Miami heat: Patent law, informed consent and benefit-sharing

This article considers whether the granting of patents in respect of biomedical genetic research should be conditional upon the informed consent of research participants. It focuses upon several case studies. In Moore v the Regents of the University Of California, a patient sued his physician for breach of fiduciary duty and lack of informed consent, because the doctor had obtained a patent on the patient's cell line, without the patient's authorisation. In Greenberg v Miami Children's Hospital, the research participants, the Greenbergs, the National Tay Sachs and Allied Diseases Association, and Dor Yeshorim brought a legal action against the geneticist Reubon Matalon and the Miami Children's Hospital over a patent obtained on a gene related to the Canavan disease and accompany genetic diagnostic test. PXE International entered into a joint venture with Charles Boyd and the University of Hawaii, and obtained a patent together for ‘methods for diagnosing Pseudoxanthoma elasticum’. In light of such case studies, it is contended that there is a need to reform patent law, so as to recognise the bioethical principles of informed consent and benefit-sharing. The 2005 UNESCO Declaration on Bioethics and Human Rights provides a model for future case law and policy-making.

A legal perspective of carbon rights and benefit sharing under REDD+: A conceptual framework and examples from Cambodia and Kenya

This article discusses two key issues in REDD+ design and implementation at the national level – carbon rights, and benefit sharing. Both carbon rights and benefit sharing can be understood as new legal concepts (although they build on existing law), and as legal concepts they offer a framework for addressing related areas of REDD+ policy. Many countries are currently considering how to manage carbon rights and benefit sharing issues, including Cambodia and Kenya. Both of these countries host existing forest carbon projects and are also in the process of designing national REDD+ programmes. This article uses a conceptual framework for carbon rights and benefit sharing derived from legal analysis to consider the cases of both Cambodia and Kenya, and also includes a general discussion of the challenges countries might encounter when considering how to manage carbon rights and benefit sharing in the context of REDD+ implementation.

Marine protected areas and small-scale fisheries in South Africa: promoting governance, participation, equity and benefit sharing

This monograph studies the progress achieved by conservation partners in South Africa on the implementation of the Convention on Biological Diversity (CBD) Programme Element Two components of governance, participation, equity and benefit sharing, from the perspective of small-scale fishing communities. It explores the strategies and mechanisms used by different authorities to create the conditions whereby local communities can benefit from marine protected areas (MPAs), of which South Africa has gazetted 24, highlighting examples of best practice. The monograph will be useful for researchers, scientists, fishworker organizations, environmentalists and anyone interested in the protection of marine biodiversity and the promotion of sustainable fisheries management.

Patents, the Healthcare System and Benefit-Sharing

Lorraine Sheremeta, Research Associate, Health Law Institute, University of Alberta

Innovative approaches For enhancing the flow of funds into the Benefit Sharing Fund of the International Treaty on Plant Genetic Resources for Food and Agriculture: an evaluation of options

This report assesses the implications and revenue-generating potential of options for reform of the International Treaty on Plant Genetic Resources for Food and Agriculture in the context of the structure of the global seed industry and the emerging landscape of plant variety innovation for different crops. The implementation of these options would require modifications of Treaty and provisions of the Standard Material Transfer Agreements to alter the nature of payment obligations related to different categories of products, the payment rates under different options and the coverage of crops in Annex-I to the Treaty.

Harnessing Natural Resources for Development: New Legal Regimes for Localized Benefit Sharing in the Mining Sector

Thesis (Ph.D.)--University of Washington, 2016-06

WIPO and the Reinforcement of the Nagoya Protocol: Towards Effective Implementation of an Access and Benefit Sharing Regime for the Protection of Traditional Knowledge Associated with Genetic Resources

Traditional knowledge associated with genetic resources (TKaGRs) is acknowledged as a valuable resource. Its value draws from economic, social, cultural, and innovative uses. This value places TK at the heart of competing interests as between indigenous peoples who hold it and depend on it for their survival, and profitable industries which seek to exploit it in the global market space. The latter group seek, inter alia, to advance and maintain their global competitiveness by exploiting TKaGRs leads in their research and development activities connected with modern innovation. Biopiracy remains an issue of central concern to the developing world and has emerged in this context as a label for the inequity arising from the misappropriation of TKaGRs located in the South by commercial interests usually located in the North. Significant attention and resources are being channeled at global efforts to design and implement effective protection mechanisms for TKaGRs against the incidence of biopiracy. The emergence and recent entry into force of the Nagoya Protocol offers the latest example of a concluded multilateral effort in this regard. The Nagoya Protocol, adopted on the platform of the Convention on Biological Diversity (CBD), establishes an open-ended international access and benefit sharing (ABS) regime which is comprised of the Protocol as well as several complementary instruments. By focusing on the trans-regime nature of biopiracy, this thesis argues that the intellectual property (IP) system forms a central part of the problem of biopiracy, and so too to the very efforts to implement solutions, including through the Nagoya Protocol. The ongoing related work within the World Intellectual Property Organization (WIPO), aimed at developing an international instrument (or a series of instruments) to address the effective protection of TK, constitutes an essential complementary process to the Nagoya Protocol, and, as such, forms a fundamental element within the Nagoya Protocol’s evolving ABS regime-complex. By adopting a third world approach to international law, this thesis draws central significance from its reconceptualization of biopiracy as a trans-regime concept. By construing the instrument(s) being negotiated within WIPO as forming a central component part of the Nagoya Protocol, this dissertation’s analysis highlights the importance of third world efforts to secure an IP-based reinforcement to the Protocol for the effective eradication of biopiracy.

Towards a relational theory of copyright law

This research provides a systematic and theoretical analysis of the digital challenges to the established exclusive regime of the economic rights enjoyed by authors (and related rightholders) under the law of copyright. Accordingly, this research has developed a relational theory of authorship and a relational approach to copyright, contending that the regulatory emphasis of copyright law should focus on the facilitation of the dynamic relations between the culture, the creators, the future creators, the users and the public, rather than the allocation of resources in a static world. In this networked digital world, the creative works and contents have become increasingly vital for people to engage in creativity and cultural innovation, and for the evolution of the economy. Hence, it is argued that today copyright owners, as content holders, have certain obligations to make their works accessible and available to the public under fair conditions. This research sets forward a number of recommendations for the reform of the current copyright system.

The legal nature of justice in REDD+

Formation of Reduced Emissions from Deforestation and Degradation (REDD+) policy within the international climate regime has raised a number of discussions about ‘justice’. REDD+ aims to provide an incentive for developing countries to preserve or increase the amount of carbon stored in their forested areas. Governance of REDD+ is multi-layered: at the international level, a guiding framework must be determined; at the national level, strong legal frameworks are a pre-requisite to ensure both public and private investor confidence and at the sub-national level, forest-dependent peoples need to agree to participate as stewards of forest carbon project areas. At the international level the overall objective of REDD+ is yet to be determined, with competing mitigation, biological and justice agendas. Existing international law pertaining to the environment (international environmental principles and law, IEL) and human rights (international human rights law, IHRL) should inform the development of international and national REDD+ policy especially in relation to ensuring the environmental integrity of projects and participation and benefit-sharing rights for forest dependent communities. National laws applicable to REDD+ must accommodate the needs of all stakeholders and articulate boundaries which define their interactions, paying particular attention to ensuring that vulnerable groups are protected. This paper i) examines justice theories and IEL and IHRL to inform our understanding of what ‘justice’ means in the context of REDD+, and ii) applies international law to create a reference tool for policy-makers dealing with the complex sub-debates within this emerging climate policy. We achieve this by: 1) Briefly outlining theories of justice (for example – perspectives offered by anthropogenic and ecocentric approaches, and views from ‘green economics’). 2) Commenting on what ‘climate justice’ means in the context of REDD+. 3) Outlining a selection of IEL and IHRL principles and laws to inform our understanding of ‘justice’ in this policy realm (for example – common but differentiated responsibilities, the precautionary principle, sovereignty and prevention drawn from the principles of IEL, the UNFCCC and CBD as relevant conventions of international environmental law; and UNDRIP and the Declaration on the Right to Development as applicable international human rights instruments) 4) Noting how this informs what ‘justice’ is for different REDD+ stakeholders 5) Considering how current law-making (at both the international and national levels) reflects these principles and rules drawn from international law 6) Presenting how international law can inform policy-making by providing a reference tool of applicable international law and how it could be applied to different issues linked to REDD+. As such, this paper will help scholars and policy-makers to understand how international law can assist us to both conceptualise and embody ‘justice’ within frameworks for REDD+ at both the international and national levels.

Opening digital learning to deeper inquiry

This chapter presents an historical narrative on the recent evolution of information and communications technology (ICT) that has been, and is, utilized for purposes of learning. In other words, it presents an account of the development of e-learning supported through the Web and other similar virtual environments. It does not attempt to present a definitive account; as such an exercise is fraught with assumptions, contextual bias, and probable conjecture. The concern here is more with contextualizing the role of inquiry in learning and the evolving digital tools that enable interfaces that promote and support it. In tracking this evolution, both multi-disciplinary and trans-disciplinary research has been pursued. Key historical developments are identified as well as interpretations of the key drivers of e-learning over time and into what might be better described as digital learning. Innovations in the development of digital tools are described as dynamic and emergent, evolving as a consequence of multiple, sometimes hidden drivers of change. But conflating advancements in learning technologies with e-learning seems to be pervasive. As is the push for the “open” agenda – a growing number of initiatives and movements dominated by themes associated with access, intellectual property, public benefit, sharing and technical interoperability. Openness is also explored in this chapter, however, more in terms of what it means when associated with inquiry. By investigating opportunities for the stimulation and support of questioning online – in particular, why-questioning – this chapter is focused on “opening” content – not just for access but for inquiry and deeper learning.

The doomsday vault: Seed banks, food security, and climate change

"It could easily provide the back-drop for a James Bond movie. Deep inside a mountain near the North Pole, down a fortified tunnel, and behind airlocked doors in a vault frozen to -18 degrees Celsius, scientists are squirreling away millions of seed samples. The samples constitute the very foundation of agriculture, the biological diversity needed so the world's major food crops can adapt to the next pest or disease, or to climate change. It's little wonder that the Svalbard Global Seed Vault has captured the public's imagination more than almost any agricultural topic in recent years. Popular press reports about the ‘Doomsday Vault,’ however, typically mask the complexity of the endeavor and, if anything, underestimate its practical utility." Cary Fowler This chapter considers the use of seed banks to address concerns about intellectual property, climate change and food security. It has a number of themes. First of all, it is interested in the use of ‘Big Science’ projects to address pressing global scientific concerns and Millennium Development Goals. Second, it highlights the increasing use of banks as a means of managing both property and intellectual property across a wide range of fields of agriculture and biotechnology. Third, it considers the linkage of intellectual property, access to genetic resources and benefit sharing. There are a variety of positions in this debate. Some see requirements in respect of access to genetic resources and benefit sharing as an inconvenient burden for science and commerce. Others defend access to genetic resources and benefit sharing as meaningful and productive. Those inclined to somewhat more conspiratorial views suggest that access to genetic resources and benefit sharing are a ruse to facilitate biopiracy. This chapter has a number of components. Section I focuses upon the Consultative Group on International Agricultural Research (CGIAR) network – often raised as a model for Climate Innovation Centres. Section II considers the Svalbard Global Seed Vault – the so-called Doomsday Vault. After a consideration of the World Summit on Food Security in 2009, it is concluded in this chapter that any future international agreement on climate change needs to address intellectual property, plant genetic resources and food security.

23andMe Inc.: Patent law and lifestyle genetics

The venture, 23andMe Inc., raises a host of issues in respect of patent law, policy, and practice in respect of lifestyle genetics and personalised medicine. The company observes: ‘We recognize that the availability of personal genetic information raises important issues at the nexus of ethics, law, and public policy’. 23andMe Inc. has tested the boundaries of patent law, with its patent applications, which cut across information technology, medicine, and biotechnology. The company’s research raises fundamental issues about patentability, especially in light of the litigation in Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories Inc. and Association for Molecular Pathology v. United States Patent and Trademark Office and Myriad Genetics Inc. There has been much debate and controversy over 23andMe Inc. filing patent applications – particularly in respect of its granted patent on ‘Polymorphisms associated with Parkinson’s Disease’. The direct-to-consumer marketing of genetic testing by 23andMe Inc. has also raised important questions of bioethics and human rights. It is queried whether the terms of service for 23andMe Inc. provide adequate recognition of the concepts of informed consent and benefit-sharing, especially in light of litigation in this area in the United States. Given the patent thickets surrounding genetic testing, the case study of 23andMe Inc. also highlights questions about patent infringement and patent exceptions. The future reform of patent law, policy, and practice needs to take into account new developments in lifestyle genetics and personalised medicine – as exemplified by 23andMe Inc.

After the gold rush: Patent law and biological inventions

In response to scientific breakthroughs in biotechnology, the development of new technologies, and the demands of a hungry capitalist marketplace, patent law has expanded to accommodate a range of biological inventions. There has been much academic and public debate as to whether gene patents have a positive impact upon research and development, health-care, and the protection of the environment. In a satire of prevailing patenting practices, the English poet and part-time casino waitress, Donna MacLean, sought a patent application - GB0000180.0 - in respect of herself. She explained that she had satisfied the usual patent criteria - in that she was novel, inventive, and useful: It has taken 30 years of hard labor for me to discover and invent myself, and now I wish to protect my invention from unauthorized exploitation, genetic or otherwise. I am new: I have led a private existence and I have not made the invention of myself public. I am not obvious (2000: 18). MacLean said she had many industrial applications. ’For example, my genes can be used in medical research to extremely profitable ends - I therefore wish to have sole control of my own genetic material' (2000: 18). She observed in an interview: ’There's a kind of unpleasant, grasping, greedy atmosphere at the moment around the mapping of the human genome ... I wanted to see if a human being could protect their own genes in law' (Meek, 2000). This special issue of Law in Context charts a new era in the long-standing debate over biological inventions. In the wake of the expansion of patentable subject matter, there has been great strain placed upon patent criteria - such as ’novelty', ’inventive step', and ’utility'. Furthermore, there has been a new focus upon legal doctrines which facilitate access to patented inventions - like the defence of experimental use, the ’Bolar' exception, patent pooling, and compulsory licensing. There has been a concerted effort to renew patent law with an infusion of ethical principles dealing with informed consent and benefit sharing. There has also been a backlash against the commercialisation of biological inventions, and a call by some activists for the abolition of patents on genetic inventions. This collection considers a wide range of biological inventions - ranging from micro-organisms, plants and flowers and transgenic animals to genes, express sequence tags, and research tools, as well as genetic diagnostic tests and pharmaceutical drugs. It is thus an important corrective to much policy work, which has been limited in its purview to merely gene patents and biomedical research. This collection compares and contrasts the various approaches of a number of jurisdictions to the legal problems in respect of biological inventions. In particular, it looks at the complexities of the 1998 European Union Directive on the Legal Protection of Biotechnological Inventions, as well as decisions of member states, such as the Netherlands, and peripheral states, like Iceland. The edition considers US jurisprudence on patent law and policy, as well as recent developments in Canada. It also focuses upon recent developments in Australia - especially in the wake of parallel policy inquiries into gene patents and access to genetic resources.