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 9: Strategic patenting by the pharmaceutical industry: towards a concept of abusive practices of protection

Hanns Ullrich

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


Like other sector inquiry reports, the Pharmaceutical Sector Inquiry Final Report is of an ambivalent nature. As an instrument of Community competition policy, it aims at providing information both on the function- ing of the market involved in general and on the possible existence of restrictive practices that prevent the good functioning of the market. As a general policy instrument of the Internal Market, its purpose is to reveal possible friction between the operation of the market and its regulatory framework, or even a possible malfunctioning of the regulatory frame- work. More specifically, the Pharmaceutical Sector Inquiry Report was triggered by concern regarding the falling or an allegedly insufficient level of innovation on an otherwise dynamic market of major economic and political importance. Consequently, the sector inquiry does not address the entire health market, nor even the entire pharmaceutical market, but only two of its sectors which constitute linchpins for innovation, namely firstly the interface between proprietary products and generic products: for instance, that between the protected innovation and its dissemination by the operation of competitive markets; and, secondly, the interaction between the manufacturers of proprietary medicines, the source of innovation activities. Although at first sight, there appears to be little logic in this approach, since invention and innovation precede the dissemination of new tech- nologies, it is indicative of the preoccupations of the authors of the Report. A slowdown in the transition of the new medicines from the protected status of a proprietary medicine to the status of generic products manufactured and distributed in open competition

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