Brussels Court Clarifies the EU’s SPC Manufacturing Waiver Regulation Rules

On November 13, 2025, the president of the French-speaking Brussels Enterprise Court ruled in the long-running battle between Sandoz and Regeneron about the correct interpretation of the EU’s Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation regarding exports to a non-EU market. The Brussels Court dismissed Regeneron’s claim that Sandoz had provided a defective notification and agreed with Sandoz’s interpretation of the Regulation.

Background

The SPC Manufacturing Waiver Regulation, as amended in 2019, allows EU-based manufacturers to produce a generic or biosimilar version of an SPC-protected medicine during the term of the SPC, if it is for the purposes of exporting to a third country outside the EU, or for stockpiling during the final six months of protection before launch onto the EU market.

At the beginning of 2024, Sandoz submitted a notification to the Belgian Intellectual Property Office and to Regeneron under the SPC Manufacturing Waiver Regulation in connection with its biosimilar aflibercept products, AFQLIR® (brand name in the EU) and ENZEEVU® (brand name in the U.S.). These products are used in the treatment of vision impairment caused by neovascular age-related macular degeneration and diabetic macular oedema.

Through this notification, made prior to the expiry of Regeneron’s SPC, Sandoz indicated that it intended to manufacture the biosimilars for export,, and at the same time allow for stockpiling for day-one launch in the EU. No marketing authorization (MA) had at that point been granted to Sandoz in a third country of export, and the notification therefore stated that the number of the MAs was not yet available. A few months after the date of the notification, the number of MAs in the U.S. was provided by Sandoz through an update to the notification, in accordance with the requirements of the SPC Manufacturing Waiver Regulation.

Following this update, Regeneron initiated accelerated proceedings on the merits before the French-speaking Brussels Enterprise Court arguing that neither the initial notification nor the updated notification was valid and that Sandoz could therefore not rely on the SPC manufacturing waiver. (Regeneron did not contest Sandoz’s entitlement to rely on the waiver for stockpiling for day-one launch in the EU.)

Arguments of the parties

Regeneron based its position on three arguments:

1. First, Regeneron claimed that the EU legislator did not intend manufacturers to send “empty notifications” (namely, notifications without an MA reference number) that do not allow the SPC holder to verify its rights in the third country of export. According to Regeneron, the country of export should always be mentioned and the manufacturer should always be in possession of an MA prior to submitting a notification under the SPC Manufacturing Waiver Regulation. Regeneron based this argument on the alleged intention of the legislator, which it derived from a linguistic interpretation of a statement of the legislator in the fourth revised proposal of the Regulation of December 18, 2018.
2. Regeneron also argued that the updated notification of Sandoz was defective because the third countries of export were not “free of IP rights.” It mentioned in particular the injunctions it had obtained in the U.S.
3. Finally, Regeneron contended that, if the manufacturer had not yet obtained an MA in the country of export and/or that country was not “free of rights,” this would inevitably result in a stockpiling of the products in the EU, as it would not be possible for the products to be exported. Regeneron argued that such stockpiling (as opposed to the stockpiling for EU launch) would be unlawful because the SPC Manufacturing Waiver Regulation does not contain a right to stockpile for export.

Sandoz disputed all these arguments, saying that the text of the SPC Manufacturing Waiver Regulation was clear and allowed notifications to be made before an MA is obtained. It also asserted that there was no need under the Regulation to mention the third country of export or whether it was “free of rights,” and that there was no limit on the duration for stockpiling for export.

Furthermore, Sandoz argued that the correct interpretation of the Regulation was clear from the text and that there was no need to make inferences about the intention of the legislator. It also pointed out that its position was supported by case law, with five previous Belgian and Dutch judgments having been decided on the same subject matter.

Decision of the Brussels Enterprise Court

The French-speaking Brussels Enterprise Court agreed with Sandoz’s arguments.

It held that the text of the SPC Manufacturing Waiver Regulation was clear and did not need any further interpretation. It also held that there was no need for an MA to have been obtained prior to filing a notification, and that a manufacturer was not required to mention potential third countries of export. The Court emphasized that the SPC Manufacturing Waiver Regulation is the result of a compromise which seeks to balance the rights of the SPC holder with those of the generic/biosimilar manufacturer, and that sensitive information such as potential third countries of export does not need to be shared in advance.

The French-speaking Brussels Enterprise Court relied on previous judgments by the Dutch-speaking Brussels Enterprise Court and the Brussels Court of Appeal (albeit the latter on the basis of a prima facie assessment), and also on Dutch case law. The court chose not to follow the one judgment that has taken a different stance in this matter (namely, a decision of the Munich Landgericht on October 20, 2023). In making this decision, the president of the court observed that the Munich judgment had sought to add a condition to the law in a manner found to be unconvincing by more recent judgments, e.g., the judgment of the Brussels Court of Appeal. On this basis, the president confirmed the existing Belgian and Dutch case law and concluded that a reference for preliminary ruling to the Court of Justice of the EU was not necessary because the law was clear and did not require interpretation.

This judgment follows and confirms no fewer than five earlier decisions issued in Belgium and the Netherlands on the interpretation of the SPC Manufacturing Waiver Regulation and is in line with a recent UK judgment handed down by Justice Meade of the UK High Court on November 24, 2025 in a case involving Alvotech against Regeneron and Bayer. In his reasoning, Justice Meade found it clear that Regeneron’s arguments based on the travaux préparatoires (which he considered of no real assistance as being impractical and wrong in principle, given the legislative process and how the regulation significantly changed) and the German judgment “were overengineered” (para. 17 of the UK judgment). Belgian judgments were considered to be authoritative and exemplary in the correct interpretation of the regulation: “As will be seen, the Dutch and Belgian courts reached a different conclusion on this question and I prefer their point of view, which was fully argued before them and which they supported by more detailed analysis. If the mere existence of a right in the export territory which was arguably infringed meant that the export waiver automatically did not apply, then EU/UK manufacturers would continue to be disadvantaged relative to manufacturers in non-EU/UK countries, who would be free to manufacture in preparation for export to the territory in question and would be free to sell there if they could successfully challenge the validity or scope of the right in question.” (para. 52 of the UK judgment)

Conclusion

The aim of the SPC Manufacturing Waiver Regulation was to remove a major competitive disadvantage for EU-based manufacturers as compared to manufacturers based in non-EU countries (where SPC-type protection may be either unavailable or unenforceable) and ensure a better deal for patients. It seeks to allow EU-based generics and biosimilars to compete on the global market, and this most recent court judgment can be seen as a major victory for such companies in the context of their manufacture of products intended for export to non-EU markets.

This latest judgment brings welcome clarity to the complex world of SPC compliance and notifications. There is now a clear consensus between the Dutch- and French-speaking Brussels Enterprise Courts as regards the interpretation of the SPC Manufacturing Waiver Regulation, and it is fully in line not only with Dutch case law, but also with a recent UK judgment.