First Book Laying Down the Law with Embryonic Stem Cell Patents

(IPRinfo 4/2010)

Amina Agovic
LLD Cand, INNOCENT Graduate School, IPR University Center

Aurora Plomer and Paul Torremans (eds): Embryonic Stem Cell Patents: European Patent Law and Ethics. Oxford University Press, 2010. ISBN 978-0-19-954346-5

Stem cell science is deemed one of the most significant areas in biomedical research today. Yet, remarkable as it is, human embryonic stem cell (hESC) research is embroiled in a saga of legal, patent and ethical controversies.

Aurora Plomer’s and Paul Torremans’ book Embryonic Stem Cell Patents: European Patent Law and Ethics takes an incisive look at key challenges surrounding patentability of hESC technology. Having already written a number of reports and articles on the issue, both Plomer and Torremans are well positioned to spin off this essentially a collection of essays on stem cell innovation and patents.

The book is compiled of fourteen essays by a group of renowned legal, medical and ethical academic experts, editors Plomer and Torremans included. It is divided into four parts with a unifying theme centred around Article 6 of the the EC Directive 98/44/EC on the legal protection of biotechnological inventions (Directive).

Patent exclusion a problematic issue
A strong emphasis is placed on one of the most problematic issues on the subject to date: Article 6(2)(c) excludes patents on uses of human embryos for industrial or commercial purposes.

To the editors, clarification of the legal scope of Article 6 is paramount in order for Europe to take lead in stem cell (SC) research, while at the same time, such would ensure that such research would be conducted in line with clear ethical limits, thereby preserving and maintaining benefit to society.

This publication makes a seamless transition from historical account of Article 6(2)(c) of the Directive to the contemporary havoc of patenting hESCs. The book not only offers a complete overview of the European patent law in relation to hESCs, but it also offers a valuable insight for exploring many issues concerning hESC research.

It considers legal and philosophical accounts of the European Court of Justice (ECJ) and European Patent Office’s (EPO) reasoning in the leading litigated cases, as well as the institutional tensions between national and transnational European research and patent regimes. Its broad coverage of patent law, ethics and philosophy puts it ahead of any other books on the market and even tables possible solutions in dealing with patentability of hESC inventions in Europe.

Part I begins and ends with Gerard Porter’s scrutiny of the historical origins of the Directive followed by the analysis of the Directive’s controversial nature. Significant accent is placed on the drafting history of Article 6(2)(c).

Part II follows with a discourse and overview of issues concerning morality, research and ethics. It provides an outline of divergent policies on hESC research in Europe, ethical obstacles to conducting research on human embryos and a philosophical perspective on moral arguments on commodification and instrumentalisation of the embryo.

In examining philosophical analysis of moral arguments against hESC research and patents in Chapter 4, A M Viens explores three separate moral considerations: commodification, exploitation and objectification. Viens depicts lack of substantive definition of morality and inconsistent judicial precedents as primary obstacles to patenting hESC inventions.

Confusing interpretations on human embryos
The lengthiest section of the book is Part III, titled European Patent Law. It reflects on the arduous implementation of the Directive in national European laws and inconsistent and confusing interpretations of the moral exclusion on human embryos by national and European patent offices.

There, in Chapter 5, Åsa Hellstadius explores the implementation of the Directive into national laws and the transposition of Article 6(2)(c) into domestic legislations. She draws on the inter-relationship between the wording of the exclusion on uses of human embryos in patent law and restrictions on hESC research outside patent law as well as national patenting practices on hESC inventions.

Subsequent three chapters track the landmark ruling in the WARF case from the perspective of the European Patent Convention (EPC) and EU legal orders.

Examining the jurisprudence of the ECJ and ECHR (European Court of Human Rights), Aurora Plomer in Chapter 8 argues that, absent a European consensus on the rights of human embryo, any moral exclusion of hESCs from patentability should be dealt by national laws subject to Article 27.2 of the TRIPs Agreement.

In Chapter 9, Antonina Bakardjieva Engelbrekt takes us through an analysis of the role played by key institutional players such as the EU and the European Patent Organisation in patenting hESCs. She also examines basic rules and principles that define and at the same time impose limits on their jurisdictional practices in general with emphasis on the ECJ and the EPO’s jurisdictions.

Part IV concludes the book with the analysis of wider issues surrounding the matter of patents on hESCs raised in previous chapters. Some of those include the TRIPs Agreement and moral exclusion and possibility of an ethical examination of patents by patent offices.

Thus, for example, Elodie Petit in Chapter 11, ponders over an idea of including an ethics committee into the patent examining procedure and argues for further serious analysis of the idea. For those keen on adventures outside patent law, the final chapter, Chapter 14, takes on competition law and the extent to which that area of law can be used to remedy present imbalances in the patent system.

It is over ten years since the enactment of the Directive. Yet this collection of informative and long awaited original essays is the first of its kind in the field. Although this book is connected by a single thematic thread, it still manages to address a number of diverse topics surrounding patentability of hESCs.

As such, the publication can be read either article by article or from cover to cover, depending on the reader’s interests. Nevertheless, one of the clearest messages is that stem cell technology brings about a huge number of topical issues even if only analysed from the perspective of Article 6(2)(c).

Embryonic Stem Cell Patents: is a stimulating read which provides certain guiding principle for broadening perspectives. It can warmly be recommended to newcomers to the stem cell patent debate as well as to a broad audience of experts, academics in both ethical and legal disciplines, scientists, policy makers and regulators in SC field.