On 19 June 2014, in a marked contrast to recent cases, the Court of Justice of the European Union (CJEU) delivered a potentially favourable judgment on the question of whether a particular co-ingredient (in this case of a plant protection product) can be the subject of a Supplementary Protection Certificate (SPC).
SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation.
Bayer Cropscience AG v Deutsches Patent- und Markenamt (C-11/13) - Safeners
Bayer is the owner of a European patent covering Isoxadifen, a safener and component of several herbicides. When used in herbicides, safeners are generally considered to be substances that are intended to prevent the harmful effects of a herbicidal active substance in order to increase the effectiveness of that active substance.
The question that was referred to the CJEU by the Bundespatentgericht (Germany) was whether the terms "product" and "active substance" in Regulation 1610/96 (which deals with the granting of SPCs to plant protection products) could be interpreted as covering a safener.
In short, the CJEU concluded that the terms "product" and "active substance" in this Regulation must be interpreted as covering a substance intended to be used as a safener, where that substance has a toxic, phytotoxic or plant protection action of its own. How such activity has to be demonstrated is less clear.
Whilst confirming that safeners are potentially eligible for protection by way of SPCs, the CJEU has striven to arrive at this conclusion without suggesting that safeners, as a class of substance, are automatically eligible for such protection. The judgment requires the courts to consider what the substance actually does when in use. Significantly, however, it appears that it is not necessary for a substance to be labelled as an active substance as such in the marketing authorisation documents in order to be considered to be an "active substance" according to Regulation 1610/96.
Additionally, in line with decisions relating to biocidal products and medicinal products, and in order to address the comment from the referring court that safeners such as Isoxadifen have at most an indirecteffect on plants, the CJEU has suggested that the term "active substances" should be considered to include a substance whose action may be characterised as either direct or indirect.
The CJEU's efforts to tie the answer to the question to the activity of the substance at hand also sits alongside previous decisions relating to Article 1(b) of Regulation 469/2009 (which deals with the granting of SPCs to medicinal products).
Article 1(b) defines the product that is the subject of the SPC as "the active ingredient or combination of active ingredients of a medicinal product", and has been interpreted narrowly in the past, notably in Massachusetts Institute of Technology (MIT; C-431/04) in which the CJEU decided that the concept of a "combination of active ingredients of a medicinal product" did not include a combination of two substances, only one of which has therapeutic effects of its own for a specific indication, the other rendering possible a pharmaceutical form of the medicinal product which is necessary for the therapeutic efficacy of the first substance for that indication.
More recently, in GlaxoSmithKline Biologicals (GSK) v Comptroller-General of Patents (Case C 210/13), the CJEU concluded that an adjuvant does not fall within the definition of an "active ingredient" in Article 1(b) of Regulation 469/2009, and also that the combination of an active ingredient having therapeutic effects on its own and an adjuvant does not fall within the definition of a "combination of active ingredients". In its reasoned order, the CJEU essentially considered that the adjuvant in question did not have a therapeutic effect of its own, and pointed out that adjuvants are listed as "excipients" in the EU legislation governing the grant of a marketing authorisation (in line with the UK Comptroller-General's arguments).
In contrast to the CJEU's order in GSK's adjuvant case, in the present judgment the CJEU chose not to focus on the definition of "active substance" in Directive 91/414/EEC (the legislation concerning marketing authorisations for plant protection products). Instead it attempted to rely solely on the wording of the plant protection products SPC Regulation 1610/96, and its purpose which is to compensate for the delay in the exploitation of a patent on account of the time required to obtain a marketing authorisation for the patented active substance.
The CJEU has stated that it is for the relevant national court to ascertain whether the substance at issue can, on account of its action as a safener, be classified as an "active substance", i.e. in the CJEU's words, whether the substance has "a toxic, phytotoxic or plant protection action of its own". Disappointingly, the CJEU has offered no clear guidance on how this determination should be made, or what activity would constitute "a toxic, phytotoxic or plant protection action". Clearly this will be a point of very significant practical interest, and it will be of great interest to see how the Bundespatentgericht applies the CJEU's judgment to the facts of the Bayer case when it returns to that court.
Consequently, it remains to be seen whether further references to the CJEU will be required on this point, and whether national courts will be prepared to extend the rationale behind this decision to cases involving SPCs for medicinal products. It will also be interesting to see if a similar approach is taken in the Forsgren / Protein D reference to the CJEU (case C-631/13).
Please contact us if you are interested in filing SPCs, or already have pending or granted SPCs, particularly where the substance in question may be a safener, or may not explicitly be identified as an active ingredient in the relevant marketing authorisation.