Synthetic Biology, Innovation and Intellectual Property: Toward a UK Strategy
Innogen hosts workshop on intellectual property rights in synthetic biology research and development.
The legal and institutional dynamics of life science intellectual property (IP) are becoming increasingly complex. Although the US Supreme Courtâ€™s decision in AMP v. Myriad narrowed patentable subject matter, there remain issues about individual and institutional practices associated with life science IP, including access to research exemptions, exclusivity in licensing, and increased commercialisation delays and costs. The legal issues and associated practices are inextricably linked to policies and programmes supporting life science innovation, particularly since open innovation approaches are being promoted to government, universities and the private sector as viable, if not preferable, alternatives to traditional approaches to knowledge and IP management.
Amidst these dynamics the promising field of synthetic biology is emerging, and now finds itself embroiled in the debate about options for open innovation versus traditional IP management. For example, as recently reported in Nature, some biotechnology companies are choosing to not pursue patent rights over its discoveries, instead strategically favouring open access to creative incentives for other synthetic biology firms to design their own custom organisms, as the success of the field depends on the ability to create standardised parts that can be combined in predictable ways. This open-source push reignites discussion about copyrighting engineered DNA sequences, which prevents work from being reproduced without permission, but allows substantial modification by the users â€“ much in the way that computer programmes are protected. Whether DNA sequences or their products could be copyrighted remains unclear, but raises other concerns about the duration of copyright protection.
The changing landscape of life science IP, potential responses from public institutions, and the reaction of the private sector, jointly create difficult conditions for setting an innovation strategy for synthetic biology. If these uncertainties are not carefully managed through a coherent IP strategy, the UKâ€™s potential to be a world leader in synthetic biology innovation will be jeopardised.
On 24 â€“ 25 June 2013, the Innogen Institute, in partnership with the Synthetic Biology Special Interest Group, hosted an invitation-only workshop at the Institute of Physics on intellectual property rights in synthetic biology research and development. The workshop brought together experts in synthetic biology, intellectual property, innovation systems, and public policy to develop a UK specific, but globally contextualised, intellectual property and knowledge management strategy of synthetic biology innovation.
The workshop framed the discussions around â€˜exceptionalism versus optimisationâ€™ and the role of intellectual property in synthetic biology innovation. Three specific recommendations have been made, including: the need for a synthetic biology IP watching function; the need for the identification of synthetic biology value chains; and the need for evaluating potential strategies of blended intellectual property rights.
These recommendations will be explored further in a forthcoming white paper that will form the basis of a panel discussion on synthetic biology IP at the July 2013 Six Academies meeting on synthetic biology.