Daiichi Sankyo Co. Ltd and Sanofi-Aventis Deutschland GmbH v DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon.
Date: 2013-07-18
35. According to settled case-law, 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 European Union 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 (see, inter alia, Case C‑379/98 PreussenElektra  [2012] ECR I‑2099, paragraph 39; Joined Cases C‑94/04 and C‑202/04 Cipolla and Others  [2006] ECR I‑11421, paragraph 25; and Case C‑180/11 Bericap Záródástechnikai  [2012] ECR I‑0000, paragraph 58).
41. The TRIPs Agreement was concluded by the Community and its Member States by virtue of shared competence (Joined Cases C‑300/98 and C‑392/98 Dior and Others  [2000] ECR I‑11307, paragraph 33, and Case C‑431/05 Merck Genéricos – Produtos Farmacêuticos  [2007] ECR I‑7001, paragraph 33). In those circumstances, the parties to the main proceedings and the governments which have submitted observations argue that, in order to answer the first question, it must be examined whether, at the present stage of development of the law, the European Union has exercised its powers in the field of patents, or, more precisely, of patentability.
42. They rely on the case-law on mixed agreements which states that, to establish the dividing line between the obligations which the European Union assumes and those which remain the responsibility of the Member States, it must be determined whether, in the field covered by the relevant article of the agreement in question, the European Union has exercised its powers and adopted provisions to implement the obligations which derive from it (Case C‑240/09 Lesoochranárske zoskupenie  [2011] ECR I‑1255, paragraphs 31 and 32 and the case-law cited).
50. As follows from that provision, in particular the second sentence which states that the common commercial policy is within the context of ‘the Union’s external action’, that policy relates to trade with non-member countries, not to trade in the internal market.
51. It is also common ground that the mere fact that an act of the European Union, such as an agreement concluded by it, is liable to have implications for international trade is not enough for it to be concluded that the act must be classified as falling within the common commercial policy. On the other hand, a European Union act falls within the common commercial policy if it relates specifically to international trade in that it is essentially intended to promote, facilitate or govern trade and has direct and immediate effects on trade (Opinion 2/00 [2001] ECR I‑9713, paragraph 40; Case C‑347/03 Regione autonoma Friuli-Venezia Giulia and ERSA  [2005] ECR I‑3785, paragraph 75; and Case C‑411/06 Commission  v Parliament and Council  [2009] ECR I‑7585, paragraph 71).
52. It follows that, of the rules adopted by the European Union in the field of intellectual property, only those with a specific link to international trade are capable of falling within the concept of ‘commercial aspects of intellectual property’ in Article 207(1) TFEU and hence the field of the common commercial policy.
58. The primary objective of the TRIPs Agreement is to strengthen and harmonise the protection of intellectual property on a worldwide scale (Case C‑89/99 Schieving-Nijstad and Others  [2001] ECR I‑5851, paragraph 36). As follows from its preamble, the TRIPs Agreement has the objective of reducing distortions of international trade by ensuring, in the territory of each member of the WTO, the effective and adequate protection of intellectual property rights. Part II of the agreement contributes to attaining that objective by setting out, for each of the principal categories of intellectual property rights, rules which must be applied by every member of the WTO.
59. Admittedly, it remains altogether open to the European Union, after the entry into force of the FEU Treaty, to legislate on the subject of intellectual property rights by virtue of competence relating to the field of the internal market. However, acts adopted on that basis and intended to have validity specifically for the European Union will have to comply with the rules concerning the availability, scope and use of intellectual property rights in the TRIPs Agreement, as those rules are still, as previously, intended to standardise certain rules on the subject at world level and thereby to facilitate international trade.
60. Consequently, as the Commission observes, to regard the rules on patentable subject-matter in Article 27 of the TRIPs Agreement as falling within the field of the common commercial policy rather than the field of the internal market correctly reflects the fact that the context of those rules is the liberalisation of international trade, not the harmonisation of the laws of the Member States of the European Union.
61. In the light of the above considerations, the answer to the first part of Question 1 is that Article 27 of the TRIPs Agreement falls within the field of the common commercial policy.
80. It follows, admittedly, from Article 70(2) read in conjunction with Article 65(1) of the TRIPs Agreement that every member of the WTO is, from the entry into force of the WTO Agreement, or at the latest one year after that date, required to fulfil all the obligations arising from the TRIPs Agreement in respect of existing subject-matter (Case C‑245/02 Anheuser-Busch  [2004] ECR I‑10989, paragraph 49). That existing subject-matter includes inventions protected by a patent on that date in the territory of the WTO member concerned (see, to that effect, the Report of the WTO Appellate Body, issued on 18 September 2000, Canada – Term of Patent Protection (AB‑2000‑7), WT/DS170/AB/R, paragraphs 65 and 66).