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19 May 2014

Amended UK Legislation in Relation to Clinical Trial Exemptions

In February 2013, the UK Government announced its intention to broaden the scope of the exemptions from patent infringement in relation to clinical trials. Following on from that announcement, the proposed amendment to the text of Section 60 of the UK Patents Act has recently been published. It is anticipated that the amended legislation will come into force in October 2014.

Current UK law only provides exemption from infringement for certain activities required for approval of generic medicinal products as set out under the EU Bolar exemption.  Tests or trials conducted in order to obtain marketing authorisations for innovative drugs fall outside the scope of the exemption.  The current provisions are significantly narrower than those provided in many other EU countries including Germany and France.

In contrast, the new provision is intended to provide an exemption from infringement for activities required to secure regulatory approval to market innovative drugs in any country.  The exemption also covers activities involved in heath technology assessment (e.g. data to support assessment by the National Institute for Health and Clinical Excellence (NICE)).  The aim behind the amendment is to make the UK a more attractive location in which to run clinical and field trials by bringing the UK exemptions into line with the broadest exemptions available in other EU countries.

Details of the new legislation can be found here

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