Aurora Plomer

Challenges to Human Embryonic Stem Cell Patents

The patenting of human embryonic stem (hES) cells has produced one of the most unusual and fraught situations in the history of science, ethics, and law. This Commentary examines legal and moral challenges to three foundational patents held by the Wisconsin Alumni Research Foundation (WARF). We conclude that, in the United States, technical challenges may, paradoxically, produce a stronger patent position for WARF. In the European Union, moral challenges mean confusion for member states. We demonstrate that hES cell intellectual property will be guided and bound by a welter of moral, technical, and legal inputs, with discrete national and jurisdictional dimensions.

The Patentability of Human Embryonic Stem Cells in Europe

Applicants in Europe are left with few options for the patent protection of hES cell–related technology.

After Brüstle: EU accession to the ECHR and the future of European patent law

The aim of the Directive on Biotechnological Inventions 1998 1 was to harmonize national patent laws in order to bolster Europes competitiveness in fields involving biotechnological applications. From the beginning, the Directive was met with a barrage of opposition from politicians, political lobbies, religious organizations and academics who called for the need to ensure that ethical principles would not be sacrificed on the altar of commerce and market forces. 2 Human rights were specifically invoked to justify the importation of moral exclusions into the Directive. 3 Yet, little thought was given at the time to the implications and the potential tensions created by the lack of integration between the European Union (EU) and the Council of Europe (CoE) legal orders and courts. This paper analyses and evaluates how the historical tensions are manifested in the paradoxical judgment of the Grand Chamber of the European Court of Justice (CJEU) in the Brustle case. 4 It is suggested that the CJEU ruling represents a disproportionate interference with the autonomy of Member States and is inconsistent with the degree of autonomy vested in Member States by the European Convention legal order. More generally, the paper uses the Brustle case as a lens through which to analyse and evaluate the potential impact of the current proposal for the EUs accession to the European Convention on Human Rights (ECHR) on the resolution of emerging tensions.

Patents, Human Rights and Access to Science

Contents: 1. Patents, Profits and the Public 2. The Moral Architecture of Human Rights and Rights of Access to Science 3. The Human Rights Paradox: Intellectual Property Rights and Rights of Access to Science 4. From Moral Ideals to Legal Obligations: THE Genesis of Article 15 ICESCR 5. The UNs Official Thinking on Article 15 ICESCR 6. UNESCO : Biotechnology, Bioethics & the Right to Enjoy the Benefits of Scientific Progress 7. Conclusion Index

Stem Cell Research Funding Policies and Dynamic Innovation: A Survey of Open Access and Commercialization Requirements

This article compares and contrasts the pressures of both open access data sharing and commercialization policies in the context of publicly funded embryonic stem cell research (SCR). First, normative guidelines of international SCR organizations were examined. We then examined SCR funding guidelines and the project evaluation criteria of major funding organizations in the EU, the United Kingdom (UK), Spain, Canada and the United States. Our survey of policies revealed subtle pressures to commercialize research that include: increased funding availability for commercialization opportunities, assistance for obtaining intellectual property rights (IPRs) and legislation mandating commercialization. In lieu of open access models, funders are increasingly opting for limited sharing models or “protected commons” models that make the research available to researchers within the same region or those receiving the same funding. Meanwhile, there still is need for funding agencies to clarify and standardize terms such as “non-profit organizations” and “for-profit research,” as more universities are pursuing for-profit or commercial opportunities.

The Right to Access the Benefits of Science and Intellectual Property Rights

The question of whether intellectual property rights are fundamental human rights and what the limits of these rights may be, has acquired global urgency in the wake of the extension of intellectual property rights to foundational fields of knowledge in the life-sciences. An enduring puzzle is the rationale for the juxtaposition of the right of individual inventors with the right of everyone to share in the benefits of science in Article 27 of the Universal Declaration of Human Rights 1948. A commonly held view is that intellectual property rights are rooted in liberal and market oriented ideologies. This paper retraces the drafting history and shows that, in reality, Article 27(2) was opposed by liberal countries and supported by socialist South American countries. The second part seeks to explain the paradox through an analysis of the links between positivist and communitarian philosophies of human rights and Anglo-Saxon economic/utilitarian and continental legal cultures on the nature and purpose of intellectual property rights.

Participation of children in clinical trials: UK, European and international legal perspectives on consent.

The Declaration of Helsinki was, until recently, the leading international code on the conduct of clinical trials on human subjects. The Council of Europes Convention on Human Rights and Biomedicine (1997) and the ICH guidelines for Good Clinical Practice (1996) represent a significant step towards increased harmonization of standards in the conduct of medical experiments on human subjects. But in spite of emerging areas of consensus, there remain important areas of unclarity and divergence. Medical practitioners involved in paediatric research in the UK are concerned about the lack of certainty in the law, particularly on the application of consent rules to emergency research. This paper examines UK, European and International norms on participation of children in medical research and compares the circumstances under which consent rules may be waived under each normative regime.

Patents, Profits and the Public

Litigation on the patentability of isolated genes and cells in the Myriad, WARF and Brustle cases has resulted in landmark rulings from the highest courts in the US and Europe. From the patients’ and researchers’ perspective, the concerns center primarily on the adverse impact of the patents on access to science and its benefits, a universal and fundamental human right enshrined in Article 17 of the Universal Declaration of Human Rights (UDHR) and Article 15 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) respectively. The first chapter of the book sets out the context and challenges posed by the modern patent system to the right of everyone to access the benefits of science in international law.

Human Dignity and Patents

In the early 90s, the Open University used to offer a Philosophy course entitled ‘Life and Death’ which paid homage to the rich diversity of moral and religious views on the value of human life. Two decades later metaphysical questions about human dignity, the meaning of life, its beginning and its end, have made their way into patent law and patent tribunals and transnational central courts in Europe. This article argues that this is an unnecessary and unwelcome development to address legitimate public concerns about the adverse impact of patents on access to knowledge and essential medicines. The internalization and transplantation of human dignity & human rights within the formal structure of the patent system carries the risk of cutting across regulatory frameworks on research and the system of constitutional protection of fundamental human rights in democratic societies. The argument falls into four parts. The first part charts the rise of human dignity in international law and European human rights law and the increasing ‘thinning’ of the concept of human dignity into an abstract indeterminate concept in the new wave of bio-rights instruments. The second part draws on recent scholarship on the history of human rights which underscores the political malleability of human rights as a moral utopia. The third part shows how the importation of indeterminate human rights, dignity-based restrictions into European law on biotechnological patents has facilitated the displacement and re-enactment within patent law and the courts of moral and religious disputes which have nothing to do with patents per-se. The last part reviews the EPO’s boards ‘dignity’ based decisions against the US SC ruling in Myriad and makes some suggestions as to how best to address legitimate public concerns about the negative impact of patents.