Posted: January 7th, 2019
Abraxis Bioscience LLC v. Comptroller General of Patents, Opinion of AG SAUGMANDSGAARD ØE, 13 December 2018, Case C‑443/17
In the light of all the foregoing considerations, I propose that the Court give the following answer to the question referred by the High Court of Justice (England & Wales), Chancery Division (Patents Court), United Kingdom:
Article 3(d) 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 precludes the grant of such a certificate where the marketing authorisation relied upon in support of the application for a supplementary protection certificate under Article 3(b) of that regulation is not the first marketing authorisation for the active ingredient or combination of active ingredients at issue as a medicinal product.
This is so even in a situation, such as that at issue in the main proceedings, where the marketing authorisation relied upon is the first to cover the formulation protected by the basic patent relied upon in support of the application for a supplementary protection certificate under Article 3(a) of that regulation.
A copy of the opinion can be read here.