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The Research and Bolar Exceptions: proposals to exempt clinical and field trials using innovative drugs from patent infringement

Reference: 2012-003

Launch date: 24 October 2012
Closing date: 19 December 2012

The purpose of this consultation is to get stakeholders’ views on proposals to amend section 60(5) of the Patents Act 1977 to provide an exception to patent infringement for activities involved in preparing or running clinical or field trials which use innovative, or non-generic, drugs.

We are also seeking evidence of the costs and specific examples of the burdens which current legislation places on stakeholders.

We propose to introduce the reform by means of a Legislative Reform Order (LRO) under section 1 of the Legislative and Regulatory Reform Act 2006 (LRRA).

The Government has prepared an initial assessment of the impacts of the measures proposed in the consultation. We seek more thorough evidence through the consultation on which to base policy decisions and legislation.

The consultation is directed at all interested parties including owners of pharmaceutical patents and bodies involved in the organisation or performance of clinical or field trials using pharmaceuticals in the UK.

Following formal consultation and response from the government, the Legislative Reform (Patents) Order 2014 External Link was laid in Parliament on 6 May 2014.