Lunch Seminar with Associate Professor Dmitry Karshtedt
Pharmaceutical Patents and Adversarial Examination
Proposals to improve the work quality of the U.S. Patent and Trademark Office (PTO) continue to generate vigorous debate. On one hand, several scholars argue 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 appropriately function only as a coarse filter because most patents are never enforced or licensed, and that devoting substantial resources to ascertaining validity is only sensible after an issued patent has actually proven 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 to turn into commercially important patents. Specifically, the competitive impact of so-called “secondary” patents, which tend to embody incremental innovations, can be readily anticipated in many cases. Thus, it stands to reason to allow interested third parties, such as generic manufacturers, to participate in the process of pharmaceutical patent examination as early as possible, and this Article proposes such an adversarial proceeding. This reform should result in better performance by the PTO in a critical technological area, help prevent issuance of pharmaceutical patents of questionable validity thanks to efforts by motivated private entities, and cut down on the waste and errors caused by repetitive adjudication.
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Dmitry Karshtedt's primary research interest is in patent law. His legal scholarship has been published in the Iowa Law Review, Vanderbilt Law Review, and Harvard Journal of Law & Technology, among other outlets, and cited in three of the leading patent law casebooks, a casebook on intellectual property, and several treatises. Professor Karshtedt's academic work has won several awards, including the Samsung-Stanford Patent Prize and the scholarship grant for judicial clerks sponsored by the University of Houston Law Center Institute for Intellectual Property and Information Law.
Before going into law, Professor Karshtedt completed a Ph.D. in chemistry from U.C. Berkeley and worked as a staff scientist for a semiconductor materials startup. He is a co-author on five scientific publications and a co-inventor on twelve U.S. patents. Professor Karshtedt received his law degree from Stanford Law School, where he served as the Senior Symposium Editor for the Stanford Law Review. Professor Karshtedt practiced in the Patent Counseling and Innovation Group at Wilson Sonsini Goodrich & Rosati and clerked for the Honorable Kimberly A. Moore on the U.S. Court of Appeals for the Federal Circuit. Immediately prior to starting his position at GW, Professor Karshtedt was a Fellow at the Center for Law and the Biosciences at Stanford Law School.