Holding
In Belcher Pharms, LLC v. Hospira, Inc., --F.4th __, 2021 U.S. App. LEXIS 26346 *(Fed. Cir. Sept. 1, 2021) the Federal Circuit affirmed a district court decision per Judge Stark in Delaware, holding the claims of U.S. Patent No. 9,283,197 ("the '197 patent") obvious and unenforceable for inequitable conduct. Regarding the latter, both courts concluded that Belcher's Chief Science Officer withheld but-for material information from the U.S. Patent and Trademark Office ("PTO") with the sole reasonable inference being a specific intent to deceive.
Background
Belcher's approved product was a 1 mg/mL injectable l-epinephrine formulation. In submissions to the FDA, Belcher, in an effort to make FDA approval as easy as possible, described its formulation development as stemming from a reference product developed by a Swiss company, Sintetica, in the 1930s. According to Belcher, Sintetica's "original formulation" of 1 mg/mL injectable l-epinephrine did not include preservatives and sulfites and had an "old" in-process pH range of 2.8 to 3.3. In contrast, the NDA described the new composition as having a lower pH range of 2.4 to 2.6 and explained that "[t]he switch [in pH] was very simple." Belcher, 2021 U.S. App. LEXIS 26346 at *3-4. "Responding to the FDA's inquiry on [the] manufacturing process for the stability validation batches, Belcher stated that the only difference between the relied-upon Sintetica batches and Belcher's proposed formulation 'is related to the in[-]process pH' and that it 'consider[ed] the in[-]process pH change to be a very minor change not requiring additional stability studies.'" Id. at *5. When the FDA requested additional information relating to the pH change, however, Belcher decided to switch back to the "old" pH range of Sintetica's original formulation, 2.8 to 3.3, to avoid a delay in approval, which Belcher received on July 29, 2015.
Belcher filed a U.S. patent application protecting its product on Aug. 15, 2014...
