학술논문

The UK research and 'Bolar' exemptions: broadening the scope for innovation?
Document Type
Journal Article
Source
J.I.P.L.P. 2013, 8(11), 837-845
Subject
Clinical trials
Community patents
Comparative law
EU law
Exemptions
Experimental use
Generic medicines
Medical research
Patents
United States
Intellectual property
European Union
Health
Legal systems
Language
English
ISSN
1747-1532
Abstract
Examines the proposal to widen the scope of the UK implementation of Directive 2001/83 art.10(6), known as the "EU Bolar" experimental use exemption, under the Patents Act 1977 s.60(5) to cover clinical trials and field tests of generic drugs. Compares: (1) how the EU Bolar exemption was implemented in other Member States; and (2) the scope of the US version under the Hatch-Waxman Act 1984. Considers the implications of the narrow reading of the exemption contained in the Agreement establishing a Unified Patent Court 2013 art.27.