Actavis & Ors v Eli Lilly And Company

Actavis & Ors v Eli Lilly And Company

Claim 7 of EP(UK) 1,173,181 is valid and infringed; all claims of EP(UK) 1,200,092 are invalid for obviousness, insufficiency, or lack of novelty. The 181 patent claims are inventive due to the unexpected efficacy and reduced side effects at 5mg daily dosing of tadalafil, not obvious from prior art. The 092 patent claims are obvious as micronisation of tadalafil with surfactant is routine and expected to improve bioavailability; claims limited only by pharmacokinetics are insufficient and lack novelty.

Parties
Claimant: Actavis Group PTC ehf; Claimant: Actavis UK Ltd; Claimant: Actelion Pharmaceuticals Ltd; Claimant: Actelion Pharmaceuticals UK Limited; Claimant: Teva UK Limited; Claimant: Teva Pharmaceutical Industries Limited; Claimant: Generics (UK) Limited (trading as Mylan); Defendant: ICOS Corporation; Defendant: Eli Lilly and Company
Jurisdiction
England and Wales
Judgment Date
10 August 2016
Procedural Posture
Patent Revocation and Infringement / Final Judgment
Outcome
Claim 7 of EP(UK) 1,173,181 upheld and infringed; all claims of EP(UK) 1,200,092 revoked.
Legal Topics
Patent Validity, Patent Infringement, Obviousness, Novelty, Added Matter, Priority, Insufficiency
Intellectual Property Pharmaceuticals Patent Validity Patent Infringement Obviousness Novelty Added Matter Priority +1 more

Case Brief

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Parties

Actavis Group PTC ehf

Claimant

Actavis UK Ltd

Claimant

Actelion Pharmaceuticals Ltd

Claimant

Actelion Pharmaceuticals UK Limited

Claimant

Teva UK Limited

Claimant

Teva Pharmaceutical Industries Limited

Claimant

Generics (UK) Limited (trading as Mylan)

Claimant

ICOS Corporation

Defendant

Eli Lilly and Company

Defendant

Procedural Posture

Patent Revocation and Infringement / Final Judgment

Legal Issues

  1. 1 Whether claims of EP(UK) 1,173,181 and EP(UK) 1,200,092 are valid
  2. 2 Whether claims are infringed by generic products
  3. 3 Whether claims are entitled to priority

Ratio Decidendi

Claim 7 of EP(UK) 1,173,181 is valid and infringed; all claims of EP(UK) 1,200,092 are invalid for obviousness, insufficiency, or lack of novelty. The 181 patent claims are inventive due to the unexpected efficacy and reduced side effects at 5mg daily dosing of tadalafil, not obvious from prior art. The 092 patent claims are obvious as micronisation of tadalafil with surfactant is routine and expected to improve bioavailability; claims limited only by pharmacokinetics are insufficient and lack novelty.

Court Disposition

Claim 7 of EP(UK) 1,173,181 upheld and infringed; all claims of EP(UK) 1,200,092 revoked.

Orders

  • Revocation of EP(UK) 1,200,092
  • Declaration of infringement of EP(UK) 1,173,181 by generic 2.5mg and 5mg tadalafil products