Boehringer Ingelheim Secures UPC Court Victory Protecting Nintedanib Patent Against Generic Competition
核心洞察
The UPC Court of Appeal overturned a lower court decision and granted Boehringer Ingelheim a preliminary injunction against Zentiva's generic nintedanib products across 17 European countries.
The ruling protects Boehringer's EP 1 830 843 B1 patent covering nintedanib use until December 2025, preventing generic competition for Ofev, which treats idiopathic pulmonary fibrosis (搜索).
The Court found that Zentiva had "set the stage" for patent infringement by completing regulatory preparations in Portugal, with only self-restraint preventing market entry.
The Unified Patent Court (UPC) Court of Appeal has delivered a significant victory for Boehringer Ingelheim, overturning a first-instance decision and granting a preliminary injunction against Zentiva's generic nintedanib products across 17 European countries. The ruling protects Boehringer's patent EP 1 830 843 B1, which covers the use of nintedanib or nintedanib esylate and remains valid until December 21, 2025.
Patent Protection for Rare Disease Treatment
Boehringer markets nintedanib under the brand name Ofev to treat idiopathic pulmonary fibrosis (搜索), a rare and progressive lung disease. The medication is also indicated for other chronic fibrosing interstitial lung diseases (搜索) in adults and systemic sclerosis-associated interstitial lung disease (搜索). In Portugal, medicines containing nintedanib as an active substance are restricted to hospital use, with almost all purchases made by public hospitals under the national health system.
Lower Court Setback Reversed
The legal battle began when the Lisbon local division rejected Boehringer's preliminary injunction application in May, ruling that "no imminent infringement has been demonstrated." Boehringer had argued there was a risk of imminent patent infringement following a notice from Portugal's National Authority of Medicines and Health Products that Zentiva's generic could be available from December 12, 2024.
The lower court's decision was based on Zentiva's argument that it was normal for generic companies in Portugal to apply for a Prior Evaluation Procedure (PEP) before patent expiration, and that no actual infringement had occurred.
Court of Appeal's "Set the Stage" Analysis
On August 13, 2025, the UPC Court of Appeal's second panel, presiding under Judge Rian Kalden, fundamentally disagreed with the lower court's assessment. The panel, which included legally qualified judges Ingeborg Simonsson and Patricia Rombach, along with technically qualified judges Andreas Gustafsson and Carola Wagner, found that Zentiva had "set the stage for offering the generics in Portugal, so that the infringement is only a matter of starting the action because the preparations for it have been fully completed."
The Court of Appeal established a crucial legal precedent, defining the test for imminent infringement: "whether the potential infringer has already set the stage for it to occur, so that the infringement is only a matter of starting the action because the preparations for it have been fully completed."
Regulatory Preparations as Evidence of Imminent Infringement
The Court found that Zentiva had concluded its Prior Evaluation Procedure prematurely and that there appeared to be nothing "in place nationally but self-restraint on Zentiva's side to prevent it from taking part in public procurement procedures, direct awards or prior consultations, acts that would likely constitute infringement by offering the products."
The judges noted that taking part in public procurement procedures with generic products while the patent remains in force would "generally constitute infringement through offering, regardless of whether a public procurement procedure is classified as pre-contractual under national law."
Competitive Impact and Market Dynamics
Boehringer successfully demonstrated competitive harm, arguing that Zentiva's generics would cost at least 30% less than the original product. The Court applied precedent from a previous Syngenta case, recognizing that transitioning from a monopoly to a competitive market leads to price erosion.
Currently, Boehringer is the only manufacturer supplying nintedanib in Portugal, where special authorization and contracts are required to supply hospitals under the national health system.
Broad Territorial Impact
While the imminent infringement analysis focused on Portugal, the UPC's structure means that demonstrating likely infringement in one contracting member state entitles the patentee to injunctive relief across all UPC contracting states where the patent is in force. The injunction now applies to Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Portugal, Romania, Slovenia, and Sweden.
Financial and Legal Consequences
Zentiva was ordered to pay Boehringer €199,000 in costs, and the judgment is immediately enforceable. The Court denied Boehringer's request for information, noting there was "no allegation of any completed infringement" and no indication that the requested information actually existed.
The case was represented by Portuguese IP firm NLP (搜索) for Boehringer Ingelheim, led by Joana Piriquito Santos, while Patrícia Paias of Portuguese firm Antas da Cunha ECIJA (搜索) represented Zentiva.