Separating sheep from goats- a European view on the patent eligibility of biomedical diagnostic methods

By Timo Minssen

New publication on the patentability of biomedical diagnostics out:

Abstract: This brief comment complements Dan Burk’s excellent paper ( Dolly and Alice, J Law and the Biosciences (2015), 1–21, doi:10.1093/jlb/lsv042 ) by providing a very brief summary of the European approach regarding patents on medical diagnostic methods. This serves as the basis for a comparative discussion of the current US approach and its’ impact on biomedical innovation. We are concerned that unless the Supreme Court clarifies its two-part test and adopts a more holistic interpretation of the eligibility-test, global standards for medical diagnostic patents will diverge to the detriment of advanced therapies and ultimately patients worldwide. In case that the current US eligibility doctrine prevails without further Supreme Court clarification, we highlight the need for developing a more flexible, well-calibrated system for alternative and complementary forms of drug development incentives. In addition to a better-funded and well-administered prize system (an interesting option for some areas of diagnostics that we did not elaborate upon), our paper highlights the need for an improved and more flexible system for regulatory exclusivities in this sector.

Citation: Separating sheep from goats: a European view on the patent eligibility of biomedical diagnostic methods Timo Minssen; Robert M. Schwartz Journal of Law and the Biosciences 2016; doi: 10.1093/jlb/lsw019

 

 

 

 

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About Timo Minssen

Timo Minssen is Professor of Law specializing in legal aspects of biomedical innovation at the University of Copenhagen (UCPH). He is the Managing Director and Founder of UCPH's new Center for Advanced Studies and Collaborative Research Programme in Biomedical Innovation Law (CeBIL). Previously, Timo had been Professor of Biotechnology Law at UCPH's Centre for Information & Innovation Law (CIIR), Visiting Research Fellow at the Universities of Cambridge and Oxford (UK), Harvard Law School and at the Chicago-Kent College of Law (US), as well as Max Planck stipendiate at the Max Planck Institute for Innovation & Competition in Munich (Germany). Moreover, he was trained in the German Court system (Referendariat) and worked for shorter periods at the European Patent Office (EPO), leading law firms, tech start-ups and and for an interdisciplinary epigenetics project as a fellow of the Swedish Pufendorf Institute for Advanced Studies.. Timo holds a German law degree (Staatsexamen) from Georg-August-University in Göttingen, as well as Swedish biotech & IPR related LL.M., LL.Lic., and LL.D. degrees from Lund University and Uppsala University. His PhD thesis delivered a comprehensive study on the patentability of biopharmaceutical technology in the US & Europe, which received the Swedish King Oscar award. He has also received the Awapatent and Jorcks Foundation Research Prizes and was a finalist of the Swedish Wallenberg Academy Fellows program.