Argument of Criticality Undercut Position that Non-Disclosed Art was Merely Cumulative

In Belcher Pharmaceuticals, LLC v. Hospira, Inc., [2020-1799] (September 1, 2021), the Federal Circuit affirmed the district court’s determination that Belcher’s Chief Science Officer engaged in inequitable conduct by withholding material information from the USPTO during prosecution of U.S. Patent No. 9,283,197.

During prosecution, Belcher argued that the prior art’s 2.2 to 5.0 pH range failed to render obvious the claimed range of 2.8 to 3.3 because the claimed range “was unexpectedly found to be critical . . . to reduce the racemization of l-epinephrine.”  The application was eventually discussing the reasons for allowance, the examiner explained that the cited art failed to render the claims unpatentable “in view of Applicant’s demonstration of criticality of a pH range between 2.8 and 3.3.”  The district court the found that the’197 patent was unenforceable for inequitable conduct. Regarding materiality, the district court found that Rubin withheld three items that were but-for material to patentability because they disclosed two aspects of the asserted claims: the pH range and the impurity levels.  The district court also found that Mr. Rubin acted with requisite intent to deceive the PTO, noting that Rubin knew that Belcher described the claimed pH range of 2.8 to 3.3 to the FDA as “old,” and described references in this range.  The district court found that when dealing with the PTO, the district court explained, Mr. Rubin did not merely withhold this information but also used emphatic language to argue that the claimed pH range of 2.8 to 3.3 was a “critical” innovation that “unexpectedly” reduced racemization.

On review the Federal Circuit noted that in view of the obviousness determination, the withheld information was “necessarily material to patentability.”  The Federal Circuit rejected the argument that these references were merely cumulative, in view of the inconsistent argument that the range disclosed in the withheld references was critical.   On the issue of intent, the Federal Circuit said that the district court found that although 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.  The Federal Circuit agreed that the reasons for withholding the references were “implausible and not credible.”