Marshall Division, Eastern District of Texas

July 2

  • Shire LLC vs. Apotex Inc. et al

    Plaintiff Shire LLC claims to own the rights to New Drug Application No. 20-712 which was approved by the Food and Drug Administration for the manufacture and sale of an extended-release capsule containing carbamazepine for the treatment of epilepsy and trigeminal neuralgia.

    According to the original complaint, Apotex Inc. submitted an Abbreviated New Drug Application No. 78-86 seeking approval to manufacture, use and sell Carbamazepine Extended Release Capsules in 100 mg, 200 mg and 300 mg doses.

    Apotex sent Shire a "Notification of Certification for U.S. Patent Nos. 5,326,570 and 5,12,013 on May 19 regarding its ANDA products.

    When Shire received the notice letter, it then requested materials from ANDA No. 78-86 and capsules form each lot of the Apotex batches.

    "To date, Shire has not received any such materials and capsules," the complaint states.

    The '570 Patent, for an Advanced Drug Delivery System and Method of Treating Psychiatric, Neurological and Other Disorders with Carbamazepine. The patent was issued July 5, 1994, to Pharmavene Inc. assigned by inventors Edward M. Rudnic and George W. Belendiuk.

    Pharmavene merged into Shire Laboratories and Shire became the owner of the '570 Patent for a drug delivery system for the oral administration of carbanazepine.

    Shire claims that Apotex then applied for certification to manufacture, use, import or sell its ANDA products. In its notice letter, Apotex stated that its ANDA products did not infringe the '570 Patent.

    But Shire claims it has not received enough information from Apotex regarding the ANDA products to "evaluate, confirm or test the correctness" of Apotex's statement that Shire's '570 Patent was not being infringed. But, upon information and belief, Shire alleges that Apotex's commercial manufacture, use and sales of ANDA will infringe the '570 Patent.

    Moreover, the submission of ANDA No. 78-986 to the FDA was itself an act of infringement.

    Another count of the suit alleges infringement of U.S. Patent No. 5,912,013 for an Advanced Drug Delivery System and Method of Treating Psychiatric, Neurological and Other Disorders with Carbamazepine issued June 15, 1999, to Shire. It was assigned to Shire by inventors Edward M. Rudnic, George Belendiuk, John McCarty, Sandra Wassink and Richard Couch.

    The second count repeats the same allegations outlined in count one, which dealt with the '570 Patent.

    Shire is asking the court for a permanent injunction to stop the manufacture and distribution of products in ANDA No. 78-986 until the expiration of the last of the '570 and '013 Patents. In addition, Shire is seeking monetary relief, attorneys' fees, costs and other just and proper relief.

    Richard A. Sayles of Sayles Werbner in Dallas is representing the plaintiff. Attorneys from Frommer Lawrence & Haug LLP in New York, N.Y., are of counsel.

    The case has been assigned to U.S. District Judge David Folsom.

    Case No. 2:08-cv-265-DF

    Tyler Division, Eastern District of Texas

    July 9

  • Konami Digital Entertainment Co. et al vs. Harmonix Music Sytems Inc et al

    Plaintiffs Konami Digital Entertainment Co. Ltd., a Japanese corporation, and Konami Digital Entertainment Inc., and Illinois corporation, claim to own the rights to U.S. Patent No. 6,390,923 issued May 21, 2002, for a Music Playing Game Apparatus, Performance Guiding Image Display Method and Readable Storage Medium Storing Performance Guiding Image Forming Program.

    Konami alleges that defendants Harmonix Music Systems Inc, MTV Networks Co. and Viacom Inc. infring the '923 Patent. Infringing acts include but are not limited to the manufacture, use and sale of the "Rock Band" video game.

    Konami also claims to own the rights to U.S. Patent No. 6,425,822 issued July 30, 2002, for a Music Game Machine with Selectable Controller Inputs. In addition, the rights to U.S. Patent No. 6,645,067 issued Nov. 11, 2003, for an invention called a Music Staging Device Apparatus, Music Staging Game Method and Readable Storage Medium.

    Defendants also are infringing the '822 Patent and '067 Patent through the "Rock Band" video game, the plaintiff alleges.

    The infringements, Konami claims, are causing irreparable harm for which there is no adequate remedy at law unless enjoined by the court. Konami is seeking a permanent injunction, compensatory damages and interest.

    In addition, the plaintiff claims the infringement was willful and deliberate, which entitles Konami to increased damages, attorneys' fees and costs.

    Otis Carroll of Ireland, Carroll & Kelley PC in Tyler is attorney-in-charge for the plaintiff, with attorneys from Paul, Hastings, Janofsky & Walker LLP in Palo Alto, Calif.

    Court assignment is pending.

    Case No. 6:08-cv-286

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