Money fights for patents and meds: what can we learn from recent court decisions in Italy?

Abstract Over the course of 2024, the two highest courts in the Italian judicial system—ie the Supreme Court of Cassation and the Constitutional Court—rendered three landmark decisions that will significantly affect the national healthcare and life science sectors. Although these three decisions are on three separate cases each involving a different subject matter, they all involve original drug producers, manufacturers of generic or biosimilar products and the national health system—and one further actor in the background: the healthcare market itself. Starting from different angles and dealing with different sources of law, the three decisions alter the intrinsic and fundamental dynamics between the three-plus-one actors. These decisions require (i) a more cautious approach to designing the IP strategy of originators, (ii) adjustments to the negotiation practice within the supply chain to benefit from the Bolar exemption and (iii) a rethinking of the entire business models—including, their financial sustainability—to account for the peculiar manner in which the national healthcare system is sustained in Italy.