Belgian Courts Solidify SPC Manufacturing Waiver Protocols Following Regeneron Legal Defeat Against Alvotech

Regeneron’s injunction against Alvotech is dismissed as Belgian courts clarify that EEA-based firms can use the SPC manufacturing waiver for EU production.

By: AXL Media

Published: Apr 3, 2026, 8:43 AM EDT

Source: Information for this report was sourced from Stibbe

Judicial Clarification of the EEA Waiver Extension

A significant legal precedent has been established regarding the territorial scope of the Supplementary Protection Certificate (SPC) manufacturing waiver within the European Economic Area (EEA). In the case of Regeneron v Alvotech, the Dutch-speaking Enterprise Court of Brussels ruled that manufacturers based in EFTA states, specifically Iceland, are eligible to benefit from the waiver regime for activities conducted within the European Union. This decision follows the 2022 incorporation of the Waiver Regulation into the EEA Agreement, which Regeneron had unsuccessfully argued included a transitional period that would have barred Alvotech from relying on the exemption for its Belgian manufacturing operations.

Transitional Periods and Manufacturing Rights

The court’s analysis focused on the distinction between manufacturing acts occurring within EFTA states and those occurring within the EU. While a transitional period exists for SPCs applied for in countries like Iceland, the court found prima facie that this period only governs acts of manufacturing within those specific territories to protect local SPC holders. It does not create a secondary barrier for EFTA-based firms seeking to manufacture products in EU member states. Consequently, Alvotech’s production in Belgium was deemed eligible for the waiver, provided that the company adhered to the standard notification requirements mandated by the original 2019 regulation.

Notification Requirements and Commercial Sensitivity

This recent judgment aligns with a series of Belgian rulings that have consistently favored a literal interpretation of the Waiver Regulation’s transparency requirements. Previous cases, including Amgen v Samsung Bioepis and Regeneron v Sandoz, established that waiver notifications do not need to prematurely disclose commercially sensitive data, such as specific export destination countries or marketing authorization (MA) numbers, until that information is publicly available. By upholding these standards, the Belgian judiciary is effectively preventing SPC holders from using administrative technicalities to obstruct the legal stockpiling and export of generic and biosimilar medicines.