Synapse - January 2019

This month on Synapse

Clinical trial liability – navigating the legal, regulatory and insurance landscape

Clinical trials can have unforeseen consequences even where protocol and best practice are followed. In this article, first published in the Journal for Clinical Studies, Katie Chandler looks at the risks, liability and insurance issues relating to clinical trials.

AG's Opinion on Abraxis and the limits of Neurim: SPCs for new formulations?

Nick Harrison explains the recent Opinion of the Advocate General on SPCs for new formulations of already authorised drugs.

Licence disputes in the UK Courts

Belinda Lavin reviews a number of licence disputes that have recently come before the UK courts, with issues ranging from royalty payments to exclusivity.

Plausibility of second medical use patents: pregabalin in the Supreme Court

Matthew Royle and Paul England explain the facts and implications of the important Supreme Court Warner-Lambert decision for the role of plausibility in assessing patent insufficiency.

Publication of the ABPI Code of Practice 2019

Georgia Powell looks at what is new in the 2019 ABPI Code of Practice, which updates and amends the previous ABPI Code of Practice 2016 and the PMCPA Constitution and Procedure.