ITALY Law and Practice Contributed by: Daniela Ampollini, Luca Pellicciari, Elena Mannini and Andrea Beltrame, Trevisan & Cuonzo
ness activity and not just for the purpose of pure research. Second, Italian law has also implemented Article 10(6) of Directive 2001/83/EC by introducing the Bolar exemption under Article 68(1)(b) of the IP Code. The Bolar exemption covers studies and experiments directed at obtaining a marketing authorisation for a medicinal product (gener - ics as well as originators) and the consequent practical requirements, including the preparation and use of the patented active substance in the amounts strictly necessary for the MA registra - tion procedure. While Bolar litigation is hardly frequent in Italy, a seminal judgment issued in 2018 by the Milan Court clarified the bounda - ries of the Bolar exemption and, in particular, the conditions that must exist for the latter to be invoked by mere API manufacturers, thus bring - ing clarity over the issues that had been left open in the unresolved Astellas v Polpharma litigation. The 2018 judgment was confirmed by the Milan Court of Appeal in 2021. 2.4 Publicly Available Drug and Patent Information MAs are published in the Official Gazette of the Italian Republic, whereas information regarding pending MA applications is usually published on the official website of the Italian Medicinal Agen - cy (AIFA). This information often includes the MA applicant, the active ingredient and the name of the medicinal product. Both these platforms are public and are, therefore, freely available. Italy has no patent linkage, ie, market approval by the competent regulatory agencies (the EMA or AIFA, the Italian medicines agency) is not sub - ject to the relevant product being clear of third parties’ patent rights. Further, no communication is due to the patent holder regarding the details of pending MA applications. The patent holder
can nevertheless submit Freedom of Information letters with the competent regulatory agency in order to obtain said information. 2.5 Reimbursement and Pricing/Linkage Markets While Italian law does not have patent linkage mechanisms (see 2.4 Publicly Available Drug and Patent Information ), it does contemplate a provision according to which generic drugs can enter into price and reimbursement negotiations with AIFA but will not become NHS-reimbursable until the expiry of the related compound patent or supplementary protection certificate. In spite of being rather controversial and often referred to as establishing some sort of otherwise prohib - ited patent linkage, this provision – which was first introduced in 2012 – survived a significant legislative reform in 2022 and is still in place. 3. Biosimilar Market Entry 3.1 Infringing Acts See the response set out in 2.1 Infringing Acts . 3.2 Data and Regulatory Exclusivity See the response set out in 2.2 Regulatory Data and Market Exclusivity . 3.3 Acceptable Pre-Launch Preparations See the response set out in 2.3 Acceptable Pre- launch Preparations . 3.4 Publicly Available Drug and Patent Information See the response set out in 2.4 Publicly Avail- able Drug and Patent Information .
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