In the often adversarial landscape of European patent litigation, the Unified Patent Court (UPC) has introduced a lesser-known, but potentially transformative institution: the Patent Mediation and Arbitration Centre (PMAC). Split between Lisbon and Ljubljana, the PMAC quietly proposes an alternative vision for dispute resolution—one that trades force for dialogue, and confrontation for consensus. But as with many dreams, the question remains: can this one become real?

That tension—between system and hope, confrontation and compromise—echoes the voice of Tupac Shakur, who, in a very different context, reminded the world that “reality is wrong, dreams are for real“. The PMAC is, in legal terms, just such a dream: the vision of a softer, consensual patent enforcement culture embedded in a system built for litigation. It is, in short, the poetic contradiction of trying to make peace inside a courthouse.

Voluntary but Vulnerable

Established under the UPC framework, the PMAC is designed to offer mediation and arbitration services for disputes concerning European patents, both with and without unitary effect. It lacks binding adjudicatory powers: parties must opt in voluntarily, and the Centre cannot issue enforceable measures on its own. This raises a fundamental concern: in high-stakes patent litigation, who will willingly abandon the power and enforceability of a UPC judgment to pursue amicable settlement, especially in the absence of procedural pressure points or jurisdictional incentives?

Waiting for Rules, Searching for Identity

The PMAC awaits the publication of its own procedural rules—a crucial document for credibility. Until then, uncertainties abound. Will arbitrators be appointed by the Centre or selected by the parties? What guarantees of independence and expertise will apply? Will arbitral awards be immediately enforceable across all UPC-participating states? Without answers, many practitioners remain hesitant. At present, the PMAC seems more like a conceptual placeholder than a fully operational forum. It struggles to define its identity: not a judicial body, yet not clearly competitive with existing international ADR centres like WIPO or ICC.

Complement or Competitor?

One central issue lies in the PMAC’s relationship with existing institutions. The WIPO Arbitration and Mediation Center, for instance, enjoys a solid reputation in IP disputes and well-established operational procedures. The PMAC does not yet provide a reason for parties to prefer it over more established alternatives. That said, its value may lie in complementarity. It could serve as a procedural pause point within UPC proceedings, particularly in FRAND licensing disputes, questions of contractual interpretation, or partial enforcement of decisions. But for that to happen, it needs not only procedural clarity but also strategic integration into the wider UPC framework.

How to Make It Matter

To make the PMAC matter, the UPC could formally integrate model mediation and arbitration clauses into its own procedural architecture, encouraging parties to include them in licensing and co-ownership agreements. It could also authorize the automatic suspension of UPC litigation when parties refer their dispute to the PMAC, thereby creating space for settlement without jeopardizing strategic positioning. The Centre would further benefit from embedding technical mediators—individuals with dual legal and scientific competence—into its process, ensuring more substantive and mutually intelligible dialogue between disputants. Finally, the PMAC must establish a transparent and credible public evaluation mechanism for mediators and arbitrators, if it hopes to earn the trust of parties accustomed to high-stakes, high-performance forums.

Conclusion – Between Symbol and Strategy

If the UPC is meant to be the backbone of a new European patent litigation order, the PMAC could be its softer voice—one that listens before it strikes. But location alone, even in cities as evocative as Lisbon and Ljubljana, does not confer relevance. For the PMAC to be more than a symbolic gesture, it will need a robust procedural framework, strategic integration into UPC mechanisms, and clear incentives for users.

This moment, then, is not just procedural. It is cultural. It is about choosing the kind of legal world we want to build. And maybe—just maybe—it is about listening to voices beyond the courtroom. Tupac, again, was not wrong when he said:

“We gotta make a change. It’s time for us as a people to start makin’ some changes.”

Because even in patent law, change does not come from inertia. It comes from belief. From structure. And from the willingness to reimagine what justice looks like.

“Reality is wrong, dreams are for real.” — Tupac Shakur

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Nearly five decades later, the biotech and pharmaceutical sectors are undergoing a similar shift. Patent strategy is no longer about protection alone; it is about construction. This structural turn found its echo in Boston, where over 20,000 professionals convened for BIO 2025. While the conference foregrounded licensing, collaboration, and translational innovation, the UPC emerged in the background as a defining force—quietly remastering the rules of IP orchestration across Europe.

The UPC’s Early Output

Two years into its operation, the UPC is no longer experimental. As of June 2025, the court has recorded 883 cases, 26% of which concern the pharma-biotech sector. These include 320 infringement actions and 369 revocation proceedings. Unitary patents account for approximately 28% of all newly granted European patents (See here). Patentees succeed in roughly 50% of merits decisions, but only in 45% of cases involving preliminary injunctions.

The message is clear: the UPC is procedurally active, technically sophisticated, and strategically significant.

Strategic Layers for Originators

Originator companies—especially those advancing assets through Phase II and III—are now composing IP strategies in layers, not lines. The first layer involves deploying split portfolios, blending unitary and national rights. Unitary patents are used in core commercial territories to access the UPC’s injunction potential, while national patents are retained in jurisdictions where procedural flexibility or divergent jurisprudence offer tactical advantages.

The second layer is regulatory. Supplementary protection certificates (SPCs) remain outside the unitary framework. While the UPC has affirmed jurisdiction over SPCs tethered to unitary patents (see Boehringer v. Zentiva, SPC No. 679, decision of the Lisbon Local Division), the proposed EU-wide SPC regulation (COM(2023) 231) remains in flux. Until a unified SPC is enacted, dual enforcement before national courts and the UPC will continue.

The third layer is contractual. Sophisticated license and development agreements now include UPC injunction buffer clauses—pre-negotiated terms that allow immediate adaptation of launch or marketing plans if a unitary injunction is issued. These clauses, once academic, are becoming the industry standard for cross-border transactions.

The fourth and most dynamic layer is analytics. Originators increasingly rely on data-driven litigation maps, triangulating EPO opposition history, critical claim clusters, and division-specific behavior within the UPC to plan filings and anticipate risks.

Strategic Counterpoints for Generics

Generic manufacturers are not merely defending against this multilayered architecture—they are developing countermelodies of their own.

One strategy involves targeting unitary patents for revocation via UPC proceedings, seeking to collapse cross-border exclusivity in a single stroke. The UPC’s centralized nullity jurisdiction offers generics a means to scale their litigation investments across Europe efficiently.

Another strategy focuses on therapeutical use patents. The UPC’s May 2025 ruling in Sanofi/Regeneron v. Amgen (UPC_CFI_505/2024, decision by the Düsseldorf Local Division) provides critical guidance. The court introduced a two-pronged test: availability of the generic product for the claimed indication, and knowledge or intent by the manufacturer. Passive inclusion in the Summary of Product Characteristics (“SmPC”) does not amount to infringement unless amplified through promotional channels.

This ruling gives generics an opportunity to structure their launches strategically. By tailoring packaging, communications, and market behavior to avoid evidentiary thresholds of intent, generic companies may reduce litigation exposure even in high-risk therapeutic categories.

A third strategy is procedural. Generics may pursue dual-path invalidity campaigns, combining UPC challenges on core patents with national invalidity actions on SPCs, especially in high-volume countries such as Germany or the Netherlands.

Finally, generics may adopt pre-emptive negotiation frameworks, offering conditional licenses or “early entry” deals post-AMM to mitigate the risk of pan-European enforcement while positioning themselves as preferred fallback suppliers.

While the current strategies of generic manufacturers remain legally valid within the framework established by the Sanofi/Regeneron v. Amgen decision, they could be gradually restricted as the UPC’s case law becomes more established. Although still young, the court tends to draw more consistent guidelines on infringements based on claimed therapeutic use, refining the distinction between objective criteria (availability of the product) and subjective criteria (knowledge or intention of the manufacturer).

As other decisions enrich this body of case law, a more demanding line of jurisprudence could emerge, raising the question of the limits within which a generic manufacturer can adjust its behavior to avoid the alleged intent without sliding into a form of bad faith. Such a development could lead to the introduction of a higher standard of proof, imposing on manufacturers not only formal abstention, but also positive obligations of neutrality or commercial prudence, thereby reducing the current tactical space.

The Technical Core of UPC Litigation

One of the UPC’s most distinctive features is the involvement of technical judges. These are not passive observers but engaged analysts of scientific and experimental evidence.

In Franz Kaldewei v. Bette (UPC_CFI_2/2023, decision of July 3, 2024, Düsseldorf Local Division), the court issued the first pan-European permanent injunction. Crucially, the panel’s technical judge, Dr. Ulrike Voß, led the review of auxiliary claims and inventive step. The judgment aligned closely with EPO reasoning, confirming that UPC jurisprudence is anchored in the European Patent Convention but now enhanced by procedural immediacy and enforcement power. This convergence reinforces the idea of a more coherent European judicial ecosystem, in which EPO decisions are reflected almost directly in the UPC, reducing uncertainty for both applicants and defendants.

For originators, this elevates the burden of proof. Validity arguments must be scientifically coherent and well-documented. For generics, the cost of litigation rises: nullity campaigns must now combine doctrinal argumentation with data integrity, trial design critique, and evidentiary clarity.

The SPC Reform: A Discordant Note

A significant source of uncertainty in the current legal framework lies in the status of supplementary protection certificates (SPCs) and the ongoing EU reform to establish a unitary SPC system. Under the present regime, SPCs remain national instruments governed by Regulation (EC) No 469/2009, and their enforcement—whether validity or infringement—falls within the exclusive jurisdiction of national courts when the underlying basic patent is a traditional European patent.

The introduction of the UPC has added a layer of complexity. While the UPC has declared itself competent to hear cases involving SPCs linked to a unitary patent—as in the case of Boehringer v. Zentiva, SPC No. 679 — there is no legislative provision in the UPCA explicitly addressing SPC jurisdiction. Articles 32–34 of the Agreement on a Unified Patent Court do not refer to SPCs, which has led some commentators to question whether the UPC’s current competence is de facto rather than de jure.

Meanwhile, the European Commission’s 2023 proposal for a unitary SPC (COM(2023) 231) aims to harmonise the procedure through a central examination and grant model administered by the EUIPO. However, the proposed regulation explicitly refrains from conferring jurisdiction to the UPC for the enforcement or invalidation of these future unitary SPCs. Instead, it maintains a bifurcated approach: grant at the EU level, but litigation at the national level, even where the underlying patent is unitary.

This disconnect threatens to undermine the very logic of procedural unification. For originators, it introduces jurisdictional fragmentation at precisely the stage where regulatory exclusivity is most commercially critical. For generics, it creates forum shopping incentives and litigation inefficiencies. The UPC, designed as a one-stop enforcement forum for cross-border IP disputes, risks becoming irrelevant in a domain where exclusivity extensions are most valuable.

Strategically, patentees must thus continue to manage SPC enforcement through national courts, even where their core patent strategy has migrated to the UPC. The contradiction is both legal and economic: harmonised protection without harmonised enforcement. Unless corrected in future revisions, the current reform risks amplifying procedural dissonance rather than resolving it.

Orchestrating Risk, Composing Value

Just as Tom Scholz did not record More Than a Feeling in a single take, companies cannot improvise their UPC strategy. They must compose it.

Every element—unitary patent, SPC, national fallback, buffer clause, scientific dossier, forum choice—becomes a layer in a multi-track recording. When aligned, these layers resonate not only legally, but commercially.

The UPC is not just a forum for enforcement. It is a space of resonance. For those who understand its rhythm, it offers more than a feeling—it offers compositional power.

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In this piece, I would like to cast light on special provisions under the Eurasian Patent Convention (EAPC) that regulate the scope of divisional applications.  As many readers will know, the territory of the EAPC covers eight countries: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan and Turkmenistan.

For a long time now, it has been the practice of the EAPO that the claims of a divisional application may not have claims which are identical to claims in the parent application.  However, this rule barely caused any inconvenience for patentees, as examiners routinely conducted compliance checks during substantive examination, thereby identifying and raising other patentability concerns concurrently. It was not considered a significant issue for applicants who almost always amended claims, thereby rendering double patenting issues moot.

In recent years, the EAPO has gradually integrated the double patenting check into the formal examination (in 2020) and requested that a 2-month non-extendable office action be issued in case the claims contravene the rule (in 2022). The explanations circulated by the EAPO as these rules were introduced can be distilled into the need for better determination of the examination process and a greater balance towards the public. Indeed, generic drug developers were in constant uncertainty as published divisional applications usually contained claims that were identical to the parent.

Following the implementation of the above-mentioned framework, examiners have become noticeably more rigorous in enforcing the double patenting requirements. The legislation does not elaborate on the concept of “identity”, except to state that it shall be “from a viewpoint of the scope of protection”. The practice has developed thus far in an incremental manner. Applicants have to swiftly work out the format of the claims that they wish to present for examination, the check is made during the formal examination, which is relatively expeditious; and in the event of an office action, the applicant cannot delay the response.

The provision pertaining to the allowable scope of divisional claims has been clarified by the formal introduction of rules prohibiting divisionals from having identical scope to the parent. Specifically, Rule 49 of the Regulations stipulates that:

“The claims of a divisional Eurasian application may not contain inventions that are identical to the inventions for which legal protection is sought under the parent Eurasian application, with the exception of limiting of the parent application in accordance with Rule 4 of the Regulations in the event of a violation of the requirement of unity of invention”.

The EAPO has adopted a broad approach to this provision. In practice, examiners consider not only the allowed claims (as one may expect) but also any other claims that have entered the substantive examination (even if these claims were not actually granted). A consequence is that when the applicant cancels a claim or a part thereof, this may potentially result in the abandonment of the scope with regard to future divisional applications.

This scenario may occur on a frequent basis. It is evident that objections pertaining to the requirement for sufficient disclosure are more prevalent than unity-related objections. In light of this, applicants may opt to pursue the most straightforward approach, which involves the streamlining of claims to the allowable scope, with the subsequent intention of filing a divisional application for the cancelled embodiments.

Of course, there exist techniques for circumventing, or reducing the impact of, the double patenting issues, and obtaining local advice is recommended before amending any claims.

On the top of the above, a more explicit ratchet exists in relation to “daisy-chaining”, which is applicable under the EAPC. Specifically, divisional applications must have basis in all prior applications (parent and divisional). What is the hitch? Paragraph 2.9 of the Eurasian Patent Rules stipulates that the specification of a divisional Eurasian application may not contain information that does not relate to the inventions claimed in this application. Should a decision be taken to comply with this rule at the time of filing, and the specification be stripped from unclaimed embodiments, this may result in the “daisy-chain” being broken. It is therefore preferable to use the initial specification when filing a divisional application, despite the need to comply with the aforementioned rule down the road.  To take any information out of the specification could result in the inability to divide the application subsequently.

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The European patent system is no longer defined by its fragmentation—it is now defined by how that fragmentation is governed. The coexistence of national patents and the Unitary Patent (UP) is not an anomaly. It is an architecture. And the fate of that architecture—whether it results in pluralism or jurisprudential disorder—depends on our ability to synchronize legal tools, not merely procedural ones.

Magritte’s Golconda is more than a visual metaphor. It is a diagnosis. Identical men in bowler hats, floating in neat rows—without interaction, without anchoring. It’s an eerie echo of today’s judicial landscape: symmetry without convergence. Mechanism without motion.

On one side, national patents remain subject to local procedure, interpretation, and legal culture. On the other, the UP, created by Regulation  (EU)  No  1257/2012 and adjudicated by the UPC, reflects a supranational ambition. But this binary view misses the real issue: can the systems speak to each other, not just coexist?

Fragmentation is structural—coherence must be strategic

The language regime of the UP drives simplification. Yet beneath, divergence is systemic: definitions of indirect infringement, standards of proof, damages, and pre‑trial methods vary significantly.

For instance, the contrast between Actavis v . Eli  Lilly (UKSC, 2017) and Okklusionsvorrichtung (BGH,  docket no X ZR 16/09) highlights differing approaches to functional interpretation. The Protocol on Article  69 EPC aimed to unify, but in practice it fosters divergence.

The EPO’s G 1/24 decision confirmed that claims must always be interpreted with reference to the description and drawings—a welcome step. As Adam Lacy and Thorsten Bausch observe, G 1/24 delivers “a short and sweet answer” — but one that leaves important questions open. It says nothing about description amendments, risks narrowing scope via validity-based interpretation, and invites strategic maneuvering across forums.

To these concerns, I add a structural critique. G 1/24 marks a shift away from “claim-only” practice, aligning with the UPC’s purposive approach. Yet while it mandates reference to the description, it fails to define the method: as context? corrective? substantive source? And crucially, it says nothing about coherence between the EPO, the UPC, and national courts. Which brings us back to Legal Inception: without cross-system coordination, harmonization remains a slogan.

The UPC introduces unity—without eliminating duality

Under Article  32 UPCA, the UPC holds exclusive jurisdiction over UPs. But European patents remain national. Consequently, patentees pursue hybrid strategies—UP in some territories, national validation elsewhere—leading to parallel litigation before UPC, Brussels, Munich, and domestic courts. This is no longer the exception—it is the procedural new normal.

Convergence will not come from governance—it will come from jurisprudence

What’s missing isn’t another rule—it’s a shared method. The UPC Case Law Navigator is a strong foundation that must evolve into a cross‑jurisdictional reference point.

Private initiatives already pave the way. The site of Pierre Véron provides the most comprehensive, up-to-date database of UPC case law. More modest efforts—such as our own English-language glossary—clarify cross-border concepts, contributing quietly but significantly to a shared interpretive foundation.

The Brussels  I  bis Regulation facilitates procedural recognition—but alignment demands doctrinal proximity.

Judicial symposia exist—but they must scale

Formats like the European Patent Judges’ Symposium, EUROTAB, and SACEPO bring together national judges, UPC judges, and EPO Boards. These are valuable but still occasional.

In France, the Third Chamber of the Paris High Court (i.e., Tribunal judiciaire de Paris), which holds exclusive jurisdiction over patent litigation, maintains a public page describing its caseload and procedural guidelines—demonstrating a commendable standard of institutional transparency (See here). A particularly telling initiative is the Protocole de procédure en matière de contentieux de brevets d’invention (i.e., Patent Litigation Protocol, or PPP), signed on 18 April 2023. Established collaboratively by judges and practitioners through professional associations, the PPP stands as a strong example of judicial–professional cooperation in building procedural clarity.

Beyond courts, institutional forums set the tone. The “Le droit des brevets en France et en Europe” conference (i.e., “Patent Law in France and Europe”) took place on 30 March 2023 at the Assemblée nationale, organized by the Institut Stanislas de Boufflers (See here)—bringing together academics, practitioners, and judges. The “Rencontres du droit des brevets” (“Patent Law Encounters”) session on 26 April 2024 was held at the Cour de cassation (co-organized by the Cour de cassation and the Institut Stanislas de Boufflers), streamed on YouTube by the Cour de cassation (video). Similarly, the LES UPC conference cycle included “UPC One Year Later: A First Overview” in Milan on 30 May 2024 and then “UPC Two Years Later: Case Law and Strategy considerations” in Paris on 26 May 2025.

These events demonstrate that structured, multidisciplinary dialogue among judges, academics, and practitioners is both possible and valuable. They offer real-world templates for the kind of ongoing trilateral forums this article advocates.

Europe doesn’t need uniformity—it needs choreography

Magritte’s Golconda depicts repetition without relation. Europe’s challenge is not to erase diversity, but to give it rhythm. The UPC, EPO, and national courts must remain distinct yet move in concert.

The tools are here. Foundations are laid. The choice now is professional and political: deliberate choreography over silent parallelism.

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Patent attorney reading description to interpret claims, After Rembrandt, Public domain, via Wikimedia Commons 

 For some background to the decision, see our post here. We also discussed the preliminary opinion and hearing here, which already pointed towards the conclusion above. 

The first question was “Is Article 69 (1), second sentence EPC and Article 1 of the Protocol on the Interpretation of Article 69 EPC to be applied to the interpretation of patent claims when assessing the patentability of an invention under Articles 52 to 57 EPC?”. The EBA at reason 6 took a pragmatic approach on the question debated between the Boards as to whether Article 69 EPC or Article 84 EPC provided the relevant legal basis: “neither are entirely satisfactory as a basis for claim interpretation when assessing patentability”.  

In doing so, they accepted the criticisms that different Boards had made of relying on each article, namely: 

• “Article 69 EPC and the Protocol are arguably only concerned with infringement actions” (reason 7); 

• Article 84 EPC “provides no guidance on how to interpret claims. It only sets out an instruction to the drafter of what needs to be in the claims, and an instruction to the EPO to determine whether the claims meet that purpose” (reason 8). 

They then concluded at reason 9 that in fact the EPC contains “no clear legal basis… for claim interpretation when assessing patentability”. But critically this didn’t prevent them answering question 2: May the description and figures be consulted when interpreting the claims to assess patentability and, if so, may this be done generally or only if the person skilled in the art finds a claim to be unclear or ambiguous when read in isolation?  

On this point, the EBA accepted at reason 10 that “whether Article 69 EPC or Article 84 EPC is taken as the basis for claim interpretation does not appear to affect the principles that are applied” and extracted the following principles from the various decisions of the boards (reason 12): 

1. The claims are the starting point and the basis for assessing the patentability of an invention under Articles 52 to 57 EPC.  

1. The description and any drawings are always referred to when interpreting the claims, and not just in the case of unclarity or ambiguity. 

In their view 1) is a “settled point” while there is divergence on 2), e.g. as to whether ambiguity is necessary before the description and drawings are considered. They took the view that restricting the reliance on the description and drawings only to special situations is contrary to Article 69 EPC. Perhaps mindful that relying on Article 69 EPC isn’t entirely consistent with their position above, the EBA additionally justify their conclusion by reference to the practice of the national courts and the UPC, and therefore the “harmonization philosophy behind the EPC” (reason 16). As they put it: “The Enlarged Board finds it a most unattractive proposition that the EPO deliberately adopt a contrary practice to that of the tribunals that are downstream of its patents.” Bravo! 

Reason 17 explains that the notion that ambiguity should influence claim interpretation would put the cart before the horses: “The finding that the language of a claim is clear and unambiguous is an act of interpretation, not a preliminary stage to such an interpretative act”. 

Finally, as for question 3 “May a definition or similar information on a term used in the claims which is explicitly given in the description be disregarded when interpreting the claims to assess patentability and, if so, under what conditions?”, this was found inadmissible essentially because it was already answered in response to question 2 (reason 1). 

All in all, this seems to us to be a very reasonable and pleasantly unsurprising decision. Any other conclusion would likely have caused significant issues in harmonizing the EPO with national courts and the UPC.  

That said, while there is great appeal in the simplicity of the decision and reasoning, it leaves some important questions unanswered. For example, the decision seems to take no position in the debate on adaptation of the description (see here). It also potentially opens the door to broad claims being interpreted more narrowly based on the description for validity, something which has always faced strong resistance from the EPO. It remains to be seen how the Technical Boards of Appeal will implement this decision in practice and whether they will deviate from the current principle that claims in examination should be given the broadest sensible meaning. Finally, a decision that allows and even requires interpretation of the claims in every case of course opens the door for skillful attorneys and their favorite pet, the famous angora cat. It will always remain a challenge to come to consistent claim interpretations between different deciding bodies, but at least everybody will apply the same basic principles from now on.  

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In 1869, the famous jurist Hugo Böhlau published an article on precisely this constitution, in which he explained the issue of “Kompetenz-Kompetenz” (‘competence-competence’) for the first time. This concept can be explained as (to cite Wikipedia): “a jurisprudential doctrine whereby a legal body, such as a court or arbitral tribunal, may have competence, or jurisdiction, to rule as to the extent of its own competence on an issue before it”.

In other words: You (as a court) have “Kompetenz-Kompetenz” if you can decide whether you may take on a case or not – or how far your judgments extend. (Given that inter alia problems like these led to the US civil war, it is surprising that it took until 1869 that this term was coined.)

This ‘Kompetenz-Kompetenz’ problem has arisen from time to time since then in a wide variety of legal scenarios, especially where arbitration is concerned. However, this issue is also not unknown to intellectual property law. An often discussed example is the tendency of UK courts to decide upon worldwide FRAND licences – something that even UK judges have described as ‘juridisdictional imperalism’.

With the Unified Patent Court, however, such ‘Kompetenz-Kompetenz’ problems are unavoidable and even the most detailed transitional provisions (which, however, do not really exist in the UPCA) will not be able to cover all constellations. It is therefore not surprising that a whole series of UPC decisions have already been issued, including those by the Court of Appeal, concerning the competence of the UPC – and some of these will be discussed later in this post.

The first case was before the local division in Helsinki. The patent, out of which preliminary measures were requested, had, however, been subject to an “opt-out”. This “opt-out” had later been withdrawn via a so-called “opt-in”.

According to the UPCA, both the “opt-out” and the “opt-in” cannot be filed unconditionally. Summarized: If a case has been filed before the UPC then the patent cannot be opted out. Consequently, if a national case has been filed in an UPC country, then the patent cannot be opted in again.

Here it was the case that in 2020, i.e. before the commencement of the UPC system in 2023, a proceeding for infringement and a nullity action had been filed in Germany.

The Helsinki division argued that due to these proceedings, the “opt-in” was ineffective and thus the UPC not competent at all.

The court of appeal, however, did not share this view. In its order it stated that only national proceedings that had started after the UPC came into place would prevent an “opt-in”. As that was not the case here, it declared the UPC competent and remitted the case to the division, where the proceeding would now start all over again.

In the second case, the patent owner had asked the UPC for determination of damages – in a case, however, where infringement had been ruled by a national court (here: the Düsseldorf regional court). The Hamburg division had now declined the competence of the court due to lack of basis in the UPC agreement. Again, the Court of Appeal took a different view – it allowed the separate proceedings and again remitted the case back to the first instance.

More complicated situations arise when it comes to the territorial reach of the UPC. Besides the UPC Agreement itself, also European law comes into place, especially the so-called “Brussels-Ia-regime”; this could be the subject of an article on its own right, though.

In the first case, where controversial territorial aspects were involved, the plaintiff had inter alia asked for an injunction in Ireland. The local division in The Hague granted that injunction, mainly on the basis that the defendant had not contested that and that, since Ireland is a signatory to the UPC Agreement, even though it has not ratified the agreement yet, an injunction in Ireland would principally be possible.

Here, the Court of Appeal did not follow that view and issued an order lifting the injunction for Ireland. This is the only case amongst those covered in this article where finally the UPC declared itself not competent.

In the second case, a request for a preliminary injunction had been granted. During the appeal stage, Romania had joined as the 18^th country of the UPC, upon which the plaintiff, asked that the injunction should cover Romania, too. The defendant had protested against this, inter alia pointing to the fact that the plaintiff had – since he had won in first instance – filed no appeal and thus the enhancement of territorial scope would be a violation of the principle of reformatio in peius. The Court of Appeal, however, had no problems with this request, and as it confirmed the injunction, issued that this injunction should cover Romania as well.

The third and final case involved the question whether and under what circumstances the UPC may grant injunctions even outside the UPC territory. Here the plaintiff sued out of a patent that was valid in Germany and the UK only. The UK is not a UPC country, it is not even member of the EU. However, as the defendant was domiciled in Germany and due to the special regulations of the “Brussels-Ia-directive”, the Düsseldorf division assumed in principle the competence of the UPC to issue such injunctions. In the present case, however, it found the patent not to be valid, so no injunction was granted.

As of yet, there is no decision concerning this question from the Court of Appeals.  Meanwhile the view of the Düsseldorf division has been more or less backed by the CJEU in its recent decision C‑339/22 (BSH Elektrogeräte GmbH ./. Electrolux AB). Consequently, plaintiffs have started to ask the UPC for injunctions not only in the UK, but also other EU countries which are not members of the UPC territory, such as Spain or Poland (e.g. here and here).

Summarizing, “Kompetenz-Kompetenz” issues have been on the table in quite a few decisions before the UPC and maybe not surprisingly, in most cases the UPC has declared itself competent. Concerning the question of territorial reach, due to the developments at the CJEU it may be that its reach is broader than initially expected.

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This procedural flexibility increases adaptability but imposes complex responsibilities. Each layer of litigation has its own dynamic, and unless the connections between them are properly managed, the result may be confusion instead of coherence. The promise of a unified patent system risks becoming a patchwork of fragmented decisions unless mechanisms for coordination, consistency, and legal dialogue are strengthened.

Jurisdictional Duality: Between Strategic Depth and Systemic Fragmentation

The first structural challenge stems from the UPC’s exclusive jurisdiction over European patents with unitary effect, while conventional European patents remain subject to shared jurisdiction between the UPC and national courts for seven years. This duality, enshrined in the Agreement on a Unified Patent Court (OJ C 175, 20 June 2013), creates a fertile ground for parallel litigation. Actions concerning the same invention can be brought before different fora, potentially yielding divergent assessments of infringement or validity. The litigation strategy becomes a tactical game, enabling parties to exploit procedural overlap—especially where no duty exists to notify courts of other ongoing proceedings.

Lis Pendens or Parallel Worlds?

To address such risks, the UPC’s Rules of Procedure incorporate lis pendens and related-action mechanisms from Brussels I bis. According to the Rules of Procedure of the Unified Patent Court (25 July 2022), when two courts are seized of actions involving the same parties and similar claims, the second-seized court may stay proceedings upon objection. However, practical obstacles hinder the effective implementation of this safeguard. The notion of “identity of parties” becomes blurred when large industrial groups litigate through multiple subsidiaries, and the absence of a real-time alert system makes it nearly impossible to detect concurrent proceedings promptly.

Beyond procedural doctrine lies an institutional gap. No communication system currently links the UPC to national courts. Furthermore, there is no legal obligation requiring parties to inform the Central Register when launching parallel actions. Despite this, early practice has shown encouraging signals. Judges from different UPC divisions have initiated informal coordination to harmonize procedural practices. As reported by the Financial Times at the end of May 2024, 373 cases had already been filed and the UPC’s case management approach was beginning to reduce procedural delays (Financial Times, 13 June 2024). But informal meetings, however promising, cannot replace structured governance. Coordination needs to be institutionalized.

Perhaps the most fundamental challenge is ensuring the UPC’s integration within the EU’s legal order. In its Opinion 1/09, the Court of Justice of the European Union made clear that any court exercising jurisdiction in EU law must preserve the autonomy and coherence of that law. The UPC Agreement, however, only permits discretionary referrals to the CJEU in Articles 21 and 22, without any timeline, threshold, or structured procedure. This loophole may lead to inconsistent applications of EU law, eroding both uniformity and legal certainty across Member States.

Building a System Worthy of Its Ambition

Several reforms are worth considering.

The creation of an automated alert system within the Central Register would ensure that any new filing is immediately signalled to other divisions and to national courts when appropriate. This would facilitate the immediate triggering of stay provisions and reduce procedural redundancy.

Institutional coordination should also be formalized through the adoption of a Judicial Coordination Charter by the UPC’s Administrative Committee. This Charter could define how to share case files, exchange technical reports, and establish a standard timeline for stay decisions, while also mandating regular meetings between UPC division presidents and national judges.

Legal integration with the EU would be enhanced by a fast-track preliminary reference procedure, enabling any UPC division to refer questions of Union law to the CJEU without paralyzing ongoing litigation. To promote interpretive coherence, judges should receive ongoing training through bilateral workshops and judge exchange programs—initiatives already recommended in the European Patent Office’s Unitary Patent Guide (November 2024).

Finally, a Mixed Evaluation Committee, composed of representatives from the UPC, the CJEU, and Member States, could be tasked with issuing interpretative guidelines, updating the Rules of Procedure, and proposing amendments to the UPC Agreement. Such a body would serve as a forum for harmonization and institutional memory, and could also study national case law predating the UPC to identify best practices and avoid abrupt discontinuities.

Envisioned this way, the future of European patent litigation starts to resemble the final dream level in Inception: a multilayered system where each level preserves its uniqueness but contributes to the integrity of the whole. With strong procedural safeguards, formal coordination mechanisms, and a shared judicial culture, the European system can transcend its current duality and evolve into something greater—swift, predictable, and truly unified.

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Brexit and the EPC: Continuity with a Catch


The EPO, an independent international organisation, continues to grant European patents covering the United Kingdom exactly as it did before Brexit.

Under the EPC, patentees designate member states at grant and, for each designated country, carry out national validation formalities. Crucially, for patents designating the UK, the UK Intellectual Property Office (UK IPO) now requires that the patentee maintain an address for service within the UK, Gibraltar, or the Channel Islands; without such an address, no contentious proceedings can proceed in the UK.

In a key reassurance, the UK IPO confirms that “granted European Patents which designate the UK are transferred onto the UK Register automatically. No validation is required” when an EEA-based address for service was in place at grant (UK IPO Guidance 2023). However, with the UK’s withdrawal from the EEA, British domiciliaries must now update their service address to comply, lest they risk ignorance-based defaults in litigation.

Loss of UPC Access and the New Opt-Out Landscape


Perhaps the most profound shift concerns the Unified Patent Court. The UK government has confirmed it will not participate in either the UPC or the Unitary Patent (UP) system. Consequently, British patentees may no longer centralise cross-border enforcement and must instead litigate separately in national courts—an expensive and potentially inconsistent alternative.

For European patents that remain validated elsewhere in Europe, an opt-out mechanism still exists. From 1 January 2023 until one month before the end of the seven-year transitional period (at least until May 2030), patentees may remove their patents from UPC jurisdiction without fee. This opt-out remains effective for the patent’s entire life unless withdrawn—though unitary patents themselves cannot be opted out. British holders with pan-European portfolios must therefore decide whether to preserve recourse to new UPC precedent or rely on traditional national forums. As of September 2024, more than 600,000 opt-outs have already been registered across Europe, including a significant share by UK-based holders (Questel, European Patent Trends — Has the UPC System Been a Success?).

Concrete Scenarios for UK Patentees

Consider a UK-based med-tech innovator whose European Patent EP2783914 B1 covers diagnostic devices in multiple EU states. Before Brexit, the firm would have paid a single renewal fee and trusted uniform EPC procedures. Post-Brexit, renewal notices arrive separately from the EPO and the UK IPO, and the company must ensure a valid UK address for service by January 2021 or face default in UK actions. Meanwhile, if the patent is validated in Germany and France, the holder can opt-out of UPC jurisdiction by March 2023, thus preserving the right to litigate through German and French national courts under established local case law.

Alternatively, a London engineering SME relying primarily on UK and Irish validation may choose to forgo costly separate EPO renewals in continental Europe and instead file direct national applications in critical states. This recalibrates budgetary allocations and simplifies docketing, but sacrifices the broad protection the EPC once provided in one fell swoop.

Proposed Legal and Strategic Remedies

To mitigate these frictions, two legislative measures are paramount.

First, UK Parliament could amend the Patents Act to introduce a “Unified Validation Protocol”, streamlining post-grant formalities through a single notification to both the UK IPO and the EPO—thereby restoring the efficiency of the former EPC-based system. This could include a six-month grace period for late renewals without penalty, drawing on analogous relief found in French patent law (cf. French Intellectual Property Code, Art. L 612-19).

Second, negotiating a bilateral judicial cooperation agreement with the EU would re-establish a limited central forum for cross-border disputes involving British patentees. A UK-EU Patent Tribunal—perhaps seated in London or Dublin and operating under UPC procedural rules—could serve as a hybrid forum, reconciling divergent national judgments while cutting litigation costs for British right-holders. Similar models exist in the EU-Norway/Switzerland trade agreements for mutual recognition of arbitration awards.

Strategically, right-holders should invest in robust docket-management systems to track dual renewal calendars and service-address requirements. Engaging patent attorneys with dual UK/EPO qualifications ensures compliance across both jurisdictions. Portfolio reviews ought to distinguish high-value “European” patents warranting parallel UK validation from niche inventions better served by direct national filings.

As Bond’s licence granted him extraordinary powers that demand equal measures of responsibility and oversight, so Brexit’s new regime confers upon British patentees both autonomy and complication. By leveraging unified validation protocols, pursuing judicial cooperation, and embracing disciplined portfolio management, UK holders can secure their rights across Europe’s fragmented but dynamic patent landscape. In this post-Brexit epoch, true mastery lies in transforming procedural challenges into strategic advantage—ensuring that every patent granted remains as resilient as 007 himself.

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Yet, the core question remains: does IP law truly foster innovation? And how can legislation fairly balance the rights and interests of authors and inventors with those of the public and users?

One way legislators have sought to strike this balance is by introducing exceptions and limitations to the exclusive rights granted under IP law, within the bounds of international law – such as those set out in Articles 13 and 30 of the TRIPS Agreement for copyright and patents, respectively.

Traditionally, copyright and patent laws have been treated as entirely separate disciplines. However, the text and data mining (TDM) exceptions introduced by Articles 3 and 4 of Directive (EU) 2019/790 on copyright and related rights in the Digital Single Market (“DSM Directive”) should not go unnoticed by patent professionals – especially in light of recent decisions and discussions. Notable examples include Kneschke v. LAION ruling from Germany (see references here, here and here), the DPG Media v. HowardsHome ruling from the  Netherlands (see here) and a recent decision from the Municipal Court of Appeals of Hungary (see  here).

This has prompted the author to reflect on the research exemption in patent law, as specifically set out in Article 27(b) of the Unified Patent Court Agreement (UPCA). Said provision states that the rights conferred by a patent shall not extend to “acts done for experimental purposes relating to the subject matter of the patented invention”. Article 27(d) of the UPCA provides for the so-called bolar exemption currently under revision in one of the biggest reforms on pharmaceutical legislation (see here and here).

The question is whether these seemingly distinct exceptions—one rooted in copyright law, the other in patent law—might start to converge in their rationale or application, particularly in an era of AI and large-scale data-driven innovation, where patents also play a pivotal role.

AI is generally considered a branch of computer science and, as such, inventions involving AI are often classified as computer-implemented inventions (see, for example, Index for Computer-Implemented Inventions). AI does not only disrupt traditional notions of inventorship, it also complicates the landscape of potential infringement. So, is the current research exemption to patent protection truly fit for an AI-driven research environment, where autonomous lab equipment or an algorithmic design exploration play increasingly central roles? And how can a patentee determine whether their patented method is being used – and, if so, whether that use is lawful or not?

Let us first look at the TDM exception in copyright law to then examine what insights it might offer for the research exception in patent law.

The TDM Exception in Copyright Law

Article 3(1) of the DSM Directive establishes a mandatory exception to copyright and related rights, allowing research organisations and cultural heritage institutions to reproduce and extract lawfully accessible content for the purposes of scientific research through TDM.  In addition to the requirement of lawful access (see especially Recital 14), this exception includes several safeguards for rightsholders:

• Copies made under the exception must be stored securely and may be retained for scientific research purposes, including the verification of results (Article 3(2)).
• Rightsholders may apply proportionate measures to protect the security and integrity of networks and databases hosting the content (Article 3(3)).
• Member States shall encourage the development of best practices among rightsholders, research institutions, and cultural heritage organisations regarding these obligations and measures (Article 3(4)).

From this, it can be concluded that the EU legislator intended to:

• Establish a uniform exception to copyright across Member States;
• Enable AI-related research, including the use of copyright-protected works and subject matter for pre-training and training of AI models. While this view remains debated, it is broadly accepted in scholarship and reiterated in recital 105 of the Artificial Intelligence (AI) Act. For a critical analysis of the AI Act’s implications for the EU copyright acquis, see Generative AI, Copyright and the AI Act by João Pedro Quintais :: SSRN);
• Ensure that content used is lawfully accessed, including through contractual arrangements, open access policies, other lawful means, or content freely available online – subject to consistency with the three-step test);
• Limit the exception to specific acts: reproductions and extractions;
• Define who can benefit from it: research organisations and cultural heritage institutions;
• Clarify the purpose: scientific research.

It should also be noted that Article 4 of the Directive – which will not be discussed in detail here – permits TDM by other entities, including for commercial purposes, unless the rightsholder has expressly opted out using appropriate means.

The Experimental Use Exception in Patent Law

For its part, Article 27(b) of the UPCA:

• Is not an instrument of EU law, and it is debatable whether the Contracting Member States intended to harmonise their domestic patent laws through the UPCA, particularly regarding the limitation of the effects of European patents without unitary effect (as discussed previously in this blog here).
• Refers to “acts for experimental purposes” related to the subject matter of the patented invention, without specifying the exact acts covered, but seemingly limiting these to activities predominantly aimed at gaining knowledge about the patented invention, while excluding commercial uses.
• Contains no restriction based on technology field, thus also applying to AI-driven research. However, the underlying assumption is still one of human-led laboratory research.
• Provides no safeguards to the rightsholders in case the invention is used under the exemption.

These features reveal several vulnerabilities in the current formulation of the research exemption under the UPCA, which could present significant challenges for litigators in cases involving automated AI-driven research. This is not only due to the lack of harmonisation across Member States, but also because of the lack of clarity regarding the scope of permitted acts, and the absence of field-specific guidance or safeguards for rightsholders.

The dialogue between the two exceptions

Considering the above, are there elements of the copyright TDM exception that could inspire future developments in patent law? Could a more nuanced and AI-aware version of the research exemption be on the horizon?

As a preliminary remark, it is worth noting that legitimate concerns have been raised that the scientific TDM exception may be potentially misused to facilitate commercial activities in the context of AI – despite the safeguards outlined above. It is, therefore, not surprising that Portugal, Spain and Italy are advocating for the protection of authors’ rights and have placed this issue—along with the revision of the current Code of Practice under the AI Act—on the agenda in Brussels (see here).

Nonetheless, the research exception under patent law may have valuable lessons to draw from the TDM exception. Any meaningful reform would need to take into consideration the following points:

• A clear and harmonised framework at the EU level;
• A precise definition of the acts covered by the exception, while preserving its core experimental purpose — namely, the acquisition of knowledge concerning the patented invention;
• A reassessment of the exception in light of AI-driven research, which is increasingly foundational to scientific progress. This should include a careful evaluation of whether the exception ought to extend to TDM or training-related automated AI technologies — bearing in mind that this move could risk broadening the scope of the exception;
• The introduction of safeguards for patent holders, allowing them to monitor the lawful acquisition and use of patented inventions. This is even more pressing given the difficulties in detecting infringement of method patents, which are common in the field of computer-implemented inventions.

Conclusion

As the boundaries between research and commercial use continue to blur in the era of AI, IP law must adapt to uphold its foundational goals: to foster innovation while ensuring access to knowledge. Drawing lessons from the TDM exception in copyright law, patent law may reflect the realities of AI-driven scientific discovery. A balanced reform would lead to a clear safeguard for the legitimate interests of patentees, while providing legal certainty for those engaging in responsible and lawful research. The time may well be right to reframe the patent research exception – before ambiguity gives way to conflict.

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To briefly recap the standard EPO approach, an antibody may generally be claimed by reference to its epitope, i.e. the structurally defined part of the antigen that it specifically binds to (G, II, 6.1.3).  In these cases, the application must enable the skilled person to produce further antibodies having the claimed functional property without undue burden.  In addition, unless the application shows a surprising technical effect or there was no reasonable expectation of success in obtaining antibodies having the required properties, the inventive step requirement will not be acknowledged (G, II, 6.2).  In practice, defining antibodies by their binding epitope is not always straightforward.  

The antibodies claimed in claim 1 of AR1 in the application underlying T326/22 encompassed a pool of antibodies for human cell surface protein CD47 that were functionally defined only.  Claim 1 was directed to an isolated monoclonal antibody (mAb) (full-length or fragments thereof) defined by the following functional features:  

(i) it binds to a discontinuous epitope on human CD47, which comprises amino acids residues Y37, K39, K41, K43, G44, R45, D46, D51, H90, N93, E97, T99, E104, and E106 of CD47 when numbered in accordance with SEQ ID NO: 147;  

(ii) it prevents CD47 from interacting with signal-regulatory-protein a (SIRPα); and  

(iii) it does not cause a significant level of agglutination of cells after administration.  

The epitope (i) to which the claimed mAb or fragment thereof binds must comprise the cited amino acids, but the epitope is not limited thereto.  Further functional requirements (ii) and (iii) are not further defined in the claim, e.g., by reference to a certain level/degree, mAb concentration or a reference CD47 Ab.  It was not contested by the parties that requirements (ii) and (iii) result from the antibodies’ binding to the epitope on CD47 as defined in (i), and not from their constant regions.  Therefore, the binding of an antibody to the claimed epitope must be such as to fulfil the two other properties mentioned ((ii) and (iii)), and this depends on the antibody’s orientation on CD47 when bound to the claimed epitope.  

The patent provided sequence information for a single antibody (2A1) and its derivatives.  The Board concluded that the claim was reproducible over its entire scope and that the patent as maintained by the Opposition Division complied with the requirements of Art. 83 EPC.  For the Board’s conclusion it was decisive that the patent described the generation of at least one mAb falling within the scope of the claim, i.e., antibody 2A1.  It was decisive that the patent provided the antigen used for immunization and the assays relied on for screening and selecting SIRPα-blocking for (ii) and non-cell agglutinating CD47 antibodies for (iii).  Further, the patent also provided means (X-ray crystallography) for determining the epitope structure on CD47 bound by the chimeric antibody 2A1 and disclosed the epitope’s structural information.  Finally, the patent taught that a cross-competitive binding assay may be used to test the candidate antibodies for their binding to 2A1’s epitope on CD47.  

The discussion on inventive step focused on whether the binding to the specific epitope was associated with any technical effect which exceeds the mere provision of antibodies against a further (arbitrary) epitope on a known antigen (CD47).  The Board was convinced that the two functional features (ii) and (iii) of the claimed antibodies were a direct consequence of the epitope they bind to.  In other words, the Board was convinced (and it was uncontested) that any antibody binding to the claimed epitope has a non-significant cell agglutinating and a SIRPα-blocking activity.    

Starting from D1 (which disclosed an anti-CD47 full-length antibody), the problem was formulated as the provision of improved antibodies.  In particular, the Board was convinced that all antibody embodiments falling within the scope of claim 1 show less cell agglutination compared to the full-length monospecific and bispecific antibodies of D1. The claimed solution was considered inventive as none of the cited documents pointed towards the epitope of claim 1.   

An alternative starting point, D13, disclosed anti-CD47 antibody fragments which lack hemagglutinating activity.  The only difference with the claimed antibodies was thus the binding epitope, and the problem was formulated as the provision of alternative CD47 antibodies or fragments thereof.  The Board took the position that the selection of the claimed epitope was still not arbitrary, since it allowed the skilled person a free choice as regards the CD47 antibody format (full-length or fragments thereof) for any intended application. D13 in contrast disclosed that the epitope bound by the anti-CD47 antibodies imposed different functional properties on these antibodies depending on their format: full-length antibodies agglutinated cells, so it did not achieve (ii) – only the fragments achieved (ii). Since none of the documents pointed to the specific claimed epitope for removing any potential restrictions as regards the format of the antibody, the Board concluded that the skilled person would also not arrive in an obvious manner at this epitope.  

This decision confirms that antibodies defined by their binding epitope can still be patented in Europe.  Applications directed to antibodies defined by their binding epitope should provide the skilled person with enough guidance enabling him or her to generate antibodies falling within the scope of the claim, e.g., the exact epitope used for immunizations, specific screening assays, how to structurally characterize the binding epitope, etc.  In addition, the choice of epitope should not be arbitrary; functional features specifically linked to the binding epitope should be well characterized and, if possible, comparative data with antibodies binding to different epitopes, provided.  This decision provides with further tools for defending the sufficiency and inventive step of antibody claims which can be added to the ones proposed by Tamaris Bucher and discussed by Brian Cordery here: The approach to the assessment of inventive step of antibodies at the EPO – is there an artificial barrier and should it be broken? 

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A Legal Legacy on the Outside Looking In

Since January 1, 2021, the European patent landscape has undergone profound changes. For the UK, this transformation raises questions of balance and continuity: how can it maintain a role in a system it historically helped shape, yet from which it is now external?

British law—and more broadly, the common law tradition—significantly informed the very conception of the UPC. Direct illustrations include the front-loaded procedure, the emphasis on expedited written phases, the role of the reporting judge, and the logic of swift preliminary injunctions. These elements are codified in the UPC Agreement, particularly in Articles 43, 52, and 62.

The British Presence: Active, Yet Peripheral

UK firms remain highly present in the initial cases handled by the UPC. British-origin firms are involved in a significant proportion of cases due to their procedural expertise and cross-border litigation experience. Their influence remains visible despite lacking a formal institutional anchor. This presence is accompanied by deliberate strategic choices: several UK firms have opened or strengthened offices in UPC member states such as Ireland, France, and Germany (JUVE Patents – “UK firms secure considerable slice of the UPC cake”). The advantages are manifold: staying authorized to represent clients before the UPC, ensuring operational continuity from an EU member state, accessing local talent, and being close to key divisions. Ireland, in particular, stands out: English-speaking, a UPC member, and with a compatible legal tradition.

From Signatory to Spectator: The UK’s Withdrawal

Although the UK signed the UPC Agreement, it withdrew before the Agreement entered into force and is therefore no longer a participating Member State. As a result, no local division is located in the UK. It finds itself as an engaged observer, yet devoid of direct institutional channels. Could this externality eventually undermine the attractiveness of its own jurisdiction?

The High Court of England and Wales still enjoys a reputation for technical excellence, and its case law remains influential. However, its territorial competence is limited to roughly 67 million consumers, compared to the approximately 297 million citizens covered today by the 17 UPC member states. Moreover, in sectors where territorial scope is pivotal—such as standard-essential patents (SEPs), network technologies, or pharmaceuticals—the UPC offers leverage that British litigation cannot match. Centralized effects, costs, and timelines all favor the new court.

Reasserting Influence: Strategic and Institutional Options

Faced with this reality, the United Kingdom has several concrete levers at its disposal to strengthen its position within the European patent ecosystem.

It could increase the visibility of its case law by systematically publishing High Court decisions in English within European databases, showcasing its litigation model at international intellectual property conferences, and forging partnerships with European bar associations.

It could also facilitate access for European rights-holders to UK courts by concluding technical bilateral agreements with major UPC member states or directly with the European Patent Office. Even without formal treaties, procedural interoperability—similar to the EPO’s Patent Prosecution Highway agreements—could suffice, enabling the extension of accelerated examination concepts to cross-border injunctions via mutual recognition protocols.

On the institutional front, the UK might explore either a revival of the original UPC accession process or propose a parallel mechanism of marginal convergence—similar to the relationship between the European Court of Human Rights and EU courts. A “Co-operation Protocol” could, for instance, allow the UK Supreme Court to request advisory opinions from the UPC on compatibility issues. However, such a consultative function is not currently foreseen under the UPC Agreement. The proposal must therefore be understood as a forward-looking idea—an institutional metaphor rather than a legally actionable mechanism.

The High Court could also position itself as the default forum for mixed disputes involving both European and British parties. Through exclusive-jurisdiction clauses in co-ownership or licensing agreements, parties could entrust the UK judiciary with interpretive authority over contractual or substantive legal issues.

Albion’s Compass: Between Influence and Isolation

In other words, like Corto Maltese, the UK is now sailing between legal continents without a precise institutional compass. It still possesses its adversarial culture, procedural rigor, and a degree of strategic freedom. The question is whether it will chart a new course or drift further from the system it helped define.

Ultimately, the same conclusion applies: what is needed is a truly integrated European patent system within the EU legal framework. And to achieve this, the UK must be included—not merely symbolically, but strategically and constructively.

Despite Brexit, the UK remains deeply embedded in European legal history—from Magna Carta and Habeas Corpus to the foundational principles of modern procedural law. Even in Strasbourg, fundamental concepts like fair trial and proportionality reflect British influence. European law, in no small part, was built from the shores of Albion.

After all, to borrow Corto’s words: “It’s no disaster to get lost. One must only remember to return.” (The Golden House of Samarkand)

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Yet, the core question remains: does IP law truly foster innovation? And how can legislation fairly balance the rights and interests of authors and inventors with those of the public and users?

One way legislators have sought to strike this balance is by introducing exceptions and limitations to the exclusive rights granted under IP law, within the bounds of international law – such as those set out in Articles 13 and 30 of the TRIPS Agreement for copyright and patents, respectively.

Traditionally, copyright and patent laws have been treated as entirely separate disciplines. However, the text and data mining (TDM) exceptions introduced by Articles 3 and 4 of Directive (EU) 2019/790 on copyright and related rights in the Digital Single Market (“DSM Directive”) should not go unnoticed by patent professionals – especially in light of recent decisions and discussions. Notable examples include Kneschke v. LAION ruling from Germany (see references here, here and here), the DPG Media v. HowardsHome ruling from the  Netherlands (see here) and a recent decision from the Municipal Court of Appeals of Hungary (see  here).

This has prompted the author to reflect on the research exemption in patent law, as specifically set out in Article 27(b) of the Unified Patent Court Agreement (UPCA). Said provision states that the rights conferred by a patent shall not extend to “acts done for experimental purposes relating to the subject matter of the patented invention”. Article 27(d) of the UPCA provides for the so-called bolar exemption currently under revision in one of the biggest reforms on pharmaceutical legislation (see here and here).

The question is whether these seemingly distinct exceptions—one rooted in copyright law, the other in patent law—might start to converge in their rationale or application, particularly in an era of AI and large-scale data-driven innovation, where patents also play a pivotal role.

AI is generally considered a branch of computer science and, as such, inventions involving AI are often classified as computer-implemented inventions (see, for example, Index for Computer-Implemented Inventions). AI does not only disrupt traditional notions of inventorship, it also complicates the landscape of potential infringement. So, is the current research exemption to patent protection truly fit for an AI-driven research environment, where autonomous lab equipment or an algorithmic design exploration play increasingly central roles? And how can a patentee determine whether their patented method is being used – and, if so, whether that use is lawful or not?

Let us first look at the TDM exception in copyright law to then examine what insights it might offer for the research exception in patent law.

The TDM Exception in Copyright Law

Article 3(1) of the DSM Directive establishes a mandatory exception to copyright and related rights, allowing research organisations and cultural heritage institutions to reproduce and extract lawfully accessible content for the purposes of scientific research through TDM.  In addition to the requirement of lawful access (see especially Recital 14), this exception includes several safeguards for rightsholders:

• Copies made under the exception must be stored securely and may be retained for scientific research purposes, including the verification of results (Article 3(2)).
• Rightsholders may apply proportionate measures to protect the security and integrity of networks and databases hosting the content (Article 3(3)).
• Member States shall encourage the development of best practices among rightsholders, research institutions, and cultural heritage organisations regarding these obligations and measures (Article 3(4)).

From this, it can be concluded that the EU legislator intended to:

• Establish a uniform exception to copyright across Member States;
• Enable AI-related research, including the use of copyright-protected works and subject matter for pre-training and training of AI models. While this view remains debated, it is broadly accepted in scholarship and reiterated in recital 105 of the Artificial Intelligence (AI) Act. For a critical analysis of the AI Act’s implications for the EU copyright acquis, see Generative AI, Copyright and the AI Act by João Pedro Quintais :: SSRN);
• Ensure that content used is lawfully accessed, including through contractual arrangements, open access policies, other lawful means, or content freely available online – subject to consistency with the three-step test);
• Limit the exception to specific acts: reproductions and extractions;
• Define who can benefit from it: research organisations and cultural heritage institutions;
• Clarify the purpose: scientific research.

It should also be noted that Article 4 of the Directive – which will not be discussed in detail here – permits TDM by other entities, including for commercial purposes, unless the rightsholder has expressly opted out using appropriate means.

The Experimental Use Exception in Patent Law

For its part, Article 27(b) of the UPCA:

• Is not an instrument of EU law, and it is debatable whether the Contracting Member States intended to harmonise their domestic patent laws through the UPCA, particularly regarding the limitation of the effects of European patents without unitary effect (as discussed previously in this blog here).
• Refers to “acts for experimental purposes” related to the subject matter of the patented invention, without specifying the exact acts covered, but seemingly limiting these to activities predominantly aimed at gaining knowledge about the patented invention, while excluding commercial uses.
• Contains no restriction based on technology field, thus also applying to AI-driven research. However, the underlying assumption is still one of human-led laboratory research.
• Provides no safeguards to the rightsholders in case the invention is used under the exemption.

These features reveal several vulnerabilities in the current formulation of the research exemption under the UPCA, which could present significant challenges for litigators in cases involving automated AI-driven research. This is not only due to the lack of harmonisation across Member States, but also because of the lack of clarity regarding the scope of permitted acts, and the absence of field-specific guidance or safeguards for rightsholders.

The dialogue between the two exceptions

Considering the above, are there elements of the copyright TDM exception that could inspire future developments in patent law? Could a more nuanced and AI-aware version of the research exemption be on the horizon?

As a preliminary remark, it is worth noting that legitimate concerns have been raised that the scientific TDM exception may be potentially misused to facilitate commercial activities in the context of AI – despite the safeguards outlined above. It is, therefore, not surprising that Portugal, Spain and Italy are advocating for the protection of authors’ rights and have placed this issue—along with the revision of the current Code of Practice under the AI Act—on the agenda in Brussels (see here).

Nonetheless, the research exception under patent law may have valuable lessons to draw from the TDM exception. Any meaningful reform would need to take into consideration the following points:

• A clear and harmonised framework at the EU level;
• A precise definition of the acts covered by the exception, while preserving its core experimental purpose — namely, the acquisition of knowledge concerning the patented invention;
• A reassessment of the exception in light of AI-driven research, which is increasingly foundational to scientific progress. This should include a careful evaluation of whether the exception ought to extend to TDM or training-related automated AI technologies — bearing in mind that this move could risk broadening the scope of the exception;
• The introduction of safeguards for patent holders, allowing them to monitor the lawful acquisition and use of patented inventions. This is even more pressing given the difficulties in detecting infringement of method patents, which are common in the field of computer-implemented inventions.

Conclusion

As the boundaries between research and commercial use continue to blur in the era of AI, IP law must adapt to uphold its foundational goals: to foster innovation while ensuring access to knowledge. Drawing lessons from the TDM exception in copyright law, patent law may reflect the realities of AI-driven scientific discovery. A balanced reform would lead to a clear safeguard for the legitimate interests of patentees, while providing legal certainty for those engaging in responsible and lawful research. The time may well be right to reframe the patent research exception – before ambiguity gives way to conflict.

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For the authors, the key passage from the ruling is paragraph 184 which states:

 “The manufacturing of the product and in particular the package insert and the SmPC of a pharmaceutical product can be important.  However, they are not always the only decisive factor to be taken into account in assessing whether the alleged infringer is in the end liable for patent infringement.  Additionally, the extent to which the alleged infringer knows or should have known that the product will be used for the claimed purpose is of relevance.”

Background

This case is part of the ongoing worldwide dispute relating to proprotein convertase subtilisin/kexin type 9 (“PCSK9”) inhibitors. Sanofi and Regeneron market alirocumab (the active ingredient in Praulent®) whilst Amgen sells the competing product evolocumab (the active ingredient in Repatha®). Since 2014, the parties have been involved in multiple national litigations, including antitrust proceedings in the US for the unlawful bundling of products resulting in a $407 million award of damages to Regeneron on 15 May 2025. This dispute was one of the few life sciences cases which escalated to the UPC very early on in the Court’s infancy, and led to one of the first revocation decisions for Amgen’s patent EP 3 666 797, the appeal for which is scheduled to be heard before the Court of Appeal on 12 August 2025.

In these proceedings, Regeneron was the proprietor, and Sanofi the exclusive licensee, of EP 3 536 712 (“EP 712”) which relates to the use of PCSK9 inhibitors to reduce elevated lipoprotein(a) (Lp(a)) levels in a defined patient group. PCSK9 inhibitors were known to lower low-density lipoprotein (LDL-C) and administered to patients with high cholesterol. EP 712 is a divisional patent, the parent currently being opted out, and the subject of German national proceedings. There are also ongoing EPO opposition proceedings, although the EPO’s preliminary opinion is that EP 712 is valid. Regeneron and Sanofi jointly sued Amgen claiming that Repatha® infringed EP 712. Amgen counterclaimed, arguing EP 712 was invalid and should be revoked.

Claim Construction

Claim 1 of EP 712 is as follows:

“A pharmaceutical composition comprising a PCSK9 inhibitor for use in reducing lipoprotein(a) (Lp(a)) levels in a patient who exhibits a serum Lp(a) level greater than 30 mg/dL and who is diagnosed with or identified as being at risk of developing a cardiovascular disease or disorder prior to or at the time of administration of the composition, or who is diagnosed with or identified as being at risk of developing a thrombotic occlusive disease or disorder prior to or at the time of administration of the composition, wherein the PCSK9 inhibitor is an antibody or antigen-binding fragment thereof that specifically binds PCSK9, wherein the patient is not on a therapeutic statin regimen at the time of administration of the composition.”

The Düsseldorf Local Division construed Claim 1 to mean that the use of PCSK9 inhibitors cannot be solely for the purposes of lowering LDL-C, which was the known use. However, it does not exclude the use of PCSK9 inhibitors to lower LDL-C and also achieve the claimed therapeutic effect of reducing elevated Lp(a) serum levels, the second medical use. It further interpreted the patient group to mean a group that objectively exhibited a serum Lp(a) level above 30 mg/dL. This meant that, without specifying when it is done or how or by whom, patient Lp(a) levels are measured at some point before treatment is started.

Validity

EP 712 was held to be valid.  In relation to the novelty attacks, the court rejected the prior art that only disclosed the known prior uses, stressing that known prior use could not deprive a patent of novelty in respect of a claimed second medical use as this would be contrary to the legal fiction that applies to second medical use claims by virtue of Article 54(4) EPC.

Of the three documents relied on to support allegations of obviousness, only one, referred to as “Parhofer 1” was found to provide the skilled person with a motivation to consider PCSK9 inhibitors to lower Lp(a) levels.  However, the Court considered that Parhofer 1 would not have given the skilled person a motivation to pursue such a course of action given the prevailing view within the common general knowledge.  The Court underlined that context, and motivation, are crucial.  In this regard, it seems that the parties’ evidence, given via expert witnesses, factual witnesses or documents, as to the prejudices or assumptions within a given field at the priority date of a patent, will often be highly influential.

Unusually for second medical use claims, the sufficiency objections were swiftly rejected by the Court. There were data in EP 712 that showed the therapeutic effect in the claimed patient population. Questions on how the UPC will handle post-filed data and plausibility therefore still remain open questions for the Court.

Infringement

As a starting point to its assessment, the Court commented that there are no statutory provisions regarding the infringement of second medical use patents, nor is the test harmonised within the UPC member states.

As the claim under consideration was an EPC 2000 claim, it was considered to be a purpose-limited product claim and, as such, it was up to the Claimants to prove that the use feature of the claim was fulfilled.  This would be the case if the Defendant offered to place or placed the alleged infringing product on the market in such a way that it knew or ought reasonably to have known that it would be used for the claimed therapeutic purpose.  In turn this required an holistic assessment of all the facts and circumstances.

Without wishing to confine itself unduly, the Court set out some potential factors of relevance when assessing infringement including: the extent or significance of the allegedly infringing use; the relevant market including what is customary on that market; the market share of the claimed use compared to other uses; and what actions the alleged infringer had taken to influence the respective market, either ‘positively’ encouraging patented use, or ‘negatively’ by taking measure to prevent the product from being used for patented use.

After setting out the test, the Court then applied it to the facts in this case. At the centre of the dispute was the Claimants’ reliance on the Summary of Product Characteristics (SmPC) and the conclusions that physicians may draw from it to prove both the objective and subjective elements of infringement. Although Repatha® is not stated to be approved for lowering Lp(a) levels in Section 4.1 of its SmPC (therapeutic use), the Claimants sought to rely on Section 5.1 SmPC (pharmacodynamic (PD) properties). This section reported that “in clinical trials, Repatha reduced unbound…Lp(a)” and it was undisputed that in fact, Repatha® lowers the Lp(a) value by at least 25%.

The Court started from the assumption that a physician’s decision to prescribe Repatha® would be based on the approved therapeutic indication (i.e. the stated indication in Section 4.1). The information in Section 5.1 on PD properties in and of itself did not show that Lp(a) levels were addressed independently, let alone that the alleged infringing product was being prescribed to reduce Lp(a) levels. However, for infringement of second medical use claims, it was irrelevant that reducing LDL-C inevitably led to the reduction of Lp(a). The alleged infringer must be responsible for placing the product on the market in a way that leads to the claimed use. Although the SmPC is important in considering the use of a pharmaceutical product, it is not decisive. As there was not sufficient evidence that Amgen had been encouraging physicians to use the contested embodiment to lower Lp(a) levels, neither the objective or subjective elements were satisfied.

The argument that Section 5.1 of the SmPC induces a physician to prescribe the product for lowering Lp(a) (and LDL-C) necessitated that the physician would be prescribing the alleged infringing medicine “off-label” (i.e. for a use not stated on the therapeutic indications section of the SmPC). No evidence was submitted demonstrating off-label use, or that there was a likelihood of this happening. The parties submitted competing expert declarations, and Amgen further provided evidence that the benefit of lowering Lp(a) serum levels was still a matter of debate, and there are regulatory hurdles for the prescriber for off-label use in particular the special need for medical justification and the risk of a refusal of reimbursement by health insurance funds. Although the Court rejected the late filed briefs of the parties which included four letters from patients submitted by the Claimants, it did comment that, in addition to the four letters not showing that any prescription had been made with the direct purpose of lowering Lp(a) levels, it would not have been a sufficient number to establish the likelihood of prescription for the claimed use.

Conclusion

Although only a first instance decision which may well be appealed, this judgment offers the pharmaceutical industry important guidance on how the UPC will approach second medical use claims.  Notably, although the label for a given medicine is important, it is not to be regarded as decisive.  If the holder of a second medical use patent can demonstrate that the alleged infringer’s product is being used, or is likely to be used, for the patented indication, it may succeed in establishing infringement, even where the patented indication has been carved out from the medicine’s label.

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Background:

Toray held a medical use patent (Japanese Patent No. 3531170) for active ingredient “nalfurafine”. The patent term was extended for 5 years, until November 21, 2022, based on the marketing approval for Remitch® which contains “nalfurafine hydrochloride” (salt form).

In 2018, Sawai and Fuso launched generic versions of “nalfurafine hydrochloride” orally disintegrating tablets (OD tablets). Toray filed a lawsuit asserting infringement of its extended patent right (Case Nos. 2018 (Wa) 38504 and 2018 (Wa) 38508). However, the Tokyo District Court dismissed Toray’s claims on March 30, 2021, reasoning that the generic products contained “nalfurafine hydrochloride” (salt form), which differed from “nalfurafine” (construed to be only in free form) claimed in the patent.

Separately, Sawai filed invalidation requests with the JPO, arguing that Toray’s patent term extension (PTE) should not have been allowed based on the marketing approval for Remitch® — again, due to the distinction between “nalfurafine” and “nalfurafine hydrochloride.” The JPO agreed and invalidated the PTE.

However, on March 25, 2021 (5 days before the Tokyo District Court ruling above), the IP High Court reversed the JPO’s decision. The court held that a person ordinarily skilled in the art would understand that, once administered, nalfurafine hydrochloride dissociates and exerts its medicinal effects as nalfurafine. Thus, nalfurafine in both free form and salt form could be viewed as the active ingredient under the patent. This IP High Court’s interpretation significantly broadened the meaning of “nalfurafine” as used in the patent.

The IP High Court’s Infringement Decision:

In its May 2025 decision, the IP High Court reversed the Tokyo District Court decision and found that Sawai and Fuso’s generic products indeed infringed Toray’s extended patent rights. Although the full decision has not yet been published (as of June 3, 2025), it is anticipated that the IP High Court again adopted the broader interpretation of “nalfurafine” to include “nalfurafine hydrochloride.”

The crux of the dispute centered on the scope of the extended patent under Article 68-2 of the Japanese Patent Act. This provision limits the effect of an extended patent to the same product (and use, if specified) as the originator’s approved product which was the basis for the patent term extension.

In 2017, the IP High Court Grand Panel issued its first major interpretation of this provision (Case No. 2016 (Ne) 10046; decision rendered January 20, 2017). The Grand Panel ruled that even if the accused product has partial differences from the approved originator’s product as identified by “ingredients, quantity, dose and administration, indication” in the marketing approval which was the basis for the patent term extension, if those differences are slight or formal when seen overall, and the accused product is substantially the same as the approved originator’s product, the effect of the extended patent would extend to the accused product. However, the exact meaning of “substantially the same” remained unclear.

Sawai and Fuso argued that their generic products differed from Remitch® due to differences in excipients, and thus were not “substantially the same.” It is possible that they contended that unique use of excipient combinations (sometimes patented) rendered their products outside the scope of the extended patent. The IP High Court appears to have rejected this argument, finding that the generic products were still substantially the same as Remitch®, despite the excipient differences.

Comments:

Once the full decision is released, we will get to know the court’s reasoning on how it assessed substantial similarity— especially in light of differing excipients — in more detail. Generic manufacturers frequently assert non-infringement based on excipient differences, sometimes bolstered by separate patents on excipient combinations. It would be particularly instructive if the court addressed these arguments, and established a threshold for when excipient differences become legally significant.

We expect that this decision will provide greater predictability in future PTE enforcement actions for originators and generic pharmaceutical in the Japanese market.

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From the first judgments, many commentators drew the conclusion that at least when it comes to inventive step, the UPC would take a different approach than the EPO (cf e.g. here, here, here and also here).

However, there seems to be disagreement about exactly what this different approach looks like. Some commentators believe that the UPC is taking the German approach, while others have left this open. This does not really help in practice when faced with the task of assessing whether the patent in question is sufficiently legally valid or whether it will be declared invalid due to inventive step in the event of a possible patent infringement.

Frankly speaking: I beg to differ. If you try to assess the validity of a given patent against an attack on inventive step, an application of the ‘problem-solution’ approach is still the best option and will probably remain so.

How do I arrive at this conclusion? For four different reasons:

First, Klaus Grabinski, President of the UPC, confirmed that he does not see any fundamental difference between the approach of the EPO and the UPC – at least that is what he said in his presentation on 16 December 2024 at the Düsseldorf Industrieclub, where I was in the audience.

Dr Grabinski explained that, in his opinion, the perception of possible differences was mainly due to the fact that the EPO assesses inventive step ‘proactively’, whereas the UPC always assesses it ‘retroactively’. Whereas the EPO, according to Grabinski, has to assess inventive step in examination proceedings, where the scope of protection of a patent has not yet been determined and where (only) an examining division is involved in the application, in proceedings before the UPC there is always a defendant, who naturally has to put all possible attacks on the table right at the beginning due to the ‘front-loaded approach’ of proceedings before the UPC.

(Of course, at this point I immediately remembered that the EPO also has opposition proceedings, where a two-sided ‘retroactive’ and to some extent front-loaded examination also takes place, and that important EPO decisions concerning inventive step were taken in opposition proceedings. But who am I to criticise one of the most brilliant and – as I can confirm from my own experience – nicest person in intellectual property worldwide?)

Second, the “problem-solution” approach needs a closer look.

This approach was developed in order to somehow get to grips with the problem of inventive step, which had been a problem for a long time – to quote from the New Yorker (“The Flash of Genius”, Article by John Seabrook, 3 January 1993”), which tackles the problem from an US perspective:

“The Doctrine of Nonobviousness is the current solution to the problem that confounded Jefferson: how to define invention. Over the last two centuries, many people have tried to define it. Learned Hand, whom patent lawyers revere as one of the great patent judges of all time, wrote that the definition of invention was “as fugitive, impalpable, wayward, and vague a phantom as exists in the whole paraphernalia of legal concepts.” The 1929 edition of “Walker on Patents,” the standard patent textbook, stated, “What constitutes invention is a very perplexing question.” In 1937, this was revised to read “An invention is the result of an inventive act.” An inventive act was generally considered to be a flash of insight that comes when the inventor is not striving for it, as in the case of Nikola Tesla, who was strolling through a park in Budapest and reciting some lines from Goethe when the concept of alternating current suddenly came into his mind and he diagrammed it in the dust with a stick […] The invention story was an important part of the invention itself.”

The need to find a rule-based approach was especially necessary for the European Patent Office because it initially recruited its examiners primarily from members of national patent offices and these brought with them very different traditions of how inventive step should be assessed. However, it should make no difference which nationality an examiner belonged to; applicants should be able to rely on all applications being treated equally.

This ‘problem-solution approach’ finally developed by the EPO is – contrary to what has often been portrayed – not a law or a commandment engraved on a stone tablet. The EPO itself has changed its practice from time to time, although this has never been stated so openly. Essentially, however, the ‘problem-solution approach’ is based on the following concepts:

Firstly, novelty and inventive activity are two different things. Lack of novelty is given if all integers of a claim are disclosed in a document. In the absence of inventive step, it is a matter of necessity that a document discloses many features but lacks at least one.

Lack of inventive step thus requires the combination of two documents (or the combination of a document with the common general knowledge, which, however, since this is usually also evidenced by documents, almost always amounts to the same thing in practice).

One aspect of the ‘problem-solution approach’ is that this ‘two’ is usually not read as ‘at least two’ – if three documents are needed to arrive at the subject-matter of a particular claim, inventive step is almost always given in practice.

However, it is also an essential basic idea of the ‘problem-solution approach’ that even if the features of a certain claim can be found in two documents, this does not automatically lead to a lack of inventive step. An impetus is needed for this to happen – or a pointer. Or as the Court of Appeal has put it here: “The mere chance that the skilled person could choose [the needed feature] is insufficient for a finding of lack of inventive step.”

This is – summarized – the essence of the problem-solution approach.

However, it is important to understand that this approach is not a mathematical formula that always delivers the same result if you put in the same variables. Like all rules or approaches in the legal field, it requires interpretation, be it of documents, knowledge or the motivation of the skilled person in the art, and here, depending on who you ask, you sometimes arrive at different results.

My thesis now is that the variability within the problem-solution approach is greater than that which would result if one were to assume that the UPC chooses a different approach than the EPO.

Looking at the first substantive decision of the appeals court of the UPC (UPC_CoA_335/2023), the Court of Appeal followed exactly the approach of the first instance – except for the interpretation of a document, which then led to the inventive step no longer being assumed to be sufficiently certain. This could have happened at the EPO in exactly the same fashion.

Thus if you need to give an estimation whether your patent will survive at the UPC, there is no need to speculate about different approaches, leave that to the academics. Rather focus on what the documents teach and what the general knowledge in your technical field is, instead of asking yourself whether the UPC would require a “closest prior art” or would allow a “general overview”, especially when at the moment there is case law that supports the first or the latter .

This even more so when taking into account that some commentators (e.g. here and here) now think that the German approach is the one used by the UPC – as someone who has practised German and EPO law for quite a while now, I can confirm that when it comes to the results the differences are marginal at best. (If you do not believe me, maybe the LD Munich may convince you, cf. here on p.68)

Third, one has to take the reality into account.

There are two boundary conditions that influence the UPC (whether it likes that or not) and will not change as long as the UPCA exists:

• Firstly, the UPC is not a patent granting authority. All patents judged by the UPC were previously granted by the EPO.
• Secondly, the UPC is not the only court in Europe to rule on patent infringements. There are still the national courts – even if, in the long term, a national patent will be required to seize the national courts in a UPC member state. However, there is always an alternative to the UPC.

It follows from the first condition that the UPC can only take a stricter view of validity than the EPO if it wishes to distance itself from the case law of the EPO. Otherwise, it would amount to a game of chance for the applicants – they would have to hope that the EPO (for whatever reason) does not apply its own case law in a given patent application and once that application was granted and no opposition filed that they are then on safe territory with the UPC. Competitors, however, would surely be willing, by filing oppositions or Third-Party-Observations, to remind the EPO about its jurisdiction.

Biblically speaking, the UPC, should it want to deviate from the EPO, is in the situation of King Rehoboam, who, when asked whether he wanted to depart from the rule of his father Solomon, replied: ’ And now whereas my father did lade you with a heavy yoke, I will add to your yoke: my father hath chastised you with whips, but I will chastise you with scorpions.” (1 Kings 12:11). This simply because the other feasible alternative pointed out in the bible – to make the yoke more lighter –  is not given.

On the other hand, it follows from the second condition that the UPC cannot actually judge more strictly than the EPO in a broad way, because it would then run the risk of the patent proprietors ‘voting with their feet’. This especially until 2030, since then for classically validated patents the “opt-out” is still given.

If one reads the bible, then you can see what happened with Rehoboam – he lost his power over Israel and the two kingdoms were divided “unto this day”. In terms of the UPC this would mean that only the unitary patents would be under the UPC jurisdiction, all other patents would be opted-out – and in the future the national patent offices will see rising numbers of applications.

If you look at the UPC, nobody there wants to suffer that tragic fate. This means that the UPC actually has no choice but to adopt the EPO’s case law as a result – differences will therefore be of a semantic rather than factual nature.

Finally, the UPC has a clear incentive to use the problem-solution approach, simply because this leads to more legal certainty, in the words of the LD Munich:

“For assessing whether an invention shall be considered obvious having regard to the state of the art, the problem-solution approach developed by the European Patent Office shall primarily be applied as a tool to the extent feasible to enhance legal certainty and further align the jurisprudence of the Unified Patent Court with the jurisprudence of the European Patent Office and the Boards of Appeal.”

Although not stated in that decision, it is apparent that legal certainty will increase the attractiveness of a court as a venue, so this is a final reason for the UPC to stick to the problem-solution approach.

So summarizing: As a result, using the problem-solution approach is and will be the best way to try to predict whether a patent will survive an attack for lack of inventive step.

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The Dual Test of Article 267 TFEU: Structure and Function

Article 267 TFEU empowers “any court or tribunal of a Member State” to request preliminary rulings from the CJEU. This notion has been refined through a long line of case law—Vaassen-Göbbels (Case 61/65), Nordsee (Case 102/81), CILFIT (Case 283/81), Corbiau (Case C-24/92), and Häupl (Case C-246/05)—which articulate a dual test. A body must meet both structural criteria (legal establishment, permanence, compulsory jurisdiction, application of binding rules, independence) and functional integration (its rulings must be regarded as national judicial acts). The two lines are closely intertwined, particularly around judicial independence, which straddles both dimensions.

UPC on Paper: Structurally Sound?

Structurally, the UPC appears to tick most boxes. Created by the UPCA, signed on 19 March 2013, it is permanent, has exclusive jurisdiction over unitary patents and most European patents unless opted out (Article 32 UPCA), and its judges swear independence (Article 21 UPCA). Panels sit permanently; local divisions handle routine cases; the central division handles revocation actions.

But What About Oversight? The Administrative Committee Problem

Despite this façade of compliance, serious concerns emerge when one examines the Administrative Committee, which accumulates legislative, budgetary, and judicial powers (Articles 11–17 UPCA). It adopts internal regulations, controls the Court’s budget, and appoints judges—all without external oversight. This concentration of powers in an intergovernmental body raises doubts under CJEU case law (ASJP, C‑64/16; LM, C‑216/18 PPU), which requires statutory safeguards to guarantee judicial independence: secure tenure, transparent appointments, and protection from political influence.

A Closed Circle of Appointments

Under Article 17 UPCA, judges are shortlisted by a Nominating Committee composed of Member State representatives and one from the CJEU. An Advisory Committee of patent experts then assesses the candidates and forwards opinions to the Administrative Committee, which makes the final appointments. The opacity of this multi-layered process, coupled with the dominance of those who benefit from centralization, raises concerns about self-reinforcing governance and lack of transparency. The concentration of appointment, regulation, and budgetary power in a single body is particularly difficult to reconcile with the CJEU’s LM standard of institutional independence.

Part-Time Judges, Permanent Doubts

Further complicating matters is the presence of part-time technical judges with ties to private practice. While they are barred from representing clients before the UPC, many continue to work in firms or consult, raising legitimate questions about conflicts of interest and the appearance of impartiality—an essential criterion under LM. No cooling-off period is imposed upon resignation, despite these judges having participated in internal trainings and potentially accessed confidential institutional knowledge. Such oversight, or lack thereof, undermines trust in the system’s neutrality. (See JUVE: Patent attorney dominance among UPC technical judges leads to conflict debate).

Effective Access to Justice: A Broader View

Judicial independence is not just an abstract principle—it directly conditions access to justice. Article 47 of the Charter and Article 19(1) TEU require Member States to guarantee effective judicial protection in all fields covered by Union law. That protection presupposes access to an independent and impartial court. Take the case of a small inventor—call her Dabus, not the AI—but a real individual with a real patent. She could challenge a patent’s validity before the UPC for €20,000, or €12,000 if eligible for micro-entity reduction. She could also go through national courts under Articles 71b–71d of Brussels I Recast. But the uncertainty and duplication inherent in the current setup create barriers—financial, strategic, and institutional. Legal uncertainty doesn’t just burden Dabus—it clouds the whole ecosystem.

Functional Autonomy? Not So Fast

Functionally, the UPC’s position is ambiguous. It derives its authority from the UPCA, which lies outside the EU treaties. Its panels are not embedded in any Member State’s hierarchy. Though Regulation 542/2014 retroactively amended Brussels I bis to label the UPC a “court of a Member State” this remains an interpretative fiction until the CJEU confirms it by accepting a reference.

The Benelux Court of Justice is often cited as a model—but it operates under the authority of national supreme courts. The UPC, by contrast, effectively replaces national courts in its field. It delivers binding rulings over a body of private law across 17 Member States, without being embedded in any one national system. Its legitimacy therefore hinges not only on what it claims to be—but on how it is received and treated within the Union’s judicial fabric.

To date, the CJEU has not received any reference from the UPC. As long as that bridge remains uncrossed, its institutional status under Union law remains untested. The statutory architecture is in place—but the system hasn’t been plugged in.

Final Feedback: Distortion, or Just Delay?

So where does the riff resolve? In my insomnia-induced reflection, the EU and the UPCA’s architects may have done just enough to engineer a plausible Article 267-compatible court—but not enough to eliminate the hum of constitutional distortion. The UPC stands today somewhere between a German-built tube amp and a battered British Telecaster: high fidelity in design, raw authority in sound, but still plugged into a socket few have dared to test. Dabus—the real one this time—may find the signal overwhelming. And the longer the CJEU remains backstage, the louder the feedback may become.

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Imagine a Rammstein concert—tight rhythms, explosive precision, and overwhelming power. That’s what many expected from the German divisions of the UPC: efficiency, control, and dominance. But two years into the life of the Court of Appeal, that expectation has begun to unravel. What we see instead is a more nuanced performance—less industrial metal, more unexpected dissonance. The Court of Appeal is not playing along with traditional tempo. It’s rewriting the setlist.

In economic terms, this resembles Joseph Schumpeter’s concept of “creative destruction,” where no established order can endure indefinitely at its peak; new entrants and shifting dynamics inevitably disrupt the status quo. Philosophically, it echoes Heraclitus’s notion that “everything flows”—no position of dominance remains static (Heraclitus was the favorite philosopher of the “the little magician from Messkirch”, if you catch the drift).

I. Statistical Composition: The Raw Numbers

Over the last twenty-four months, the UPC’s Court of Appeal has issued rulings in 41 cases spanning electronics, pharmaceuticals, biotechnology, mechanics, and related fields. Litigants treat the Court of Appeal as a reactive instrument, bringing urgent first-instance injunctions or infringement judgments before Luxembourg’s bench for reappraisal. The breakdown by type of first-instance action is as follows:

• Infringement actions: 49 percent of all appeals.

• Provisional measures/preliminary injunctions: 36 percent.

• Revocation (nullity) actions: 13 percent.

• Declarations of non-infringement: 2 percent.

This distribution shows that parties seize first-instance relief quickly, then entrust Luxembourg to confirm or correct those decisions. Not every high-speed, high-stakes choreography survives the “second act.”

II. The Appeal Effect: When the Beat Drops

Once the Court of Appeal has weighed in, roughly 36 percent of first-instance rulings do not survive intact. Specifically:

• 61.5 percent are affirmed.

• 33.3 percent are fully reversed.

• 2.6 percent are partially reversed.

In economic terms, this calls to mind Kondratiev’s long-wave cycles: rapid upward surges often contain the seeds of downward correction.

When the Court of Appeal confirms a decision, it confirms both the legal reasoning and factual findings of the local division. When it reverses, it signals that the first-instance judge’s interpretation of law or weighing of evidence was incomplete. Even partial reversals—though numerically small—highlight how Luxembourg can fine-tune single legal or factual issues without discarding the entire outcome.

III. German Divisions: Preeminence and Exposure

From the UPC’s introduction, Germany’s local divisions—Munich and Düsseldorf—drew a majority of filings. Their quick dockets and recognized expertise made them “go-to” venues. Yet high volume brings high exposure. Over these 41 appeals:

• Munich faced a 33.3 percent reversal rate.

• Düsseldorf likewise recorded 33.3 percent.

• Mannheim showed a 20 percent reversal rate (on a smaller sample).

• Hamburg, handling few cases, still has 0 percent reversals (though its sample remains limited).

When all German divisions are aggregated, the average reversal rate is roughly 30.4 percent. By comparison, Paris stands at 16.7 percent, Brussels at 0 percent (from very few matters), and Milan’s single appeal so far was fully reversed (100 percent)—a reminder that one data point cannot establish a lasting trend.

At first glance, these figures might appear unfavorable for the German divisions. In reality, volume explains most of it: Munich and Düsseldorf handle far more cases than any other UPC forum. A greater caseload naturally leads to more appeals and, consequently, a higher count of reversals. Still, the crucial takeaway is that no single division—German or otherwise—enjoys exemption from appellate correction.

IV. Provisional Measures: The Risk of Overdrive

• Of all first-instance actions, provisional measures (we included preliminary injunctions and one measure to preserve evidence) have the highest appellate reversal rate: 46.2 percent.

• Infringement actions: 31.6 percent reversal rate.

• Revocation (nullity) actions: 20 percent reversal rate.

When a first-instance judge grants an urgent interim remedy under compressed timelines—often without full expert testimony or cross-examination—the Court of Appeal has every incentive and capacity to revisit underlying assumptions, evidence, and legal thresholds. This accounts for the almost half of preliminary injunctions that falter on appeal. The moral is clear: “fast and furious” does not guarantee “lasting and robust.”

V. Forum Shopping: Strategic Volume Control and Diversification

In light of these data, many users should have begun to rethink the reflexive strategy of “always going to Germany.” While Munich and Düsseldorf still command considerable attention, quieter divisions—Paris, Brussels, The Hague, and Milan—have demonstrated greater appellate consistency.

This evolution resembles portfolio diversification: by spreading filings across several UPC divisions, litigants can mitigate the volatility of appellate outcomes. Over time, as non-German divisions attract more caseload, their reversal rates may rise slightly—thereby rebalancing the system. Ultimately, forum selection must be driven by real performance metrics, not by outdated assumptions about any one country’s inherent advantage.

VI. Reappraising the “German” Image of the UPC: Lessons Learned

From the UPC’s inception, it seemed destined to become “German” for three reasons:

1. Germany’s high volume of patent litigation.

2. The presence of four local German divisions—the highest number among Member States.

3. A perception that some German judges might display a “pro-patentee” tilt, echoing certain high-profile US benches (Judge Albright, United States District Court for the Western District of Texas (Waco/Austin)).

In practice, however, three lessons have emerged:

• No summit endures forever. Munich and Düsseldorf may have dominated early filings, but as data on appellate consistency accumulates, their comparative advantage diminishes.

• First movers bear outsized risk. By defining the first wave of UPC jurisprudence, German divisions invited close appellate scrutiny. Correcting early doctrinal “drumbeats” was inevitable.

• Market forces drive rebalancing. As other divisions prove reliable, litigants will diversify their filings. The myth of an enduring “German court” dissolves as real‐time data reshape strategy.

Practitioners should therefore allow empirical evidence—reversal rates, caseloads, judges’ expertise—to guide forum choice, rather than clinging to habit or reputation.

VII. Projections: One Year, Two Years—and Beyond

A. Methodology Explained Simply

To estimate how the UPC’s overall reversal rate might change over time, we use a straightforward idea: we blend Germany’s reversal rate and the reversal rate of all other divisions, weighted by how many cases each group handles. Here’s how:

1. Key Numbers

   • Germany’s average reversal rate: 30.4 percent

   • Non-Germany’s average reversal rate: 16.7 percent

2. Estimate Case Shares
   For each future year, decide what fraction of UPC cases Germany will handle. For instance, in Year 1, we assume Germany = 55 percent and all other divisions = 45 percent.

3. Calculate Weighted Average

   • Multiply Germany’s rate (30.4 percent) by Germany’s share (0.55) → this gives the “Germany contribution.”

   • Multiply Non-Germany’s rate (16.7 percent) by Non-Germany’s share (0.45) → this gives the “non-Germany contribution.”

   • Add those two numbers to get the overall reversal rate for that year.

4. Repeat for Each Year
   Change Germany’s share to 50 percent in Year 2, 40 percent in Year 7, 30 percent in Year 14, and so on. Always multiply each share by its respective rate, then add.

Concretely:

• Year 0 (current): Germany = 60 percent, Non-Germany = 40 percent

  • Germany contribution: 0.60 × 30.4 % = 18.24 %

  • Non-Germany contribution: 0.40 × 16.7 % = 6.68 %

  • Overall reversal rate: 18.24 % + 6.68 % = 24.92 % (≈ 25.8 % if rounding to one decimal)

• Year 1 (Germany 55 % / Non-Germany 45 %):

  • Germany: 0.55 × 30.4 % = 16.72 %

  • Non-Germany: 0.45 × 16.7 % = 7.52 %

  • Overall: 16.72 % + 7.52 % = 24.24 % (≈ 24 %)

• Year 2 (Germany 50 % / Non-Germany 50 %):

  • Germany: 0.50 × 30.4 % = 15.20 %

  • Non-Germany: 0.50 × 16.7 % = 8.35 %

  • Overall: 15.20 % + 8.35 % = 23.55 % (≈ 23.6 %)

• Year 7 (Germany 40 % / Non-Germany 60 %):

  • Germany: 0.40 × 30.4 % = 12.16 %

  • Non-Germany: 0.60 × 16.7 % = 10.02 %

  • Overall: 12.16 % + 10.02 % = 22.18 % (≈ 22.2 %)

• Year 14 (Germany 30 % / Non-Germany 70 %):

  • Germany: 0.30 × 30.4 % = 9.12 %

  • Non-Germany: 0.70 × 16.7 % = 11.69 %

  • Overall: 9.12 % + 11.69 % = 20.81 % (≈ 20.8 %)

These projections rely on two simple premises: subgroup reversal rates stay the same, and Germany’s share declines over time. Real-world factors—changes in law, shifting doctrines, or strategic rebalancing—could accelerate or slow these transitions. But the pattern is clear: as Germany’s share of UPC filings decreases, the overall reversal rate drops.

In fact, imagine all cases as ingredients in a single recipe. German divisions taste “spicy” because they have about a 30 percent reversal rate, while the rest of the UPC tastes “milder” at roughly 17 percent. When Germany supplies 60 percent of the cases, the overall flavor is blended by taking 60 percent of 30 percent (about 18 percent) and adding 40 percent of 17 percent (about 6.8 percent), yielding an overall reversal likelihood near 25 percent. If Germany’s share falls to 55 percent, you mix 55 percent of 30 percent (about 16.5 percent) with 45 percent of 17 percent (about 7.65 percent), and the average drops to roughly 24 percent. If Germany’s share falls to 50 percent, blending half of 30 percent (15 percent) with half of 17 percent (8.5 percent) yields about 23.5 percent. In other words, as fewer cases come from the high-reversal German courts and more from lower-reversal jurisdictions, the combined reversal rate naturally declines.

Final Note: When Empirical Rhythm Overtakes Reputational Riffs

Heraclitus reminded us that “every summit carries within it the seeds of its descent,” and in UPC appeals this lesson rings true. If Germany’s share of UPC filings slides from 60 percent today to 30 percent in fourteen years, our simple arithmetic forecasts the overall reversal rate dropping from about 36 percent to roughly 20.8 percent. In other words, the data hits the right notes—even if our instincts hit false ones.

For patent litigators, the lesson is unmistakable: reputations fade, but data endures. As filings continue to diversify across UPC divisions, the aggregate reversal rate will smooth out. Forum selection must shift from reliance on legend to deference to empirical evidence—a tune that plays well in a truly pan-European orchestra.

And to close with a riff from Rammstein that illuminates this dynamic:

Wir warten auf das Licht.
(“We wait for the light.”)

In UPC litigation, that light is not a single spotlight but the shared illumination of a pan-European legal symphony.

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Case number: 11/12/2024
Case date: 12 November 2024
Court: Provincial Court of Valencia

A full summary of this case has been published on Kluwer IP Law

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Launched more than a decade ago, the PDP program was intended to reduce Brazil’s reliance on imported pharmaceuticals by enabling local production of drugs deemed strategic to the Unified Healthcare System (Sistema Único de Saúde – SUS). Under these agreements, a private company (domestic or foreign) commits to transferring manufacturing technology to a government-owned producer, which then becomes responsible for local production. In exchange, the MOH agrees to purchase the medicine, often under exclusive terms, for up to ten years.

Despite its promise to lower costs, improve access, and boost domestic capabilities, the PDP program has long been criticized for lacking transparency, clear performance metrics, and safeguards to ensure value for public spending. The PDPs have also become subject to patent infringement.

Audit Findings and GAO Rulings

In 2017, a GAO audit identified serious structural flaws in the PDP program. Chief among them was the absence of any reliable mechanisms to verify whether technology had actually been transferred and absorbed. The audit also found no established methodology to determine the actual value of the know-how. As a result, several PDP agreements were suspended or terminated.

In October 2023, the MOH asked the GAO to reconsider its previous decision, arguing that uniform pricing models were unworkable due to the wide variability in technologies and agreements. The ministry also hoped to lift the recommendation that prevented new PDPs from being signed, noting its intention to revive the program under a new legal and regulatory framework (later published as Ordinance No. 4,472/2024).

However, the GAO dismissed the request, stating that the ministry had failed to address the concerns raised in the 2017 audit. While acknowledging that a single pricing formula might be impractical, the GAO emphasized that this did not exempt the government from establishing general pricing principles to ensure transparency, accountability, and fiscal responsibility. In other words, the problem isn’t the complexity of pricing; it’s the absence of a system to make pricing decisions accountable.

The GAO further stressed that the value of know-how should be assessed based on its strategic worth to the SUS, not merely on the cost of transferring it. This principle was deemed key to determining whether a PDP delivers value for the public healthcare system.

In response to MOH concerns that factoring in technology value could lead to inflated product prices, the GAO pointed out that acquisition costs should reflect the full cycle of product development and technology absorption, not just the market cost of the medicine. It further clarified that excessive pricing would still be constrained by the requirement that final prices remain compatible with those practiced within the SUS.

Another major sticking point was the MOH’s claim that much of the data necessary for valuation is either incomplete or confidential. The GAO rebutted by noting that lack of information cannot be equated with commercial secrecy, and that no requirement has been made to publicly disclose proprietary information.

No Ban, But Clear Warning

The GAO observed that its recommendation does not amount to a ban on new PDPs. Instead, it is a precautionary measure advising institutional reform before expanding a program still plagued by opaque processes and unclear results.

To support its recommendation that the MOH hold off on new agreements until proper oversight mechanisms are in place, the GAO referenced Decree No. 2,903/2017. Enacted during President Michel Temer’s administration, it establishes governance guidelines for federal programs. These include mandates for transparency and measurable performance indicators, which are applicable to the PDP initiative.

The New PDP Framework and Ongoing Concerns

While the new PDP framework under Ordinance No. 4,472/2024 has not yet been formally evaluated by the GAO, early analysis suggests it only partially addresses the concerns raised. Previously, PDPs had drawn criticism and even legal challenges for allowing up to 10 years of exclusivity in government procurement, sometimes in conflict with existing patents. The new ordinance now requires parties to disclose patent protections, bars proposals tied to active patents with more than three years left in their terms, and demands an IP compliance update demonstrating lack of constraints before the government can initiate product acquisition (Phase III).

Nonetheless, major concerns remain, especially around the program’s ability to demonstrate that its goals are being met. Although the new framework mandates evaluation reports and assessments by technical committees, no objective parameters have been defined for verifying whether the technology has been successfully absorbed and whether the project delivers public value.

Pricing provisions are also vague. The ordinance allows adjustments in exceptional circumstances and requires committee review before entering Phase III, but it fails to articulate any pricing principles or criteria that could guide price-setting and prevent abuses.

Conclusion

Despite GAO’s recommendations, the MOH has already authorized two new PDPs in 2025. It will now be required to demonstrate compliance with the standing ruling.

Although the GAO’s recommendations are non-binding, continued noncompliance could lead to legal consequences. Should the ministry fail to establish adequate pricing and evaluation mechanisms, the GAO may conclude that public funds have been misused, potentially triggering penalties such as fines, dismissal of public officials, or disqualification of private entities from entering into public contracts.

While the MOH remains committed to reviving the PDP program, the GAO has made it clear that reform must come first. Without strong safeguards, evaluation criteria, and pricing systems, Brazil’s ambitions for pharmaceutical self-reliance risk continuing under a veil of inefficiency and poor accountability.

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The ordinance consolidates and standardizes the procedures to be followed when the BRPTO’s Board of Appeals overturns a rejection decision and remands the application to the first instance for further examination. Key aspects of the ordinance include:

• Binding Nature of Appeal Decisions: Decisions rendered by the Board of Appeals are final and binding on first-instance examiners, in accordance with Article 215 of Brazil’s IP Statute. However, examiners may raise new objections based on issues not previously addressed.
• Same Examiner, When Possible: The application should be reassigned to the examiner who originally issued the rejection decision, wherever possible. If that examiner is unavailable, a qualified substitute will be designated.
• No Third-Party Submissions: At this stage, the BRPTO will not accept third-party submissions, such as technical comments or prior art suggestions.
• No Voluntary Divisional Applications: Applicants may not file voluntary divisional applications unless a lack of unity was previously raised during examination.
• New Prior Art Search is Allowed: Examiners may conduct a new prior art search if the technical considerations raised in the appeal decision justify it. All prior art references must remain consistent throughout the file wrapper.
• Procedural Safeguards and Subsequent Decisions: Any new rejection (publication code 9.2) may only be issued after the applicant has had an opportunity to respond to a new Office Action. Moreover, any final opinion must reference the binding nature of the appeal ruling.

In addition to how examiners of the first instance should proceed when analyzing cases in post-appeal prosecution, the new guidelines further establish that the notices of allowance should indicate the sequence listing section to be published with the Letters Patent (i.e., which sequence listing submitted before the BRPTO during prosecution will compose the Letters Patent). This aims at improving the organization within the PTO, as this procedure was already in force for the remaining sections of a Letters Patent, namely: set of claims, specification and drawings. Although the process brings little difference for the applicants, it is likely to improve the quality of Letters Patent issuances by the BRPTO, facilitating not only publication per se but also correction requests.

However, regulatory limitations such as the filing of voluntary divisionals are still going against the recent case law and legislation.

Ordinance No. 04/2025 provides transparency and predictability to the handling of patent applications following a successful appeal. The binding nature of appeal decisions is particularly advantageous to applicants, as it ensures greater legal certainty and procedural efficiency. However, applicants must be prepared to address new patentability issues raised during this continued examination phase. Furthermore, certain procedural limitations, notably the restrictions on filing voluntary divisional applications, continue to diverge from recent case law, raising concerns among stakeholders.

It is also expected that some aspects of the ordinance, particularly those that appear to restrict applicants’ rights beyond what is provided in the IP Statute, will likely be challenged before Brazilian courts, potentially prompting further adjustments to the BRPTO’s internal practices.

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