Keywords

Summary



Keywords

1. Approximation of laws – Uniform legislation – Industrial and commercial property – Patent law – Supplementary protection certificate for medicinal products – Conditions for granting – Product covered by a basic patent in force

(European Parliament and Council Regulation No 469/2009, Art. 3(a))

2. Approximation of laws – Uniform legislation – Industrial and commercial property – Patent law – Supplementary protection certificate for medicinal products – Conditions for granting – Product covered by a basic patent in force

(European Parliament and Council Regulation No 469/2009, Arts 3(b), (c) and (d), 4 and 5)

Summary

1. Article 3(a) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

(see para. 28, operative part 1)

2. Article 3(b) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application for a supplementary protection certificate contains not only that combination of the two active ingredients but also other active ingredients.

If the holder of such a basic patent relating to an innovative active ingredient or an innovative combination of active ingredients were to be refused a supplementary protection certificate on the ground that, in the commercial version of the medicinal product which places that active ingredient or that combination on the market for the first time, the active ingredient or the combination coexists in the medicinal product alongside other active ingredients or combinations which have other therapeutic purposes and may or may not be protected by another basic patent in force, the fundamental objective of Regulation No 469/2009, which is to ensure sufficient protection to encourage pharmaceutical research and play a decisive role in the continuing improvement in public health, could be undermined.

Moreover, in accordance with Article 5 of Regulation No 469/2009, a supplementary protection certificate thus granted in connection with a product which has obtained authorisation to be placed on the market as a medicinal product confers, upon the expiry of the patent, the same rights as were conferred by the basic patent in relation to the product, within the limits of the protection conferred by the basic patent, as provided for in Article 4 of the regulation. Accordingly, if, during the period in which the patent was valid, the patent holder could oppose, on the basis of his patent, all use or certain uses of his product in the form of a medicinal product consisting of such a product or containing it, the supplementary protection certificate granted in relation to that product would confer on the holder the same rights for all use of the product, as a medicinal product, which was authorised before the expiry of the certificate.

However, in a situation in which, first, a single active ingredient or a combination of active ingredients is protected by a basic patent in force and, second, a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83 on the Community code relating to medicinal products for human use or Directive 2001/82 on the Community code relating to veterinary medicinal products, which is the first marketing authorisation that places the single active ingredient or combination of active ingredients on the market, only the authorisation in respect of the first medicinal product placed on the European Union market comprising, among its active ingredients, the combination of the two active ingredients identified in the wording of the claims of the patent may be regarded as the first marketing authorisation for that ‘product’ as a medicinal product within the meaning of Article 3(d) of Regulation No 469/2009.

Moreover, where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent.

(see paras 34, 39-42, operative part 2)