ITALY Law and Practice Contributed by: Giovanni F Casucci, Matteo Casucci, Serena Spadavecchia and Alice Niccoli, EY Tax & Law
Utility Models Utility models have a maximum term of ten years from the filing date of the utility model applica- tion. SPCs The term of an SPC is calculated based on the time that elapses between the filing date of the basic patent application and the date of the first marketing authorisation for a medicinal or plant protection product, minus five years. However, the certificate may never be valid for more than five years after the expiry of the basic patent. 1.5 Rights and Obligations of Owners of Intellectual Property Rights Rights of the IP Owner The owner of an IP right can claim several rights, such as: • the exclusive right to make, use, sell and import the invention for the duration of the patent term; • the right to exclude others from making, using, selling or importing the invention with- out permission; and • the right to grant licences to others, allow- ing them to use the invention under agreed terms. Obligations of the IP Owner The owner of an IP right also has obligations, such as paying renewal fees to maintain the pat- ent in force. Some jurisdictions, including Italy, have sufficient exploitation requirements, mean- ing the patent owner is obliged to actively exploit the invention otherwise, in specific conditions of prolonged non-use for reasons attributable to the holder, third parties may claim a compulsory licence.
Public Information Patent information, including details of granted patents, utility models and SPCs, is available to the public in the free to use UIBM database. Information about EU patents and their status within the UPC system can also be accessed through the EPO and UPC registries. 1.6 Further Protection After Lapse of the Maximum Term SPCs are designed to extend the duration of protection for these products beyond the expiry of the basic patent. As mentioned at 1.4 Term of Each Intellectual Property Right , the maximum term is typically five years, but it can be extend- ed to a maximum of five additional years for medicinal products in certain circumstances. In accordance with Regulation (EC) No 1901/2006, the duration of the supplementary protection certificate for a medicinal product can be further extended by six months if the medicinal product has undergone a series of tests under the Paedi- atric Investigation Plan (PIP), which is a research and development programme that aims to pro- vide clinical data aimed at verifying the drug’s usability in paediatric settings. 1.7 Third-Party Rights to Participate in Grant Proceedings Third parties have the right to participate in pat- ent grant proceedings in Italy by filing third-party observations: third-party observations can be submitted in the examination phase of the patent application, after the application has been pub- lished but before the patent is granted, allow- ing individuals or entities not directly involved in the patent application to provide information or raise concerns about the patentability of the invention. Observations are submitted in writing to the UIBM: the observations may include arguments,
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