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Thursday, 13 February 2014

Of safeners, spectres and SPCs: AG Jääskinen advises on isoxadifen

The IPKat is grateful to his good friend Paul England (Taylor Wessing LLP) for compiling the following note on the Advocate General's Opinion in Case C-11/12 Bayer CropScience AG. This post should please those folk whose interest is primarily patent-oriented. This is what Paul says:

On 10 January 2013 a reference from the Bundespatentgericht for a preliminary ruling was lodged with the Court of Justice of the European Union (CJEU) in Case C-11/12 Bayer CropScience AG. This asks, for the purpose of the supplementary protection certificate (SPC) regulation on plant protection products (Regulation 1610/96), the following question:

* Are the terms ‘product’ in Article 3(1) and Article 1.8 and ‘active substance’ in Article 1.3 of that regulation to be interpreted as covering a safener?

The safener in question in this case is Bayer CropSciences' isoxadifen. “Safeners” are defined in the Plant Protection Products Regulation 1107/2009 (the PPP Regulation) as “substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the plant protection product on certain plants”. In other words, safeners are not themselves active pesticides under this legislation. Indeed, the same Regulation defines “active substances” differently, although the use of both must be approved in the same way under the PPP Regulation. Can a safener, therefore be construed as an active ingredient for the purpose of Regulation 1610/96?

If a safener is an active substance under Regulation 1610/96, then it is, in principle, protectable by an SPC. However, so far in CJEU rulings, "active substance" has been strictly construed to mean compounds that act on harmful organisms, plants, parts of plants or plant products.

Advocate General Niilo Jääskinen has now expressed his Opinion on this question in Bayer CropScience. First, he states that the term "product" and the term "active ingredient" in Regulation 1610/96 are to be interpreted to cover any substance which meets the conditions laid down in this regulation, including, where appropriate, safeners, regardless of how that substance would be defined under Regulation 1107/2009. However, this leaves open the question of what an "active ingredient" and therefore a "product" is, within the meaning of 1610/96. The reasoning of the AG in this respect is potentially significant, as follows: The case invites comparison with decisions on "active ingredients" under the different, but similar, SPC regulation for medicinal products, Council Regulation 469/2009. Indeed, the AG states that rulings on this regulation can be used to elaborate the interpretation of 1610/96. Most recently, in the field of medicinal products, a 'reasoned order' of the CJEU in Case C-210/13 GSK Biologicals SA ruled that an adjuvant to a vaccine is not an active ingredient, meaning that an adjuvant is not a product capable of SPC protection.

The AG recognizes that these earlier decisions of the CJEU on active substances, including GSK Biologicals, must be taken into account. However, he also emphasizes that the effects of the particular substance at issue must be thoroughly analyzed in each case to determine whether there is a special mechanism or activity of that substance that should also be taken into account when determining whether it is an "active substance". It is for the national court to ensure that there is actually a phyto-therapeutic effect in fact.

In doing so, the AG suggests that the definition of active substance should not be limited to substances which merely act directly on harmful organisms as a protective substance, but should also include those that trigger a chemical or biological pathway within a plant which results indirectly in such protection.

Further, and apparently recognising the arguments put forward in the controversial Neurim case, but without expressly saying so, the AG says that, given the economic purpose of SPCs to encourage innovation, it would be somewhat artificial in to distinguish between two or more substances that are patented where they are included in the same product and are the subject of a single marketing authorisation (as here), by granting an SPC for a herbicidal ingredient but not for a safener.

We wait with interest to see how the CJEU will rule. However, by raising the concept of a substance qualifying as active by virtue of an indirect effect – creating a tension with GSK Biologicals – and raising the issue of economic justification once again – the spectre of the Neurim ruling – the AG's opinion may have the indirect effect of subverting the authorities on medicinal products SPCs.
Thanks so much, Paul, for this terrific effort -- especially since there's not yet an English version of the Opinion to which we can turn.

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