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

(202) 737-7544

Practice Areas
Prescription Drugs and Biologics
Corporate Transactions
OTC Drugs and Cosmetics
Training Programs

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.

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
Paragraph IV Disputes Master Symposium,  September 30 - October 1st, 2014  New Exclusivity Challenges for Brand Names and Generics: Exploring Their Implications for Paragraph IV Challenges

ACI: FDA Boot Camp,  September 18 - 19, 2014  Hatch-Waxman and BPCIA Overview. Co-chair for the conference

Hatch Waxman Boot Camp ,  June 9-10, 2014

Summit on Biosimilars: The Definitive Forum on the Legal, Regulatory, Patent, and Commercial Realities of Biosimilars,  June 4-6, 2014

FDLI Webinar Doing Business with India: Latest Developments in Pharmaceutical Regulation,  June 3, 2014  Panel member

Blog Posts    -    see more blog entries
Court Upends FDAs Clinical Superiority Requirement for Granting Orphan Drug Exclusivity; Decision Leaves a Lot of Questions to Be Answered,  September 11, 2014
Springboarding Off of an HP&M Citizen Petition, Connecticuts Attorney General Seeks to Dislodge Exclusivity Block on Generic NEXIUM,  September 8, 2014
District Court Orders FDA to Recognize Orphan Drug Exclusivity for GRALISE; Rejects FDAs Requirement to Demonstrate Clinical Superiority of GRALISE,  September 7, 2014
Court Orders Orange Book Patent Delisting in NUEDEXTA Infringement Litigation; But Whats It Good For?,  September 4, 2014
The Generic Drug Labeling Carve-Out Scorecard,  September 2, 2014