Pharmaceutical Innovation, Competition and Patent Law

Pharmaceutical Innovation, Competition and Patent Law

A Trilateral Perspective

Edited by Josef Drexl and Nari Lee

Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care.

Chapter 2: Patentability of pharmaceutical innovations: the European perspective

Rainer Moufang

Subjects: law - academic, biotechnology and pharmaceutical law, competition and antitrust law, intellectual property law


The field of pharmaceutical inventions is undoubtedly one of the core areas of patent law. In view of the high economic interests involved, innovating companies intensely struggle for strong and far-reaching industrial property protection and use patents as essential tools in order to generate market exclusivity. Since what is at stake is human health and public welfare, society looks at these attempts with mixed feelings. On the one hand, it is widely agreed that sound legislative policy reasons demand that patent law should pursue its intrinsic goal of promoting innovation in this as in other areas in order to assist the development of new pharmaceutical products. On the other hand, striving for profit maximization may come into conflict with society’s call for providing affordable medicine to patients and with the freedom of medical practitioners in the exercise of their profession. Certainly, patent law does not stand alone in regulating pharmaceutical innovation. Legal systems usually distribute this task to different areas of law. Whereas some of them are conceived to encourage innovation, others – such as competition law and marketing regulations – are aimed at providing the necessary safeguards and controls. Nevertheless, patent law takes its share of the workload and many of its provisions either specifically address certain aspects of pharmaceutical inventions or are of particular importance for them. This contribution aims at analysing the challenges posed by pharmaceutical inventions from the perspective of European patent law. As is well known, this legal framework is a rather complex one, due to its incomplete degree of uniformity and harmonization.

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