Safety Net For Safeners?

In the EU it is possible to obtain a supplementary protection certificate (SPC) for 'active substances' of a plant protection product (PPP) and 'active ingredients' of a medicinal product extending the protection afforded to such products beyond the patent term. Two distinct but related EC Regulations govern the grant of SPCs - Regulation No 1610/96 (the PPP SPC Regulation) and Regulation No. 469/2009 (the Medicinal Product SPC Regulation). It is generally accepted that equivalent provisions in the SPC Regulations should be interpreted in the same way but is this assumption correct?

The CJEU has considered the question of what is meant by 'product' and 'active ingredient' in the Medicinal Product SPC Regulation in a number of cases. The equivalent terms - 'product' and 'active substance' - in the PPP SPC Regulation have recently been considered by the CJEU in its decision of 19 June 2014 in the Bayer CropScience reference from the German Federal Patent Court in case C-11/13.

Bayer CropScience reference

By way of background, the applicant Bayer CropScience is the holder of a European patent, issued in Germany in 1994 covering isoxadifen, a safener - a substance intended to prevent the harmful action of a herbicide in plants. In March 2003, Bayer CropScience obtained a provisional marketing authorisation (MA) in Germany for the plant protection product Maister containing: foramsulfuron, iodosulfuron and isoxadifen. Shortly thereafter, in July 2003, Bayer CropScience applied to the German Patent and Trademark office for an SPC for the safener isoxadifen.

In 2007, the German Patent and Trademark office rejected the SPC application, which Bayer CropScience appealed. The German Federal Patent Court cited a number of factors for and against safeners being covered by the term 'active substance' (see table 1) before referring the case to the CJEU for a preliminary ruling. Consistent with the Opinion of 13 February 2014 of Advocate General Jääskinen, the CJEU has confirmed that it is possible for a safener to be covered by the terms 'product' and 'active substance' "where that substance has a toxic, phytotoxic or plant protection action of its own".

CJEU decision

In arriving at its decision, the CJEU noted that there was no express provision in the PPP SPC Regulation expressly preventing or allowing SPCs for safeners. The term 'active substances' in that Regulation relates to substances which have a toxic, phytotoxic or plant protection action of their own. Consequently...