DCT

2:18-cv-05293

Indivior Inc v. Par Pharmaceutical Inc

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-05293, D.N.J., 04/03/2018
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Endo’s regular and established place of business in Cranbury, New Jersey, and Plaintiff Aquestive’s principal place of business being within the district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application for a generic version of Suboxone® sublingual film constitutes an act of infringement of a patent related to uniform, rapid-dissolve drug delivery films.
  • Technical Context: The technology concerns orally dissolving films for drug delivery, a dosage form intended to improve patient compliance and dosing accuracy compared to traditional tablets.
  • Key Procedural History: The complaint notes that the parties are involved in other ongoing litigation in the same district, concerning the same Abbreviated New Drug Application but asserting different patents.

Case Timeline

Date Event
2001-10-12 ’305 Patent Priority Date
2010-08-30 FDA approves Plaintiffs' Suboxone® sublingual film
2018-04-03 U.S. Patent No. 9,931,305 issues
2018-04-03 Complaint filed

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

U.S. Patent No. 9,931,305 - "Uniform Films for Rapid Dissolve Dosage Form Incorporating Taste-Masking Compositions"

  • Patent Identification: U.S. Patent No. 9,931,305, “Uniform Films for Rapid Dissolve Dosage Form Incorporating Taste-Masking Compositions,” issued April 3, 2018.

The Invention Explained

  • Problem Addressed: The patent’s background section describes that prior art methods for creating drug-delivery films suffered from non-uniformity ('305 Patent, col. 2:31-35). During the conventional drying process, active particles would clump together, or "self-aggregate," preventing the creation of a film where the drug was evenly distributed. This made it impossible to ensure that individual doses cut from a larger film sheet would contain an accurate and consistent amount of the active ingredient, a critical requirement for regulatory approval ('305 Patent, col. 2:44-54).
  • The Patented Solution: The invention claims to solve this problem by providing compositions and manufacturing methods that create a "non-self-aggregating uniform heterogeneity" ('305 Patent, col. 9:10-24). The solution involves creating a viscous polymer matrix and using a controlled, rapid drying process—such as applying heat primarily to the bottom of the cast film—to "lock" the uniformly distributed active particles in place before they can aggregate ('305 Patent, col. 4:65-5:5). This process is designed to avoid the formation of a "skin" on the film's surface, which would otherwise trap moisture and lead to non-uniformity ('305 Patent, col. 3:52-67).
  • Technical Importance: This approach was designed to make film-based drug delivery systems commercially viable by enabling them to meet the stringent dosage uniformity standards required by regulatory agencies like the FDA ('305 Patent, col. 2:50-54).

Key Claims at a Glance

  • The complaint asserts independent claim 26.
  • The essential elements of Claim 26 include:
    • A drug delivery composition comprising a continuously cast film made from a flowable, water-soluble or water-swellable film-forming matrix containing a polymer and at least one active.
    • The matrix must have a viscosity sufficient to maintain "non-self-aggregating uniformity" of the active.
    • The composition includes a "particulate active substantially uniformly stationed in the matrix" and a taste-masking agent.
    • The particulate active has a particle size of 200 microns or less, and the matrix is capable of being continuously cast without losing substantial uniformity.
    • The uniformity of the final film is defined by a functional limitation: "substantially equally sized individual unit doses cut from the... film which do not vary by more than 10% of a desired amount of said at least one active."

III. The Accused Instrumentality

Product Identification

  • Defendants’ generic buprenorphine hydrochloride and naloxone hydrochloride sublingual film, as described in Abbreviated New Drug Application (“ANDA”) No. 205854 (Compl. ¶1, 38).

Functionality and Market Context

  • The complaint alleges that the accused product is a generic version of Plaintiffs’ Suboxone® sublingual film, which is used for the treatment of opioid dependence (Compl. ¶36, 39). The ANDA filing purports to contain data showing the bioequivalence of the Defendants’ generic product with the Plaintiffs’ branded product (Compl. ¶39). The complaint does not provide further technical details on the formulation or manufacturing process of the accused product itself.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges infringement of at least claim 26 of the ’305 Patent but does not provide a detailed mapping of accused product features to the specific limitations of the claim (Compl. ¶45). The infringement allegation is a conclusory statement made on "information and belief," which is common in ANDA litigation filed immediately upon patent issuance and before the plaintiff has access to the defendant's confidential ANDA materials through discovery. Therefore, a claim chart summary cannot be constructed from the complaint's text.

  • Identified Points of Contention:
    • Scope Questions: The case may present a dispute over the scope of "non-self-aggregating uniformity." While the claim provides a functional definition (less than 10% dosage variance), parties may dispute whether this property must be achieved through the specific bottom-up drying methods described in the specification or if any method that results in the claimed uniformity infringes. The definition of "continuously cast" may also be a point of contention, depending on the specifics of the Defendants' manufacturing process.
    • Technical Questions: A central technical question will be whether the Defendants' generic product, as produced by their specific manufacturing process, actually meets the structural and functional limitations of the asserted claims. This will require factual evidence, obtained through discovery, regarding the formulation of the Defendants' film matrix, its viscosity, the particle size of its active ingredient, its casting and drying methods, and, crucially, quantitative data on the dosage uniformity of the final, cut film strips.

V. Key Claim Terms for Construction

The Term: "non-self-aggregating uniformity"

  • Context and Importance: This term is central to the patent's purported inventive concept of overcoming the key failure of prior art films. The entire dispute over infringement will likely hinge on whether the accused generic product possesses this specific type of uniformity.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent defines the term as the ability to provide a "substantially reduced occurrence of... aggregation or conglomeration of components" ('305 Patent, col. 9:10-15). Claim 26 itself provides a quantitative, functional definition: dosage units that "do not vary by more than 10%," which could be argued to cover any film meeting that metric, regardless of the specific mechanism preventing aggregation.
    • Evidence for a Narrower Interpretation: A defendant may argue that the term should be limited by the mechanisms described in the specification as the cause of this uniformity. The patent repeatedly contrasts the invention with conventional top-down drying methods that cause a "skin" and a "ripple effect," and highlights controlled bottom-up drying as the solution ('305 Patent, col. 3:41-4:5). This could support an argument that "non-self-aggregating uniformity" is a property that results specifically from avoiding these prior art drying problems.

The Term: "continuously cast film"

  • Context and Importance: This term defines the manufacturing process that the accused product must practice to infringe. Practitioners may focus on this term because if the Defendants’ manufacturing process is not "continuous casting" as construed by the court, there can be no infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discloses that casting methods can include "reverse roll coating, gravure coating, immersion or dip coating, metering rod... slot die or extrusion coating," and others ('305 Patent, col. 27:6-14). This suggests the term is meant to be broad and not limited to a single specific technique.
    • Evidence for a Narrower Interpretation: The detailed description of the preferred embodiment focuses heavily on a reverse roll coating apparatus ('305 Patent, FIG. 6; col. 26:50-57). A defendant could potentially argue that specific statements made during patent prosecution or details of the described embodiments limit the term to a narrower set of processes than all those theoretically possible.

VI. Other Allegations

The complaint does not contain allegations of indirect or willful infringement.

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

  • A central issue will be evidentiary and factual: Does the Defendants’ generic film product, as detailed in their confidential ANDA, actually meet the quantitative uniformity requirement of claim 26—namely, that individual doses cut from a larger sheet do not vary in active ingredient content by more than 10%? The case will turn heavily on product testing and discovery into Defendants' manufacturing quality control data.
  • A key legal question will be one of claim scope: Can the term "non-self-aggregating uniformity," which the patent teaches is achieved through specific controlled-drying techniques that avoid surface "skinning," be construed to cover a product that achieves dosage uniformity through different manufacturing means? The outcome will depend on how the court defines this central inventive concept.