Complicated Compulsory Licenses: The Waiver/Article31bis 'Solution'

Abstract

Th is chapter explains an important, yet often misunderstood exception to the TRIPS requirement that a compulsory license must be issued predominantly for domestic use (except where issued to address anticompetitive conduct). It assumes an understanding of the usual compulsory licensing requirements addressed in Chapter 5 (available at http://ssrn.com/abstract= 1922803) and builds upon it. As is further explained in this chapter, the WTO Council has created an official waiver (“the Waiver”) of the usual domestic use requirement to help countries export low-cost generic drugs made under a compulsory license to predominantly poor countries. This Waiver is alternatively referred to as the Para 6 Solution, the August 30 solution, or proposed Article 31bis.

This chapter explains when the Waiver is relevant, as well as the additional requirements necessary to use it beyond those that apply to all compulsory licenses. It ends with an evaluation of the effectiveness of the Waiver in achieving its intended purpose.

Keywords: TRIPS, patent, compulsory license, Doha Public Health Declaration, paragraph 6, Article 31bis, TRIPS Council, Canada, Rwanda, Apotex

JEL Classification: F13, F14, I18, K20, O34, K33, H51, I18, F13, L52, L65, L98