PATENTS – Amendments to the Italian provision regulating the Galenic exception enters into force

On 31 December 2023, the amended Article 68.1(c) of the Italian Industrial Property Code (“IPC”) regarding the Galenic exception entered into force. The previous version of the provision established that the patent owner’s exclusive right did not extend to the extemporaneous preparation by a pharmacy of a prescription medicine, provided that said preparation did not entail the use of “industrially manufactured active principles”. Said condition has been largely criticised both because it is not in line with the corresponding European provisions and because it introduced an excessive limitation for pharmacies, compared to generic companies that can obtain supplies from wholesalers certifying the right to sell such medicine (see page 82 of the Explanatory Report on the Law and the Italian Competition Authority Opinion of 8 October 2015). In light of the above, Article 68.1(c) was amended by deleting the limitation of the use of only non-industrial active principles for Galenic preparations.

Newsletter n. 92 – January 2024