By Kurt R. Karst – Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Doctor Who, Star Wars, and, of course, Star Trek. I remember well the voyages of the starship Enterprise under the …
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Hatch-Waxman
- Generic and Innovator Drugs: The Next GenerationMay 7th, 2013
- FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing DebateMay 5th, 2013
By Kurt R. Karst – By now everyone knows that FDA has appealed to the Second Circuit (Case No. 13-1690) the April 5, 2013 Memorandum and Order and April 10, 2013 Judgment from Judge Edward R. Korman of the U.S. District Court for the Eastern District …
- False Friends: FDA’s “Gift” on NESINA – Present or Poison? It May Depend on Which Hatch-Waxman Language is SpokenMay 3rd, 2013
By Kurt R. Karst – Frau Rommelfanger’s seventh grade German class: that’s where we first learned to appreciate “false friends,” which are pairs of words or phrases in two languages that look or sound alike, but differ significantly in meaning. Never write the word “gift” …
- FDA to Reconsider Approval of Generic BAYTRIL; Court Gives Importance to Unresolved Citizen Petition; Will the Decision Affect FDA Petition Procedures?April 30th, 2013
By Kurt R. Karst – Bayer HealthCare, LLC’s (“Bayer’s”) court challenge to FDA’s approval of Abbreviated New Animal Drug Application (“ANADA”) No. 200-495 submitted by Norbrook Laboratories, Ltd. (“Norbrook”) for Enroflox™ 100, a generic version of Bayer’s fluroquinolone animal drug Baytril® 100 (enrofloxacin) Injectable Solution, …
- DC Circuit Rules for FDA in SEROQUEL Exclusivity Case; AstraZeneca Not Entitled to 3-Year ExclusivityApril 29th, 2013
By Kurt R. Karst – In a brief opinion handed down last week by the U.S. Court of Appeals for the District of Columbia Circuit, the Court affirmed a July 5, 2012 decision from the U.S. District Court for the District of Columbia granting summary …
- “Opioid Spring” Blossoms: FDA Finds “Original” OXYCONTIN Discontinued for Safety or Effectiveness Reasons; Will Not Accept or Approve ANDAsApril 16th, 2013
By Kurt R. Karst – The cherry blossoms are finally in full bloom in Washington, D.C., and so too is FDA’s thinking on one non-abuse-deterrent drug. In a prepublication version of a notice that will be published in the Federal Register on April 18, 2013, …
- Generic BAYTRIL Approval Suspended; Bayer Alleges ANADA Approval Violates GADPTRA and APAApril 15th, 2013
By Kurt R. Karst – “GADPTRA” – Now there’s an acronym you don’t see very often on this blog. It stands for the Generic Animal Drug and Patent Term Restoration Act of 1988, Pub. Law No. 98-417, 98 Stat. 1585 (1988), which is the Hatch-Waxman …
- The President’s FY 2014 Budget Continues Push to Curb Patent Settlement Agreements, Shorten Biologics Exclusivity; Biologics Exclusivity Faces Opposition in TPP TalksApril 11th, 2013
By Kurt R. Karst – Earlier this week, the Obama Administration released the President’s Budget for Fiscal Year 2014. At first blush, FDA appears to have fared rather well, with an additional $821,453,000 in total funding. Most of the increase, however, is due to new …
- Discord Among Accord and Acorda Over AMPYRA Biostudy Sample Leads to Restricted Distribution Antitrust LawsuitApril 2nd, 2013
By Kurt R. Karst – A recent Complaint filed in the U.S. District Court for the Southern District of Florida by Accord Healthcare, Inc. and Intas Pharmaceuticals, Ltd. (collectively, “Accord Healthcare”) against Acorda Therapeutics Inc. (“Acorda”) and H.D. Smith Wholesale Drug Co. (“H.D. Smith”) is the …
- Timing is Everything! . . . In Life and In Hatch-Waxman; Fun With 180-Day Exclusivity ForfeitureMarch 31st, 2013
By Kurt R. Karst – Despite amendments to the statute, court decisions, and FDA interpretations, there has been one constant throughout the nearly 29-year history of the Hatch-Waxman Amendments: dates matter. If a company – or FDA – misses a deadline by just one day, …
- Administrative Law Trumps the “Immutable Laws of Science,” Says the DC Circuit in Challenge Over Generic Derma-Smoothe Approvals; Hill Appeals and Denial Quickly FollowsMarch 28th, 2013
By Kurt R. Karst – A recent per curiam decision from the U.S. Court of Appeals for the District of Columbia Circuit may be the last word in litigation Hill Dermaceuticals, Inc. (“Hill”) initiated in November 2011 against FDA, as Hill filed a petition for …
- The Big Day Approaches: Supreme Court to Hear Oral Argument in ANDROGEL Drug Patent Settlement Agreement CaseMarch 24th, 2013
By Kurt R. Karst – Excitement is running high in the pharmacetical world with just hours to go before the U.S. Supreme Court hears oral argument on Monday, March 25, 2013 in Federal Trade Commission v. Actavis (Docket No. 12-416) concerning whether drug patent settlement …
- Preemption, Preemption, and More Preemption – A Cert Petition, a Circuit Court Decision, and the Upcoming Battle in Mutual v. BartlettMarch 18th, 2013
By Kurt R. Karst – Over the past week we’ve been inundated with new items concerning generic drug labeling and whether federal law – the FDC Act and FDA’s implementing regulations – preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against generic drug manufacturers. …
- FTC Chimes In On Restricted Distribution and Generic Competition; Files Amicus Brief in TRACLEER CaseMarch 12th, 2013
By Kurt R. Karst – We thought it would only be a matter of time until the Federal Trade Commission (“FTC”) decided to voice its views in a lawsuit filed last September by Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) in the …
- Antitrust Law Must Play Traditional “Magna Carta of Free Enterprise” Role, Say Generic Defendants in Lawsuit Over Restricted Distribution and Biostudy Product AvailabilityMarch 6th, 2013
By Kurt R. Karst – Earlier ths week, Apotex Corp., Roxane Laboratories, Inc., and Actavis Elizabeth LLC (collectively “Counterclaim Plaintiffs”) filed their opposition to Actelion Pharmaceuticals Ltd.’s and Actelion Clinical Research, Inc.’s (collectively “Actelion’s”) Motion for Judgment on the Pleadings and to Dismiss Counterclaims in …