Bolar provisions - Recent developments and possible scenarios
Wednesday 29. November 2017
3-5 p.m (CEST)
Sign-up & questions: Jakob.blak.wested@jur.ku.dk
Bolar provisions - Recent developments and possible scenarios
This webinar on TRIPS and the life sciences will approach the issue of Bolar-provisions. What are the recent developments, unsolved issues and future scenarios?
The intersection of the TRIPS agreement, and the interpretation of the various Bolar-provisions implemented in national legislations has been a source of uncertainty and controversy for the last couple of years. In October 2017 the EU Commission announced a consultation on supplementary protection certificates (SPC’s), research exemptions and Bolar-provisions. These three features in the legal and regulatory landscape of life science share a controversial history both in courts and in the political process, leading to various implementations in jurisdictions around the globe.
This webinar will look at recent developments in relation to the so-called Bolar-provisions. Enabling generic and biosimilar manufacturers to start using patented inventions 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 subsist between different jurisdictions. This webinar will provide an update on the latest developments on Bolar-provisions and the intersection with relevant TRIPS provisions, identify some of the unresolved issues and discuss possible future developments in this area.
The specially invited presenters that will provide a starting point for this task are Martin Dræbye Gantzhorn and Klaus Ewald Madsen, both partners and Life Science experts in the Danish Law firm Bech-Bruun and Jacob Sherkow, Associate professor at New York Law School, where his research deals with both IPR, regulation and litigation in the Life Science area.
Timo Minssen, Professor of Life Science law at the University of Copenhagen and Research Fellow Jakob Wested will organize and moderate the event.
About the Webinar series “Reinterpreting TRIPS in the life sciences”
The Centre for Information and Innovation Law (CIIR) at the University of Copenhagen organizes a series of webinars focusing on issues emerging from the interpretation of TRIPS in the Health & Life sciences. The webinars aim to bring together scholars, industry and practitioners in a constructive discussion on the pressing legal issues arising at this intersection.
Materials & Readings
- O'Connor, Sean M., Enabling Research or Unfair Competition? De Jure and De Facto Research Use Exceptions in Major Technology Countries (2009). PATENT LAW & THEORY: A HANDBOOK OF CONTEMPORARY RESEARCH, Toshiko Takenaka ed., Edward Elgar Publishing Co., 2009.
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EU Commissions public consultation on SPC’s, patent research exemptions
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Anthony Tridico, Jeffrey Jacobstein, Leythem Wall, Facilitating generic drug manufacturing: Bolar exemptions world wide, WIPO magazine June 2014.
Other materials (Not Open access)
- Agarwal, Devika, and Radhika Agarwal. "Delhi High Court broadly interprets the Bolar exemption in India." Journal of Intellectual Property Law & Practice 12.8 (2017): 623-624.
- Papadopoulou, JD Frantzeska. "Legal Transplants and Modern Lawmaking in the Field of Pharmaceutical Patents–A Way to Achieve International Harmonisation or the Source of Deeper Divergences." IIC-International Review of Intellectual Property and Competition Law 47.8 (2016): 891-911.
- Kupecz, András, et al. "Safe harbors in Europe: an update on the research and Bolar exemptions to patent infringement." Nature biotechnology 33.7 (2015): 710-715.