Hospira UK Ltd v Genentech Inc [2015] EWHC 1796 (Pat) (24 June 2015)

Hospira UK Ltd v Genentech Inc [2015] EWHC 1796 (Pat) (24 June 2015)

Baselga 97 did not disclose the results of the relevant Phase III clinical trial and thus did not directly and unambiguously disclose the claimed therapeutic effect (increased time to disease progression) of the combination of trastuzumab and a taxane. Therefore, the claims of the patent are novel. Furthermore, the skilled person would not have found it obvious to expect the claimed clinical benefit based on Baselga 97 and the common general knowledge, given the uncertainties in translating preclinical and early clinical data to Phase III outcomes. The patent is not invalid for lack of novelty or inventive step.

Citation
[2015] EWHC 1796 (Pat)
Parties
Claimant: Hospira UK Limited; Defendant: Genentech Inc
Jurisdiction
England and Wales
Judgment Date
24 June 2015
Procedural Posture
Patent Revocation Action / First Instance Judgment
Outcome
Claim for revocation dismissed; patent upheld.
Legal Topics
Patent Validity, Novelty, Inventive Step (obviousness), Swiss Form Claims, Purpose Limited Product Claims, Therapeutic Effect, Clinical Trial Disclosure
Intellectual Property Patents Patent Validity Novelty Inventive Step (obviousness) Swiss Form Claims Purpose Limited Product Claims Therapeutic Effect +1 more

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Parties

Hospira UK Limited

Claimant

Genentech Inc

Defendant

Procedural Posture

Patent Revocation Action / First Instance Judgment

Legal Issues

  1. 1 Whether the claims of European Patent (UK) No. 1 037 926 lack novelty over Baselga 97
  2. 2 Whether the claims lack inventive step (are obvious) over Baselga 97

Ratio Decidendi

Baselga 97 did not disclose the results of the relevant Phase III clinical trial and thus did not directly and unambiguously disclose the claimed therapeutic effect (increased time to disease progression) of the combination of trastuzumab and a taxane. Therefore, the claims of the patent are novel. Furthermore, the skilled person would not have found it obvious to expect the claimed clinical benefit based on Baselga 97 and the common general knowledge, given the uncertainties in translating preclinical and early clinical data to Phase III outcomes. The patent is not invalid for lack of novelty or inventive step.

Court Disposition

Claim for revocation dismissed; patent upheld.

Orders

  • The patent is not revoked.
  • Costs to be determined separately.