Opinion of the Advocate General in Merck & Co Inc. v Deutsches Patent- und Markenamt published (Case C-125/10, referred by the German Federal Patent Court)
The present procedure for a preliminary ruling concerns the interpretation of Article 13 (1) of Council Regulation (EC) 1768/92 regarding the creation of a supplementary protection certificate for medicinal products in the light of the paediatric medicinal product Regulation (EC) 1901/2006.
The following question was referred to the ECJ by the German Federal Patent Court:
“Can a supplementary protection certificate for medicinal products be granted if the period of time between the filing of the application for the basic patent and the date of first authorisation for marketing in the Community is shorter than five years?”
The opinion of Advocate General Yves Bot is in the affirmative by stating (recital 60, English translation of the German version by the authors):
“In the contrary, having analyzed the system of the regulation 1768/92 and of the Paediatric Medicinal Product Regulation and in particular their objectives, I tend to take the […] view, that the grant of a supplementary protection certificate must be possible, if less than five years passed between the dates of application for the patent and the grant of the first market authorisation. […] [A]lso, I am of the opinion that the extension of the duration by six months does not commence as of the expiration of the patent, but as of the entry into force of the supplementary protection certificate, which is determined in such way that from the expiration of the patent the (negative) duration of the certificate is substracted.”
This means that the Advocate General Bot pleads to accept the grant of a SPC with negative duration in order to allow a use of the six months extension of duration of the SPC under the paediatric medicinal product Regulation (EC) 1901/2006.
Read the decision (in various languages) here.
Head note: Tilman Müller-Stoy and Christopher Brückner