NAPP Pharmaceutical Holdings Ltd v Dr Reddy's Laboratories (UK) Ltd & Anor

James Abrahams QC and Henry Ward (instructed by Powell Gilbert LLP) for the Claimant Michael Silverleaf QC and Benet Brandreth (instructed by Bird & Bird LLP) for the First Defendant Justin Turner QC and Anna Edwards-Stuart (instructed by Olswang LLP) for the Second Defendant Hearing dates: 7-9 June 2016 ____________________

i) the suitability of the API for transdermal delivery, which depends on its physicochemical properties;

i) the appropriate delivery rate of drug (which depends on both the flux and the appropriate dosing level);

i) flux across the stratum corneum does not tend to be heavily influenced by small changes in the local environment (such as the precise composition of the TDS);

ii) interpatient variability means that plasma levels from very similar formulations are likely to be indistinguishable.