Introduction
The Court of Rome recently ruled on the interest to act in interim proceedings for non-infringement in patent matters, outlining significant interpretative principles on the conditions necessary for the admissibility of such actions.
The dispute
The case stems from the interim application brought in November 2024 by two German pharmaceutical companies, Formycon AG and Klinge Biopharma GmbH, against Regeneron Pharmaceuticals Inc., a leading American biotechnology company, owner of two UE patents.
The applicants brought an action before the Court of Rome, enterprise chamber, seeking an interim declaration of non-infringement of the Italian fractions of patents EP 2364691 and EP 2944306 by their biosimilar product 'FYB203'. In support of their application, the companies pleaded both the alleged non-interference of the product with the patents in question and the invalidity of the same in application of Articles 51, 46, 48 and 76(1) of the IPC.
On the other hand, the urgency of obtaining a court ruling stemmed from the need to start production as early as June 2025, as it could not wait for the time of an ordinary action without incurring substantial economic losses.
In a statement of defense, Regeneron contested the admissibility and validity of the opposing claims. Specifically, Regeneron first of all objected that the action was null and void due to the ambiguity as to the identity of the product and the absence of evidence as to its formulation, as well as the lack of periculum in mora and lack of interest to act; to support its preliminary defense, Regeneron claimed that it had never made any objection as to the marketing of the opposing drug in Italy.
On the merits, the respondent argued the full validity of its patents and requested the rejection of all opposing claims
Rejection of the appeal
By order of 5 February 2025, the Court of Rome declared the precautionary appeal inadmissible due to the applicants’ lack of interest to act, thus defining the necessary conditions for the admissibility of an action for non-infringement in interim proceedings
The Court first of all recalled the well-established jurisprudence of the Supreme Court according to which the interest to act must be concrete and current and requires not only the ascertainment of a generic legal principle, but that the party manifests the need to obtain a legally appreciable useful result that cannot be achieved without the intervention of the court. As the Supreme Court has repeatedly clarified, in fact, the process cannot be used only in anticipation of possible future prejudicial effects for the plaintiff, since the suit is an instrument for the resolution of a current dispute and not for the anticipation of hypothetical future disputes.
With reference to actions of mere ascertainment, also negative, the Court specified how their admissibility presupposes the existence of a specific warning by the holder of the right, characterized moreover by a degree of consistency and seriousness such as to generate a state of objective uncertainty worthy of judicial protection.
In examining the present case, the Court noted the absence of any dispute by Regeneron as to the production and marketing in Italy of the respondents' biosimilar drug, nor of any concrete steps to enforce its intellectual property rights arising from the Italian fractions of the patents at issue.
The ruling also made it clear that both previous correspondence between the parties regarding other fractions of the same patents and pending litigations in other jurisdictions (France, the United Kingdom and the United States), as they related to different fractions of the same patents, were irrelevant to the existence of an interest to act in Italy.
The decision concludes with an enunciation of the principle that the judicial process is an instrument for resolving a dispute, and cannot turn into an opportunity to obtain a legal opinion or an authorization to exercise an activity whose lawfulness the person concerned doubts.
Conclusions
The ruling in comment therefore offers a significant contribution to the elaboration of the preliminary conditions of an action of non-infringement, reaffirming the need of a concrete and current threat by the owner of an industrial property right as an essential requisite for the configurability of an interest to act. This decision is remarkable, as it is aimed at preserving the proper litigious function of civil proceedings, avoiding their improper use / abuse.
Article published in today's Lexology Newsletter, written by Barbara La Tella and Daniela Gervasio.