSORY LICENSING      A. Know-How Transfer Orders      B. Goal-Attainment Ensuring Orders IV. SIDE-EFFECTS PREVENTING ORDERS V. TRIPS-COMPATIBILITY OF ANCILLARY ORDERS      A. Know-How Transfer Orders      B. Local Manufacturing Orders VI. CONCLUDING REMARKS 

I. INTRODUCTION

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organization (WTO) is one of the key international conventions in the field of intellectual property (IP). It is the first international treaty that lays down the mandatory minimum standard of patent protection for nations across the world. Given the comprehensive coverage of WTO membership, (1) the TRIPS Agreement has effectively established an international standard for IP protection in member states. With respect to copyright and patents, this Agreement expressly allows for compulsory licenses to be granted by competent authorities, with an aim to facilitate an adjusting mechanism to balance IP protection, on the one hand, and social or economic policy goals in general, on the other. (2)

Specifically, Article 31 of the TRIPS Agreement authorizes WTO members to issue compulsory licenses on patents to address national emergencies, extreme urgency, or other socioeconomic issues arising at the domestic level, subject to the procedures and limitations stipulated in the same article. (3) Through Article 9.1, one of the incorporation clauses in the TRIPS Agreement, the compulsory license scheme as to the author's translation and reproduction rights for developing countries, as provided in the Appendix of the Berne Convention (1971), essentially merges into and becomes an integral part of the TRIPS Agreement. This involuntary license regime affords developing countries leeway to adapt the level of copyright protection to address local economic, social, or cultural needs. (4)

In light of the important role that compulsory licensing could play in contemporary IP systems, the WTO reaffirms the members' right to grant such licenses in the Declaration on the TRIPS Agreement and Public Health, adopted in November 2001 at the Doha Ministerial Conference (Doha Declaration).5 One of the main themes in the Doha Declaration is that patent protection should be implemented in a manner that permits WTO members to protect public health and to promote access for the general public to essential medicines. For that purpose, WTO members may use, to the full extent, the flexibilities as set forth in Articles 30 and 31 of the TRIPS Agreement. (6)

Following the guidance of the Doha Declaration, WTO members have made use of the compulsory license scheme to address their domestic issues, particularly in meeting the demands of public health. For instance, Brazil, (7) India, (8) Taiwan, (9) and Thailand (10) have issued compulsory licenses on pharmaceuticals essential for treating deadly diseases in recent years. Even so, relative to the large number of patents now in effect for WTO members, the frequency and number of compulsory licenses to date have been low. (11)

II. CONDITIONS FOR COMPULSORY LICENSING TO BE EFFECTIVE

The compulsory license does not exist in a vacuum. Rather, the success of a compulsory licensing regime depends on the industrial and technological contexts that the licensee encounters. For a compulsory license to be effective, a number of conditions must be present. First of all, licensees with sufficient capacities are indispensable. (12) The lack of technical sophistication and ability to learn has been a significant detriment to technological transfer in developing countries. (13) Existing manufacturing capacity also matters with respect to the quantity and speed at which the compulsory licensee could put the patented technology or copyrighted work into production. …

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