Neurim Pharmaceuticals (1991) Limited & Anor. v Generics (UK) Limited & Anor.

Neurim Pharmaceuticals (1991) Limited & Anor. v Generics (UK) Limited & Anor.

The Court of Appeal held that the patent plausibly disclosed the claimed effect for sufficiency. The skilled person would read the patent as demonstrating that melatonin is effective in enhancing the restorative value of sleep in primary insomnia patients aged 55 or older. The skilled person would presume the trials were competently conducted and that the sleep quality question was administered in a way capable of producing meaningful data specific to NRS. The criticisms raised by Mylan did not undermine the judge's evaluative assessment, and the appeal was dismissed.

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
Civil Appeal / Appeal From High Court (patents Court) to Court of Appeal
Outcome
Appeal dismissed
Legal Topics
Patent Validity, Sufficiency of Disclosure, Plausibility, Second Medical Use Patents, Infringement
Intellectual Property Law Patent Law Patent Validity Sufficiency of Disclosure Plausibility Second Medical Use Patents Infringement

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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

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

Legal Issues

  1. 1 Whether European Patent (UK) No. 3 103 443 (EP443) plausibly discloses the claimed therapeutic effect for sufficiency under patent law
  2. 2 Whether the data in the patent supports the claimed effect specific to non-restorative sleep (NRS) in patients aged 55 or older
  3. 3 Whether the 'lay-patient argument' undermines plausibility

Ratio Decidendi

The Court of Appeal held that the patent plausibly disclosed the claimed effect for sufficiency. The skilled person would read the patent as demonstrating that melatonin is effective in enhancing the restorative value of sleep in primary insomnia patients aged 55 or older. The skilled person would presume the trials were competently conducted and that the sleep quality question was administered in a way capable of producing meaningful data specific to NRS. The criticisms raised by Mylan did not undermine the judge's evaluative assessment, and the appeal was dismissed.

Court Disposition

Appeal dismissed