Life sciences patents monthly roundup—July 2026

In this edition, at the UPC, the Court of Appeal issues two decisions on preliminary injunctions; the first providing guidance on the urgency requirement, finding that a three-month delay in filing was not adequately justified, and the second confirming the grant of a preliminary injunction where the parties were direct competitors. 

In the context of parallel proceedings, the UPC’s Brussels Local Division considers alignment with parallel UK proceedings in making orders regarding evidence production and disclosure. In a further case, the UPC also considers the requirements for a licence to be considered exclusive such that the licensee has a right to bring proceedings for infringement.

In France, the Paris Court of Appeal upheld the refusal of a supplementary protection certificate, holding that the combination was not specifically identifiable in the basic patent.

In Belgium, the Brussels Enterprise Court rejected the argument that bioequivalence of a biosimilar establishes infringement by equivalence under patent law.

Finally, in the UK, in an expedition application the High Court accepted urgency linked to a pending NICE appraisal but, although granting a degree of expedition, ultimately declined to expedite to the requested trial date owing to delay in commencing proceedings and prejudice to the defendants.

We welcome any new readers this month, and please do let us know if you have any colleagues who would also be interested in receiving the newsletter. We will take a break for the summer in August but will return with the next newsletter in September. 

Krystyna Szczepanowska-Kozlowska and Tom Edwards

Our July edition includes updates from the following jurisdictions. Click below to jump to any of these sections.

UPC | France | Belgium | UK

UPC

Court of Appeal provides guidance on urgency when seeking a preliminary injunction

In its decision on Guardant’s appeal of the first instance decision rejecting its application for a PI against Sophia Genetics’ cancer detection test kits using liquid biopsy, the UPC Court of Appeal has provided helpful guidance on the requirement to act with urgency when seeking a preliminary injunction:

• There is no need for a patentee to assert all alleged infringed patents in one application for provisional measures. Waiting to consolidate all patents in one application may constitute an unreasonable delay in seeking relief.
• A patentee is generally not obliged to monitor the market but, once it becomes aware of specific facts suggesting infringement, it must investigate diligently and this can include investigating possible infringement in other jurisdictions.
• If a patent holder is aware, on the basis of a document, that one or more of its patents has been infringed, it must not turn a blind eye to the fact that the document also indicates infringement of other patents.
• If the applicant is a legal entity, the decisive date for assessing urgency is when its authorised representative body or an individual capable of pursuing or reporting the infringement becomes aware of it. This may include, for example, an employee of the IP department, a senior member of the sales department or a shopper engaged to investigate IP infringements.
• If there is a delay for technical analysis, the applicant should explain when the analysis began, which patent features required it, how long it took, and why that duration was reasonable.

Overall, the UPC Court of Appeal did not consider Guardant to have acted with sufficient urgency because the application was filed three months after they became aware of the infringement and this delay had not been adequately justified.

UPC Court of Appeal, Guardant Health v. Sophia Genetics, July 2, 2026, UPC-CoA-19/2026.

Contributors: Beverley Potts, Tom Edwards and Rafi Allos

Court of Appeal confirms the necessity of a preliminary injunction when parties are direct competitors

The UPC Court of Appeal has confirmed the grant of a preliminary injunction sought by Align Technology against Angelalign covering orthodontic aligners and treatment software.

The injunction was necessary because the parties are direct competitors in the field of clear aligner therapy and the continued supply of the alleged infringing software posed a concrete risk to the patentee’s market position. Clinicians were likely to use the aligner system for current and future patients so their choice of a provider could have a lasting effect on the patentee’s market share.

In contrast, the defendant’s software could be used without the challenged features, and the defendant could seek damages for later entry if it was later determined that the injunction was unwarranted.

UPC Court of Appeal, Angelalign Technology v. Align Technology, July 8, 2026, UPC_CoA_36/2026.

Contributors: Beverley Potts, Tom Edwards and Rafi Allos

UPC aligns its order to produce evidence with parallel national proceedings

In a decision of an application to produce evidence by GC Aesthetics in its litigation against Establishment Labs concerning patents covering soft tissue breast implants, the LD Brussels has emphasised that, where UPC and UK (or other national proceedings) run in parallel, evidence requests should be aligned as far as possible.

It therefore ordered the production of evidence in categories where this had been agreed in the UK proceedings and aligned the deadline for production of the evidence with the UK disclosure order. The court emphasised that this creates a common evidence basis, avoids duplication, reduces the disclosure burden, and preserves proportionality and procedural efficiency.

In this instance, the LD Brussels made an order for production of documents including clinical reports and technical analyses of Establishment Labs’s products pursuant to the UPC’s rules providing for production of documentary evidence, which include the following:

• The requesting party has presented evidence “reasonably available” in support of its claims.
• The requested evidence is “specified” and in control of the other party.
• The other party’s confidential information is protected.
• The request satisfies the requirements of proportionality, equity and fairness.

LD Brussels, GC Aesthetics v. Establishment Labs, June 26, 2026, UPC_CFI_1357/2025 and UPC_CFI_629/2025

Contributors: Beverley Potts, Tom Edwards and Rafi Allos

UPC confirms the standing of an exclusive licensee

The UPC has confirmed that Promosome’s patent concerning mRNA technology is invalid for lack of novelty and not infringed. Promosome was, however, the exclusive licensee and had standing to sue in the UPC. What is decisive is whether the licensee is entitled solely to use and to exclude others, including the patent proprietor, from using the patented invention.

The court also confirmed that the seven-year transitional period does not affect the UPC’s competence for infringement prior to June 1, 2023. There is no legal basis for making a distinction between acts carried out before entry into force of the UPCA and acts that started before June 1, 2023 and continued afterwards.

LD Munich, Promosome v. BionTech/ Pfizer, July 7, 2026, UPC_CFI_846/2024 UPC_CFI_485/2025 UPC_CFI_535/2025.

Contributors: Beverley Potts, Tom Edwards and Rafi Allos

France

Paris Court of Appeal clarifies Article 3(a) SPC requirements in AstraZeneca Dapagliflozin/Metformin ruling

In a decision dated July 10, 2026, the Paris Court of Appeal upheld the INPI's refusal to grant AstraZeneca AB a supplementary protection certificate (SPC) for the combination “dapagliflozin or one of its pharmaceutically acceptable salts and metformin or one of its pharmaceutically acceptable salts,” confirming that the combination did not satisfy the requirements of Article 3(a) of Regulation (EC) No 469/2009.

Applying the two-step test derived from the CJEU’s case law and in particular its judgment of December 19, 2024 (C-119/22 and C-149/22), the court found that Article 3(a) was not satisfied for several interlinked reasons.

First, the technical problem actually disclosed by the basic patent was limited to providing a new SGLT2 inhibitor compound (dapagliflozin) to treat diabetes, not a new combination therapy as such.

Second, although claim 7 expressly listed metformin as the first of many possible antidiabetic agents to be combined with dapagliflozin, it was cited merely as one example among a very large number of possible combinations, with nothing in the patent indicating why this particular combination was necessary to solve the technical problem.

Third, paragraph [0054] of the description, introduced by the words "it is believed that", was found to express only a hypothesis regarding a possible effect of the combination, unsubstantiated by any data, and paragraph [0055] merely mentioned metformin as one possible option among other biguanides without any particular incentive to select it.

Fourth, AstraZeneca's own correspondence with the French Patent Office acknowledged that establishing a synergistic effect for the dapagliflozin/metformin combination would require further research and clinical trials.

Fifth, the court held that a skilled person would have had to make multiple successive selections—choosing the biguanide family among 13 listed families (claim 6), then metformin among 31 listed compounds (claim 7)—meaning the combination was not "specifically identifiable" at the priority date.

Paris Court of Appeal, July 10, 2026, AstraZeneca A.B.  v. Director of the French Patent Office, Docket No. 24/18803

Contributors: Elise Romelly and Laetitia Benard

Belgium

The Brussels Enterprise Court rejects allegations that bioequivalence means infringement by equivalence

On January 8, 2026, the president of the Dutch-speaking Brussels Enterprise Court rejected allegations of infringement by equivalence based on a product’s bioequivalence in a dispute between Regeneron Pharmaceuticals Inv. and BV Celltrion Healthcare Belgium concerning Celltrion’s biosimilar Eydenzelt (aflibercept), a biosimilar of Regeneron’s Eylea.

Based on its European patent EP 2 364 691, which relates to formulations of a VEGF antagonist suitable for intravitreal administration, Regeneron applied for preliminary measures against Celltrion’s biosimilar, including a preliminary injunction, a prohibition against advertising and the offer of samples, and a recall of products due to infringement of claim 1 of the patent.

The president held that Regeneron had a sufficient interest to bring the claim, as it sought to prevent financial losses and reputational damage, but failed to show a prima facie infringement of claim 1 by equivalence.

Regeneron argued that the formulation elements used in Eydenzelt are technical equivalents of those claimed in the patent. The president disagreed: Regeneron had failed to discharge its burden of proving that the differences between the two formulations—in particular, histidine as a buffer in Celltrion’s biosimilar versus sodium phosphate as specified in claim 1 the patent—were technically equivalent. The president also held that:

• Bioequivalence is not the same as technical equivalence under patent law.
• Bioequivalence does not require identical composition between a biosimilar and its reference medicine.
• Conversely, technical differences in formulation do not exclude bioequivalence.
• Using a medicine as reference product alone cannot establish infringement, or every biosimilar would infringe every formulation patent covering its reference medicine.

For completeness, the president also found that the balance of interests favoured Celltrion, noting in particular:

• Regeneron had already profited from a long-standing, multi-billion-euro monopoly on aflibercept (extended by a supplementary protection certificate), and its anticipated losses were quantifiable and recoverable – unlike Celltrion’s harder-to-quantify harm from a wrongful injunction.
• Regeneron had waited to bring proceedings until October 2025 despite earlier awareness of Eydenzelt’s formulation.
• The public interest, including cost savings from biosimilar competition, weighed against enjoining a biosimilar absent sufficient evidence of infringement.

Pres. Brussels Enterprise Court, Regeneron Pharmaceuticals Inc. v. BV Celltrion Healthcare Belgium, January 8, 2026

Contributors: Jarne Jacobs, Marie Barani and Peter Van Dyck

UK

Janssen obtains modest degree of expedition of revocation action given pending NICE HTA process

Janssen sought expedition of its patent revocation action and a counterclaim for infringement against the USA (patentee) and 2seventiy bio (exclusive licensee) to the 2026 autumn court term in connection with a patent relevant to its CAR-T therapy, Carvykti. Janssen argued it needed commercial certainty ahead of NICE's Health Technology Assessment (HTA) of Carvykti, as potential damages or royalty liability (no injunction was sought) affected its price/cost-effectiveness case.

Despite the absence of a threat of an injunction, Mellor J accepted that Janssen cleared the “good reason”/urgency factor of the test for expedition applications, noting that if the patent were invalid, swift clearance would benefit NHS patients given the pending NICE appraisal.

Weighing the remaining expedition test factors, Mellor J declined Janssen’s request that trial be expedited to October 2026 on the basis that Janssen did not start the UK proceedings immediately upon grant of the patent and did not start proceedings against 2seventy bio from the outset, which presumably would have required Janssen to seek a DNI.

He also found that a trial in October 2026 which would have been approximately four months from when the USA accepted it had been properly served with Janssen’s action would have caused significant prejudice to the USA and 2seventy bio notwithstanding their familiarity with the issues from parallel UPC proceedings. It also became apparent that there was in fact no slot in the court diary in October 2026 that could accommodate the trial.

The trial was ultimately listed for March 2027 which involved some degree of expedition, though Mellor J indicated he would have expedited to early December 2026 had a slot been available because that would have been ahead of when the NICE committee’s formal assessment meeting would have taken place. He granted Janssen permission to apply for any autumn 2026 term vacancy that opened up, provided any such application was made before the end of the summer 2026 court term.

Janssen v. USA [2026] EWHC 1848 (Pat) 

Contributors: Kathryn Hambly and Rafi Allos