Short Summary
STADAPHARM GmbH applied under Rule 262.1.b RoP to access the written pleadings and evidence filed in main proceedings (UPC_CFI_698/2024) between Accord Healthcare companies and Novartis AG concerning a declaration of non-infringement action related to EP2501384 (nilotinib). The Milan Central Division dismissed STADAPHARM's application, finding that its interest in using the documents in parallel German preliminary injunction proceedings was outweighed by the need to safeguard the integrity of the UPC proceedings, and also dismissed STADAPHARM's objection regarding the digital signature on Novartis's written pleadings.
Detailed Summary
This preliminary order of the Milan Central Division of the Unified Patent Court, dated 3 February 2025, concerns an application by STADAPHARM GmbH, a German pharmaceutical company, under Rule 262.1.b RoP seeking access to the written pleadings and evidence filed in main proceedings UPC_CFI_698/2024. The main proceedings involve three companies of the Accord Healthcare Group (based in the Netherlands, Spain, and the UK) as claimants against Novartis AG in a declaration of non-infringement (DNI) action concerning Novartis's patent EP2501384, which relates to the drug nilotinib. The Accord claimants assert that their generic version of nilotinib does not infringe the patent.
STADAPHARM sought access to the case file, including the statement of claim and annexes TW01 to TW36, citing its general right as a member of the public under Rule 262.1 RoP and a specific interest arising from the fact that Novartis had obtained a preliminary injunction against STADAPHARM before the Munich Regional Court on 5 December 2024 (docket no. 21 O 14561/24) based on the same patent. STADAPHARM had appealed that PI to the Munich Court of Appeal. STADAPHARM argued it needed access to ensure Novartis did not present different arguments in the German and UPC proceedings, to inform the Munich Court of Appeal of Novartis's defence strategy, and to avoid conflicting decisions on the same patent.
The judge-rapporteur initially issued a preliminary order on 2 January 2025 directing that the parties to the main proceedings be heard by written submissions within 15 days. The judge-rapporteur also noted that an application under Rule 262.1.b could only relate to documents filed at the date of application and could not extend to future filings, as this would undermine the discretion of the judge-rapporteur and the adversarial process.
Novartis opposed the request, arguing that: (i) since it had filed no documents at the time, the request should be rejected for lack of specific interest; (ii) the general interest of justice under Article 45 UPCA must be balanced with the integrity of proceedings, citing the Nordic Baltic RD decision in UPC_CFI_8/2023, App_33494/2024, which held that access is typically granted only after proceedings terminate; (iii) STADAPHARM's stated intention to use Novartis's defence before the Munich Court of Appeal would interfere with Novartis's right of free legal defence; (iv) preliminary injunction proceedings differ from main proceedings and there was no real risk of contradictory decisions; and (v) the documents contained confidential information protected under Rule 262A RoP and Regulation EU 2016/679.
STADAPHARM also challenged the validity of Novartis's reply on the grounds that the electronic signature of Novartis's counsel displayed an error. Novartis responded that the signatures were valid and that the error was a known Adobe Acrobat Reader quirk, demonstrated by opening the file with Kofax Power PDF Advanced which showed all signatures as valid. The Court found the invalidity claim insufficiently proven, holding that Rule 4.1 RoP does not preclude lodging a non-digitally signed submission when the document is unequivocally referable to the lawyer who lodged it, and that the court's duty to consult parties under Rule 264 RoP is substantive and cannot be undermined by technical quirks, particularly given the UPC's transnational nature.
On the merits of the access request, the Court held that the general interest of justice and the integrity of the proceedings outweighed STADAPHARM's specific interest. The Court found that STADAPHARM's interest in using the documents for its defence before the Munich Court of Appeal was clearly outweighed by the general interest in safeguarding the integrity of the UPC proceedings. The Court further held there was no risk of contradictory decisions, as a DNI decision could not conflict with a preliminary injunction, which by its nature could be revoked at any time.
Finally, the Court dismissed Novartis's request for legal cost compensation, holding that a decision on legal costs under Rule 150 RoP only follows a decision on the merits, and that access proceedings are not litigation in a technical sense but are instrumental to ensuring transparency of judicial activity. The Court cited Paris CD in UPC-CFI 412/23 Appl. 56176/2024 for the principle that such proceedings are not intended to resolve disputes but to ensure the right of access is not exercised in a manner prejudicing overriding interests.
The Court therefore: (1) dismissed STADAPHARM's objection regarding the validity of Novartis's written pleadings; (2) dismissed STADAPHARM's request to access case documents; and (3) dismissed Novartis's request for legal cost compensation. The order is subject to appeal within 15 days of service.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before Milan (IT) Central Division- Section. Understanding the court's reasoning in STADAPHARM GmbH vs Accord Healthcare B.V., Accord Healthcare S.L.U., Accord Healthcare Limited, Novartis AG is valuable context for structuring arguments or assessing risk in similar proceedings.
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