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

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

The inventive concept of rivastigmine for treatment of Alzheimer's disease was obvious in light of the Weinstock prior art; resolving RA7 into its enantiomers was a routine step for a skilled team, and the chemistry involved was trivial. No unexpected technical effect was demonstrated beyond what would be anticipated from resolution of a chiral compound.

Parties
Claimant: Generics (UK) Limited (trading as Mylan); Defendant: Novartis AG
Jurisdiction
England and Wales
Judgment Date
30 September 2011
Procedural Posture
Patent / Final Judgment
Outcome
claims for invalidity succeed; counterclaim dismissed
Legal Topics
Patent Validity, Supplementary Protection Certificate, Inventive Step, Obviousness
Intellectual Property Pharmaceutical Law Patent Validity Supplementary Protection Certificate Inventive Step Obviousness

Case Brief

Summary, issues, holding and outcome

More case intelligence is available

Unlock the full research layer for this judgment.

Full judgment text Downloadable case file Legal principles 4 Authorities cited 6 Party arguments 2
Sign in to unlock

Parties

Generics (UK) Limited (trading as Mylan)

Claimant

Novartis AG

Defendant

Procedural Posture

Patent / Final Judgment

Legal Issues

  1. 1 Whether UK Patent No 2 203 040 and SPC/GB98/038 are invalid for lack of inventive step
  2. 2 Whether the resolution of RA7 into its enantiomers was obvious to a skilled team
  3. 3 Whether Mylan's threatened marketing of generic rivastigmine would infringe the SPC

Ratio Decidendi

The inventive concept of rivastigmine for treatment of Alzheimer's disease was obvious in light of the Weinstock prior art; resolving RA7 into its enantiomers was a routine step for a skilled team, and the chemistry involved was trivial. No unexpected technical effect was demonstrated beyond what would be anticipated from resolution of a chiral compound.

Court Disposition

claims for invalidity succeed; counterclaim dismissed

Orders

  • UK Patent No 2 203 040 and SPC/GB98/038 declared invalid
  • Counterclaim for infringement dismissed