Hyman Phelps and McNamara
Kurt R. Karst
Photo of Kurt R. Karst

(202) 737-7544

Practice Areas
Prescription Drugs and Biologics
Corporate Transactions

J.D., American University Washington College of Law
B.A., Political Science and German, Marquette University

Bar Admissions
District of Columbia

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Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. As the co-founder and primary author of Hyman, Phelps & McNamara's FDA Law Blog, Mr. Karst often leads the response to new rules and regulations, sharing his interpretation with the broader legal community.

Mr. Karst's knowledge of FDA precedents and timely analysis of developments helps clarify and shape the industry's understanding of Hatch-Waxman, in particular. He is a prolific writer, contributing to the blog and publishing articles in major legal journals. Mr. Karst has co-authored and contributed to several text books, including Generic and Innovator Drugs: A Guide to FDA Approval Requirements; Pharmaceutical, Biotechnology, and Chemical Inventions; Fundamentals of US Regulatory Affairs; and FDLI's Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives.

Mr. Karst clerked for Hyman Phelps & McNamara while attending law school and served as articles editor for the American University Law Review. Before joining the firm, Mr. Karst lobbied for F. Hoffmann-La Roche Inc. In 1995, he was awarded a Fulbright Scholarship for post-graduate studies in Germany.

Related Experience
Prescription Drugs and Biologics
• Counsels clients on Hatch-Waxman patent and exclusivity matters.
• Develops strategies around exclusivity status and Orange Book Patent Listings.
• Obtains approvals for INDs, NDAs, and ANDAs.
• Helps clients obtain orphan drug designations as part of a broader product strategy.
• Advises clients on PDUFA and GAIN.
• Provides counsel on REMS.

OTC Drugs and Cosmetics
• Helps clients market OTC drugs.

• Advises clients on marketing and unapproved drug enforcement issues.

Awards & Recognition
• Who's Who Legal Directory, Life Sciences, Regulatory Section, 2015
• Who's Who Legal Directory, Life Sciences, Patent Litigation Section, 2015

Articles / Publications    -    see more articles
FDA Amendments Act - HPM Issues Detailed Summary and Analysis,  October 2007

FDA Announces Proposed Regulations to Overhaul and Expand the Availability of Experimental Drugs and to Clarify Permissible Charges to Patients,  December 12, 2006

Rep. Waxman and Sens. Schumer and Clinton Introduce Biogenerics Bill,  September 29, 2006

FDA's Final Compliance Policy Guide for Marketed Unapproved Drugs ─ Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle?,  August 11, 2006

New Law Reins in "Authorized Generics" Despite Generic Industry Court Losses, But Leaves Several Ambiguities,  June 2006

Speaking Engagements    -    see more speaking engagements
FDA Boot Camp ,  September 30 - October 1, 2015  Kurt Karst is speaking on the "Hatch Waxman and BPCIA Overview" on March 11, 2015

CONVERGE - Where Healthcare Meets Innovation,  September 1-2, 2015  9/1 Panelist: Getting Real about Superbugs

American Intellectual Property Law Association Webinar – Biosimilars: Regulation, Litigation and New Developments Patent Practitioners and Regulatory Attorneys Should Know,  August 27-28, 2015  KRK 8/27 Presentation: “The New Drug Approval Process: NDA Submission and Review”]

Drug Information Association: Annual Meeting,  June 14-18, 2015  6/17 Panel Member: “Does Bioequivalent Always Mean Therapeutically Equivalent? Impact of FDA’s Proposed Rule on Generic Labeling”]

RDD Europe 2015,  May 5-8, 2015  FDA's Orange Book and ANDA's: Questioning the Policies and Precedents Surrounding RLD Patent Listings.

Blog Posts    -    see more blog entries
No False Starts: FDA Prevails in Eisai Challenge Over NCE Exclusivity Start Dates for BELVIQ and FYCOMPA,  September 30, 2015
FDA’s Seventh Annual Report to Congress on 505(q) Citizen Petitions: A Lot of the Same Old Same Old,  September 29, 2015
How Effective is a “Depomed Threat” at Resolving an Orphan Drug Clinical Superiority Dispute?,  September 27, 2015
Tag-Team Enforcement: After Years of FTC Proceedings, Rhode Island Businessman Pleads Guilty to FDC Act and Tax Violations,  September 25, 2015
Amgen Wants Patent Dance Redo and a Halt to Hospira’s EPOGEN Biosimilar,  September 24, 2015