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Duty of Candor and Good Faith With the USPTO Covers Non-Inventors and Non-Practitioners
The Federal Circuit decision in Belcher Pharm. v. Hospira, Inc., 11 F.4th 1345 (Fed. Cir. 2021), confirms important details regarding the duty of candor and good faith when interacting with the United States Patent & Trademark Office (USPTO). For example, withholding information that is material to the patentability of a pending claim of a patent application during prosecution can cause a resultant patent to be found unenforceable. In view of the Belcher decision, the USPTO released a Notice on July 29, 2022 that provides additional guidance on the duty of candor and good faith. Practitioners and non-practitioners that are associated with the examination of patents and patent applications should be vigilant about information that may be material to patentability to avoid having an issued patent be deemed unenforceable.
Federal Circuit Decision
The decision concerns Belcher's U.S. Patent No. 9,283,197, which discloses an injectable liquid formulation having a concentration of 1.0 – 1.06 mg/mL of L-epinephrine, a pH between 2.8 and 3.3, and certain specified percentages of degradation products. Id. at 1347–1350. The subject matter of the '197 patent also was submitted in a New Drug Application (NDA) to the Federal Drug Administration (FDA). Id. The information and arguments submitted to the FDA were different than the information and arguments presented to the USPTO. Based on this difference, the Federal Circuit determined that the '197 patent was unenforceable because Belcher engaged in inequitable conduct by intentionally and deceptively withholding material information from the USPTO during prosecution of the '197 patent, where such material information was disclosed to the FDA. Id. at 1354.
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