FTCC | Studio Legale Associato


European Case Law

Court of Justice  (Grand Chamber) 25 July 2018, in  case C–121/17  (Teva UK Ltd and Others v Gilead Sciences Inc.)

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

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:

–        the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and

–        each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

categoria:European Case Law