UPC and life sciences: the first strategic lessons

Two and a half years after its opening, the Unified Patent Court (UPC) has issued enough life sciences decisions for a strategic map to become possible. Pharmaceutical and biotech litigation before the Court is no longer an experimental field: it follows an identifiable grammar.

The tension structuring that grammar can be captured in one formula: the Court rewards rigour, not volume. Rights are won at the drafting and grant stage; they are lost at the launch stage. In between, the UPC applies an evidentiary and procedural discipline that forgives neither loose claim language nor improvised pre-launch conduct.

For in-house counsel, originators as well as manufacturers of generics and biosimilars, these early lessons form an operational framework, which the developments of 2025 and 2026 have sharpened on several decisive points.

Acquiring strong rights

First lesson: the patentability of biological inventions tolerates no documentary shortcuts. The Amycel case (UPC_CFI_195/2024, The Hague Local Division), concerning a cultivated mushroom strain, is a reminder that biological characterisations and deposits under the Budapest Treaty remain essential: strains, cell lines and modified micro-organisms require exact documentation from the outset.

Second lesson: the Court construes claims strictly and performs no "judicial rescue" of defective wording. The Alexion appeals (UPC_CoA_402/2024 and UPC_CoA_405/2024) establish this for antibody claims: the text must align with the description from filing onwards. That requirement has now reached the EPO itself: in decision G 1/24 of 18 June 2025, the Enlarged Board of Appeal held that the description and drawings must always be consulted when interpreting the claims, aligning the Office's practice with that of the UPC.

Third lesson: EPO opposition has become the dress rehearsal for trial. The case law (10x Genomics v. NanoString, Carrier v. Bitzer, Meril v. Edwards) confirms that the UPC conducts its own validity analysis, independently of opposition proceedings, and stays its proceedings only where an EPO decision is imminent and concrete. A revocation action before the UPC can therefore only be anticipated by stress-testing the patent in opposition.

Second medical use claims: the two-limb test

For second medical use claims, the Düsseldorf Local Division laid down, in Sanofi/Regeneron v. Amgen (UPC_CFI_505/2024, 13 May 2025), a two-limb test: causality (could the offering of the product lead to the claimed therapeutic use?) and knowledge (did the defendant know it, or should it have known it?). Validity and infringement are assessed separately: absent the evidentiary link, infringement is rejected even where validity is established.

The validity limb of the same saga saw a remarkable reversal: after the first revocation ordered by the Munich Central Division on 16 July 2024, analysed in our article on the first revocation action before the UPC, the Court of Appeal reversed that decision on 25 November 2025 (UPC_CoA_529/2024) and upheld the patent, at the end of a holistic assessment ofinventive step finding no reasonable expectation of therapeutic success. The lesson stands as a warning: before the UPC, the value of an antibody family can flip from one instance to the next.

Pre-launch activities: where the exemptions end

The experimental use and Bolar exemptions stop before commercial launch. The Boehringer Ingelheim v. Zentiva decision (UPC_CoA_446/2025, 13 August 2025) allows cross-border preventive measures as soon as the launch infrastructure is substantially complete, including in light of pricing, reimbursement and public procurement activities. We have devoted a detailed analysis to this imminent infringement case law and its geography of risk.

The December 2025 provisional agreement on the EU pharmaceutical package, which will extend the Bolar exemption to pricing, reimbursement and tender steps, will not change the underlying line: regulatory steps will be covered, not the building of actual launch capability. For generic manufacturers, fine-grained pre-launch mapping becomes a compliance requirement in its own right.

Injunctions, patients and proportionality

The injunction remains the default remedy, but the Court accepts narrow accommodations where patient interests so require: Edwards v. Meril (UPC_CFI_15/2023) recognises limited clinical carve-outs, whileInsulet v. EOFlow (UPC_CoA_768/2024) limits the weight of patient-transition arguments. Proportionality also extends to procedural economy: in Merz v. Viatris, the Paris Local Division capped submissions at around 70 pages after a 470-page defence.

The Court of Appeal extended that line on 27 April 2026 in the same case (UPC_CoA_917/2025): public interest and patient access arguments must be supported by tangible evidence, supply data and medical material included, failing which they yield to the preservation of exclusivity. Provisional measures are now won on the evidentiary battlefield.

The SPC, a jurisdictional blind spot

The supplementary protection certificate remains the most uncertain layer of the edifice. The CJEU trilogy (Teva v. Gilead, C-121/17; Santen, C-673/18; Royalty Pharma, C-650/17) has narrowed the scope and duration of the SPC: only the first authorisation counts, and the duration calculation follows a strictly textual reading.

The unitary SPC project, with centralised examination before the EUIPO, remains under negotiation: the European Parliament adopted its position in February 2024, but final adoption is still awaited. Three jurisdictional models are plausible: exclusive UPC jurisdiction, the most coherent solution; shared jurisdiction, at the risk of fragmentation; or national jurisdiction, prolonging the current asymmetry. Until that point is settled, synchronising SPCs and regulatory timelines is a matter of litigation strategy as much as portfolio management.

Strategic implications

For originators: draft for literal interpretation, align grant and enforcement, build resilient validity defences from the opposition stage, and document the claimed therapeutic efficacy. For generics and biosimilars: file early EPO oppositions, map every pre-launch step and avoid any appearance of imminence, with the choice of forum remaining, as we have shown in relation to forum shopping before the UPC, a lever to be operated early.

For all, the cross-cutting lesson is the same: the UPC has established itself as a credible forum that rewards precision and preparation. The decisions in the Court's register now form a body of case law that every life sciences strategy must integrate upstream, well before the first procedural act.

Key takeaways

• The UPC applies strict claim construction, with no judicial rescue of defective wording; G 1/24 (EPO, 18 June 2025) has aligned the Office's practice with this approach.
• Infringement of second medical use claims follows a two-limb test, causality and knowledge, distinct from the validity assessment (Düsseldorf, 13 May 2025).
• The Amgen sequence, revocation on 16 July 2024 then reversal on appeal on 25 November 2025, shows that the value of an antibody patent can flip from one instance to the next.
• Pre-launch exemptions end where launch infrastructure begins: cross-border preventive measures are available from that stage (Boehringer, 13 August 2025).
• Patient interest arguments carry weight only if proved with concrete data (Merz v. Viatris, 27 April 2026).
• The jurisdictional regime of the unitary SPC remains open; that uncertainty must be built into portfolio strategies today.

Frequently asked questions

Does the UPC follow EPO opposition decisions?

No: the UPC conducts its own validity analysis and stays proceedings only if an EPO decision is imminent and concrete; opposition nonetheless remains the best dress rehearsal for litigation.

How does the UPC deal with second medical use claims?

Through a two-limb test: could the offering of the product lead to the claimed therapeutic use, and did the defendant know or should it have known; without proof of both elements, infringement is rejected even if the patent is valid.

Can a biosimilar prepare its launch during the life of the patent?

Trials and regulatory steps covered by the Bolar exemption remain lawful, but assembling a substantially complete launch infrastructure may amount to imminent infringement and trigger cross-border provisional measures.

Is the unitary SPC already in force?

No: the proposed regulation, with centralised examination before the EUIPO, is still under negotiation following the European Parliament's position of February 2024, and the question of jurisdiction has not been settled.

Dhenne Avocats assists life sciences companies before the Unified Patent Court, from portfolio audits to the conduct of infringement and revocation actions, together with pharmaceutical regulatory matters. Talk to us.

This article is an original and substantially updated adaptation of an analysis by Matthieu Dhenne first published on Kluwer Patent Blog on November 6, 2025: UPC: Early Strategic Insights for Life Sciences.