On 9th July 2020, the Court of Justice of the European Union (CJEU) handed down their emphatic judgement concerning Supplementary Protection Certificates (SPCs) in Santen v INPI (C‑673/18). For those interested in the details and history of the case they can be found in my earlier blog, published in January, where I discussed the Advocate General’s preliminary and non-binding opinion. As far as this judgement is concerned the conclusion is clear: “a marketing authorisation (MA) cannot be considered to be the first MA … where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of an MA for a different therapeutic application” – emphasis added Put another way, the CJEU has decided that the literal wording of Articles 1(a), (b) and 3(d) of the SPC Regulation mean what they say. The previous CJEU decision in Neurim is consigned to the scrapheap.
Insights: Article 3 (d)
It may only be the opinion of the Advocate General but after almost a decade of fog surrounding Article 3(d) of the SPC Regulation this latest offering in Santen v INPI suggests that clarity may be about to prevail.In the past the decisions and opinions of the CJEU & Advocate General have often been criticised for their lack of clarity and applicability but this is not a criticism that can be levelled at Giovanni Pitruzzella. If the CJEU choose to follow his guidance then Neurim will be scrubbed from the record books and Article 3(d) will, once again, mean what is says.As a quick reminder, Article 3(d) of the SPC regulation states that a certificate shall be issued if:“the authorization [for the product] is the first authorization to place the product on the market as a medicinal product”The “medicinal product” and “product” are defined in Article 1 of the regulation and essentially relate to “any substance or composition presented as having curative or preventive properties with regard to human or animal diseases” and “the active ingredient or the composition of active ingredients in a drug” respectively.