Can the Bolar exception stop an anti-counterfeiting seizure?

A holder of a patent or supplemental protection certificate (SPC) suspecting infringement, may ask the court for an 'seizure regarding counterfeiting‘ to be allowed to perform. But what if the opposing party claims that its acts are perfectly legal because they fall under a statutory exception, such as the Bolar exception for pharmaceutical testing? According to a ruling by the President of the Brussels French-speaking Business Court on 26 June 2025, such a defense is insufficient to stop the evidentiary measure. The complex assessment of this exception belongs in proceedings on the merits, not in the urgent attachment phase.

The facts: a battle between an innovator and a biosimilar producer

The case revolves around the pharmaceutical company Regeneron, the holder of a Supplementary Protection Certificate (SPC) for the active ingredient aflibercept. This substance is the basis for their well-known eye medication EYLEA®. This certificate provides protection in Belgium until the end of 2025.

On the other side is Amgen, a biotechnology giant that has developed a so-called "biosimilar" of aflibercept. For this product to enter the European market, Amgen must submit a comprehensive registration dossier to the competent authorities. A crucial step in this process is the sterilization of the pre-filled syringes in which the drug is presented. For this service, Amgen in Belgium relies on Sterigenics, a company specializing in sterilization services.

Regeneron discovered through public databases (such as those of the U.S. FDA) that Sterigenics was designated as a "manufacturer" in Belgium for biosimilars of aflibercept. Based on these indications, Regeneron argued that an infringement of its SPC was imminent and, through a unilateral petition, sought and obtained the President's permission to conduct a seizure for counterfeiting at Sterigenics' facilities.

Both Amgen and Sterigenics challenged this decision through a third-party opposition proceeding, seeking to have the attachment revoked.

The decision of the president of the enterprise court

The president declares Amgen and Sterigenics' third-party opposition unfounded. The anti-counterfeiting seizure therefore stands. The president systematically refutes all arguments of the opposing parties.

At the heart of the discussion was whether the activities of Amgen and Sterigenics constituted an infringement or whether they were justified by the so-called Bolar exception. This exception in patent law allows generic and biosimilar manufacturers to conduct all the necessary studies and tests required to obtain a marketing authorization during the validity period of a patent or SPC. According to Amgen and Sterigenics, the sterilization was merely a test phase for the regulatory file and therefore not a commercial act.

However, the president judges that the seizure stage is not the right place to have this complex debate. The reasoning is as follows:

1. The president's role is limited: The judge adjudicating an application for an anti-counterfeiting seizure must only consider whether two conditions are met: (1) the intellectual property right invoked appearsprima facievalid and (2) there are sufficient indications of an (imminent) breach.
2. The Bolar exception is a defense on the merits: Whether the acts effectively and exclusively served to obtain a market license requires a detailed examination of the facts. This is the job of the judge on the merits, not the president who must decide quickly and on the basis of limited information.
3. The seizure just serves to gather evidence: The president emphasizes the probative or evidentiary finality of the measure. The purpose is precisely to gather evidence about the nature, scope and destination of the allegedly infringing acts. The evidence gathered could, ironically, even support Amgen's and Sterigenics' contention that their activities fall under the Bolar exception.

The president ruled that Regeneron had provided sufficient evidence, including by referring to official documents listing Sterigenics as the manufacturer. This was enough to justify the evidentiary measure.

Legal analysis and interpretation

This judgment is a clear affirmation of established case law on the nature and purpose of the anti-counterfeit seizure, as governed by Article 1369bis/1 of the Judicial Code. The procedure is a tool for gathering evidence, not an advance ruling on the dispute itself.

The ratio decidendi of the decision lies in the strict delineation of the powers of the president versus the judge on the merits. The president conducts a marginal review and can deny a measure only if the claim is manifestly unfounded is. This would be the case if the protection invoked is clearly invalid, or if there is no indication of infringement.

However, a defense such as the Bolar exception is not a simple denial. It recognizes the substantive act (e.g., producing or possessing the product) but frames it within a legal justification. Assessing this requires an in-depth analysis of the facts and intent of the parties, which is beyond the president's saisin.

The ruling emphasizes that, until the application of the exception is undisputed and crystal clear, the holder of the intellectual property rights enjoy the benefit of the doubt to be allowed to collect evidence.

What this specifically means

• For the holder of a patent or ABC: This ruling confirms that an anti-counterfeiting seizure is a powerful and efficient tool for gathering evidence of possible infringement. You do not have to provide conclusive proof of infringement; serious evidence will suffice. In principle, a complex defense by the opposing party will not be able to block the evidentiary measure.
• For a (biosimilar) manufacturer: Invoking the Bolar exception is not a free pass to avoid an anti-counterfeiting seizure. It is critical to meticulously document your research and development activities in order to prove in subsequent proceedings on the merits that all actions were strictly necessary to obtain a market license.
• For technical service providers (logistics, packaging, sterilization): Be aware that you may become involved in an intellectual property dispute even if you are not the principal or the ultimate seller. The mere possession of the goods on Belgian territory may be sufficient to be the subject of a seizure. Have clear contractual agreements with your customers regarding liability and cooperation in the event of such proceedings.

FAQ (Frequently Asked Questions)

What exactly is a descriptive anti-counterfeiting seizure?
It is a specific legal proceeding that the holder of an intellectual property right (such as a patent, trademark or copyright) allows, with the permission of the president of the enterprise court (or court of first instance), to have a by the president appointed expert to prepare a detailed description of products or processes suspected of constituting infringement. The purpose is purely evidence gathering; the goods are not taken.

What does the Bolar exception entail?
This is a statutory exception in patent law specific to the pharmaceutical sector. It allows manufacturers of generic or biosimilar drugs, during the term of protection of the original drug, to conduct the necessary studies and tests to apply for a marketing authorization. This allows them to market their product immediately after the expiration of the patent or SPC.

Can I refuse an anti-counterfeiting seizure?
No. The seizure is carried out on the basis of a court order. Cooperation is mandatory. Refusing access to the expert may lead to forfeiture of penalties. However, as in this case, the validity of the order can be challenged afterwards in the same court through a third-party opposition procedure.

Conclusion

This ruling by the Brussels Enterprise Court sharpens the chalk lines: the procedure of an anti-counterfeiting seizure serves to uncover the truth through evidence gathering. A complex defense, such as invoking the Bolar exception, will generally have to wait for the proceedings on the merits and cannot prematurely halt the search for evidence. Thus, the threshold for obtaining a seizure remains relatively low for the patentee, as long as clear indications of possible infringement are available.