Federal patent laws grant exclusive rights to inventors and prohibit infringement of these rights. The Food, Drug, and Cosmetic Act (FDCA) exempts from patent infringement activities undertaken to meet regulatory requirements that delay commercial marketing of certain products regulated by the FDCA. The Supreme Court held the exception applicable to medical devices subject to significant premarket regulatory delay, but the recent district court decision of Baxter Diagnostics, Inc. v. AVL Scientific Corp. restricted the experimental use exception to those medical devices that must meet specific premarket approval requirements. This Note examines the codification and judicial interpretation of the statutory experimental use exception and argues that the Baxter court applied inappropriate criteria to determine medical device eligibility for infringement protection. The author suggests an eligibility inquiry more consonant with the plain language and Supreme Court interpretation of the statutory experimental use exception.
Medical Device Eligibility for the Statutory Experimental Use Exception to Patent Infringement,
17 Hastings Comm. & Ent. L.J. 705
Available at: https://repository.uchastings.edu/hastings_comm_ent_law_journal/vol17/iss3/6