ITALY Law and Practice Contributed by: Daniela Ampollini, Luca Pellicciari, Elena Mannini and Andrea Beltrame, Trevisan & Cuonzo
infringement cannot be established if the sup - plied means are considered staple commercial products unless the supplying party has actively encouraged the receiving individual or entity to engage in infringing activities. Specifically regarding small molecule products, activities such as marketing and pre-marketing — like informative campaigns, distributing pro - motional materials, pre-order sales to whole - salers, distributors, or pharmacies, and stor - age — can constitute acts of infringement. This also includes listing the product as available in commercial databases (eg, Farmadati), submit - ting public or private tender offers, and award - ing a tender. Conversely, merely submitting or obtaining marketing authorisation applications, initiating price negotiations for reimbursement, or approving a reimbursement price does not in itself warrant infringement proceedings unless there is evidence of an imminent market launch. With regards to second medical uses, carving out (ie, skinny labelling) is not considered sufficient to rule out infringement of a second medical use patent. In the recent case of Novartis v Medac, 10 January 2022, the Court of Milan issued an injunction specifically ordering the generic to not only carry out and maintain a carve-out of the protected indication from the SmPC and PIL but also to take further steps to inform the vari - ous stakeholders in the market that the product could not be used in the protected indication. 2.2 Regulatory Data and Market Exclusivity With regards to data and market exclusivity, Directive (EC) 2001/83 and Regulation (EC) No 726/2004 apply. Accordingly, medicinal prod - ucts intended for human use benefit from an eight-year period of data protection and a ten- year period of marketing protection (the latter
being extendable up to 11 years if the MA holder obtains authorisation for a new therapeutic indi - cation which brings a significant clinical benefit compared to other therapies). Orphan medicinal products are regulated by Regulation (EC) No 141/2000 and the Commis - sion Regulation (EC) No 847/2000, which pro - vides for a market exclusivity lasting ten years, to which two additional years may be added if the product is compliant with paediatric investi - gation plan (PIP). Challenges to data and market exclusivity are not common. Two different fora could be rele - vant: if the challenge is brought against the regu - latory authority that granted the MA in breach of regulatory exclusivity, the forum would be the Administrative Court. In the case of a chal - lenge against a generic company violating the regulatory exclusivity regime, the ordinary courts would be competent. 2.3 Acceptable Pre-Launch Preparations Italian law contemplates two different exempt - ed uses of the patented product. First, Article 68(1) (a-bis) of the IP Code establishes that the exclusive right of the patentee shall not extend to acts that are performed for purely experimen - tal purposes relating to the subject matter of the patented invention and to the use of biological material for the purpose of breeding or discov - ering and developing other plant varieties. An experimental purpose is deemed to exist when - ever the activity aims at achieving technical pro - gress that wins over the patented invention and its shortcomings, ie, at obtaining new inventions. Although rarely discussed before Italian courts, it is generally accepted that the experimental use exception also applies when the experimental activity is carried out in the framework of a busi -
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