Hospira UK Ltd v Genentech Inc [2014] EWHC 3857 (Pat) (21 November 2014)

Hospira UK Ltd v Genentech Inc [2014] EWHC 3857 (Pat) (21 November 2014)

The proposed amendments to the claims of both patents, as originally drafted, would extend the scope of protection contrary to section 76(3)(b) Patents Act 1977 and Article 123(3) EPC, because they would cover formulations with more than one antibody or lyoprotectant not previously covered. However, the fallback amendments replacing 'comprising' with 'consisting of' cure this defect. The claims as amended with 'consisting of' do not extend the scope of protection. On the substantive issues, the claims are not obvious over the common general knowledge or the cited prior art, and the insufficiency attack fails. The amendments with 'consisting of' are allowable.

Citation
[2014] EWHC 3857 (Pat)
Parties
Claimant: Hospira UK Limited; Defendant: Genentech Inc.
Jurisdiction
England and Wales
Judgment Date
21 November 2014
Procedural Posture
Patent Infringement and Validity (amendment and Revocation Proceedings) / High Court Trial Judgment
Outcome
Amendments allowed only with 'consisting of'; otherwise, amendments refused for extension of scope. Claims as amended with 'consisting of' are valid and not obvious or insufficient.
Legal Topics
Patent Amendment, Obviousness, Insufficiency, Extension of Scope, Product by Process Claims, Added Matter, Pharmaceutical Formulations

Case Brief

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Parties

Hospira UK Limited

Claimant

Genentech Inc.

Defendant

Procedural Posture

Patent Infringement and Validity (amendment and Revocation Proceedings) / High Court Trial Judgment

  1. 1 Whether the proposed amended claims of EP (UK) 1 516 628 and EP (UK) 2 275 119 are obvious over the common general knowledge and/or prior art (Carter and Draber)
  2. 2 Whether the claims of 119 are insufficient
  3. 3 Whether the proposed amendments extend the scope of protection

Ratio Decidendi

The proposed amendments to the claims of both patents, as originally drafted, would extend the scope of protection contrary to section 76(3)(b) Patents Act 1977 and Article 123(3) EPC, because they would cover formulations with more than one antibody or lyoprotectant not previously covered. However, the fallback amendments replacing 'comprising' with 'consisting of' cure this defect. The claims as amended with 'consisting of' do not extend the scope of protection. On the substantive issues, the claims are not obvious over the common general knowledge or the cited prior art, and the insufficiency attack fails. The amendments with 'consisting of' are allowable.

Court Disposition

Amendments allowed only with 'consisting of'; otherwise, amendments refused for extension of scope. Claims as amended with 'consisting of' are valid and not obvious or insufficient.

Orders

  • Genentech's amendments to replace 'comprising' with 'consisting of' are allowed.
  • Other proposed amendments refused for extension of scope.