Supplementary Protection Certificates (SPC ): A Handbook

The supplementary protection certificate (SPC) prolongs the term of patents for pharmaceutical products for a maximum of five additional years, ie the certificate becomes effective at a time when the respective pharmaceutical is widely known on the market and thus generates the maximum revenue, which explains the enormous economic value of the SPC. The SPC's legal bases are two European SPC-Regulations. The SPC is based upon European or national patents. SPCs protect some of the most valuable products in the pharmaceutical industry where each day of additional protection may be worth millions of Euros. At the same time, the requirements for obtaining such protection, the scope of protection, etc are highly disputed and have been the subject of numerous decisions of the ECJ. There is only limited detailed literature on SPCs, not reflecting the economic relevance SPCs have obtained in recent years. German jurisprudence on SPCs is of special importance, as this has often been the basis for decisions of the ECJ. Further, the German market is one of the leading markets for pharmaceuticals and thus for SPCs. Consequently, German case law is used to illustrate the comments.