By Kurt R. Karst – Last fall, we reported on a decision from Judge Richard E. L. Strauss of the Superior Court of California, County of San Diego, in which he granted motions for summary judgment ruling that Bayer AG and several generic drug …
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- CIPRO Patent Settlement Case is Appealed to the California Court of AppealMay 20th, 2010
- Losartan – D.C. Circuit Denies FDA’s Petition for Panel Rehearing and Rehearing en banc; Roxane/Apotex Case ContinuesMay 18th, 2010
By Kurt R. Karst – Late on May 17th, the U.S. Court of Appeals for the District of Columbia Circuit denied, in separate orders (here and here), FDA’s petition for panel rehearing and rehearing en banc of the D.C. Circuit’s March 2, 2010 decision in Teva …
- Outstanding Pre-FDAAA Citizen Petition Causes FDA to Rule Against 180-Day Exclusivity Forfeiture for Generic SKELAXINMay 14th, 2010
By Kurt R. Karst – FDA’s recent decision to approve Sandoz Inc.’s (“Sandoz’s”) ANDA No. 40-445 for a generic version of King Pharmaceuticals, Inc.’s (“King’s”) SKELAXIN (metaxalone) Tablets, 800 mg, with a period of 180-day exclusivity is one of the few cases in which …
- Blown 30-Month ANDA Tentative Approval and Approval Dates – A Growing Industry Concern; Is Litigation in the Works?May 11th, 2010
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 …
- 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 …