Neurim v Mylan [2022] EWCA Civ 699
In these proceedings the Claimants allege infringement by Mylan of European Patent (UK) No. 3 103 443 (“EP443”). EP443 is a second medical use patent which (as unconditionally proposed to be amended) claims the use of a prolonged release formulation of melatonin in a 2 mg dose for improving the restorative quality of sleep in a patient aged 55 years or older suffering from primary insomnia characterised by non-restorative sleep (“NRS”).
In previous proceedings brought by the Claimants against Mylan for infringement of EP702, Marcus Smith J dismissed a number of challenges to the validity of EP702 advanced by Mylan for the reasons given in his judgment dated 4 December 2020, [2020] EWHC 3270 (Pat). Shortly afterwards, however, EP702 was revoked as a result of Neurim’s withdrawal of an appeal against an order for revocation by the Opposition Division of the European Patent Office at the conclusion of a hearing before the Board of Appeal. EP443 is a divisional of European Patent (UK) No. 1 441 702. Marcus Smith J rejected Mylan’s challenge to the validity of EP443 for the reasons given in the December Judgment as supplemented in a judgment dated 8 March 2022, [2022] EWHC 519 (Pat).
Mylan appealed Marcus Smith J’s decision that EP443 plausibly disclosed the claimed effect notwithstanding Mylan’s “lay patient argument”, namely that the data disclosed in EP443, being patients’ responses to two questions taken from the Leeds Sleep Evaluation Questionnaire, would not be considered by the skilled person to be specific to NRS.
The appeal was heard by Newey, Arnold and Birss LLJ on 19 May 2022 and was dismissed.
Piers Acland QC, Adam Gamsa and Mitchell Beebe appeared for Mylan, instructed by Taylor Wessing LLP