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

11 Pages Posted: 30 Aug 2018

See all articles by Jakob Wested

Jakob Wested

Centre for Advanced Studies in Biomedical Innovation Law (CeBIL); University of Copenhagen

Timo Minssen

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law

Date Written: August 21, 2018

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

Suggested Citation

Wested, Jakob and Minssen, Timo, Research and Bolar Exemptions in the U.S. and Europe: Recent Developments and Possible Scenarios (August 21, 2018). Available at SSRN: https://ssrn.com/abstract=3236127 or http://dx.doi.org/10.2139/ssrn.3236127

Jakob Wested (Contact Author)

Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) ( email )

Karen Blixens Plads 16
København S, 2300
Denmark

University of Copenhagen ( email )

Karen Blixens Plads 16
København S, 2300
Denmark

Timo Minssen

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law ( email )

Karen Blixens Plads 16
Copenhagen, 2300
Denmark
+46 708 607517 (Phone)

HOME PAGE: http://jura.ku.dk/cebil/staff/profile/?pure=en/persons/381631

Here is the Coronavirus
related research on SSRN

Paper statistics

Downloads
114
Abstract Views
572
rank
254,266
PlumX Metrics