Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Company LLC

Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Company LLC

Claims 1, 3, 4, 6, 13 and 14 of the patent are invalid for insufficiency as the specification does not plausibly disclose efficacy for the full claimed scope. None of the claims are obvious over the cited prior art. Even if claims 1 and 3 were valid, Actavis did not infringe because it was not foreseeable that its product would intentionally be administered for pain, given the steps taken by Actavis and the NHS guidance. Pfizer made actionable threats of infringement proceedings in certain communications to third parties.

Parties
Claimant: Generics (UK) Limited trading as Mylan; Claimant: Actavis Group PTC EHF; Defendant/claimant: Warner-Lambert Company LLC; Defendant: Actavis UK Limited; Defendant: Caduceus Pharma Limited; Part 20 Claimant: Pfizer Limited; Intervener: Secretary of State for Health
Jurisdiction
England and Wales
Judgment Date
10 September 2015
Procedural Posture
Patent Infringement and Revocation / Final Judgment After Trial
Outcome
Claims 1, 3, 4, 6, 13 and 14 of the patent are invalid for insufficiency; no infringement by Actavis; Pfizer liable for certain groundless threats.
Legal Topics
Patent Validity, Patent Infringement, Second Medical Use Patents, Swiss Form Claims, Groundless Threats, Remedies, Regulatory Compliance
Intellectual Property Pharmaceutical Law Patent Validity Patent Infringement Second Medical Use Patents Swiss Form Claims Groundless Threats Remedies +1 more

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Parties

Generics (UK) Limited trading as Mylan

Claimant

Actavis Group PTC EHF

Claimant

Warner-Lambert Company LLC

Defendant/claimant

Actavis UK Limited

Defendant

Caduceus Pharma Limited

Defendant

Pfizer Limited

Part 20 Claimant

Secretary of State for Health

Intervener

Procedural Posture

Patent Infringement and Revocation / Final Judgment After Trial

Legal Issues

  1. 1 Whether claims 1, 3, 4, 6, 13 and 14 of European Patent (UK) No. 0 934 061 are invalid for insufficiency
  2. 2 Whether any claims are obvious over prior art
  3. 3 Whether Actavis infringed claims 1 and 3 under section 60(1)(c) or 60(2) of the Patents Act 1977

Ratio Decidendi

Claims 1, 3, 4, 6, 13 and 14 of the patent are invalid for insufficiency as the specification does not plausibly disclose efficacy for the full claimed scope. None of the claims are obvious over the cited prior art. Even if claims 1 and 3 were valid, Actavis did not infringe because it was not foreseeable that its product would intentionally be administered for pain, given the steps taken by Actavis and the NHS guidance. Pfizer made actionable threats of infringement proceedings in certain communications to third parties.

Court Disposition

Claims 1, 3, 4, 6, 13 and 14 of the patent are invalid for insufficiency; no infringement by Actavis; Pfizer liable for certain groundless threats.

Orders

  • Declaration of invalidity of claims 1, 3, 4, 6, 13 and 14
  • Declaration of non-infringement by Actavis and related parties