The Court of Justice of the European Union has ruled that substances intended to be used as safeners in plant protection products can, in principal, be the subject of a Supplementary Protection Certificate provided the substance has a toxic, phytotoxic or plant protection action of its own.
As background to this case, Bayer Crop Science AG (“Bayer”) is the proprietor of European Patent No. 0719261, due to expire on 8 September 2014, which covers Isoxadifen, a safener. Safeners are an interesting class of chemical compounds which enhance the phytotoxic effects of herbicidal compounds typically by reducing the herbicidal injury to the desired crop species whilst providing no protection to competing weed species, the enhancement being typically observed for specific safener-herbicide co-applications.
In view of the limited period of protection afforded by the basic ‘261 patent with regard to the length of time required to obtain the necessary Marketing Authorisation for offering plant protection products on the German market, Bayer applied to the German Patent and Trademark Office for a Supplementary Protection Certificate (SPC) in respect of Isoxadifen and the salts and esters thereof. The German Patent and Trademark Office refused the application resulting in Bayer bringing an action against this decision before the Federal Patent Court which was subsequently referred to the Court of Justice of the European Union (CJEU).
Following the evolution of case law from the CJEU, the initial reasons given by the German Patent and Trademark Office for refusal of the application were considered moot by the Federal Patent Court. However, the Court nevertheless sought clarification from the CJEU as to whether safeners fall within the scope of the term ‘active substances’ within the meaning of Regulation No. 1610/96 providing for SPC’s for plant protection products.
On 19 June 2014, the CJEU handed down its judgment in the case (C-11/13, Bayer Crop Science AG vs German Patent and Trademark Office). The CJEU ruled that:
The term ‘product’ in Article 1.8 and Article 3(1) of Regulation (EC) No. 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, and the term ‘active substances’ in Article 1.3 of that regulation, must be interpreted as meaning that those terms may cover a substance intended to be used as a safener, where that substance has a toxic, phytotoxic or plant protection action of its own.
In addition, the CJEU affirmed that “Regulation 1610/96 makes no distinction according to whether the action is direct or indirect [and thus] there is no need to restrict the term ‘active substances’ to those whose action may be characterised as direct.”
However, the CJEU has explicitly indicated that it is a matter for the National Courts to “ascertain, in the light of all the relevant factual and scientific evidence, whether the substance at issue in the main proceedings can, on account of its action as a safener, be classified as an ‘active substance’ within the meaning of Article 1.3 of Regulation No 1610/96.” It appears, therefore, that each case will likely turn on the facts presented before the presiding National Court as to the mode of action of the safener and whether this qualifies the substance as valid subject matter for an SPC in that Member State in accordance with the present ruling.
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