DCT

2:17-cv-07115

Indivior Inc v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-07115, D.N.J., 09/14/2017
  • Venue Allegations: Venue is alleged to be proper based on Defendant's systematic and continuous business contacts within the District of New Jersey, including being registered to do business, maintaining a registered agent, holding state licenses, employing personnel, and deriving revenue from sales within the state.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of a New Drug Application to the FDA for a generic version of Plaintiff's Suboxone® sublingual film constitutes an act of infringement of a patent related to abuse-deterrent oral film compositions.
  • Technical Context: The technology concerns pharmaceutical formulations for treating opioid dependence, specifically using a sublingual film designed to deliver active ingredients with a specific absorption profile that discourages parenteral abuse.
  • Key Procedural History: This is a Hatch-Waxman action initiated in response to Defendant’s regulatory filing seeking approval for a generic drug. The asserted patent is listed in the FDA's "Orange Book" as covering Plaintiff's Suboxone® product. A subsequent Inter Partes Review proceeding (IPR2019-00329), concluded after this complaint was filed, resulted in the cancellation of claims 1-5, 7, and 9-14 of the patent-in-suit, with only dependent claim 8 found patentable.

Case Timeline

Date Event
2009-08-07 '454 Patent Earliest Priority Date
2010-08-30 FDA approval of Plaintiff's Suboxone® sublingual film
2017-06-27 '454 Patent Issue Date
2017-09-14 Complaint Filing Date
2018-11-13 IPR (IPR2019-00329) against '454 Patent Filed
2022-09-30 IPR Certificate Issued, cancelling claims 1-5, 7, & 9-14

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

U.S. Patent No. 9,687,454 - "Sublingual and Buccal Film Compositions"

  • Issued: June 27, 2017

The Invention Explained

  • Problem Addressed: The patent addresses the potential for abuse of combination-drug tablets used for treating narcotic dependence, such as those containing buprenorphine (an agonist) and naloxone (an antagonist). The background section notes that a patient could store a tablet in their mouth without swallowing, and later extract the agonist for abuse by injection ('454 Patent, col. 2:1-6).
  • The Patented Solution: The invention is a self-supporting, orally dissolvable film designed to be difficult to remove from the mouth once administered due to its mucoadhesive properties ('454 Patent, col. 2:15-18). The core of the solution is the use of a buffer to control the local pH of the film. This controlled pH is engineered to achieve two distinct goals simultaneously: optimize the sublingual absorption of the buprenorphine agonist, while inhibiting the absorption of the naloxone antagonist, which is intended to pass into the digestive system where it is rendered ineffective ('454 Patent, col. 2:28-36). This design aims to deliver the intended therapy while the presence of the antagonist deters abuse.
  • Technical Importance: The claimed formulation provides a delivery system for combination opioid-addiction therapy that is designed to be more abuse-deterrent than prior orally ingestible tablet forms ('454 Patent, col. 2:7-11).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" but does not identify any specific claims (Compl. ¶17). Independent claim 1 is foundational to the patent.
  • The essential elements of Independent Claim 1 include:
    • An oral, self-supporting, mucoadhesive film
    • Comprising "about 40 wt % to about 60 wt % of a water-soluble polymeric matrix"
    • Comprising "about 2 mg to about 16 mg of buprenorphine"
    • Comprising "about 0.5 mg to about 4 mg of naloxone"
    • Comprising "an acidic buffer"
    • Wherein the weight ratio of buprenorphine to naloxone is about 4:1
    • Wherein the weight ratio of the buffer to buprenorphine is from 2:1 to 1:5
    • Wherein application of the film results in a specific, detailed pharmacokinetic profile (Cmax and AUC values) for both buprenorphine and naloxone.
  • The complaint does not explicitly reserve the right to assert dependent claims, but this is standard practice.

III. The Accused Instrumentality

Product Identification

  • Defendant's generic buprenorphine hydrochloride and naloxone hydrochloride sublingual film, for which Defendant filed New Drug Application (NDA) No. 208042 with the FDA (Compl. ¶¶1, 15).

Functionality and Market Context

  • The complaint alleges that the accused product is a generic version of Plaintiff's Suboxone® sublingual film and that its NDA refers to and relies on Plaintiff's own NDA for Suboxone® (Compl. ¶¶1, 16).
  • The NDA filing purports to contain data showing the bioequivalence of the accused generic product with Suboxone® (Compl. ¶16).
  • The complaint does not provide further technical details regarding the composition or specific functionality of the accused product, as these details would be contained within the confidential NDA.

IV. Analysis of Infringement Allegations

The complaint provides only a conclusory allegation of infringement and does not include a claim chart or specific factual allegations mapping the features of the accused product to the elements of any asserted claim (Compl. ¶17). Therefore, a claim chart summary cannot be constructed from the complaint.

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Scope Questions: The infringement analysis will likely focus on whether the specific formulation detailed in Defendant's confidential NDA meets the quantitative limitations of the asserted claims. Questions will arise as to whether the accused product's composition falls within the claimed weight percentage ranges for the polymeric matrix (e.g., "about 40 wt % to about 60 wt %") and the precise dosages for the active ingredients.
    • Technical Questions: A central technical question will be whether the accused product, when administered, results in the specific pharmacokinetic (PK) profile recited in the final limitation of Claim 1. Proving that the accused product achieves the claimed Cmax and AUC ranges for both buprenorphine and naloxone will be a significant evidentiary matter for the Plaintiff.

V. Key Claim Terms for Construction

  • The Term: "mucoadhesive"

    • Context and Importance: This property is central to the patent's stated goal of abuse deterrence by making the film difficult to remove once administered. Practitioners may focus on this term because the required degree of adhesion is not quantitatively defined, creating a potential area for dispute over whether the accused product is sufficiently "sticky" to meet the claim limitation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the desire to provide a dosage that "cannot be easily removed from the mouth" ('454 Patent, col. 2:9-11), which could support a functional definition based on ease of removal rather than a specific scientific metric.
      • Evidence for a Narrower Interpretation: The patent links "moderate dissolving films" with a "good level of mucoadhesion" ('454 Patent, col. 4:31-32). A party could argue this ties the term "mucoadhesive" to particular polymer types or dissolution rates described in the specification.

  • The Term: "acidic buffer"

    • Context and Importance: The buffer is the mechanism for achieving the claimed differential absorption of the two active ingredients. The dispute will likely center on what chemical systems meet the definition and whether the accused product's excipients function as a "buffer" in the manner required by the claims.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent discloses examples such as "sodium citrate, citric acid, and combinations thereof" ('454 Patent, col. 13:40-42), which could support construing the term to cover a range of acidic buffering agents.
      • Evidence for a Narrower Interpretation: The specification also refers to a "buffering system" with a "buffer capacity sufficient to maintain the ionization of naloxone" ('454 Patent, col. 2:41-46). A party could argue this language requires a more complex system with a specific, measurable capacity, potentially narrowing the term's scope beyond just the presence of an acid.

  • The Term: "about"

    • Context and Importance: This term is used repeatedly in Claim 1 to qualify numerical ranges for weight percentages and dosages. Its interpretation is critical for determining whether a product that is numerically close to, but not exactly at, a claimed range limit still infringes.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: In patent law, "about" is generally understood to account for normal measurement variability. Plaintiff would likely argue for this standard interpretation.
      • Evidence for a Narrower Interpretation: The specification provides numerous examples with precise figures (e.g., Table 1, col. 15-16). A party could argue that in a "predictable art" like chemistry, and in view of the detailed examples, "about" should be interpreted very narrowly.

VI. Other Allegations

  • Indirect Infringement: The complaint seeks to enjoin Defendant from "inducing and/or encouraging the use of methods, claimed in the patent-in-suit" (Compl. p. 6, ¶C). The alleged basis for this is the act of filing an NDA to market a drug whose FDA-approved label will inevitably instruct users to perform an infringing use.
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, it does request a judgment that this is an "exceptional case" under 35 U.S.C. § 285 and an award of attorneys' fees (Compl. p. 6, ¶E).

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

  • A core issue will be one of procedural viability and claim scope: Given that a post-filing Inter Partes Review cancelled all independent claims and most dependent claims, the case's survival hinges on whether the accused product can be proven to infringe the single surviving dependent claim 8. This raises the question of whether the accused product meets not only the broad limitations of the original base claim but also the specific narrowing limitations incorporated into claim 8.
  • A key evidentiary question will be one of functional performance: Can the plaintiff demonstrate, using data from the defendant's confidential NDA and any subsequent testing, that the accused generic film produces the specific, multi-part pharmacokinetic profile (i.e., the Cmax and AUC ranges for both active ingredients) recited in the lengthy functional limitation of claim 1, which is a prerequisite for infringing the surviving claim 8?