Eli Lilly And Company v Genentech, Inc [2019] EWHC 388 (Pat) (01 March 2019)

Eli Lilly And Company v Genentech, Inc [2019] EWHC 388 (Pat) (01 March 2019)

The court held that ixekizumab falls within the scope of claim 1 of the patent and would be specifically identifiable by the skilled person at the priority date, but not under claim 12, as its therapeutic effect on psoriasis was not plausible or specifically identifiable at the priority date. The law on whether an SPC can be granted based on a third party marketing authorisation is not clear and requires a reference to the CJEU.

Citation
[2019] EWHC 388 (Pat)
Parties
Claimant: Eli Lilly and Company; Defendant: Genentech, Inc
Jurisdiction
England and Wales
Judgment Date
01 March 2019
Procedural Posture
Patent/intellectual Property / First Instance Judgment With Reference to CJEU
Outcome
Reference to the CJEU ordered; all claims of the patent held invalid; declaration sought by Lilly granted subject to CJEU reference.
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

Patent/intellectual Property / First Instance Judgment With Reference to CJEU

Legal Issues

  1. 1 Whether an SPC can be granted based on a third party 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 court held that ixekizumab falls within the scope of claim 1 of the patent and would be specifically identifiable by the skilled person at the priority date, but not under claim 12, as its therapeutic effect on psoriasis was not plausible or specifically identifiable at the priority date. The law on whether an SPC can be granted based on a third party marketing authorisation is not clear and requires a reference to the CJEU.

Court Disposition

Reference to the CJEU ordered; all claims of the patent held invalid; declaration sought by Lilly granted subject to CJEU reference.

Orders

  • A question is to be referred to the CJEU on 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 on the precise wording of the question.