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In the second of a four-part series, Sophie Topham of Marks & Clerk explains the rules around the exemption for studies, tests, and trials required for generic and biosimilar medicines.
As mentioned in the first of this four-part series of articles discussing the experimental use exemption from infringement in the UK, Section 60 UKPA 1977 in fact provides for three categories of experimental use exemption from infringement.
This article looks at the second category, which is commonly referred to as “the Bolar exemption”.
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Marks & Clerk, generics, biosimilars, infringement, patents, application, EU directive, human trials