The entry into operation of the Unified Patent Court (UPC) in June 2023 introduced significant changes to the European patent system through the creation of a centralized jurisdiction coexisting with the traditional framework established under the European Patent Convention (EPC). This new system enables the centralization of patent litigation across multiple Member States through a single proceeding before the UPC, both for unitary patents and for European patents that have not been opted out of its jurisdiction.

For the Life Sciences sector, and biotechnology in particular, this development is especially significant. In this field, patent protection not only incentivizes innovation but also constitutes the core pillar of the business model. The combination of high development costs, scientific uncertainty, stringent regulatory requirements, lengthy timelines, and strong dependence on exclusivity makes patents particularly critical assets.

In this context, the UPC introduces a highly valuable strategic tool. However, its significance cannot be assessed solely in terms of procedural efficiency, as it also creates new risk dynamics requiring a reassessment of intellectual property strategies.

After nearly two years of operation, the UPC now allows for an initial assessment based on actual data and emerging judicial practice.

A system consolidated in record time

Since its launch, the UPC has recorded a steadily increasing level of activity. According to the UPC’s first Annual Report, published in February 2025, together with the statistics available on its official portal, the Court had already registered more than 600 proceedings since becoming operational, including infringement actions, revocation actions, and applications for provisional measures.

The Life Sciences sector occupies a prominent position in this context, with complex pharmaceutical and biotechnology disputes. In addition, a strong concentration of cases remains in certain divisions, particularly in Germany, reflecting the continuity of historical litigation patterns in Europe.

These figures support the conclusion that the UPC has rapidly established itself as a relevant and fully operational forum for patent litigation.

Patent protection with effect across multiple European States: A clear and confirmed advantage

One of the UPC’s primary objectives was to overcome the fragmentation inherent in the traditional European patent system, under which patents are granted centrally through the European Patent Office while enforcement largely depends on parallel national litigation. Early practice confirms that this objective is being effectively achieved.

The possibility of obtaining measures with effect across multiple jurisdictions has been actively used, particularly in proceedings involving provisional measures. Several early decisions of the Court demonstrate a willingness to grant injunctions with broad territorial scope, thereby enhancing the attractiveness of the system for patent proprietors.

In the pharmaceutical sector, where protection against the market entry of generics or biosimilars is critical, this capacity for rapid and coordinated enforcement represents a significant practical benefit.

This approach is consistent with the objectives identified in the European Commission’s Impact Assessment on the Unitary Patent Package (European Commission, SWD (2011) 482 final, section 2.3), which emphasized the need to reduce fragmentation and improve the overall efficiency of the system.

In addition, recent sector-specific analyses have identified a further strategic dimension: the possibility of obtaining pan-European decisions strengthens the patent proprietor’s bargaining position by increasing the potential impact of infringement actions and, consequently, its leverage in licensing negotiations and settlement discussions (European Biotechnology Magazine, “Is the Unified Patent Court affordable for small biotechs?”, 2026).

The UPC has therefore fulfilled its role as a centralized enforcement mechanism, particularly valuable in high-impact commercial disputes.

Centralization of protection and concentration of risk

However, the UPC’s most transformative feature lies not only in the centralization of protection, but also in the concentration of risk.

Article 65 of the UPC Agreement provides that a revocation decision may produce effects across all participating Member States. This mechanism represents a qualitative shift from the traditional model, under which patent validity was litigated on a country-by-country basis.

As noted by Tilmann (The Unified Patent Court System, Oxford University Press, 2020, chapter 8), the nature of patent risk evolves from a distributed model to a significantly more concentrated one.

In sectors such as biotechnology, where corporate value frequently depends on a limited number of key patents, this feature is particularly significant, as it substantially increases the potential impact of an adverse decision.

The UPC therefore enhances enforcement efficiency while simultaneously amplifying the consequences of adverse rulings, requiring a more rigorous and strategically oriented assessment of patent protection.

Persistent complexity: Coexistence of systems and rights

One of the most significant aspects revealed by practice during the UPC’s first years of operation is that the system does not eliminate the complexity of the European patent landscape; rather, it introduces new combinations of protection and litigation that must be managed in a coordinated manner.

Since not all EPC Contracting States participate in the UPC — including key jurisdictions such as the United Kingdom, Spain, and Switzerland — proprietors seeking broad territorial protection must combine different instruments, including the Unitary Patent, national validations of European patents, and, in some cases, additional national patents.

Furthermore, in certain UPC participating States, the issue of double protection between a Unitary Patent and a national patent has not yet been fully harmonized. This may allow, in some circumstances, the coexistence of overlapping rights covering the same invention within the same territory. As a consequence, parallel rights capable of independent enforcement may arise, potentially generating scenarios of parallel litigation.

This practical complexity has been highlighted in recent sector analyses, which note that the current interaction between Unitary Patents, national validations, and parallel jurisdictional frameworks may continue to produce fragmented protection scenarios despite the existence of the UPC (European Biotechnology Magazine, 2026).

This situation demonstrates that, notwithstanding the progress introduced by the UPC, patent protection in Europe still requires carefully structured strategic planning.

Multiplicity of proceedings: The Amgen/Sanofi example

Recent practice confirms that the UPC does not necessarily replace existing proceedings but rather coexists with them within an increasingly complex litigation landscape.

The litigation between Amgen and Sanofi concerning pharmaceutical patents relating to PCSK9 inhibitors for cholesterol reduction illustrates this situation particularly well, as related disputes have proceeded simultaneously before the UPC, the European Patent Office, and national courts.

Such cases demonstrate that, in certain disputes, the UPC does not reduce procedural multiplicity, but instead adds further layers of strategic complexity.

Moreover, in the pharmaceutical and biotechnology sectors, innovation protection does not depend exclusively on patents. Regulatory mechanisms — including data exclusivity, market exclusivity, and supplementary protection certificates (SPCs) — operate alongside patent protection and remain strategically significant.

Although the UPC does not directly modify these regulatory instruments, it does influence the way they are incorporated into broader enforcement and commercialization strategies. In disputes involving the market entry of generics or biosimilars, effective coordination between patent litigation and regulatory frameworks becomes particularly important.

In complex Life Sciences disputes, the UPC therefore operates not as a replacement for existing mechanisms, but as an additional layer within a broader multi-forum enforcement environment requiring increasingly sophisticated coordination.

Costs and access: Efficiency with uneven impact

The European Commission has stated that the new system aims to “make patent protection in Europe more accessible, less costly and more effective”, particularly for innovative companies operating across multiple markets (European Commission, Unitary Patent and Unified Patent Court, 2023).

In sectors such as pharmaceuticals, where exclusivity periods are decisive, the possibility of obtaining injunctions or infringement judgments with pan-European effect may have a direct impact on competition and revenues.

However, efficiency does not necessarily translate into simplicity. The UPC introduces a new procedural framework, with specific rules, strict deadlines, and litigation dynamics requiring more complex strategic preparation.

The UPC may offer efficiency compared to parallel litigation across multiple countries. Nevertheless, absolute costs remain high, especially in sectors such as Life Sciences, where technical complexity requires a high degree of specialization.

The system also incorporates a cost recovery regime (Article 69 UPCA), under which the losing party may be required, within certain limits, to bear a substantial portion of the successful party’s costs. This mechanism increases the financial exposure associated with litigation and reinforces the need for prior strategic assessment.

An analysis by the European Parliament (The Unified Patent Court: Challenges and Opportunities, Policy Department for Citizens’ Rights and Constitutional Affairs, 2022, pp. 54–58) noted that, while the system may improve overall efficiency, its practical impact may vary depending on company size and may prove less accessible for certain stakeholders.

This distinction is particularly evident in the biotechnology sector. More recent sector analyses have emphasized that actual litigation costs and the risks associated with centralized revocation may lead smaller biotechnology companies to adopt the system more cautiously (European Biotechnology Magazine, 2026).

Beyond direct costs, these analyses further indicate that the UPC introduces a degree of strategic asymmetry among market participants by favouring companies with greater capacity to absorb significant procedural risks and manage complex pan-European litigation. For small and medium-sized biotechnology companies, this dynamic affects not only decisions regarding litigation, but also the way in which patent portfolios are structured and the assessment of whether such portfolios should fall within the UPC’s jurisdiction.

Unlike large pharmaceutical companies, which typically maintain broad and diversified patent portfolios, many biotech companies depend on a limited number of core patents. In this context, the risk of centralized revocation becomes more significant, litigation costs have a greater relative impact, and the capacity to manage complex disputes is more limited.

In practice, this difference translates into more intensive use of the UPC by companies with greater litigation resources, whereas smaller companies tend to adopt a more selective approach depending on the asset involved and the level of risk assumed.

Accordingly, while the UPC improves efficiency, its effective use may favour parties with greater financial and organizational resources.

Strategy in practice: selective use and hybrid approaches

The experience of the UPC’s first years demonstrates that companies are not adopting the system uniformly, but rather in a highly strategic manner.

A selective use of the system can be observed depending on the asset involved, with differentiated decisions being made within the same portfolio, combining the UPC and national jurisdictions, and using the opt-out mechanism as a strategic tool.

Many companies avoid automatically exposing their most valuable patents to the risk of centralized revocation.

In this context, recent analyses suggest that certain biotechnology companies are adopting a tactical use of the system, resorting to the UPC in specific actions, particularly offensive actions, while limiting the exposure of their most critical assets to the risk of centralized invalidity (European Biotechnology Magazine, 2026).

The UPC does not replace patent strategy; it makes it more important than ever.

Conclusion: A tool requiring strategic planning

The UPC has proven to be an effective and fully operational system capable of improving patent enforcement in Europe.

At the same time, it introduces structural changes affecting risk management, system complexity, and access to litigation.

As recent analyses have noted, the UPC’s impact is not limited to procedural aspects, but is beginning to influence the very incentives of the innovation system by altering how companies assess risk, structure their portfolios, and make litigation decisions (European Biotechnology Magazine, 2026).

The initial experience allows for one clear conclusion:

The UPC is an effective tool, but its impact is not even and depends largely on the profile of the patent proprietor and the strategy adopted.

In the Life Sciences sector, and particularly in biotechnology, this translates into the need for a selective and well-founded approach.

In this context, the management of intellectual property in Europe requires increasingly sophisticated analysis, in which the use of the UPC must be assessed alongside the other tools available within the EPC system.

At Herrero & Asociados, we advise companies in the Life Sciences sector on the development of protection and litigation strategies tailored to this evolving environment, combining technical expertise, regulatory knowledge, and continuous monitoring of UPC developments to identify the most appropriate solution in each case.