Abstract
Our third webinar on 29th November 2018, focused on research exemptions and Bolar provisions in the U.S. and Europe. Presentations were provided by legal scholar Jacob Sherkow from New York Law School and Martin Dræbye Gantzhorn and Klaus Ewald Andersen, both partners in the law firm Bech-Bruun. The Webinar was moderated by Prof. Timo Minssen, and was organized by Jakob Wested in collaboration with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
In October 2017, the EU Commission announced a consultation on supplementary protection certificates (SPCs), research exemptions and Bolar-provisions. These three features in the legal and regulatory landscape of Life Science have a controversial history, both in courts and in the political process leading to their various implementation in jurisdiction around the globe. During the webinar we discussed recent developments with a special focus on the so-called 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.
The webinar provided an update on the latest developments on Bolar-provisions and the intersection with relevant TRIPS provisions, identified some of the unresolved issues and presented some comments on possible future developments in this important and exciting area of law.
In October 2017, the EU Commission announced a consultation on supplementary protection certificates (SPCs), research exemptions and Bolar-provisions. These three features in the legal and regulatory landscape of Life Science have a controversial history, both in courts and in the political process leading to their various implementation in jurisdiction around the globe. During the webinar we discussed recent developments with a special focus on the so-called 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.
The webinar provided an update on the latest developments on Bolar-provisions and the intersection with relevant TRIPS provisions, identified some of the unresolved issues and presented some comments on possible future developments in this important and exciting area of law.
| Original language | English |
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| Publisher | Social Science Research Network (SSRN) |
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| Number of pages | 11 |
| Publication status | Published - 15 Jul 2018 |