Italian Competition Authority (Rome) World Bank (Washington)

Luca Arnaudo

Italian Competition Authority (Rome), Syracuse University College of Law (New York), World Bank (Washington)
Project Consultant / Professor

Luca Arnaudo, Ph.D., is a senior officer of the Italian Competition Authority (AGCM), where he has been a case handler of landmark cases in the field of pharmaceutical antitrust; from 2020 to 2022 he served as an advisor at the Directorate General of the Italian Medicines Agency (AIFA). A distinguished lecturer at Syracuse University College of Law (NY), where he teaches biotech law, an adjunct professor of market regulation at LUISS Guido Carli University (Rome), and a visiting professor at various universities in Europe and the Americas, Luca has written 3 academic books and over 40 articles on antitrust, regulation, pharmaceutical law, geo-economics, and cognitive law (most of which available at


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Italian Competition Authority (Rome)
Italian Competition Authority (Rome)
Babes-Bolyai University (Cluj-Napoca)
World Bank (Washington)
Italian Competition Authority (Rome)


682 Bulletin

Gabriella Muscolo, Luca Arnaudo Patent Settlements: An overview of US, EU and national case law


Pharmaceutical activities have always been patent-sensitive, according to applicable legal frameworks. However, the vertical increase in W16 patenting since the 1980s has transformed the industrial and competitive dynamics of the sector, making it fundamentally IPRs intensive. Add to this impressive trend the extraordinarily complex and expanding web of market exclusivities associated with IPRs based on specific therapeutic features (say, the growing relevance of orphan drugs for treating rare diseases), and it is easy to understand how patent litigation – and related settlement opportunities – has become a central battleground for pharmaceutical companies. Accordingly, and proportionally to the number of patents, the possibility of using patents in an anti-competitive manner has been unleashed, with IPRs becoming a formidable tool (also) for defending monopolistic positions far beyond the original intentions of the patent system envisaged for the sector.


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