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


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.


Stem cell patents EU US Biotechnology Directive Technical expertise General courts

This entry was posted in Bioethics, Biotechnology, Enhancement, Genetics, Health Law Policy, Human Subjects Research, Intellectual Property, Reproductive Technology, Stem Cells, Timo Minssen and tagged , , , by Timo Minssen. Bookmark the permalink.

About Timo Minssen

Timo Minssen is Professor of Biotechnology Law specializing in legal aspects of biomedical innovation at the University of Copenhagen (UCPH), Centre for Information & Innovation Law (CIIR), Denmark. Before joining UCPH, Timo graduated from law school in Göttingen (Germany) in 2001 and was trained in the German court system from 2002-2003. He also passed the Swedish “juris licentiate” (LL.Lic.) and “juris doctor” exams (LL.D.) and holds two IP- and Biotech- related masters degrees from the Universities of Uppsala and Lund (Sweden). In addition he worked for a Life Science company and for various law firms in Sweden and Germany. From 2007-2009 Timo was a stipendiary at the Max Planck Institute for Intellectual Property and Competition Law in Munich. He was also responsible for a course in comparative patent law at the Chicago-Kent College of Law (USA) and worked for the European Patent Office. At Lund University he is engaged as a teacher at the Faculty of Law and in interdisciplinary epigenetics research at the Pufendorf Institute for Advanced Studies. At UCPH he is co-leading CIIR’s Copenhagen Biotech & Pharma Forum and teaches international classes for both students and pharma professionals in EU-, Competition-, and Pharmaceutical Law and IPR. Timo is a frequent speaker on a variety of topics and has published extensively in comparative US and European patent law, EU- and Competition Law. In 2013-14, he was a Visiting Scholar at Harvard Law School's Petrie-Flom Center and at the University of Oxford. In 2016 he will be Visiting Research Fellow at the University of Cambridge.