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Indivior Inc. v. Actavis Laboratories UT, Inc.

United States District Court, D. Delaware

May 14, 2019

INDIVIOR INC., INDIVIOR UK LIMITED, and AQUESTTVE THERAPEUTICS, INC., Plaintiffs,
v.
ACTAVIS LABORATORIES UT, INC., Defendant.

          Jack B. Blumenfeld and Jeremy A. Tigan, MORRIS, NICHOLS, ARSHT & TUNNEL LLP, Wilmington, DE; Jeffrey B. Elikan (argued), Erica Andersen (argued), Philip S. May, Jeffrey H. Lerner, R. Jason Fowler, and Ashley M. Kwon, COVINGTON & BURLING LLP, Washington, D.C., attorneys for Plaintiffs.

          John C. Phillips, Jr. and Megan C. Haney, PHILLIPS, GOLDMAN, MCLAUGHLIN & HALL, P.A., Wilmington, DE; Michael Nutter, WINSTON & STRAWN LLP, Chicago, IL; Stephen R. Smerek (argued) and David P. Dalke, WINSTON & STRAWN LLP, Los Angeles, CA, attorneys for Defendant.

          MEMORANDUM OPINION

          ANDREWS, U.S. DISTRICT JUDGE

         Presently before the Court is the issue of claim construction of multiple terms in U.S. Patent Nos. 9, 931, 305 and 9, 687, 454. The Court has considered the Parties' Joint Claim Construction Brief. (D.I. 46). The Court heard oral argument on March 6, 2019. (D.I. 53).

         I. BACKGROUND

         On April 3, 2018, Indivior Inc., Indivior UK Limited, and Aquestive Therapeutics, Inc. (collectively, "Plaintiffs") filed suit against Actavis Laboratories UT, Inc. ("Defendant") alleging infringement of U.S. Patent Nos. 9, 931, 305 ("the '305 patent") and 9, 687, 454 ("the '454 patent"). (D.I. 1, 6). The '454 patent concerns "self-supporting dosage forms which provide an active agent for treating narcotic dependence while providing sufficient buccal adhesion of the dosage form." ('454 patent, abstract). The '305 patent concerns "rapid dissolve thin film drug delivery compositions for the oral administration of active components." ('305 patent, abstract).

         The parties dispute a term in claims 1 and 26 of the '305 patent. Claim 1 is representative and reads as follows:

1. A drug delivery composition for making individual unit doses in a self-supporting film-dosage form, which individual unit doses cut from a self-supporting continuously cast film contain a desired amount of at least one active, said composition comprising:
(i) said self-supporting continuously cast film having said active substantially uniformly stationed therein, said self-supporting continuously cast film formed from a flowable water-soluble or water swellable film-forming matrix comprising a polymer selected from the group consisting of cellulose, a cellulose derivative, polyethylene oxide (PEO), pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, polysaccharides, sodium alginate, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, and combinations thereof;
wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of said active substantially locked-in the matrix; and
(ii) a taste-masking agent selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof to provide taste-masking of said active; wherein said active has a particle size of 200 microns or less; and wherein the uniformity of the self-supporting continuously cast film is measured by substantially equally sized individual unit doses cut from a self-supporting continuously cast film which do not vary by more than 10%, of said desired amount of said at least one active.

         ('305 patent, cl. 1) (disputed term italicized).

         The parties also dispute terms in claim 1 of the '454 patent. Claim 1 reads as follows:

1. An oral, self-supporting, mucoadhesive film comprising:
(a) about 40 wt% to about 60 wt% of a water-soluble polymeric matrix;
(b) about 2 mg to about 16 mg of buprenorphine or a pharmaceutically acceptable salt thereof;
(c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically acceptable salt thereof; and
(d) an acidic buffer;
wherein the film is mucoadhesive to the sublingual mucosa or the ...

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