Safe and sound: CJEU confirms a safener can be an active ingredient too

Author: Laura Whiting (Hogan Lovells International LLP)

Bayer CropScience AG v Deutsches Patent- und Marken Amt, Case C-11/13, EU:C:2014:2010, 13 February 2014, Judgment, Court of Justice of the European Union (CJEU)

Journal of Intellectual Property Law & Practice (2014), doi: 10.1093/jiplp/jpu139, first published online: August 1, 2014

The CJEU has confirmed the broader interpretation of ‘active substance’ proposed by AG Jääskinen (EU:C:2014:86) in the context of supplementary protection certificates (SPCs) for plant protection products—will this decision result in a move away from the strict approach previously applied in relation to SPCs for medicinal products?

Legal context

Bayer is a direct reference from the German Patent and Trade Mark Office (DPMA) in relation to the scope of supplementary protection certificates (SPCs) for plant protection products. The referral concerns the question of whether a ‘safener’—a substance contained in a plant protection product which improves herbicide selectivity for weeds by protecting crop plants from the toxic effect of the herbicide—falls within the scope of the terms ‘product’ and ‘active substance’ in Plant Protection Regulation 1610/96 (the ‘PP Regulation’). Like the SPC Regulation (469/2009), the PP Regulation requires that a valid authorization to place the ‘product’ on the market has been granted as a pre-requisite to the grant of a certificate (Art 3(b)). Under Article 1(8) of the PP Regulation, a product is the active substance or combination of active substances in the plant protection product.


The product concerned in this reference is MaisTer, a combination of the herbicides foramsulfuron and iodosulfuron, and the safener isoxadifen. Bayer's marketing authorization for MaisTer named only foramsulfuron and iodosulfuron as the active substances (although an earlier provisional MA had also listed isoxadifen as an active substance). Bayer applied for an SPC for isoxadifen based on this MA. The application was rejected on the grounds that the safener was not an ‘active substance’ and therefore could not be a ‘product’ under the PP Regulation.


The Court of Justice of the European Union (CJEU) has ruled that the definition of ‘active substance’ can include safeners (or other substances) where the substance has a ‘toxic, phytotoxic or plant protection action of its own’. In such a case, the safener may be entitled to SPC protection if it satisfies the other requirements of the PP Regulation.

Article 1(3) of the PP Regulation defines an active substance as a substance which has ‘general or specific action: (a) against harmful organisms; or (b) on plants, parts of plants or plant products’. The CJEU interpreted Article 1(3) in light of Article 1(1) which sets out the effects which a ‘plant protection product’ containing one or more active substance may have. Therefore, according to the decision, any substance which exerts a toxic, phytotoxic or plant protection action itself is to be included in the definition, whether or not its action is direct or indirect. This is slightly different to the definition proposed by AG Jääskinen, who considered an active substance was one which ‘causes an action, chemical or biological, as an integral part of a causal chain whose objective is to produce a general or specific action’ on a plant.

The Advocate General's reasoning took support from two earlier CJEU decisions. Söll v Tetra (C-420/10, Judgment, EU:C:2012:111) related to the interpretation of Directive 98/8 on the placing of biocidal products on the market, which also contains a definition of active substance. In that case, the CJEU found that a flocculating agent could be an active substance in a biocidal product, as although it did not have a direct harmful effect on the organism itself, it was an integral part of a causal chain in controlling it. Chemische Fabrik Kreussler v Sunstar Deutschland (C-308/11, Judgment, EU:C:2012:548) related to the definition of ‘medicinal product’ in Directive 2001/83 on medicinal products for human use. The CJEU there considered that a substance which does not interact with a human cellular constituent may nonetheless qualify as a medicinal product if it directly or indirectly restores, corrects or modifies human physiological functions.

The CJEU's reasoning follows the rationale of Söll and Chemische Fabrik Kreussler in not requiring a direct relationship between the active substance in question and the effect produced. The Court also relied on its previous decisions concerning the SPC Regulation in which both excipients (Judgment in MIT, C-431/04, EU:C:2006:291) and adjuvants (Order in GSK, C-210/13, EU:C:2013:762) were held not to be entitled to SPC protection on the basis that both were substances ‘with no pharmaceutical effects of [their] own’ and therefore could not satisfy the definition of ‘product’ in the SPC Regulation. These cases are cited by the CJEU in support of its reasoning that a substance with no toxic, phytotoxic or plant protection action could not be considered to be an active substance.

Having set out the test under which a safener may qualify as an active substance, the CJEU then referred the decision on the facts of this specific case back to the national court.

Practical significance

The CJEU's decision does not suggest that medicinal products and plant protection products should be treated differently. While it relied on its decisions in MIT and GSK, no factual comparison between those cases and the present one was undertaken. It is therefore unclear whether this decision marks the start of a divergence between the legal treatment of SPCs for plant protection products and those for medicinal products, or whether it indicates the first step in a shift in direction for the jurisprudence of both systems.

Applying the Bayer decision to SPCs for medicinal products could (with the appropriate facts) potentially open up a wider category of products to SPC protection. In the case of adjuvants in particular, following the reasoning of the CJEU, it could be argued that if the adjuvant has an effect on the effectiveness or tolerability (or other qualities) of the active substance, then it should qualify as a ‘product’ under the SPC Regulation.

The CJEU will have an opportunity to consider the question of adjuvants again in Forsgren (C-631/13, a reference lodged on 2 December 2013). In this case, the adjuvant is a protein carrier molecule which is covalently bonded to various pneumococcal polysaccharides in a vaccine composition and is said to intensify the effect of those polysaccharides. It is further said to have a therapeutic effect of its own. The CJEU has been asked whether this carrier protein is itself an active ingredient either by virtue of its own therapeutic action or as a result of its intensifying effect on the pneumococcal polysaccharides. If the reasoning in Bayer were followed, this should be enough to qualify it as an active substance—but readers will have to wait for the answer, as no dates in the procedure have yet been set.

1 comment:

  1. Forsgen will be interesting if a compound can have both an adjuvant activity and a separate therapeutic activity. In what circumstances does it infringe or not infringe the SPC?