Edwina B. Clarke

Edwina B. Clarke — Patent Litigation Practice Summary

Specialty & side. Clarke is an appellate specialist whose patent work sits squarely in Hatch-Waxman / pharmaceutical litigation, handled at the Federal Circuit and Supreme Court level rather than at trial. Both tracked appearances — Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. No. 2021-1070) and Novartis Pharmaceuticals Corp. v. HEC Pharm Co., Ltd. (D. Del.; S. Ct. No. 22-671) — were for Novartis as plaintiff/patent owner in ANDA suits over its Gilenya (fingolimod) method-of-treatment patents. That makes her tracked patent docket uniformly patent-owner/plaintiff-side; her firm bio also notes broader Federal Circuit pharma work, including an appeal for Indivior in Indivior Inc. v. Dr. Reddy's Laboratories (Fed. Cir. 2019). She has described her own BigLaw positioning as "more on the defense side" generally, but her new firm is expressly plaintiff-side.

Firm context. Clarke joined Goodwin Procter in 2017 and became a partner in its Supreme Court & Appellate practice in Boston, where the tracked Novartis appeals originated. In March 2025 she co-founded Zimmer, Citron & Clarke LLP (Boston/D.C.), a plaintiff-side appellate boutique, and she is currently a partner there. Earlier career: law clerk to Justices Stephen Breyer and David Souter (U.S. Supreme Court) and to judges on the First and Ninth Circuits and the SDNY.

Notable matters & outcomes. The tracked Novartis appeals are the signature patent matters. In Accord Healthcare/HEC Pharm, the Federal Circuit initially affirmed validity, but on panel rehearing (after Judge O'Malley's retirement) reversed, holding that the "absent an immediately preceding loading dose regimen" negative claim limitation lacked written description support and invalidating the patent — a decision widely covered as key negative-limitation precedent. Clarke was listed as counsel on Novartis's certiorari petition, which the Supreme Court denied (Novartis v. HEC Pharm, 143 S. Ct. 1748 (2023)).

PTAB/IPR; bar & education. I found no evidence that Clarke appears regularly in IPR/PGR proceedings; her patent practice is court-of-appeals-focused. She holds a J.D. from Yale Law School (2013) and a B.A. from Yale University (2009, summa cum laude), and per her Goodwin bio is admitted in multiple federal courts of appeals; she has been named to Benchmark Litigation's "40 & Under Hot List" and recognized by Best Lawyers in America for appellate litigation.