Judgment — ECLI:EU:C:2015:659
Date: 2015-10-06
Language of the case: German
Court formation: Eighth Chamber
Subject matter: Intellectual, industrial and commercial property;Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Austria

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012, OJ 2012 C 371, p. 7. That publication contained, for the marketing authorisations issued pursuant to Article 13 of Regulation No 726/2004, the following customary headings: ‘Date of the decision’, ‘Name of the medicinal product’, ‘INN (international non-proprietary name)’, ‘Holder of the marketing authorisation’, ‘Number of the entry in the Community Register’, ‘Pharmaceutical form’, ‘ATC code (Anatomical Therapeutic Chemical Code)’ and ‘Date of notification’ (my emphasis). 11 Application for the grant of an SPC for the product ‘Brentuximab vedotin or pharmaceutically acceptable salts thereof’. 12 The expiry date was subject to the timely payment of the annual fees. 13 Commission Implementing Decision C(2014) 6095 (final) of 22 August 2014 on the annual renewal of the conditional marketing authorisation for the orphan medicinal product for human use ‘ADCETRIS — Brentuximab vedotin’, granted by Decision C(2014) 7764 (final), and amending that decision, produced in the English version by Seattle Genetics. 14 The order for reference refers, in this connection, to decisions adopted in Belgium, Portugal, Slovenia and the United Kingdom. Seattle Genetics states that the date of notification of the decision granting market authorisation has been taken to be the relevant date by competent patent authorities and courts in Belgium, Estonia, Portugal, Slovenia and the United Kingdom, whereas the date of adoption of the decision has been taken as the relevant date in Denmark, the Netherlands and Sweden. The Commission confirms that that approach has indeed been taken in those three Member States and states that there has been a shift in the practice followed by the competent authorities in Portugal, Slovenia and the United Kingdom, where the date of notification is now used, rather than the date of the decision. 15 See recital 7 in the preamble to Regulation No 469/2009 and paragraphs 18 and 27 of the explanatory memorandum for the Commission’s proposal of 11 April 1990, which led to the adoption of Regulation No 1768/92 (COM(90) 101 final). 16 The referring court states that, in this case, under Austrian rules of procedure, the decisive criterion would be the date of publication or notification of the administrative decision and that, if those rules were to be applied to the case in the main proceedings, the date of notification of the marketing authorisation decision would then be taken as the relevant date, such that the date of expiry of the SPC at issue would be deferred to 30 October 2027. 17 The referring court states that, according to one author (Sredl, V., ‘Das ergänzende Schutzzertifikat im deutschen Patentnichtigkeitsverfahren’, in Gewerblicher Rechtsschutz und Urheberrecht (GRUR), 2001, vol. 7, pp. 596 and 598), the legal situation varies according to the national law of the Member State in question and that, under the laws of a significant number of Member States, the authorisation takes effect upon signature of the authorisation instrument, rather than at the time it is notified. 18 See, in particular, the judgment in Zentrale zur Bekämpfung unlauteren Wettbewerbs (C‑59/12, EU:C:2013:634, paragraphs 25 and 26). 19 See, by analogy, my Opinion in Georgetown University (C‑484/12, EU:C:2013:745, point 29). 20 The Italian Government maintains that ‘in the absence of any [EU] rules governing the procedure before the competent authorities of each Member State’, the concept in question must be appraised on the basis of the law of the Member State in which the marketing authorisation takes effect. 21 These considerations are apparent from the Commission’s proposal which led to the adoption of Regulation No 1768/92 (explanatory memorandum, COM(90) 101 final, paragraphs 16, 18 and 27). 22 See, in particular, the Opinion of the Economic and Social Committee on the Commission’s proposal which led to the adoption of Regulation No 1768/92 (OJ 1991 C 69, p. 23, section 3.2). 23 See the sixth recital in the preamble to Regulation No 1768/92, which is repeated, in substance, and expanded upon in recitals 7 and 8 in the preamble to Regulation No 469/2009. The Court has referred to these objectives repeatedly (see, inter alia, the judgment in Medeva, C‑322/10, EU:C:2011:773, paragraph 24 and the case-law cited). 24 See the Order in Astrazeneca (C‑617/12, EU:C:2013:761, paragraph 48) and, prior to that, with regard to Regulation No 1768/92, the judgment in Hässle (C‑127/00, EU:C:2003:661, paragraphs 57, 58 and 72). 25 See, with regard to Regulation No 1768/92, the judgment in Yamanouchi Pharmaceutical (C‑110/95, EU:C:1997:291, paragraph 25). 26 Pursuant to Article 13(1) of that regulation. 27 In this connection, see, with regard to Regulation No 1768/92, the judgment in AHP Manufacturing (C‑482/07, EU:C:2009:501, paragraphs 35 and 36 and the case-law cited). 28 The referring court mentions, in particular, the judgment in Yamanouchi Pharmaceutical (C‑110/95, EU:C:1997:291, paragraph 24), in which the Court stated that ‘[t]he first marketing authorisation in the Community … serves a purely temporal purpose’, the judgment in Neurim Pharmaceuticals (1991) (C‑130/11, EU:C:2012:489), according to which ‘Article 13(1) of Regulation No 469/2009 must be interpreted as meaning that it refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the [SPC]’, and the Order in Astrazeneca (C‑617/12, EU:C:2013:761, paragraph 48, to which I alluded in point 24 of this Opinion). 29 Bearing in mind that the principal position advocated by the Italian Government is that the concept of which the Court’s interpretation is sought should be defined on the basis of the laws of the Member States. 30 See points 40 et seq. of this Opinion. 31 Special rules governing the way in which the legal effects of such decisions adopted by the Union come into being may be found, for example, in the field of intellectual property rights. 32 According to settled case-law, in order to interpret a provision of EU law in autonomous and uniform fashion, ‘it is necessary to consider not only its wording but also the context in which it occurs and the objectives pursued by the rules of which it is part’ (see, inter alia, the judgments in Kirin Amgen, C‑66/09, EU:C:2010:484, paragraph 41, and Zentrale zur Bekämpfung unlauteren Wettbewerbs, C‑59/12, EU:C:2013:634, paragraph 25). 33 The Latvian Government maintains that the wording in its own language version (‘the date on which the first [marketing authorisation] was obtained’, in the Latvian version) is more precise than that in other language versions and suggests that the relevant date is the date on which the decision granting the authorisation was adopted. For its part, the Lithuanian Government maintains that the forms of words used in the German, French, Lithuanian and English versions also suggest that meaning. Those arguments are not decisive, in my opinion or in that of the Commission, which considers that the wording used in the other language versions of the text gives no clear indication as to which solution to choose. In any event, if the various language versions of the provision of EU law at issue are to be regarded as truly divergent, then the provision ‘must be interpreted by reference to the purpose and general scheme of the rules of which it forms part’ (see, inter alia, the judgment in Hässle, C‑127/00, EU:C:2003:661, paragraph 70). 34 Recital 9 in the preamble to the regulation offers no further clarification, merely stating that the duration of the protection granted by an SPC commences ‘from the time the medicinal product in question first obtains authorisation to be placed on the market’. 35 See footnote 10 to this Opinion. 36 Indeed, although Article 13(2) of Regulation No 726/2004 merely provides that ‘notification of marketing authorisation shall be published in the [OJ]’, and even though the non-exhaustive list of the information to be published that is set out in Article 13(2) includes only ‘the date of authorisation’, the Commission’s usual practice is to mention both the ‘date of the decision’ granting marketing authorisation and the ‘date of notification’ of the decision. 37 See, in particular, Article 8(1)(a), which concerns the content of the application for an SPC, Article 9(2)(d) and (e), which concerns publication of applications for an SPC, and Article 11(1)(d) and (e), which concerns publication of the grant of SPCs. 38 See, in particular, Article 7(1), which concerns the time-limit for lodging an application for an SPC, and Article 20, which sets out additional provisions relating to the enlargement of the Community. 39 C‑125/10, EU:C:2011:812, paragraphs 39, 42 and 45, concerning the duration of the SPC, as provided for in Article 13(1) of Regulation No 1768/92 (which corresponds to Article 13(1) of Regulation No 469/2009), read together with Article 36 of Regulation No 1901/2006. 40 C‑66/09, EU:C:2010:484, paragraphs 42 and 52, in which the Court sought, by this form of words, to draw a distinction between ‘the entry into force of the Community marketing authorisation’ and ‘its grant within the meaning of Article 3(b)’ of Regulation No 1768/92 in its interpretation of Articles 7 and 19a of that regulation. 41 A basic patent is a guarantee, ‘to reward the creative effort of the inventor,’ that the patentee ‘has the exclusive right to use an invention with a view to manufacturing industrial products and putting them into circulation for the first time, either directly or by the grant of licences to third parties, as well as the right to oppose infringements’ (judgment in Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraph 9). 42 See recital 9 in the preamble to Regulation No 469/2009. 43 In its proposal of 11 April 1990, which led to the adoption of Regulation No 1768/92 (COM(90) 101 final), the Commission pointed out that the period of protection offered by a European patent was generally 20 years, but the period during which a medicinal product could actually be exploited was reduced to 8 years on average (explanatory memorandum, COM(90) 101 final, paragraph 2). See also the Opinion of the Economic and Social Committee on the Commission’s proposal (OJ 1991 C 69, p. 22, section 1.4). 44 See recitals 2 to 5 in the preamble to Regulation No 469/2009. 45 See, in particular, the judgments in Forsgren (C‑631/13, EU:C:2015:13, paragraph 33) and Actavis Group PTC and Actavis UK (C‑577/13, EU:C:2015:165, paragraph 34). 46 See, in particular, the judgments in Synthon (C‑195/09, EU:C:2011:518, paragraph 46 and the case-law cited) and Merck Sharp & Dohme, paragraph 32) and the Opinion of Advocate General Fennelly in Farmitalia (C‑392/97, EU:C:1999:277, point 20, in which the Advocate General stated that ‘the extent to which patentees can recover investment in research ... is the essential purpose of ... Regulation [No 1768/92]’). 47 See the explanatory memorandum for the Commission’s proposal which led to the adoption of Regulation No 1768/92 (COM(90) 101 final, paragraphs 5 and 36), the Opinion of the Economic and Social Committee on the Commission’s proposal (OJ 1991 C 69, p. 22, section 2.1), the third recital in the preamble to Regulation No 1768/92 and recital 4 in the preamble to Regulation No 469/2009. 48 See the explanatory memorandum for the Commission’s proposal which led to the adoption of Regulation No 1768/92 (COM(90) 101 final, paragraphs 36, 51 and 52), the third and eighth recitals in the preamble to Regulation No 1768/92 and recitals 4 and 9 in the preamble to Regulation No 469/2009. According to the eighth recital in the preamble to the proposal for a regulation, the Commission’s initial intention was for the ‘duration of the protection granted by [an SPC to] be determined to enable a medicinal product to be given the effective protection it would have if it were not subject to authorisation to be placed on the market’. 49 In addition to the judgments of the Court whose content I mentioned in points 35 and 36 of this Opinion, see the judgments in Neurim Pharmaceuticals (1991) (C‑130/11, EU:C:2012:489, paragraph 23 and the case-law cited) and Actavis Group PTC and Actavis UK (C‑443/12, EU:C:2013:833, paragraph 31). 50 See, by analogy, the judgment in Mensch und Natur (C‑327/09, EU:C:2011:249, paragraphs 24 and 25) and my Opinion in that case (C‑327/09, EU:C:2010:709, point 42), which concerned a Commission decision refusing authorisation to place a product on the EU market as a food or food ingredient, which the Court regarded as a decision within the meaning of the fourth paragraph of Article 249 EC, which became the fourth paragraph of Article 288 TFEU. 51 Legal consequences flow from this principle in fields other than administrative law, in particular where a party has not been apprised of a writ of summons or a judicial decision (see, in particular, Article 19(4) of Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (service of documents), and repealing Council Regulation (EC) No 1348/2000 (OJ 2007 L 324, p. 79) and the judgment in Plumex, (C‑473/04, EU:C:2006:96, paragraph 32). 52 The decisions which the Commission adopted on 25 October 2012 and 22 August 2014, granting marketing authorisation for the medicinal product Adcetris and then renewing that authorisation, expressly state that the period of validity of the authorisation commences on the date of notification of the decision (see points 11 and 15 of this Opinion). In the observations which it submitted to the Court, the Commission stated that this was standard wording. 53 Seattle Genetics cites the minutes of the second meeting of SPC experts held on 9 October 2006 in Brussels, and to the recommendations to applicants for a marketing authorisation (usually referred to as a Notice to Applicants), which are published by the Commission and to which the Commission also referred in its observations (see the Commission’s Health and Consumers Directorate-General’s Notice to Applicants, Revision 4, Volume 2A — Procedures for marketing authorisation, Chapter 1 — Marketing Authorisation, June 2013, at http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a_chap1_2013-06_en.pdf. 54 See, on the Agency’s website, in EMA Procedural advice for users of the centralised procedure for generic/hybrid applications, EMEA/CHMP/225411/2006, March 2015, the answer to question 12: ‘When can I submit my generic/hybrid application considering the protection period of the reference medicinal product?’), available at the following address: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004018.pdf.