Research and Bolar Exemptions in the U.S. and Europe: Recent Developments and Possible Scenarios

Abstract

In October 2017, the EU Commission announced a consultation on supplementary protection certificates (SPCs), research exemptions and Bolar-provisions. Granting generic and biosimilar manufacturers limited access to patented inventions during the market authorization procedure is important to allow them to have a marketable product upon patent expiry. However, the boundaries of this right are still unclear, and substantial differences seem to persist between various jurisdictions. Thus, the intersection of the provisions of the TRIPS agreement and the interpretation of the various research exemptions and Bolar-provisions implemented in national legislations has been a source of uncertainty and controversy for many years.

Keywords: LIfe Science, Bolar Provision, Research Exemption, Patent, TRIPS Agreement

JEL Classification: K11, K19, K23