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48 Food & Drug L.J. 571 (1993)
Supplementary Protection Certificates in the European Economic Community

handle is hein.journals/foodlj48 and id is 619 raw text is: Supplementary Protection Certificates in the European Economic Community EDWARD H. MAZER, ESQ.* I. INTRODUCTION On July 2, 1992, the European Parliament enacted supplementary pro- tection certificate (SPG) legislation' which became effective on January 2, 1993 in the European Economic Community (EEC).2 The SPC legisla- tion extends market exclusivity rather than patent term. This will be achieved by denial of marketing approval to generic competitors during the allotted term of market exclusivity. The SPC legislation is noteworthy because it represents the culmination of several years' work to reconcile the interests of the EEC member states and the pharmaceutical industry. In the EEC, national governments fre- quently pay a significant percentage of the cost of the pharmaceuticals used by their citizens. Therefore, some countries, such as Germany, which sought to keep expenditures down were strongly opposed to any SPC leg- islation. Other countries, including Italy and France, felt that in view of the large development costs and lengthy regulatory review times, the pat- ent life remaining after market approval did not permit adequate returns for the research-based pharmaceutical companies. II. PHARMACEUTICAL INDUSTRY RESPONSE The European pharmaceutical industry was able to wage an effective campaign to gain extended protection for pharmaceuticals. They noted that the United States and Japan already had passed patent term exten- sion legislation,' and showed that the effective patent life after marketing approval was getting shorter in Europe. European-based pharmaceutical companies, while very successful, were losing their competitive edge to U.S. and Japanese competitors based on several criteria, including: total sales, percent of total pharmaceutical industry employment, percent of to- * Mr. Mazer is the Group Patent Counsel for Schering Plough Corporation, Madison, New Jersey. A previous version of this article was presented at The Food and Drug Law Institute's semi- nar Regulation of Human Medicinal Products in the European Community, Arlington, Va. (June 10, 1992). 1. 1992 O.J. (L182) 1-5. 2. The EEC is a confederation of 12 countries: Belgium, Denmark, France, Germany, Greece, Holland, Ireland, Italy, Luxembourg, Portugal, Spain, and the United Kingdom. 3. See Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98-417, 98 Stat. 1585 (1984); Law No. 27 of 1987, reprinted in OFFICIAL GAZETTE, May 25, 1987, at 2. These statutes became effective January 1, 1988.

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