Keywords

Summary



Keywords

1. Actions for failure to fulfil obligations — Proof of the failure — Burden of proof on the Commission — Presumptions — Not permissible — Failure to comply with the obligation, imposed on Member States by a directive, to provide information — Consequences

(Arts 10 EC and 226 EC)

2. Actions for failure to fulfil obligations — Subject-matter of the dispute — Delimited in the course of the pre-litigation procedure — Subsequent narrowing of the subject-matter — Permissible

(Art. 226 EC)

3. Approximation of laws — Legal protection of biotechnological inventions — Directive 98/44 — Patentability of inventions making use of biological material — Patentability of elements isolated from the human body or otherwise produced by means of a technical process — National legislation which does no more than set out the conditions for the patentability of any invention — Not permissible in the absence of case-law affirming the patentability of the said inventions or elements

(European Parliament and Council Directive 98/44, Arts 3(1) and 5(2))

4. Approximation of laws — Legal protection of biotechnological inventions— Directive 98/44 — Unpatentability of certain specific processes, such as the cloning of human beings and uses of human embryos for industrial and commercial purposes — National legislation merely precluding the patentability of inventions contrary to public policy and morality — Not permissible

(European Parliament and Council Directive 98/44, Art. 6(1) and (2))

Summary

1. While, in proceedings under Article 226 EC for failure to fulfil obligations, it is 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. It is indeed for that reason that some directives impose upon the Member States an obligation to provide information.

In the absence of such information, the Commission is not in a position to ascertain whether a Member State has genuinely implemented a 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 therefore of itself justify recourse to the procedure under Article 226 EC. The Member State concerned cannot then complain that the Commission’s application instituting proceedings lacks precision, since the lack of precision results from that State’s conduct.

(see paras 26-27, 29)

2. The subject-matter of an action under Article 226 EC for failure to fulfil obligations is 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. That requirement cannot, however, 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.

That is the case where the Commission, after alleging that a Member State has failed to transpose a directive at all, later specifies that the transposition pleaded for the first time by that State at a subsequent stage of the procedure 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 paras 35, 39-40)

3. A Member State fails to fulfil its obligations under Articles 3(1) and 5(2) of Directive 98/44 on the legal protection of biotechnological inventions if it has not provided that, first, inventions making use of biological material and, second, elements isolated from the human body or otherwise produced by means of a technical process are patentable, but has done no more than set out generally the conditions for the patentability of any invention, and also does not cite any judicial decision specifically affirming the patentability of such inventions or elements. In those circumstances it appears that, despite the objective of clarification pursued by Directive 98/44, a state of uncertainty remains as to whether it is possible to obtain protection for biotechnological inventions under the law of the Member State concerned.

(see paras 59-61, 71-73)

4. A Member State fails to fulfil its obligations under Article 6(2) of Directive 98/44 on the legal protection of biotechnological inventions if it does not expressly lay down that certain specific processes, such as the cloning of human beings and uses of human embryos for industrial and commercial purposes, are not patentable, but merely precludes in general terms, first, the patentability of inventions whose exploitation would be contrary to public policy and morality and, second, acts of disposition of the human body.

Unlike Article 6(1) of that 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 paras 78, 80)