Neurim Pharmaceuticals (1991) Ltd & Anor v Generics (UK) Ltd & Anor [2022] EWCA Civ 699 (27 May 2022)

Neurim Pharmaceuticals (1991) Ltd & Anor v Generics (UK) Ltd & Anor [2022] EWCA Civ 699 (27 May 2022)

The Court held that the skilled person would read the patent as a whole and assume the trials were competently conducted to assess the effect of melatonin on non-restorative sleep. The plausibility requirement was met because the skilled person would understand the data as relevant to NRS, either due to the likely use of the full LSEQ or appropriate instructions, and there was no evidence to the contrary. The judge was entitled to reject the contrary expert evidence and to prefer the evidence supporting plausibility. The appeal was dismissed.

Citation
[2022] EWCA Civ 699
Parties
Claimant/respondent: Neurim Pharmaceuticals (1991) Limited; Claimant/respondent: Flynn Pharma Limited; Defendant/appellant: Generics (UK) Limited; Defendant/appellant: Viatris UK Healthcare Limited
Jurisdiction
England and Wales
Judgment Date
27 May 2022
Procedural Posture
Patent Appeal / Appeal From High Court (patents Court) to Court of Appeal
Outcome
Appeal dismissed
Legal Topics
Patent Validity, Sufficiency, Plausibility, Second Medical Use Patents
Intellectual Property Law Patent Validity Sufficiency Plausibility Second Medical Use Patents

Case Brief

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Parties

Neurim Pharmaceuticals (1991) Limited

Claimant/respondent

Flynn Pharma Limited

Claimant/respondent

Generics (UK) Limited

Defendant/appellant

Viatris UK Healthcare Limited

Defendant/appellant

Procedural Posture

Patent Appeal / Appeal From High Court (patents Court) to Court of Appeal

Legal Issues

  1. 1 Whether European Patent (UK) No. 3 103 443 (EP443) is invalid for insufficiency due to lack of plausibility
  2. 2 Whether the patent plausibly discloses the claimed therapeutic effect for the treatment of primary insomnia characterised by non-restorative sleep

Ratio Decidendi

The Court held that the skilled person would read the patent as a whole and assume the trials were competently conducted to assess the effect of melatonin on non-restorative sleep. The plausibility requirement was met because the skilled person would understand the data as relevant to NRS, either due to the likely use of the full LSEQ or appropriate instructions, and there was no evidence to the contrary. The judge was entitled to reject the contrary expert evidence and to prefer the evidence supporting plausibility. The appeal was dismissed.

Court Disposition

Appeal dismissed

Orders

  • Appeal dismissed; High Court order upheld