Dmitry Karshtedt
91 Geo. Wash. L. Rev. 1259
Proposals to improve the work quality of the U.S. Patent and Trademark Office (“PTO” or “USPTO”) continue to generate vigorous debate. On one hand, several scholars maintain that the short times allotted to the examination of patent applications and the agency’s other operational constraints yield numerous patents of questionable validity and conclude that the PTO must be fixed. On the other hand, a noteworthy dissenting view defending the PTO’s “ignorance” as “rational” holds that examination should function chiefly as a coarse filter because most patents are never enforced or licensed and that devoting substantial resources to ascertaining validity is sensible only after an issued patent proved to be valuable. This Article does not take a side in this debate, but instead uncovers a point of potential agreement between these two positions. It argues that there is a class of patent applications—those intended to support the marketing of branded small-molecule pharmaceutical products—that one can predict with some degree of confidence will turn into commercially important exclusive rights. Specifically, the economic and social impacts of so-called “secondary” drug patents, which cover incremental innovations, can be readily anticipated in many cases. Thus, it stands to reason that interested third parties, such as generic manufacturers, should be allowed to participate in the process of pharmaceutical patent examination as early as possible. This Article proposes such an adversarial proceeding. This reform should result in better performance by the PTO in a critical technological area, help prevent the issuance of questionable patents that can lead to unnecessarily high drug prices, and cut down on the waste of resources, errors, and other destabilizing effects caused by repetitive adjudication of patent validity.
