Testing The Limits Of Therasense: Patent Owner's Decision Not To Appeal Obviousness Holding Created But-for Materiality And Knowledge Of Withheld References Established Intent

• Published date: 21 September 2021
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Patent, Trials & Appeals & Compensation
• Law Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Author: Mr Paul W. Browning, Amanda K. Murphy, Kyu Yun Kim and Stacy Lewis

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. In stark contrast to what Belcher told the FDA, the patent application described the formulation having a pH range of 2.8 to 3.3 as something that "seemed impossible" and "had never been accomplished before." Belcher, 2021 U.S. App. LEXIS 26346 at *5. "The patent similarly states that the idea of raising the in-process pH above the range of 2.2 to 2.6 was contradictory to what one of skill in the art would have thought before the claimed invention." Id. Claims 6 and 7 were at issue in the litigation. Claim 6...