Fed Circuit Watch: Regeneron Denied Redemption in Misconduct Case

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On December 26, 2017, the Court of Appeals for the Federal Circuit denied a request for rehearing en banc for reconsideration made by Regeneron Pharmaceuticals, Inc., in a precedential decision.  This petition was filed following the original decision affirming specific intent litigation misconduct held in the original appellate case.  Judges Prost, Lourie, Dyk, Moore, O’Malley, Wallach, Taranto, Chen, Hughes, and Stoll joined the majority per curiam decision; Judges Newman and Reyna dissented.

To recap, the original appellate decision was based on Regeneron’s failure to disclose four prior art references during prosecution of its patent.  The Fed Circuit panel found that in doing so, Regeneron had the specific intent to deceive the USPTO during prosecution.  This act essentially invalidated its patent in the subsequent patent litigation.  Regeneron sought to have an enlarged panel of the Fed Circuit rehear its appeal, but this was then denied.

Judge Newman, like in the original case, dissented.

She argued that:

. . . [I]nequitable conduct in patent prosecution can be retrospectively imposed by “adverse inference” arising from later misconduct in litigation, without a showing of deceptive intent before the Patent Office.[1]  This departure from precedent is a disservice to the patent practitioner, the patentee, and the public.[2]

She continues to argue that deceptive intent cannot be inferred, but rather, citing Therasense,[3] must be proved by clear and convinving evidence.  Without this proved deceptive intent is a departure from past Federal Circuit precedent and an unwarranted finding of specific intent to deceive without neither a hearing nor evidentiary support.[4]

Judge Newman, usually quite astute when dealing with patent appeals, noted a possible constitutional issue in her dissent.  That is, whether a federal court can infer specific intent to deceive, and specifically finding beyond any USPTO proceeding that did not adjudicate any specific intent issues to deceive, such that an applicant’s procedural due process rights have been violated under the Fifth Amendment of the Constitution.[5]  This remains to be seen on certiorari to the U.S. Supreme Court.

[1] Regeneron Pharms., Inc. v. Merus N.V.reh’g en banc denied, 878 F.3d 1041, aff’g, 864 F.3d 1343 (Fed. Cir. 2017).

[2] Id.

[3] See Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1290-91 (Fed. Cir. 2011) (en banc).

[4] See Regeneron, supra (Newman, J., dissenting, slip op. at 3).

[5] Id. (slip op. at 4).