Bayer CropScience AG v Deutsches Patent- und Markenamt.
Date: 2014-06-19
33. It follows from the above that the term ‘active substances’, for the purposes of the application of Regulation No 1610/96, relates to substances which have a toxic, phytotoxic or plant protection action of their own. In this regard, since Regulation No 1610/96 makes no distinction according to whether that action is direct or indirect, there is no need to restrict the term ‘active substances’ to those whose action may be characterised as direct (see by analogy, so far as concerns pharmaceutical products, Chemische Fabrik Kreussler , C‑308/11, EU:C:2012:548, paragraph 36, and, as regards biocidal products, Söll , EU:C:2012:111, paragraph 31).
34. Conversely, a substance with no such toxic, phytotoxic or plant protection action cannot be considered to be an ‘active substance’ within the meaning of Regulation No 1610/96 and, consequently, cannot give rise to the issue of a supplementary protection certificate. That interpretation corresponds to that applied in respect of medicinal products, the Court already having had the opportunity to hold that a substance with no pharmaceutical effects of its own, such as an excipient or an adjuvant, does not constitute an active ingredient and, consequently, cannot give rise to the grant of a supplementary protection certificate ( Massachusetts Institute of Technology , EU:C:2006:291, paragraph 25, and order in Glaxosmithkline Biologicals and Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma , C‑210/13, EU:C:2013:762, paragraph 35).
38. However, it must be observed that, although that classification is a necessary condition for the issuance of a supplementary protection certificate, it is not sufficient in that respect: the four cumulative conditions listed in Article 3(1) of Regulation No 1610/96 must be fulfilled. That provision states, essentially, that a supplementary protection certificate cannot be issued unless, at the date of the application, the product is protected by a basic patent in force and has not already been the subject of a certificate. It is also necessary for that product to have obtained a valid MA ‘in accordance with Article 4 of Directive [91/414] or an equivalent provision of national law’, that MA being, lastly, the first authorisation of the product as a plant protection product (see, to that effect, Hogan Lovells International , EU:C:2010:673, paragraph 51).
39. In this connection, Regulation No 1610/96 seeks to limit the erosion of the effective protection accorded to patented inventions in the area of plant protection by reason, in particular, of the time required to obtain an MA. The supplementary protection certificate is designed to re-establish a sufficient period of effective protection of the patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of the basic patent which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed and the date on which the first MA in the European Union was granted ( Hogan Lovells International , EU:C:2010:673, paragraphs 49 and 50).