An Update on Research- & Bolar Exemptions in the U.S. and Europe: Unsolved Questions and New Developments in an Increasingly Important Area of Law

Abstract

In October 2017, the EU Commission announced a consultation on supplementary protection certificates (SPCs) and research exemptions, including Bolar-type provisions. The consultation will provide valuable input for the Commission when preparing an evaluation of the current EU legislation, and any future policy proposals on SPCs and patent exemptions, including the assessment of the impact of different policy options. The considerable interest in the consultation, which received 231 responses from a great variety of stakeholders, came as no surprise, since these legal and regulatory features of the innovation system are as important to the pharma and life science sector as they are controversial. This is not only reflected in various court decisions, but also in the political processes leading to different legislative implementations in various jurisdictions.

While the SPC topic has already received considerable attention in this journal, this paper will focus on the equally significant research and Bolar-type exemptions. After all, the provision of exemptions to patent infringement for research activities offers an important – and controversial – legislative tool for the balancing of incentives for the individual and the interests of society. Likewise, granting generic and biosimilar manufacturers limited access to patented inventions during the market authorization procedure is crucial to allow them to have a marketable product upon patent expiry and hence to give patients access to cheaper drugs. However, the boundaries of these rights are still unclear, and substantial differences persist between various jurisdictions, i.e. both within the EU and around the globe. Thus, the intersection of the provisions in the TRIPS agreement and the interpretation of the various research exemptions and Bolar-type provisions implemented in national legislations has been a source of uncertainty and controversy for many years.

Focusing on pharmaceutical technology, this article provides a basic overview of the background of the exemptions to patent protection provided by Bolar type-provisions and research exemptions in the EU and US, and examines their intersection with relevant TRIPS provisions. Furthermore, it provides an overview and discussion of unresolved issues and possible future developments in this increasingly important and exciting area of law. To achieve these goals, we will start out with a brief description of the contextual background to the chosen topic (1.) Next, we will summarize the current U.S. perspective on available exemptions for use of patented inventions considering the common law and the statutory exemptions from infringement (2.) This is followed by a brief overview of the corresponding situation in Europe , including a presentation of some of the unresolved issues pertaining to the application and interpretation of the exemptions (3.). This provides the basis for a discussion of some of the nascent trends addressing the challenges (4.), which will finally allow us to conclude the paper with some final remarks (5.).