This paper addresses the topic of patenting related to the notion of Responsible Research and Innovation (RRI). Focusing on patents in the field of biotechnology, we assess to what extent current patenting practices of the European Patent Organization, and more specifically of its executive body, the European Patent Office (EPO) align with RRI principles. We first argue for including patenting as a relevant topic in the context of RRI and then provide an operationalisation of RRI principles that functions as an (...) analytic tool in the article. We find that the dimensions of RRI currently do not have a strong position in the EPO. Subsequently, we discuss the potential for improving the alignment of the EPO with RRI principles. We conclude the article with some final reflections on the applicability of RRI to the policies and practices of the European Patent Organization. (shrink)

Concerns have been voiced about the ethical implications of patenting practices in the field of biotechnology. Some of these have also been incorporated into regulation, such as the European Commission Directive 98/44 on the legal protection of biotechnological inventions. However, the incorporation of ethically based restrictions into patent legislation has not had the effect of satisfying all concerns. In this article, we will systematically compare the richness of ethical concerns surrounding biotech patenting, with the limited scope of ethical concerns actually (...) addressed in the patent system. As sources of our analyses we will use literature and document studies and a survey with important stakeholders and experts related to Norwegian patenting in the aquacultural biotechnology sector. We will structure the analyses with an ethical matrix, developed for this purpose. Showing the misalignment of the discussions within and outside the patent system, we suggest that an important reason for the ethical controversy still surrounding patenting is that ethical questions keep being framed in a narrow way within the system. Until a richer set of ethical considerations is addressed head-on within the patent system, the patent system will continue to evoke academic and interest group criticism, potentially contributing to a legitimacy crisis of the whole system. (shrink)

This essay identifies two legal lineages underlying the common heritage concept, and applies each to the human genome. The essay notes some advantages and disadvantages of each approach, and argues that patenting of human genes would be allowable under either approach.

In the opening years of the 21st century, it became fashionable to describe the human genome as belonging to the common heritage of humanity. The United Nations, in its Universal Declaration on the Human Genome and Human Rights, now identifies the human genome as part of the common heritage, as does the international Human Genome Organization and the Council of Europe. The common heritage concept has played a prominent role in arguments against patenting the human genome or portions thereof. This (...) essay considers whether the common heritage designation will advance the political and legal goals of its proponents. (shrink)

The Svalbard Global Seed Vault provides a backup of seed collections from genebanks around the world. It’s unique character has made it iconic in the public imagination as a ‘Noah’s Ark’ for crop plants. Its remote location and strict controls on access have, however, also lent it an air of mystery, swirling with conspiracy theories. In this paper, I first clarify the aims of the Vault, the history of its development and the policies and practices of its current operation. Given (...) concerns around its potential links to the biotechnology industry, I go on to ask whether GM crops are currently stored in the Vault. Presenting several reasons for why GM crops are formally excluded, while indicating the potential for both change and unintentional contamination, I am compelled to question whether GM crops should be excluded. Answering this requires an interrogation of their potential conservation value as modern contributors to crop biodiversity. In exploring this issue, I suggest that there has been surprisingly little discussion of the moral status and conservation value of bio-technological crop plants and indeed, of how we care for all the techno-lifeforms we are currently engaged in co-creating. I suggest that these are becoming important issues as biotechnological techniques and applications begin to rapidly evolve and diversify. Emphasizing the scope for a refreshed interdisciplinary research agenda exploring the interface between biotechnology and biodiversity conservation, I conclude the article by proposing new concepts of synbiodiversity and symbiodiversity to encourage further debate. (shrink)

Developing and applying a framework for understanding the complexities of economic and legal considerations in two recent Supreme Court rulings was the focus of this research. Of especial concern was the protection of intellectual property in the pharmaceutical industry. Two cases from 2013 were selected: FTC v. Activis and Association for Molecular Pathology v. Myriad Genetics, Inc.. Part of the rationale for the selection was the importance of the Supreme Court rulings and the importance of the pharmaceutical sector. A qualitative (...) content analysis of the Court’s reported decision in each case was analyzed. Since ethical considerations may or may not be consistent with efficiency considerations of plaintiffs, defendants, or the courts, both efficiency and ethical arguments were included. Equally important to the understanding of the economic and ethical issues in the two above- mentioned cases was the development of a rationale for including and excluding a variety of ethical theories, ultimately influenced by Markkula Center For Applied Ethics Of Santa Clara University and Schumann :93–111, 2001). The refinement and use of a levels analysis approach portrays societal, organizational, and individual impacts, and allows for deeper understanding of litigated cases, irrespective of the country in which the litigation takes place :385–393, 2004; Foss et al., J Manag Stud 47:455–482, 2010). A rationale for this framework is the societal and organizational impacts on the myriad of stakeholders in the pharmaceutical sector. We suggest that this framework can be applied to other industries and other complex conflicts among stakeholders as well. (shrink)