Case C‑121/17

Teva UK Ltd and Others

v

Gilead Sciences Inc.

(Request for a preliminary ruling from the High Court of Justice (England & Wales), Chancery Division (Patents Court))

(Reference for a preliminary ruling — Medicinal products for human use — Treatment of human immunodeficiency virus (HIV) — Originator medicines and generic medicines — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3(a) — Conditions for obtaining — Concept of a ‘product protected by a basic patent in force’ — Criteria for assessment)

Summary — Judgment of the Court (Grand Chamber), 25 July 2018

Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Conditions for obtaining — Product covered by a basic patent in force — Application to a product composed of a combination of active ingredients — Criteria for assessment

(European Parliament and Council Regulation No 469/2009, Art. 3(a))

Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

Accordingly, having regard to the objectives pursued by Regulation No 469/2009, the claims cannot allow the holder of the basic patent to enjoy, by obtaining a supplementary protection certificate, protection which goes beyond that granted for the invention covered by that patent. Thus for the purposes of the application of Article 3(a) of that regulation, the claims of the basic patent must be construed in the light of the limits of that invention, as it appears from the description and the drawings of that patent. It follows from the above that the subject matter of the protection conferred by a supplementary protection certificate must be restricted to the technical specifications of the invention covered by the basic patent, such as claimed in that patent.

(see paras 43, 46, 57, operative part)