Late last year the Court of Justice of the European Union introduced a ban on the patenting of stem cells when their production involves the destruction of human embryos. In the United States, the patentability of human genes is again under legal review by Federal Courts, after challenges from patient advocacy groups critical of the privatization of basic research and diagnostic tools. In the meantime, we are witnessing a proliferation of ‘open innovation’ arrangements that circumvent traditional intellectual property barriers in order to enable corporate and nonprofit actors to collaborate in drug discovery and development. These are just some indicators of significant changes in how we allocate and manage property rights in the life sciences.
BioProperty investigates this changing landscape and its impact on the organization of medical research.
Disputes over what is patentable, and who should have control over the tools and products of research, are a perennial feature of the governance of science, but some trends suggest long-term changes in the intellectual property regimes of the biosciences. First, there is a growing consensus that the current intellectual property regime fails to incentivise medical innovation in the way it is expected to do, and does not direct resources to the areas most in need of research. The crisis of productivity in pharmaceutical R&D is behind the plethora of public-private partnerships and academic-corporate collaborations that have emerged over the last decade. These hybrid organizational models require novel combinations of proprietary and shared resources.
Second, technologies like pluripotent human stem cells or human-animal chimeras are pressing more urgently the question of the appropriability of human beings and human materials (the ability of the innovator to capture profits generated by such innovation). This is leading to greater public scrutiny of the patent system, including the appearance on the scene of new social movements aiming to influence the allocation and distribution of property rights in the biosciences. Intellectual property is no longer a technical domain to be determined by experts. The rules of the game are changing because new stakeholders – from patient groups to global philanthropic foundations – are becoming increasingly proactive in shaping the structures of ownership in the life sciences.
The BioProperty project brings together expertise in the social sciences, law and policy to study the impact of these trends. Our work focuses on three areas of the contemporary life sciences: the production and use of human stem cells, the circulation of genetically modified animals, and new partnerships for R&D on neglected tropical diseases. In these three areas we study the role of intellectual property rights, and of informal mechanisms of appropriation and exchange.
We are particularly interested in new models of ‘open innovation’ used to intensify collaboration between public and private actors in global health research. Product development partnerships, patent pools, ‘open laboratories’, changes in the definition of the pre-competitive space, new licensing mechanisms; these are all being used to pool resources and speed up the development of new therapies against diseases that account for a large share of the global disease burden but do not offer profitable targets for corporate investment.
These models introduce new and complex combinations of exclusion and sharing. Proprietary assets are used to trigger new forms of collaboration, rather than to keep competitors out; in some cases, patenting is excluded in pre-competitive phases of the research process, or free access to technical infrastructures is granted to investigators working on specific diseases; in others, drugs are sold on a royalty-free basis in less-developed countries, or representatives of those countries are more actively involved in the design of research agendas.
The jury is still out on the ability of these arrangements to speed up the development of new therapies or facilitate access to the medical products. We have little nuanced evidence of how these collaborative models operate in practice, and insufficient comparative insight into the factors that might influence their success. A key objective of BioProperty is to understand better, sometimes through ethnographic research, how the diverse actors that come together in these ventures understand the purpose of their cooperation, and what are the variables that constrain an effective exchange of knowledge and technologies. Ultimately, we hope to contribute to the public debate on the future of property rights in the life sciences, by making visible some of the elusive connections between intellectual property, scientific productivity, and a fair distribution of biomedical resources.
Blog author, Javier Lezaun, is James Martin Lecturer in Science and Technology Governance at the Institute for Science, Innovation and Society. He is currently directing BioProperty, a research programme on the future of property rights in the biosciences funded by the European Research Council
Find out more about the BioProperty programme