Life sciences patents monthly roundup—May 2026

This month, at the Unified Patent Court (UPC), the Düsseldorf Local Division’s dismissal of Align Technology’s provisional measures application against Angelalign reinforces the applicant’s evidential burden in technically complex medical device cases. 

In addition, the UPC Central Division (Milan)’s revocation of a Remdesivir patent for lack of inventive step provides a further illustration of the UPC’s holistic approach to the assessment of inventive step and in its decision the Milan Central Division draws a sharp distinction between a reasonable expectation of success and a mere hope of success. 

In Belgium, the Brussels Enterprise Court’s recently published decision in Out and Out Chemistry v. Trasis considered the court’s long-arm jurisdiction, but notably fails to refer to the CJEU’s Electrolux decision as part of its assessment. In a second published decision, the president of the Brussels Enterprise Court confirms the Belgian approach to notification requirements under the supplementary protection certificate (SPC) manufacturing waiver.  

Belgium

Brussels Enterprise Court fails to apply CJEU BSH/Electrolux decision

On September 22, 2025, the Brussels Enterprise Court dismissed both the infringement and invalidity claims in a dispute between Out and Out Chemistry SPRL (Out Chemistry) and Trasis SA (Trasis) concerning EP3297977, which relates to a method for performing multiple radiopharmaceutical synthesis processes in series, together with a corresponding device and cassette. 

Out Chemistry asserted (i) literal and equivalent infringements of the Belgian and French parts of EP3297977 and (ii) unfair competition claims. Trasis counterclaimed for revocation of the Belgian part of EP3297977 on grounds of insufficiency, lack of novelty, and lack of inventive step. 

Concerning inventive step, the court applied Articles 52 to 57 of the European Patent Convention and rejected Trasis' counterclaim, which relied on a combination of prior art documents from two different technical fields. The court found no explicit or implicit link between the documents that would prompt a skilled person to combine them and that Trasis had failed to show why such a combination would have been made. 

The court also held that, even if the documents were combined, they did not disclose the reconditioning and reuse of a QMA cartridge and did not lead to the patented solution. The court further held that the dependent claims were inventive as the independent claim was inventive, and found, based on European Patent Office (EPO) guidelines, that the generic disclosure of a dilution technique did not suffice to deprive the specific application of that technique of an inventive step. 

Regarding the French part of EP3297977, the court declared itself competent under Article 4 of the Brussels Ibis Regulation as the court of the defendant's domicile. However, noting that the Paris court had been seized over the invalidity of the French part of EP3297977 and referring to the CJEU preliminary question in Case C-339/22 (BSH/Electrolux), the court stayed the infringement proceedings. 

The judgment is notable because, by the time of the court’s decision, the CJEU had already delivered its judgment in Electrolux. In that judgment, the CJEU confirmed that a court seized on the basis of the defendant’s domicile may rule on infringement of foreign designations of a European patent, even where validity is put in issue, while validity itself remains reserved to the courts of the member state of registration. 

While infringement proceedings may be stayed if the court of the member state of registration has been seized with invalidity proceedings, the court may only do so where it considers this justified and appropriate, in particular where it considers there is a reasonable, non-negligible possibility of the patent being declared invalid. However, the court did not refer to the Electrolux decision nor explain how it came to its decision to stay the proceedings. 

On infringement of the Belgian part of EP3297977, the court found neither literal infringement, nor infringement by equivalents under the function-way-result test. The unfair competition claims were likewise dismissed. 

Brussels Enterprise Court, (14th ch.), September 22, 2025, Out and Out Chemistry SRL v. Trasis SA 

Contributors: Françoise Billen, Peter Van Dyck, Jarne Jacobs and Marie Barani 

Brussels Enterprise Court President confirms Belgian approach to notification for SPC manufacturing waiver  

On November 12, 2025, the president of the Brussels Enterprise Court confirmed the Belgian approach to the notification requirements for relying on the SPC manufacturing waiver in a dispute between Regeneron and Sandoz.

Regeneron, holder of an SPC for aflibercept, claimed that Sandoz’s notification to manufacture aflibercept biosimilars in Belgium for export to third countries was not compliant with Article 5.5 of Regulation 2019/933, as it did not include the references to the marketing authorisations in the destination countries. Sandoz subsequently updated its notification twice with the references to the U.S. and the UK marketing authorisations.  

Based on the legislative background of the SPC manufacturing waiver, the president rejected Regeneron’s interpretation, considering that information on third countries’ marketing authorisation only had to be provided once it was made public, which Sandoz had done through its subsequent updates. The president thereby confirmed the Belgian approach and its alignment with the Hague Court’s position. 

The president expressly rejected the Munich Court’s approach, under which a company seeking to rely on an SPC manufacturing waiver must provide the reference of at least one marketing authorisation and identify the export destination. 

The president also dismissed Regeneron’s claim of (imminent) infringement based on the notification update, finding that a notification update did not establish that Sandoz had started or would start manufacturing biosimilars for export to the U.S. The president further declined to refer Regeneron’s questions to the CJEU.  

President of Brussels Enterprise Court, November 12, 2025, Regeneron Pharmaceuticals Inc. v. Sandoz GmbH 

Contributors: Françoise Billen, Peter Van Dyck, Jarne Jacobs and Marie Barani 

UPC

Düsseldorf Local Division dismisses Align Technology's application for provisional measures against Angelalign, emphasising the applicant's burden of proof 

On May 12, 2026, the Düsseldorf Local Division dismissed Align Technology's application for a preliminary injunction against the Angelalign group, finding that Align had failed to demonstrate with sufficient certainty that Angelalign's “A7 Premolar Extraction Solution” clear aligners infringe EP 4 295 806 B1. This is the second provisional measures application between the parties—in February 2026, the same court granted Align a pan-UPC injunction on a different patent (EP 4 346 690).  

The court construed claim 1 as requiring all claimed features to be realised in a single appliance, not across different treatment phases performed by successive aligners. The court therefore rejected Align's attempt to demonstrate infringement by reference to promotional material referring to different phases of the overall treatment. The court stressed that the burden of proof lies squarely with the applicant and rejected Align's generalised assertions as insufficiently substantiated. Validity, urgency, and all other issues were left undecided.  

The decision reinforces that applicant bears the evidential burden and must provide reasonable evidence satisfying the court with a sufficient degree of certainty that the patent is infringed. In that the decision gives guidance on the evidentiary standard required to establish infringement in technically complex, multi-stage medical device technologies. Especially where the accused technology involves multi-stage processes, patentees should consider obtaining independent technical assessments or detailed reverse-engineering evidence before filing. 

LD Düsseldorf, May 12, 2026, Align Technology, Inc. v. Angelalign France Technology SASU and others, UPC_CFI_1747/2025 
 

Contributors: Stephan Neuhaus and Caroline Bley

UPC Central Division (Milan) revokes Remdesivir patent for lack of inventive step 

On May 4, 2026, the UPC Central Division (Milan) revoked European patent EP 3 854 403 in its entirety. The patent, held by the Academy of Military Medical Sciences (AMMS), claimed the use of Remdesivir for treating SARS-CoV-2 infections and had a priority date of January 21, 2020—which is shortly after the virus was sequenced but before the WHO declared a public health emergency. Gilead Sciences filed its revocation action on the date of grant (June 18, 2025).  

The court dismissed the insufficiency of disclosure attack but found the patent lacking in inventive step. Applying the holistic approach set out in Amgen v. Sanofi/Regeneron (UPC_CoA 528/24), the court held that the objective technical problem was identifying a drug with antiviral activity against SARS-CoV-2, and that prior art publications explicitly recommending Remdesivir—a known broad-spectrum antiviral effective against SARS-CoV-1 and MERS-CoV via inhibition of the highly conserved RdRP enzyme—gave the skilled person a realistic starting point with a high expectation of success. 
In its assessment, the court stated that the skilled person is “an objective, rational figure who does not display fear of failure,” rejecting AMMS's attempt to attribute subjective caution to this notional individual. The court also rejected arguments that prior art publications were merely “promotional” because they originated from Gilead-associated researchers, holding that speculation about industry funding cannot undermine the credibility of peer-reviewed scientific work.  

The decision highlights the UPC's approach to inventive step. The Court further drew a sharp distinction between a “reasonable expectation of success” and a “mere hope of success,” holding that this distinction does not depend on the researcher's subjective state of mind. 

A reasonable expectation of success exists when scientific data or experiments indicate that a tested solution can yield a positive result, despite the general uncertainty arising from necessary experimentation. Hope of success, by contrast, arises only when a result is based on sheer assumptions or contradictions in the sources.  

Gilead's parallel EPO opposition remains pending.  

CD Milan, May 4, 2026, Gilead Sciences, Inc. v. Academy of Military Medical Sciences, UPC_CFI_552/2025 

Contributors: Stephan Neuhaus and Caroline Bley