This article is an overview of the transitional provisions of Council Regulation (EEC) No. 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (now Regulation (EC) No. 469/2009). It discusses the rationale and structure of the provisions concerning the initial entry into force of the Regulation, the subsequent enlargement of the EU and the conflict with existing national regimes for extended patent protection. An analysis of the Community legislation is carried out in the light of the national law of the Member States and the case-law of the ECJ.
Patent law Supplementary protection certificates Transitional provisions Pharmaceutical regulatory law