The ECJ ruled in GSK Biologics that an adjuvant that is part of a medical product, which adjuvant influences the therapeutic effects of the active ingredient of the product but is not an active ingredient in itself, is not a ‘product’ or ‘active ingredient’ within the meaning of the SPC Regulation. This means a supplemental protection certificate (SPC) cannot be granted for that adjuvant. But in his opinion in Bayer CropScience, the Advocate General of the ECJ seems to reach a different conclusion for a “safener”, a product that regulates the phytotoxicity of an herbicide. If the ECJ follows the AG’s opinion, safeners and other adjuvants in plant protection products might well qualify for SPCs.
Both cases concern the interpretation of the terms ‘product’ and ‘active ingredient’ or ‘active substance’ in the SPC Regulation 469/2009 for medicinal products, and the Plant SPC Regulation 1610/96 concerning plant protection products.
The European Court of Justice (ECJ) stuck to a narrow interpretation of “active ingredient” in the SPC Regulation for medicinal products in GSK Biologics, in line with earlier case law. The ECJ considered that it is not unusual for an adjuvant to influence the therapeutic efficacy of the active ingredient of a medicinal product even though it does not have therapeutic effects of its own. However, this indirect effect does not make it an ‘active ingredient’ within the meaning of Article 1(b) SPC Regulation and, therefore, no SPC can be granted for that ingredient.
In Bayer CropScience, AG Jääskinen opined that the terms ‘product’ and ‘active substance’ in the Plant SPC Regulation have to be understood as covering any substance which meets the conditions that are laid down in that Regulation and that this can include safeners. Further, the AG recognises that earlier decisions of the ECJ about ‘active substances’ in other SPC regulations, such as Regulation 469/2009 for medicinal products, must be taken into account. However, he also emphasises that the effects of particular substances must be analysed thoroughly in each case to determine whether it is an ‘active substance’. He seems to suggest that indirect effects can also be taken into account. Although he does not state this explicitly, his suggested broader interpretation of the Plant SPC Regulation is likely to be inspired by a broad definition of ‘active substances’ in Article 1(3) Plant SPC Regulation. In the SPC Regulation, ‘active ingredient’ is not defined but only appears as in the definition of ‘product’ of Article 1(b).
It now remains to be seen whether the ECJ will follow this broader interpretation of ‘active substance’ in the Plant SPC Regulation in its judgment in Bayer CropScience, and whether this will have implications for the interpretation of the other SPC Regulation. If the AG’s opinion is followed, safeners and other adjuvants in plant protection products might well qualify for SPCs. The current practice of national IPOs in this respect varies, with some IPOs granting and others refusing SPCs for safeners. The same was the case – until recently – for the practice regarding adjuvants in medical products.