DCT

1:16-cv-01009

Indivior Inc v. Actavis Laboratories Ut Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:16-cv-01009, D. Del., 10/31/2016
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware based on Defendant’s incorporation in Delaware.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Suboxone® sublingual film constitutes an act of infringement of three patents related to pharmaceutical film compositions.
  • Technical Context: The technology involves orally dissolvable films for delivering buprenorphine and naloxone, a combination therapy used for the maintenance treatment of opioid dependence.
  • Key Procedural History: The complaint details significant prior litigation between the same parties over the same patents and ANDA product (C.A. 1:13-cv-01674-RGA). In that earlier case, the U.S. District Court for the District of Delaware issued a trial opinion finding asserted claims of U.S. Patent No. 8,603,514 valid and infringed by all dosage strengths of Defendant’s proposed generic product. The current action arises from a subsequent Paragraph IV certification notice letter from the Defendant specifically addressing the 4 mg/1 mg dosage strength.

Case Timeline

Date Event
2001-10-12 ’514 Patent Priority Date
2002-04-11 ’150 Patent Priority Date
2009-08-07 ’832 Patent Priority Date
2010-08-30 FDA approves Suboxone sublingual film
2011-09-13 ’150 Patent Issue Date
2013-07-02 ’832 Patent Issue Date
2013-08-27 Plaintiffs receive first Paragraph IV notice from Watson re: ANDA No. 204383
2013-10-08 Plaintiffs file initial complaint in prior litigation (1:13-cv-01674-RGA)
2013-12-10 ’514 Patent Issue Date
2014-02-04 Plaintiffs receive second Paragraph IV notice re: '514 Patent
2015-11-01 Trial commences in prior litigation (approximate date)
2016-06-03 Trial opinion issued in prior litigation finding infringement of '514 Patent
2016-09-16 Plaintiffs receive new Paragraph IV notice from Actavis re: 4 mg/1 mg strength
2016-10-31 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,475,832 - Sublingual and Buccal Film Compositions

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of co-administering two therapeutic agents where one (an agonist for treating narcotic dependence) should be absorbed orally, while the other (an antagonist to prevent abuse) should remain substantially unabsorbed until it reaches the stomach (U.S. Patent No. 8,475,832, col. 1:19-31). It also notes the abuse potential of tablet forms, which can be stored in the mouth and later extracted for injection (U.S. Patent No. 8,475,832, col. 1:56-62).
  • The Patented Solution: The invention is a self-supporting oral film containing both the agonist (buprenorphine) and the antagonist (naloxone). The film includes a buffer system designed to create a specific local pH (e.g., 3.5) when placed in the mouth. This controlled pH is claimed to optimize the absorption of the buprenorphine through the oral mucosa while simultaneously inhibiting the absorption of the naloxone, which is then swallowed (’832 Patent, col. 2:5-14).
  • Technical Importance: This pH-control mechanism in a film format provided a potential method to deliver a bioequivalent therapy to existing tablets while possibly reducing the risk of parenteral abuse (’832 Patent, col. 2:1-4).

Key Claims at a Glance

  • The complaint asserts "one or more claims" without specifying which ones (Compl. ¶47). Claim 1 is a representative independent claim.
  • The essential elements of Claim 1 include:
    • A film dosage composition comprising a polymeric carrier matrix;
    • A therapeutically effective amount of buprenorphine or a pharmaceutically acceptable salt thereof;
    • A therapeutically effective amount of naloxone or a pharmaceutically acceptable salt thereof; and
    • A buffer in an amount to provide a local pH for the composition of from about 3 to about 3.5 in the presence of saliva.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 8,017,150 - Polyethylene Oxide-Based Films and Drug Delivery Systems Made Therefrom

The Invention Explained

  • Problem Addressed: The patent's background describes how conventional methods of making drug-delivery films often fail to produce uniform products. Particle aggregation and non-uniform drying processes (which can create a "ripple effect") lead to inconsistent and inaccurate dosing, a critical failure for pharmaceutical products (’150 Patent, col. 2:15-51).
  • The Patented Solution: The invention claims a film with "a non-self-aggregating uniform heterogeneity" of its components (’150 Patent, Abstract). This is achieved by using a specific polymer component, which includes polyethylene oxide (PEO) blended with hydrophilic cellulosic polymers, in combination with a controlled drying process that avoids forming a "skin" on the film's surface, thereby allowing moisture to escape uniformly (’150 Patent, col. 3:41-4:4).
  • Technical Importance: The invention provided a method to manufacture homogenous, rapidly dissolving oral films that could deliver a precise and consistent dose of a pharmaceutical agent, addressing a key manufacturing challenge for this dosage form (’150 Patent, col. 2:31-44).

Key Claims at a Glance

  • The complaint asserts "one or more claims" without specifying them (Compl. ¶51). Claim 1 is a representative independent claim.
  • The essential elements of Claim 1 include:
    • A mucosally-adhesive water-soluble film product comprising an analgesic opiate pharmaceutical active;
    • At least one water-soluble polymer component including polyethylene oxide in combination with a hydrophilic cellulosic polymer;
    • Wherein the polymer component includes greater than 75% polyethylene oxide and up to 25% hydrophilic cellulosic polymer;
    • Wherein the polyethylene oxide includes specific low and high molecular weight variants within defined ranges; and
    • Wherein the low molecular weight polyethylene oxide is about 60% or more of the polymer component.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 8,603,514 - Uniform Films for Rapid Dissolve Dosage Form Incorporating Taste-Masking Compositions

Technology Synopsis

This patent addresses the challenge of incorporating active ingredients with unpleasant tastes into a rapidly dissolving film (U.S. Patent No. 8,603,514, col. 2:45-50). The solution involves coating particles of the active pharmaceutical ingredient with a taste-masking agent and then uniformly distributing these coated particles throughout the film matrix, which is formed by wet casting or extrusion (’514 Patent, Abstract).

Asserted Claims

The complaint asserts "one or more claims" (Compl. ¶55). However, it also notes that in prior litigation involving the same parties and product, claims 62, 64, 65, 69, and 73 of the ’514 Patent were found to be valid and infringed (Compl. ¶38, 56).

Accused Features

The Defendant's generic sublingual film product as described in ANDA No. 204383 is accused of being covered by one or more claims of the patent (Compl. ¶55).

III. The Accused Instrumentality

Product Identification

Defendant Actavis’s proposed generic version of the 4 mg/1 mg dosage strength of Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride) sublingual film (Compl. ¶1, 42).

Functionality and Market Context

The accused product is the subject of Abbreviated New Drug Application (ANDA) No. 204383, which seeks FDA approval for commercial manufacture and sale (Compl. ¶1, 43). As a generic drug, it is intended for the same therapeutic use as the branded product—the maintenance treatment of opioid dependence (Compl. ¶14). The ANDA filing relies on the NDA for the branded Suboxone® film and purports to contain data demonstrating bioequivalence between the generic and branded products (Compl. ¶43).
No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or provide a detailed narrative of its infringement theory. Instead, it makes conclusory allegations that Defendant's product is "covered by one or more claims" of each of the Patents-in-Suit (Compl. ¶47, 51, 55). The act of infringement alleged is the statutory act of filing ANDA No. 204383 seeking approval to market the generic drug prior to the expiration of the patents, pursuant to 35 U.S.C. § 271(e)(2) (Compl. ¶48, 52, 57). Because no specific factual allegations mapping the features of the accused product to the elements of any asserted patent claim are provided, a claim chart summary cannot be constructed from the complaint.

  • Identified Points of Contention:
    • Scope Questions: A central issue for the ’832 Patent will be whether the specific excipients in Actavis's formulation constitute a "buffer" as claimed, and whether that formulation creates a "local pH of from about 3 to about 3.5" in the presence of saliva. For the ’150 Patent, a key question may be whether the term "non-self-aggregating uniform heterogeneity," which is defined in the patent by reference to the results of a specific manufacturing process, reads on a product whose own manufacturing process is not detailed in the complaint.
    • Technical Questions: For the ’150 Patent, the dispute will likely involve detailed chemical analysis to determine if the polymer blend in Actavis's film meets the specific molecular weight ranges and component ratios required by the claims. For the ’514 Patent, a technical question will be whether the formulation of the generic film results in a uniform distribution of taste-masked active ingredients as claimed, an issue that was previously litigated and decided in Plaintiffs' favor (Compl. ¶37).

V. Key Claim Terms for Construction

  • The Term: "buffer" (from Claim 1 of the '832 Patent)

    • Context and Importance: The inclusion of a "buffer" to control local pH is a central element of the asserted claims of the ’832 Patent. The definition of this term will be critical to determining whether the excipients used in the Defendant's generic formulation, regardless of their primary purpose (e.g., as fillers or stabilizers), perform the claimed buffering function within the specified pH range.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claims themselves do not limit the buffer to any specific chemical composition, which may support a functional definition covering any substance that provides the claimed pH effect (’832 Patent, col. 12:1-4).
      • Evidence for a Narrower Interpretation: The specification provides specific examples of suitable buffers, such as "sodium citrate, citric acid, and combinations thereof" (’832 Patent, col. 13:9-10). A defendant may argue that the term should be construed as limited to these or structurally similar acidic buffers.

  • The Term: "non-self-aggregating uniform heterogeneity" (from the '150 Patent)

    • Context and Importance: This phrase appears to be a term of the patentee's own lexicography and is used to distinguish the claimed invention from prior art films that allegedly suffered from particle clumping and non-uniformity. The entire infringement analysis for the ’150 Patent could depend on whether the Defendant's film exhibits this claimed property.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification defines the term functionally as the "substantial absence of aggregates or conglomerates as is common in conventional mixing and heat drying methods" (’150 Patent, col. 6:38-42), suggesting the term could cover any film that achieves this result, regardless of the specific manufacturing method.
      • Evidence for a Narrower Interpretation: The patent extensively describes a controlled, rapid drying process as the means to achieve this uniformity (’150 Patent, col. 4:12-19). A defendant may argue that the term is inextricably linked to this disclosed process and does not cover films that achieve uniformity through other means.

VI. Other Allegations

  • Indirect Infringement: The complaint does not contain counts for indirect infringement (inducement or contributory infringement). The infringement allegations are based on the statutory act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶¶ 46-58).
  • Willful Infringement: The complaint does not allege willful infringement.

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central legal question will be the preclusive effect of prior litigation: To what extent does the previous judgment that Defendant’s ANDA product infringes the ’514 Patent (C.A. 1:13-cv-01674-RGA) prevent re-litigation of infringement and validity issues for that specific patent in this new case?
  • A key technical question will be one of compositional scope: For the ’832 and ’150 Patents, which were not adjudicated to be infringed in the prior trial opinion, the dispute will likely focus on whether the precise chemical formulation of Actavis’s generic film—including its polymer types, molecular weights, component ratios, and excipients—falls within the scope of the patent claims as construed by the court.