Keywords
Summary

Keywords

Approximation of laws – Uniform legislation – Industrial and commercial property – Patent right – Supplementary protection certificate for medicinal products – Transitional measures for Lithuania covering medicinal products which obtained a marketing authorisation in that State

(Council Regulation No 1768/92 as amended by the 2003 Act of Accession, Arts 7 and 19a(e), and Council Regulation No 2309/93)

Summary

Articles 7 and 19a(e) of Regulation No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded, must be interpreted as not allowing the holder of a valid basic patent in respect of a product to apply to the competent Lithuanian authorities, within six months of the date upon which the Republic of Lithuania acceded to the European Union, for the grant of a supplementary protection certificate where an authorisation to place that product on the market as a medicinal product was obtained more than six months before accession under Regulation No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, but the product did not obtain a marketing authorisation in Lithuania.

Under Article 19a(e) of Regulation No 1768/92, a supplementary protection certificate may be granted only in respect of a product for which a first authorisation to place it on the market as a medicinal product has been obtained in Lithuania. This provision does not lay down any derogation concerning products which have been the subject of a Community marketing authorisation. Since the provision is couched in clear and unambiguous terms, it must, in accordance with the rule that transitional provisions are to be interpreted strictly, be construed in a manner which accords with its wording and which reflects the will of the European Union legislature as resulting from the negotiations which led to the 2003 Act of Accession.

It follows that, since Article 19a(e) of Regulation No 1768/92 lays down an exception to the period prescribed in Article 7 of that regulation, within which an application for a supplementary protection certificate is to be lodged, only for the holder of a national marketing authorisation, the holder of a Community marketing authorisation obtained at least six months before 1 May 2004 cannot rely on Article 19a(e) to obtain a supplementary protection certificate in Lithuania.

(see paras 33, 35, 53, operative part)