ITALY Law and Practice Contributed by: Daniela Ampollini, Luca Pellicciari, Elena Mannini and Andrea Beltrame, Trevisan & Cuonzo
Trevisan & Cuonzo Palazzo Beccaria
Via Brera, 6 20121 Milan Italy
Tel: +39 02 8646 3313 Fax: +39 02 8646 3892
Email: info@trevisancuonzo.com Web: www.trevisancuonzo.com
1. Life Sciences and Pharma/ Biopharma Patent Litigation 1.1 Claimants/Plaintiffs to an Action The standing to bring patent infringement actions lies with the registered patent holder. Established case law confirms that exclusive licensees have the autonomous right to initi - ate patent infringement proceedings, provided they can demonstrate their status as exclusive licensees when filing the case in court. This can be achieved by either submitting a copy of the exclusive license agreement along with the initial statement of claim or, preferably, by registering a confirmatory license with the Italian Patent Office. The latter option is often preferred due to the sensitive data and information that may be included in the license agreement. No statutory provision clarifies whether co-own - ers have autonomous legal standing to sue for infringement, ie, to bring a patent infringement action without other co-owners as co-plaintiffs, and the point is debated. In practice, this debate is often less significant because the ability of a patent co-owner to take independent action is typically governed by the contractual agree - ments that either led to the invention (such as
R&D agreements) or were specifically created to establish and regulate co-ownership of the patents related to that invention. Revocation actions and declaratory actions for non-infringement can be initiated by anyone with an interest in the matter, and the threshold for doing so is typically low. A statement that the party filing for revocation or declaratory relief is interested in doing business in the technical field relevant to the patent will normally suffice. A higher threshold normally applies to declara - tory actions of non-infringement when filed in the form of preliminary proceedings in that an addi - tional layer is required in relation to the urgency of the action, ie, the petitioner needs to estab - lish it would suffer irreparable harm absent the requested preliminary declaratory relief. 1.2 Defendants/Other Parties to an Action Patent infringement actions in the life sciences industry would normally target the infringing MA holder and the related Italian affiliate distribu - tor, along with any further party involved in the manufacturing and supply chain of the infringing generic or biosimilar product, as long as they are active on the Italian territory. It is quite uncom -
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