Pharmaceutical Innovation, Competition and Patent Law
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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.
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Chapter 5: Clinical data, data exclusivity and private investment protection in Europe

A Trilateral Perspective

Christian R. Fackelmann


In the last two decades, the mean term of effective patent or other exclusive right protection enjoyed by new original drugs in Europe and in the US has been extended by several years. This is due, among other things, to a considerable number of newly introduced, exclusive rights protecting pharmaceutical developments and data (hereinafter called ‘complementary protection instruments’). The present chapter deals with the economically and thus, practically, most important of these rights, the so-called data exclusivity for original pharmaceutical products. The discussion shall approach data exclusivity from three different perspectives. Section 5.2 takes a technical point of view. What is the object of clinical data for which protection is claimed, and how and when is such data generated in the pharmaceutical research process? Section 5.3 then explains, from a legal perspective, the different types of data exclusivity: what are the respective requirements, what is the scope of protection and how can one make strategic use of them? This includes a brief introduction to the various pharmaceutical marketing authorisation procedures on national and European level. Concluding the discussion, section 5.4 analyses and evaluates the economic effects of data exclusivity: is it really a new type of intellectual property right or merely an instrument of private investment protection? ‘All industries are different, but some are more different than others. The pharmaceutical industry fits the latter category.’ So what are the main differences between pharmaceutical and other products, and what are the key features of the development and marketing authorisation of drugs?

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