No. 151 - 6 October 2026
Can a defendant challenge whether the registered proprietor is actually entitled to a Unitary Patent? Rule 8.4 RoP appears, at first sight, to give a rather straightforward answer: for the purposes of proceedings under the Rules, the person shown as proprietor in the Register for Unitary Patent Protection “shall be treated as such”.
The Brussels Local Division has now held that this does not prevent an entitlement challenge as a defence. According to the Court, the fiction created by R. 8.4 RoP is limited to procedural purposes and does not extend to questions of substantive law.
This is particularly noteworthy because the Court expressly acknowledges diverging UPC case law and departs from the approach previously taken by the Munich and The Hague Local Divisions.
The case concerns EP 3 689 383, a Unitary Patent owned by the United States of America, represented by the Department of Health and Human Services. 2seventy bio brought the infringement action as alleged exclusive licensee. The patent proprietor, the NIH, intervened in support of 2seventy bio.
The defendants challenged 2seventy bio's standing on several grounds. Among other things, they argued that the NIH had never acquired the shares of all inventors in the invention and therefore could not have transferred the necessary rights to 2seventy bio. They also disputed whether the required prior notice under Art. 47 UPCA had been given.
Against this background, the defendants sought production of various documents from the NIH under R. 190 RoP.
The most interesting part of the order concerns the effect of R. 8.4 RoP.
For a European patent with unitary effect, R. 8.4 provides that, “for the purposes of proceedings under these Rules”, the person shown in the Register for Unitary Patent Protection as proprietor shall be treated as such.
The Brussels Local Division accepts that this creates a legal fiction. But it gives the words “for the purposes of the proceedings” a limited meaning. According to the Court, the fiction applies to the application of the Rules of Procedure and, more specifically, to the administrative tasks to be performed by the Court and the parties. It does not extend to questions of substantive law.
Consequently, a defendant may raise lack of entitlement as a defence where that issue is relevant to an action falling within the UPC's jurisdiction. The Court emphasises that entitlement was not being asserted as a stand-alone claim – for which the UPC would appear to lack jurisdiction under Art. 32 UPCA – but as a defence against the claimant's standing.
In other words: registration determines whom the UPC treats as proprietor for procedural purposes, but does not necessarily make substantive entitlement immune from challenge.
This is not yet settled UPC law.
The Brussels Local Division expressly addresses earlier decisions of the Munich Local Division and The Hague Local Division which had treated the presumption as non-rebuttable also in relation to substantive-law questions. By contrast, the Munich Central Division had allowed entitlement to be addressed notwithstanding the wording of R. 8 RoP.
The Brussels Local Division sides with the latter approach. It expressly states that, “with all due respect”, it deviates from the position taken by the Munich and The Hague Local Divisions.
Its principal argument is the right of defence. An interpretation under which R. 8.4 RoP prevented a defendant from raising what may be a decisive substantive defence would, in the Court's view, not be compatible with that principle.
It may also be worth considering NanoString v 10x Genomics (Court of Appeal, 26 February 2024, UPC_CoA_335/2023) in this context. There, the Court of Appeal relied on registration under R. 8.4 RoP as sufficient to establish the patent proprietor’s entitlement to apply for provisional measures. However, this was in the context of preliminary-injunction proceedings, requiring only that entitlement be more likely than not.
A second practically important point concerns Art. 47(2) and (3) UPCA.
A licensee entitled to bring proceedings must give the patent proprietor prior notice. The Brussels Local Division holds that compliance with this requirement must be assessed at the time the action is brought.
The Court identifies that point as the date on which the action is recorded in the register following the Registry's formal examination of the Statement of Claim under R. 16 RoP.
The burden of proving compliance lies solely with the claimant.
Importantly, however, the Court distinguishes between the existence of prior notice and the evidence used to prove it. The required notice must already have been given when the action is brought. But the claimant may subsequently introduce additional evidence supporting the evidence already submitted under R. 13.1(f) RoP.
The order also contains detailed guidance on intervention.
The Court first makes clear that the Rules do not provide for an “aggressive” or “principal” intervention. An intervener joins proceedings to support, in whole or in part, a claim, order or remedy sought by an existing party. It cannot use the intervention to bring independent claims against other parties.
Things become more complicated where, as here, the intervener is the patent proprietor and the defendants subsequently bring counterclaims for revocation.
Under Art. 47(5) UPCA, a party wishing to challenge validity must bring the relevant action against the proprietor. The NIH could therefore simultaneously be an intervener supporting the licensee in the infringement action and a defendant in the counterclaims for revocation.
The latter status does not automatically transform the NIH into a co-claimant in the infringement action. The Court accepts this asymmetry. Whether an intervener should be reclassified as co-claimant or co-defendant under the Court's case-management powers pursuant to R. 305 and R. 315 RoP depends on the circumstances of the individual case.
Finally, the order provides further guidance on R. 190 RoP.
Following the Court of Appeal's approach in Polytechnic v Dall, a party seeking production of evidence must first make the underlying claim plausible on the basis of the evidence reasonably available to it. The request cannot be used for a fishing expedition.
The Brussels Local Division emphasises that this is only a plausibility assessment at the particular stage of the proceedings. It does not prejudge how the panel will ultimately decide the same issue on the merits.
That distinction mattered here because the Court had to consider the plausibility of the defendants' entitlement challenge in order to decide whether the NIH should be required to produce the requested documents.
On the facts, the defendants ultimately failed to establish the necessary plausibility for their entitlement theory. Among other things, the Court considered that co-authorship of a scientific publication does not correspond to the legal test for co-inventorship and was insufficient to overcome the relevant presumptions under US law.
Thus, the defendants were entitled to raise the entitlement defence despite R. 8.4 RoP – but that did not mean that their particular entitlement challenge was sufficiently plausible to justify an order for production of evidence.
