Not all Bolar exemptions are the same
The ‘regulatory review’ defence, better known as the ‘Bolar exemption’ after a similar provision in US law, first came into force in October 2005. Its purpose was to address uncertainty about the scope of application of the experimental use exemption to patent infringement. The uncertainty particularly focused on whether applicants for generic marketing authorisations, under the abridged procedure, could be liable for patent infringement for conducting the necessary bioequivalence and stability studies.
The Bolar exemption is set out in Article 10(6) of Directive 2001/83/EC (as amended):
10(6) 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…
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