A divided panel of the Federal Circuit affirmed the district court’s holding that Regeneron engaged in inequitable conduct during prosecution of the asserted patent. Regeneron Pharm., Inc. v. Merus N.V., No. 2016-1345 (Fed. Cir. July 27, 2017). In this case, Regeneron sued Merus for patent infringement and Merus asserted a counterclaim of unenforceability due to inequitable conduct based on evidence of withholding of four references from the USPTO during prosecution. Merus argued that the four references were cited in a third-party submission in related U.S. patent prosecution and in European opposition briefs, were but-for material, and withheld with the specific intent to deceive. Regeneron argued that they were cumulative references and it did not have any specific intent to deceive. The district court held a first bench trial to determine the materiality of the withheld references but failed to hold the scheduled second bench trial on specific intent. In its first trial, the district court found Regeneron’s repeated violations of discovery orders and improper release of relevant and non-privileged documents, and based on the misconduct drew an adverse reference on specific intent and concluded that Regeneron had committed inequitable conduct.
The asserted patent relates to using large DNA vectors to target and modify endogenous genes and chromosomal loci in eukaryotic cells and this technology may be used to modify genes in mice to develop antibodies for use in humans. Prior to issuance of the notice of allowance, a third-party submitted three references in the parent application. Regeneron failed to disclose the third-party submission and a fourth reference in the present application but disclosed them in every related application having the same specification. On appeal, the Federal Circuit concluded that the district court did not err in finding each of the withheld references but-for material and that it didn't abuse its discretion in drawing the adverse inference of specific intent based on discovery misconduct that obfuscated its prosecution misconduct.
In here dissent, Judge Newman complained that misconduct during litigation must not affect a finding of inequitable conduct and specific intent must be based on conduct during prosecution and should not be based on any adverse inference, particularly litigation misconduct.
Full text of the opinion is available here.
The asserted patent relates to using large DNA vectors to target and modify endogenous genes and chromosomal loci in eukaryotic cells and this technology may be used to modify genes in mice to develop antibodies for use in humans. Prior to issuance of the notice of allowance, a third-party submitted three references in the parent application. Regeneron failed to disclose the third-party submission and a fourth reference in the present application but disclosed them in every related application having the same specification. On appeal, the Federal Circuit concluded that the district court did not err in finding each of the withheld references but-for material and that it didn't abuse its discretion in drawing the adverse inference of specific intent based on discovery misconduct that obfuscated its prosecution misconduct.
In here dissent, Judge Newman complained that misconduct during litigation must not affect a finding of inequitable conduct and specific intent must be based on conduct during prosecution and should not be based on any adverse inference, particularly litigation misconduct.
Full text of the opinion is available here.
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