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 more speaking engagements
•  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


Blog Posts    -    see fewer blog entries
•  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
•  Congress Continues Spree of Proposing Alternative Incentives for Product Development: the “CBRN Countermeasure PRV” (Part 1),  October 22, 2015
•  You Win Some, You Lose Some: Federal Circuit Denies En Banc Review in BPCIA Dispute & Otsuka Files Suit Over 3-Year Exclusivity,  October 19, 2015
•  No False Starts: FDA Prevails in Eisai Challenge Over NCE Exclusivity Start Dates for BELVIQ and FYCOMPA,  September 30, 2015
•  FDA’s Seventh Annual Report to Congress on 505(q) Citizen Petitions: A Lot of the Same Old Same Old,  September 29, 2015
•  How Effective is a “Depomed Threat” at Resolving an Orphan Drug Clinical Superiority Dispute?,  September 27, 2015
•  Tag-Team Enforcement: After Years of FTC Proceedings, Rhode Island Businessman Pleads Guilty to FDC Act and Tax Violations,  September 25, 2015
•  Amgen Wants Patent Dance Redo and a Halt to Hospira’s EPOGEN Biosimilar,  September 24, 2015
•  The Promoting Life-Saving New Therapies for Neonates Act of 2015: A New Twist on Transferable Vouchers,  September 20, 2015
•  FDA Gives a “Nudge Nudge Wink Wink” in Denial of NORD Petition on Special Treatment of Orphan Drugs,  September 15, 2015
•  Lather, Rinse, Repeat: Senators Take Another Stab at Passing the Preserve Access to Affordable Generics Act,  September 14, 2015
•  In Appeal Over Colchicine 505(b)(2) Approval, Plaintiffs-Appellants and PhRMA Allege Lower Court Decision Upsets Hatch-Waxman Scheme,  September 9, 2015
•  Multiple Parties Chime in as the Federal Circuit Gears Up for a Rehearing in the ZARXIO Biosimilar Patent Dance/180-Day Notice Appeal,  September 9, 2015
•  Waking From a Drug Coma: How to Bring a Drug Out of Discontinued Status – It’s As Easy As 1, 2, 3 . . . 4, and 5,  September 7, 2015
•  Clearing the Air on Pre-GDUFA Year 3 ANDAs; OGD Issues Revised (and Much Improved) Communications MAPP,  August 18, 2015
•  Merger Mania: Consolidation and the Potential Effects on Exclusivity,  August 17, 2015
•  FDA Prevails in Challenge Over Methylphenidate ANDA Rating Downgrade, But the Decision is Appealed; Meanwhile, the Agency Flip-Flops on Dexmethylpheni,  August 12, 2015
•  A Look At FDA’s Rationale for Granting – and the Scope of – Exclusivity for Abuse-Deterrent OXYCONTIN,  August 10, 2015
•  FDA Publishes Fiscal Year 2016 User Fee Rates; Only a Modest Increase in PDUFA/BsUFA Rates, But Significant Hikes for Some GDUFA Fees,  August 2, 2015
•  The Veloxis Case: Uncut, Unrated, and Unsealed!,  July 29, 2015
•  Who’s on First? FDA Raises the Specter of 180-Day Exclusivity Eligibility/Forfeiture for Generic RESTASIS and Asks If There’s a Phantom “First Applica,  July 28, 2015
•  Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations Bills,  July 24, 2015
•  BPCIA Federal Circuit Follies, or Can We All Agree to Disagree? A Divided Federal Circuit Finds the Patent Dance Voluntary, But Rules that Notice of C,  July 21, 2015
•  A Walk Among the SBAs: Waxing Poetic on a Bygone Era, the Development of the Exclusivity Summary, and the Need for Change,  July 16, 2015
•  Pediatric Exclusivity: Amazingly Powerful, Essentially Ironclad . . . and Often Overlooked,  July 7, 2015
•  BIO & NORD Report Explores a World With and Without the Orphan Drug Tax Credit,  July 6, 2015