Hospira (UK) Ltd v [2015] EWCA Civ 57 (06 February 2015)

Hospira (UK) Ltd v [2015] EWCA Civ 57 (06 February 2015)

The Court held that the claimed dosing regimen (8 mg/kg loading dose followed by 6 mg/kg every three weeks) was obvious to a skilled team at the priority date, based on the FDA label, pharmacokinetic evidence, and the lack of any surprising or unanticipated advantage in the claimed regimen. The evidence supported that the skilled team would have sufficient confidence to try the regimen, and the judge did not err in his approach or findings.

Citation
[2015] EWCA Civ 57
Parties
Claimant/respondent: Hospira (UK) Limited; Defendant/appellant: Genentech, Inc.
Jurisdiction
England and Wales
Judgment Date
06 February 2015
Procedural Posture
Patent Appeal / Court of Appeal Judgment on Appeal From High Court
Outcome
Appeal dismissed
Legal Topics
Obviousness, Inventive Step, Pharmaceutical Patents, Dosing Regimen, Clinical Trials
Intellectual Property Patent Law Obviousness Inventive Step Pharmaceutical Patents Dosing Regimen Clinical Trials

Case Brief

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Parties

Hospira (UK) Limited

Claimant/respondent

Genentech, Inc.

Defendant/appellant

Procedural Posture

Patent Appeal / Court of Appeal Judgment on Appeal From High Court

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 High Court judge erred in finding the patent invalid for obviousness

Ratio Decidendi

The Court held that the claimed dosing regimen (8 mg/kg loading dose followed by 6 mg/kg every three weeks) was obvious to a skilled team at the priority date, based on the FDA label, pharmacokinetic evidence, and the lack of any surprising or unanticipated advantage in the claimed regimen. The evidence supported that the skilled team would have sufficient confidence to try the regimen, and the judge did not err in his approach or findings.

Court Disposition

Appeal dismissed

Orders

  • The appeal by Genentech, Inc. is dismissed.