FDA and PTO Panel

Director Deborah Sterling, Ph.D., will speak on the FDA and PTO Panel at the Federal Circuit Bar Association’s 2023 Bench & Bar® Conference on Saturday, July 1, 2023 in Colorado Springs, CO.

Panel Overview

In July 2021, the Biden Administration issued an Executive Order on Promoting Competition in the American Economy which launched a “whole-of-government” approach to competition policy across the American economy. With respect to the biopharmaceutical industry, among other things, the Executive Order alleged that patent laws “have been misused to inhibit or delay — for years and even decades — competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs,” and called on the FDA to enumerate and describe to the PTO any concerns about such alleged misuses. This led to an exchange of letters, and the PTO’s opening of two workstreams and dockets in late 2022 related to the alleged intersection of patents and drug pricing: one concerning “Joint FDA-USPTO Collaboration Initiatives,” and another concerning “USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights.” Drawing on a variety of different perspectives, from government, to industry, to private practice, this panel will discuss the background, dynamics, boundaries, and implications of this unprecedented interagency approach to patent and drug pricing policy.

Director Anna G. Phillips will also speak at the 2023 Bench & Bar® Conference as the co-moderator of the Patent Remedies Panel on Friday, June 30.