Abstract
Pharmaceutical innovation reveals a degree of cumulativeness. New medical uses of patented large or small molecules may be discovered, including through serendipitous events; new formulations of patented biopharmaceuticals may be developed (i.e. “biobetters” and biosimilars offering innovation in drug delivery); patented compounds may be integrated into fixed-dose combinations providing therapeutic advantages that each of the compounds cannot offer as a mono-product; patented research tools and platform technologies may be necessary to research and develop novel drugs, and the former may or may not be incorporated into these drugs.
There are generally two models of follow-on innovation - independent and centrally managed by the pioneer inventor. This work compares the US and European regimes of non-consensual patent use. It suggests that the US system generally offer greater freedom to operate of independent follow-on innovators. The main limitation of the European system seems to be its fragmented nature, creating a situation where a single unauthorized follow-on activity may be lawful in one jurisdiction but not in another. In both Europe and the US, research tool uses, early-stage R&D, and research aimed at introducing incremental innovation seem more vulnerable to blocking strategies, as compared to late-stage R&D, product commercialization efforts and R&D related to potentially breakthrough and disruptive innovations, provided the latter are not too incipient.
There are generally two models of follow-on innovation - independent and centrally managed by the pioneer inventor. This work compares the US and European regimes of non-consensual patent use. It suggests that the US system generally offer greater freedom to operate of independent follow-on innovators. The main limitation of the European system seems to be its fragmented nature, creating a situation where a single unauthorized follow-on activity may be lawful in one jurisdiction but not in another. In both Europe and the US, research tool uses, early-stage R&D, and research aimed at introducing incremental innovation seem more vulnerable to blocking strategies, as compared to late-stage R&D, product commercialization efforts and R&D related to potentially breakthrough and disruptive innovations, provided the latter are not too incipient.