Counterfeit seizure dismissed: the impact of the Bolar exemption and the duty to disclose

In a ruling dated July 17, 2025, the Brussels Court of Appeals raised the bar for obtaining a seizure order regarding counterfeiting . The Court ruled that there can be no infringement when acts fall under the so-called Bolar exemption (acts for the purpose of market authorization). Moreover, it confirmed that the applicant of a unilateral seizure has a strict duty of information: the concealment of exculpatory elements, such as the non-commercial nature of shipments, leads to the revocation of the seizure.

The facts and procedural background

The dispute is in the pharmaceutical sector between U.S. biopharmaceutical giant Amgen and Samsung Bioepis, a manufacturer of biosimilar drugs.

Amgen holds several patents (including a European and a U.S. patent) relating to the active ingredient denosumab. Amgen suspected that Samsung Bioepis was infringing by having denosumab manufactured and exported to the United States through the Belgian company Catalent.

Based on these suspicions, Amgen initially - after appealing a dismissal order - obtained authorization for a seizure on counterfeiting from Catalent. This was done through a unilateral request that did not involve Samsung Bioepis.

Samsung Bioepis then filed a third-party opposition to this decision. It argued that the Belgian court lacked international jurisdiction and that there was no (imminent) infringement because the activities fell under the exception for regulatory approval (the Bolar exemption).

The Court's decision

The Brussels Court of Appeal ruled in favor of Samsung Bioepis on July 17, 2025, overturning the previously granted seizuret. The decision rests on three crucial pillars:

1. International jurisdiction (Article 35 Brussels I-bis Regulation).

Although the patents were partly US and the parties are not domiciled in the EU (US and South Korea), the Court confirmed its international jurisdiction to order protective measures (such as a seizure regarding counterfeiting). Because the evidence was located in Belgium (at Catalent), there is a sufficiently real connection to Belgian jurisdiction even if the merits dispute were to be conducted elsewhere.

2. The Bolar exemption and lack of infringement.

The heart of the case revolved around whether there were “indications of infringement” (art. 1369bis/1 Judicial Code). Amgen pointed to exports to the U.S. as evidence of infringement. However, the Court noted that these shipments were labeled “IND” (Investigational New Drug). This indicates use for clinical trials and regulatory approval (by the FDA). Such acts fall under the Bolar exemption and do not constitute patent infringement, either under Belgian or US law.

[In another case (albeit one in which Amgen was also a party), the president of the Brussels French-speaking Enterprise Court ruled in a judgment dated June 26, 2025 however, that the Bolar exception is a defense on the merits that cannot be taken into account when granting a seizure regarding counterfeiting].

3. Breach of the duty to inform

The court weighed heavily on Amgen's failure to mention in its unilateral request that the shipments were marked “IND.” By omitting this crucial context, Amgen violated its obligation to fully and objectively inform the judge. This led to the ruling that the measure had been obtained on incomplete grounds.

The seizure was revoked and Amgen was ordered to return or destroy all information obtained.

Legal analysis and interpretation

This statement contains essential lessons for the practice of intellectual property law in Belgium.

The scope of the Bolar exemption. The ruling confirms a broad interpretation of the Bolar exemption. The Court clarifies that the exemption is not limited to acts for European market approvals. Acts in Belgium (such as production and exports) that serve for regulatory approval in third countries (such as the U.S.) are also covered by the exemption. Amgen's argument that the exemption would not apply to exports to the U.S. was dismissed by the Court as “insufficiently nuanced” since data from U.S. trials can also be used for EU registrations.

Strict duty of loyalty in unilateral proceedings In unilateral request proceedings (such as a seizure concerning counterfeiting), the opposing party is not present to offer rebuttal. Therefore, a heightened duty of fairness rests on the petitioner (duty of candor). The Court emphasizes, “The applicant is obliged to provide the court with correct, complete and as objective information as possible“. The selective presentation of facts - here the concealment of the ‘IND’ code on FDA documents - is mercilessly punished. The penalty is rejection, even if there were theoretically other arguments.

International clout of the Belgian court The ruling reaffirms the role of the Belgian court as a forum for cross-border gathering of evidence. Through article 35 of the Brussels I-bis Regulation a Belgian court can order measures to support foreign proceedings on the merits (e.g., in the U.S. or Korea), as long as the evidence is located in Belgium. This makes Belgium a strategic location in global patent litigation.

Specifically, what does this mean for you?

The impact of this ruling varies depending on your position in a dispute:

• For patent holders (innovators): Be extremely careful when requesting a seizure regarding counterfeiting. You should not only provide evidence of infringement, but also anticipate possible defenses such as the Bolar exemption. If you have information that may weaken your case (such as indications of regulatory use), you must transparently disclose it to the court and explain why you nevertheless believe there is infringement. Withholding information can be fatal to your claim.
• For generic/biosimilar manufacturers: Ensure accurate record keeping and labeling of your products. Explicitly including codes such as “IND” or references to clinical trials on your shipping documents can act as a shield against seizures. If you do face a seizure, third-party opposition is an effective means of challenging the legality of the measure obtained, especially if the Bolar exclusion applies.
• For logistics service providers (such as Catalent): As a third party, you may become involved in patent litigation. It is essential to know that judges can impose seizures to gather evidence even if you yourself are not a party to the main litigation.

Frequently Asked Questions (FAQ)

Can I have a seizure in Belgium for infringement of a U.S. patent?
Yes. Belgian courts have international jurisdiction to order provisional or protective measures (such as a seizure on counterfeiting) if the evidence or infringing goods are located in Belgium. This applies even if the infringement proceedings on the merits are conducted abroad (e.g., the U.S.).

What exactly does the Bolar exemption entail?
Under the Bolar exemption, it is not patent infringement to use, manufacture or import a patented invention as long as it is done solely for acts reasonably related to obtaining a marketing authorization for drugs (such as clinical trials and regulatory filings).

What are the consequences if I withhold information in a seizure request?
The judge expects full transparency in a unilateral request. If it appears that you have concealed relevant, potentially exculpatory information (such as indications of non-commercial use), the court may find that you have not fulfilled your duty to disclose. This usually leads to the annulment of the seizure and an order to return or destroy all evidence obtained.

Conclusion

The July 17, 2025 ruling is an important warning to patent holders: the fight against counterfeiting must not come at the expense of procedural fairness. The Bolar exemption provides firm protection for the development of biosimilars, and the Belgian courts are vigilant about the duty of disclosure in unilateral actions.