Opinion Advocate General Emiliou in Halozyme, Inc. v. Úřad průmyslového vlastnictví, 23 April 2026, Case no. C‑456/24
“[A] substance which is expressly designated as an ‘excipient’ in that marketing authorisation cannot be regarded as an ‘active ingredient’ for the purposes of that regulation”
Conclusion
86. In the light of the foregoing, I propose that the Court of Justice answer the first question referred as follows:
Article 1(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products
must be interpreted as meaning that the qualification of a substance as an ‘active ingredient’ within the meaning of that provision is to be determined by reference to the classification of substances set out in the marketing authorisation relied upon in support of the application for a supplementary protection certificate.
Consequently, a substance which is expressly designated as an ‘excipient’ in that marketing authorisation cannot be regarded as an ‘active ingredient’ for the purposes of that regulation.
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