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Indivior Inc. v. Mylan Technologies Inc.

United States District Court, D. Delaware

March 22, 2018

INDIVIOR INC., INDIVIOR UK LIMITED, and MONOSOL RX, LLC Plaintiffs;
v.
MYLAN TECHNOLOGIES INC., MYLAN PHARMACEUTICALS INC. and MYLAN N.V., Defendants. RECKITT BENCKISER PHARMACEUTICALS INC., RB PHARMACEUTICALS LIMITED, and MONOSOL RX, LLC Plaintiffs;
v.
ALVOGEN PINE BROOK INC. Defendant.

          Mary W. Bourke, Dana K. Severance, Daniel M. Attaway, WOMBLE BOND DICKINSON (US) LLP, Wilmington, DE; Daniel A. Ladow, James P. Bollinger, Timothy P. Heaton, J. Magnus Essunger, Sujatha Vathyam, Katherine Harihar, TROUTMAN SANDERS LLP, New York, NY; Charanjit Brahma, Craig Crockett, TROUTMAN SANDERS LLP, San Francisco, CA; Daniel Sharpe, TROUTMAN SANDERS LLP, Washington, DC; Jeffrey B. Elikan, Jeffrey H. Lerner, Erica N. Anderson, R. Jason Fowler, Nicholas F. Lenning, COVINGTON & BURLING LLP, Washington, DC; James F. Hibey, STEPTOE & JOHNSON LLP, Washington, DC; Cassandra A. Adams, STEPTOE & JOHNSON LLP, New York, NY. Attorneys for Plaintiffs.

          Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP, Wilmington, DE; Steven H. Sklar, Gregory C. Bays, David M. Airan, J. Karl Gross, Nicole E. Kopinski, LEYDIG, VOIT & MAYER, LTD., Chicago, IL. Attorneys for Defendant.

          MEMORANDUM OPINION

          ANDREWS, U.S. DISTRICT JUDGE.

         Plaintiffs brought separate patent infringement actions against Mylan Technologies Inc., Mylan Pharmaceuticals Inc., and Mylan N.V., and Alvogen Pine Brook Inc., in 2015. (No. 15-0477-RGA, D.I. 1, D.I. 48; No. 15-1016-RGA, D.I. 1, D.I. 66).[1] The two cases were consolidated. (D.I. 140). On September 26, 2017, Plaintiffs and the Mylan Defendants entered into a Settlement Agreement, leaving Alvogen as the sole remaining defendant. (D.I. 242).

         Alvogen filed Abbreviated New Drug Application ("ANDA") No. 205954, seeking approval for a generic version of the 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg dosage strengths of Plaintiffs' Suboxone® sublingual film. (D.I. 211-1 at 5-6). Suboxone® sublingual film is indicated for maintenance treatment of opioid dependence. (Id. at 2). Since its FDA approval for certain dosage strengths in 2010, Suboxone® sublingual film has been exclusively manufactured in the United States by Plaintiff MonoSol and exclusively sold in the United States by Plaintiff Indivior Inc.[2] (Id.). Approval of additional dosage strengths followed in 2012. (Id.).

         At issue in this case is the process for drying the sublingual film.

         The Court held a bench trial September 26-27, 2017. Plaintiffs assert that Alvogen's ANDA submission constitutes infringement of claim 24 of U.S. Patent No. 8, 900, 497 ("the '497 patent"), and claims 62, 63, 65, 69, 71, and 73 of U.S. Patent No. 8, 603, 514 ("the '514 patent). (Trial Transcript ("Tr.") 9:24-10:4; D.I. 235 at 1-2).[3], [4] Alvogen does not argue that the asserted claims are invalid. (Tr. 5:4-15).

         Independent claim 1 of the '497 patent reads as follows:

1. A process for making a film having a substantially uniform distribution of components, comprising the steps of:
(a) forming a flowable polymer matrix comprising an edible polymer, a solvent and a desired amount of at least one active, said matrix having a substantially uniform distribution of said at least one active;
(b) casting said flowable polymer matrix;
(c) rapidly evaporating at least a portion of said solvent upon initiation of drying to form a visco-elastic film within about the first 4.0 minutes to maintain said substantially uniform distribution of said at least one active by locking-in or substantially preventing migration of said at least one active within said visco-elastic film:
(d) further drying said visco-elastic film to form a self-supporting edible film having a substantially uniform distribution of said at least one active component; and wherein said substantially uniform distribution of said at least one active component is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active.

(emphasis added). Dependent claim 24 of the '497 patent covers, "The process of claim 1, wherein said active is in the form of a particle."

         Independent claim 62 and dependent claims 63, 65, 69, 71, and 73 of the '514 patent read as follows:

62. A drug delivery composition comprising:
(i) a cast film comprising a flowable water-soluble or water swellable film-forming matrix comprising one or more substantially water soluble or water swellable polymers; and a desired amount of at least one active; wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the active in the matrix;
(ii) a particulate active substantially uniformly stationed in the matrix; and
(iii) a taste-masking agent selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof to provide taste-masking of the active; wherein the particulate active has a particle size of 200 microns or less and said flowable water-soluble or water swellable film-forming matrix is capable of being dried without loss of substantial uniformity in the stationing of said particulate active therein; and wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active.
63. The drug delivery composition of claim 62, wherein the particulate active has a particle size of 150 microns or less.
65. The drug delivery composition of claim 62, wherein said variation of drug content is less than 5% by weight per film dosage unit.
69. The drug delivery composition of claim 62, wherein said taste-masking agent is present in the amount of about 0.1-30% by weight of the drug delivery composition.
71. The drug delivery composition of claim 62, wherein said active is selected from the group consisting of antimicrobial agents, non-steroidal antiinflammatory drugs, anti-tussives, decongestants, antihistamines, expectorants, anti-diarrheals, Fh antagonists, proton pump inhibitors, general non-selective CNS depressants, general non-selective CNS stimulants, selective CNS functional modifiers, anti-parkinsonism drugs, narcotics, analgesics, erectile dysfunction therapies, anti-pyretics, psychopharmacological drugs and combinations thereof.
73. The drug delivery composition of claim 62, wherein said active is an opiate or opiate derivative.

(emphasis added).

         I. LEGAL STANDARD

         A patent is infringed when a person "without authority makes, uses, offers to sell, or sells any patented invention, within the United States ... during the term of the patent. ..." 35 U.S.C. § 271(a). A two-step analysis is employed in making an infringement determination. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). First, the court must construe the asserted claims to ascertain their meaning and scope. See Id. The trier of fact must then compare the properly construed claims with the accused infringing product. See Id. This second step is a question of fact. Bai v. L & L Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998). "Literal infringement of a claim exists when every limitation recited in the claim is found in the accused device." Kahn v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir. 1998). "If any claim limitation is absent from the accused device, there is no literal infringement as a matter of law." Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000). The patent owner has the burden of proving infringement by a preponderance of the evidence. See SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988).

         For jurisdictional purposes, 35 U.S.C. § 271(e)(2)(A) defines filing an ANDA application for a drug covered by a patent as an act of infringement. 35 U.S.C. § 271(e)(2)(A); see also Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997) ("[Section] 271(e)(2) provided patentees with a defined act of infringement sufficient to create case or controversy jurisdiction to enable a court to promptly resolve any dispute concerning infringement and validity.").

         II. INFRINGEMENT OF THE '514 AND '497 PATENTS

         A. Findings of Fact

         1. Alvogen's proposed commercial manufacturing process for its ANDA product (hereinafter, "ANDA process") is designed to avoid the "rippling effect." 2. There is insufficient evidence for me to conclude that Alvogen's ANDA process uses unconventional drying.

         3. The extent of bottom drying employed by Alvogen is conventional.

         4. Drag bars used in Alvogen's ANDA process do not substantially dry films from the bottom, alone or in conjunction with any other bottom heat sources.

         5. Contact between the web and lower plenum of the oven in Alvogen's ANDA process does not substantially dry films from the bottom, alone or in conjunction with any other bottom heat sources.

         6. Air flow underneath the web in Alvogen's ANDA process does not substantially dry films from the bottom, alone or in conjunction with any other bottom heat sources.

         7. There exist two plausible explanations for films produced using Alvogen's exhibit batch process and commercial process having equal moisture contents.

         8. Alvogen does not infringe the "drying" limitation of the '497 patent or the "dried" limitation of the ' 514 patent.

         9. Dr. Prud'homme's testimony that a viscoelastic solid results after about four minutes of drying is given little weight.

         10. Dr. Fassihi's visual evidence demonstrating that Alvogen's mix remains a liquid after four ...


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