Language of document :

Judgment of the Court (Fourth Chamber) of 21 March 2019 (request for a preliminary ruling from the High Court of Justice (Chancery Division) — United Kingdom) — Abraxis Bioscience LLC v Comptroller General of Patents

(Case C-443/17) 1

(Reference for a preliminary ruling — Medicinal product for human use — Supplementary protection certificate for medicinal products — Regulation (EC) No 469/2009 — Article 3(d) — Conditions for granting — Grant of first authorisation to place the product on the market as a medicinal product — Authorisation covering a product as a medicinal product constituting a new formulation of a known active ingredient)

Language of the case: English

Referring court

High Court of Justice (Chancery Division)

Parties to the main proceedings

Applicant: Abraxis Bioscience LLC

Defendant: Comptroller General of Patents

Operative part of the judgment

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, read in conjunction with Article 1(b) of that regulation, must be interpreted as meaning that the marketing authorisation referred to in Article 3(b) of that regulation, relied on in support of an application for a supplementary protection certificate concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorisation for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of a marketing authorisation as an active ingredient.


1 OJ C 309, 18.9.2017.