Overview
Michael F. Werno is an associate in the Litigation practice of Paul Hastings and is based in the firm’s New York office. His practice focuses on complex litigation in the fields of pharmaceuticals and biotechnology.
Mr. Werno has experience litigating cases arising under both the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA). His experience includes developing strategies on validity and infringement, taking and defending depositions, drafting appellate briefs, and leading work with expert witnesses at multiple trials. He has represented life sciences companies in litigations involving pharmaceutical formulations, therapeutic antibodies, biotechnology, and medical devices.
Mr. Werno received his law degree from Boston University School of Law in 2015, where he served as Executive Editor of the Journal of Science & Technology Law. He earned a Masters of Physiology degree from North Carolina State University in 2010, and a B.S. in Biological Anthropology and Anatomy from Duke University in 2008. Mr. Werno is admitted to the New York State Bar, the New Jersey State Bar, and the United States District Court for the District of New Jersey. Mr. Werno is also admitted to practice before the United States Patent and Trademark Office.
Representations
- Representing COVID-19 vaccine developer BioNTech SE in a declaratory judgment litigation in the District of Massachusetts involving BioNTech's COMIRNATY®, the first approved COVID-19 vaccine.
- Representing Horizon Therapeutics in Hatch-Waxman litigation concerning its drug PROCYSBI®, used to treat the ultra rare orphan disease nephropathic cystinosis
- Represented Arbor Pharmaceuticals in a Hatch-Waxman litigation involving its antihypertension drug Edarbi®
- Represented Zimmer Biomet in patent infringement litigation concerning its personalized knee, shoulder, and hip systems.
- Represented Mitsubishi Tanabe in the first-ever Zoom Hatch-Waxman trial in the District of New Jersey, where all invalidity challenges to Mitsubishi Tanabe’s blockbuster Invokana® diabetes medication were rejected
- Representing a major pharmaceutical company in connection with BPCIA litigation relating to its biosimilar version of Humira®.
- Represented a major pharmaceutical company in a Hatch-Waxman action involving an anti-obesity drug, obtaining a favorable judgment of infringement and no invalidity of the asserted patents following a bench trial
- Represented a major pharmaceutical company in a Hatch-Waxman action involving its antiemetic drug product, obtaining a favorable judgment of infringement and no invalidity of the asserted patents following a bench trial
- Represented a major pharmaceutical company in a breach of contract suit brought in the Delaware Chancery Court arising out of research and development relating to Prolia® and Xgeva®
Engagement & Publications
- Michael F. Werno, Note, "More Questions Than Answers? The Uncertainties Surrounding Reverse Payment Settlements In The Post-Actavis World," 21 B.U. J. Sci. & Tech. L. 200 (2015).
Involvement
- Member of the State Bars of New York and New Jersey and admitted to practice before the Federal Circuit, the District of New Jersey, and the United States Patent and Trademark Office.