The Unified Patent Court and Pharmaceutical Litigation: A New Centre of Gravity for European Patent Disputes
Introduction : The Unified Patent Court (UPC) has rapidly become one of the most consequential forums for pharmaceutical patent disputes in Europe. For innovator companies, generic manufacturers, and biosimilar developers, the UPC offers a single procedural route capable of producing enforceable remedies across multiple European Union member states. Its early pharmaceutical case law has already shaped key issues such as preliminary injunctions, evidence preservation, the scope of injunctions, and the treatment of second medical use patents.
The Court has issued more than 50 rulings in pharmaceutical cases, including decisions from the UPC Court of Appeal. These rulings are increasingly important because they establish procedural standards that affect the timing, evidence, and commercial consequences of patent disputes involving medicines and biologics.
Why the UPC Matters for Pharmaceuticals
Pharmaceutical patent disputes are unusually time-sensitive. A generic or biosimilar launch can materially reduce the value of an innovative medicine, particularly where the product faces a limited remaining patent term. The UPC addresses this commercial reality by allowing a patentee to seek centralised remedies across participating UPC member states rather than pursuing separate national actions.
For pharmaceutical companies, the UPC offers three principal advantages:
Broad territorial reach: A UPC decision can cover all participating member states for which the patent is in force.
Speed: The Court is designed to deliver first-instance decisions within a defined procedural framework, making it attractive where launch risk is imminent.
Provisional relief: The UPC can grant preliminary injunctions, preservation of evidence, inspection orders, and seizure orders before or alongside main proceedings.
These features make the UPC particularly relevant where a generic or biosimilar manufacturer is preparing to launch, where confidential manufacturing information is at risk, or where a patentee needs to prevent irreversible market disruption.
Preliminary Injunctions: The Central Battleground
Preliminary injunctions are often the most valuable remedy in pharmaceutical patent litigation. A successful injunction can prevent or delay a generic or biosimilar launch across multiple markets, preserving market share during the pendency of main proceedings.
Under Article 62(4) of the Agreement on a Unified Patent Court (UPCA) and Rule 211.2 of the UPC Rules of Procedure, an applicant must establish to a sufficient degree of certainty that:
The applicant is entitled to commence proceedings.
The patent is valid.
The patent is infringed or infringement is imminent.
There is urgency or the applicant acted without unreasonable delay.
The injunction is necessary.
The balance of interests favours granting relief.
The UPC has shown willingness to grant provisional measures in life-sciences disputes, including preliminary injunctions, seizure orders, evidence-preservation orders, and premises-inspection orders. At the same time, early practice shows that preliminary injunctions are not automatic: reported first-instance inter partes applications have been granted and refused in broadly equal numbers.
For originators, this means that injunction applications must be prepared with exceptional care. The applicant should present strong validity and infringement arguments, evidence of imminent launch, and a clear explanation of the harm that would result if relief is denied.
Evidence Preservation and Inspection Orders
Evidence preservation is another area where the UPC has become particularly important. Pharmaceutical infringement may depend on difficult-to-access information, including manufacturing processes, product compositions, batch records, technical documentation, and digital data.
Article 60 UPCA permits the Court to order prompt and effective provisional measures to preserve relevant evidence before main proceedings begin. Such measures may include:
A detailed description of an allegedly infringing product or process.
Taking samples.
Seizure of allegedly infringing goods.
Seizure of materials and implements used in production or distribution.
Preservation and disclosure of digital media and data.
Disclosure of passwords necessary to access digital material.
These measures may be ordered ex parte or inter partes. However, the UPC Court of Appeal has emphasised that an applicant seeking ex parte relief must disclose all material facts within its knowledge that could affect the court’s decision.
This creates a high standard of candour. Applicants should not present only favourable evidence; they must proactively disclose material weaknesses, including potential validity concerns, non-infringement arguments, or facts relevant to urgency.
The Consequences of Not Following Through
Evidence-preservation orders are not a substitute for main proceedings. Under Article 60(8) UPCA and Rule 198.1 of the Rules of Procedure, an applicant that obtains evidence-preservation or inspection measures must commence proceedings on the merits within the prescribed period.
The Düsseldorf Local Division has clarified the consequences of failing to do so. Where the applicant did not commence main proceedings within the required time, the Court lifted the inspection order and ordered the return, destruction, and deletion of evidence obtained under the measure.
For pharmaceutical companies, this is an important compliance point. An evidence-preservation application should be part of a fully prepared litigation plan, not a standalone investigative tool. Before applying, the patentee should be ready to file a main infringement action, identify the relevant patent and product, and address the likely defences.
Scope of UPC Injunctions
One of the UPC’s most significant features is the potential breadth of its remedies. A UPC injunction may cover all UPC member states in which the relevant patent is validated and in force. This can be particularly powerful for pharmaceutical companies seeking to prevent parallel generic or biosimilar launches across Europe.
However, breadth also creates complexity. A patentee must consider the territorial scope of the patent, validation status, potential opt-outs, and the commercial importance of each market. An injunction covering multiple jurisdictions may be commercially decisive, but it may also increase exposure if the patent is later found invalid or not infringed.
The UPC’s early decisions have therefore made injunction scope a central strategic issue. Patentees must assess whether a broad UPC action is preferable to targeted national proceedings, while defendants must consider whether revocation or non-infringement actions in selected forums can reduce exposure.
Second Medical Use Patents
Second medical use patents remain a critical issue in pharmaceutical litigation. These patents protect a known compound for a new therapeutic use, often through Swiss-type or purpose-limited product claims.
The UPC has already addressed issues relating to the infringement of second medical use patents. For originators, the challenge is to establish that the alleged infringing activity is directed to the protected medical use. For generics, the challenge is to demonstrate that the product is marketed for a non-patented indication and that the label, prescribing information, and promotional materials do not induce infringement.
This area requires close coordination between patent, regulatory, and commercial teams. The wording of packaging, patient information leaflets, clinical guidance, and promotional material can materially affect infringement risk.
Practical Strategy for Innovators
Pharmaceutical innovators should treat the UPC as a core part of European enforcement strategy.
Identify “crown jewel” patents and decide early whether they should remain within UPC jurisdiction.
Prepare litigation-ready evidence on validity, infringement, launch risk, and irreparable harm.
Monitor generic and biosimilar regulatory approvals, market-access filings, and commercial launch signals.
Preserve evidence of product launches, promotional activity, and potentially infringing manufacturing or distribution activity.
Coordinate UPC enforcement with EPO oppositions, national proceedings, and regulatory strategy.
Ensure that second medical use claims are supported by clear label and prescribing information.
Practical Strategy for Generics and Biosimilars
Generic and biosimilar companies should not assume that a UPC action can be managed as a conventional national dispute.
Conduct early freedom-to-operate and invalidity analysis.
Assess whether a revocation counterclaim or separate revocation action is appropriate.
Prepare evidence on non-infringement, particularly for second medical use products.
Monitor UPC proceedings in relevant local divisions and divisions with a reputation for particular procedural approaches.
Evaluate the risk of pan-European injunctions and plan launch timing accordingly.
Consider whether settlement, licensing, or design-around options may reduce litigation exposure.
Key Takeaway
The UPC has become a new centre of gravity for European pharmaceutical patent disputes. Its ability to grant broad injunctions and preserve evidence quickly makes it a powerful forum for innovators, while its speed and territorial reach create substantial risk for generics and biosimilars. Success before the UPC will depend on early preparation, rigorous evidence, and a coherent strategy that integrates patent, regulatory, and commercial considerations.
Author: Vipasha Srivastava in case of any queries please contact/write back to us via email to content@khuranaandkhurana.com or at Khurana & Khurana, Advocates and IP Attorney
Endnotes
Taylor Wessing, “How the UPC is reshaping pharmaceutical patent litigation” (2026), noting that the UPC has issued more than 50 pharmaceutical rulings and has shaped procedural standards on preliminary injunctions, evidence preservation, and injunction scope.
IAM, “Considerations and strategies for pharmaceutical companies before the UPC” (2026), discussing the UPC’s impact on evidence gathering, preliminary relief, and second medical use patents.
Osborne Clarke, “Life sciences are at the fore of preliminary injunction trends” (2025), summarising the UPC’s requirements for preliminary injunctions and reporting the early split between granted and refused inter partes PI applications.
EPLN, “UPC Case Law Summary – May 2026 Edition,” discussing the consequences of failing to commence main proceedings after evidence-preservation measures.
Grunecker, “The Third Year of the UPC” (2026), explaining Article 60 UPCA and the availability of ex parte or inter partes evidence-preservation measures.
UPC Rules of Procedure, Rule 196, setting out available evidence-preservation measures.
UPC Court of Appeal guidance on the duty to disclose material facts in ex parte applications.
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