Two forthcoming publications on (1) European Stem Cell Patenting, and (2) IP issues in Biobanking

On 18th December 2014, the CJEU rendered its’ much-anticipated decision in C‑364/13 International Stem Cell Corporation v Comptroller General of Patents (ISCC). Qualifying its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilised human ova stimulated by parthenogenesis, the Court held that in order to constitute 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 would allow patents on innovative parthenotes which had not been genetically modified to achieve totipotent capabilities. Hence the judgment establishes a crucial limitation of the broad interpretation of “human embryos” in Brüstle, where the CJEU held that parthenotes are covered by the term “human embryo” since they are “capable of commencing the process of development of a human being”. The ISCC decision is to be welcomed since it provides an ethically justifiable leeway for patenting and offers reasonable support to the commercial viability of European cell therapy research. Yet, ISCC’s impact still depends on national implementations and only applies to certain hESC cells. Thus, further clarifications would be helpful concerning other non-totipotent hESCs.

2) Michiel Verlinden Timo Minssen^, and Isabelle Huys, IPRs in biobanking- Risks and opportunities for translational research (accepted and forthcoming in Intellectual Property Quarterly, April/May 2015).

Rapid technological advances, bio-pharmaceutical innovation gaps, and the gradual shift to more “open” and “transparent” innovation models highlight the importance of an effective governance and use of biobanks. This raises important legal questions such as how to deal with intellectual property rights (‘IPRs’) that may arise out of the collection and use of samples and data in biomedical research. Against this background, our paper aims to (1) provide the biobank community with an introduction and a general overview of the most relevant IPRs in biobanking, (2) give IP lawyers a basic understanding of the biobank setting and various forms of biobanks, (3) analyse the risks and opportunities associated with IPRs in biobanking, and (4) investigate proposals for an more effective use of IPRs in translational research and innovation. To achieve these objectives, we first identify and describe in section 1 the types of IPRs that we consider as most relevant in the various phases of a biobank’s ‘life-cycle’. Section 2 specifies challenges in finding an appropriate balance between open and closed collaboration models. Considering these challenges, section 3 analyses and discusses potential strategies and options to stimulate the exchange of human biological samples, data and research results. It also looks into the question of how to address, govern and manage IPRs directed to biobank material and data. This ultimately allows us to draw conclusions in section 4.