Opinion of the Advocate General — ECLI:EU:C:2005:155
Date: 2005-03-10
Language of the case: Italian
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Intellectual, industrial and commercial property;Approximation of laws;Patents
Procedure: Action for failure to fulfil obligations - successful;Action for failure to fulfil obligations - unfounded
Origin: Italy

summary form, the legal and factual particulars on which those complaints are based. (9) 43. The Italian Government cannot plead a situation which it helped to create. The lack of precision in the application can be attributed to the conduct of the defendant in the proceedings, from which it follows that that complaint cannot succeed. 44. It is therefore necessary to examine the five complaints put forward by the Commission, since there is no presumption that a Member State has failed to fulfil its obligations and the burden of proof falls on the party alleging that failure. (10) 45. First of all, the Commission complains that Italian law infringes Article 3(1) of the Directive, in that it does not permit the patenting of a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. 46. In the defence, the Italian Government cites Articles 12 and 13 of Royal Decree No 1127/39 and the wide definition of patentable inventions contained therein, as interpreted in the case-law of the national courts. 47. The reply does not clarify the extent to which that approach is supposedly contrary to the obligation laid down in Article 3(1) of the Directive and to the aims pursued by the Directive in general. The reply also fails to refute the arguments put forward by the defendant and to prove the breach. Accordingly, the first complaint must be dismissed. 48. Second, the Commission complains that Article 5(2) of the Directive, which permits the patenting of an element isolated from the human body, has not been implemented in Italian law. 49. The Italian Government again refers to the wide definition of a patentable invention which applies in Italy. It adds that the only rule‑making aspect of Article 5(2) is in its final phrase, which states ‘even if the structure of that element is identical to that of a natural element’. In the opinion of the Italian Government, such circumstances do not give rise to any difficulty because, under the case-law of the Corte di cassazione, artificial processes capable of bringing about technical progress are patentable and such progress occurs every time a natural function is artificially reproduced. 50. It is appropriate to apply to this complaint the same reasoning as was used with regard to the previous complaint; in other words, no evidence has been adduced to indicate that the definition of a patentable invention which is in force in Italy conflicts with the letter or the spirit of the Community provision, and, in particular, that it threatens the coherence of the Community legal order in that sphere. I do, however, have doubts about the explanation relating to the final phrase of Article 5(2). Nevertheless, that new complaint was not put forward by the applicant on whom it is incumbent to prove the failure to fulfil obligations, nor are there any grounds for the Court to examine the complaint of its own motion. 51. The second complaint must therefore be dismissed in its entirety. 52. The basis for the third complaint is that the requirement that certain processes, such as the cloning of human beings and the use of human embryos for industrial or commercial purposes, are to be regarded as unpatentable has not been transposed into Italian law, as prescribed in Article 6(2) of the Directive. The Commission is of the opinion that Article 13 of Royal Decree No 1127/39 sets out only the general rule, which prohibits the patenting of inventions where their exploitation would be contrary to public policy or morality, and that, as such, it is an accurate reflection of Article 6(1) of the Directive. 53. The Italian Government pleads Article 13 of Law No 40 of 19 February 2004 on Medically Assisted Reproduction, which prohibits experimentation involving human embryos and provides that the production of human embryos and their selection for eugenic purposes, cloning, and fertilisation by gametes from other species are punishable by a prison sentence, a fine and suspension from professional practice. The Italian Government further claims that legislation of such a nature unequivocally classifies the practices of cloning and of altering a person’s genetic identity as contrary to public policy, thereby categorically precluding the patentability of such practices. 54. As a preliminary point, it is important to note that the national provision referred to was enacted after the expiry of the period laid down in the reasoned opinion, and also after the Commission had brought this action for failure to fulfil obligations on 27 October 2003. Accordingly, the provision cannot be taken into account for the purpose of analysing the conduct complained of. 55. Purely for academic purposes, it is appropriate to point out that notwithstanding that, in the light of the wording of Article 13 of Law No 40/2004, the competent authorities would, pursuant to Article 13 of Royal Decree No 1127/39, probably reject a patent application for processes involving cloning or manipulation of human embryos for commercial or industrial purposes, Article 6(1) of the Directive requires that inventions be considered unpatentable where their exploitation would be contrary to ordre public (public policy) and provides that ‘exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation’. That statement may be interpreted as requiring the transposition of the principle that commercial processes involving the use of human embryos are not patentable. In any event, it is clear from a careful reading of the Directive that the principle must be transposed. 56. For the reasons set out in point 54 of this Opinion, it is appropriate to declare, with regard to the third complaint, that there has been a failure to fulfil obligations. 57. The fourth complaint put forward by the Commission is more ambiguous in nature than the previous ones, and focuses on ascertaining whether, under Italian law, patents in respect of biotechnological inventions receive treatment equivalent to that granted in Articles 8 to 11 of the Directive. 58. The Italian Government claims that those provisions merely extend the protection provided by a biotechnological patent to material resulting from application of the patented process. In its view, Article 1bis(1)(b) of Royal Decree No 1127/39 meets those criteria in that it confers on the holder of the patent the exclusive right to apply a particular process, and to use, market, sell or import for such purposes the product directly obtained from the process concerned. 59. I am not convinced by the defence put forward in that regard. Without undertaking an interpretation of Italian law, it is clear from merely reading Articles 8 to 11 of the Directive and Article 1bis of the Royal Decree that the Community provisions govern specific situations which fall outside the scope of the protection accorded to the product of a patent under the Italian legislation. 60. Thus, for example, Article 8 of the Directive governs the protection of a product but, unlike the Italian legislation, it refers not only to patentable processes but also to the biological material itself, provided that such material is capable of propagation or multiplication. Article 9 of the Directive provides specifically for protection to be extended to products containing patented genetic material in which the latter continues to perform its function. That case differs conceptually from the connection between the process and the product, which is the only case governed by the Italian legislation. Articles 10 and 11 contain specific derogations from the general rule providing for the extension of the protection (propagation or multiplication for placing on the market; specific features of agricultural use) which are not reflected at all in Article 1bis of Royal Decree No 1127/39. 61. On those grounds, it is appropriate to uphold this part of the application. 62. Finally, by its fifth complaint the Commission contends that Italian law contains no provision governing the entitlement of a holder of a registered plant variety right to obtain, on reasonable terms, a compulsory licence from the proprietor of a biotechnological invention where the licence is necessary for the exploitation of the plant variety concerned. 63. The Italian Government invokes Article 5 of Royal Decree No 1127/39, which precludes the application or use of a protected invention to exploit another industrial invention without the consent of the holder. Moreover, the Italian Government states that the Royal Decree provides for an extensive system of compulsory licensing. Article 54(2)(b) of Royal Decree No 1127/39 permits such licences where it is not possible to use the patented invention without infringing rights attaching to a prior patent. In such cases, it is appropriate to grant protection to the holder of the subsequent right to the extent necessary for exploitation of the invention, provided that the latter constitutes significant technical progress of considerable economic importance compared with the first invention. The Italian Government also asserts that, although the wording of the legislation implies that, in principle, the administrative authorities have a margin of discretion when it comes to granting such licences, in practice they grant licences only provided that the other conditions are met. 64. Italian law does not provide for all the cases of compulsory cross-licensing governed by Article 12 of the Directive, although it is clear that both are underpinned by the same philosophy. In addition to the apparently discretionary nature of the licence under Royal Decree No 1127/39, an interpretation of the national legislation by reference to the Directive requires that the rules governing patents be extended by analogy to plant varieties and that the concept of an ‘appropriate royalty’ as consideration for the use of the licence also be introduced. Furthermore, Article 12(3)(a) expressly makes the grant of a licence conditional on the provision by the applicant of proof that he has applied unsuccessfully to the holder of the patent or of the plant variety right to obtain a contractual licence, a requirement which is absent from the Italian legislation. 65. For the reasons set out, this part of the application must be declared well founded. Costs 66. The Italian Republic has not applied for costs from the applicant, and accordingly it must bear its own costs, in accordance with Article 69(5) of the Rules of Procedure. 67. As regards the Commission’s costs, given the fact that each party has been partially unsuccessful, and, above all, the evasive procedural strategy of the defendant Member State, which has prevented the proceedings from progressing in the usual manner, I propose that those costs be shared equally between the parties, in accordance with Article 69(3) of the Rules of Procedure. Conclusion 68. In the light of the foregoing considerations, I propose that the Court of Justice should declare that the Italian Republic has failed to fulfil its obligations under Article 6(2) and Articles 8 to 12 of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, that the remainder of the application should be dismissed, and that the defendant Member State should be expressly ordered to pay its own costs and half of the costs incurred by the Commission. 1 – Original language: Spanish. 2 – OJ 1998 L 213, p. 13. 3 – This footnote is not relevant to the English translation. 4 – Cass. 28 June 2001, No 8879. 5 – Case 363/85 [1987] ECR 1733, paragraph 7. 6 – Case C-131/88 Commission v Germany [1991] ECR I-825, paragraph 8. 7 – See, for example, Case C-152/98 Commission v Netherlands [2001] ECR I‑3463, paragraph 21; Case C-384/97 Commission v Greece [2000] ECR I-3823, paragraph 35; and Case C-214/96 Commission v Spain [1998] ECR I-7661, paragraph 25. 8 – Joined Opinion in Case C-367/98 Commission v Portugal, Case C-483/99 Commission v France and Case C-503/99 Commission v Belgium [2002] ECR I-4731, point 76. 9 – Case C-347/88 Commission v Greece [1990] ECR I-4747, paragraph 28. 10 – See particularly Case 96/81 Commission v Netherlands [1982] ECR 1791, paragraph 6; Case C‑404/00 Commission v Spain [2003] ECR I-6695, paragraph 26; and Case C-434/01 Commission v United Kingdom [2003] ECR I-13239, paragraph 21.