C‑11/13 Bayer CropScience AG v Deutsches Patent- und Markenamt

The Court of Justice of the European Union rules that a supplementary protection  certificate (SPC) can be granted in respect of a safener.

Legal Background

Supplementary protection certificates can be granted in the European Union in respect of  plant protection products pursuant to Regulation (EC) No 1610/96 of the European  Parliament and of the Council of 23 July 1996, and in respect of medicinal products for  human or animal use pursuant to Regulation (EC) No 469/2009 of the European  Parliament and of the Council of 6 May 2009.

Under the latter Regulation, where “product” is defined as “active ingredient”, it is  established caselaw of the CJEU that excipients and adjuvants do not fulfil the  requirement of being an active ingredient, and that an SPC cannot be obtained in respect  of such substances (Massachusetts Institute of Technology C-431/04, Glaxosmithkline  Biologicals and Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham  Pharma, C‑210/13).

Under the former Regulation, it fell to be determined in the present case whether a  “safener” could be considered to be a “product”, defined in the Regulation Article 1.8 to  be an “active substance”, which in turn is defined in Article 1.3 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.”

Factual Background

A safener is a compound added to a herbicide product which is "intended to prevent the harmful  effects of a herbicidal active substance, in order to increase its effectiveness". There is no  doubt that a herbicide itself can be the subject of an SPC, but what about the safener as such? In  the present case, Bayer sought from the Deutsches Patent- und Markenamt an SPC on the basis of a  patent covering isoxadifen, a safener, and a marketing authorisation in respect of a combination  herbicide containing isoxadifen in combination with two herbicidal components foramsulfuron and  iodosulfuron. The application having been refused, Bayer appealed, and in the course of the appeal  the Bundespatentgericht referred to the CJEU the question:

“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?”

Basically considering that the question should be answered “yes” at least in the circumstances of  the particular case, the CJEU in fact ruled as follows:

“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.”

Analysis

The judgment teases the reader by stating that it is for the national court to ascertain whether a  substance which is a safener can be classified as an ‘active substance’ for the purposes of  granting an SPC. This observation notwithstanding, the CJEU used information from the referring  decision to clearly indicate an answer, which, although stated as quoted above in the terms “may  cover a substance” is in context clearly to be read definitively, so that in this case the terms  “product” and “active substance” do cover a substance which acts a safener.

The reasoning is brief. First, the CJEU considered that no express provision of the 

Regulation either specifically authorises or excludes the possibility of covering a safener. Secondly, while it considered that the term ‘active substances’ relates to substances which have a  toxic, phytotoxic or plant protection action of their own, it saw no need to restrict the term  ‘active substances’ to those whose action may be characterised as direct, and therefore considered  that the term could extend to substances with indirect action. Thirdly, the CJEU saw as significant  that the safener isoxadifen was examined in connection with a procedure granting of the marketing  authorisation of the combination product, and that the duration of that procedure reduced the  effective duration of protection provided by the patent. On the basis of these considerations, it  indicated a positive answer to the question referred.

It is not expressly clear from the decision whether this effectively means that all safeners would  qualify for SPC protection. However, it is clear from the reasoning that at least an indirect  toxic, phytotoxic or plant protection action is required. Since a safener by definition may be  regarded as having an effect at least on toxicity, it is likely that the decision will be taken to  apply to safeners in general, but this cannot be concluded with certainty. The last clause of the  answer to the question (“where that substance has a toxic, phytotoxic or plant protection action of  its own”) will give any EU court some flexibility in how it chooses to apply the decision, and  leads to the prospect of divergent national rulings or further references to the CJEU on similar  matters.

Superficially, this result contrasts with the situation for excipients and adjuvants. However,  neither is technically completely cognate with a safener, which can perhaps legitimately be  considered more “active” than the other two. Moreover, the definition of “active substance” in  relation to plant protection products is not identical to the definition of “active ingredient” in  relation to medicinal products, and this divergence may also justify the different outcome. This  decision indicates a clear path for obtaining SPCs in respect of safeners, but is unlikely to  increase the scope for SPCs for pharmaceutical constituents that have no active effect of their own.