In Regeneron Pharmaceuticals v. Merus N.V., Appeal No. 2016-1346 (Fed. Cir., July 27, 2017), a split three-judge panel of Prost, Wallach and Newman (Newman dissenting) affirmed the district court’s ruling that claim 1 of Regeneron’s U.S. Pat. No. 8,502,018 is unenforceable due to inequitable conduct (IC). The ruling was unusual since the court originally stated that it would hold two hearings; one on the materiality of 4 nondisclosed references, and another on the specific intent to deceive element of IC. Claim 1 reads:

“A genetically modified mouse, comprising in its germline human unrearranged variable region gene segments inserted at an endogenous mouse immunoglobulin locus.” Continue reading →

In the 2003 panel decision in Schering Corp. v. Geneva Pharm., Inc., the panel rejected “the contention that inherent anticipation requires recognition [of the claim element not found] in the prior art.” The claims were directed to a bioactive metabolite of an earlier patented drug that was not mentioned in the earlier patent. Hearing en banc was denied, but Judges Lourie and Newman dissented. Continue reading →