UK experimental use exemptions: Part 4—the SPC manufacturing and stockpiling waiver
UK experimental use exemptions: Part 2—the Bolar exemption
UK experimental use exemptions: part 1—the original
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In the third article of a four-part series on experimental use exemptions from infringement in the UK, Sophie Topham of Marks & Clerk considers the expansion of the original exemption.
In the third article of a four-part series on experimental use exemptions from infringement in the UK, we consider the expansion of the original experimental use exemption (Section 60(5)(b) UK Patents Act [UKPA] 1977) introduced by the Legislative Reform (Patents) Order 2014/1997.
Sections 60(6D)-(6G) UKPA 1977 were added to the UKPA in order to expand upon the original exemption provided by Section 60(5)(b) to broadly cover acts undertaken for the purpose of a “medicinal product assessment”. The new provisions came into force in October 2014.
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Marks & Clerk, generics, biosimilars, infringement, patents, application, EU directive, human trials