Stem cell patenting on the other side of the pond

By Timo Minssen

We are pleased to announce a new publication in the International Review of Intellectual Property and Competition Law (IIC). Our paper analyzes new case law in European stem cell patenting and compares these developments with the US situation and International treaties. Further information and an abstract is available below:

Authors: Ana Nordberg & Timo Minssen, University of Copenhagen, Centre for Information and Innovation Law (CIIR)

Title: A “Ray of Hope” for European Stem Cell Patents or “Out of the Smog into the Fog”? An Analysis of Recent European Case Law and How it Compares to the US
Journal: IIC – International Review of Intellectual Property and Competition Law, 47(2), 138-177
DOI: 10.1007/s40319-016-0449-x

ABSTRACT: 

In Case C-364/13, International Stem Cell Corporation (ISCO) v. Comptroller General of Patents (18 December 2014), the Court of Justice of the European Union distinguished its earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to the patent eligibility of non-fertilised human ova stimulated by parthenogenesis. The Court found that in order to be considered a human embryo – and thus to be unpatentable under the EU Biotechnology Directive – the stimulated ovum must have the “inherent capacity to develop into a human being”. This permits the patenting of innovative pluripotent parthenotes and their applications. Yet the ISCO decision also leaves considerable discretion to national courts and the full impact of the decision still depends on national implementations. Moreover, ISCO only applies to very specific human embryonic stem cells (hESCs) and lacks further clarification concerning other non-totipotent hESCs, such as stem cells created through somatic cell nuclear transfer. Considering the significance of Brüstle and ISCO for regenerative medicine and cellular therapy, the persistent legal uncertainty is unfortunate. Irrespective of these flaws, however, ISCO has opened patentability doors that were previously closed and thereby reinvigorated crucial debates. Hence, the principles established in this decision and further European case law might have the “inherent capacity” of developing into a reasonable doctrine on stem cell patenting. Meanwhile, new US case-law developments have rendered the patentability of isolated hESCs rather elusive, making a brief comparison inevitable.

Keywords

Stem cell patents EU US Biotechnology Directive Technical expertise General courts

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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.