UPC Court of Appeal — Boehringer Ingelheim v. Zentiva (UPC_CoA_446/2025) — Marketing Authorisation Alone Does Not Imminent-Infringe, But Completion of National Pricing & Reimbursement Procedures Can

Background

Boehringer Ingelheim holds European Patent EP 1 830 843, validated across most UPC contracting states (Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Portugal, Romania, Slovenia, and Sweden), expiring 21 December 2025. The patent claims second medical use of nintedanib for fibrotic diseases. Boehringer markets the product Ofev® for idiopathic pulmonary fibrosis (IPF) in Portugal as a hospital-only restricted prescription medicine.

Zentiva, a generic manufacturer, obtained two Portuguese marketing authorisations from INFARMED (the national medicines authority) on 30 August 2024 for generic Nintedanib Zentiva products. On 6 December 2024 INFARMED granted Zentiva an agreed price, reimbursement rate, and conditions for hospital procurement. INFARMED’s notice of 12 December 2024 stated that hospitals could now purchase the generic, and that the marketing-authorisation holder had “one year to start commercialising it.”

Boehringer applied to the UPC Local Division Lisbon for provisional measures (preliminary injunction) and for an order to communicate information. The Local Division rejected the application on 8 May 2025, finding insufficient evidence of an imminent threat of infringement. Boehringer appealed.

The Court’s Holding

The Court of Appeal set out four headnotes that meaningfully clarify the imminent-infringement standard for UPC provisional measures in the pharmaceutical-generics context:

(1) The mere application for a marketing authorisation by a generics company does not amount to an imminent infringement, and the grant of such an authorisation does not create one either.

(2) Completion of the national procedures for health-technology assessment, pricing, and reimbursement for a generic medicine can amount to an imminent infringement. The assessment must be made with due regard to the national regulatory and legislative context and considering the circumstances of the case.

(3) A request for an order to communicate information in a case of alleged imminent infringement is denied where there is no indication that the requested information actually exists and where any explanation that the requested information is reasonably necessary for the purpose of advancing that party’s case is lacking.

(4) Although national law is a source of law pursuant to Art. 24 UPCA, it is for the parties to bring forward facts and evidence about the content of national law and its application.

Applying that framework, the Court of Appeal found in this case that the completion of Portuguese pricing and reimbursement and the INFARMED notice — including the express statement that Zentiva had “one year to start commercialising” the product — together amounted to imminent infringement, sufficient to support provisional measures. The panel drew the operative line: regulatory and pricing approvals that put the generic in a position to launch on demand, in a market context where launch is the natural next step, qualify as imminent infringement; pre-pricing regulatory steps generally do not.

Key Takeaways

• The UPC has now articulated what was widely called the “setting the stage” test for imminent infringement in pharmaceutical generics. The Court of Appeal’s framing — pricing-and-reimbursement completion plus a regulatory notice consistent with imminent commercial launch — is the operative test.
• Generics manufacturers cannot insulate themselves from provisional measures by stopping short of an actual launch order. Once national health-system procurement procedures are complete, originator patentees will generally be able to obtain UPC provisional relief in the relevant local division.
• The decision is highly fact-specific. The result depends on the national regulatory and commercial context — what “setting the stage” means in Portugal differs from what it means in Germany or France. Originators should plead the national-context facts thoroughly; generics should preserve evidentiary daylight between regulatory completion and commercial launch decisions.
• The headnote on national law (point 4) is procedurally important: the UPC will not take judicial notice of the national pricing-and-reimbursement framework. Parties must adduce the relevant national-law content as evidence.
• For requests to communicate information (R. 206 RoP), the Court of Appeal makes clear that mere allegation of imminent infringement is not enough — the applicant must show that the information sought actually exists and is reasonably necessary.

Why It Matters

The originator vs. generic battle over the boundary between regulatory preparation and infringement has been one of the most contested areas of pharmaceutical patent litigation across European national courts. The UPC Court of Appeal has now provided a single, doctrinally clear test that all UPC local divisions must follow. That should reduce forum-shopping among UPC local divisions for generics-launch cases and make the timing of provisional-measures applications more predictable.

For originator companies, the practical guidance is to monitor pricing-and-reimbursement workflows in each UPC contracting state and to be ready to file for provisional measures within a short window after pricing approvals issue, before the generic actually launches. For generics companies, the practical guidance is the inverse: be aware that the provisional-measures clock starts ticking the moment national pricing approvals issue, and structure launch communications carefully to avoid creating evidence of imminent launch beyond what the regulatory record itself shows.

Beyond pharmaceuticals, the headnote on imminent infringement has implications for any sector where the UPC will be asked to decide whether pre-launch activity creates an imminent threat — including agrochemicals, medical devices, and emerging technologies (AI hardware, wearables) where regulatory pathways are increasingly relevant. The Court of Appeal’s framework is meant to be portable across regulated industries, even though the case itself involves second-medical-use pharmaceutical claims.