Update on Regeneron Pharmaceuticals Inc. v. Merus N.V.

On Tuesday, September 12, 2017, as expected, Regeneron Pharmaceuticals Inc. petitioned  the Court of Appeals for the Federal Circuit (CAFC) for a rehearing en banc of its panel decision rendered in Regeneron Pharmaceuticals Inc. v. Merus N.V., 864 F3d 1343, 123 USPQ2d 1469 (Fed. Cir. 2017). On September 26, 2017, Washington Legal Foundation (WLF) filed an amicus brief with the CAFC requesting the court grant Regeneron’s petition for rehearing en banc. WLF’s brief asserts that the panel decision conflicts with the court’s earlier precedent in Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276 (Fed. Cir. 2011)(en banc) and Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008), and that inequitable conduct claims are likely to proliferate as a result of the panel decision.

On December 26, 2017, the CAFC denied Regeneron’s combined petition for panel rehearing and rehearing en banc. Regeneron Pharmaceuticals Inc. v. Merus N.V., 878 F3d 1041, 125 USPQ2d 1266 (Fed. Cir. 2017).  Judges Newman and Reyna dissented from the denial of the petition for rehearing en banc. Judge Newman wrote in the dissent that inequitable conduct in patent prosecution, retrospectively imposed by adverse inference arising from later litigation misconduct, without a showing of deceptive intent before the USPTO, is a departure from precedent and a disservice to the patent practitioner, the patentee, and the public.

PWB practice tips: Supervision of patent prosecution and patent litigation, especially of the same patent(s), should be kept separate. Potentially troublesome prior art should be submitted via an Information Disclosure Statement (IDS) no matter what stage of prosecution. If necessary, a request for continued examination (RCE) should be filed in order to have prior art considered.  If the issue fee has already been paid, the USPTO’s Quick Path IDS (QPIDS) Pilot Program (extended to run through September, 2018) should be used, which program eliminates the requirement for processing of an RCE with an IDS.  The examiner will consider the IDS and either reopen prosecution or else issue a corrected notice of allowability.