ZENTIVA K.S. v NOVARTIS (CFI, 21 March 2025)

Date	21 March 2025
Court	CFI
Division	Milan (IT) Central Division- Section
Type of action	Application Rop313
Registry reference	App_9038/2025 · ORD_10348/2025
Parties	ZENTIVA K.S., ZENTIVA PORTUGAL, LDA

Official decision (PDF) · UPC registry entry

Dhenne Avocats represents claimants and defendants in European patent disputes before the Unified Patent Court, including the Paris divisions.

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Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 27 March 2025 (UPC_CFI_698/2024, ORD_10348/2025), the Milan Central Division (Judges Postiglione, presiding and rapporteur, Knijff and Werner, technically qualified) dismissed the application by ZENTIVA K.S. and ZENTIVA PORTUGAL to intervene in support of three Accord Healthcare companies, claimants in an action for a declaration of non-infringement of Novartis’ EP 2 501 384 (nilotinib administered in applesauce). Zentiva, which also markets generic nilotinib with a similar carve-out in its SmPC, bears the costs of the sub-proceedings.

Question

Does a competitor in a situation parallel to the claimant’s have the legal interest required to intervene under Rule 313?

Decision

Rule 313.1 requires a legal interest that is direct and present, not a mere factual interest (paragraphs 17 and 18, citing Ocado v Autostore). The similarities between Zentiva’s and Accord’s positions do not show that the decision would directly affect Zentiva, for which it remains res inter alios acta (paragraph 22), res judicata does not extend beyond the parties (paragraphs 24 to 26). Article 33 UPCA does not make joint handling a prerequisite for intervention, and the convenience of joining pending proceedings is not a ground for it (paragraph 28). Rule 313.2 requires that the intervener’s claims not contradict those of the party supported (paragraphs 29 to 35). Zentiva can defend its position in separate proceedings (paragraphs 36 to 38). As intervention is a sub-proceeding, its costs follow Article 69 UPCA (paragraphs 39 and 40).

Key points for practice

Practical point: a generic company sharing a competitor’s SmPC carve-out cannot intervene in that competitor’s action on that basis alone, it must bring its own proceedings.

Provisions applied

Agreement on a Unified Patent Court: Arts 33 and 69
Rules of Procedure: Rules 313.1, 313.2 and 317
Case law cited: Ocado v Autostore, Court of Appeal, UPC_CoA_404/2023, Insulet v Menarini, Milan Central Division, 1 October 2024 (UPC_CFI_380/2024, ORD_52068/2024)

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.

Going further

Lexicon: Written procedure (UPC), Court fees and costs (UPC).

Source and translations

Official source: Unified Patent Court registry link recorded in the record
Original language: not recorded
Translation available: no translation recorded the firm’s French record is a summary, not a translation
Date checked: not recorded

Only the official text is authoritative. A machine translation is never presented as official, republishing a third-party document requires a verified basis in rights, and a link to the source is preferred.

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Proceedings, related decisions, appeals, parties and patents as recorded in the registry and in the Dhenne Avocats corpus. Each link states its source.

Proceedings

No case number recorded in this record.

Parties

claimantZENTIVA PORTUGAL, LDA8 decisions in the corpus Follow this party
claimantZENTIVA K.Snormalised name: Zentiva, k.s5 decisions in the corpus Follow this party

Exact name as it appears in the record, group affiliation only where sourced and dated.

Decisions in the same proceedings and documented appeals

No other decision in the corpus bears the same case number, and no appeal is documented in the corpus to date.

What the record states

Nature of the act: Application Rop313
Outcome (Dhenne Avocats summary): La demande d'intervention de Zentiva est rejetée faute d'intérêt juridique direct et actuel. Zentiva supporte les frais de l'incident.
Appeal: No appeal documented in the corpus, this does not mean that no appeal was lodged.
Instance: First-instance decision, whether it has become final is not recorded.

Patents mentioned

EP 2 501 384 mentioned in: Dhenne Avocats analysis Follow this patent

Scope: Dhenne Avocats corpus. Registry-based links are marked “official number”; links derived from the analyses are marked as such. An erroneous link can be withdrawn without deleting any record.

Patents and standards

Publication	Role in the dispute	Family	Standard and declaration	Pool	Sources
`EP 2 501 384`	Mentioned in the analysis (role not qualified) Also mentioned in 4 other decision(s): Novartis v ZENTIVA PORTUGAL (CFI, 31 July 2025) · STADAPHARM v ACCORD HEALTHCARE (CoA, 14 April 2025) · Accord Healthcare v Novartis (CFI, 10 April 2025) · STADAPHARM v Novartis (CFI, 3 February 2025)	not recorded	not recorded	not recorded	Espacenet links not checked mentioned in: Dhenne Avocats analysis

The statuses “asserted in litigation”, “declared essential”, “listed by a pool” and “essentiality examined by a court” are distinct and may coexist. Validity, infringement and technical essentiality are different questions. Scope: patents cited in the decisions of the Dhenne Avocats corpus, with no essentiality score or prediction.

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