President Biden's Executive Order on Promoting
Competition in the American Economy, 86 FR 36987 (2021),
expressed concerns about the patent system being misused to
unnecessarily inhibit or delay entry of generic drugs or biologics
to the marketplace for years, denying Americans access to lower
cost drugs. The President called for action “to help
ensure that the patent system, while incentivizing innovation, does
not unjustifiably delay generic drug or biosimilar competition
beyond that reasonably contemplated by applicable law.”
The Food and Drug Administration (FDA) was charged with the task
of identifying any concerns with the patent system being used in
such an unjustified way. To this end, the FDA reached out to
the U.S. Patent and Trademark Office (USPTO) in a cooperative
spirit to promote further interactions to better understand their
overlap in work and information, particularly where inconsistent
statements might be made to each agency.
