Strategies for multiple SPC applications: issues highlighted by recent CJEU referrals

Multiple SPC strategies based on the same product may confront issues under Article 3 of the SPC Regulation. In this article we consider how such issues arise in relation to the case in Novartis (Case 354-19) as well as multiple SPC strategies more generally.

This article was first published by Lawtext Publishing Ltd in the BioScience Law Review vol 17 issue 2 pp43-49 who have agreed to Simmons & Simmons making it available on elexica.

In Novartis (Case 354-19), the Swedish court has recently referred a question to the CJEU concerning the correct interpretation of Article 3(c) of the SPC Regulation. However, the case and its underlying facts highlights how multiple SPC strategies have developed following the CJEU’s decision in Neurim, in particular based on new therapeutic indications for the same product. As well as Article 3(c), multiple SPC strategies based on the same product may confront issues under the other grounds for validity set out in Article 3 of the SPC Regulation. In this article we consider how such issues may arise in relation to the case in Novartis, as well as multiple SPC strategies more generally.

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