Keywords

Summary



Keywords

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1. Approximation of laws ° Uniform laws ° Industrial and commercial property ° Patent law ° Creation of a supplementary protection certificate for medicinal products ° Powers of the Community

(EEC Treaty, Arts 36 and 222; Council Regulation No 1768/92)

2. Approximation of laws ° Measures designed to establish the single market ° Creation of a supplementary protection certificate for medicinal products in order to prevent heterogeneous development of national laws likely to hinder the free movement of goods ° Legal basis ° Article 100a of the Treaty

(EEC Treaty, Arts 100, 100a and 235; Council Regulation No 1768/92)

Summary

1. Neither Article 222 nor Article 36 of the Treaty reserves a power to regulate substantive patent law to the national legislature, to the exclusion of any Community action in the matter.

Article 222, which provides that the Treaty does not in any way prejudice the rules in Member States governing the system of property ownership, cannot be interpreted as reserving to the national legislature, in relation to industrial and commercial property, the power to adopt measures which would adversely affect the principle of free movement of goods within the common market as provided for and regulated by the Treaty and as excluding any action by the Community legislature in the matter.

Article 36, which provides that the provisions of Articles 30 to 34 are not to preclude prohibitions or restrictions justified on grounds of the protection of industrial and commercial property, is not designed to reserve certain matters to the exclusive jurisdiction of Member States but permits national laws to derogate from the principle of the free movement of goods to the extent to which such derogation is and continues to be justified for the attainment of the objectives referred to in that article.

It follows that the Community had power to adopt Regulation No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products and extending the duration of the protection conferred by a patent in certain cases.

2. Regulation No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, which, having regard to the period needed to obtain marketing authorization, permits the duration of the protection conferred by the patent to be extended in the case of medicinal products for which such authorization has been granted, was validly adopted on the basis of Article 100a of the Treaty, and did not therefore have to be adopted on the basis of Article 100 or Article 235.

The creation of that certificate, at a time when it appeared that various Member States were in the process of strengthening the protection conferred on medicinal products by patent law, was intended to prevent the heterogeneous development of national laws, 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. It therefore came within the scope of Article 100a.

Falling as it did within the scope of Article 100a, the creation of the certificate, which strikes a balance between the interests of patent holders on the one hand and those of consumers and the generic medicines industry on the other, did not fall within the scope either of Article 100, from which Article 100a is precisely intended to derogate, or of Article 235, which is available as the legal basis for a measure only when no other Treaty provision confers the necessary powers on the institutions to adopt it, which would have been the case only if the point at issue were the creation of a new industrial property right, which the supplementary certificate in question is not.