Kurt Karst is a Director at Hyman, Phelps & McNamara, P.C. Mr. Karst provides regulatory counseling to pharmaceutical manufacturers concerning Hatch-Waxman patent and exclusivity issues, myriad drug development issues, pediatric testing issues, and orphan drug issues. Previously, he was a lobbyist for F. Hoffman-La Roche Inc. Mr. Karst served as an articles editor for the American University Law Review, and in 1995, was awarded a Fulbright Scholarship for post-graduate studies in Germany. He has published in the American University Law Review, the Food and Drug Law Journal and Update, RAPS FOCUS, and many other publications, and is co-author of the Food and Drug Law Institute's Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives.
Mr. Karst is a graduate of the American University Washington College of Law, and holds a Bachelor of Arts degree in political science and German from Marquette University. He is admitted to practice law in Maryland and the District of Columbia, and is a primary author of the FDA Law Blog (www.FDAlawblog.net).
Articles / Publications
Real-World Implications of United States v. Caronia, January 31, 2013
FDA Amendments Act - HPM Issues Detailed Summary and Analysis, October 2007
FDA Announces Proposed Regulations to Overhaul and Expand the Availability of Experimental Drugs and to Clarify Permissible Charges to Patients, December 12, 2006
Rep. Waxman and Sens. Schumer and Clinton Introduce Biogenerics Bill, September 29, 2006
FDA's Final Compliance Policy Guide for Marketed Unapproved Drugs ? Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle?, August 11, 2006
New Law Reins in "Authorized Generics" Despite Generic Industry Court Losses, But Leaves Several Ambiguities, June 2006
District Court Rules on Simvastatin 180-Day Exclusivity, May 5, 2006
FDA Issues Long-Awaited Prescription Drug Labeling Regulations, January 26, 2006
FDA's Unauthorized User Fee Money Grab, August 12, 2005
FDA Draft Guidance on Exploratory IND Studies, April 22, 2005
FDA Issues Good Review Management Principles and Practices Guidance Document, April 22, 2005
How FDA's New Labeling Rule Could Preempt State Law
Comments, Pediatric Testing of Prescription Drugs: The Food and Drug Administration's Carrot and Stick for the Pharmaceutical Industry
Blog Posts
FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate, May 5, 2013
False Friends: FDA's "Gift" on NESINA - Present or Poison? It May Depend on Which Hatch-Waxman Language is Spoken, May 2, 2013
FDA to Reconsider Approval of Generic BAYTRIL; Court Gives Importance to Unresolved Citizen Petition; Will the Decision Affect FDA Petition Procedures, April 30, 2013
DC Circuit Rules for FDA in SEROQUEL Exclusivity Case; AstraZeneca Not Entitled to 3-Year Exclusivity, April 29, 2013
"Opioid Spring" Blossoms: FDA Finds "Original" OXYCONTIN Discontinued for Safety or Effectiveness Reasons; Will Not Accept or Approve ANDAs, April 16, 2013
Generic BAYTRIL Approval Suspended; Bayer Alleges ANADA Approval Violates GADPTRA and APA, April 15, 2013
President's 2014 Budget Continues Push to Curb Patent Settlement Agreements, Shorten Biologics Exclusivity; Biologics Exclusivity Faces Opposition, April 11, 2013
D.C. Circuit Decision May Force FDA and Other Agencies to Expedite Responses to FOIA Requests, April 9, 2013
Court Orders FDA to Approve OTC Emergency Contraception w/o Restrictions-Describes Intervention by Sebelius as "Unprecedented & Politically Motivated", April 7, 2013
Discord Among Accord and Acorda Over AMPYRA Biostudy Sample Leads to Restricted Distribution Antitrust Lawsuit, April 2, 2013
Timing is Everything!... In Life and In Hatch-Waxman; Fun With 180-Day Exclusivity Forfeiture, March 31, 2013
Admin Law Trumps "Immutable Laws of Science," Says DC Circuit Challenge Over Generic Derma-Smoothe Approvals; Hill Appeals & Denial Quickly Follows, March 28, 2013
The Big Day Approaches: Supreme Court to Hear Oral Argument in ANDROGEL Drug Patent Settlement Agreement Case, March 24, 2013
Second Circuit Comes to a Split Decision on Standing in NRDC Lawsuit Over OTC Triclosan and Triclocarban Products, March 19, 2013
Preemption, Preemption, and More Preemption - A Cert Petition, a Circuit Court Decision, and the Upcoming Battle in Mutual v. Bartlett, March 18, 2013
KV Says "Heckler/Chaney Defense" is Inapplicable in Appeal Concerning Compounded 17P and Orphan Drug MAKENA, March 13, 2013
FTC Chimes In On Restricted Distribution and Generic Competition; Files Amicus Brief in TRACLEER Case, March 12, 2013
Antitrust Law Must Play Traditional "Magna Carta of Free Enterprise Role, Say Generic Defendants in Lawsuit Over Restricted Distribution, March 6, 2013
Rebel Without a Cause: Sun Sues FDA Over 180-Day Exclusivity for Generic ZOMETA, March 3, 2013
Inter Partes Review and Forfeiture of 180-Day Generic Drug Exclusivity, February 28, 2013
Waxman, Slaughter Introduce Bill to Ramp Up Reporting on Antimicrobial Drug Use in Animals as Senate Considers Animal Drug User Fee Agreements, February 27, 2013
U.S. Supreme Court Asked to Review Hatch-Waxman "Safe Harbor" LOVENOX Method Patent Case, February 25, 2013
Will New Recommendations From NIH Curb Use of the Animal Efficacy Rule?, February 20, 2013
The Orphan Drug Act: 30 Years and Still Going Strong!, February 13, 2013
A New Wrinkle in Generic ACTOS 180-Day Exclusivity; What Might it Mean for Post-MMA Exclusivity?, February 11, 2013
Function Over Form or Form Over Function? Two Petitions Challenge FDA's NCE Exclusivity Approach for Combination Drugs, February 10, 2013
Insanity? A Nearly Unchanged Preserve Access to Affordable Generics Act is Introduced in Congress, February 5, 2013
From the Bleacher Seats: Amici Weigh in for the FTC in ANDROGEL Drug Patent Settlement Agreement Supreme Court Case, February 4, 2013
Reissue Patents and FDA's Hidden Policy on 180-Day Exclusivity: A Vestigial Remnant or More?, February 3, 2013
Actelion Seeks Judgment on the Pleadings in Lawsuit Over Restricted Distribution and Biostudy Product Availability, January 23, 2013
FDA's Fourth Annual Report to Congress on 505(q) Citizen Petitions; Agency Continues to Express Concerns About the Use and Effects of 505(q), January 21, 2013
FTC Issues FY 2012 Patent Settlement Report; Says a Record Number of Agreements Filed With "Pay-for-Delay" Potential, January 17, 2013
Biosimilar Substitution: Battles are Brewing at the State Level, January 17, 2013
FDA Sets GDUFA Fiscal Year 2013 Facility User Fee Rates; Fewer Facilities Result in Higher Rates, January 16, 2013
DC District Court Sews Up Generic VANCOCIN Litigation; Decision Merely Refines and Adds New Details to Previous Preliminary Injunction Decision, January 14, 2013
When is 5-Year NCE Exclusivity Less Than 5 Years?, January 9, 2013
A Pre-MMA 180-Day Exclusivity Punt? What Gives?, January 8, 2013
FDA and Ranbaxy Prevail in Dispute Over Generic DIOVAN 180-Day Exclusivity; Court Grants Motions for Summary Judgment, January 2, 2013
Trade Groups Sue Alameda County Over Drug Take-Back and Disposal Ordinance, December 19, 2012
"No-AG" Agreements are Not "Reverse Payments" Subject to Antitrust Scrutiny Says District Court in LAMICTAL Litigation, December 17, 2012
Actelions Preemptive Strike Over REMS and Biostudy Product Availability Draws Antitrust Counterclaims, Another Drug, and Another Company Into the Mix, December 5, 2012
Endo Sues FDA; Seeks Court Orders for FDA Determinations on the Discontinuation of "Old" Opana® ER and With Respect to Approved and Pending ANDAs, December 2, 2012
ASBM Says Distinct USAN Names for Biosimilars are Needed, November 29, 2012
Apotex Seeks Exclusivity-Triggering Court Decision in Declaratory Judgment Action Over Generic BENICAR Patent, November 26, 2012
"Product Hopping" Antitrust Lawsuit Takes on a Heightened Profile with Proposed FTC AmicusBrief, November 25, 2012
Cumberland Sues FDA After the Agency Denies Citizen Petition and Approves Generic ACETADOTE, November 16, 2012
With Briefing Over, Post-Mensing Generic Drug Preemption Appeal Awaits Word From the Supreme Court, November 14, 2012
FDA Presses "Heckler Defense" in Appeal of Unapproved Thiopental Sodium Death Row Inmate Case, November 12, 2012
Does a Hatch-Waxman Patent Delisting Counterclaim Terminate a 30-Month Litigation Stay?, November 8, 2012
"New" CDER Exclusivity Board Focuses on Clarity and Consistency of Exclusivity Decisions, November 6, 2012
Excuses, Excuses! A Round-Up of Exceptions Under the Failure to Obtain Timely Tentative Approval 180-Day Exclusivity Forfeiture Provision, November 1, 2012
Court Orders ANDA Approval in Pre-MMA 180-Day Exclusivity Case; Decision Appears to Have Post-MMA Implications, October 29, 2012
Our GDUFA Cup Runneth Over! FDA Sets Several FY 2013 User Fee Rates, October 25, 2012
Rehearing Sought in Hatch-Waxman Safe Harbor" Case; Plaintiffs-Appellees Contend Fed Circuit Panel Decision Expands "Safe Harbor" Into a "Safe Ocean", October 23, 2012
The End of the Road: Franck's Compounding Case is Moot, October 16, 2012
"No-AG" Agreements are Anticompetitive, Says the FTC for a Second Time, October 15, 2012
Fungal Meningitis Outbreak Prompts Calls for Greater Regulation of Compounders, October 10, 2012
Actelion Preemptively Sues Generic Companies Over REMS and Biostudy Product Availability Issues; Case Could be a Bellwether for Future Efforts, October 9, 2012
U.S. Supreme Court is Again Asked to Take Up Drug Patent Settlement Agreements; This Time It's ANDROGEL, October 8, 2012
What's the Hang-up? Apotex Sues FDA Over Compliance Failure That's Stalling ANDA Approvals, October 4, 2012
FDA Sued Over Generic DIOVAN 180-Day Exclusivity; Lawsuit Takes Issue With FDA Forfeiture Decision and "Trust Me" Approach to Exclusivity Decisions, October 3, 2012
New Legislation Would Provide Exclusivity Add-on for Significant Drug Combinations, October 2, 2012
Another Orphan Drug Battle; Depomed Sues FDA Over GRALISE Orphan Drug Exclusivity, September 26, 2012
Legislative Fix Would Allow FDA to Collect GDUFA User Fees, September 19, 2012
The Whole Ball of Wax: FDA Says Supreme Court Review of Holistic Candlers Case is Not Warranted, September 18, 2012
Patent Settlement Agreements: The Next Barrage, September 17, 2012
Revised Formula Yields a Lower Priority Review Voucher User Fee of $3,559,000; Will That Help Spark Greater Interest in the Program?, September 12, 2012
The Brand-Name Side of the Exclusivity Equation; Exclusivity Under Fire, September 10, 2012
KV Takes a Hit With the Dismissal of Its Case Against FDA Over Compounded 17P, September 6, 2012
The Coming 505(q) Citizen Petition Cliff and Some Interesting Petition Strategies, September 4, 2012
The Obesity Epidemic: FDA's Growing Waistline!, September 3, 2012
Hot Ticket Item - Patent Settlement Agreement Challenges, August 29, 2012
FDA Gears Up for GDUFA Implementation and ANDAgeddon, August 23, 2012
In Litigation Over Animal Feed Antibiotic Withdrawals, District Court Says FDA Needs to Move Forward, August 22, 2012
Congressional Interest in FDA Remains High, Even After the Enactment of FDASIA, August 20, 2012
Push for 12-Year Biologics Exclusivity in TPP Agreement Continues as the Next Round of Negotiations Approaches, August 16, 2012
FDA is Sued Again Over Pre-MMA 180-Day Exclusivity; This Time the Drug is Generic ACTOS, August 15, 2012
Running Into a Glass Door (or Window); a Problem With the New "Window ANDA" Forfeiture Provision, August 12, 2012
FDA Rescinds Orphan Drug Exclusivity for Wilate; A First-of-its-Kind Decision, August 8, 2012
Federal Circuit Rules That Hatch-Waxman "Safe Harbor" is Quite Broad in Dispute Over Enoxaparin Method Patent, August 7, 2012
"Big RLD" Versus "Little rld" - What's the Difference?, August 6, 2012
Supreme Court Asked to Take Up Post-Mensing Bartlett Generic Drug Labeling Preemption Decision, August 2, 2012
PDUFA V Begins With Relatively Modest Changes to User Fee Rates, July 31, 2012
STOPP Act Would Establish New Requirements for Tamper-Resistant Drugs, July 24, 2012
New Director Tapped to Head FDA's Office of Generic Drugs, July 13, 2012
DC District Court Rules for FDA in Generic SEROQUEL Exclusivity Case; Grants Motion for Summary Judgment, July 9, 2012
FDA Sued for Abrogating MAKENA Orphan Drug Exclusivity; Suit Alleges FDA is Turning a Blind Eye to Compounded 17P and Bowing to Political Pressure, July 8, 2012
FDA Announces Intent to Take Enforcement Action With Respect to Certain Marketed Unapproved Oxycodone Drug Products; Denies Lannett "Grandfather Drug, July 5, 2012
Presidential Commission Seeks Comment on the Development of Medical Countermeasures for Children, June 28, 2012
FDA Petitioned on 180-Day Exclusivity Forfeiture for Tentative Approvals that Occur on the 30-Month ANDA Submission Anniversary Date, June 27, 2012
On the Eve of PDUFA Reauthorization, DC District Court Strikes Down FDA Interpretation of PDUFA, June 25, 2012
FDA Once Again Departs From Conventional Bioequivalence Metrics and Sets Partial AUC Parameters for Generic ADDERALL XR, June 24, 2012
A 505(b)(2) NDA in Search of a Basis for Submission and Approval; the Curious Case of Morphine Sulfate Oral Solution, June 21, 2012
When Can't a "Listed Drug" Serve as a Reference Product for a 505(b)(2) Application?, June 19, 2012
New Study Examines Citizen Petitions; Concludes that Petitions are on the Rise and that 505(q) Has Been Unsuccessful, June 17, 2012
"Bring Out Your Dead" Says OGD in a Pre-GDUFA House Cleaning Move as the Agency Prepares for ANDAgeddon, June 13, 2012
House Passes Bill to Repeal Medical Device Excise Tax; Veto Threat Looms, June 7, 2012
FDA Takes Another Hit in Court in Animal Feed Antibiotics Litigation; Court Says Agency's Petition Denials Are Arbitrary and Capricious, June 6, 2012
FTC Commissioner Objects to Certain Provisions in Senate FDA User Fee Reauthorization Legislation, June 5, 2012
House Passes FDA Reform Act of 2012; Next Up - Conference Committee, May 31, 2012
Pennsylvania District Court Issues an XL Decision in WELLBUTRIN XL Antitrust, Sham Citizen Petition Case, May 30, 2012
Making the House FDA Reform Act of 2012 PAYGO Compliant - Are Expedited 505(q) Citizen Petition Responses the Answer?, May 28, 2012
U.S. Senate Slogs Through Amendments and Passes FDA Safety and Innovation Act; Onward to the House Bill, May 25, 2012
FDA's PLAIR Program Collides With Hatch-Waxman, May 23, 2012
Decisions, Decisions, Decisions! Our Updated Labeling Carve-Out Citizen Petition Scorecard, May 16, 2012
New Reports on FDA Drug Approval Performance Emerge as House Committee Considers User Fee Reauthorization Legislation, May 10, 2012
Defendants Rack Up Another State Court Win in Mensing and RLD Liability Theory Decisions, May 8, 2012
Updated House Energy & Commerce UFA Bill Would Shorten FDA's 505(q) Petition Response Timeframe; Require Timely Responses to RLD Withdrawal Petitions, May 7, 2012
New Bill Would Change Clinical Trial Registry Reporting Requirements and Enforcement Measures for Studies Supported by Federal Grants, May 3, 2012
GAO Report Says That FDA Has Met Most PDUFA Performance Goals; Agency Plans to Take Steps to Address Lingering Stakeholder Concerns, May 2, 2012
Eleventh Circuit Rules Against the FTC in ANDROGEL Patent Settlement Appeal; Sen. Bingaman Pushes for Legislative Remedy, April 30, 2012
Senate and House Bills Seek to Legislatively Overturn the Supreme Court s Mensing Decision, April 19, 2012
Absolutely, Totally, and in All Other Ways Inconceivable? Nope, Says the Federal Circuit in YASMIN Hatch-Waxman Method Patent Litigation, April 18, 2012
Supreme Court Rules in Patent Use Code Case; Reverses Federal Circuit Decision, April 17, 2012
The Other Shoe Drops: ViroPharma Sues FDA - Challenges Denial of 3-Year Exclusivity and ANDA Approvals, April 16, 2012
FDA Denies ViroPharma Citizen Petition and Approves Generic VANCOCIN; ViroPharma Lawsuit to Follow, April 10, 2012
First Dust Up Over Generic PROVIGIL 180-Day Exclusivity Quickly Put on Hold With TRO/PI Motion Withdrawal, But is Followed Up With a Second Lawsuit, April 5, 2012
FDA's Third Annual Report to Congress on 505(q) Citizen Petitions; Agency Says the Jury is Still Out on the Petition Law, But There are Concerns, April 3, 2012
Pallone Bill Takes an "Oscar Rogers Approach" to 180-Day Exclusivity Forfeiture and FDA's Office of Generic Drugs: FIXIT!, April 1, 2012
AstraZeneca Loses TRO Bid in Second Generic SEROQUEL Lawsuit, March 29, 2012
Leahy Bill Would Legislatively Undo the U.S. Supreme Court's Mensing Decision, March 29, 2012
Another Loss in Court for FDA; Judge Leon Rules for Death Row Inmates in Unapproved Thiopental Sodium Case, March 27, 2012
Nonprofit Groups Prevail in Lawsuit Against FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal Feed, March 27, 2012
D.C. District Court Denies Preliminary Injunction In Generic SEROQUEL Litigation; Dismisses "Premature" Lawsuit Without Prejudice, March 26, 2012
You Had Us At "Biosimilars," FDA; Agency Ties Up Yet Another Biosimilars Loose End With Petition Response Concerning Certain "Biological Drugs", March 21, 2012
"RLD Theory of Liability" Continues to Fall Flat; Multiple Court Decisions Build Momentum in Generic Drug Failure-to-Warn Preemption Litigation, March 19, 2012
AstraZeneca Sues FDA Over Generic SEROQUEL Labeling Carve-Out Issue After FDA Issues Non-Response Citizen Petition Denial, March 13, 2012
FDA Cements "It's Our Party and We'll Punt if We Want to" Stance on 180-Day Exclusivity Failure to Obtain Tentative Approval Forfeiture Decisions, March 11, 2012
A Trio of Reports Discuss the Benefits of the Pediatric "Carrot and Stick" Statutes, the Orphan Drug Act, and Hatch-Waxman, March 6, 2012
On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate, February 29, 2012
FDA Flexes New Enforcement Muscle; Issues Warning Letter for Failure to Meet Required Postmarketing Study Milestone Dates, February 28, 2012
YASMIN Case: Is it Conceivable (or Not) that Hatch-Waxman Method Patent Infringement Lawsuits Limited to Info in the "Indications & Usage", February 22, 2012
Seeking a Second Bite at the Apple? Lannett Petitions FDA on the "Grandfather" Status of Morphine Sulfate, February 20, 2012
FDA Wraps Up Responses to 2003 & 2004 Petitions on "Biosimilars"; Denies Outstanding Requests, February 16, 2012
BMJ Article on Clinical Trial Reporting Foments Discontent on Capitol Hill, February 15, 2012
Full Circle: Rush Bill Would Make Most Patent Settlement Agreements Unlawful, February 13, 2012
"Soon" Has Finally Come; FDA Issues Three Highly Anticipated Biosimilars Draft Guidances, February 10, 2012
The Coda in the ANGIOMAX Symphony; Approaching Fine (the End), February 9, 2012
The Year of the Orphan; Orphan Drug Designations and Approvals Hit All-Time High in 2011, February 8, 2012
DC District Court Grants FDA Summary Judgment in Generic LOVENOX Dispute, February 7, 2012
Drug Shortage Prevention Act Seeks to Improve Communication and Expedite Review of Drugs in Shortage, February 3, 2012
GAO Report Criticizes FDA on Antibiotic Labeling; Finds No Evidence of Encouraged Innovation, February 1, 2012
PTO Challenged After Denying a Patent Term Extension Based on First Commercial Marketing or Use Grounds, January 31, 2012
A New Hatch-Waxman DJ Jurisdiction Decision.... And an Added Twist, January 24, 2012
Leap Year and Hatch-Waxman - An Unusual Conundrum Years in the Making, January 23, 2012
FDA Sends User Fee Pacts to Congress; Proposed Generic Drug User Fee Statute Includes Some Unique Provisions, January 18, 2012
FDA Denies Petition Seeking to Add Application Information to Drug Labels, January 12, 2012
A Federal Court Win on the RLD Theory of Liability; More of Moore Will Likely be Called For, January 9, 2012
"Size Matters," Says FDA, When it Comes to Generic Drug-RLD Sameness, January 4, 2012
ULTRA Bill Introduced in the House; Legislation Seeks to Permit Broader Use of Scientific Data to Support Surrogate Endpoints for "Ultra Orphan" Drug, January 2, 2012
Revelations: FDA's Perspective on Drugs Marketed Pursuant to a Pending DESI Proceeding and the Unapproved Drugs CPG, December 14, 2011
Pending DESI Program Proceedings - The List, December 11, 2011
FDA Proposes Generic Drug User Fee System and Performance Goals, December 7, 2011
FDA Proposes Biosimilar and Interchangeable Biological Product User Fee System and Performance Goals, December 6, 2011
FDA Proposes to Depart From Conventional Bioequivalence Metrics; Draft Guidance Proposes Partial AUC for Generic RITALIN LA, November 30, 2011
GAO Says FDA Needs to do More to Address "Economic Adulteration", November 27, 2011
FDA Withdraws Avastin Breast Cancer Indication Approval, November 22, 2011
NJ District Court Dismisses Patent Use Code Counterclaim as Not Valid Under Current Law; All Eyes Move to the Supreme Court PRANDIN Use Code Case, November 21, 2011
FDA is Sued After Approving Generic Topical Corticosteroid Drug Products; Lawsuit Seeks Withdrawal or Suspension of ANDA Approvals, November 16, 2011
The FAIR Generics Act Makes its Debut; the Bill Takes a New Tack in Addressing Patent Settlement Agreements, November 16, 2011
Patent Settlement Agreements Remain in the Spotlight, But Not the Unified Spotlight the FTC Might Want, November 15, 2011
The Showdown Over AIA Section 37 Looms...., November 14, 2011
New Jersey District Court Says ANDA Approval Delay and Patent Uncertainty Are Insufficient to Support DJ Jurisdiction in Generic DETROL LA Litigation, November 10, 2011
Will the Hatch-Waxman Lock be Sprung in 2012?, November 7, 2011
FDA Prevails in 10th Circuit Unapproved Morphine Sulfate Case; Court Does Not Reach Merits of Grandfather Claim, November 6, 2011
Burr Amendment to Senate FDA Approps Bill Seeks FDA Approval Time Transparency, November 2, 2011
California Court of Appeal Affirms Superior Court Decision that CIPRO Patent Settlement Agreements Do Not Violate State Antitrust Laws, November 1, 2011
PTO Says PTE Not Available in "Reverse Photocure" Case, October 31, 2011
Betelgeuse, Betelgeuse, Betelgeuse! The ANDA "RLD Theory of Liability" Rears Its Ugly Head, October 27, 2011
FTC Issues FY 2011 Patent Settlement Report; Attempts to Keep Up the Heat on Passage of the Preserve Access to Affordable Generics Act, October 25, 2011
VIAGRA Patent Decision Gives Rise to Dispute Over ANDA Approval, Concern About 180-Day Exclusivity Forfeiture; Court Rigidly Applies Patent Statute, October 24, 2011
Sessions/Coburn Amendment to FDA Approps Bill Seeks To Effectively Nullify AIA Section 37 ANGIOMAX PTE Provision, October 20, 2011
FDA Proposes to Clarify and Update Orphan Drug Regulations, October 19, 2011
Office of Orphan Products Development SOPP Clarifies Orphan Drug Designation Policies, October 16, 2011
Lawsuit Seeks to Compel FDA Compliance with PDUFA User Fee Waiver Provisions, October 13, 2011
Landmark NORD Report on Orphan Drugs Authored By HP&M Director Shows FDA Flexibility in Approval, October 11, 2011
Lawyer, Physician, and Bioethicist Takes Over the Reins at FDA's Orphan Drug Shop, October 6, 2011
A Flurry of Generic Drug Labeling Carve-Out Citizen Petitions; Scorecard Updated, October 3, 2011
Rep. McCaul Seeks to Reinvigorate Interest in the Creating Hope Act of 2011; Introduces Companion Bill in the House, September 29, 2011
District Court Vacates 30-Month Stay Extension; Says Stay Only Applies to ANDAs Containing a Paragraph IV Certification, September 27, 2011
It Ain't Over 'Til It's Over ' The ANGIOMAX PTE Battle Takes Yet Another New Turn, September 26, 2011
GDUFA Negotiations Completed; Safety, Access, Transparency Are the Primary Aims of the New Program, September 22, 2011
FDA Ramps Up Enforcement on Marketed Unapproved Human Drugs - Revised CPG Says New Products Will be Subject to Immediate Enforcement Action, September 19, 2011
USTR Embraces "TEAM" Approach in TPP Talks; Senators Back 12-Year Exclusivity for Biologics, September 13, 2011
Last-Ditch Effort to Jettison "The Dog Ate My Homework Act" from the America Invents Act Fails, September 8, 2011
NORD Petition Requests FDA Policy Statement on Orphan Drug Review Flexibility, September 8, 2011
FDA Issues Proposed PDUFA V Performance Goals & Procedures, September 7, 2011
Citizen Petition Requests Rulemaking Process for 505(b)(2) NDA Therapeutic Equivalence Rating Decisions, September 6, 2011
Nevada State Court Judge Says There's a Hole in Mensing Preemption for Some "Dear Doctor" Letters, September 5, 2011
FDA Issues Report to Congress on Findings and Recommendations of Rare and Neglected Tropical Disease Groups, September 1, 2011
FTC Issues Long-Awaited Final Report on Authorized Generics; Report Examines Both Short-Term Effects, Long-Term Impact on Competition & Drug Prices, August 31, 2011
Public Citizen Petitions FDA to Amend Generic Drug Labeling Regulations in the Wake of Mensing, August 29, 2011
Strength in Numbers? The Lobbying Push for a PTE, August 21, 2011
Tobacco Companies Sue FDA Over Graphic Warnings Rule, August 17, 2011
FDA Says Tenth Circuit Should Say Adieu to Grandfather Drug Case Without Much Ado; Not So Fast, Says Cody/Lannett, August 15, 2011
ANGIOMAX - The Other Patent Battle, August 11, 2011
FDA Denies ECR & Laser GRASE Petitions Following Voluntary Dismissal of Related Lawsuits, August 10, 2011
FDA Approval of Generic IMITREX STATdose Sheds Some Light on Auto-Injector "Sameness" Issues - But What About Other Combination Products?, August 8, 2011
Sturm und Drang: The TPP Agreement and Biologics Exclusivity, August 7, 2011
PDUFA IV User Fees End With a Bang, Not a Whimper! Application Fee Increases by a Whopping 19.4% (or Almost $300K), July 31, 2011
District Court Says "Shall" Means "Must" in Challenge to PTO Denial of Interim Patent Term Extension, July 25, 2011
Will the Fourth Time be the Charm? FDA is Once Again Asked for Guidance on Drug Delivery Device Patent Orange Book Listing, July 21, 2011
President Obama to Nominate Maureen K. Ohlhausen to the Federal Trade Commission, July 20, 2011
The Scope of New Chemical Entity Exclusivity and FDA's "Umbrella" Exclusivity Policy, July 20, 2011
Court Dismisses, on Ripeness Grounds, Cephalon Challenge to Generic FENTORA Approval, July 18, 2011
The MDCO PTE Decision: In Play on Capitol Hill and in Action at the PTO, July 14, 2011
Priority Review Vouchers - Not Much Bang for the Buck, July 11, 2011
New Jersey District Court Denies Preliminary Injunction Motion in Generic CARBATROL Pre-MMA 180-Day Exclusivity Case; An Appeal Quickly Follows, July 7, 2011
Will the Dog Days of Summer Offer a Reprieve to FDA and the Regulated Industry (and Your Bleary-Eyed Bloggers)? Doubtful, July 6, 2011
FDA is Sued Over Product Designation Determination; Lawsuit Seeks Device Declaration and to Vacate FDA's Drug Findings, June 30, 2011
Is Info in Paragraph IV Certification Notice Ltr Accompanied by Offer of Conf. Access Subject to Public Disclosure? One District Court has an Answer, June 29, 2011
Efforts to Obtain a PTE for ANGIOMAX Patent Continue as the U.S. House Passes an Amendment to the America Invents Act in "After Business Hours" Vote, June 28, 2011
Supreme Court Issues Decision on Generic Drug Preemption; To Borrow From Harry Caray - "Holy Cow! Generics Win! Generics Win!", June 23, 2011
In a Rare Move, District Court Extends 30-Month Stay on FDA ANADA Approval, June 20, 2011
Smarter than the Average Bear? Two Recent Lifecycle Management Strategies of Note, June 13, 2011
FDA Issues Final 505(q) Citizen Petition Guidance, Says Certification/Verification Statement Accuracy is Paramount, June 9, 2011
GAO Report Finds BPCA and PREA to be Ongoing Successes, But Says that FDA Needs to Improve Tracking of Products Studied for Pediatric Uses, June 6, 2011
FDA Denies Citizen Petition on Generic COMBIVIR 180-Day Exclusivity "First Applicant" Issue, June 1, 2011
FDA is Sued Over Generic CARBATROL; Lawsuit Challenges FDA Decisions on Pre-MMA 180-Day Exclusivity, May 30, 2011
Nonprofit Groups Sue FDA Over Subtherapeutic Uses of Penicillin & Tetracyclines in Animal Feed, Seek Approval Withdrawals & Citizen Petition Responses, May 26, 2011
A Flurry of Amicus Briefs Filed in the K-DUR Patent Settlement Appeal Seek a Reversal of a New Jersey District Court Decision, May 23, 2011
ISTA Sues FDA Over Generic XIBROM Approval, Says ANDA Approval Should Disappear in the Blink of An Eye, May 17, 2011
FTC Alleges Companies Were Asleep At the Wheel When They Failed to Report Settlement Agreements on AMBIEN CR, May 15, 2011
FDA Completes Implementation of Affordable Care Act Sec. 10609 "Generic Loophole" Provisions, May 12, 2011
D.C. District Court Grants FDA Motion for Summary Judgment in Spat Over Generic ALDARA Cream, May 10, 2011
FDA Gets the Ball Rolling on Biosimilar/Interchangeable Biological Product User Fee Program, May 9, 2011
The FTC's Latest Patent Settlement Report Will Serve as Fodder for the Commission's Crusade Against Patent Settlement Agreements, May 8, 2011
D.C. Circuit is Asked to Review Two DESI "New Drug" Decisions, May 2, 2011
Academics Criticize the MMA's Failure-to-Market Forfeiture Provisions as Anemic Mechanism for Parked Exclusivity & MMA's DJ Provisions as Paper Tiger, April 27, 2011
Analyst Report Suggests Recent Uptick in NDA/BLA Refuse-to-File Letters Signals Changes at FDA, April 26, 2011
Amendment to the America Invents Act Would Give MDCO Some Legislative Security in Battle Over ANGIOMAX PTE, April 20, 2011
ViroPharma's Preemptive Strike Over Generic VANCOCIN Fails; District Court Grants FDA's Motion to Dismiss, April 19, 2011
FDA Reports to Congress on Generic Anti-Epileptic Drugs; Concludes Additional Study of Brand-Generic Switching is Needed to Better Understand Risks, April 13, 2011
Lawsuit Alleges False Marking Based on Orange Book "Advertising", April 13, 2011
Simultaneously Qualifying for and Forfeiting 180-Day Exclusivity Eligibility for Failure to Obtain Timely Tentative Approval, April 12, 2011
NJ District Court Punts in ASACOL DJ Action to Trigger 180-Day Exclusivity Forfeiture; Rules that Subsequent ANDA Applicant Lacks Standing, April 5, 2011
Decision in Lannett THALOMID Bioequivalence Study Sample Antitrust Lawsuit Could Reignite Debate on Generic Drug Availability and REMS Restrictions, April 1, 2011
Oral Argument in the Mensing-Demahy Generic Drug Labeling Preemption Case, March 30, 2011
Orange Book Patent Listing Precipitates DJ Action to Trigger Generic KEPPRA XR 180-Day Exclusivity Forfeiture, March 28, 2011
FDA Issues New Guidance on PDUFA User Fee Waivers, Reductions, and Refunds; Guidance Represents the Culmination of 18 Years of FDA, March 21, 2011
Sen. Casey Takes Over the Reins for the Creating Hope Act; New Bill Substantially Mirrors Sen. Brownback's 2010 Version, March 21, 2011
Judge Snuffs Out Holistic Candlers Lawsuit; Constitutional Challenge Falls on Deaf Ears, March 20, 2011
Recent Hatch-Waxman Scholarship Suggests Patent Settlement & Product Hopping Create "Lethal Combination", March 15, 2011
Orange Book Patent Delisting Counterclaim Raised in 505(b)(2) Application Patent Infringement Litigation, March 8, 2011
Supreme Court Shuts Another Door on Patent Settlement Agreement Antitrust Challenge - Denies Certiorari in CIPRO Case, March 7, 2011
FDA Announces Major Enforcement Action on Marketed Unapproved Prescription Cough, Cold, and Allergy Drug Products, March 2, 2011
Snowmageddon, a Government Shutdown, and Other Acts of Nature (Mother or Human) What are the Effects on FDA Approval Decision Deadlines?, March 1, 2011
Fifth Circuit Vacates District Court "Second Inspection Ruling" in Compounding Pharmacy Case, February 28, 2011
The Itch is Scratched FDA Denies XYZAL Carve-Out Petition; Another Precedent Added to the Generic Drug Labeling Carve-Out Citizen Petition Scorecard, February 24, 2011
District Court's Extension of 30-Month Stay on Generic XYZAL Approval Ends; ANDA Sponsors Itching for FDA Decision on Carved-Out" Urticaria-Only Label, February 23, 2011
Legislation to Ban Authorized Generics During 180-Day Exclusivity Period Makes a Comeback in Congress, February 21, 2011
The President's FY 2012 Budget Would Create New User Fees, Ban Patent Settlements, and Reduce BPCIA Reference Product Exclusivity, February 15, 2011
Subsequent ANDA Sponsor Says DETROL LA Patent Has Gotta Go; But Would a Final Court Decision Trigger 180-Day Exclusivity?, February 10, 2011
The Fat Lady Goes Back to Her Dressing Room; Federal Circuit Denies MDCO Motions in ANGIOMAX PTE Litigation, February 6, 2011
OGD Finished 2010 on a High Note - Really High!, February 3, 2011
Orphan Drug Designations and Applications Took Off in 2010 While Orphan Drug Approvals Tapered Off, January 31, 2011
The Preserve Access to Affordable Generics Act Resurfaces Early in the 112th Congress, January 30, 2011
Another Week, Another Missive on BPCIA Exclusivity, January 26, 2011
Reports Detail FDA's 505(q) Citizen Petition Response Track Record; Section 505(q) May Have Some Unintended Consequences, FDA Says (Part I), January 24, 2011
Tussle over BPCIA "Market" Versus "Data" Exclusivity Continues; This Time the Generic Supporters Chime In, January 21, 2011
NJ District Court Declines to Exercise Declaratory Judgment Jurisdiction in Feud Over Generic ANTARA; Lupin is Given Another Bite at the Apple, January 19, 2011
High Court Denies Apotex Petition on 180-Day Exclusivity, January 18, 2011
Apotex Seeks to Trigger 180-Day Exclusivity for Generic LEXAPRO Tablets, January 17, 2011
PTO Sued After Denying "Mildly Tardy" Second Interim PTE Request, January 12, 2011
Déjà vu! Senators Follow House Colleagues in Making BPCIA Exclusivity Clarifications; New Study Suggests Benefits of Longer Drug Exclusivity Period, January 11, 2011
32 State AGs Urge U.S. Supreme Court to Take on Patent Settlement Agreements, January 10, 2011
FDA Seeks to Clean Up Unapproved Cough/Cold/Allergy Drug Market, January 6, 2011
BPCIA's Principal Authors Seek to Clarify Congressional Intent With Respect to 12-Year Exclusivity Period; PhRMA/BIO Request "Umbrella Exclusivity", January 5, 2011
Here We Go Again.... Amphastar Renews Generic LOVENOX Case Against FDA, December 30, 2010
U.S. Supreme Court Petitioned to Review Federal Circuit Patent Use Code Decision, December 28, 2010
Sandoz Requests 180-Day Exclusivity Forfeiture Decision for Generic HECTOROL, December 21, 2010
Provisions to Promote Approval of Rare and Neglected Disease Products Survive Chopping Block in the Senate's FY11 Omnibus Approps Bill, December 15, 2010
Sanofi Seeks Summary Judgment in Generic LOVENOX Dispute; Administrative Record Highlights Disagreements at FDA Over Generic Approval, December 14, 2010
Apotex Cert Petition on 180-Day Exclusivity Forfeiture Decision is DOA, Says Teva in Opposition Brief, December 13, 2010
Supreme Court Will Review Generic Drug Preemption Cases, December 10, 2010
Drug Purchasers Petition U.S. Supreme Court to Consider CIPRO Patent Settlement Case, December 8, 2010
McNeil Petitions the U.S. Supreme Court on OTC Drug Labeling Failure-to-Warn Preemption Issue, December 7, 2010
Legal Setbacks and Legislative Inaction May Push the FTC to Consider "Plan C" to Address Patent Settlement Agreements, November 29, 2010
Sandoz Attempts to Clear Up Post-Losartan "Bottleneck" with DJ Action on Disclaimed Patent, November 22, 2010
FDA Says There is No Scientific Evidence of Problems in Switching Bioequivalent Anti-epileptic Meds, But Further Study is Warranted, November 21, 2010
District Court Grants FDA Motion to Dismiss in Unapproved Morphine Sulfate Litigation, November 17, 2010
FDA Files Amicus Brief on Generic Drug Preemption, November 16, 2010
Generic Drug Industry Headed for a "180-Day Exclusivity Cliff", November 16, 2010
Applicant Claims PTE Eligibility Based on PhotoCure Dicta; A Set-up to a Court Challenge?, November 14, 2010
PTO Clarifies PTE Availability in Post-PhotoCure and Post-Ortho-McNeil World; PhotoCure Takes Advantage of.... PhotoCure, November 10, 2010
Senator Cites Ethical "Defect" in Biosimilars Law Exclusivity Provisions; Proposes Legislative Fix, November 4, 2010
Solicitor General Files Amicus Brief in Mensing Cases on Generic Drug Preemption; Recommends that the Supreme Court Deny Review, November 2, 2010
REMS and 180-Day Exclusivity Forfeiture - Some Interesting Disclosures to the SEC, October 28, 2010
Another Capitol Hill Missive Objects to the Inclusion of Patent Settlement Provisions in FY 2011 Appropriations Bill, October 27, 2010
FDA Grants Petition Requesting a "Superseding" 30-Month Stay for Generic HECTOROL, October 25, 2010
Improving Access to Clinical Trials Act Becomes Law, October 19, 2010
Generic LIPITOR - the Brass Ring of All Brass Rings for 180-Day Exclusivity; How Will Exclusivity Resolve?, October 12, 2010
Another Push to Legislatively Overturn Forest Group False Marking Decision, October 11, 2010
IOM Issues Report on Rare Diseases and Orphan Products; Recommends an Integrated National Strategy, October 7, 2010
Does Subsequent Paragraph IV Filer Have Legally Cognizable Interest in When 1st Filer's 180-Day Exclusivity Period Begins for DJ Jurisdiction Purposes, October 6, 2010
It Lives!! Apotex Asks the Supreme Court to Review Generic COZAAR/HYZAAR 180-Day Exclusivity Decision, October 5, 2010
WSJ Stakes Out Position on Patent Settlements; Takes Issue with the FTC's "Evangelical Zeal", October 5, 2010
Flare-Up Over Generic Herpes Drug Could be Short-Lived, September 27, 2010
Novartis Sues FDA Over Generic FAMVIR; Alleges that FDA Failed to Require a Split Certification, September 23, 2010
Senators Vigorously Object to the Inclusion of Patent Settlement Provisions in FY 2011 Appropriations Bill, September 21, 2010
FDA Set to Announce Public Hearing on BPCI Act Implementation, September 20, 2010
OGD Has Put the Brakes on ANDA Supplement Reviews; Will it Help Push Generic Drug User Fees Along?, September 16, 2010
Put it on Mr. Underhill's Bill! FDA Sets Priority Review Voucer Redemption Fee at Almost $4.6 Million, September 14, 2010
Sen. Leahy Introduces the Food Safety Accountability Act of 2010, September 14, 2010
ViroPharma Sues FDA Over Generic VANCOCIN; Alleges that FDA Violated the APA in Effectively Amending Bioequivalence Regulations, September 13, 2010
All Eyes are on APP's Intervention Motion as the Government Bows Out of ANGIOMAX PTE Litigation, September 9, 2010
Psych! Second Circuit Denies Rehearing Petition in CIPRO Patent Settlement Litigation after Panel Invites Petition, September 9, 2010
Cody/Lannett Unapproved Morphine Sulfate Litigation Gets New Legs; But FDA Motion to Dismiss Tries to Pull the Rug Out From Under Them, September 6, 2010
Report Predicts Tough Road Ahead for Some Generics After Federal Circuit Patent Use Code Decisions, September 3, 2010
APP Moves Forward With Appeal Notice in ANGIOMAX PTE Litigation in Light of PTO/FDA Indecision, September 2, 2010
District Court Denies Apotex Declaratory Judgment Motion on Generic ARICEPT; Does Not Accept Prompt Launch" & "Indefinite Delay" Jurisdiction Theories, September 1, 2010
GAO Issues Report on Non-Inferiority Studies; Finds No Evidence of "Biocreep," But More Conservative Use of Such Studies to Support Approval, August 30, 2010
Patent Expiration, Pediatric Exclusivity, and Generic Drug Approval - Some Interesting Tensions Between the FDC Act and Patent Law, August 18, 2010
New Analysis Takes Issue with CBO Patent Settlement Legislation Cost Estimate, August 16, 2010
FDA Issues NOOH Proposing to Withdraw All Midodrine HCl Approvals, August 16, 2010
Another Advocacy Group Asks FDA to Increase Marketed Unapproved Drugs Enforcement Crackdown, August 12, 2010
180-Day Exclusivity - From Abacavir Sulfate to Zolpidem Tartrate, August 10, 2010
Senator Brownback Introduces Creating Hope Act of 2010;Would Change Priority Review Voucher Program;Extend to Applications for Rare Pediatric Diseases, August 5, 2010
UPDATE - Generic Drug Labeling Carve-Out Citizen Petition Scorecard, August 4, 2010
MDCO Prevails in ANGIOMAX PTE Case - District Court Grants Summary Judgment; Will the PTO Appeal?, August 3, 2010
NRDC Sues FDA for Failing to Take Action on Triclosan and Triclocarban, August 3, 2010
Up, Up and Away! FDA Sets Fiscal Year 2011 User Fee Rates, August 3, 2010
Preserve Access to Affordable Generics Act Included in FY 2011 Financial Services and General Government Appropriations Bill, July 30, 2010
Federal Circuit Denies Rehearing Petition in PRANDIN Patent Use Code Case; Dissents Argue that "Section viii" Carve-Outs Eviscerated, June 29, 2010
DC District Court Denies Sanofi Summary Judgment Motion in Generic ELOXATIN Case; Refuses to Reinstate 30-Month Stay on ANDA Approvals, July 28, 2010
The Other Shoe Drops.... Sanofi Sues FDA Over Generic LOVENOX Approval, July 27, 2010
District Court Denies Motion for Temporary Restraining Order and Preliminary Injunction in Marketed Unapproved Morphine Sulfate Oral Solution Case, July 26, 2010
FDA Takes Action on LOVENOX Citizen Petition and Approves Sandoz ANDA, July 23, 2010
FDA Sued Over Enforcement Action on Marketed Unapproved Morphine Sulfate Oral Solution, July 22, 2010
Rep. Schakowsky Introduces Safe Cosmetics Act of 2010; Bill Would Increase Regulation of Cosmetics, July 21, 2010
Federal Circuit Denies Rehearing Petition in LEVAQUIN Patent Term Extension Case, July 19, 2010
Senate FY 2011 FDA Appropriations Bill Should be Another Big Step Forward for Rare and Neglected Disease Patients and Advocates, July 16, 2010
Graceway Sues FDA Over Generic ALDARA Cream Decisions; Alleges that Petition Response is Contrary to Basic Science, Common Sense, and Precedent, July 13, 2010
Analysis Shows Patent Use Codes Have Doubled Since August 2003, July 8, 2010
D.C. Circuit Affirms District Court Ruling Concerning Losartan 180-Day Exclusivity Forfeiture Issue, July 6, 2010
Coalition for Mercury-Free Drugs Fails to Prove Standing in Thimerosal Case, July 5, 2010
House Passes Patent Settlement Legislation as Part of the War Funding Bill, July 2, 2010
NORD Chair/HPM Director Presents Opening Testimony at First Ever FDA Orphan Drug Hearing, June 30, 2010
Pfizer Withdraws Subpart H Drug MYLOTARG From the Market, June 22, 2010
High Court Declines to Hear Solvay and Duxbury FCA Cases, June 21, 2010
Senator Nelson Takes Another Crack at the Drug Price Competition Act, June 16, 2010
Relinquishment and Waiver of 180-Day Exclusivity Post-MMA; What is FDA Precedent and Where Might FDA be Headed?, June 14, 2010
"Preserve Access to Affordable Generics Act" Resurfaces in Senate; Patent Settlement Litigation Front Heats Up, June 10, 2010
A New 180-Day Exclusivity Punt - But Don't Read Too Much Into It, June 7, 2010
Is Another Challenge to the PTO's PTE "Product" Interpretation Looming?, June 3, 2010
Pennsylvania District Court Decision Signals a New Turn in the Generic Drug Preemption Debate; A Tough Pill to Swallow for the Generic Industry, June 2, 2010
Sen. Kerry Introduces ANGIOMAX PTE Amendment to Tax Extenders Act of 2009, May 27, 2010
U.S. Supreme Court Invites Solicitor General to Express the Views of the United States in Generic Drug Preemption Cases, May 25, 2010
Court Orders and PTO Grants Second Interim PTE for ANGIOMAX, May 24, 2010
CIPRO Patent Settlement Case is Appealed to the California Court of Appeal, May 20, 2010
Losartan - D.C. Circuit Denies FDA's Petition for Panel Rehearing and Rehearing en banc; Roxane/Apotex Case Continues, May 18, 2010
You Better Watch Out, and You Can Pout, but FDA User Fee Invoices Are Coming Out; FDA is Making a List and Checking it Twice - You Should Too!, May 18, 2010
Outstanding Pre-FDAAA Citizen Petition Causes FDA to Rule Against 180-Day Exclusivity Forfeiture for Generic SKELAXIN, May 14, 2010
Blown 30-Month ANDA Tentative Approval and Approval Dates - A Growing Industry Concern; Is Litigation in the Works?, May 11, 2010
Federal Circuit Affirms Two District Court Decisions Concerning PTE Availability; Decisions Embrace an "Active Ingredient" Approach to PTEs, May 10, 2010
A New Hope? Second Circuit Invites Further Review in CIPRO Patent Settlement Case, May 4, 2010
Federal Circuit Sides with FDA & PTO: CYDECTIN PTE Decision; Court Rules that Approval Phase Begins when Administrative NADA is Initially Submitted, May 3, 2010
FTC Annual Report Highlights the Commission's Patent Settlement Efforts, April 25, 2010
A Not So Sweet 16 for FDA and PDUFA!, April 21, 2010
Advocacy Groups Ask FDA to Further Crack Down on Marketed Unapproved Drugs, April 20, 2010
District Court Decision Sidesteps 30-Month Stay Tolling Issue; Denies Patent Infringement Litigation Stay, April 19, 2010
Federal Circuit Reverses District Court Decision in Patent Delisting Counterclaim Case; All Orange Book Information is Not "Patent Information", April 15, 2010
FDA Sued by Animal Rights Advocates and Ear (Holistic) Candle Advocates, April 14, 2010
PLAIRs - What are They and What are FDA's Current Policies?, April 11, 2010
The Rarely Used Exception to the First Permitted Commercial Marketing/Use PTE Criterion, April 6, 2010
Generic COZAAR/HYZAAR 180-Day Exclusivity - Teva Wins, FDA Too (Despite Itself) in the DC District Court; Appeals Abound, April 5, 2010
Mass Forfeiture of 180-Day Exclusivity!, April 1, 2010
FDA Rules Against Patent Expiration 180-Day Exclusivity Forfeiture for Generic COZAAR/HYZAAR, But in Doing So FDA Repudiates Its Own Decision and Asks, March 29, 2010
Here We Go Again! MDCO Launches Another Lawsuit Against the PTO Over ANGIOMAX PTE, March 26, 2010
Health Care Reform Becomes Law - HP&M Issues Summary of Drug and Device Provisions, March 24, 2010
PTO Once Again Denies PTE for ANGIOMAX Patent... But Not Before Issuing an Interim Extension; MDCO is Outraged, March 22, 2010
FDA Relies on Drug Listing Information in the Latest Round of Marketed Unapproved Drug Warning Letters, March 19, 2010
Court Orders and Declares that Teva Has Not Forfeited 180-Day Exclusivity for generic COZAAR/HYZAAR, March 17, 2010
PTO's ANGIOMAX PTE Denial is Vacated and the Case Goes Back to PTO - What Happens in the Interim?, March 17, 2010
FDA Grants Petition on Pioglitazone Split Certification Issue; It's Caveat Utilitor on Old Orange Book Patent Listings, March 16, 2010
Rep. Hinchey Introduces the FDA Improvement Act of 2010; the Bill Would Unravel User Fee Legislation, Among Other Changes, March 15, 2010
FDA Rules Against Forfeiture for Generic ALDARA Cream, March 9, 2010
District Court Dismisses Wyeth Lanham Act Case Concerning Generic PROTONIX, But Leaves the Door Open for Further Litigation, March 8, 2010
"COMPLAINT FOR FALSE PATENT MARKING" - Have you Received One? If Not, You Might Soon!, March 7, 2010
FDA May Increase Misdemeanor Prosecutions Against Responsible Corporate Officials, March 4, 2010
Rep. Watson Introduces the Compassionate Access Act of 2010, March 3, 2010
PTO Denies PTE for ADVAIR DISKUS Patent; Again Clarifies that PTEs Not Available for "Synergistic Combinations" Containing Previously Approved Drugs, March 2, 2010
Teva Prevails in Generic COZAAR/HYZAAR 180-Day Exclusivity Forfeiture Litigation; the Decision is a Game-Changer, March 2, 2010
OGD's ANDA Backlog and Median ANDA Approval Times are Up - WAY UP! "The Solution Lies in Resources," Says FDA Commissioner Hamburg, February 25, 2010
Court Dismisses FTC Challenge to ANDROGEL Settlement Agreements; President's Proposed Health Bill Would Adopt Measure to Curb Settlement Agreements, February 24, 2010
Recent Rulings Once Again Shine the Light on Sham Citizen Petition Antitrust Issues, February 9, 2010
Has FDA Already Resolved One Critical Issue Concerning Forced Rx-to-OTC Switches?, February 8, 2010
All for One and One for All - FDA Denies Graceway Petition on Generic ALDARA Cream, February 3, 2010
Requests for Orphan Drug Designation Explode in 2009; But Designation Success Rate is Low, February 2, 2010
The Medicines Company Tosses Up a Hail Mary Pass - Sues PTO and FDA Over ANGIOMAX Patent Term Extension Decisions, February 1, 2010
FDA Denies Petition on "Original NDA" Patent Certification Issue, January 28, 2010
2009 - Another Banner Year for Orphan Drug Designations, January 21, 2010
Down and Out in MA - The PTO Denies The Medicines Company's Request for Reconsideration for ANGIOMAX Patent Term Extension, January 20, 2010
FTC Releases Analysis of Pay-for-Delay Settlements; Renews Call for Legislation, January 13, 2010
Inclusion of Pay-for-Delay Ban in Health Care Bill Urged; FTC to Hold Press Conference Announcing Pay-for-Delay Analysis, January 12, 2010
FDA Issues Exclusivity Decision for EMEND; Agency Reverses Course and Grants NCE Exclusivity, January 5, 2010
Tufts Report Concludes that Product Approvals for Neglected Diseases are on the Rise, January 3, 2010
Speaking Engagements
International Congress on Paragraph IV Litigation, September 23 - 24, 2013
180-Day Exclusivity and Forfeiture: A Dissection of Key Filing Benchmarks and Timing Considerations for Counsel on Both Sides
ACI Biosimilars Conference, June 6 - 7, 2013
Panel Member: The Next Frontier of Biosimilar Challenges: Naming and Substitution at the Pharmacy Level
Respiratory Drug Delivery Conference, May 21 - 24, 2013
Orphan Drug Approval in the US (and Some EU Comparisons): Regulatory Mechanisms for Rare Pulmonary Disorders
FXConferences, May 9, 2013
FxTrans Promotion Webinar
ACI Paragraph IV Disputes conference, May 7 - 8, 2013
Panel discussion moderator for "New Exclusivity Challenges: Brand Names Take Notice - It's Not Just a Concern for Generics Anymore"
Food and Drug Law Institute Annual Conference, April 22 - 24, 2013
Moderator for the "Drug Exclusivity Session"
Specialty Pharma Association Annual Conference, April 16 - 18, 2013
FDA Updates
ACI's FDA Boot Camp, March 19 - 20, 2013
Drugs and Biologics
CHPA Annual Executive Conference, March 11 - 13, 2013
Top Game Changing Regulatory Decisions
Real-World Implications of United States v. Caronia, January 31, 2013
Global IP Convention, January 23 - 30, 2013
Patent and Non-Patent Exclusivities for Drug and Biological Products in the USA - An Overview and Current Developments
Paragraph IV Disputes, December 3 - 5, 2012
Hatch-Waxman and BPCIA 101 - A Primer on IP Basics and Regulatory Fundamentals
ACI: Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs, October 17 - 19, 2012
Making the Case for An Rx to OTC Switch: Legal and Regulatory Considerations
ACI: Maximizing Pharmaceutical Patent Life Cycles, October 10 - 11, 2012
Exclusivities and Forfeitures: New Developments, Controversies, and Related Concerns
C5 EU Pharma Regulatory Law Conference, September 25 - 26, 2012
Co-presenter: Demystifying the Scope and Potential Impact of Proposed Legislation on Biosimilars to Enable You to Make Strategic Decisions Now
Practicing Law Institute Webinar, August 15, 2012
Understand and Plan Your Biosimilars Strategy Now
ACI Hatch-Waxman Boot Camp, June 25 - 26, 2012
Orange Book Listings, De Listings and Related Challenges
Respiratory Drug Delivery Conference, May 13 - 17, 2012
To 505(b)(2) or Not To 505(b)(2) Jumping the Legal Hurdles for Inhaled Drug Products
Thompson Interactive Webinar, April 2, 2012
PDUFA V: Preparations for the New Fees and Performance Goals
ACI FDA Boot Camp, March 20 - 21, 2012
Hatch-Waxman and BPCIA Overview
University of Texas College of Pharmacy International Conference on Drug Development, February 29, 2012
Legal Considerations to Establish Biosimilarity and Therapeutic Interchangeability
Thompson Webinar, November 15, 2011
Navigating the Orphan Drug Designation Process: Benefits of Obtaining Designation
FDA News Webinar, October 27, 2011
Marketed Unapproved Drugs
RAPS Regulatory Convergence Conference, October 22 - 26, 2011
"Generics in the US: A Regulatory Primer on Filing and Recent Actions" and the Workshop on "Pay-to-Delay Agreements"
Informa Inhalation Drug Development Conference, October 12, 2011
ACI: Maximizing Pharmaceutical Patent Life Cycles, October 5, 2011
REMS Studies and Generic Entry: Exploring the Latest Regulatory Conundrum Affecting Pharmaceutical Patent Life Cycle Strategies
Informa Global Generic Strategy Summit, September 20 - 21, 2011
FDA Regulation of Generic Drugs
FDLI Conference: Brands, Generics, and Hatch-Waxman-New Challenges; Unabated Controversy, June 24, 2011
180-Day Exclusivity Forfeiture
World Orphan Drug Conference, April 13 - 15, 2011
Disease Subsetting
Thompson Audio Conference, March 15, 2011
Navigating the Orphan Drug Designation Process, & the Benefits of Obtaining Designation
Generic Pharmaceutical Association Annual Meeting, February 16 - 18, 2011
Generic Drug Preemption
ACI: The Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions, January 26 - 27, 2011
New Trends and Challenges in PTE Litigation: Key Cases to Watch
Pharmalot Webinar, December 9, 2010
Navigating The FDA Accelerated Approval Process
CBI Life Sciences Congress on Paragraph IV Disputes, October 18 - 19, 2010
FDA Forfeiture Provisions and Review of Strategic Developments
ACI: FDA Boot Camp., September 27 - 28, 2009
Nature of the Approval Process
Specialty Pharma Association Fall Conference, September 15 - 17, 2010
FDA Update
Rodman & Renshaw Global Investment Conference - 12th Annual Healthcare Conference, September 15, 2010
Panel Discussion on "As the Drug Patent Landscape Evolves, Strategic Challenges and Opportunities Develop"
ACI Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions Conference, August 19, 2010
New Trends and Challenges in PTE Litigation: Key Cases to Watch
C5 Conference: Maximising Pharmaceutical Patent Life Cycles, June 23 - 24, 2010
Update on Regulatory Protections Available to Extend Patent Lifecycles: Comparing and Contrasting Europe and US
AIPLA Spring Meeting, May 6 - 8, 2010
ACI Paragraph IV Disputes Conference, April 26, 2010
Bioequivalence and the 'Same Active Ingredient' vis-à-vis Patentability
Respiratory Drug Delivery Meeting, April 25 - 29, 2010
Legal Perspective on Approval and Legal Challenge Process for Topically Active Generic Inhalers
Thompson Interactive Audio Conference, March 23, 2010
Navigating the Orphan Drug Designation Process, and the Benefits of Obtaining Designation
CBI West Coast Forum on Early Access Programs (EAP), March 10, 2010
Understand and Navigate the Legal Landscape for Early Access Programs
Biotech & Pharmaceutical Patenting Conference, February 17 - 18, 2010
CBI Inaugural Forum on Pre-Approval Expanded Access Programmes for the Bio/Pharmaceutical Industry, November 18, 2009
Understanding the Role of EMEA and FDA During Patient Compassionate Use and Expanded Access
CBI's 2nd Annual Pharmaceutical Congress on Paragraph IV Disputes, October 22 - 23, 2009
Differences of Opinion on NCEs - What are the Scope and Limits?
American Conference Institute conference on Maximizing Pharmaceutical Patent Lifecycles, October 7 - 8, 2009
Bioequivalence and the "Same Active Ingredient" vis-à-vis Patentability
CBI's 2nd Annual Forum on Early Access Programs, October 7, 2009
Operating Compliantly and Legally during Pending Approval
Thompson Interactive Audio Conference, July 30, 2009
FDA Unapproved Drug Initiative - Determine, Prove and Ensure Compliance
FDANews Webinar - The Real Impact of Wyeth v. Levine, March 24, 2009
How to Survive in a Post-Preemption World
IPA/AAPS/FIP Conference - To and thru the Skin, February 20 - 21, 2009
Thompson Interactive Audio Conference, January 13, 2009
New Drug Exclusivity Provisions: How They'll Impact Your Product Lifecycle Management
CBI Pharmaceutical Congress on Paragraph IV Disputes, October 15 - 16, 2008
Navigating Regulations and Enforcement Trends to Increase Preparedness and Optimize Paragraph IV Strategies