The UK Bolar Exemption

These points are from a talk by Phil Bilney at Fieldfisher’s Pharma Patent Seminar on 16 October 2014.

1. A Bolar Exemption allows applicants for generic marketing authorisations under the abridged procedure to be exempt from patent infringement when conducting the necessary bioequivalence and stability studies (see TaylorWessing’s information about this here)

2. There was uncertainty about the scope of the UK experimental use exemption (s.60(5)(b) Patent Acts 1977). Directive 2001/83/EC set up the Bolar Exemption. Article 10(6) of this says:

‘Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.’ [Paragraphs 1 to 4 are concerned with bioequivalents and biosimilars]

This was implemented ‘narrowly’ in the UK, and ‘broadly’ in Germany and France.

3. After a formal consultation new paragraphs 6D to 6G were inserted into s.60 of the UK Patents Act to exclude ‘anything done in or for the purposes of a medicinal product assessment’ for regulatory purposes from infringement. This derisks clinical trial studies required for any regulatory approval, including marketing authorisations and Health Technology Assessments required by the British NHS.

4. This brings the UK into line with the majority of EU member states, and makes the UK a more attractive place for clinical trials.

5. However not all uncertainty is removed. It is unclear to what extent the exemption covers research tools and also third party manufacture and supply of a drug to the party conducting the trial. In addition it is not clear how the exclusion will relate to the Unified Patent Court and how opting in and out of the Unitary Patent will affect matters.

The IPKat discusses this here.

You may also wish to see related articles 10 Points on Regulatory Data Exclusivity and 10 Points on SPC’s (Supplementary Protection Certificates).

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