Clash of the Titans: Conflicts in the Regulation of Medical Devices by the FDA and PTO

Abstract

This paper discusses two of the conflicts created by the fact that both the Food and Drug Administration and the Patent and Trademark Office regulate medical devices and drugs. A brief description of the two agencies is made to give a sense of their goals and of their resources involved. The conflicts discussed are the effect each agency has on the monopolistic power a company may have in the market, and the problem arising from the term “substantial equivalence†being used by the agencies for very contrary goals. With each conflict, the method to resolve the problem is discussed, be it by acts of Congress, the Courts, or the industry itself.