Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Belcher Pharmaceuticals, LLC v. Hospira, Inc., 20-1799 (September 1, 2021), affirming patent unenforceability due to inequitable conduct where emphatic, contrary material information provided to the FDA and the PTO was sufficient to establish intent to deceive as the single most reasonable inference able to be drawn from the evidence.
In applying for FDA approval of a “new” epinephrine formulation, Belcher switched from a lower pH range to the prior art’s “old” pH range of 2.8 to 3.3 to expedite FDA approval. Belcher also stated to the FDA that changes in pH ranges were “minor changes” and cited prior art literature claiming these processes were “well known.” However, when applying for a patent on this “new” formulation, Belcher used emphatic language to characterize its invention to fit legal arguments that its pH ranges were not obvious over the prior art. For example, it characterized the invention as answering questions that “seemed impossible,” that the invention “had never been accomplished before,” and that it provided “unexpected” results and was “contradictory to one of skill in the art.” The district court found that Belcher’s use of emphatic language to argue that the claimed pH range of 2.8 to 3.3 was a “critical” innovation and provided “unexpected” results, in view of its characterizations to the FDA, supported a finding that intent to deceive was the only reasonable inference to be drawn.
The Federal Circuit affirmed finding no clear error and reasoned that the contradiction between the information provided to the FDA and the PTO to obtain the patent was but-for material as Belcher’s “critical” pH range arguments overcame the PTO’s rejections. Regarding intent to deceive, the Federal Circuit noted the contrary, emphatic arguments made by Belcher to the PTO and that such behavior is sufficient to establish deceptive intent when the same person is involved with both the FDA submissions and patent prosecution. The Federal Circuit rejected that post hoc rationales for withholding material prior art can avoid a finding of intent to deceive especially when relying on evidence in addition to credibility evidence, such as the same person being involved in both the FDA approval process and patent prosecution.