This year’s selection covers a wide range of patent-related topics, including a Supreme Court ruling which lies at the intersection of IP and competition law, the very first European judgment on the merits tackling the SPC manufacturing waiver, a Supreme Court ruling regarding the admissibility of evidence stemming from a saisie that has later been annulled, and some other interesting decisions regarding saisie orders. As ever, pharma and biotech are well represented, but there’s something to pique the interest of every patent litigator. 

 Over to the Stibbe team:

"Navigating the intersection between IP and competition law

Belgian Supreme Court, 20 February 2025, Victrix Socsan and Télé-Secours v. Tunstall

The refusal to grant a licence for IP rights can sometimes conflict with competition law. This topic has already been explored in the case law of national courts and the Court of Justice of the European Union, most notably in the landmark case IMS Health (C418/01) of 29 April 2004. Such refusal has often been addressed under the prohibition of abuse of dominant position. Proving such a dominance, however, is often a task that can prove difficult in practice.

Since 2020, Belgium has added new provisions to its Code of Economic Law (CEL) to prohibit abuses of economic dependency, in addition to its provisions relating to the abuse of a dominant position. Economic dependency is defined as “the position of subjection of a company to one or more other companies characterised by the absence of a reasonably equivalent alternative available within a reasonable timeframe, at reasonable conditions and costs, enabling the latter or each of the latter to impose services or conditions that could not be obtained under normal market circumstances”. Three conditions must be met to characterise an abuse of economic dependence: (i) one company must be economically dependent on another; (ii) this situation must be exploited abusively; and (iii) this has an effect on competition in the relevant Belgian market or a substantial part of it. Provided that the above conditions are met, Courts can sanction abusive behaviour, regardless of the existence of a dominant position on the Belgian market. Belgian Courts have already applied these provisions on several occasions, for instance in relation to a manufacturer’s refusal to continue supplying goods to retail stores or the refusal to provide banking services. Yet it wasn’t until 2022 that a Belgian Court applied these provisions for the first time to the field of IP, in the case Tunstall v. Télé-Secours and Victrix.

Télé-Secours, a Belgian telecare services provider, historically relied on software and hardware from its provider, Tunstall. Tunstall holds EP 2 160 038 which protects among other things, “a system for transmitting dual tone multi-frequency ("DTMF") digits across a packet-switched network”. Eventually, when Télé-Secours tried to replace Tunstall’s software by a software developed by the company Victrix (now part of Careium), Tunstall alleged patent infringement against both Victrix and Télé-Secours, claiming that Victrix’ sale of the software and its use by Télé-Secours infringed its patent rights. In response, Victrix and Télé-Secours counterclaimed by requesting the Brussels Enterprise Court to order Tunstall to offer a licence for the use of its patent, arguing that the refusal constituted an abuse of dominant position and/or of economic dependence. While the Court rejected the claim based on the abuse of dominant position because it considered that such a position was not established, it found that Tunstall’s refusal did constitute an abuse of both Télé-Secours and Victrix’ economic dependence towards Tunstall. The Court notably concluded that Victrix could not enter the relevant Belgian market without a licence from Tunstall. Tunstall was thus ordered to grant a licence.

Tunstall appealed this judgment and the Brussels Court of appeal overturned the order to grant a licence. The Court notably found that Tunstall’s refusal to grant a licence to Victrix could not constitute an abuse of economic dependence because there was no preexisting contractual relationship between both parties. The Court referred to Belgian case-law and legal authorities pointing towards such a requirement of a preexisting contract.

Victrix and Télé-Secours appealed to the Supreme Court, which examined amongst other things the necessity of a preexisting contract to establish economic dependency. The Supreme Court quashed the Court of appeal decision, ruling that economic dependency can exist in the absence of a preexisting contractual relationship between the licensor and the licensee. This decision underscores that the refusal by an established company to license IP rights to a company trying to enter a market can be deemed abusive without having to establish dominance, nor any contractual relationship between parties. The case has been remanded to the Court of appeal of Mons for further proceedings.

Clarifying the boundaries of the SPC manufacturing waiver

Brussels Enterprise Court, 23 December 2024, Amgen and Amgen Fremont v. Samsung Bioepis

With its judgment of 23 December 2024, the Brussels Enterprises Court delivered the first decision on the merits in Europe interpreting the SPC manufacturing waiver. Since its introduction in 2019, the SPC manufacturing waiver has raised complex legal questions across the European Union. Designed to level the playing field for EU-based manufacturers, the SPC manufacturing waiver allows them to produce biosimilar or generic medicines during the SPC protection period for export to third countries or for stockpiling ahead of SPC expiry, provided certain requirements are met. In this decision, the Court specifically addressed and clarified the (notification) requirements that must be fulfilled in order to rely on the waiver.

The case concerned a dispute between Samsung Bioepis (SB) and Amgen. SB sought to manufacture biosimilar denosumab (the active ingredient in Amgen’s Prolia® and XGEVA®) under the SPC manufacturing waiver during the protection period of Amgen’s SPC 2010C/039, with the intention to export the products to third countries. To that end, SB notified the competent Belgian authority (namely the Belgian IP Office) of its intention, using the standard notification form, stating that the manufacturing was for export purposes and that the relevant marketing authorisation reference numbers would be provided “as soon as publicly available”, in accordance with article 5(5)(e) of the SPC Regulation.

Amgen challenged the validity of SB’s notification, arguing that it was incomplete due to the absence of both the marketing authorisation reference numbers and the identification of the export countries.

The Court rejected this argument. It ruled that article 5(5) of the SPC Regulation does not require the manufacturer to already possess marketing authorisations in the export countries at the time of the notification under article 5(2) of the Regulation. On the contrary, the provision states that the reference number must be supplied “as soon as it is made public”. The Court also held that there is no requirement to provide a list of the export countries. It therefore confirmed SB’s interpretation of the Regulation.

The Court also clarified two other disputed issues. First, the Court dismissed Amgen’s argument that manufacturing under the waiver is only permitted where no relevant patent rights exist in the country of destination. The Court found that this condition is not reflected in the wording of the Regulation, and that such an interpretation would run counter to its objective of creating a level playing field between EU and non-EU manufacturers. Second, the Court rejected the argument that stockpiling under the waiver is only allowed if strictly necessary for immediate export. It ruled that the Regulation imposes no maximum time limit for temporary stockpiling and that such stockpiling is permitted for a customary period consistent with normal business practices.

For these reasons, the Court dismissed Amgen’s claims, finding that no infringement of the SPC had occurred and confirming that SB’s notification complied with the requirements of the Regulation. Amgen’s claim based on unfair commercial practices was held inadmissible, due to its failure to demonstrate a serious risk of infringement.

This judgment sets an important precedent in the interpretation of the SPC manufacturing waiver. In reaching its decision, the Court considered two foreign interim rulings on the same Regulation. The District Court of Munich had taken a more restrictive approach, requiring the manufacturer to specify the marketing authorisation reference number in the notification. The Court of The Hague, by contrast, stressed the importance of the wording and context of the Regulation and held that the omission of a requirement to identify export countries was intentional, designed to avoid premature disclosure of commercially sensitive information.

The Brussels Enterprise Court aligned itself with the reasoning of the Court of The Hague, establishing a more flexible precedent, albeit one still open to appeal.

Fruit of the poisonous tree: how the annulment of a saisie order affects the resulting evidence

Cour de cassation, 14 March 2024, Prefamac and Gatic v. Autodesk and Microsoft

Can evidence from a saisie still be used if the order authorizing the saisie has been revoked? Until recently, Belgian courts took distinct approaches to answering this question. On one side stood the Brussels Court of appeal, and on the other, the Antwerp Court of appeal.

Both courts were confronted with the following question : can findings from an expert report obtained under a court-authorized saisie still be admitted in main proceedings despite the annulment of the order authorising the saisie? The practical reality being that by the time an annulment occurs, the saisie has often already yielded potentially critical evidence, raising complex questions about the admissibility of such evidence.

In the case brought before the Antwerp Court of appeal, a saisie order was under opposition, but there had not yet been a final decision rendered in those proceedings. The Court nevertheless relied on the expert’s findings in the proceedings on the merits and found the defendants liable for copyright infringement. In its ruling of 14 May 2018, the Court stated that even if the saisie order were to be annulled, it could still take into account the findings made by the court-appointed expert as factual presumptions based on the so-called Antigone jurisprudence, under which unlawfully obtained evidence only needs to be declared inadmissible if it violates a rule sanctioned by nullity, if the irregularity of the evidence compromises its reliability, or if its use is contrary to the right to a fair trial. It thus saw no reason to exclude the expert’s report from the proceedings on the merits.

The facts were slightly different in the case brought before the Brussels Court of appeal, where an opposition against the saisie order had already been upheld. The Court, in a judgment dated 11 September 2018, held that since the saisie order was definitely annulled, the expert report was inadmissible and it thus declined to find any copyright infringement by the defendant with respect to software due to a lack of evidence.

In a landmark decision issued on 14 March 2024 directed against the Antwerp decision discussed above, the Belgian Supreme Court brought clarity to the legal uncertainty created by the differing appellate rulings. It held that if the order authorising a saisie is annulled, this annulment also automatically extends to the evidence stemming from that saisie. Consequently, this evidence can no longer be used in court in any way.

This decision puts an end to the legal debate and confirms that the validity of the saisie is a necessary condition for the admissibility of any resulting evidence in subsequent litigation. It is therefore important to carefully substantiate any saisie request. If the request shows inconsistencies or weaknesses that could lead to an annulment of the order during subsequent opposition proceedings, the plaintiff risks encountering evidentiary problems in the proceedings on the merits.

This decision further resonates beyond Belgium’s borders since the issue is likely to arise before the UPC as well, particularly where a request is made by the right holder to access an expert report filed in pursuance of an (ex parte) order to preserve evidence.

Further updates on the saisie front

Court of appeal of Brussels, 31 October 2024, GSK and ID Biomedical v. Pfizer ; French-speaking Enterprise Court of Brussels, 26 June 2025, Sterigenics and Amgen v. Regeneron Pharmaceuticals ; Court of appeal of Brussels, 17 July 2025, Samsung Bioepis v. Amgen

As usual, Belgian Courts have been busy handling saisie requests in complex patent cases often involving parallel proceedings abroad. Among other things:

- On 31 October 2024, the Brussels Court of appeal issued a ruling concerning a saisie requested by GSK against Pfizer in relation to its RSV vaccine “Abrysvo”;

- On 26 June 2025, the French-speaking Brussels Enterprise Court also issued a ruling concerning another saisie, this time concerning aflibercept biosimilar products including those of Amgen, Samsung Bioepis and Celltrion;

- On 17 July 2025, the Brussels Court of appeal issued a ruling concerning a saisie requested by Amgen against Samsung and its sub-contractor in relation to Samsung Denosumab biosimilar product.

Those decisions, which include two decisions of the Brussels Court of appeal, gave Belgian Courts the opportunity to confirm and add valuable clarifications to their long-standing case law on saisies. In particular:

- A saisie can be performed at the premises of a third-party (like a subcontractor of the alleged infringer(s)) and not only at the premises of the (main) infringer.

- A saisie can be performed in Belgium based on foreign patents, for the purpose of foreign patent infringement proceedings, under the same conditions as for a Belgian patent or a Belgian part of a European patent.

- The patentee must disclose in its saisie request all elements which are relevant for a prima facie assessment, but not more than that. Elements which could only become relevant in the context of proceedings on the merits do not need to be disclosed to the Court. This standard seems to be in line with the one applied by the UPC, in particular as set out in the orders rendered by the Cour of appeal on 15 July 2025 in the Tiru cases.

- The fact that a patent is subject to opposition or revocation proceedings, in Belgium or abroad, or even that it has been annulled in first instance, does not take away the presumption of validity of the patent nor preclude the patentee from obtaining a saisie. In particular, the Brussels Court of appeal considered that the fact the patentee had abandoned the UK part of a European patent did not mean that the Belgian part of the same patent loses its presumption of validity. The same court also confirmed that upon revocation of the patent in first instance, the patentee who has appealed the revocation decision can still request a saisie if he shows that the appeal has reasonable chances of success. As to this matter, Belgian courts seem to be less strict than the UPC. In its orders of 15 July, the UPC Court of appeal decided that, in principle, the UPC does not assess patent validity when ordering evidence preservation measures, “except where the presumption of validity can clearly be called into question, for example, following a decision by an Opposition Division or a Board of Appeal of the European Patent Office in a parallel opposition procedure, or in revocation proceedings before another court concerning the same patent”.

- Whether exemptions to exclusive patent rights (such as the Bolar exemption) apply is generally not a matter to be decided upon by the Court in the assessment of a saisie request or when reviewing the legality of granted saisie orders, as this is something for the judge on the merits to decide on. However, in a case where documents relied upon in the saisie request tended to indicate that the products had been used for clinical trials only, and that the Bolar exemption was thus likely to apply, it was decided that the applicant should have clarified why those documents could nevertheless constitute indications of infringement.

- In opposition proceedings, the request of the seized party that a bond be provided by the patentee is generally rejected unless there is concrete evidence that the solvency of the patentee is doubtful.

The question whether the court-appointed expert should refrain from filing and/or communicating the saisie report to the patentee pending an opposition filed by the seized party remains to be determined on a case by case basis. While some decisions uphold the principle that the opposition proceedings do not have a suspensive effect, several other decisions grant a suspension of the filing of the report as a provisional measure pending opposition in first instance.

Source: https://ipkitten.blogspot.com/2025/09/keeping-up-with-belgian-patent.html