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.
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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