CJ rules safeners eligible for SPC protection

Supplementary protection certificates

SPCs have been available in EU countries for plant protection products, such as pesticides or herbicides, since the mid-1990s. The regulatory approval process for plant protection products involves demonstrating to the regulator that the product is both sufficiently effective and does not cause any harmful effect on human or animal health or unacceptable influence on the environment. As performing the necessary tests can involve significant amount of time and investment, SPCs were introduced to compensate the patent holder for the delay in commercial exploitation of the product due to the requirement to carry out these tests to obtain marketing authorisation.

Safeners

A safener is an ingredient contained in the formulation of a plant protection product. Although safeners do not have pesticidal or herbicidal activity when administered on their own, they are included in the formulation order to reduce the toxic effects of the active ingredient on certain plants. Safeners may thereby increase the effectiveness of a plant protection product by improving its selectivity and by limiting its toxic or ecotoxic effects.

Bayer’s SPC request for isoxadifen

Like any other chemical product, safeners may themselves be patented, independently of the plant protection product with which they are formulated. Bayer hold a patent for isoxadifen, a safener which forms part of the formulation of two approved plant protection products. Bayer looked to extend the patent term for this substance by means of an SPC. The German Patent Office and German Federal Patent Court were uncertain, and referred the matter to the CJ.

Regulation 1610/96 (the plant protection SPC regulation), which permits SPCs for plant protection products, defines the term ‘product’ as “the active substance or combination of active substances of a plant protection product”. The question the CJ had to answer, given that safeners have at the most an indirect effect on plants or harmful organisms, was whether a safener was covered by the term ‘active substance’ within the meaning of the plant protection SPC regulation.

The court noted that the term ‘active substances’, in the plant protection SPC regulation relates to substances which have a toxic, phytotoxic or plant protection action of their own. However, the regulation makes no distinction according to whether that action is direct or indirect, and saw no reason to restrict the term ‘active substances’ to those whose action may be considered direct.

In addition, the CJ noted that the regulations for grant of an SPC are a separate act of legislation from those relating to the regulatory approval process itself. Therefore, even though safeners are regulated differently from active substances, it is still necessary to submit data concerning the other ingredients when making a submission for marketing approval of the active substance.

Findings of the CJ

Based on the above, the court considered that the regulatory submission for a plant protection product containing a safener would delay the commercial exploitation of a patent for that safener. For those reasons, the court interpreted the term ‘product’ in the plant protection SPC regulation to mean it 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.

This view of the CJ is slightly at odds with its previous viewpoint on pharmaceutical excipients, which, in the MIT decision (C-431/04), it considered ineligible for SPC protection in their own right. However, the CJ distinguished that case on the grounds that the means of action of a safener is not necessarily comparable to that of an excipient in a medicinal product and that a safener is sometimes essential for the use of an active substance - the active substance may not receive regulatory approval without the safener.

A clear view for SPC applicants

The court’s decision is straightforward, especially in comparison with its recent decisions on SPCs for combination products. Consequently, SPC applicants are for once clear on where they stand on this matter. For more details, please contact your usual D Young & Co adviser.