Supplementary protection certificates - Opinion of Advocate General Jääskinen in case C-11/13 Bayer CropScience
On 13 February 2014, Advocate General Jääskinen delivered his Opinion in case C-11/13, Bayer CropScience, referred for a preliminary ruling by the Federal Patent Court, Germany.
The case concerns the interpretation of whether the definitions of ''product'' and ''active substance'' set out in Regulation (EC) 1610/96 concerning Supplementary Protection Certificates (the SPC Regulation) also cover ''safeners'', as defined in Article 2, paragraph 3, a) of Regulation (EC) 1107/2009 concerning the placing of plant protection products on the market. If so, safeners and possibly other adjuvants used in plant protection products might qualify for a SPCs.
By way of background, the applicant Bayer CropScience is the holder of a European patent, issued in Germany in 1994, entitled "Substituted isoxazolines, the process for their preparation, agents containing them and their use as reducing phytotoxicity." In March 2003, Bayer CropScience obtained a provisional marketing authorization for plant protection product Maister issued by the Bundesamt für und Verbraucherschutz Lebensmittelsicherheit. According to the authorization, the active substances in Maister are the following chemical compounds: foramsulfuron, iodosulfuron and isoxadifen. At the same time, in July 2003, Bayer CropScience applied to the Deutsches Patent -und Markenamt for a supplementary protection certificate for isoxadifen.
However, in the final marketing authorizations from June 2006 and December 2007, the safener called "isoxadifen", which is the subject of the main proceedings, was no longer listed as one of the active substances in Maister. In 2007 Deutsches Patent- und Markenamt rejected the application for supplementary protection certificate, taking a decision which was subsequently appealed by Bayer CropScience before the referring court.
In particular, the local court in Germany took the view that a ''safener'' is not eligible for a SPC since Regulation 1107/2009 distinguishes between active substance, plant protection product and safeners. The question that arose was whether a ''safener'' could fall within the concept of ''active substance'' or ''product'' for the purposes of the SPC Regulation.
The AG took the view that a "safener" falls within the definitions of "active substance" and "product" under the SPC Regulation, even though its effect may be only indirect. Indeed, since the SPC Regulation does not distinguish between direct and indirect effects, safeners having an indirect effect on the active ingredient or product may also qualify for a SPC. In his Opinion, the AG underlines that the effects of a particular substance must be analysed thoroughly and on a case by case basis, so as to determine whether these may fall within the notion of "active substance" or "product". In this respect, he concludes that indirect effects can be taken into account. Interestingly, the AG's Opinion refers to the ECJ interpretation in a parallel case involving biocides, where a chemical substance having 'indirect effects' on target organisms (in that case, insects and larvae) through a causal chain of chemical or biological actions, was regarded as a biocidal product (see Case C-420/10, Söll GmbH v Tetra GmbH).
If the AG Opinion is followed by the ECJ, there could be several repercussions for the plant protection products industry: first, safeners and possibly other adjuvants may qualify for SPCs thereby departing from earlier decisions taken in the context of pharmaceuticals products, where adjuvants are normally not eligible for a SPC. For example, in the GSK Biologics Case, the ECJ ruled that an adjuvant used in a medicinal product cannot be regarded as an "active ingredient" or a "product" within the meaning of the SPC Regulation, even though it may have an influence on the therapeutic effects of the active ingredient or the product. Second, if safeners and possibly other adjuvants are equated to "active ingredients" or "products", they may become subject to the same testing conditions and level of scrutiny as plant protection product active ingredients and products. Third, if the "indirect effects" of a safener (and other adjuvants) are confirmed to be comparable to those of an active ingredient, some products currently regarded as "fertilisers" or "biostimulants", which have an indirect effect on the product, active substance and/or target organism, may need to be (re-)assessed in light of Regulation (EC) 1107/2009 concerning plant protection products.