November 8-10, 2021 | Virtual Conference

Register Now en English


Michael Shumsky

Hyman, Phelps & McNamara, P.C.

Mike Shumsky represents pharmaceutical companies in high-stakes regulatory matters and litigation arising under the Hatch-Waxman Act, Biologics Price Competition and Innovation Act, and Orphan Drug Act, and offers strategic counseling to clients regarding lifecycle management initiatives, regulatory affairs, and legislative concerns. He frequently appears in proceedings before the FDA, and has briefed and argued both FDA-related and non-FDA cases throughout the country. Mike also maintains an active appellate practice and regularly appears in cases before the U.S. Supreme Court, including the landmark federal preemption cases PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013).

Law360 and Super Lawyers each named Mike a “Rising Star,” and his oral advocacy and brief-writing have garnered praise from courts and commentators. See, e.g., Teva Pharms. USA, Inc. v. Sebelius, 595 F.3d 1303, 1310 (D.C. Cir. 2010); ANDA Exclusivity Protected from Patent Delisting Under Appeals Court Ruling, The Pink Sheet, Mar. 8, 2010.

Before joining Hyman, Phelps & McNamara in 2019, Mike was a share partner in the Washington DC office of Kirkland & Ellis LLP, which he joined after clerking for the Hon. Diarmuid F. O’Scannlain on U.S. Court of Appeals for the Ninth Circuit. Mike received his J.D. from Yale Law School, where he served as Book Reviews Editor on the Yale Law Journal and was awarded the Thomas I. Emerson Prize for his article on the Supreme Court’s severability doctrine. Mike earned his A.B. from Harvard College, where he was elected to Phi Beta Kappa.

Outside of his day-to-day law practice, Mike serves as an adjunct professor at Columbia Law School and is an active supporter of the Ulman Foundation, a nonprofit that supports young adults impacted by cancer and their families.

Get Started & Register

Whether you are an AAM member, general attendee, or exhibitor, come meet the leaders and decision-makers who are determining the future of generics and biosimilars.

Register Now

Skip to content