Will freedom to research and innovate be restricted as the induced pluripotent stem cell field advances toward the clinic, or are concerns premature within a rapidly changing ecosystem?
Intellectual property (IP) rights lie at the core of the commercialization process, serving as a powerful incentive to harness the potential of technologies for therapeutic applications. However, when filed inappropriately—with broad or premature claims, for example—or when mismanaged, patents can obstruct vital precompetitive collaborations, dampen investor interest and threaten clinical translation and patient access. Moreover, uncertainties, including those around the validity of claims or the priority of ownership rights, can depress progress.
Although the total number of stem cell patent filings has declined since 2008, patents for iPSC technologies continue to increase8. Analysis of the blistering pace of scientific progress in this area indicates that the growth is unlikely to abate. Widespread concern has been voiced that the emerging ecosystem is becoming burdened by prohibitive and cumulative licensing fees that could restrict scientists’ freedom to research and patients’ equitable access to resulting medical benefits. Although these concerns may be allayed through innovation and industry growth cycles, the upstream production and downstream differentiation of iPSCs into desired cell lineages for application requires numerous interrelated, complex technologies. This distinguishes cellular patents from the evolution of other highly patented industries such as small-molecule drugs and electronics. No single company currently controls the IP for all techniques, methods and reagents required for the production of iPSCs. A global race is underway to establish the most suitable and efficient methods for each of these component technologies.
Author(s): MacKenna Roberts, Ivan B Wall, Ian Bingham, Dominic Icely, Brock Reeve, Kim Bure, Anna French and David A Brindley
Organization(s): Oxford–University College London Centre for the Advancement of Sustainable Medical Innovation, University of Oxford
Source: Nature Biotechnology