United States Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) Host Listening Session

The USPTO and FDA held a joint listening session focused on the patent system for drugs. Speakers from patient advocacy and industry groups, academia, and brand and generic pharmaceutical companies weighed in on the relationship between patents and affordable access to medicines.

The session stemmed from a joint July 2022 announcement that the two agencies planned to execute a number of initiatives aimed at lowering drug prices, as directed in July 2021 by President Joe Biden’s “Executive Order on Promoting Competition in the American Economy.”

The agencies’ collaboration efforts have been met with skepticism by industry amid concerns about the ability of companies to comply with some of the obligations proposed by the USPTO thus far that would burden companies and even potential jeopardize their IP position.

Worries over balance, fairness and diversity of thought were raised by some about the USPTO’s lineup of panelists. At least six of the speakers over the course of the day represented entities funded by John and Laura Arnold, a Texas billionaire couple who have been active in sponsoring efforts around drug pricing legislation. T1 International, I-MAK, Generation Patient and Patients for Affordable Drugs are all backed by Arnold Ventures, and collectively had six speaking spots throughout the session, with T1I featured on three separate panels.

Our national partner, BIO, addressed common misconceptions of intellectual property in the life sciences, noting that bioscience companies actually produce fewer patents than comparable businesses in other sectors — such as one-tenth of those produced in high tech or communication technology — and that patents in the life sciences are invalidated less often via litigation, at about 25% of the time, relative to the 40-45% across all industries.

Public comments from BIO (Hans Sauer, author), PhRMA, Hudson Institute, National Multiple Sclerosis Society, Novartis and many others can be found here.