- Court of Justice rules on interpretation of Article 3(b) of SPC Regulation (Merck Sharp Dohme v Comptroller General)
- What are the practical implications of this case?
- What was this case about?
- What did the court decide?
- Case details
Life Sciences analysis: The Court of Justice has ruled that an end of procedure notice for a marketing authorisation (MA) application may not be treated as equivalent to a granted MA within the meaning of Article 3(b) of Regulation (EC) 469/2009, the Supplementary Protection Certificate (SPC) Regulation. Further, the fact no MA has been granted by the Member State concerned at the time the SPC application is lodged in that Member State does not constitute an irregularity that can be cured under the SPC Regulation, Art 10(3).
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