Hospira (UK) Ltd v

Hospira (UK) Ltd v

The claimed dosing regimen (8 + 6 q3w) for trastuzumab was obvious to the skilled team based on the FDA label and pharmacokinetic evidence; there was sufficient confidence that the regimen would be efficacious, and no inventive step was demonstrated for the specific dose.

Parties
Claimant/respondent: Hospira (UK) Limited; Defendant/appellant: Genentech, Inc.
Jurisdiction
England and Wales
Judgment Date
06 February 2015
Procedural Posture
Civil Appeal / Judgment on Appeal
Outcome
appeal dismissed
Legal Topics
Patent Validity, Obviousness, Pharmacokinetics, Dosing Regimen, Inventive Step
Intellectual Property Patent Validity Obviousness Pharmacokinetics Dosing Regimen Inventive Step

Case Brief

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Parties

Hospira (UK) Limited

Claimant/respondent

Genentech, Inc.

Defendant/appellant

Procedural Posture

Civil Appeal / Judgment on Appeal

Legal Issues

  1. 1 Whether the claimed dosing regimen for trastuzumab (Herceptin) was obvious to a person skilled in the art at the priority date
  2. 2 Whether the evidence supported obviousness for the specific claimed regimen (8 + 6 q3w)
  3. 3 Whether the burden of proof was properly applied

Ratio Decidendi

The claimed dosing regimen (8 + 6 q3w) for trastuzumab was obvious to the skilled team based on the FDA label and pharmacokinetic evidence; there was sufficient confidence that the regimen would be efficacious, and no inventive step was demonstrated for the specific dose.

Court Disposition

appeal dismissed

Orders

  • Appeal dismissed; patent held invalid for obviousness.