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The Implementation Of Fda Determinations In Litigation - Why Do We Defer To The Pto But Not To The Fda?, William G. Childs

Faculty Scholarship

This Article examines the possible inequity of the treatment of licensees' rights in tort litigation in comparison to patent rights in patent litigation. In particular, this Article presents the presumptions afforded from issued patents as a valid model for the proper treatment of FDA approval in litigation. Presently, most academic discussion proposes either preclusion of tort claims or leaving the system more or less as it stands. This Article, on the other hand, proposes a middle ground.

This Article begins by examining the differences between the USPTO and the FDA. In particular, the quantity and quality of the review provided …