11 November 2010 the Court of Justice of the European Union issued a preliminary ruling in the case C-229/09 that Supplementary protection certificates for plant protection products may validly be obtained based on provisional marketing authorisations
In this recent decision by the Court of Justice (CJ) it was ruled that a supplementary protection certificate (SPC) may also be validly issued based on a provisional MA granted by a competent national authority of a Member State. That is a MA which has been granted pursuant to Article 8(1) of European Council Directive 91/414/EEC.
The case in question, C-229/09, was referred to CJ during the course of proceedings between Hogan Lovells International LLP and Bayer CropScience AG by the Bundespatentgericht (German Federal Patent Court).
Lovells petitioned for invalidation of a SPC granted to Bayer in Germany on the product ‘iodosulfuron’. Lovells disputed that the certificate was valid since it was issued based on a provisional MA granted by the Bundespatentgericht and not a definitive MA. Lovells stated that according to Article 3(1)(b) of the Regulation relating to SPC (Regulation No 1610/96) a SPC can only be granted after a definitive MA has been issued under the conditions laid down in Article 4 of Directive 91/414/EEC – thus, it cannot be based on a provisional MA under Article 8(1) of the same directive.
However, the CJ based their decision on that Article 8(1) stipulates that the provisional MA is to be granted only if the product is expected to satisfy the same requirements as provided in Article 4. Thus, they found the criteria of both the provisional and the definitive MA to be equivalent and thereby found no reason to exclude provisional MAs from forming the basis in respect to granting a SPC on a plant protection product.
Jakob Leffland Reimers, Associate, Awapatent