TY - JOUR
T1 - Promoting "Academic Entrepreneurship" in Europe and the United States
T2 - Creating an Intellectual Property Regime to Facilitate the Efficient Transfer of Knowledge from the Lab to the Patient
AU - Tvarnø, Christina D.
AU - Bagley, Constance E.
PY - 2016
Y1 - 2016
N2 - In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the European Union (“EU”) needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (“PPPPs”), but focuses on the regulatory infrastructure necessary to support the efficient commercialization of publicly funded university medical research in both the European Union and the United States (“U.S.”). Our comparative analysis of the EU and U.S. approaches to translational medicine shows that there are lessons to be shared. The EU can apply the experiences from the U.S. Bayh-Dole Act and PPPPs in the United States, and the United States can emulate certain of the open innovation aspects of the European Innovative Medicines Initiative and the tighter patenting standards imposed by the European Patent Office. Thus, a secondary purpose of this article is suggesting amendments to the U.S. laws governing the patenting and licensing of government-funded technology to prevent undue burdens on the sharing of certain upstream medical discoveries and research tools.
AB - In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the European Union (“EU”) needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (“PPPPs”), but focuses on the regulatory infrastructure necessary to support the efficient commercialization of publicly funded university medical research in both the European Union and the United States (“U.S.”). Our comparative analysis of the EU and U.S. approaches to translational medicine shows that there are lessons to be shared. The EU can apply the experiences from the U.S. Bayh-Dole Act and PPPPs in the United States, and the United States can emulate certain of the open innovation aspects of the European Innovative Medicines Initiative and the tighter patenting standards imposed by the European Patent Office. Thus, a secondary purpose of this article is suggesting amendments to the U.S. laws governing the patenting and licensing of government-funded technology to prevent undue burdens on the sharing of certain upstream medical discoveries and research tools.
M3 - Journal article
SN - 1053-6736
VL - 26
SP - 1
EP - 78
JO - Duke Journal of Comparative and International Law
JF - Duke Journal of Comparative and International Law
IS - 1
ER -