Neurim v Generics UK Limited (t/a Mylan) [2020] EWCA Civ 793
This was an appeal from the decision of Marcus Smith J in [2020] EWHC 1362 (Pat) to refuse to grant an interim injunction to prevent Mylan launching a generic prolonged-release melatonin product.
Neurim Pharmaceuticals (1991) Limited is the registered proprietor of EP(UK) 1,441,702 B1 (the Patent). Flynn Pharma Limited is registered as an exclusive licensee. The Patent claims prolonged release pharmaceutical formulations concerning the active ingredient melatonin to improve the restorative quality of sleep in a patient suffering from primary insomnia characterised by non-restorative sleep. Flynn distributes a pharmaceutical formulation claimed by the Patent under the brand name Circadin. Mylan propose imminently to release a “generic” rival to Circadin.
Marcus Smith J had refused to order the interim injunction, deciding that damages caused by a wrongful failure to grant it would be an adequate remedy for Neurim and Flynn under Stage 2 of the American Cyanamid test. Floyd LJ, delivering the lead judgment, held that the Judge was right to refuse to grant interim injunctive relief at Stage 2. It could not be assumed that a short period of generic competition followed by a final injunction would lead to the collapse of the price of Circadin or cause Neurim to lose a very substantial portion of the UK income forecast until the Patent’s expiry. Floyd LJ rejected the Claimants’ submission that the decision would have grave consequences for the pharmaceutical industry generally, but instead held that the facts of this case were extremely unusual and did not give rise to a principle of general application.
Mark Vanhegan QC and Adam Gamsa appeared for Mylan