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

(202) 737-7544
kkarst@hpm.com
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Practice Areas
Prescription Drugs and Biologics
Corporate Transactions
Enforcement

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

Bar Admissions
District of Columbia
Maryland

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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.

Enforcement
• 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, 2015-2016


Articles / Publications    -    see more articles
•  Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation,  April 2011

•  Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition,  May 2013

•  FDA Amendments Act - HPM Issues Detailed Summary and Analysis,  October 2007

•  The Drug User Fee Catch-22,  May 2007

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


Speaking Engagements    -    see fewer speaking engagements
•  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
•  FDA Boot Camp, Hatch Waxman and BPCIA Overview; and Post Conference Workshop on Hatch Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute, September 21 - 23, 2016
•  ACI Paragraph IV Disputes Master Symposium, KRK Panel Member: "Regulatory Exclusivity", September 19-21, 2016
•  American Journal of Managed Care Roundtable Audioconference, Topic to be determined, May 4, 2016
•  Webinar: Avoiding Drug Substance Patents and Exclusivities: Prodrugs, Deuterated Drugs and 505(b)(2) Applications, April 14, 2016
•  Barclay’s Select Series: Generic Pharmaceuticals Symposium, KRK Speech: “An Inside Look at the Latest Regulatory and Legal Trends”], April 6, 2016
•  Webinar re Section 505(b)(2), March 24, 2016
•  FDA Boot Camp, KRK 3/10 Panelist: “Hatch-Waxman and BPCIA Overview”], May 9-11, 2016
•  FDA Boot Camp, Kurt Karst is speaking on the "Hatch Waxman and BPCIA Overview" on March 11, 2015, September 30 - October 1, 2015
•  CONVERGE - Where Healthcare Meets Innovation, 9/1 Panelist: Getting Real about Superbugs, September 1-2, 2015
•  American Intellectual Property Law Association Webinar – Biosimilars: Regulation, Litigation and New Developments Patent Practitioners and Regulatory Attorneys Should Know, KRK 8/27 Presentation: “The New Drug Approval Process: NDA Submission and Review”], August 27-28, 2015
•  Drug Information Association: Annual Meeting, 6/17 Panel Member: “Does Bioequivalent Always Mean Therapeutically Equivalent? Impact of FDA’s Proposed Rule on Generic Labeling”, June 14-18, 2015
•  RDD Europe 2015, FDA's Orange Book and ANDA's: Questioning the Policies and Precedents Surrounding RLD Patent Listings., May 5-8, 2015
•  Paragraph IV Disputes, FDA Update: Survey of Agency Activity Impacting Paragraph IV Litigation, April 27-29, 2015
•  U.S. Biosimilars Conference, US Federal Trade Commission and State Law Updates: Understanding teh Controversy Surrounding Competition, Substitution, and Naming int eh Biosimilars Arena, April 20-21, 2015
•  Kurt Karst is speaking at the FDA Boot Camp on March 11, 2014, Kurt Hatch-Waxman and BPCIA Overview, March 10-11, 2015
•  Respiratory Drug Delivery Asia 2014; Goa, India, Jumping Legal Hurdles with the US FDA: The Generic Inhaler Challenge, November 12-14, 2014
•  Paragraph IV Disputes Master Symposium, New Exclusivity Challenges for Brand Names and Generics: Exploring Their Implications for Paragraph IV Challenges, September 30 - October 1st, 2014
•  ACI: FDA Boot Camp, Hatch-Waxman and BPCIA Overview. Co-chair for the conference, September 18 - 19, 2014
•  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, Panel member, June 3, 2014
•  ACI: Paragraph IV Disputes, Assessing GDUFA Implementation and Additional Regulatory Developments at FDA Which Impact Paragraph IV Litigation, April 28 - 29, 2014
•  FDANEWS Webinar -, March 25, 2014
•  ACI Conference on Pharmaceutical and Biotechnology Patent Life Cycles, Exclusivities: New Developments, Controversies and Concerns for Small and Large Molecules and Combination Products, February 25 - 27, 2014
•  World Congress of Biosimilars and Biobetters, Legal & Regulatory Challenges to Biosimilar Approval and Substitution in the United States, November 13- 16, 2013
•  ACI Paragraph IV Disputes Master Symposium, New Exclusivity Challenges for Brand Names and Generics, October 3 - 4, 2013
•  International Congress on Paragraph IV Litigation, 180-Day Exclusivity and Forfeiture: A Dissection of Key Filing Benchmarks and Timing Considerations for Counsel on Both Sides, September 23 - 24, 2013
•  ACI Legal and Regulatory Summit on Generic Drugs, Summit Co-Chair. Summit Opening remarks. Moderator for the session on "Insights from the Office of Generic Drugs"., July 17 - 18, 2013
•  ACI Biosimilars Conference, Panel Member: The Next Frontier of Biosimilar Challenges: Naming and Substitution at the Pharmacy Level, June 6 - 7, 2013
•  Respiratory Drug Delivery Conference, Orphan Drug Approval in the US (and Some EU Comparisons): Regulatory Mechanisms for Rare Pulmonary Disorders, May 21 - 24, 2013
•  FXConferences, FxTrans Promotion Webinar, May 9, 2013
•  ACI Paragraph IV Disputes conference, Panel discussion moderator for "New Exclusivity Challenges: Brand Names Take Notice - It's Not Just a Concern for Generics Anymore", May 7 - 8, 2013
•  Food and Drug Law Institute Annual Conference, Moderator for the "Drug Exclusivity Session", April 22 - 24, 2013
•  Specialty Pharma Association Annual Conference, FDA Updates, April 16 - 18, 2013
•  ACI's FDA Boot Camp, Drugs and Biologics, March 19 - 20, 2013
•  CHPA Annual Executive Conference, Top Game Changing Regulatory Decisions, March 11 - 13, 2013
•  Real-World Implications of United States v. Caronia, January 31, 2013
•  Global IP Convention, Patent and Non-Patent Exclusivities for Drug and Biological Products in the USA - An Overview and Current Developments, January 23 - 30, 2013
•  Paragraph IV Disputes, Hatch-Waxman and BPCIA 101 - A Primer on IP Basics and Regulatory Fundamentals, December 3 - 5, 2012
•  ACI: Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs, Making the Case for An Rx to OTC Switch: Legal and Regulatory Considerations, October 17 - 19, 2012
•  ACI: Maximizing Pharmaceutical Patent Life Cycles, Exclusivities and Forfeitures: New Developments, Controversies, and Related Concerns, October 10 - 11, 2012
•  C5 EU Pharma Regulatory Law Conference, Co-presenter: Demystifying the Scope and Potential Impact of Proposed Legislation on Biosimilars to Enable You to Make Strategic Decisions Now, September 25 - 26, 2012
•  Practicing Law Institute Webinar, Understand and Plan Your Biosimilars Strategy Now, August 15, 2012
•  ACI Hatch-Waxman Boot Camp, Orange Book Listings, De  Listings and Related Challenges, June 25 - 26, 2012
•  Respiratory Drug Delivery Conference, To 505(b)(2) or Not To 505(b)(2)  Jumping the Legal Hurdles for Inhaled Drug Products, May 13 - 17, 2012
•  Thompson Interactive Webinar, PDUFA V: Preparations for the New Fees and Performance Goals, April 2, 2012
•  ACI FDA Boot Camp, Hatch-Waxman and BPCIA Overview, March 20 - 21, 2012
•  University of Texas College of Pharmacy International Conference on Drug Development, Legal Considerations to Establish Biosimilarity and Therapeutic Interchangeability, February 29, 2012
•  Thompson Webinar, Navigating the Orphan Drug Designation Process: Benefits of Obtaining Designation, November 15, 2011
•  FDA News Webinar, Marketed Unapproved Drugs, October 27, 2011
•  RAPS Regulatory Convergence Conference, "Generics in the US: A Regulatory Primer on Filing and Recent Actions" and the Workshop on "Pay-to-Delay Agreements", October 22 - 26, 2011
•  Informa Inhalation Drug Development Conference, October 12, 2011
•  ACI: Maximizing Pharmaceutical Patent Life Cycles, REMS Studies and Generic Entry: Exploring the Latest Regulatory Conundrum Affecting Pharmaceutical Patent Life Cycle Strategies, October 5, 2011
•  Informa Global Generic Strategy Summit, FDA Regulation of Generic Drugs, September 20 - 21, 2011
•  FDLI Conference: Brands, Generics, and Hatch-Waxman-New Challenges; Unabated Controversy, 180-Day Exclusivity Forfeiture, June 24, 2011
•  World Orphan Drug Conference, Disease Subsetting, April 13 - 15, 2011
•  Thompson Audio Conference, Navigating the Orphan Drug Designation Process, & the Benefits of Obtaining Designation, March 15, 2011
•  Generic Pharmaceutical Association Annual Meeting, Generic Drug Preemption, February 16 - 18, 2011
•  ACI: The Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions, New Trends and Challenges in PTE Litigation: Key Cases to Watch, January 26 - 27, 2011
•  Pharmalot Webinar, Navigating The FDA Accelerated Approval Process, December 9, 2010
•  CBI Life Sciences Congress on Paragraph IV Disputes, FDA Forfeiture Provisions and Review of Strategic Developments, October 18 - 19, 2010
•  ACI: FDA Boot Camp., Nature of the Approval Process, September 27 - 28, 2009
•  Specialty Pharma Association Fall Conference, FDA Update, September 15 - 17, 2010
•  Rodman & Renshaw Global Investment Conference - 12th Annual Healthcare Conference, Panel Discussion on "As the Drug Patent Landscape Evolves, Strategic Challenges and Opportunities Develop", September 15, 2010
•  ACI Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions Conference, New Trends and Challenges in PTE Litigation: Key Cases to Watch, August 19, 2010
•  C5 Conference: Maximising Pharmaceutical Patent Life Cycles, Update on Regulatory Protections Available to Extend Patent Lifecycles: Comparing and Contrasting Europe and US, June 23 - 24, 2010
•  AIPLA Spring Meeting, May 6 - 8, 2010
•  ACI Paragraph IV Disputes Conference, Bioequivalence and the 'Same Active Ingredient' vis-à-vis Patentability, April 26, 2010
•  Respiratory Drug Delivery Meeting, Legal Perspective on Approval and Legal Challenge Process for Topically Active Generic Inhalers, April 25 - 29, 2010
•  Thompson Interactive Audio Conference, Navigating the Orphan Drug Designation Process, and the Benefits of Obtaining Designation, March 23, 2010
•  CBI West Coast Forum on Early Access Programs (EAP), Understand and Navigate the Legal Landscape for Early Access Programs, March 10, 2010
•  Biotech & Pharmaceutical Patenting Conference, February 17 - 18, 2010
•  CBI Inaugural Forum on Pre-Approval Expanded Access Programmes for the Bio/Pharmaceutical Industry, Understanding the Role of EMEA and FDA During Patient Compassionate Use and Expanded Access, November 18, 2009
•  CBI's 2nd Annual Pharmaceutical Congress on Paragraph IV Disputes, Differences of Opinion on NCEs - What are the Scope and Limits?, October 22 - 23, 2009
•  American Conference Institute conference on Maximizing Pharmaceutical Patent Lifecycles, Bioequivalence and the "Same Active Ingredient" vis-à-vis Patentability, October 7 - 8, 2009
•  CBI's 2nd Annual Forum on Early Access Programs, Operating Compliantly and Legally during Pending Approval, October 7, 2009
•  Thompson Interactive Audio Conference, FDA Unapproved Drug Initiative - Determine, Prove and Ensure Compliance, July 30, 2009
•  FDANews Webinar - The Real Impact of Wyeth v. Levine, How to Survive in a Post-Preemption World, March 24, 2009
•  IPA/AAPS/FIP Conference - To and thru the Skin, February 20 - 21, 2009
•  Thompson Interactive Audio Conference, New Drug Exclusivity Provisions: How They'll Impact Your Product Lifecycle Management, January 13, 2009
•  CBI Pharmaceutical Congress on Paragraph IV Disputes, Navigating Regulations and Enforcement Trends to Increase Preparedness and Optimize Paragraph IV Strategies, October 15 - 16, 2008


Blog Posts    -    see more blog entries
•  United Therapeutics Sues FDA After Agency Denies Orphan Drug Exclusivity for ORENITRAM,  August 9, 2017
•  Fitting New Scientific Advances Into an Old Regulatory Paradigm (Part 2): Gene Therapy and Orphan Drug “Sameness”,  July 26, 2017
•  Fitting New Scientific Advances Into an Old Regulatory Paradigm: Fusion Proteins and Orphan Drug “Sameness”,  July 25, 2017
•  All Backed Up: FDA Reverses Course and Denies NCE Exclusivity for PREPOPIK,  July 23, 2017
•  FDA’s Hatch-Waxman Public Meeting and Progression of the Agency's Drug Competition Action Plan,  July 19, 2017