The European Court of Justice (ECJ) has decided that a safener can fall within the definition of an 'active substance' as outlined in Articles 1.8 and 3(1) of the Plant SPC Regulation if it has a direct or indirect toxic, phytotoxic or plant protection action of its own. With this judgment, the ECJ seems to diverge from its earlier narrow interpretation of the term 'active ingredient' in pharmaceutical products. The recent ruling suggests that a Supplementary Protection Certificate (SPC) can be granted for safeners. It is up to national IPOs to interpret whether a specific safener or other substance has a direct or indirect action of its own.
A safener is a substance or preparation added to a plant protection product to eliminate or reduce phytotoxic effects of the plant protection product on certain plants (Article 2(3)(a) Regulation 1107/2009). In Bayer Cropscience, the ECJ ruled that the terms 'product' and 'active substance' in Articles 1.3, 1.8 and 3(1) Plant SPC Regulation 1610/96 may cover a substance used as a safener. This is the case when the safener has a "general or specific action" (Article 1.3); that is, when it has a toxic, phytotoxic or plant protection action of its own on harmful organisms, plants, part of plants or plant products. Notably, the ECJ finds it irrelevant whether this action is direct or indirect.
Consequently, the effect that safeners have in down- or up-regulating the efficacy of a plant protection product or on its side effects may be considered an indirect toxic, phytotoxic or plant protection action of its own. This means that safeners in plant protection products might qualify for SPCs.
As reported earlier, AG Jääskinen had come to a similar result in this case by holding that safeners could be 'active substances' as long as the conditions in the Plant SPC Regulation were met.
With this judgment, the ECJ seems to diverge from the narrow interpretation of the term 'active ingredient' that it gave in earlier case law regarding pharmaceutical products. For instance, in GSK Biologics the ECJ looked at the interpretation of "adjuvant" in the SPC Regulation 469/2009 for Medical Products. In that case, the ECJ held that even though an adjuvant influences the therapeutic efficacy of a medicinal product's active ingredient, this adjuvant did not fall within the definition of 'active ingredient' within the meaning of Article 1(b) SPC Regulation 469/2009 because it did not have any pharmaceutical effect of its own. Therefore, no SPC could be granted for an adjuvant.
These two decisions seem difficult to reconcile, as a safener and an adjuvant seem to have a similar purpose, although the definitions of both are specific. Both can have an indirect effect on the efficacy of another active ingredient. The ECJ, and the same AG in both cases, seems to see no incompatibility between the two decisions; it considers the interpretation in Bayer Cropscience to be in line with the interpretation it applied regarding medicinal products (e.g., GSK Biologics).
In any event, Bayer Crop Science seems to introduce an important advantage for the innovative plant technology branch: the ECJ endorses the obtaining of SPCs for safeners in plant protection products as long as the substances have a direct or indirect action. It is now up to national IPOs in the course of SPC requests to interpret whether a specific safener or other substance has a direct or indirect action of its own. This judgment will probably not harmonise currently diverging national practices because it is not completely clear when a substance can be considered to have "an indirect action of its own".
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