Kurt R. Karst Director 202-737-7544
Kurt R. Karst

Overview

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 InventionsFundamentals 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.

Industries

Education & Admissions

Education

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

Admissions

District of Columbia
Maryland

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.

Enforcement
Advises clients on marketing and unapproved drug enforcement issues.

Honors & Awards

  • Who’s Who Legal Directory
    Life Sciences Regulatory Section
    2015
  • Who’s Who Legal Directory
    Life Sciences, Patent Litigation Section
    2015-2016

Speaking Engagements

  • FDLI’s Patient Organizations: An Introduction to U.S. Drug Law and Regulation Conference, Hatch-Waxman and Other Statutory Incentives, November 7-8, 2018
  • FDA: Past, Present and Future Conference, Commentary on Drug Presentation: “The History and Political Economy of the Hatch-Waxman Amendments”, October 19, 2018
  • Paragraph IV Disputes: Master Symposium, Brand and Generic Perspectives on the Latest FDA Initiatives in the Hatch-Waxman Space, October 1-3, 2018
  • FDA Boot Camp,  September 26-28, 2018
  • GRx+Biosims: Engineering the Future of Generic + Biosimilars Medicines, Legal Issues in GDUFA, FDARA, and Administrative Proposals, September 5-7, 2018
  • Asian Biologics and Biosimilars Conference, August 20-21 2018
  • RAPS Webcast – RAC (US) Prep Virtual Program, May 31, 2018
  • Coalition for Healthcare Communications Rising Leaders Conference, May 22-23, 2018
  • Barclays High Yield Bond & Syndicated Loan Conference, Healthcare and the FDA: Keeping Up With Disruptions, May 21-23, 2018
  • International Convention of The Economy of Innovation, The U.S. Pharmaceutical Industry – Driving Forces – Patents and FDA, April 30, 2018
  • European Biosimilars Congress, Biosimilars in The United States: A Progress Report and Peek into the Future, April 26, 2018
  • Paragraph IV Disputes Seminar, The Impact of New FDA Leadership on Hatch-Waxman Practice, April 23-25, 2018
  • FDA Boot Camp, Hatch-Waxman and BPCIA Overview, March 7, 2018
  • RAPS RAC(US) Prep Virtual Program, Fundamentals of US Regulatory Affairs, March 1, 2018
  • Webinar: Marketing Drugs, Medical Devices and Foods in the U.S. – What you need to know, November 8, 2017
  • AAM Fall Technical Conference, November 6-8, 2017
  • DIA Combination Products Conference, Generics for Combination Products: It’s Complicated, October 24-26, 2017
    2017 Rare Diseases and Orphan Products Breakthrough Summit, An Evergreen & Sustainable Approach to Orphan Drugs, October 17, 2017
  • Paragraph IV Disputes, Brand and Generic Perspectives on the FDA Final MMA Rule: Assessing Its Impact on Hatch-Waxman Practice, October 3, 2017
  • FDA Boot Camp, Post-Conference Workshop: Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute, September 13-15, 2017
  • FDA Boot Camp, Hatch-Waxman and BPCIA Overview, September 13-15, 2017
  • RAPS Regulatory Convergence, Effective Orphan Drug Development in a Challenging Regulatory Environment, September 9-12, 2017
  • DIA 2017 Conference, Drug Pricing: Access Versus Innovation, June 18-22, 2017
  • National Organization for Rare Diseases, Corporate Council Meeting, The ‘Evergreening’ Issues with Orphan Drugs, May 19, 2017
  • Paragraph IV Disputes, Q&A with the FDA on the Final MMA Rule: Understanding the Impact for Hatch-Waxman Practice, April 24-26, 2017
  • Hatch-Waxman and BPCIA Overview (Drugs, Biologics and Biosimilars, March 22-24, 2017
  • Regulatory Pathway for Repurposed Drugs, March 15-17, 2017
  • Generic Drug Submissions and Patents & Exclusivity, January 31, 2017
  • International Conference and Expo on Generic Drug Market and Contract Manufacturing, Biosimilars in the United States: A Progress Report and A Peek Into the Future, November 7-9, 2016
Education

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

Admissions

District of Columbia
Maryland

Practice Areas
Industries
FDA Regulatory Categories