Marco Stief - Böcker

This commentary offers the definitive guide to supplementary protection certificates (SPC); a key element in the regulation of the pharmaceutical and medical market within Europe. Beyond providing an overview of the European legislation and the CJEU case-law on SPCs, it also depicts and summarises national law and jurisprudence on leading pharmaceutical markets such as Germany, France and the United Kingdom as well as The Netherlands, Italy and Switzerland. Patent lawyers, those practising in the medical and pharmaceutical field as well as judges and academics will find this an invaluable resource.

The supplementary protection certificate (SPC) prolongs the term of patents for pharmaceutical products for a maximum of five additional years. The SPC's legal bases are two European SPC Regulations and 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. Despite the economic relevance SPCs have obtained in recent years, there exists only limited detailed literature on the subject. German jurisprudence on SPCs is of special importance, as this has often been the basis for decisions of the European Court of Justice (ECJ) and the German market is one of the leading markets for pharmaceuticals and thus for SPCs. This book is addressed to patent attorneys - in particular in-house and external - working for pharmaceutical companies, and attorneys-at-law specialising in patent law, especially in Europe but essentially worldwide.

This handbook focuses on German jurisprudence to identify key principles and trends, thereby providing valuable assistance and arguments in other jurisdictions.Germany is one of the world’s leading jurisdictions for patent litigation. In Europe alone, approximately 60% of patent disputes are heard before courts in Germany. Answers to key questions in patent law and the possible interpretation thereof may be found in case law from German courts. Pharmaceutical, biological and chemical patents are key matters in patent law. The fields present multiple challenges and legal disputes, especially in relation to matters of ‘state of the art’ and the different identifications of a substance and the resulting patents. German courts have given valuable insights to resolving globally significant issues.