Novartis AG v Generics (UK) Ltd (t/a Mylan) [2012] EWCA Civ 1623 (12 December 2012)

Novartis AG v Generics (UK) Ltd (t/a Mylan) [2012] EWCA Civ 1623 (12 December 2012)

The invention claimed in the patent and SPC was obvious in light of the Weinstock publications; the skilled team would have selected RA7, resolved it into its enantiomers, and formulated the (-) enantiomer as a pharmaceutical for Alzheimer's disease as a routine and non-inventive step.

Citation
[2012] EWCA Civ 1623
Parties
Appellant/defendant: Novartis AG; Respondent/claimant: Generics (UK) Limited (trading as Mylan)
Jurisdiction
England and Wales
Judgment Date
12 December 2012
Procedural Posture
Appeal / Court of Appeal Judgment
Outcome
Appeal dismissed; revocation of SPC and patent upheld.
Legal Topics
Patent Validity, Obviousness, Supplementary Protection Certificate, Pharmaceutical Patents
Intellectual Property Pharmaceutical Law Patent Validity Obviousness Supplementary Protection Certificate Pharmaceutical Patents

Case Brief

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Parties

Novartis AG

Appellant/defendant

Generics (UK) Limited (trading as Mylan)

Respondent/claimant

Procedural Posture

Appeal / Court of Appeal Judgment

Legal Issues

  1. 1 Whether claims 1 to 9 of UK Patent No. 2,203,040 and SPC/GB98/038 are invalid for lack of inventive step
  2. 2 Whether the invention was obvious in light of prior art (Weinstock publications)
  3. 3 Appropriate legal test for obviousness in pharmaceutical patents

Ratio Decidendi

The invention claimed in the patent and SPC was obvious in light of the Weinstock publications; the skilled team would have selected RA7, resolved it into its enantiomers, and formulated the (-) enantiomer as a pharmaceutical for Alzheimer's disease as a routine and non-inventive step.

Court Disposition

Appeal dismissed; revocation of SPC and patent upheld.

Orders

  • SPC/GB98/038 and UK Patent No. 2,203,040 remain revoked.
  • No interim injunction granted to Novartis.