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The CJEU’s many attempts to clarify the law around SPCs has created more questions than answers, as Katie Cambrook and Ben Millson of Bristows explain.
The European Supplementary Protection Certificate (SPC) Regulation incentivises pharmaceutical research and development by providing an extension to patent protection to compensate for time lost in obtaining a marketing authorisation (MA).
It has proved a challenge to interpret and has been responsible for a steady stream of referrals to the Court of Justice of the European Union (CJEU) since its inception. Although the CJEU has managed to settle some of the debates about SPCs, several remain live.
Protected by the basic patent in force
Article 3(a) of the SPC Regulation requires that, for an SPC to be granted, “the product is protected by a basic patent in force”.
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SPCs, CJEU, Neurim, Pharma, Teva, bristows, decision, claim, invention, European, Royalty, article, claims, Patents, second medical use, Novartis