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Make Sure EU SPC Applications Cite The ‘First’ Marketing Authorization, Firms Told

 
• By Ian Schofield

A ruling by the Court of Justice of the EU has produced a clear definition of what constitutes the “first” marketing authorization when companies apply for SPCs on pharmaceutical products.

Patented
SPCs extend effective patent protection (Shutterstock)

Pharmaceutical companies seeking a supplementary protection certificate in Europe have been advised to make sure that their application is based on the first EU marketing authorization (MA) granted for the product concerned, even if that MA was subsequently withdrawn.

The advice is aimed at companies that may be planning to apply for an SPC based on a new MA for a product containing the same active substance as a...

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