By Kurt R. Karst – The growing application backlog and median time for ANDA approval by FDA’s Office of Generic Drugs (“OGD”) has been a thorn in the side of the generic drug industry for quite some time now. As we previously reported, the …
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Hatch-Waxman
- Blown 30-Month ANDA Tentative Approval and Approval Dates – A Growing Industry Concern; Is Litigation in the Works?May 11th, 2010
- Federal Circuit Affirms Two District Court Decisions Concerning PTE Availability; Decisions Embrace an “Active Ingredient” Approach to PTEsMay 10th, 2010
By Kurt R. Karst – On May 10, 2010, a 3-judge panel of the U.S. Court of Appeals for the Federal Circuit (Circuit Judges Newman, Rader, and Linn) issued its unanimous decisions in two cases that should solidify as to when a patent covering …
- A New Hope? Second Circuit Invites Further Review in CIPRO Patent Settlement CaseMay 4th, 2010
By Kurt R. Karst – Last week’s decision by a 3-judge panel of the U.S. Court of Appeals for the Second Circuit in In re: Ciprofloxacin Hydrochloride Antitrust Litigation affirming a 2005 decision by the U.S. District Court for the Eastern District of New York …
- Federal Circuit Sides with FDA and PTO in CYDECTIN PTE Decision; Court Rules that Approval Phase Begins when Administrative NADA is Initially SubmittedMay 3rd, 2010
By Kurt R. Karst – Earlier today, the U.S. Court of Appeals for the Federal Circuit ruled 3-0 to affirm a March 2009 decision from the U.S. District Court for the District of Columbia granting summary judgment to FDA and the U.S. Patent and Trademark …
- FTC Annual Report Highlights the Commission’s Patent Settlement EffortsApril 25th, 2010
By Kurt R. Karst – Last Friday, at the American Bar Association’s Section of Antitrust Law Spring Meeting in Washington, D.C., Federal Trade Commission (“FTC”) Chairman Jon Leibowitz issued the FTC’s 2010 Annual Report. Among other things, including allegedly false or unsupported claims concerning dietary …
- District Court Decision Sidesteps 30-Month Stay Tolling Issue; Denies Patent Infringement Litigation StayApril 19th, 2010
By Kurt R. Karst – The U.S. District Court for the District of Delaware’s recent decision in Millennium Pharmaceuticals, Inc. v. Teva Parenteral Medicines, Inc., denying a stay of patent infringement proceedings concerning generic versions of Schering’s INTEGRILIN (eptifibatide) Injection is (to our knowledge) the …
- Federal Circuit Reverses District Court Decision in Patent Delisting Counterclaim Case; All Orange Book Information is Not “Patent Information”April 15th, 2010
By Kurt R. Karst – Earlier this week, the U.S. Court of Appeals for the Federal Circuit issued its decision in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., No. 2010-1001, interpreting the patent delisting counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I), as added by …
- The Rarely Used Exception to the First Permitted Commercial Marketing/Use PTE CriterionApril 6th, 2010
By Kurt R. Karst – [We interrupt this blog posting to bring you some breaking news . . . . For those of you following the battle over generic COZAAR/HYZAAR 180-day exclusivity, we updated our April 5th post with information on a D.C. Circuit decision. …
- Generic COZAAR/HYZAAR 180-Day Exclusivity – Teva Wins, FDA Too (Despite Itself) in the DC District Court; Appeals AboundApril 5th, 2010
By Kurt R. Karst – When we last blogged on the issue of 180-day exclusivity for generic versions of Merck & Co., Inc.’s blockbuster drugs COZAAR (losartan potassium) Tablets and HYZAAR (hydrochlorothiazide; losartan potassium) Tablets, FDA had issued an 8-page decision concluding that Teva …
- Mass Forfeiture of 180-Day Exclusivity!April 1st, 2010
By Kurt R. Karst – FDA’s recently posted approval letter for Orchid Healthcare’s (“Orchid’s”) ANDA No. 78-357 for a generic version of Schering-Plough Corp.’s (“Schering’s”) blockbuster drug CLARINEX (desloratadine) Tablets, 5 mg, reads like any run-of-the-mill ANDA approval letter; however, it’s what is not said …
- FDA Rules Against Patent Expiration 180-Day Exclusivity Forfeiture for Generic COZAAR/HYZAAR, But in Doing So FDA Repudiates Its Own Decision and Asks to be SuedMarch 29th, 2010
By Kurt R. Karst – Late last Friday, FDA teed up the next battle over 180-day exclusivity for generic versions of Merck & Co., Inc.’s blockbuster drugs COZAAR (losartan potassium) Tablets and HYZAAR (hydrochlorothiazide; losartan potassium) Tablets when the Agency issued its 8-page decision …
- Here We Go Again! MDCO Launches Another Lawsuit Against the PTO Over ANGIOMAX PTEMarch 26th, 2010
By Kurt R. Karst – Earlier today, The Medicines Company (“MDCO”) announced that the company filed a new Administrative Procedure Act (“APA”) lawsuit in the U.S. District Court for the Eastern District of Virginia (Alexandria Division) challenging the Patent and Trademark Office’s (“PTO”) March 19, 2010 …
- PTO Once Again Denies PTE for ANGIOMAX Patent . . . But Not Before Issuing an Interim Extension; MDCO is OutragedMarch 22nd, 2010
By Kurt R. Karst – Just days after Judge Claude M. Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) issued his opinion and order vacating the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for …
- Court Orders and Declares that Teva Has Not Forfeited 180-Day Exclusivity for generic COZAAR/HYZAARMarch 17th, 2010
By Kurt R. Karst – It has been quite a wild ride since a 3-judge panel of the D.C. Circuit issued its March 2, 2010 opinion ruling that FDA’s interpretation of the 180-day exclusivity forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) fails at Chevron step one …
- PTO’s ANGIOMAX PTE Denial is Vacated and the Case Goes Back to PTO – What Happens in the Interim?March 17th, 2010
By Kurt R. Karst – In a March 16, 2010 opinion and order, Judge Claude M. Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) vacated the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for U.S. …