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

 

 

 

 

Timo Minssen

Timo Minssen

Timo Minssen is Professor of Law at the University of Copenhagen (UCPH) and the Founder and Managing Director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL). His research concentrates on Intellectual Property-, Competition & Regulatory Law with a special focus on new technologies in the pharma, life science & biotech sectors including biologics and biosimilars. His studies comprise a plethora of legal issues emerging in the lifecycle of biotechnological and medical products and processes - from the regulation of research and incentives for innovation to technology transfer and commercialization.

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