Commission of the European Communities v Italian Republic.
Date: 2005-06-16
23. So far as concerns the f a irst of those contentions, in accordance with the case-law an application must, by virtue of Article 21 of the Statute of the Court of Justice and Article 38(1)(c) of the Rules of Procedure of the Court of Justice, contain inter alia a brief statement of the pleas in law on which the application is based. Accordingly, in any application lodged under Article 226 EC, the Commission must indicate the specific complaints upon which the Court is called to rule and, at the very least in summary form, the legal and factual particulars on which those complaints are based (see, inter alia, Case C-347/88 Commission  v Greece  [1990] ECR I-4747, paragraph 28).
24. The application lodged by the Commission, according to which it essentially alleges that the Italian Republic has not adopted any measure necessary for transposing the Directive, contains a clear statement of this complaint and of the legal and factual particulars on which it is based.
25. Admittedly, it is common ground that in that pleading the Commission did not seek to show in what way the Italian law in force did not comply with the Directive.
26. However, it should be remembered that while, in proceedings under Article 226 EC for failure to fulfil obligations, it is indeed incumbent upon the Commission, which has the burden of proving the allegation that the obligation has not been fulfilled, to place before the Court the information needed to enable the Court to establish that it has not been fulfilled, in doing which the Commission may not rely on any presumption, it is also for the Member States, under Article 10 EC, to facilitate the achievement of the Commission’s tasks, which consist in particular, pursuant to Article 211 EC, in ensuring that the provisions of the EC Treaty and the measures taken by the institutions pursuant thereto are applied (see, inter alia, Case 96/81 Commission  v Netherlands  [1982] ECR 1791, paragraphs 6 and 7, and Case C-408/97 Commission  v Netherlands  [2000] ECR I-6417, paragraphs 15 and 16). It is for that reason that Article 15 of the Directive, like other directives, imposes upon the Member States an obligation to provide information.
27. The information which the Member States are thus obliged to supply to the Commission must be clear and precise. It must indicate unequivocally the laws, regulations and administrative provisions by means of which the Member State considers that it has satisfied the various requirements imposed on it by the directive. In the absence of such information, the Commission is not in a position to ascertain whether the Member State has genuinely implemented the directive completely. The failure of a Member State to fulfil that obligation, whether by providing no information at all or by providing insufficiently clear and precise information, may of itself justify recourse to the procedure under Article 226 EC in order to establish the failure to fulfil the obligation (Case 96/81 Commission  v Netherlands , cited above, paragraph 8).
28. In the present case, it is common ground that the Italian Government not only did not reply to the Commission’s letter of formal notice but additionally did not state in its response to the reasoned opinion that the Directive was to be regarded as already transposed by the domestic law in force. Quite to the contrary, since it informed the Commission, both in its response to the reasoned opinion and in its subsequent letter of 10 July 2003, of the fact that the provisions needed to transpose the Directive were about to be adopted, the Italian Government implicitly, but certainly, gave the Commission to understand that the domestic law in force was not capable, without the adoption of specific measures, of transposing the Directive correctly and completely.
29. In those circumstances, the Italian Government cannot complain that the Commission, in its application, simply stated that the Directive had not been transposed at all within the period laid down and did not seek to show in what way the provisions of Italian domestic law in force did not comply with the Directive. As the Advocate General has stated in point 43 of his Opinion, the alleged lack of precision in the application results from the Italian Government’s own conduct during the pre-litigation procedure (see, to this effect, Case C-408/97 Commission  v Netherlands , cited above, paragraph 17).
30. That finding is not called into question by the fact that Article 1(1) of the Directive provides that the Member States are, ‘if necessary’, to adjust their national patent law to take account of the Directive’s provisions. While this article allows the Member States to secure the substantive transposition of the Directive by means of their domestic legal rules in force, it does not in any event absolve them from the formal obligation to inform the Commission of the existence of those rules so that it can be in a position to assess whether the rules comply with the Directive.
31. Consequently, the Italian Government’s present argument must be rejected. To the extent that, as to the remainder, the Italian Republic’s line of argument seeks to dispute the allegation that it has failed to fulfil its obligations, that failure is to be examined when considering the substance.
32. So far as concerns, second, the admissibility of the arguments put forward in the reply in order to demonstrate that the domestic law in force did not comply with certain provisions of the Directive, it is to be remembered that it was only in its defence that the Italian Government pleaded that the domestic law in force complied with the Directive.
33. In these circumstances, the Commission cannot be reproached for having responded to those arguments for the first time in its reply; the Commission is entitled, as the Court has held, to clarify the form of order sought in order to take into account information furnished by a Member State in its defence (Case C‑243/89 Commission  v Denmark  [1993] ECR I-3353, paragraph 20). Also, Article 42(2) of the Rules of Procedure expressly provides that a party is entitled to introduce a new plea in law in the course of proceedings in order to take account of matters of law or fact which come to light in the course of the procedure.
34. Consequently, the Italian Government cannot complain that the Commission put forward in its reply arguments which did not appear in its application.
35. It is, however, to be remembered that, in accordance with settled case-law, the subject-matter of an action under Article 226 EC for failure to fulfil obligations is also delimited by the pre-litigation procedure provided for by that provision, so that the application must be based on the same grounds and pleas as the reasoned opinion (see, inter alia, Case C-96/95 Commission  v Germany  [1997] ECR I-1653, paragraph 23, Case C-439/99 Commission  v Italy  [2002] ECR I-305, paragraph 11, and Case C-287/00 Commission  v Germany  [2002] ECR I-5811, paragraph 18).
36. According to the case-law, the purpose of the pre-litigation procedure is to give the State concerned the opportunity, on the one hand, to comply with its obligations under Community law and, on the other, to avail itself of its right to defend itself against the complaints formulated by the Commission (see Case C‑392/96 Commission  v Ireland  [1999] ECR I-5901, paragraph 51, Commission  v Italy , cited above, paragraph 10, and Case C-117/02 Commission  v Portugal  [2004] ECR I‑5517, paragraph 53).
37. The proper conduct of that procedure constitutes an essential guarantee required by the Treaty not only in order to protect the rights of the Member State concerned, but also so as to ensure that any contentious procedure will have a clearly defined dispute as its subject-matter (see Case C-1/00 Commission  v France  [2001] ECR I-9989, paragraph 53, and Case C-287/00 Commission  v Germany , cited above, paragraph 17).
38. In the present case, it is clear that, as the Italian Government submits, in complaining in the course of the pre-litigation procedure that the Italian Republic had not adopted the provisions necessary to comply with the Directive, the Commission was essentially alleging that the Italian Republic had not transposed the Directive at all. On the other hand, in the arguments put forward in its reply regarding the domestic law in force, the Commission submits that the Italian Republic has not transposed certain provisions of the Directive, thereby requiring the domestic law in force to be examined in detail in order to ascertain which of those provisions have not in fact been transposed correctly or completely.
39. However, the requirement that the subject-matter of an action brought under Article 226 EC be circumscribed by the pre-litigation procedure provided for by that provision cannot be stretched so far as to mean that in every case the statement of complaints set out in the letter of formal notice, the operative part of the reasoned opinion and the form of order sought by the action must be exactly the same, provided that the subject-matter of the proceedings has not been extended or altered (see, to this effect, Case C-279/94 Commission  v Italy  [1997] ECR I-4743, paragraph 25, and Case C-139/00 Commission  v Spain  [2002] ECR I-6407, paragraph 19).
40. That is the case where, as here, the Commission, after alleging that a Member State has failed to transpose a directive at all, specifies in its reply that the transposition pleaded for the first time by the Member State concerned in its defence is in any event incorrect or incomplete so far as certain provisions of the directive are concerned. Such a complaint is necessarily included in the complaint alleging a complete failure to transpose and is subsidiary to that complaint (see, to this effect, Commission  v Portugal , cited above, paragraph 55).
41. It should be noted that in this instance the pre-litigation procedure attained its objective of protecting the rights of the Member State in question. The Italian Republic had the opportunity to comply with its obligations under the Directive since, as its response to the reasoned opinion and its subsequent letter of 10 July 2003 attest, it informed the Commission of the point reached in the procedure for adoption of the legislation envisaged for that purpose. In addition, the Italian Republic had the opportunity, in the course of this procedural phase, to show that its domestic law in force complied with the requirements laid down by the Directive, even if it considered it unnecessary to avail itself of that opportunity in this instance (see, in this regard, Case 274/83 Commission  v Italy  [1985] ECR 1077, paragraph 20).
42. Consequently, the Italian Government cannot complain that the Commission has extended or altered the subject-matter of the action as defined by the pre-litigation procedure.
46. It is to be noted first of all that, as is common ground, the Italian Government, contrary to its obligation under Article 10 EC and Article 15 of the Directive, did not inform the Commission, whether during the period for transposition or during the pre-litigation procedure, of the domestic legal measures by means of which it considered that it had transposed the Directive. For the reasons set out in paragraph 30 of this judgment, it is irrelevant in this regard that the transposition pleaded did not have to be carried out because the domestic law in force complied with the Directive.
47. However, since the present action concerns not a failure to fulfil the obligation to provide information but a failure to fulfil the obligation to bring into force the laws, regulations and administrative provisions necessary to comply with the Directive, the mere fact that the Italian Republic did not inform the Commission that, in its view, the Directive was already transposed by the domestic law in force cannot, contrary to what the Commission appears to suggest, be sufficient to prove the alleged failure to fulfil an obligation.
48. In so far as the domestic legal provisions pleaded by the Italian Government were in force when the period set in the reasoned opinion expired, the Court must take them into account when determining whether that obligation has not been fulfilled (see, to this effect, Case C-152/98 Commission  v Netherlands  [2001] ECR I‑3463, paragraph 21).
50. It should be remembered that, according to settled case-law, each of the Member States to which a directive is addressed is obliged to adopt, within the framework of its national legal system, all the measures necessary to ensure that the directive is fully effective, in accordance with the objective that it pursues (see, inter alia, Case C-478/99 Commission  v Sweden  [2002] ECR I-4147, paragraph 15, and Case C-233/00 Commission  v France  [2003] ECR I-6625, paragraph 75).
51. While it is therefore essential that the legal situation resulting from national implementing measures is sufficiently precise and clear to enable the individuals concerned to know the extent of their rights and obligations, it is none the less the case that, according to the very words of the third paragraph of Article 249 EC, Member States may choose the form and methods for implementing directives which best ensure the result to be achieved by the directives, and that provision shows that the transposition of a directive into national law does not necessarily require legislative action in each Member State. The Court has thus repeatedly held that it is not always necessary formally to enact the requirements of a directive in a specific express legal provision, since the general legal context may be sufficient for implementation of a directive, depending on its content. In particular, the existence of general principles of constitutional or administrative law may render superfluous transposition by specific legislative or regulatory measures provided, however, that those principles actually ensure the full application of the directive by the national authorities and that, where the relevant provision of the directive seeks to create rights for individuals, the legal situation arising from those principles is sufficiently precise and clear and that the persons concerned are put in a position to know the full extent of their rights and, where appropriate, to be able to rely on them before the national courts (see, inter alia, Case 29/84 Commission  v Germany  [1985] ECR 1661, paragraphs 22 and 23, and Case C-233/00 Commission  v France , cited above, paragraph 76).
52. Consequently, it is important in each individual case to determine the nature of the provision, laid down in a directive, to which the action for failure to fulfil obligations relates, in order to gauge the extent of the obligation to transpose imposed on the Member States (Case C-233/00 Commission  v France , paragraph 77).
58. The Court has already held that, by requiring the Member States to protect biotechnological inventions by means of their national patent law, the Directive aims to prevent damage to the unity of the internal market which might result from the Member States’ deciding unilaterally to grant or refuse such protection (Case C-377/98 Netherlands  v Parliament and Council  [2001] ECR I-7079, paragraph 18). In so doing, the Directive seeks, as is apparent from the fourth, fifth and sixth recitals in its preamble, to clarify the legal prot ection of biotechnological inventions in a context marked by differences between national laws and practices that could well become greater, in particular as a result of national case-law interpreting those laws.
66. As the Court has held in this connection, the elements of the human body are not patentable in themselves and their discovery cannot be the subject of protection. Only inventions which combine a natural element with a technical process enabling it to be isolated or produced for an industrial application can be the subject of an application for a patent ( Netherlands  v Parliament and Council , cited above, paragraph 72).
67. Thus, as is stated in the 20th and 21st recitals in the preamble to the Directive, an element of the human body may be part of a product which is patentable but it may not, in its natural environment, be appropriated ( Netherlands  v Parliament and Council , paragraph 73).
68. That distinction applies to work on the sequence or partial sequence of human genes. The result of such work can give rise to the grant of a patent only if the application is accompanied by both a description of the original method of sequencing which led to the invention and an explanation of the industrial application to which the work is to lead, as required by Article 5(3) of the Directive. In the absence of an application in that form, there would be no invention, but rather the discovery of a DNA sequence, which would not be patentable as such ( Netherlands  v Parliament and Council , paragraph 74).
69. Thus, the protection envisaged by the Directive covers only the result of inventive scientific or technical work, and extends to biological data existing in their natural state in human beings only where necessary for the achievement and exploitation of a particular industrial application ( Netherlands  v Parliament and Council , paragraph 75).
78. Unlike Article 6(1) of the Directive, which allows the administrative authorities and courts of the Member States a wide discretion in applying the exclusion from patentability of inventions whose commercial exploitation would be contrary to ordre public  (public policy) and morality, Article 6(2) allows the Member States no discretion with regard to the unpatentability of the processes and uses which it sets out, since the very purpose of this provision is to give definition to the exclusion laid down in Article 6(1) (see, to this effect, Netherlands  v Parliament and Council , paragraphs 37 to 39). It is apparent from the 40th recital in the preamble to the Directive that processes for cloning human beings must be excluded ‘unequivocally’ from patentability, since there is a consensus on this question within the Community.
79. It follows that, by expressly excluding from patentability the processes and uses to which it refers, Article 6(2) of the Directive seeks to grant specific rights in this regard.
83. As to the provisions of Law No 40/2004, it is common ground that this Law was adopted after the time-limit set in the reasoned opinion. It is settled case-law that in the context of proceedings under Article 226 EC the question whether a Member State has failed to fulfil its obligations must be determined by reference to the situation prevailing in the Member State at the end of the period laid down in the reasoned opinion, and the Court cannot take account of any subsequent changes (see, inter alia, Case C-378/98 Commission  v Belgium  [2001] ECR I‑5107, paragraph 25, and Case C-352/02 Commission  v Greece  [2003] ECR I‑5651, paragraph 8).
102. According to the case-law, in proceedings for failure to fulfil obligations under Article 226 EC it is incumbent upon the Commission to prove the allegation that the obligation has not been fulfilled and in so doing it may not rely on any presumption (see, inter alia, Case 96/81 Commission  v Netherlands , cited above, paragraph 6, Case C-408/97 Commission  v Netherlands , cited above, paragraph 15, and Commission  v Portugal , cited above, paragraph 80).