Stem cell research: how far is it legal, ethical or patentable?

Patents on biotechnological inventions are considered essential to foster innovation and investment. Professor Aurora Plomer has led a groundbreaking interdisciplinary project to clarify the current legal uncertainty in Europe on the scope of application of moral exceptions to patents on human embryonic stem cells under the EU Directive on Biotechnological Inventions.

Stem cell research and embryonic stem cell research in particular, offers the prospect of developing important new therapies for serious and life-threatening diseases. At the same time, human embryonic stem cell research and the commercialisation of this research raise difficult and controversial legal and moral questions.

Ten years ago, the European Union adopted a Directive aimed at harmonising the legal protection of biotechnological inventions amongst Member States. The Directive specifies a list of inventions excluded from patentability on moral grounds. But there is considerable uncertainty about the scope of exclusion of moral prohibitions on patents. In particular, it is unclear whether the clause prohibiting industrial and commercial uses of human embryos extends to human embryonic stem cells and their derivatives.

Clarification on the scope of moral exclusions in European patent law is essential in order to provide a stable environment for researchers and industry alike in this fast growing knowledge economy.

The multi-faceted nature of these questions required the combined efforts of experts from different disciplines who took part in a project coordinated by Professor Plomer and funded under the FP6 programme. The multi-disciplinary team consisted of world-wide experts in the field of ethics, intellectual property law, international private law, stem cell research and industry.

Professor Plomer is the lead author of the report from the project 'Stem Cell Patents: European Patent Law and Ethics'. The report provides a unique comprehensive and detailed legal analysis of the scope of moral exclusions on stem cell patents in Europe and has been cited as an authority by the former president of the EPO in his submission to the forthcoming leading case involving the Wisconsin Alumni Research Foundation, which is awaiting hearing by the Enlarged Board of Appeal. Because of its significance, the report has been published by the European Commission.

Professor Plomer is pursuing further research into the potential systemic legal duplication and conflict between moral controls on research and moral controls on hESC patents through an award from the Welcome Trust: 'Is there a future for patent ethics committees?'.

She is actively engaged with colleagues at the University of Berkeley and Stanford in the emerging challenges facing the patent system in the US, UK and Europe.


For further information, please contact Professor Aurora Plomer at:

tel: 0114 222 6755

email : a.plomer@sheffield.ac.uk