Orange Book Blog

At the intersection of Patent and FDA Law

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Category: Declaratory Judgment Jurisdiction

  • Federal Circuit Affirms Dismissal of Prasco’s Declaratory Judgment Suit Against Medicis

    Prasco v. Medicis Pharm. Corp., No. 2007-1524 (Fed. Cir. 2008) Medicis markets a benzoyl peroxide cleansing product, Triaz.  Prasco sells a competing benzoyl peroxide cleansing product, Oscion.  Prasco filed a declaratory judgment complaint, requesting judgment that Oscion does not infringe four patents owned or licensed by Medicis.  Prasco alleged declaratory judgment jurisdiction based on three facts:  (1) Medicis marked its…

  • Federal Circuit Vacates Dismissal of Delaratory Judgment Counterclaims in Fosamax Case as Moot

    Merck & Co. v. Apotex, No. 2007-1362 (Fed. Cir. 2008) Fosamax (alendronate sodium) is one of the all-time best-selling drugs for the treatment and prevention of osteoporosis, with over $3 billion in U.S. sales last year.  Merck listed ten patents in the Orange Book for Fosamax:  U.S. Patent No. 4,621,077, which claims a method of inhibiting bone resorption…

  • Mutual Pharmaceutical Jumps the Gun By Sending Paragraph IV Notice Letter Before Acceptance of ANDA

    GlaxoSmithKline v. Mutual Pharm., No. 08-549 (E.D. Pa. 2008) The U.S. District Court for the Eastern District of Pennsylvania recently granted a motion for judgment on the pleadings in a paragraph IV case because the ANDA filer sent its notice letter prematurely, before FDA had accepted the ANDA for filing.  The case concerns Mutual Pharmaceutical’s generic version of…

  • Federal Circuit Refuses to Rehear Caraco v. Forest

    We previously reported that on April 1, in a 2-1 decision in Caraco v. Forest, the Federal Circuit held that an ANDA applicant may in some circumstances bring a declaratory judgment action for noninfringement even if the patentee has granted the applicant a covenant not to sue.  Today, the Federal Circuit denied Forest's petition for rehearing or…

  • OBB News Briefs

    The Federal Trade Commission announced the release of its FY 2007 Summary of Pharmaceutical Company Settlement Agreements.  For commentary, see FDA Law Blog, Pharmalot. Wyeth sued Sandoz over a generic version of Protonix I.V.  The WSJ Health Blog recapped all the Protonix ANDA litigation. India's drugmakers recently threatened to stop production of 33 bulk drugs, Pharmalot…

  • District Court Dismisses Impax’s Declaratory Judgment Complaint in ANDA Case Against Medicis

    Impax Labs. v. Medicis Pharm., No. C-08-0253 MMC (N.D. Cal. 2008) Last Wednesday, the U.S. District Court for the Northern District of California dismissed a declaratory judgment complaint filed by Impax against Medicis, ruling that the court lacks jurisdiction because there is no case or controversy between the parties.  The decision is interesting because it…

  • Federal Circuit Finds Declaratory Judgment Jurisdiction Despite Covenant Not to Sue

    Caraco Pharm. Labs. v. Forest Labs., No. 2007-1404 (Fed. Cir. 2008) In a 2-1 decision, the Federal Circuit held today that an ANDA applicant’s declaratory judgment action for noninfringement meets Article III’s "case or controversy" requirement notwithstanding that the patentee has granted the applicant a covenant not to sue.  Today’s decision will likely bring a…

  • Dismissal of Invalidity Counterclaims Thwarts Apotex’s Attempt to Trigger 180-Day Exclusivity on Cosopt

    Merck v. Apotex, No. 06-5789 (D.N.J. 2007) Merck has sold Cosopt (dorzolamide hydrochloride/timolol maleate), an opthalmic drug indicated for the treatment of ocular hypertension and open-angle glaucoma, since 1998.  In October 2005, Hi-Tech Pharmacal filed the first ANDA for a generic version of Cosopt with paragraph IV certifications to the Orange Book-listed patents: U.S. Patent…

  • District Court Explains Dismissal of Merck v. Apotex Fosamax Suit

    Merck & Co. v. Apotex, No. 06-230 (D. Del. 2007) Last month (as we reported then), the U.S. District Court for the District of Delaware granted Merck’s motion to dismiss the patent suit Merck filed against Apotex concerning generic Fosamax.  The court indicated at the time that an opinion would "follow at the court’s earliest…

  • District Court Dismisses Merck’s Fosamax Suit Against Apotex, Despite Apotex’s Opposition

    Merck & Co. v. Apotex, No. 06-230 (D. Del. 2007) A year ago, Merck sued Apotex alleging that Apotex’s ANDA for generic Fosamax infringed nine patents on pharmaceutical formulations of alendronate, the active ingredient in Fosamax.  Apotex answered with counterclaims of patent invalidity and noninfringement.  Then, after Merck reviewed portions of Apotex’s ANDA, Merck granted…