Kurt R. Karst Director 202-737-7544
Kurt R. Karst
Practice Areas
Industries
FDA Regulatory Categories

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 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.

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

  • Best Lawyers, 2021-2024
  • Who’s Who Legal Directory
    Life Sciences Regulatory Section
    2015
  • Who’s Who Legal Directory
    Life Sciences, Patent Litigation Section
    2015-2016
  • Life Science Star LMG Life Sciences 2023

Speaking Engagements

  • ACI’s Paragraph IV Disputes Conference, April 25-26, 2024
  • Co-Chair, ACI’s FDA Boot Camp, March 13-14, 2024
  • ACI’s Summit on Life Sciences IP Due Diligence: Exploring the Regulatory Aspect of Life Sciences IP Due Diligence: Examining the Implications of Recent Developments at the FDA on Diligencing, November 28-29, 2023
  • Panel Moderator, APIIC Plenary Event:  Pathway to Build Supply Chain Resilience for Critical Drugs, Supply Chain Sustainability and Investments, November 8, 2023
  • ACI’s Virtual Course: Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA, The Orange Book: Listings, De- Listings and Other Matters of Interest, October 12, 2023
  • GRx+Biosims 2023: Generics and Biosimilars Conference, 180-Day Exclusivity – What is Past is Prologue, October 2-4, 2023
  • C0-Chair and Speaker, ACI’s FDA Boot Camp, Exploring New FDA Initiatives, September 20-21, 2023
  • ACI’s Paragraph IV Disputes-Strategies for Brand Name and Generics, Best Practices for Utilizing FDA’s Citizen Petition Process to Achieve Market Exclusivity, April 19-20, 2023
  • Co-Chair, ACI, FDA Bootcamp: Training in Core Regulatory Concepts for Life Sciences Attorneys, Business Executives, and Policy Analysts, March 22-23, 2023
  • IP Counsels Committee Conference, When Agencies Unite: FDA and PTO Tasked at Reducing Drug Patenting, November 14-16, 2022
  • GRx+Biosims 2022, Generics and Biosimilars Conference, UFA Riders and pH Adjusters and Q1/Q2 assessments, November 7-9, 2022
  • World Intellectual Property Forum, The Evolving Nature of, and Recent Challenges and Changes to, FDC Act Patent and Non-Patent Exclusivities in the United States, October 10-12, 2022
  • Speaker, ACI PIV Disputes Master Symposium, 60 Minutes on Patents, Politics and Policy: An Analysis of Proposed Hatch-Waxman Reform Measures, September 21-22, 2022
  • Co-Chair, ACI’s FDA Boot Camp (Virtual Event), September 14-15, 2022
  • Speaker ACI’s Paragraph IV Dispute Conference, Brand and Generic Perspectives on the Latest FDA Initiatives Impacting Pharmaceutical Patents, April 26-27, 2022
  • Co-Chair, ACI’s FDA Boot Camp (Virtual Event), March 23-24, 2022
  • Generics + Biosimilars Conference, Moderator: Approval Pathways for Complex Generics – 505(j) vs. 505(b)(2), November 8-10, 2021
  • ACI, Paragraph IV Disputes Conference, November 9-10, 2021
  • ACI, FDA Boot Camp (Virtual), Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry, September 29-30, 2021
  • ACI, FDA Boot Camp, Co-Chair, March 24-25, 2021
  • ACI Life Sciences IP Due Diligence Conference, Understanding the Impact of New Developments at FDA on the IP Due Diligence Review Process, November 9-10, 2020
  • ACI Livestream Event: Paragraph IV Disputes, October 6-7, 2020
  • ACI FDA Boot Camp, Co-Chair, September 22-24, 2020
  • Barclay’s Credit Healthcare Symposium, January 22, 2020
  • National Center for Advancing Translational Sciences: Repurposing Generic Drugs Research and Regulatory Challenges Conference, December 5-6, 2019
  • ACI Life Sciences IP Due Diligence Conference, Understanding the Impact of New Developments at FDA on the IP Due Diligence Review Process (Co-speaker), November 14-15, 2019
  • AIPLA Annual Meeting, Public Policy, Patent Law and the Changing Life Sciences Landscape, October 24-26, 2019
  • ACI Paragraph IV Disputes Master Symposium, Analyzing the Effect of the Latest FDA Initiatives on Generic Drug Access and ANDA Litigation, October 3-4, 2019
  • RAPS Regulatory Convergence, Patents and FDA Exclusivities for Drugs and Biologics, September 21-24, 2019
  • ACI FDA Boot Camp, Navigating the Approval Process for Drugs and Biologics, September 18-19, 2019
  • ACI Paragraph IV Disputes Conference, April 29-30, 2019
  • Access! 2019 Annual Meeting, Biosimilars Bullies – Can They Be Stopped, February 4-6, 2019
  • 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