It is now seven years since the Council of the European Communities adopted Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, which entered into force on January 2 1993. This Regulation was intended to compensate the patent proprietor for the fact that, because of the long time taken by state marketing authorization procedures for medicinal products, the period of effective protection under the remaining term of the patent after such authorization has been obtained has been reduced considerably. The supplementary protection certificate (SPC) is a property right in its own right, which is granted separately for each member state of the EEC. It does not lead to a general extension of the term of a patent, and the question of the subject matter and extent of protection conferred by SPCs is consequently of decisive importance. Among specialists, this issue is the subject of highly charged debate, and the practice with regard to granting in the various member states also shows that, in some cases, very different standards are applied, with the consequence that, in the United Kingdom for example, certificates can be granted for active agents in a medicinal product in the form of their bases or salts thereof, whereas in Germany the Federal Patent Court (BPatG) has hitherto taken the line that the subject matter of an SPC can only be for the active agent shown in the marketing authorization. In the opinion of the BPatG, only the courts hearing infringement cases are entitled to determine the extent of protection conferred by an SPC, not the German Patent and Trade Mark Office.
