ITALY Law and Practice Contributed by: Daniela Ampollini, Luca Pellicciari, Elena Mannini and Andrea Beltrame, Trevisan & Cuonzo
3.5 Reimbursement and Pricing/Linkage Markets The provision discussed in 2.5 Reimburse- ment and Pricing/Linkage Markets is worded to explicitly apply to “equivalent products”, ie, generics only. It is unclear whether it should also apply to biosimilars, as these are not “equiva - lents” by definition. 4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates Supplementary Protection Certificates (SPCs) are available in Italy for medicinal products under the conditions set forth in EC Regulation No 469/2009. A thick body of national case law revolving around the grant or validity require - ments of SPCs for medicinal products has formed over the years, fostered by the continu - ous stream of referrals decided by the Court of Justice of the European Union (CJEU) ever since the 1990s. As of today, the most controversial requirement is arguably Article 3(a) of the SPC Regulation and, in particular, the interpretation of the actual meaning of the wording “protect - ed by the basic patent” following the Medeva (C-322/10), Actavis (443/12) and Eli Lilly (493/12) CJEU judgments. Recent case law from the Milan Court has also engaged with the interpre - tation of the meaning of the expression “active ingredient” as used in the SPC Regulation and eventually applied the principles set forth on the subject in the Forsgren referral (C-631/13). Some controversy has also arisen as to whether the SPC Regulation allows the grant of a cer - tificate to a patent holder who is not, at the same time, the holder of the relevant marketing authorisation. While it is known that this ground
is being used in court proceedings (as part of broader invalidity claims encompassing other reasons for invalidity), Italian courts have yet to pronounce on the issue. With regards to Article 3(c) of the SPC Regulation No 469/2009, Italian case law has followed the ECJ’s reasoning set out in the Actavis case (C-443/2012), stating that said article must be interpreted as precluding the patent holder from obtaining two separate SPCs: one in relation to the active ingredient of a medicinal product and another for the active ingredient in combination with a different active ingredient and marketed as a different medicinal product (see Court of Milan, 8 August 2014, in Darts-IP). The implementation of the European legislation regarding SPCs also extends to the so-called SPC waiver introduced with EU Regulation No 2019/933. In particular, Article 5(2) lists a number of acts which do not require the SPC holder’s consent, such as: • the manufacturing of a product or medicinal product when aimed at export to third coun - tries (so-called manufacturing waiver); and • the manufacture of a medicinal product for storage in the Member State until the exclusive rights expire (so-called stockpiling waiver). For the above-mentioned activities not to infringe on the SPC, the interested party must fulfil certain requirements, such as notifying the SPC holder and the Italian Patent and Trademark Office (IPTO) at least three months prior to the commencement of the manufacturing process. 4.2 Paediatric Extensions Paediatric extensions are available in Italy, in line with Regulation (EC) No 1901/2006. Said Regu - lation established that the duration of the SPC
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