Патенти

1. That the provisions and effect of Article 47 of the Spanish Treaty of Accession to the European Communities will continue to apply to pharmaceutical products 1.1. imported from Spain; or 1.2. first marketed in Spain until (a) 7 October 1995; or (b) 31 December 1995; or (c) 7 October 1996; or (d) 31 December 1996; or (e) the end of the third year after the particular pharmaceutical, protected by a product patent in one or more Member State(s) of the European Union and which was previously unpatentable in Spain, has become patentable in Spain stating which of such dates is applicable with regard to such acts. 2. That the provisions and effect of Article 209 of the Portuguese Treaty of Accession to the European Communities will continue to apply to pharmaceutical products 2.1. imported from Portugal; or 2.2. first marketed in Portugal; until (a) 1 January 1995; or (b) 31 December 1995; or (c) 1 June 1998; or (d) 31 December 1998; or (e) the end of the third year after the particular pharmaceutical, protected by a product patent in one or more Member State(s) of the European Union and which was previously unpatentable in Portugal, has become patentable in Portugal stating which of such dates is applicable with regard to such acts. 3. After the expiration of Article 47 (and/or Article 209, as appropriate), in a case where: 3.1. an undertaking is the proprietor (the "Proprietor") of a patent (the "Patent") in one or more Member States of the European Communities (the "Member State") for a pharmaceutical product (the "Pharmaceutical"); 3.2. the pharmaceutical was first put on the market in a country by the proprietor after that country's accession to the EC but at a time when the pharmaceutical could not be protected by a product patent in that country; 3.3. a third party imports the pharmaceutical from that country into the Member State; 3.4. and the patent legislation in the Member State granted the proprietor of the patent the right to oppose by legal action the importation of the pharmaceutical from that country do the rules set forth in the EC Treaty concerning the free movement of goods prevent the proprietor from availing himself of the right referred to in paragraph 3.4. above, in particular if: (a) the proprietor has and continues to have a legal and/or ethical obligation to market and to continue marketing the pharmaceutical in that country; and/or (b) that country's and/or EC legislation effectively requires that, once the pharmaceutical is put on the market in that country, the proprietor supplies and continues to supply sufficient quantities to satisfy the needs of domestic patients; and/or (c) that country's legislation grants to its authorities, and its authorities exercise, the right to fix the sales price of the pharmaceutical in that country and legislation prohibits the sale of the pharmaceutical at any other price; and/or (d) the price of the pharmaceutical in that country has been fixed by its authorities at a level at which substantial exports of the pharmaceutical from such country to the Member State are anticipated with the result that the economic value of the patent would be significantly eroded and research and development for future pharmaceuticals planned by the proprietor significantly undermined, contrary to the rationale underlying the recent introduction by the EC Council of the Supplementary Protection Certificate?