Dec 4th, 2020, in Neurim Pharmaceuticals (1991) Ltd & Anor v Generics UK Ltd (t\a MYLAN)  the England and Wales High Court (Patents Court) rejected all the claims of Mylan for the invalidity of the EP1,441,702.
The case has been in headlines, since June 2020 when the UK appeals court refused the grant of an interim injunction to prevent Mylan launching a generic prolonged-release melatonin product. This was a potentially positive development for generic firms and signaled a new approach to generic launches in the UK, giving greater confidence to generic firms to launch at risk.
The EP1,441,702 Patent claims prolonged release pharmaceutical formulations relating to melatonin to improve the restorative quality of sleep in a patient suffering from primary insomnia characterized by non-restorative sleep. Mylan obtained marketing authorization for a generic version of Circadin and obtained the revocation of the patent at European Patent Office's Opposition Division. Neurim appealed the decision and issued quia timet infringement proceedings against Mylan to bring an application for interim injunction. Mylan in turn counterclaimed for revocation of the patent based on lack of novelty, obviousness, and insufficiency. The Court of Appeal refused to grant the interim injunction and ordered an expedited trial which took place in Oct/Nov 2020.
The decision however turned out to be a bit of a damp squib for Mylan as court rejected its contention that the Patent is invalid by reason of insufficiency.