Regeneron Pharmaceuticals, Inc. & Anor v Alvotech HF & Anor

Regeneron Pharmaceuticals, Inc. & Anor v Alvotech HF & Anor

A valid SPC export waiver notification does not require the marketing authorisation reference number for the export country to be included at the time of notification. The statutory language and legislative purpose, as reflected in Article 5(5)(e) and Recital 17, permit the notification to be made before the MA is granted, with the obligation to update the notification once the MA number is publicly available. The Claimants' interpretation would undermine the level playing field objective and is not supported by the text or purpose of the Regulation.

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/intellectual Property / Judgment After Expedited Trial
Outcome
Claim dismissed
Legal Topics
Supplementary Protection Certificate (spc), SPC Manufacturing Waiver, Patent Infringement, Biosimilars, Notification Requirements
Intellectual Property Pharmaceutical Law Supplementary Protection Certificate (spc) SPC Manufacturing Waiver Patent Infringement Biosimilars Notification Requirements

Case Brief

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Parties

Regeneron Pharmaceuticals, Inc.

Claimant

Bayer PLC

Claimant

Alvotech HF

Defendant

Fisher Clinical Services UK Limited

Defendant

Procedural Posture

Patent/intellectual Property / Judgment After Expedited Trial

Legal Issues

  1. 1 Whether a valid SPC export waiver notification requires the marketing authorisation (MA) reference number for the export country to be included at the time of notification
  2. 2 Whether the absence of an MA number at the time of notification invalidates the waiver and exposes the manufacturer to infringement
  3. 3 Whether the SPC owner is entitled to injunctive relief if the notification is invalid

Ratio Decidendi

A valid SPC export waiver notification does not require the marketing authorisation reference number for the export country to be included at the time of notification. The statutory language and legislative purpose, as reflected in Article 5(5)(e) and Recital 17, permit the notification to be made before the MA is granted, with the obligation to update the notification once the MA number is publicly available. The Claimants' interpretation would undermine the level playing field objective and is not supported by the text or purpose of the Regulation.

Court Disposition

Claim dismissed

Orders

  • Claimants' claim to an injunction refused