Advances in medicine and the life sciences — in genetics, artificial intelligence, cell engineering, etc — continually push the boundaries of what is possible, sometimes outpacing existing regulations and ethical guidelines. Striking a balance between promoting innovation and protecting patients and the public is an ongoing challenge.
Examples of LML research in this field can be found below:
Patents
M Aboy, K Liddell, M Jordan, C Crespo, J Liddicoat, ‘European patent protection for medical uses of known products and drug repurposing’ (2022) 40(4) Nature Biotechnology 465.
M Aboy, C Crespo, K Liddell, T Minssen and J Liddicoat, “After six years, what has been Mayo’s impact on patent applications related to biotech, diagnostics, and personalized medicine?” (2019) 37(5) Nature Biotechnology 513.
M Aboy and J Sherkow, “IP and FDA Regulation of De Novo Medical Devices” in I G Cohen (ed.) Innovation & Protection: The Future of Medical Device Regulation (2022).
Regulatory exclusivities
J Liddicoat, K Liddell, J Darrow, M Aboy, M Jordan, C Crespo, T Minssen, ‘Repositioning Generic Drugs: Empirical Findings and Policy Implications’ (2022) 53(9) International Review of Intellectual Property and Competition Law 1287.
J Liddicoat, K Liddell, M Aboy and J Wested, “Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity” (2021) 52(7) International Review of Intellectual Property and Competition Law 825.
V Van de Wiele, J Darrow and A S Kesselheim, “No Parking Here: A Review of Generic Drug 180-Day Exclusivity and Recent Reform Proposals” (2021) 20(1) Yale Journal of Health Policy, Law, and Ethics 1.