Actavis Group PTC EHF
Actavis UK Ltd
(Request for a preliminary ruling from the High Court of Justice (England and Wales), Chancery Division (Patents Court)]
(Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3 — Conditions for obtaining such a certificate — Successive marketing of two medicinal products containing, wholly or partially, the same active ingredient — Combination of active ingredients, one of which has already been marketed in the form of a medicinal product with a single active ingredient — Whether it is possible to obtain a number of certificates on the basis of the same patent and two marketing authorisations)
Summary — Judgment of the Court (Third Chamber), 12 December 2013
1. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Conditions for granting — Patent protecting a single innovative active ingredient — Successive marketing of two medicinal products containing, wholly or partially, that active ingredient — Supplementary protection certificate granted for the medicinal product containing only that active ingredient — Application for a certificate relating to the medicinal product containing that active ingredient in combination with another active ingredient that is not protected by the patent — Not permissible
(European Parliament and Council Regulation No 469/2009, Art. 3(c))
2. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Purpose
(European Parliament and Council Regulation No 1049/2009)
1. Article 3(c) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding the holder of a patent protecting an innovative active ingredient and a marketing authorisation for a medicinal product containing that ingredient as the single active ingredient who has already obtained a supplementary protection certificate for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, from obtaining — on the basis of that same patent but a subsequent marketing authorisation for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent — a second supplementary protection certificate relating to that combination of active ingredients.
For the purpose of the application of Article 3(c) of that regulation, it cannot be accepted that the holder of a basic patent in force may obtain a new supplementary protection certificate for medicinal products, potentially for a longer period of protection, each time he places on the market in a Member State a medicinal product containing, on the one hand, the principle active ingredient, protected as such by the holder’s basic patent and constituting the core inventive advance of that patent, and, on the other, another active ingredient which is not protected as such by that patent.
(see paras 30, 43, operative part)
2. See the text of the decision.
(see paras 31, 40, 41)