Santen SAS v Directeur général de l’Institut national de la propriété industrielle.
Date: 2020-07-09
25


The Netherlands Government argues that the Court decided, in paragraph 48 of the judgment of 28 July 2011, Synthon (C‑195/09, EU:C:2011:518), that it follows from Article 19(1) of Regulation No 1768/92 that that regulation is not applicable to products placed on the market in France before 1 January 1985. That interpretation of Regulation No 1768/92 is fully transposable to Regulation No 469/2009, since that latter regulation is merely a codification of Regulation No 1768/92. The Netherlands Government infers from this that, since an MA was granted in France for a medicinal product whose active ingredient is ‘ciclosporin’ on 23 December 1983, Santen’s application does not fall within the scope of Regulation No 469/2009. The questions referred for a preliminary ruling are thus hypothetical.
26


In that regard, it should be recalled that it is solely for the national court before which the dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine in the light of the particular circumstances of the case both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court. Consequently, where the questions submitted concern the interpretation of a rule of EU law, the Court is in principle bound to give a ruling (judgment of 10 December 2018, Wightman and Others, C‑621/18, EU:C:2018:999, paragraph 26 and the case-law cited).
27


It follows that questions relating to EU law enjoy a presumption of relevance. The Court may refuse to rule on a question referred for a preliminary ruling by a national court only where it is quite obvious that the interpretation of EU law that is sought bears no relation to the actual facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it (judgment of 10 December 2018, Wightman and Others, C‑621/18, EU:C:2018:999, paragraph 27 and the case-law cited).
35


In this connection, according to settled case-law, even if, formally, the referring court has limited its questions to the interpretation of certain aspects of EU law, that does not prevent this Court from providing the referring court with all the elements of interpretation of EU law which may be of assistance in adjudicating in the case pending before it, whether or not that court has referred to them in the wording of its questions (see, to that effect, judgment of 5 June 2018, Coman and Others, C‑673/16, EU:C:2018:385, paragraph 22 and the case-law cited).
41


In the absence of any definition of the concept of ‘active ingredient’ in Regulation No 469/2009, the meaning and scope of those terms must be determined by considering the general context in which they are used and their usual meaning in everyday language (judgments of 4 May 2006, Massachusetts Institute of Technology,C‑431/04, EU:C:2006:291, paragraph 17, and of 21 March 2019, Abraxis Bioscience, C‑443/17, EU:C:2019:238, paragraph 25).
42


The Court has already held in this respect that the term ‘active ingredient’ is generally accepted in pharmacology not to include substances forming part of a medicinal product which do not have an effect of their own on the human or animal body (judgments of 4 May 2006, Massachusetts Institute of Technology, C‑431/04, EU:C:2006:291, paragraph 18, and of 15 January 2015, Forsgren, C‑631/13, EU:C:2015:13, paragraph 23) and that, for the purposes of applying Regulation No 469/2009, that term concerns substances producing a pharmacological, immunological or metabolic action of their own (judgment of 15 January 2015, Forsgren, C‑631/13, EU:C:2015:13, paragraph 25). It follows that the term concerned refers to substances which have, at least, a therapeutic effect of their own.
44


Under Article 4 of that regulation, the protection conferred on the product by the SPC, although it extends only to the product covered by the MA, covers, on the other hand, any use of that product as a medicinal product which was authorised before the expiry of the SPC. It follows that the term ‘product’ within the meaning of Regulation No 469/2009 is not dependent on the manner in which that product is used and that the intended use of the medicinal product does not constitute a decisive factor for the grant of an SPC (see, to that effect, judgment of 19 October 2004, Pharmacia Italia, C‑31/03, EU:C:2004:641, paragraphs 19 and 20).
45


Such an interpretation is supported by an analysis of the origins of Regulation No 469/2009. Thus, paragraph 11 of the Explanatory Memorandum of 11 April 1990 to the Proposal for a Council Regulation (EEC) concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final), which led to Regulation No 1768/92, itself repealed and replaced by Regulation No 469/2009, indicates that the term ‘product’ is understood to mean an active ingredient in the strict sense and that minor changes to the medicinal product such as a new dose, the use of a different salt or ester or even of a different pharmaceutical form will not lead to the issue of a new SPC (see, to that effect, judgments of 4 May 2006, Massachusetts Institute of Technology, C‑431/04, EU:C:2006:291, paragraph 19, and of 21 March 2019, Abraxis Bioscience, C‑443/17, EU:C:2019:238, paragraph 26).
51


In addition, in the light of the strict definition of the term ‘product’ within the meaning of Article 1(b) of Regulation No 469/2009, as is apparent from paragraphs 40 to 45 above, the analysis of the wording of Article 3(d) of that regulation presupposes that the first MA for the product as a medicinal product for the purpose of that provision means the first MA for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue (see, to that effect, judgment of 21 March 2019, Abraxis Bioscience, C‑443/17, EU:C:2019:238, paragraph 34), irrespective of the therapeutic application of that active ingredient, or of that combination of active ingredients, in respect of which that MA was obtained.
55


Thus, as is apparent from paragraph 11 of the Explanatory Memorandum referred to in paragraph 45 above, the EU legislature intended, in establishing the SPC regime, to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product (see, to that effect, judgment of 21 March 2019, Abraxis Bioscience, C‑443/17, EU:C:2019:238, paragraph 37).
56


That objective would be undermined if it were possible, in order to fulfil the condition set out in Article 3(d) of Regulation No 469/2009, to take into account solely the first MA to fall within the limits of the protection of the basic patent covering a new therapeutic application of a given active ingredient, or a given combination of active ingredients, and to disregard an MA which had been granted previously for a different therapeutic application of the same active ingredient or of the same combination (see, to that effect, judgment of 21 March 2019, Abraxis Bioscience, C‑443/17, EU:C:2019:238, paragraph 38).
57


That interpretation also enables a fair balance to be struck between, on the one hand, the objective of the SPC regime, as it is made apparent from recitals 3 to 5 and 9 of Regulation No 469/2009, of compensating for the inadequacy of protection conferred by a patent for the purpose of covering the investment put into research concerning new active ingredients or combinations of active ingredients and, therefore, of encouraging such research and, on the other hand, the EU legislature’s intention, as set out in recital 10 of that Regulation, to achieve that objective in a manner that takes into account all the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector (see, to that effect, judgment of 21 March 2019, Abraxis Bioscience, C‑443/17, EU:C:2019:238, paragraph 36).