CJEU allows SPCs to plant safeners

On 19 June 2014, the CJEU indicated in Case C-11/13, Bayer CropScience AG that plant safeners may be the subject of a Supplementary Protection Certificate (SPC).

Plant safeners are compounds which may be used together with or separately to a herbicide, to protect plants which are not the target of the herbicide, from its action.  In the present case, the SPC was applied for on the basis of a patent directed to the safener itself and a marketing authorisation for a herbicide comprising two herbicidal compounds (Foramsulfuron and Iodosulfuron) and the safener (Isoxadifen). 

The question which was referred to the CJEU was “Are the terms “product” in Article 3(1) and Article 1.8 and “active substances” in Article 1.3 of Regulation No 1610/96 to be interpreted as covering a safener?”   

Regulation No 1610/96 defines “active substances” as “substances or micro-organisms including viruses, having general or specific action: (a) against harmful organisms; or (b) on plants, parts of plants or plant products”.

The CJEU indicated that the regulation does not specifically authorise or exclude safeners  and it considered that active substances as defined by the regulation relates to substances that have a toxic, phytotoxic or plant protection action of their own.  The CJEU indicated that there is no specification in the regulation that the active substance should have a direct effect and that substances with an indirect effect should also be encompassed.

The judgement hence stated that “the answer to the question whether a safener is an active substance, within the meaning of Article 1.3 of Regulation No 1610/96, therefore depends on whether that substance has a toxic, phytotoxic or plant protection action of its own.  If that is the case, it falls within the concept of a “product”, within the meaning of Article 1.8 of that regulation and may therefore, provided the conditions set out in Article 3 of Regulation No. 1610/96 are observed, give rise to the issue of a supplementary protection certificate”.

Plant safeners are therefore capable of being the subject of an SPC.  This is in contrast to the situation for “excipients” in medical products.

Jodie Albutt, Associate