Eli Lilly And Company v Genentech, Inc

Eli Lilly And Company v Genentech, Inc

The law on whether an SPC can be granted to a patent proprietor based on a third party's marketing authorisation without that party’s consent is not clear. The policy arguments and case law support Lilly’s interpretation, but Genentech’s arguments cannot be dismissed. Therefore, a reference to the CJEU is necessary. Additionally, the Patent claims defended by Genentech are invalid, so the SPC application must fail, but the reference is still necessary due to the possibility of appeal and the broader EU context.

Parties
Claimant: ELI LILLY AND COMPANY; Defendant: GENENTECH, INC
Jurisdiction
England and Wales
Judgment Date
01 March 2019
Procedural Posture
Patents/intellectual Property / Judgment After Trial, With Reference to CJEU to Be Made
Outcome
Reference to the CJEU to be made; Patent claims defended by Genentech held invalid; SPC application must fail if that conclusion stands.
Legal Topics
Supplementary Protection Certificates (spc), Patent Validity, Third Party Marketing Authorisation, Interpretation of SPC Regulation, Scope of Patent Protection
Intellectual Property Law Pharmaceutical Law European Union Law Supplementary Protection Certificates (spc) Patent Validity Third Party Marketing Authorisation Interpretation of SPC Regulation Scope of Patent Protection

Case Brief

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Parties

ELI LILLY AND COMPANY

Claimant

GENENTECH, INC

Defendant

Procedural Posture

Patents/intellectual Property / Judgment After Trial, With Reference to CJEU to Be Made

Legal Issues

  1. 1 Whether an SPC can be granted to a patent proprietor based on a third party's marketing authorisation without that party’s consent
  2. 2 Whether ixekizumab is protected by the Patent within the meaning of Article 3(a) of the SPC Regulation
  3. 3 Whether the Patent claims are valid and cover ixekizumab

Ratio Decidendi

The law on whether an SPC can be granted to a patent proprietor based on a third party's marketing authorisation without that party’s consent is not clear. The policy arguments and case law support Lilly’s interpretation, but Genentech’s arguments cannot be dismissed. Therefore, a reference to the CJEU is necessary. Additionally, the Patent claims defended by Genentech are invalid, so the SPC application must fail, but the reference is still necessary due to the possibility of appeal and the broader EU context.

Court Disposition

Reference to the CJEU to be made; Patent claims defended by Genentech held invalid; SPC application must fail if that conclusion stands.

Orders

  • A question will be referred to the CJEU as to whether the SPC Regulation precludes the grant of an SPC to the proprietor of a basic patent in respect of a product which is the subject of a marketing authorisation held by a third party without that party’s consent.
  • Counsel to be heard as to the precise wording of the question.