Published February 28, 2026 | Version 1.0
Book chapter Open

Gli "usi commerciali sleali" nella "test data exclusivity": le carenze di un modello economico controintuitivo

  • 1. ROR icon University of Trento

Description

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This article explores the concept of “Unfair Commercial Use” as interpreted by WTO member States’ upon signing the TRIPs treaty, and implementing Art. 39(3) in their respective legal systems. I argue that industrialized Countries understood “unfair commercial use” to actually mean plain competition, therefore agreeing to introduce a de facto monopoly for submitted test data, which negatively affect competition in pharmaceutical markets. Despite the general understanding of Intellectual Property Law and its acceptance by economic theory, this understanding is counterintuitive and contrary to the belief that markets rely on competition to function. An argument for a different interpretation of “Unfair Commercial Use” will be argued for, as a tentative to restore - at least partially - the economic soundness of the model that justifies the protection of test data, in favor of innovation and access to therapy.

Files

Gli “usi commerciali sleali” nella “test data exclusivity”_ le carenze di un modello economico controintuitivo (2)(1).pdf

Additional details

Funding

Ministero dell'università e della ricerca
CLIPKOS

Dates

Available
2026-02-28