United States District Court, D. Delaware
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"). 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).
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.
FINDINGS OF FACT
Plaintiff Recro Gainesville LLC ("Recro") is a
Massachusetts limited liability company having its principal
place of business at 1300 Gould Dr., Gainesville, GA 30504.
Defendant Actavis Laboratories FL, Inc. ("Actavis")
is a Florida corporation having its principal place of
business at 2945 W. Corporate Lakes Blvd, Weston, FL.
court has subject matter jurisdiction, as well as personal
jurisdiction over all parties.
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).
Actavis asserted a defense of non-infringement of both the
'096 and '742 patent.
'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.
'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.
The Asserted Claims
'096 Patent, Claims 1, 4, and 5
1, 4, and 5 of the '096 patent read:
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.
composition according claim 1, wherein the pharmaceutically
active ingredient is hydrocodone bitartrate.
composition according to claim 4, wherein the hydrocodone
bitartrate is present in an amount of from 5 to 250 mg.
'742 Patent, Claims 1, 6, 13, 14, 16, and 19
1, 6, 13, 14, 16, and 19 of the '610 Patent read:
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
composition according to claim 1, wherein the subsequent
population comprises opiate-containing particles.
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
composition according to claim 1, wherein the first and
subsequent populations have different in vitro dissolution
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.
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.
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.
'742 and '096 patents have been listed in the Orange
Book in connection with Zohydro® ER capsules.
Actavis submitted ANDA No. 206952 to the FDA seeking approval
to market hydrocodone bitartrate extended-release capsules in