Regeneron Pharmaceuticals, Inc & Anor v Alvotech HF & Anor [2025] EWHC 3050 (Pat) (24 November 2025)

Regeneron Pharmaceuticals, Inc & Anor v Alvotech HF & Anor [2025] EWHC 3050 (Pat) (24 November 2025)

A notification under Article 5 of the assimilated SPC Regulation is valid if it contains the information required by Article 5(5)(a)-(d), and the export country marketing authorisation number under Article 5(5)(e) must be provided as soon as it is publicly available. The three-month notice period runs from the initial notification, not from the later provision of the MA number. The Defendants' notifications were valid, and the Claimants are not entitled to injunctive relief.

Citation
[2025] EWHC 3050 (Pat)
Parties
Claimant: Regeneron Pharmaceuticals, Inc.; Claimant: Bayer Plc; Defendant: Alvotech Hf; Defendant: Fisher Clinical Services UK Limited
Jurisdiction
England and Wales
Judgment Date
24 November 2025
Procedural Posture
Patent Infringement and SPC Waiver Declaratory Relief / Final Judgment After Expedited Trial
Outcome
Claim dismissed
Legal Topics
Supplementary Protection Certificate (spc), SPC Manufacturing Waiver, Patent Infringement, Legislative Interpretation, Notification Requirements
Intellectual Property Pharmaceutical Law Supplementary Protection Certificate (spc) SPC Manufacturing Waiver Patent Infringement Legislative Interpretation Notification Requirements

Case Brief

Summary, issues, holding and outcome

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Parties

Regeneron Pharmaceuticals, Inc.

Claimant

Bayer Plc

Claimant

Alvotech Hf

Defendant

Fisher Clinical Services UK Limited

Defendant

Procedural Posture

Patent Infringement and SPC Waiver Declaratory Relief / Final Judgment After Expedited Trial

Legal Issues

  1. 1 Whether a valid notification under the SPC manufacturing waiver requires the export country marketing authorisation (MA) number to be included at the time of notification or only when publicly available
  2. 2 Whether the Defendants' notifications complied with Article 5 of the assimilated SPC Regulation
  3. 3 Whether the Claimants are entitled to injunctive relief if the notifications are invalid

Ratio Decidendi

A notification under Article 5 of the assimilated SPC Regulation is valid if it contains the information required by Article 5(5)(a)-(d), and the export country marketing authorisation number under Article 5(5)(e) must be provided as soon as it is publicly available. The three-month notice period runs from the initial notification, not from the later provision of the MA number. The Defendants' notifications were valid, and the Claimants are not entitled to injunctive relief.

Court Disposition

Claim dismissed

Orders

  • No injunction granted against the Defendants
  • Defendants entitled to manufacture under the SPC waiver, subject to compliance with notification updates