In a precedential decision authored by Judge Reyna, the U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday upheld a Delaware district court’s ruling that Belcher Pharmaceuticals Inc.’s Chief Science Officer engaged in inequitable conduct, making its U.S. Patent No. 9,283,197 unenforceable. Belcher brought the suit against Hospira, Inc. for infringement of the ‘197 patent under the Hatch-Waxman Act, but the district court found that the Belcher Chief Science Officer withheld material information from the U.S. Patent and Trademark Office (USPTO) during patent prosecution, and the CAFC affirmed.
The ‘197 patent is titled “More Potent and Less Toxic Formulations of Epinephrine and Methods of Medical Use.” The patent relates to an epinephrine product that did not include “preservatives and sulfites,” which cause side effects. The new drug application (NDA) to the U.S. Food and Drug Administration (FDA) was submitted in 2012 and approved in 2015, and the ‘197 patent issued in 2016. Hospira thereafter submitted an NDA to the FDA seeking approval of an epinephrine formulation. As part of that application, it certified that “the ’197 patent’s claims are invalid, unenforceable, and/or not infringed by Hospira’s NDA product.” Belcher sued for infringement under the doctrine of equivalents and Hospira’s affirmative defenses and counterclaims of non-infringement, invalidity and unenforceability.
During the trial, Belcher’s Chief Science Officer, Darren Rubin, testified that he oversaw the patent prosecution process and also helped to draft the application and respond to the examiner’s office action initially rejecting the application based on Canadian Patent Application No. 2002643 A (“Helenek”). Rubin also was integral to the FDA approval process. Rubin testified that he knew of three facts pertinent to the case before and during the patent’s prosecution: 1) Swiss company Sintetica SA’s “original formulation” of 1 mg/mL injectable l-epinephrine, which Sintetica developed in the 1930s and registered in Switzerland in 1947; 2) a company named JHP’s epinephrine product, which had a pH within the range of 2.8 to 3.3 at 15 months (the same pH range as Belcher’s formulation); and 3) a reference called Stepensky relating to the “racemization” process for epinephrine. Hospira’s expert witness testified that each of these three pieces of information were “but-for material to patentability” because they disclosed the pH range and the impurity levels of the asserted claims, and the district court agreed. The court also found that clear and convincing evidence showed that Rubin acted with intent to deceive the USPTO.
The Federal Circuit reviewed the district court’s decision on materiality and intent for clear error and on inequitable conduct abuse of discretion. Belcher did not challenge the district court’s decision that the relevant claims of the ‘197 patent were obvious based on JHP’s product, which makes the JHP product “necessarily material to patentability,” said the CAFC. Belcher argued that the JHP product and other withheld references were immaterial because they were “cumulative” of the Canadian patent, Helenek, which disclosed “epinephrine formulations with pH between 2.2 and 5.0, including epinephrine solutions with a pH range of 3.0 to 4.0,” but the Federal Circuit said that argument was “directly at odds with” Belcher’s argument during prosecution that its claimed pH range of 2.8 to 3.3 was “critical”. The examiner only allowed the claims after Belcher made this criticality argument.
As to intent, while the district court said there was no direct evidence of deceptive intent “the evidence of record persuaded it ‘clearly and convincingly that this is the only reasonable inference that can be drawn.’” Rubin was involved in the FDA approval process and knew that Belcher had reverted from its original pH range of 2.4 to 2.6 to the 2.8 to 3.3 range “because the latter range corresponded to the reference product made by Sintetica, and therefore using that range would expedite FDA approval.” Later, during prosecution, “Rubin performed an about-face and emphatically and repeatedly advanced the position that the 2.8 to 3.3 pH range was a ‘critical’ innovation contrary to the knowledge of a person of ordinary skill in the art that yielded “unexpected results,” namely reducing racemization of l-epinephrine.”
On appeal, Belcher argued that Rubin believed these references to be irrelevant “given their high overages.” Belcher conceded that Rubin was acting in a “self-serving” manner to preserve a patent, but that his behavior did not rise to the level of deceptive intent. Relying on its reasoning in Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324, 1334 (Fed. Cir. 2012), the Federal Circuit rejected that argument, concluding that there was no clear error in the district court’s finding of intent because it “viewed [Rubin’s] testimony in light of the other evidence to reach its intent conclusion.”