Hyman Phelps and McNamara
Kurt R. Karst
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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, 2015-2016

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 more speaking engagements
•  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

Blog Posts    -    see fewer blog entries
•  Let’s Play a Game: What’s Missing from FDA’s Recent Approval Letter for Generic COPAXONE 40 mg/mL?,  October 19, 2017
•  ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II: A Follow-Up,  September 13,2017
•   DC Circuit Rules for FDA in 3-Year Exclusivity Dispute; Hashes Out ABILIFY’s “Zone of Exclusivity” vis-à-vis ARISTADA,  August 31, 2017
•  Trailblazer Amarin Takes on a New Fight with ITC Complaint Against Synthetic Omega-3 Oil Manufacturers and Dietary Supplement Distributors,  August 30, 2017
•  FDA Goes Farther Down the 3-Year Exclusivity Rabbit Hole With XTAMPZA ER-ROXYBOND Exclusivity Decision,  August 15, 2017
•  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
•  FDA Determines that Deuterated Compounds are NCEs and Different Orphan Drugs Versus Non-deuterated Versions,  July 16, 2017
•  Should the Best Pharmaceuticals for Children Act be Amended to Accommodate 505(b)(2) NDA Labeling Carve-outs? “YES”, According to a Bill in the Senate,  July 4, 2017
•  ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II,  June 28, 2017
•  GAO Examines FDA’s Implementation of GDUFA: Application Review Times Have Improved, But the Agency Needs a Plan for Carryover Fees,  June 27, 2017
•  FDA, Ahead of GDUFA II Enactment, Starts the Ball Rolling with Pre-Submission Facility Correspondence Guidance,  June 20, 2017
•  Should Free Speech Protections Include an Exception for Exclusivity-Protected Information?,  June 8, 2017
•  User Fee Reauthorization Moves One Step Closer to Reality with House Committee Passage,  June 8, 2017
•  Adieu, “Orange Book FR Safety or Effectiveness Determinations List”; Hello, “Orange Book Patent Listing Dispute List”,  June 6, 2017
•  Amgen SENSIPAR Pediatric Exclusivity Dispute is Put on Ice While FDA Dispute Resolution Process Proceeds,  June 5, 2017
•  Amgen Sues FDA After Agency Denies Pediatric Exclusivity for SENSIPAR,  May 30, 2017
•  For the Love of Money: The Trump Administration’s Fiscal Year 2018 FDA Budget Plan,  May 23, 2017
•  Schrader Amendment to House UFA Package Creates New “Competitive Generic Therapy” Pathway and 180-Day Exclusivity,  May 19, 2017
•  Examining the “Drug Innovation Paradox”: Should the Length of Exclusivity Reflect the Time it Takes to Develop a Drug?,  May 10, 2017
•  FDA User Fee Package Includes “Technical Corrections” to Address Orphan Drug Clinical Superiority,  May 9, 2017
•  FDA’s Ruling on Generic ZITHROMAX 180-Day Exclusivity: A Little Something for Everyone!,  May 8, 2017
•  How Long is 60 Days? 59 Days and Change, or a Full 60 Days? A New Challenge to PTE Application Timeliness Raises the Issue,  May 4, 2017
•  Texas Department of Criminal Justice Challenges FDA Thiopental Sodium Import Prohibition,  May 1, 2017
•  Griffith Bill Proposes Legislative Fix to “Route-of-Abuse” Exclusivity Block,  April 9, 2017
•  Is a Challenge to FDA’s “Route-of-Abuse” 3-Year Exclusivity Approach to Abuse-Deterrent Drug Products on the Horizon?,  April 6, 2017
•  The Improving Access to Affordable Prescription Drugs Act: A Different Tack on Exclusivity,  April 5, 2017
•  The Hidden Orange Book: Breaking Up Is Hard to Do (But Sometimes It’s for the Best),  March 29, 2017
•  Is a Hatch-Waxman 30-Month Stay Terminated if the Dismissal of a Patent Infringement Action is Later Vacated? FDA Says “No”,  March 28, 2017
•  Down the Tubes: FDA Settles PREPOPIK NCE Exclusivity Dispute; ANDA Submissions in Unsettled State,  March 27, 2017
•  Should the Best Pharmaceuticals for Children Act be Amended to Accommodate 505(b)(2) NDA Labeling Carve-outs?,  March 16, 2017
•  GAO Issues Report on Qualified Infectious Disease Products,  March 13, 2017
•  Orphan Drugs: The Current Firestorm, a Real Evergreening Issue, and a Possible Solution,  March 12, 2017
•  FDA Defines the Scope of 3-Year Exclusivity for MORPHABOND After Wrestling With Different Approaches,  February 21, 2017
•  Abuse-Deterrence and 3-Year Exclusivity: FDA Decisions Further Elucidate Scope and a “Route of Abuse” Approach to Exclusivity,  February 9, 2017
•  The FTC Takes Action for Alleged Anticompetitive Citizen Petitioning Activities Surrounding Generic VANCOCIN,  February 7, 2017
•  FDA’s 180-Day Exclusivity Q&A Guidance: Two Items of Note,  February 5,2017
•  The Lower Drug Costs Through Competition Act: Prioritized Review for Some ANDAs . . . and a Priority Review Voucher,  February 1, 2017
•  Some Noteworthy Changes to the 2017 Orange Book Preface & Patent and Exclusivity Information Addendum,  January31, 2017
•  FDA Sued Over 180-Day Exclusivity Determination for Generic NAMENDA XR; It’s All About the “Causal Connection”,  January 30, 2017
•  505(b)(2) NDA and ANDA Amendments: Don’t Forget to Meet the New Verification Requirement,  January 26, 2017
•  Orphan Drug Approvals and Designations Dipped in 2016, But Orphan Drug Designation Requests Skyrocketed,  January 25, 2017
•  Bigger, Better, Faster, Stronger: The New Orange Book Makes Its Debut,  January 24, 2017
•  At long last, FDA Issues Guidance on Biosimilar Interchangeability,  January 17, 2017
•  Need Some Holiday Reading? Recent FDA Scholarship Worth a Spin,  December 28, 2016
•  When Does the Expiration of Pediatric Exclusivity Allow ANDA (or 505(b)(2) NDA) Approval? The Case of Generic BENICAR,  December 27, 2016
•  Now You See It, Now You Don’t: Vanishing Drug Approval Information and Other FDA Actions Making Drug Approvals Opaque,  December 22, 2016
•  Cures Act Changes Regarding the Regulation of Combination Products (Section 3038); Importing Hatch-Waxman Into Medical Device Approval/Clearance,  December 19, 2016
•  Solicitor General Urges SCOTUS to Take Up Sandoz and Amgen Petitions on the BPCIA’s Notice and Patent Dance Provisions,  December 8,2016
•  Breaking Zen: FDA Denies Vanda’s Petition on FANAPT 3-Year Exclusivity; Approves Generic,  December 4, 2016
•  Noteworthy Takeaways From FDA’s 180-Day Exclusivity Forfeiture Decision on Generic EDLUAR,  November 29, 2016
•  A New Orange Book First: FDA Unilaterally Changes a Patent Use Code,  November 20, 2016
•  FDA Appeals PREPOPIK NCE Exclusivity Decision to the D.C. Circuit; Similarly Situated Parties Petition FDA,  November 16, 2016
•  How FDA Announces Drug Approval Decisions: A Broken FDA “System” That Must Be Fixed,  November 6, 2016
•  In a Veloxis-Like Analysis, FDA Rules That EMBEDA 3-Year Exclusivity Does Not Block MORPHABOND 505(b)(2) Approval,  October 24, 2016
•  Who you Gonna Call . . . . to Resolve a Compliance Status Block on Approval?,  October 24, 2016
•  FDA Issues Final Hatch-Waxman Regulations to Implement Some of the Provisions of the 2003 Medicare Modernization Act,  October 6, 2016
•  FDA Licenses First HUMIRA Biosimilar; Denies AbbVie Petition on Fifth Amendment Takings,  September 26, 2016
•  On Second Thought: DC District Court Does a 180 on PREPOPIK NCE Exclusivity; Remands to FDA,  September 13, 2016
•  Rehearing Sought in Colchicine 505(b)(2) Listed Drug/Patent Certification Dispute,  September 6, 2016
•  Did You Catch That “New” Drug Product Addition to the Orange Book?,  August 25, 2016
•  FDA’s Eighth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers, But the Same Punchline,  August 23, 2016
•  FDA Prevails in PRADAXA Patent Term Extension Regulatory Review Period Challenge,  August 22, 2016
•  DC Circuit Affirms MITIGARE 505(b)(2) NDA Approval, and Sidesteps COLCRYS Patent Certification Issue,  August 11, 2016
•  FDA Publishes Fiscal Year 2017 User Fee Rates: Across-the-Board Decreases in PDUFA/BsUFA Rates; Facilities Get Hit With GDUFA Fee Increases,  August 1, 2016
•  FDA Prevails in Otsuka Challenge to Scope of ABILIFY 3-Year Exclusivity, Leaving Intact ARISTADA 505(b)(2) NDA Approval,  July 31, 2016
•  The Third Time’s the Charm for RAVICTI and Orphan Drug Designation: Another “Greater Safety” Clinical Superiority Precedent,  July 25, 2016
•  Chemistry Amendment Saves Sun From Forfeiting 180-Day Exclusivity Eligibility for Generic GLEEVEC,  July 13, 2016
•  A New “Greater Safety” Orphan Drug Clinical Superiority Precedent: PURIXAN????,  July 5, 2016
•  AstraZeneca, iPR Launch Preemptive Lawsuit Against FDA Over Generic CRESTOR Approval,  June 28, 2016
•  Lannett Sues FDA Over Temozolomide Capsules ANDA Approval Rescission,  June 28, 2016
•  PTO Prevails in Challenge to Drug Eluting Stent PTE Denial, and Encounters Some Interesting Characters Along the Way . . . Including a Unicorn!,  June 27, 2016
•  The PRICED Act Takes a Stab at Reducing Biological Product Reference Product Exclusivity From 12 Years to 7 Years,  June 23, 2016
•  A New and Improved (Updated) List of Pending DESI Program Proceedings,  June 21,2016
•  The CREATES Act Would Create a Cause of Action to Obtain Restricted Product Sample and to Facilitate Shared REMS,  June 17, 2016
•  Just When FDA Thought It Was Out, They Pull It Back In: AstraZeneca Raises 505A(o) and Orphan Drug Exclusivity Carve-Outs in CRESTOR Petition,  June 8, 2016
•  FDA, Sandoz Prevail at D.C. Circuit on Generic FUSILEV Approval,  June 6, 2016
•  It’s Finally Here! FDA’s VASCEPA Exclusivity Determination on Remand: NCE Exclusivity Granted!,  May 31, 2016
•  FDA Rejects “Extraordinary” Position in Battle Over BUTRANS Patent Term Extension,  May 23, 2016
•  FDA More Than Doubles the Number of Orphan Drug Designation Revocations Overnight,  May 20, 2016
•  RLD Designation Citizen Petitions: One Item on Our GDUFA II Wish List,  May 18, 2016
•  FDA Certitudes: The Creation of an OTC Drug Monograph User Fee Program,  May 10, 2016
•  Speculating About the Prospects of Exclusivity A Potentially Risky Game,  May 5, 2016
•  The COMBAT Act Would Add New Brand and Generic Exclusivity-Stacking Incentives for Abuse-Deterrent Opioid Development,  May 2, 2016
•  A Hole in One? Eagle Sues FDA Over BENDEKA Orphan Drug Exclusivity in Depomed-like Lawsuit,  April 28, 2016
•  Tested Mettle: Vifor Fresenius Petitions FDA to Make a Decision on NCE Exclusivity for Iron-based Phosphate Binder VELPHORO,  April 27, 2016
•  The FTC’s “Pay-for-Delay” Lawsuit Against Endo: Is There a Hole in the Commission’s Generic LIDODERM 180-Day Exclusivity Analysis?,  April 19, 2016
•  Orphan Drug Clinical Superiority: An Overview of Precedents Shows that MC-to-PC Clinical Superiority is Not so Unusual,  March 27, 2016
•  FDA Proposes a Tier-Based Approach to Evaluate “Bioequivalence” of Abuse Deterrence of Generic SODF Opioids,  March 24, 2016
•  Not a Blowout: DC District Court Upholds FDAs Pre 2014 Interpretation on NCE Exclusivity for Combos But Wants Additional Briefing on Retroactivity,  March 16, 2016
•  FDA’s BPCIA Deemed to be a License Guidance Provides Practical Help with Development, But Limits Exclusivity,  March 14, 2016
•  Congress Puts Pressure on FDA and Proposes Incentives to Ramp Up Generic Drug Reviews,  March 3, 2016
•  Just the Facts, Maam: OGD Director Uhl Provides the Lowdown on GDUFA Implementation,  February 25, 2016
•  Sandoz Petitions High Court to Review the Federal Circuit’s Decision on the BPCIA’s 180 Day Notice of Commercial Marketing Provision,  February 17, 2016
•  An Oldie But a Goodie: Revisiting a Not-Quite Yet Vestigial Remnant of a Pre-MMA Era,  February 15, 2016
•  NDA Approval Date Resets: More Than a One-off,  February 10, 2016
•  Orphan Drug Approvals Dipped in 2015, While Designations and Designation Requests Continue Upward Trend,  February 9, 2016
•  Eisai Says That the Recently Enacted IRTNMTA Should Result in a Longer PTE for FYCOMPA Patent,  February 8, 2016
•  FDA’s Orange Book Preface Gets a Facelift: What’s New?,  February 3, 2016
•  Trailblazer Amarin Continues to Blaze New Trails: ANDA Paragraph IV Litigation Dismissed,  January 27, 2016
•  FTC Releases Latest Staff Report on Drug Patent Settlement Agreements; Post-Actavis Trends Seem to Be Forming,  January 19, 2016
•  Briefing in Appeal Over Colchicine 505(b)(2) Approval Wraps Up; Oral Argument and a Decision are Patiently Awaited,  January 11, 2016
•  Any Given Patient for Any Given Indication: AbbVie Petitions FDA on Interchangeable Biosimilars,  December 28, 2015
•  Legislators Want GAO Studies on Non-Biologic Complex Drugs & FDA Inspections, and Want a Raft of Documents as Questions are Raised About ANDA Review E,  December 22, 2015
•  “C” Will Always Follow “P”, Except When the BPCIA is the “BCPIA”, Says District Court in NEULASTA Decision,  December 14, 2015
•  Orphan Drugs Under Fire: Recent Reports Reject Call for Additive Exclusivity & Urge Orphan Drug Act Reforms,  December 8, 2015
•  In a Rare Move, FDA Initiates Procedures to Suspend Approval of an ANDA,  December 4, 2015
•  The Cosmetic Modernization Amendments of 2015 Seek a Facelift for the Cosmetics Industry,  November 30, 2015
•  Under Control: Some Controlled Substances May Have a Later Exclusivity Start Date With the Enactment of a New Law,  November 30, 2015
•  FDA Law Blog is Tapped for the ABA Journal’s Blawg 100 – Our 5th Time!,  November 24, 2015
•  Sex, Drugs, and Rock & Roll (FDA Style): FDA’s Unapproved Drug Machine Continues to Dole Out Enforcement and Legal Decisions,  November 18, 2015
•  There’s an App for That Too! FDA Gives a Post-Halloween Treat and Releases the Orange Book Express App,  November 9, 2015
•  The Lost MAPP is Found! FDA Releases MAPP on NDA Classification Codes,  November 4, 2015
•  Cross-Motions for Summary Judgment Filed in PRADAXA Patent Term Extension Dispute,  October 27, 2015