ITALY Law and Practice Contributed by: Daniela Ampollini, Luca Pellicciari, Elena Mannini and Andrea Beltrame, Trevisan & Cuonzo
mon for healthcare providers and hospitals that sell or prescribe infringing generic or biosimilar products to be involved in patent infringement proceedings, even though they are technically infringers. Healthcare regulatory authorities (such as the Italian Medicines Agency) may be involved at a very early stage of the case as the target of pretrial proceedings aimed at collect - ing evidence, for instance, in cases where dem - onstrating infringement requires accessing the related MA dossier or Drug Master File. The Ital - ian Patent and Trademark Office is not a party to patent infringement proceedings; however, it must be formally notified of court actions regard - ing national patents or nationally validated EPs. 1.3 Preliminary Injunction Proceedings Preliminary injunctions are available subject to the requirements of prima facie case and urgen - cy. The former requires a reasonable case that the patent is both valid and infringed and is nor - mally dealt with by Italian courts via the appoint - ment of a Court Technical Adviser (CTA). Whilst experienced in patent matters, judges of the IP courts have a purely legal background. A CTA is, therefore, normally appointed to tackle the tech - nicalities that need to be untangled to assess validity and infringement. CTAs are selected amongst senior patent attorneys registered with the court. The urgency requirement is met whenever a reasonable case can be made that the market launch of the infringing GX, biosimilar or medical device is imminent. Delay in seeking relief might be a factor that works against urgen - cy. Balance of convenience can also be a factor, especially in relation to the interest of patients or other third parties who may be at risk of losing treatments or diagnostic tools if the infringing product or device is removed from the market. Preliminary injunctions (PIs) can be granted ex parte, although only in very exceptional cases.
Standard practice is for PIs to be issued inter partes. The timeline for an inter partes prelimi - nary injunction is at least six months, depend - ing on the court involved. Generally speaking, the trigger for a PI is any activity beyond mar - ket approval that can qualify as preparatory for the market launch of the infringing product or device. Courts are normally strict when applying this threshold, although ways to work around/ mitigate this threshold are available, such as sending notice/warning letters. A response that is either ambiguous or explicitly declines an undertaking not to launch the infringing product or device on the market might be used as lever - age to argue urgency at the PI hearing. Once lodged with the competent court, the PI motion will be assigned to a single, designated instructing Judge of the IP Chamber who will handle the proceedings and eventually adju - dicate the PI. Upon receiving the motion, the instructing judge will either: • issue the PI ex parte (if a request has been made to this sense and if the conditions for an ex parte PI are met) and set up an inter partes PI hearing while assigning the defend - ant a deadline to submit their defence prior to the PI hearing; or • issue a decree setting up a PI hearing and assign the defendant a deadline to submit its defence. The defence would normally need to consider validity as well as infringement and urgency/ procedural defences, although only the latter will likely trigger an immediate rejection, ie, a rejection for lack of urgency/other procedural requirements. Defences on the substance of the case, namely on validity and infringement, will normally need the benefit of a technical back - ground in order to be adjudicated. Thus, if at the
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