Inconsistent Positions At FDA And USPTO Render Patent Unenforceable

Unenforceability of a patent for a drug formulation was affirmed by the US Court of Appeals for the Federal Circuit earlier this month in Belcher Pharmaceuticals, LLC v. Hospira, Inc., Appeal No. 2020-1799 (Fed. Circ. Sept. 1, 2021). The decision highlights the potential impact of contradictory positions taken before the Food and Drug Administration (FDA) and the US Patent and Trademark Office (USPTO).

The decision quickly drew the attention of Congress, with Senate Judiciary Subcommittee on Intellectual Property Chair Patrick Leahy (D-Vermont) and Ranking Member Thom Tillis (R-North Carolina) writing a letter to the USPTO to request the agency "take steps to reduce patent applicants' making inappropriate conflicting statements in submissions to the [USPTO] and other federal agencies."