Duty of Candor and Good Faith With the USPTO Covers Non-Inventors and Non-Practitioners

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.

The Federal Circuit analyzed the conduct of the Chief Science Officer at Belcher, who was responsible for both: a) coordinating the submission of the NDA to the FDA; and b) prosecuting the '197 patent at the USPTO. This Chief Science Officer's conduct included admitting the following facts at trial:

• He possessed a label for a prior art epinephrine product called ADRENALIN before and during prosecution of the '197 patent. Id. at 1350–1353;
• He knew, during prosecution of the '197 patent, that the prior art ADRENALIN's concentration of L-epinephrine and pH range of 2.8 to 3.3 were identical to the concentration and pH range in the pending claims of the '197 patent. Id.;
• He failed to disclose this prior art ADRENALIN to the USPTO examiner during prosecution of the '197 patent. Id.;
• He also failed to disclose a material reference to the patent examiner during prosecution of the '197 patent, even though: a) he knew about the reference prior to the filing of the '197 patent; b) he emailed and quoted the reference to Belcher's FDA consultant; and c) he cited the reference to the FDA twice during the FDA approval process for Belcher's drug product. Id.; and
• He argued to the patent examiner during prosecution of the '197 patent in support of secondary indicia of non-obviousness that the claimed pH range of 2.8 to 3.3 was "critical" to the claims and "unexpectedly" reduced racemization, despite: a) his representation to the FDA that the optimum pH range for the composition was lower, namely, 2.4 to 2.6; and b) the fact that the withheld prior art ADRENALIN had a pH range of 2.8 to 3.3. Id.

The district court found the Chief Science Officer to have committed inequitable conduct even under a heightened clear-and-convincing standard. Based on the facts listed above, the district court found, and the Federal Circuit agreed, that the prior art ADRENALIN was "necessarily material to patentability". Id. at 1351–1354. The Federal Circuit also agreed with the district court that Belcher exhibited deceptive intent based on the facts listed above and also because the Chief Science Officer's trial testimony was implausible and lacked credibility given: a) his prior knowledge and withholding of the material disclosures; b) his central role in both the FDA approval process and the prosecution of the '197 patent; and c) his statements during prosecution of the '197 patent regarding the criticality of the claimed pH range of 2.8 to 3.3 to overcome obviousness, where such statements were contrary to the data in the NDA. Id.