The Export and Stockpiling Waivers: New Exceptions for Supplementary Protection Certificates

Abstract

Regulation (EU) 2019/933 of 20 May 2019 enacted two new exceptions applicable to supplementary protection certificates. Pursuant to these exceptions, and during the pendency of a certificate, it is possible to manufacture in the European Union with the goal to export to third countries where no patent protection exists, and it is also possible to manufacture and stockpile generic versions of a product protected by a certificate as to enable entry into the market as from day one after the expiration of the certificate. The objectives of the new Regulation touch the core of the economics of the pharmaceutical industry in terms of competitiveness, entry to market, job creation and public health protection. The impact is estimated in billions of Euros and tens of thousands of new jobs. The effect goes beyond Europe since one of the exceptions is intended to satisfy the needs of third countries. Moreover, the normative model developed may be transplanted by countries adopting similar types of sui generis exclusivity. This article examines the new legal regime and the legal challenges ahead.