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CJEU – Opinion AG / Staat der Nederlanden v. Warner Lambert / SPC / Carve out

Posted: October 5th, 2018

Opinion of Advocate General Kokott, 4 October 2018, Case C‑423/17, Staat der Nederlanden v. Warner-Lambert Company LLC

A communication whereby the marketing authorisation applicant or holder for a generic medicine, notifies the authority that he is not including in the summary of product characteristics and the package leaflet, those parts of the summary of product characteristics for the reference medicine referring to indications or dosage forms covered by the patent right of a third party should be considered as a request to limit the marketing authorisation for that generic medicinal product to the remaining indications or dosage forms. 

“In light of the foregoing, I propose that the Court answer the request for a preliminary ruling from the Gerechtshof the Haag (Court of Appeal, The Hague, Netherlands) as follows:

“1. Articles 10 and 11 of Directive 2001/83/EC on the Community code relating to medicinal products for human use, as amended by Directive 2012/26/EU, must be interpreted as meaning that a communication whereby the marketing authorisation applicant or holder for a generic medicine, within the meaning of Article 10, notifies the authority that he is not including in the summary of product characteristics and the package leaflet, pursuant to the second sentence of Article 11, those parts of the summary of product characteristics for the reference medicine referring to indications or dosage forms covered by the patent right of a third party should be considered as a request to limit the marketing authorisation for that generic medicinal product to the remaining indications or dosage forms.

“2. Article 11 and Article 21(3) of Directive 2001/83 must be interpreted as precluding the competent authority from making public the summary of characteristics and the package leaflet of a medicinal product, including those parts referring to indications or dosage forms which are covered by patent law, in a situation where the marketing authorisation applicant or holder has notified the authority that, in accordance with the second sentence of Article 11 of the directive, he is not including such indications or dosage forms in the summary of characteristics and the package leaflet.”

A copy of the opinion can be read here.

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