Hässle AB v Ratiopharm GmbH.
Date: 2003-12-11
26.  According to Article 7 of Regulation No 1768/92, read in conjunction with Article 3(b) and (d) thereof, the application for a certificate must be submitted within six months of the date on which the first authorisation to place the product on the market as a medicinal product is granted in the Member State for which the application is made or, where the marketing authorisation is granted prior to the basic patent, within six months of the date on which the patent is granted.
29.  It was with the intention of limiting such consequences and making it possible for products which had already obtained authorisation to be marketed as medicinal products on the date on which Regulation No 1768/92 entered into force to take advantage of the scheme established by the regulation that the legislature included Article 19, which forms part of the transitional provisions.  Article 19(2) operates, in the circumstances provided for in Article 19(1), as a derogation from Article 7 of the regulation (see, to that effect, Case C-110/95   Yamanouchi Pharmaceutical   [1997] ECR I-3251, paragraph 19).
36.  In that regard, it must also be borne in mind that recourse to Article 100a as a legal basis is possible if the aim is to prevent the emergence of future obstacles to trade resulting from the heterogenous development of national laws provided that the emergence of such obstacles is likely and the measure in question is designed to prevent them (see, among others,  Case C-376/98   Germany   v   Parliament and Council   [2000] ECR I-8419, paragraph 86, and Case C-377/98   Netherlands   v   Parliament and Council   [2001] ECR I-7079, paragraph 15).
37.  In that connection, as the Court found at paragraphs 34 and 35 of its judgment in Case C-350/92   Spain   v   Council   [1995] ECR I-1985, at the time Regulation No 1768/92 was adopted, provisions concerning the creation of a supplementary protection certificate for medicinal products existed in two Member States and were at the draft stage in another State.  That regulation establishes, as a matter of fact, a uniform Community approach by creating a certificate which may be obtained by the holder of a national or European patent under the same conditions in each Member State and by providing, in particular, for a uniform duration of protection.  It thus aims to prevent the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market.
38.  However, although, when Regulation No 1768/92 was adopted, all the Member States wished to protect innovation in the pharmaceutical industry by making it possible, by granting a certificate, to provide sufficient protection for holders of patents, enabling them to cover the investment put into the research (see, in that connection, the third recital of Regulation No 1768/92), a number of them wished to protect for a longer period the pursuit of other legitimate objectives concerning their public-health policies (see, in that regard, the 10th recital of that regulation) and, in particular, ensure the financial stability of their health system by supporting the generic medicinal product manufacturing industry.
39.  It is in order to take account of those different criteria that Article 19 of Regulation No 1768/92 made transitional provision for different relevant dates.
40.  The setting of different relevant dates for different Member States thus appears to be justified insofar as each of those dates reflects the assessment made by each Member State in the light, in particular, of its health system, the organisation and financing of which varies from one Member State to the next.
43.  Secondly, so far as concerns the obligation to state reasons, it should be noted that, whilst the statement of reasons required by Article 190 of the EEC Treaty (after amendment, Article 190 of the EC Treaty, now in turn, Article 253 EC) must show clearly and unequivocally the reasoning of the Community authority which adopted the contested measure so as to enable the persons concerned to ascertain the reasons for it and to enable the Court to exercise its review, it is not required to go into every relevant point of fact and law. The question whether a statement of reasons for a measure satisfies those requirements must be assessed with reference not only to its wording but also to its context and the entire body of legal rules governing the matter in question (see, in particular, Case C-466/93   Atlanta Fruchthandelsgesellschaft and Others (II)   [1995] ECR I-3799, paragraph 16; Case C-122/94   Commission   v   Council   [1996] ECR I-881, paragraph 29; and Case C-183/95   Affish   [1997] ECR I-4315, paragraph 63).
44.  In that regard, the Court has previously held (see, among others, Case C-168/98   Luxembourg   v   Parliament and Council   [2000] ECR I-9131, paragraph 62) that, in the case of a measure of general application, the statement of reasons may be confined to indicating the general situation which led to its adoption, on the one hand, and the general objectives which it is intended to achieve, on the other.
46.  Those legitimate objectives concerning health policies include, in some circumstances, the financial stability of the health system of the Member States.
55.  It is, therefore, necessary to place that expression in its context and to interpret it in relation to the spirit and purpose of the provision in question.
70.  According to settled case-law, the various language versions of a provision of Community law must be uniformly interpreted and, in the case of divergence between those versions, the provision in question must be interpreted by reference to the purpose and general scheme of the rules of which it forms part (Case C-257/00   Givane and Others  [2003] ECR I-345, paragraph 37, and the case-law cited).
73.  At paragraph 24 of   Yamanouchi Pharmaceutical  , the Court held that the effect of Articles 8(1)(a)(iv) and (b), 9(2)(d) and 11(1)(d) of Regulation No 1768/92 is that the first marketing authorisation in the Community is not intended to take the place of the marketing authorisation provided for in Article 3(b) of the abovementioned regulation, that is to say, the authorisation granted by the Member State in which the application is submitted; instead, it constitutes a further condition applying in the event that the latter authorisation is not the first authorisation to place the product on the market as a medicinal product in the Community.
90.  Article 19 of Regulation No 1768/92 cannot be interpreted independently but must be interpreted in conjunction with Article 3 thereof.  However, as the Commission rightly pointed out, infringement of Article 19 is comparable to the case of the certificate being issued contrary to the requirements of Article 3.
91.  That must be the outcome of non-compliance with the relevant date provided for in Article 19(1) of Regulation No 1768/92 even if it is not possible to infer from the wording or the origin of Article 15(1) of the aforementioned regulation that the list of grounds of invalidity of a certificate set out therein is not exhaustive.