An assessment of implications of adaptive licensing for pharmaceutical intellectual property and regulatory exclusivity rights in the European Union.
One of the key advantages of adaptive licensing (AL) is to align the licensing of new medicines more closely with patient needs for earlier access to beneficial treatments. From an innovators perspective, "earlier" market access may seem an obvious incentive to gain earlier revenue generation. However, this is offset with an "earlier" start to patent and regulatory protection periods, which, depending on the technology, disease, population, and timing of subsequent asset protection periods, can present a conflict.
Novartis Pharma AG, Basel, Switzerland.
A
A
Meier
Centre for Advancement for Sustainable Medical Innovation (CASMI), Oxford, United Kingdom.
S D
SD
Faulkner
Hoyng ROKH Monegier (HRM), Amsterdam, The Netherlands.
C
C
Schoonderbeek
Hoyng ROKH Monegier (HRM), Amsterdam, The Netherlands.
B
B
Jong
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
J
J
Kung
The Oxford - UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), The University of Oxford, Oxford, United Kingdom.|Department of Paediatrics, University of Oxford, Children's Hospital, John Radcliffe, Oxford, United Kingdom.|Said Business School, University of Oxford, Park End Street, Oxford, United Kingdom.|Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, United Kingdom.|Harvard Stem Cell Institute, Cambridge, Massachusetts, USA.|University of California - San Francisco, Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), San Francisco, California, USA.
D
D
Brindley
Centre for Advancement for Sustainable Medical Innovation (CASMI), Oxford, United Kingdom.
R
R
Barker
D020811:Biomedical Technology / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005062:European Union; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence*; D006301:Health Services Needs and Demand; D006801:Humans; D018973:Intellectual Property; D013997:Time Factors