Should the market permit already be there at the time of the SPC export notification?

In late 2024, the Dutch-speaking enterprise court in Brussels already ruled that a biosimilar producer need not immediately identify the specific exporting countries in its advance notice under the SPC export exemption - a judgement that we discussed in an earlier post on the Amgen v. Samsung Bioepis case . On Nov. 12, 2025, the president of the French-speaking enterprise court in Brussels joined that line in Regeneron v. Sandoz and refined it. Nor is a manufacturer of a biosimilar drug required to have marketing authorization in the exporting third countries at the time of notification; subsequent notification is sufficient. At the same time, the ruling exposes a sharp threshold for the preventive injunction claim: without concrete evidence of commencement of implementation, the injunction judge does not intervene.

The facts

Regeneron, a US biotech company, held Belgian Supplementary Protection Certificate (SPC) No. 2013C/029 for the active ingredient aflibercept - the active ingredient of EYLEA, used in the treatment of certain eye conditions. The SPC expired, including the pediatric extension, on Nov. 23, 2025.

On Feb. 19, 2024, Sandoz, which specializes in generic and biosimilar drugs, sent a written notification to Regeneron. Sandoz announced its intention to manufacture a biosimilar of aflibercept in Belgium, both for export to third countries and for stockpiling for launch on the EU market after the expiration of the SPC. The standard form was completed except for section (e) - the reference number of the market authorization in the exporting third countries. There it said “not yet available”.

On August 16, 2024, Sandoz completed a first update with the U.S. market authorization number, granted on August 9, 2024. A second update followed on Jan. 28, 2025 with the U.K. market authorization number, granted on Jan. 17, 2025.

Regeneron ruled that the original notice was “empty” or “quasi-empty” due to the lack of a market license, and initiated a cease-and-desist action on Sept. 16, 2024. At the time of the pleadings in October 2025, no effective manufacturing or export act had been shown - both parties stated at the hearing they did not know whether biosimilar had already been manufactured.

The decision

The injunction judge dismisses the main claims and declares the subsidiary claims inadmissible. The reasoning proceeds along three key points.

On the merits, the court considers the text of Article 5(5)(e) of Regulation (EC) No. 469/2009 clear: the manufacturer must notify the market authorization reference number “as soon as it is publicly available.” This implies that the permit need not exist at the time of notification. The court emphasizes that it must rely on the adopted legal text, and that recitals and legislative history can only be examined in the case of unclear or ambiguous text. The fact that an earlier December 2018 draft seemed to require the prior acquisition of a market permit is irrelevant: the final compromise includes the addition “as soon as it is publicly available,” and that addition must be given meaning. Consequently, the February 19, 2024 notification is sufficient, as are the August 16, 2024 and January 28, 2025 updates.

As to the subsidiary claims - a declaration that Sandoz may only rely on the export exemption for effective exports to the United States and the United Kingdom - the court applies Art. 18(2) Jud.C. toe. An action to prevent a serious threatened violation of law requires a concrete and serious threat, not a mere theoretical possibility. Evidence of commencement of production, storage or export was lacking; a mere abstract risk is not sufficient to impose injunctions or penalties.

Finally, the judge sees no reason for a preliminary question: in his view, Article 5(5) of the Regulation does not require interpretation.

Legal analysis and interpretation

An established Benelux line

With this judgment, a clear converging line is emerging. Belgian jurisprudence already preceded Sandoz: the Dutch-speaking enterprise court in Brussels ruled in the same sense on December 23, 2024 in Amgen v. Samsung Bioepis, and the Brussels Court of Appeal followed on November 4, 2024. In the Netherlands, the Hague Court of Appeal joined that flexible reading of the export exemption on Feb. 11, 2025. The French-speaking enterprise court of Brussels concurred.

In contrast, the isolated German ruling of the Munich Landgericht of October 20, 2023, which did require prior communication of at least one market authorization number, is increasingly weak. The judge in this case explicitly rejects them, in line with what the Brussels Court of Appeal did earlier.

For litigants, this is relevant. In an industry where production and export strategies span multiple jurisdictions, predictability is a scarce commodity. Benelux is now unequivocally aligning itself with a flexible reading of the export exemption, while Germany - for now - is taking a stricter course. Producers considering Belgian, Dutch or Luxembourg production sites operate in a more favorable legal environment than those opting for German sites.

Text over legislative history

The court decisively rejects the “global reading” advocated by Regeneron based on recitals and earlier drafts. His reasoning is principled: only an obscure, ambiguous or incomplete text opens the door to interpretation using legislative history. The Regulation is not obscure on this point.

This is a welcome reminder of the hierarchy of interpretive sources. When parties devote dozens of pages to successive drafts and compromises between institutions, it is tempting to let interpretation be guided by what could have been written. The court draws the line: that exercise becomes legitimate only when the text itself falls short. The addition “once publicly available” in the final text is not an accidental twist, but the result of a political compromise, and the judge gives it its natural meaning.

The injunction claim and the threshold of a “serious threat”

The rejection of the subsidiary claim deserves at least as much attention as the substantive decision. The court strictly applies Art. 18(2) Ger.W.: a preventive action requires proof of an actual and serious threat, not an abstract risk. It is an important nuance for IP disputes, in which holders are sometimes tempted to seek a cease-and-desist order based on mere notices or market intentions of a counterparty.

In this case, both parties stated at the hearing that they did not know whether Sandoz had already started production. In the absence of any factual element of actual or imminent infringement, the court could not but declare the declaratory relief claim inadmissible. Indeed, the test concerns both the likelihood of the infringement and the extent of the potential consequences - and that a mere formal notice does not meet either criterion. The lesson is clear: a holder of an SPC or patent seeking preventive action must offer more than a formal notice and a presumed intent. A focused indication of commencement of execution - raw material movements, contracts with production sites, capacity reservations - greatly increases the chances of success.

Specifically, what does this mean?

For holders of an ABC or patent in the pharmaceutical sector. The threshold for a preventive injunction claim is real. A formal notification under Regulation (EU) 2019/933 without an accompanying market authorization is not in itself evidence of a serious threat. Anyone who believes that a competitor is wrongfully invoking the export exemption would do well to gather factual evidence of commencement of production or export before going to the injunction judge. Conversely, an initial notice without a market license cannot be relied upon as conclusive proof of non-compliance.

For manufacturers of biosimilars and generics. This decision provides legal certainty for manufacturing investments in Belgium. Timely notification - even without a specified market permit on date of shipment - opens the door to the export exemption, provided the update follows as soon as the market permit is publicly available. The practical tip lies in careful documentation: record the time of public availability of each market permit, and send the update without delay. Failure to do so will only affect exports to the country in question - not the general validity of the notification.

Frequently asked questions (FAQ)

What is the export exemption on a supplementary protection certificate?
A supplementary protection certificate (SPC) extends patent protection for medicinal products for up to five years after the basic patent expires. The export exemption, introduced by Regulation (EU) 2019/933, allows manufacturers of generics and biosimilars to manufacture a drug already on the territory of a member state during the term of the SPC, provided it is intended for export to third countries where the protection does not (or no longer) apply. The exemption aims to strike a balance between the protection of innovators and the competitiveness of the European pharmaceutical industry.

Must the manufacturer have a market license at the time of prior notification?
According to this decision and the parallel Benelux case law: no. The manufacturer must communicate the market authorization reference number as soon as it is publicly available, possibly through an update of the original notification. At the time of sending the notification itself, a market authorization is not required. However, the notification must contain sufficient information to identify the purpose of production, the place of manufacture and the period concerned.

When can the injunctione judge impose a production ban under a SPC?
The injunction judge may, pursuant to Article XVII.14, § 2 CEL impose a prohibition when a current violation is demonstrated, or take preventive action under art. 18, second paragraph Jud.C. when a right is seriously threatened. That serious threat requires more than a theoretical possibility: there must be a concrete threat, assessed both in terms of the likelihood of the violation and the magnitude of the possible consequences. A mere notification under Regulation (EU) 2019/933, without any evidence of commencement of implementation, is not sufficient.

Conclusion

This judgement consolidates a well-established Benelux line around the SPC export exemption: the market license need not exist at the time of notification, and subsequent notification suffices as soon as it is publicly available. However, the real added value of the ruling lies elsewhere. The court explicitly recalls that a preventive injunction claim requires more than a suspicious notice - without concrete evidenceinjunction judge does not intervene. An important procedural nuance for any holder of an SPC or patent who wants to react quickly in Belgium to a competitor's market intentions.