Michelle L. Ernst

michelle.ernst@lw.com

+1.212.906.1780

Profile

Michelle Ernst is a patent litigator and trial lawyer who represents brand-name pharmaceutical companies in district court (especially Hatch-Waxman) trials, Federal Circuit appeals, and before the United States Patent and Trademark Office.

Michelle advises companies in the life sciences, pharmaceutical, biotechnology, and healthcare industries on a full spectrum of patent and intellectual property matters, including diligence, portfolio development, and pre-suit investigation, in addition to litigation, trial, and appeal.

Michelle has a degree in Genetics and Molecular and Cell Biology (summa cum laude), was a cancer cytogeneticist prior to and during law school, and conducted cancer research as a Fulbright scholar in Singapore.

She leverages her scientific expertise and a comprehensive understanding of the pharmaceutical and biotechnology industries to help clients navigate the full litigation cycle. Michelle forges trusted relationships to craft litigation and commercial strategies that are responsive to the sophisticated science that drives her clients’ innovative businesses.

Michelle is a member of various professional organizations for women practitioners in the patent and intellectual property space, including ChIPs (Chiefs in Intellectual Property) and WIN (the Women in IP Network.

She also maintains an active pro bono practice and has worked on veterans’ rights and asylum matters.

Experience

Michelle’s experience includes:

Amgen v. MSN – Represents Amgen in Hatch-Waxman patent litigation concerning Amgen’s Parsabiv® product
Allele v. Regeneron – Represents Regeneron in patent litigation concerning its COVID-19 antibody, REGEN-COV®️
Eli Lilly v. MSN – Represents Eli Lilly in Hatch-Waxman patent litigation concerning Lilly’s Olumiant® product
Sebela v. Prinston – Represented Sebela in Hatch-Waxman patent litigation concerning Sebela’s Brisdelle® product
Biogen v. Teva – Represented Biogen in Hatch-Waxman patent litigation concerning Biogen’s Vumerity® product
Cephalon & Eagle Pharmaceuticals v. Slayback Pharma – Represented Eagle in Hatch-Waxman patent litigation concerning its Bendeka® oncology product, in which the patents found valid and infringed
Neptune Generics v. Corcept Therapeutics – Defended Corcept against Neptune’s challenge to a patent covering its Korlym® drug product, in which the Patent Trial and Appeal Board (PTAB) found that Neptune failed to prove that any of the challenged claims were unpatentable
Mallinckrodt Pharmaceuticals v. B. Braun Medical – Secured a favorable settlement for Mallinckrodt in Hatch-Waxman patent litigation concerning its Ofirmev® injectable acetaminophen product
Merck Sharp & Dohme v. Warner Chilcott – Represented Merck in Hatch-Waxman patent litigation involving its NuvaRing® contraceptive product.*
Janssen Pharmaceutica NV v. Mylan Labs – Represented Janssen Pharmaceutica (Johnson & Johnson) in Hatch-Waxman patent litigation concerning Dyloject®, an injectable nonsteroidal anti-inflammatory drug.*
Stiefel Labs v. Perrigo Israel Pharms – Represented Stiefel Laboratories, a GSK company, in Hatch-Waxman patent litigation involving OLUX-E®, a topical corticosteroid for treating psoriasis and atopic dermatitis.*
Celgene Corp. v. Fresenius Kabi – Represented Celgene in Hatch-Waxman patent litigation involving Istodax®, an injectable used to treat patients with T-cell lymphoma.*
Advised Chardan Healthcare Acquisition 2, a special-purpose acquisition company, on patent aspects of its business combination with Renovacor, an early-stage biotechnology company developing AAV-based gene therapies for cardiovascular and central nervous system diseases resulting from BAG3 gene dysfunction
Advised Siemens Healthineers, a medical technology company, on the patent portfolio aspects of its acquisition of Varian Medical Systems, a world leader in the field of cancer care that uses artificial intelligence, machine learning, and data analysis to improve cancer treatment