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CJEU revisits Art. 3(a) and 3(c) of the SPC Regulation –
Teva BV u.a. vs Merck Sharp & Dohme Corp

Authors: Dr. Michael Best, Dr. Oliver Ladendorf, Dr. Jonas Thelemann

There have been several decisions of the CJEU trying to clarify the meaning of the term "product" in Regulation (EC) No 469/2009 (the SPC regulation), such as Actavis v Sanofi (C-443/12, GRUR 2014, 157 - Actavis I), Actavis v Boehringer (C-577/13, GRUR Int. 2015, 446 - Actavis II) and the more recent CJEU decision Royalty Pharma (C-650/17, GRUR 2020, 596). The earlier decisions, however, were not interpreted uniformly in the relevant jurisdictions and in particular the possibility to obtain an SPC for combination products and the relation of Article 3(a) and 3(c) of the SPC regulation appeared to require further interpretation by the CJEU.

The decision of the CJEU in the joined cases C-119/22 and C-149/22 now sheds some light on the interpretation of these two key provisions of the SPC regulation and deviates to some extent from the earlier case law of the CJEU.

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