The experimental use exemption, although based on the Community Patent Convention, is provided in national law by national statutes and varies from one European country to another. As a result, the “regulatory review” defence, better known as the “Bolar exemption” was introduced into European law to address uncertainty about the scope of the experimental use exemption, and specifically provide protection for clinical trials and other tests necessary for generics to obtain abridged marketing authorisations. However, varying implementations in the Member States have themselves created Bolar provisions of differing scope.This webinar examines this divergence, with a focus on the key European jurisdictions. It also looks at other developments relating to Bolar, with particular reference to the new UK experimental exemption regime and third party supply.
Dr Paul England - Senior Professional Support Lawyer - Taylor Wessing Patent Group
Dr Paul England is the senior professional support lawyer in the Taylor Wessing Patents Group where he specialises in UK and multi-jurisdictional patent litigation. He has a particular interest in the life sciences and associated exclusivity issues, having begun his career as a scientist and taken a doctorate in biochemistry and molecular biology at the University of Oxford. Paul's work covers advice and training to the Patents Group on legal developments and their application in these areas, as well as providing value-added services to clients. Paul publishes regularly on patent law and related exclusivity rights and speaks at conferences several times a year. He is leading the Group and clients on the Unified Patent Court (UPC) and Unitary Patent and the implications of Brexit for patents. Paul is currently preparing a practitioner's Guide to the UPC with a number of European judges, and he is the Consulting Editor of Intellectual Property in the Life Sciences (Second edition) and Patent Transactions in the Life Sciences (Globe Law and Business). He is also the author of 'Expert Privilege' in Civil Evidence (Hart Publishing). Paul is on the Editorial Board of Intellectual Property Life Sciences Review and the Journal of Intellectual Property Rights. He is Secretary of The Academy of Experts and chairs the Lawyers Network of Linacre College, Oxford.