DCT

1:18-cv-00497

Indivior Uk Ltd v. Actavis

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00497, D. Del., 04/30/2018
  • Venue Allegations: Venue is alleged to be proper as Defendant is incorporated in the State of Delaware and conducts business in the district.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of Abbreviated New Drug Applications (“ANDAs”) to the FDA for a generic version of Suboxone® sublingual film constitutes an act of patent infringement.
  • Technical Context: The technology concerns formulations and manufacturing methods for rapidly dissolving oral films that provide uniform dosages of active pharmaceutical ingredients.
  • Key Procedural History: The patents-in-suit are listed in the FDA’s “Orange Book” as covering Plaintiffs’ Suboxone® sublingual film product. On March 8, 2018, Defendant sent Plaintiffs Paragraph IV Notification Letters advising that it had filed ANDAs seeking approval to market a generic version of the film and certifying that the patents-in-suit are invalid, unenforceable, or will not be infringed. This lawsuit, filed under the provisions of the Hatch-Waxman Act, followed.

Case Timeline

Date Event
2001-10-12 Earliest Priority Date for ’221 Patent
2001-10-12 Earliest Priority Date for ’305 Patent
2010-08-30 FDA approves Plaintiffs' New Drug Application for Suboxone® sublingual film
2018-01-02 ’221 Patent Issued
2018-03-08 Plaintiffs receive Defendant’s Paragraph IV Notification Letters
2018-04-03 ’305 Patent Issued
2018-04-30 Complaint Filing Date

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 the technical challenges of creating uniform, rapid-dissolving oral films for drug delivery. Key problems include the potential for non-uniform distribution of the active ingredient due to particle aggregation during conventional drying processes, which can lead to inaccurate dosing, as well as the unpleasant taste of many pharmaceutical agents. (’305 Patent, col. 1:56-col. 2:42).
  • The Patented Solution: The invention claims to solve these problems by providing a film in which the active pharmaceutical ingredients are contained within taste-masked or controlled-release coated particles. These particles are then uniformly distributed throughout a water-soluble polymer matrix. The patent also describes manufacturing processes, including wet casting and controlled drying, designed to maintain this uniformity and prevent particle aggregation. (’305 Patent, Abstract; col. 4:21-41).
  • Technical Importance: This approach enables the creation of a palatable oral dosage form that can be accurately dosed, which is particularly important for both patient compliance and meeting regulatory standards for dosage uniformity. (’305 Patent, col. 2:43-60).

Key Claims at a Glance

  • The complaint asserts at least independent claim 26. (Compl. ¶20).
  • The essential elements of claim 26 include:
    • A continuously cast film produced on a manufacturing line comprising a flowable water-soluble or water swellable film-forming matrix.
    • A particulate active substantially uniformly stationed in the matrix.
    • A taste-masking agent selected from flavors, sweeteners, flavor enhancers, and combinations thereof to provide taste-masking of the active.
    • The particulate active has a particle size of 200 microns or less.
    • The matrix is capable of being continuously cast without substantial loss of uniformity in the stationing of the particulate active.
    • The uniformity is measured by individual unit doses which do not vary by more than 10% of a desired amount of the active.
  • The complaint does not explicitly reserve the right to assert dependent claims but refers to "one or more claims." (Compl. ¶20).

U.S. Patent No. 9,855,221 B2 - Uniform Films for Rapid-Dissolve Dosage Form Incorporating Anti-Tacking Compositions

  • Patent Identification: U.S. Patent No. 9,855,221 B2, “Uniform Films for Rapid-Dissolve Dosage Form Incorporating Anti-Tacking Compositions,” issued January 2, 2018.

The Invention Explained

  • Problem Addressed: The patent identifies the problem of "tackiness" in edible films, where film strips may adhere to one another in packaging or to a user's mouth, making them difficult to handle and use. This problem can be exacerbated by components like flavors, plasticizers, and temperature or humidity changes. (’221 Patent, col. 4:13-43).
  • The Patented Solution: The invention addresses this by incorporating "anti-tacking agents" (such as lubricants, antiadherants, and glidants) into the film composition. These agents are intended to reduce the film's coefficient of friction and prevent adherence, thereby improving the ease of conversion, storage stability, and consumer use. (’221 Patent, Abstract; col. 3:44-col. 4:43; col. 4:67-col. 5:2).
  • Technical Importance: By improving the physical handling properties and stability of the film, this technology facilitates both large-scale manufacturing and packaging and enhances the end-user experience. (’221 Patent, col. 4:36-43).

Key Claims at a Glance

  • The complaint asserts at least independent claims 1 and 8. (Compl. ¶26).
  • The essential elements of independent claim 1 include:
    • A continuously cast film for delivery of an active in individual self-supporting oral unit doses.
    • An ingestible, water-soluble, polymer matrix.
    • At least one anti-tacking agent selected from a specific list of chemical classes (e.g., stearate, stearic acid, vegetable oil, wax, silica).
    • A substantially uniform distribution of the active, locked-in within the polymer matrix.
    • The uniformity is measured by unit doses not varying by more than 10% of the desired amount of active.
  • The essential elements of independent claim 8 are similar to claim 1 but recite a more specific polymer matrix (e.g., cellulose, PEO, pullulan) and a slightly different list of anti-tacking agents.
  • The complaint refers to "one or more claims," suggesting the possibility that dependent claims may also be asserted. (Compl. ¶26).

III. The Accused Instrumentality

Product Identification

  • The accused product is Defendant Actavis’s generic sublingual film containing buprenorphine hydrochloride and naloxone hydrochloride. (Compl. ¶¶1, 17, 19).

Functionality and Market Context

  • The complaint alleges that Actavis's ANDA submissions seek approval to manufacture and sell a generic version of Plaintiffs' Suboxone® sublingual film. (Compl. ¶1). The ANDAs purport to contain data showing the bioequivalence of Actavis's generic product with Suboxone®. (Compl. ¶17). Suboxone® is a product for the treatment of opioid dependence. (Compl. ¶13).
  • The complaint alleges that the '305 and '221 patents are listed in the FDA's Orange Book as covering the Suboxone® sublingual film, thereby putting potential generic manufacturers on notice. (Compl. ¶¶14-15).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or sufficient technical detail to map specific features of the accused generic product to the elements of the asserted claims. The infringement allegation is predicated on the Defendant's submission of ANDAs for a product that is asserted to be bioequivalent to Plaintiffs' Orange Book-listed Suboxone® sublingual film. (Compl. ¶¶16-17). The core of the infringement theory is that a generic product that is bioequivalent to Suboxone® will necessarily contain the elements recited in the asserted claims of the patents covering that product. (Compl. ¶¶20, 26).

  • Identified Points of Contention:
    • For the ’305 Patent, a central question may be whether the excipients used in the Actavis formulation meet the definition of a "taste-masking agent" as recited in claim 26.
    • For the ’221 Patent, a key issue may be whether any component of the Actavis generic film functions as an "anti-tacking agent" and falls within the scope of the specific chemical groups listed in independent claims 1 and 8.
    • For both patents, a technical question may arise as to whether the Actavis product, as manufactured, achieves a "substantially uniform distribution" of the active ingredient such that dosage units "do not vary by more than 10%," as required by the claims. The evidence for this could involve analysis of Actavis’s manufacturing process and testing of its final product.

V. Key Claim Terms for Construction

  • The Term: "anti-tacking agent" (’221 Patent, claims 1, 8)

  • Context and Importance: This term is central to the invention of the ’221 Patent. The definition will determine whether any of the excipients in the Defendant’s formulation fall within the claim scope. Practitioners may focus on whether the term is limited to the explicit list provided in the claims or could be interpreted more functionally.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes anti-tacking agents by their function, stating they "assist in the flow characteristics of the material" and "impart reduced film-to-film coefficient of friction." (’221 Patent, col. 19:28-44). This functional language may support an argument that the term covers any agent performing that role.
    • Evidence for a Narrower Interpretation: Claims 1 and 8 use the transitional phrase "selected from the group consisting of," followed by a specific Markush group of chemical classes. This language may support a narrower construction, limiting the claim to only those agents explicitly listed. The specification also provides specific examples, such as Vitamin E TPGS and SIPERNAT 500LS silica. (’221 Patent, col. 19:66-col. 20:25).

  • The Term: "taste-masking agent" (’305 Patent, claim 26)

  • Context and Importance: This term defines a key component of the claimed composition in the ’305 Patent. The dispute may turn on whether the components in the accused product that address the drug's taste qualify as a "taste-masking agent" under the patent's definition.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: Claim 26 defines the agent functionally as being "selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof to provide taste-masking of the active." This broad functional definition could be argued to encompass a wide range of excipients that affect the product's taste profile.
    • Evidence for a Narrower Interpretation: The specification focuses heavily on the concept of "taste-masked or controlled-release coated particles." (’305 Patent, Abstract; col. 4:21-24). A party could argue that the term should be interpreted in light of these specific embodiments, suggesting that a "taste-masking agent" is not merely a flavor or sweetener mixed into the matrix, but rather a component specifically associated with the active particulate, such as a coating.

VI. Other Allegations

  • Indirect Infringement: The complaint is an action for statutory infringement under 35 U.S.C. § 271(e)(2) based on the ANDA submission. (Compl. ¶¶21, 27). The prayer for relief also requests an injunction against inducing infringement, but the complaint does not allege specific facts supporting a claim of inducement, such as instructions on a product label. (Compl. Prayer for Relief ¶E).

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

  • A core issue will be one of definitional scope: How will the court construe the functional terms "anti-tacking agent" (’221 Patent) and "taste-masking agent" (’305 Patent)? The outcome may depend on whether the specific excipients used in Actavis's generic formulation are found to fall within the patent's definitions, particularly given the specific chemical lists in the ’221 patent claims.
  • A key evidentiary question will be one of compositional and process equivalence: Given that the lawsuit was triggered by a bioequivalence certification, discovery will likely focus on the precise formulation and manufacturing process of the Actavis generic. This will be necessary to determine if it meets the quantitative "10% variance" uniformity limitation and includes components that function as the claimed anti-tacking or taste-masking agents.
  • A central legal and factual question will be whether the product claims, which are tied to the "continuously cast film" manufacturing method and resulting uniformity, can be read upon a bioequivalent product that may be produced by a different process. The case may explore the boundary between product claims and product-by-process limitations.