Life Sciences Monetization After San Diego: The UPC as Portfolio Strategy

The lesson of this year's BIO International Convention in San Diego1is not that the market has finally discovered the Unified Patent Court; it has been aware of it for some time. It is that life sciences transactions have begun to treat the Court as something other than a forum for resolving disputes. They treat it as a mechanism that converts territorial patent power into price. In licensing, acquisition, financing and partnering, the UPC exerts its influence well before any claim is filed — through the enforceability that counterparties expect it to deliver.2

The familiar way of describing the Court no longer suffices. It is true that the UPC is where one goes when a biosimilar launches, when a competitor threatens an at-risk entry, or when a validity attack must be met; but that description captures only its adjudicatory face. The Court is also a portfolio instrument. It shapes what a patent family can credibly do, in which territories, on what timescale, and how much stands to be lost should validity be decided adversely. These are not questions of litigation housekeeping — they feed directly into valuation.

The economics of a load-bearing floor

The protective stack in life sciences has not changed in its composition. It still rests on European patents, European patents with unitary effect, supplementary protection certificates, and the regulatory exclusivities that define the commercial window for a medicine.3The UPC does not adjudicate regulatory data protection, marketing protection or orphan exclusivity, and it does not purport to. What it does is alter the patent and SPC layer against which those regulatory periods are ultimately monetized. The Court leaves the structure of the stack intact while changing the economic performance of one of its load-bearing floors.

The first change is one of scale. A UPC injunction is not simply a French, German, Dutch or Italian remedy transposed onto a wider map. Where a European patent has effect in Contracting Member States, a decision of the Court may extend across that territory; where the patent has unitary effect, protection is uniform throughout the participating Member States in which that effect subsists.4This is not yet the whole of Europe. It is the present UP and UPC territory — eighteen Member States — which, in a great many life sciences matters, coincides with the commercial heart of the European launch.

The second change is less welcome. Centralised enforcement carries with it centralised vulnerability: the very system that turns a patent into cross-border leverage also concentrates the risk of revocation in one forum.5For a therapeutic antibody, a platform diagnostic, a delivery device or a manufacturing process on which milestone payments and royalty streams depend, this is no procedural detail but a risk borne by the asset itself. Central enforceability adds value only to the extent that the patent can also withstand a central challenge.

Diligence as price formation

This is why the commercial centre of gravity has shifted upstream, into the transaction itself. The value of a life sciences asset has always turned less on the mere existence of patents than on their capacity to exclude, to delay, to license, to settle and to command a premium. The Court makes that capacity easier to model: within its domain it replaces the old national mosaic with a more legible European enforcement profile, without of course abolishing the territorial differences that persist beyond its reach. Uncertainty does not disappear; it is concentrated and rendered communicable. And communicable uncertainty is exactly the kind that buyers, licensees, lenders and boards know how to price.

Due diligence changes accordingly. The traditional question — in which jurisdictions should we obtain opinions? — retains its place, for national opinions remain indispensable outside the system and for issues the Court does not absorb. But it no longer suffices. The question that now governs is whether the portfolio will perform before a single Court whose remedial reach, evidentiary powers and damages framework can move the economics of the transaction.6A weak UPC profile depresses a valuation; a robust one sustains a premium. That variable belongs in the financial model rather than in an appendix reserved for litigation.

It is in this precise sense that the UPC operates as a court of transaction. It does so not by negotiating contracts or displacing the market, but because the judgment it is expected to render lowers transaction costs. European patent value was long assembled as a mosaic of local probabilities — one assessment of validity in Germany, another in France, others in the Netherlands and in Italy, each with its own timetable and its own remedial grammar. The Court allows a counterparty to price at least part of the European position through a single institutional lens,7converting a scatter of national opinions into an enforcement profile that can be traded.

Readiness as a discipline

The variable is worth naming — UPC-readiness — provided the term is kept rigorous rather than promotional. Readiness is a discipline. It requires clean title and priority; a defensible claim construction; sufficiency, added matter, novelty and inventive step tested under pressure; infringement evidence that does not rest on wishful thinking; a clear map of licensee standing; SPC status synchronised with the patent family; and a regulatory calendar read against the patent calendar.8A family unable to answer these questions is not only ill-prepared for litigation; it is, more fundamentally, imperfectly described as an asset.

The opt-out is the clearest illustration, since it reduces a strategic choice to an entry in a register. It is neither timid nor bold; it is a financial decision. Opting out preserves national fragmentation and limits exposure to a central revocation action, while remaining within the system — or withdrawing an earlier opt-out — keeps open the possibility of relief across the whole of the UPC territory, subject to the limits on reversibility that the Agreement and the Rules impose.9Any transaction that cannot say who made that election, on what authority, for which patent, application or certificate, and with what blocking effect, has not completed its intellectual property diligence.

Case law read as valuation

The first life sciences decisions of the Court already furnish the grammar of this diligence. In NanoString v. 10x Genomics, the Court of Appeal made the grant of provisional relief depend on its own appraisal of the patent, of the claim, and of the degree of certainty required at the interim stage.10The significance of that ruling reaches beyond the law of interim measures. It tells the deal lawyer, the banker and the investment committee that a patent's present value is a function of how it would fare under a compressed examination of validity and infringement.

The Amgen/Sanofi sequence makes the same point more starkly. A first-instance revocation of a biologics patent, followed by appellate review of validity, is not merely an episode in the law of antibody patentability; it is a valuation event, in which a single family may pass from leverage to impairment and back again along a procedural path that every counterparty can observe.11The market does not wait for such a dispute to mature before pricing that possibility; it does so at the term-sheet stage.

Second medical use claims sharpen the analysis still further. Their worth seldom resides in the wording of the claim; it lies in the alignment between therapeutic use, label, market conduct, knowledge and proof. The decision of the Düsseldorf Local Division in Sanofi/Regeneron v. Amgen shows why: infringement of a purpose-limited therapeutic claim is not established by invoking a molecule, but through a structured inquiry into the use for which the product is offered, placed on the market and understood by its users.12That inquiry is transactional before it is forensic. A purchaser needs to know that the proof will be available before a competitor launches, and not only once disclosure has disappointed everyone concerned.

Drafting around the Court

This poses a fresh drafting problem for those who negotiate deals. Representations and warranties can no longer stop at ownership, prosecution status and pending disputes. They must now reach the jurisdictional posture before the UPC, the history of any opt-out and the authority on which it was made or withdrawn, the weak points of validity, exposure to pending opposition before the EPO, SPC dependencies, the enforcement rights of licensees, the preservation of evidence, constraints of confidentiality, and control over the conduct of UPC proceedings. Covenants, in turn, should settle who may commence an action before the Court, who may settle it, who bears the risk of central revocation, who controls amendment of the claims, and how milestones or earn-outs are to respond if a key claim is limited or struck down.

The same holds for the sequencing of disputes. Infringement actions, standalone revocation actions, counterclaims, referrals to the central division and stays are far from neutral procedural branches; they are instruments of timing capable of shifting the balance of bargaining power.13A company that can explain in advance how a hypothetical action before the Court would unfold is better placed than one that discovers its own enforcement profile only once a statement of claim, or an action for revocation, has been filed.

Evidence, too, must be considered upstream. The Court affords the parties means of obtaining and preserving proof, subject to the protection of confidential information.14This matters in life sciences because the decisive facts are so often technical, clinical, regulatory or industrial: batches and assays, release specifications, labelling and SmPC wording, tender documents, supply chains, indications and the realities of commercialisation. A portfolio without a plan for evidence is unprepared not merely for litigation but, more tellingly, for the transaction.

Large portfolios, a single forum

Discovery driven by artificial intelligence, and computational biotechnology more broadly, only intensify these considerations. Such portfolios grow quickly, branch early and frequently rest on platform claims, screening outputs, regions of sequence space, biomarkers or model-assisted hypotheses. The larger and more ramified the family, the greater the value in expressing its European enforcement profile through a single forum. The Court does nothing to simplify the underlying science; what it simplifies is the legal question that counterparties put to that science — whether the portfolio can be turned into enforceable exclusivity on a European scale without exposing it to a centralised loss.

For biotechnology and medical-device companies, the management of a portfolio thus becomes an exercise in valuation. The relevant questions are no longer confined to which applications to file, which claims to pursue, which divisionals to maintain and which certificates to seek. They extend to which assets should remain exposed to the Court, which should be opted out, which should be tested under pressure before a fundraising, and which may be presented to a counterparty as ready for enforcement before the UPC. The better portfolio memorandum today reads at once as a damages model and as the skeleton of a pleading.

For investors, technology-transfer offices, universities, acquirers and lenders alike, UPC diligence belongs at the financial core of the transaction rather than as a contingency bolted on once the price has been agreed. It is itself a determinant of that price. The more heavily a deal depends on European exclusivity, the less tenable it becomes to treat the Court as a mere litigation footnote. In this limited but decisive sense the UPC is not merely a court before which the parties may one day appear; its anticipated decision is already being traded before they do, so that the Court itself forms part of the asset.

Where value is set

The thread running through all of this is straightforward. The question in life sciences is no longer simply whether one would prevail if forced to litigate before the UPC. It is what the portfolio is worth to a buyer, a licensee, an investor or a lender, given how it would perform before the Court. That question is posed in the deal room long before it reaches the courtroom — and the deal room does not displace the Court so much as capitalise its likely answer.

In life sciences, then, the UPC is not merely the place where value is defended; it is increasingly the place where value is set. Its function in law remains that of adjudication, but its effect in commerce is transactional, and the enforcement profile it generates has become one of the figures a counterparty reads into the price. Those undertakings that come to see the Court as an element of portfolio strategy, rather than as a form of litigation insurance, will turn that understanding to account. The others will go on describing it as a courtroom, even as the market has already begun to treat it as an asset.

• 1Biotechnology Innovation Organization, BIO International Convention 2026, June 22-25, 2026, San Diego, official convention page.
• 2Agreement on a Unified Patent Court, OJ C 175, June 20, 2013, art. 1 and art. 32(1)(a)-(e) (jurisdiction over infringement, declarations of non-infringement, provisional measures, revocation actions, and revocation counterclaims).
• 3UPCA art. 3(a)-(c); Regulation (EU) No. 1257/2012 of the European Parliament and of the Council of Dec. 17, 2012, arts. 3 and 5; Regulation (EC) No. 469/2009 of the European Parliament and of the Council of May 6, 2009, arts. 3-5; Directive 2001/83/EC of the European Parliament and of the Council of Nov. 6, 2001, art. 10(1); Regulation (EC) No. 726/2004 of the European Parliament and of the Council of Mar. 31, 2004, art. 14(11); Regulation (EC) No. 141/2000 of the European Parliament and of the Council of Dec. 16, 1999, art. 8.
• 4UPCA arts. 34, 62(1), and 63(1); Regulation (EU) No. 1257/2012, art. 5(1)-(2). On the present territorial coverage, see European Patent Office, Unitary Patent, section 'Current states in the UP and UPC system (18)' (Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Romania, Slovenia, and Sweden).
• 5UPCA art. 32(1)(d)-(e); id. art. 65(1)-(5); Convention on the Grant of European Patents (European Patent Convention), arts. 138(1) and 139(2).
• 6UPCA art. 59(1)-(2) (orders to produce evidence); id. art. 62 (provisional and protective measures); id. art. 63 (permanent injunctions); id. art. 68(1)-(3) (damages, including lost profits, infringer's profits, and reasonable royalties or fees).
• 7UPCA arts. 32-34, 59, 62, 63, and 68.
• 8EPC arts. 54, 56, 83, and 123(2); UPCA art. 65(2); UPCA art. 47(1)-(2) (parties and enforcement by patent proprietors and exclusive licensees); Regulation (EC) No. 469/2009, arts. 4-5; UPCA art. 30.
• 9UPCA art. 83(1), (3), and (4); Rules of Procedure of the Unified Patent Court, Rule 5 (lodging of an application to opt out and withdrawal of an opt-out).
• 10UPC Court of Appeal, Order of Feb. 26, 2024, UPC_CoA_335/2023, App_576355/2023, NanoString Technologies Inc. et al. v. 10x Genomics Inc. et al.; see also UPCA art. 62(4) (reasonable evidence and sufficient degree of certainty for provisional measures).
• 11UPC, Central Division, Munich Section, Decision of July 16, 2024, UPC_CFI_1/2023, Sanofi-Aventis Deutschland GmbH et al. v. Amgen Inc. (EP 3 666 797); UPC Court of Appeal, Decisions of Nov. 25, 2025, UPC_CoA_528/2024 and UPC_CoA_529/2024, Amgen Inc. v. Sanofi-Aventis Deutschland GmbH et al. and related Regeneron proceedings.
• 12UPC, Local Division Duesseldorf, Decision of May 13, 2025, UPC_CFI_505/2024, Sanofi Biotechnologies SAS and Regeneron Pharmaceuticals Inc. v. Amgen Inc. et al.; UPCA arts. 25 and 26.
• 13UPCA art. 33(3) (counterclaims for revocation and the local or regional division's options); id. art. 33(4)-(5) (standalone revocation actions before the central division and sequencing with infringement actions).
• 14UPCA art. 58 (protection of confidential information); id. art. 59 (orders to produce evidence); id. art. 60 (orders to preserve evidence and inspect premises).