Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Recro Gainesville, LLC v. Actavis Laboratories FL, Inc.

United States District Court, D. Delaware

February 24, 2017

RECRO GAINESVILLE LLC, Plaintiff,
v.
ACTAVIS LABORATORIES FL, INC., Defendant.

          MEMORANDUM

         I. INTRODUCTION

         In this patent infringement action, Plaintiff Recro Gainesville LLC ("Recro") alleges infringement by Actavis Laboratories FL, Inc. of U.S. Patent No. 9, 132, 096 ("the '096 patent") and U.S. Patent No. 6, 902, 742 ("the '742 patent").[1] The court held a three-day bench trial in this matter on October 3, 4 and 7 of 2016. (D.I. 133-135). Presently before the court are the parties' post-trial proposed findings of fact and conclusions of law concerning infringement of the patents-in-suit. (D.I. 125, 126).

         Pursuant to Federal Rule of Civil Procedure 52(a), and after having considered the entire record in this case and the applicable law, the court concludes that: (1) Actavis' proposed AND A products infringe all of the asserted claims of the '096 patent; and (2) Actavis' proposed ANDA products infringe all of the asserted claims of the '742 patent. These findings of fact and conclusions of law .are set forth in further detail below.

         II. FINDINGS OF FACT[2]

         A. The Parties

         1. Plaintiff Recro Gainesville LLC ("Recro") is a Massachusetts limited liability company having its principal place of business at 1300 Gould Dr., Gainesville, GA 30504.

         2. Defendant Actavis Laboratories FL, Inc. ("Actavis") is a Florida corporation having its principal place of business at 2945 W. Corporate Lakes Blvd, Weston, FL.

         3. The court has subject matter jurisdiction, as well as personal jurisdiction over all parties.

         B. Background

         4. Recro has alleged infringement of U.S. Patent Nos. 6, 902, 742 ("the '742 patent") and 9, 132, 096 ("the '096 patent") against Actavis under 35 U.S.C. § 271(e)(2)(A).

         5. Actavis asserted a defense of non-infringement of both the '096 and '742 patent.

         C. The Patents-in-Suit

         6. The '742 patent, entitled "Multiparticulate Modified Release Composition, " issued on June 7, 2005, to Dr. Devane, Dr. Stark, Mr. Fanning, and Dr. Rekhi as named inventors. The face of the '742 patent claims priority to U.S. Patent Application No. 60/106, 726, filed on November 2, 1998. According to the Orange Book, the expiration date of the '742 patent is November 1, 2019.

         7. The '096 patent, entitled "Abuse Resistant Pharmaceutical Compositions, " issued on September 15, 2015, naming Dr. Rekhi and Dr. Richard Sidwell as inventors. The face of the '096 patent claims priority to September 12, 2014. According to the Orange Book, the expiration date of the '096 patent is September 12, 2034.

         1. The Asserted Claims

         a. '096 Patent, Claims 1, 4, and 5

         Claim 1, 4, and 5 of the '096 patent read:

         1. An oral pharmaceutical composition comprising a first population of beads and a second population of beads; said first bead population comprising a pharmaceutically active ingredient selected from the group consisting of hydrocodone and pharmaceutically acceptable salts thereof, wherein said first bead population is substantially free of polyethylene oxide; and said second bead population comprising polyethylene oxide and a permeable or semi-permeable coating selected from the group consisting of an ammonio methacrylate copolymer, a methacrylic acid copolymer and a mixture thereof, wherein said second bead population is substantially free of any pharmaceutically active ingredient.

         4. The composition according claim 1, wherein the pharmaceutically active ingredient is hydrocodone bitartrate.

         5. The composition according to claim 4, wherein the hydrocodone bitartrate is present in an amount of from 5 to 250 mg.

         b. '742 Patent, Claims 1, 6, 13, 14, 16, and 19

         Claims 1, 6, 13, 14, 16, and 19 of the '610 Patent read:

         1. A multiparticulate modified release composition comprising a first population of active ingredient-containing particles and at least one subsequent population of active ingredient-containing particles, the active ingredient contained in the first population being an opiate and the active ingredient in the subsequent population being an opiate or non-opiate, wherein the subsequent population of active ingredient-containing particles further comprise a modified release coating or, alternatively or additionally, a modified release matrix material, such that the composition following oral delivery to a subject delivers the active ingredients of the first and subsequent populations in a pulsatile manner.

         6. The composition according to claim 1, wherein the subsequent population comprises opiate-containing particles.

         13. The composition according to claim 6, wherein at least one of the active ingredients of the first and subsequent populations comprises hydrocodone or a pharmaceutically acceptable salt thereof, an enantiomer or mixtures thereof, or mixtures thereof.

         14. The composition according to claim 1, wherein the first and subsequent populations have different in vitro dissolution profiles.

         16. The composition according to claim 15, which in operation releases substantially all of the active ingredient from the first population prior to release of the active ingredient from the subsequent population.

         19. The composition according to claim 16, wherein the mean in vitro dissolution profile in an aqueous medium is such that substantially all of the active ingredient of the first population is released within about two hours.

         D. Zohydro® ER

         8. Zohydro® ER extended-release capsules contain hydrocodone bitartrate and are indicated "for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate." Recro licenses the '742 and '096 patents to Pernix Therapeutics Holdings, Inc. ("Pernix") and Pernix markets and sells Zohydro® ER capsules in the United States.

         9. The '742 and '096 patents have been listed in the Orange Book in connection with Zohydro® ER capsules.

         E. Actavis' ANDA

         10. Actavis submitted ANDA No. 206952 to the FDA seeking approval to market hydrocodone bitartrate extended-release capsules in ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.