Novartis AG v Generics (UK) Ltd (t/a Mylan)

Novartis AG v Generics (UK) Ltd (t/a Mylan)

The invention was obvious in light of the Weinstock publications; selecting RA7, resolving it into enantiomers, and preparing a pharmaceutical composition with the (-) enantiomer (rivastigmine) were routine steps for the skilled team. There was no inventive step.

Parties
Appellant/defendant: Novartis AG; Respondent/claimant: Generics (UK) Limited (trading as Mylan)
Jurisdiction
England and Wales
Judgment Date
12 December 2012
Procedural Posture
Civil Appeal / Appeal From High Court Judgment Revoking Patent and SPC
Outcome
Appeal dismissed; High Court judgment upheld
Legal Topics
Patent Validity, Obviousness, Supplementary Protection Certificate, Drug Development, Chirality
Intellectual Property Pharmaceutical Law Patent Validity Obviousness Supplementary Protection Certificate Drug Development Chirality

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Parties

Novartis AG

Appellant/defendant

Generics (UK) Limited (trading as Mylan)

Respondent/claimant

Procedural Posture

Civil Appeal / Appeal From High Court Judgment Revoking Patent and SPC

Legal Issues

  1. 1 Whether claims 1-9 of UK Patent No. 2,203,040 and SPC/GB98/038 for rivastigmine are invalid for lack of inventive step
  2. 2 Whether the invention was obvious in light of prior art (Weinstock publications)
  3. 3 Whether resolution of RA7 into enantiomers and use of (-) enantiomer as a medicinal product was obvious

Ratio Decidendi

The invention was obvious in light of the Weinstock publications; selecting RA7, resolving it into enantiomers, and preparing a pharmaceutical composition with the (-) enantiomer (rivastigmine) were routine steps for the skilled team. There was no inventive step.

Court Disposition

Appeal dismissed; High Court judgment upheld

Orders

  • Patent and SPC remain revoked
  • No error of law or principle found in High Court judgment