Answering a challenging question: is the SPC Regulation still fit for purpose in a changed pharmaceutical industry?

Abstract

Building on a technology-centric framework, this book questions whether the system of supplementary protection certificates (SPC) for medicinal products established in Europe in the 1990s is still fit for purpose in light of the current pharmaceutical innovation landscape. After comprehensively setting the stage by describing the legal and economic environment surrounding the pharmaceutical market, the book rapidly dives into in-depth analysis of regulatory texts and case law, establishing itself as a key reference for practitioners, scholars, judges and legislators in life sciences. Traditionally, the pharmaceutical industry was focused on patenting small-molecule medicines. Over the last decades, the industry has pivoted towards biotechnological medicinal innovation and is increasingly securing secondary patents for new indications, formulations, dosages and so forth. The SPC Regulation was built to serve the former model. The book aims to assess whether these technological developments and go-to-market patenting strategies challenge the nearly unchanged SPC system. The main output of the book is a systematic and well-balanced disentanglement of the case law surrounding the SPC Regulation, which lays out the evolution and inconsistency of the decisions of the Court of Justice of the European Union and their application to biotechnological medicinal products and secondary innovation. This technical differentiation benefits greatly from the scientific expertise of the book’s author and her ability to dissect said subject matter with ease and precision. The incorporation of historical materials, opinions by advocate generals, national judgments and summary tables augments the strength of the author’s arguments.