2023 FCBA Bench & Bar Conference
Federal Circuit Bar Association
Federal Circuit Bar Association
The Broadmoor
Colorado Springs, CO
Stacy Amin, head of Morrison Foerster’s FDA + Healthcare Regulatory and Compliance Group, is Co-Moderating the “FDA and PTO Panel” on July 1, 2023 at the 2023 Federal Circuit Bar Association Bench & Bar Conference.
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.
For more information, visit the Bench & Bar event site.