ITALY Law and Practice Contributed by: Daniela Ampollini, Luca Pellicciari, Elena Mannini and Andrea Beltrame, Trevisan & Cuonzo
only with reference to certain, specific pieces of information relating to the origin and the distribu - tion network of the infringing goods or services. 1.15 Defences and Exceptions to Patent Infringement Typical defences against infringement are non- infringement, invalidity, and exemptions set forth in Article 68 of the Italian IP Code, the most important being the experimental use exemp - tion and the Bolar exemption. The experimental use exemption shields “activities carried out in a private, non-commercial environment and for non-commercial purposes, or of an experimental nature”. The prevailing interpretation is that this exemption typically shields only those research and development activities aimed at achieving innovations, overcoming or winning over the patented product or process, ie, achieving new inventions. The Bolar exemption instead covers studies and experiments directed at obtaining a mar - keting authorisation (MA) for a medicinal prod - uct (generics as well as originators) and the consequent practical requirements, including the preparation and use of the patented active substance in the amounts that are strictly nec - essary for the MA registration procedure. While Bolar litigation is hardly frequent in Italy, a semi - nal judgment issued in 2018 by the Milan Court clarified the boundaries of the Bolar exemption and, in particular, the conditions that must exist for the latter to be invoked by mere API manu - facturers, thus bringing clarity over the issues that had been left open in the unresolved Astel - las v Polpharma litigation. The 2018 judgment was confirmed by the Milan Court of Appeal in 2021. Other available defences are the prior-user right defence, patent exhaustion, and violation of
competition law and/or the contractual promise to offer FRAND licences. In contrast, a com - pulsory licence is generally not a defence, as Italian law expressly indicates that there is no obligation of a compulsory licence in favour of an infringer. As regards the prior-user right, the impact of this defence is rather limited as the law establishes that the prior user may continue to use the patented invention as long as such use remains within the limits of the prior use. According to the case law, this means that the prior user will not have the possibility to expand the invention’s use beyond the specific use pre - viously made, both from a quantitative and a qualitative perspective. Patent exhaustion may be used when the product claimed by the patent was put into the market by the patent holder or with its consent in the EEA territory. Finally, as stated above, violation of competition law and/ or the contractual promise to offer licences on fair, reasonable and non-discriminatory (FRAND) terms may be a defence in the case of stand - ard essential patents, depending on the specif - ic remedy sought. In particular, an Italian court would follow the CJEU case law in determining the circumstances in which an injunction may be granted based on a standard essential patent. 1.16 Stays and Relevance of Parallel Proceedings Italian patent law does not contain any provi - sion requiring the stay of infringement or invalid - ity proceedings due to pending opposition pro - ceedings before a patent office or related foreign proceedings unless both parties request it. Ital - ian courts remain fairly independent in the face of foreign judgments but may, in any event, be inclined to consider and potentially draw guid - ance from decisions issued in parallel litigation abroad. Greater relevance is usually given to decisions rendered by European courts whose
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