Reverse Burden of Proof and the Protection of Trade Secrets in European Pharmaceutical Patent Litigation

Abstract

The first part of this article (Chapters I-III), discusses the reverse burden of proof in patent law and trade secret protection in pharmaceutical patent litigation. The first part of the article will focus on a discussion at an international level. After going through a few important principles of international law, and their implications for the research question, the author will move on to discuss the reverse burden of proof as established in Art. 34 (1) of TRIPS. Thereafter, the author turns his focus to the protection of trade secrets. After some general thoughts on the protection of trade secrets internationally, the author will attempt to develop guidelines and alternatives for how to interpret Art. 34 (3) of TRIPS, and discuss how the potential tension between patent and trade secret protection could be resolved in the light of said article.

The second part of the article (Chapters IV-V) focuses on recent regional development (EU). Despite the Brexit vote, it still appears that Europe would not be too far away from creating a patent with unitary effect and a Unified Patent Court. The UPC Agreement includes a provision (Art. 55) very similar to Art. 34 of TRIPS, which was discussed in the first part of this article. Since the UPC Agreement is not yet applicable, there is no case law on the interpretation of this provision. Nevertheless, owing to the clear similarities with TRIPS, a natural assumption would be to interpret the provision similarly to Art. 34 of TRIPS. But this is not crystal-clear, inter alia since the UPC Agreement is a separate, regional, treaty with its own rules on applicable law. In addition to Art. 55 of the UPC Agreement, the new Trade Secret Directive and its possible implications for this particular topic will be discussed.

Keywords: Patent law, patent litigation, pharmaceutical patents, unitary patent, unified patent court, European patent law, reverse burden of proof, trade secrets, trade secrets directive