(Rule 313 RoP), UPC_CFI_698/2024 (CD Milan, March 27, 2025)
Facts :
Entities belonging to Accord Healthcare Group (Applicant) filed on November 14, 2024, an application for a declaration of non-infringement (DNI) of EP2501384B1 (Patent) against Novartis (Patentee).
The Patent relates to a treatment for chronic myeloid leukemia (CML), in particular to a way of orally administering the compound internationally known as ‘nilotinib’ dispersed in apple sauce.
The Applicant requested the CD of Milan to declare that its generic version of nilotinib does not infringe the Patent regarding in particular the activities of making, offering, placing on the market, using and/or importing or storing. Such claim has been made in consideration of the fact that the Summary of Product Characteristics (SPC) of Accord nilotinib product clearly indicated that it was not suitable for use in dispersion and that patients should use other products for this purpose.
On February 28, 2025, Zentiva filed a request to intervene pursuant to Rule 313 RoP, highlighting that, like the companies belonging to ACCORD Group, Zentiva sold nilotinib in generic form in the treatment of CML and therefore Zentiva had a parallel interest in intervening in the UPC proceedings that were aimed at defining the infringement perimeter of NOVARTIS’ patent. Zentiva had been carving out, as well as ACCORD, references to the dispersion of nilotinib capsules in applesauce from the SPCs relating to the Zentiva marketing authorizations. These include the language “For patients with swallowing difficulties, including pediatric patients that are not able to swallow the hard capsules, other medicines containing nilotinib should be used instead of Nilotinib Zentiva” translated in all languages of the countries where nilotinib was distributed.
Based on the above, Zentiva points out the existence of an “identity of factual and legal elements” with respect to the subject matter of the proceedings. This would justify Zentiva’s intervention according to Rule 313 RoP.
Decision :
Rule 313.1 RoP stipulates that an Application to intervene may be lodged by any person establishing « a legal interest in the result of an action submitted to the Court (hereinafter “the intervener”) ».
The intervener must proove an interest justifying the support to the reasons of one of the parties and, specifically, not a mere factual interest, but a legally qualified interest, determined by the need to prevent the direct impact, in its own domain, of any harmful consequences deriving from the judgement.
In the present case, the similarities between the claim of ACCORD and the interests of ZENTIVA are not in doubt. But there is no assertion that the outcome of the present judgment has a direct impact on ZENTIVA such as to establish a legal interest to participation.
The Court observes that the res judicata occurs only between the parties who participate in the proceedings. A decision in the present proceedings would not be res judicata in any proceedings brought by ZENTIVA against anyone.
In this case clearly ZENTIVA’s intervention is not entirely dependent on ACCORD winning the case, but it could also diverge on the merits during the proceedings.
Thus a distinction must be made between prospective interveners who have a direct interest in the outcome of the specific form of order sought by the party they are supporting, and those who have only an indirect and parallel interest in the outcome of the case by virtue of factual similarity between their situation and that of one of the parties.
In the present case, there is no need for ZENTIVA to be heard in the non-infringement proceedings because the decision in these proceedings shall have no direct effect on it. Whatever is decided between ACCORD and NOVARTIS will always and in any case remain res inter alios acta for ZENTIVA. The application is therefore unfounded.
Headnotes (ROP 313)
1) Parallelism between two cases or the allegation that the outcome of a judgment has a direct impact on another does not establish a legal interest to intervention pursuant to RoP 313.
2) The expression ‘made in support, in whole or in part, of a claim, order or relief sought by one of the parties‘ in Rule 313.2 RoP must be interpreted as meaning that the intervening party’s remedies must be non-contradictory to those of the party who has been supported, and therefore in accordance with art. 67 ZPO and art. 105 It. CPC, and not in the sense of a partial identity.
3) res judicata does not extend beyond the parties involved in the proceedings, nor a judgment given between different parties is binding in another dispute where the parties were/are/have been not present.
4) Article 33 of the UPCA regulates numerous hypotheses of case connections on the same patent, providing for separate adjudications (bifurcation) as well as the stay of proceedings or joint decisions. These solutions are all part of UPC legal system and are not prejudicial to the right to defense. As a matter of fact, joint treatment of two proceedings is just one of the possibilities of dealing with a case and does not constitute a prerequisite for the intervention of a party, since the intervention of a party in a proceeding (RoP 313) is not left to a case-by-case assessment at the judge’s discretion, but must be based on a right that is jeopardized by the failure of the party to intervene.