Intellectual Property Related Generic Defense Strategies in the European Pharmaceutical Market

Das Buch wertet die Untersuchung des Arzneimittelsektors der Europäischen Kommission aus. Im Mittelpunkt dieser Untersuchung stehen die Praktiken der Pharmaunternehmen, den Wettbewerb durch Generika und die Entwicklung konkurrierender Originalpräparate zu verhindern bzw. zu erschweren. Die interdisziplinäre Arbeit gibt den Entscheidungsträgern der Pharmaindustrie wertvolle Hinweise welche Auswirkungen die Untersuchung hat.

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Munich Intellectual Property Law Center – MIPLC

Herausgegeben von Prof. Dr. Christoph Ann, Prof. Dr. Robert Brauneis, Prof. Dr. Josef Drexl, LL.M. (Berkeley), Prof. Dr. Thomas Möllers und Prof. Dr. Dres. H.c. Joseph Straus

The Munich Intellectual Property Law Center (MIPLC) is a project of four partners from two continents: The Max Planck Institute for Intellectual Property, Competition and Tax Law, the University of Augsburg, the Technische Universität München and the George Washington University Law School, Washington D.C. Apart from an LL.M. program in intellectual property law taught by faculty from all over the world, MIPLC is also devoted to research in all areas of intellectual property, including adjacent areas of economics and science. Together with ist partner organisations worldwide, MIPLC also organizes conferences on topical intellectual property issues. In ist MIPLC Book Series, the best research results of the Center and proceedings of conferences organized by the Center will be published. The series will cover a wide variety of subjects of interest for academic researchers, as well as for practitioners, including policy makers interested in intellectual property and adjacent fields. They will benefit from the output of research performed by researchers from all over the world who study and work at the Center. In der Schriftenreihe des MIPLC werden die besten Forschungsergebnisse und Tagungsberichte von internationalen Wissenschaftlern, die am Center forschen und arbeiten, veröffentlicht. Die Titel werden eine Vielfalt von Themen behandeln, die insbesondere für Wissenschaftler, Praktiker und Entscheidungsträger, die sich mit dem Recht des geistigen Eigentums und angrenzenden Gebieten beschäftigen, von Interesse sein werden.

This book discusses the implications of the 2009 EU Commission’s Pharmaceutical Sector Inquiry on originator’s opportunities to apply Intellectual Property related measures in defending against generic competition. It argues that on the one hand recent developments in EU competition law do indeed impose potential limitations on an originator’s ability to block or delay generic market entry. On the other hand, the book calls for a differentiated assessment of the rather broad allegations made by the sector inquiry. The book thereby presents and thoroughly analyzes six key issues identified by the EU Commission in the inquiry’s final report: Blocking/defensive patenting, patent thickets, patent-related disputes and litigation, follow-on innovation, authorized generic entries and patent settlement agreements as well as interventions into generic marketing authorization. The analysis aims at reducing legal uncertainty by providing a clearer picture of legal boundaries between legitimate and problematic conduct under Arts. 101 and 102 TFEU. The book also puts the sector inquiry’s findings into a forward-looking perspective by highlighting industry trends with the potential to transform traditional originator and generic business models. The author studied economics and law, has gained substantial expertise about strategy development as a consultant to the pharmaceutical industry and currently leads strategic research management at a large life sciences public research organization in Germany.