Arnie Clarke

Name That Drug

The role of the European Medicines Agency (EMA) as a regulator is to protect and promote public and animal health by evaluating and supervising medication for both human and veterinary use. The EMA was created to harmonise the working practices of the various EU member state territories. It also reduces...

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Blurred Lines

A long-standing complaint of patent applicants and patentees at the EPO has been the strict assessment of added subject matter caused by amendment of an application or patent. Various tests have been developed for the assessment of whether an amendment complies with the requirement that: “The European patent application or...

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Amended UK Exemption for Medicinal Product Assessments

In order to satisfy the public need for generic medicines to obtain approval and reach the market immediately on patent expiry, a statutory EU Bolar exemption was established. This provides exemption from patent infringement for studies, tests or trials conducted with a view to obtaining approval of medicinal products using...

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