DCT

5:18-cv-00514

Aquestive Therap Inc v. BioDelivery Sciences Intl Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 5:18-cv-00514, D.N.J., 01/13/2017
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant transacts business, sells the accused product, and has marketing representatives in the district. The complaint further notes that Defendant has previously consented to jurisdiction in the district in prior litigation.
  • Core Dispute: Plaintiff alleges that Defendant’s BELBUCA® (buprenorphine) buccal film product infringes a patent related to the formulation and manufacture of uniform, rapidly dissolving oral films.
  • Technical Context: The technology concerns pharmaceutical drug delivery via dissolvable oral films, which are presented as an alternative to conventional tablets or pills, particularly for achieving accurate dosing.
  • Key Procedural History: The complaint alleges a significant litigation history between the parties over the patent-in-suit. Plaintiff previously sued Defendant in 2014 for infringement of the same patent by a different product (Bunavail™). Subsequently, Defendant unsuccessfully petitioned for inter partes review (IPR) of the patent, with the Patent Trial and Appeal Board (PTAB) declining to institute proceedings in 2015. Plaintiff alleges this history establishes Defendant’s willful infringement and subjects Defendant to a statutory bar against future IPR challenges on the asserted claims.

Case Timeline

Date Event
2001-10-12 '167 Patent Priority Date
2014-07-01 '167 Patent Issue Date
2014-10-13 Defendant receives actual notice of '167 Patent in prior litigation
2014-10-28 Defendant files IPR petitions challenging the '167 Patent
2015-05-20 PTAB denies institution of Defendant's IPR petitions
2015-10-23 FDA approves Defendant's accused BELBUCA product
2017-01-13 Complaint Filing Date

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

U.S. Patent No. 8,765,167 - Uniform Films for Rapid-dissolve Dosage Form Incorporating Anti-tacking Compositions (Issued July 1, 2014)

The Invention Explained

  • Problem Addressed: The patent describes shortcomings in conventional oral films used for drug delivery. Prior art manufacturing processes allegedly led to the "aggregation or conglomeration of particles," resulting in non-uniform films where the active ingredient was unevenly distributed ('167 Patent, col. 2:21-26). This non-uniformity makes accurate and repeatable dosing difficult, a critical failure for pharmaceutical products ('167 Patent, col. 2:10-20). Additionally, conventional drying methods could damage heat-sensitive ingredients, and the resulting films often suffered from tackiness, complicating packaging and use ('167 Patent, col. 2:54-58; col. 4:1-6).
  • The Patented Solution: The invention discloses an oral film composition and a method for making it that ensures a "substantially uniform distribution" of the active component. This is achieved by using specific polymer combinations and, critically, a "controlled drying process" which "rapidly forms a viscoelastic matrix to lock-in said active in place" ('167 Patent, Abstract; col. 6:20-27). This process, which may involve applying heat to the bottom of the film rather than the top, prevents the formation of a surface "skin" that traps moisture and promotes particle aggregation ('167 Patent, col. 6:30-44). The invention also incorporates anti-tacking agents to reduce stickiness and improve handling ('167 Patent, Abstract).
  • Technical Importance: This technology aims to overcome key manufacturing hurdles that previously limited the viability of oral films as a reliable drug delivery platform, enabling the production of films with consistent, accurate dosages ('167 Patent, col. 2:10-20).

Key Claims at a Glance

  • The complaint identifies independent claim 95 as exemplary and asserts numerous claims, including independent claims 13 and 109 (Compl. ¶¶17, 28).
  • The essential elements of independent claim 95 are:
    • An oral film for delivering an active component.
    • An ingestible, water-soluble polymer matrix comprising a polymer from a specific group (hydroxyethylcellulose, hydroxypropylcellulose, carboxymethyl cellulose).
    • At least one anti-tacking agent comprising sodium benzoate.
    • A substantially uniform distribution of the active component within the matrix.
    • The film is formed by a "controlled drying process" that rapidly forms a viscoelastic matrix to lock in the active component.
    • The film is self-supporting and the uniform distribution is defined by unit doses not varying by more than 10% from the desired amount of the active component.
  • The complaint asserts a large number of dependent claims and reserves the right to assert others (Compl. ¶28).

III. The Accused Instrumentality

Product Identification

  • BELBUCA® (buprenorphine) buccal film (Compl. ¶2).

Functionality and Market Context

  • BELBUCA is described as a pharmaceutical product for the "transmucosal delivery of buprenorphine hydrochloride," an opioid analgesic (Compl. ¶¶21, 23).
  • The complaint provides a list of BELBUCA's ingredients, which includes carboxymethylcellulose sodium, hydroxyethylcellulose, hydroxypropylcellulose, and sodium benzoate (Compl. ¶23). These ingredients correspond directly to polymer and anti-tacking agent limitations in asserted claim 95.
  • The complaint alleges the product is commercially significant, stating Defendant has received at least $125 million to develop and market it (Compl. ¶26).
  • The complaint includes Table 6, which details the specific film sizes for various dosage strengths of BELBUCA, ranging from 75 mcg to 900 mcg (Compl. ¶22). This table provides visual evidence linking specific product configurations to dosage amounts.

IV. Analysis of Infringement Allegations

'167 Patent Infringement Allegations

Claim Element (from Independent Claim 95) Alleged Infringing Functionality Complaint Citation Patent Citation
An oral film for delivery of a desired amount of an active component comprising: an ingestible, water-soluble polymer matrix comprising a polymer selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose and carboxymethyl cellulose and combinations thereof; BELBUCA is a buccal film whose listed ingredients include hydroxyethylcellulose, hydroxypropylcellulose, and carboxymethylcellulose sodium. ¶¶21, 23 col. 12:41-43
at least one anti-tacking agent comprising sodium benzoate; BELBUCA’s list of ingredients includes sodium benzoate NF. ¶23 col. 19:25
a substantially uniform distribution of said desired amount of said active component within said polymer matrix, wherein said active component is selected from the group consisting of... pharmaceutical agents... BELBUCA’s active ingredient is buprenorphine hydrochloride, a pharmaceutical agent. As a regulated drug product sold in multiple dosage strengths, it is alleged to have a uniform distribution of this agent. ¶¶20, 23 col. 15:29-33
said film being formed by a controlled drying process which rapidly forms a viscoelastic matrix to lock-in said active in place within said matrix and maintain said substantially uniform distribution; The complaint does not specify Defendant's manufacturing process but alleges infringement of the claim requiring this process. ¶¶17, 28 col. 6:20-27
wherein said film is self-supporting and the active component is substantially uniformly distributed, whereby said substantially uniform distribution is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said active component. The complaint alleges that BELBUCA is a pharmaceutical product that meets this definition of uniformity, which aligns with regulatory standards for dosage consistency. ¶¶17, 22 col. 2:15-20

Identified Points of Contention

  • Technical Questions: A central technical question will be whether the accused BELBUCA product is manufactured using a "controlled drying process" as claimed. The complaint provides no specific factual allegations regarding Defendant's manufacturing methods, suggesting this will be a primary focus of discovery. The plaintiff will need to obtain evidence to prove that the undisclosed process meets the claim limitations, either literally or under the doctrine of equivalents.
  • Evidentiary Questions: While the claim defines "substantially uniform distribution" with a 10% variance metric, the parties may dispute the evidence required to prove this element is met. The analysis may depend on whether meeting final-product regulatory standards for dose uniformity is sufficient, or if Plaintiff must also show a particular microscopic distribution of particles within the film matrix.

V. Key Claim Terms for Construction

  • The Term: "controlled drying process"

  • Context and Importance: The infringement analysis for the product-by-process limitations in the claims hinges entirely on the meaning of this term. Its construction will determine what types of manufacturing methods fall within the patent's scope.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the objective of the process as avoiding the "rippling" effect and preventing the formation of a top "skin" before the film's interior is dry (col. 6:30-44). A party may argue the term should be construed functionally to cover any drying method that achieves this result, such as bottom-up heating, controlled microwave drying, or balanced air flow, all of which are mentioned as possibilities (col. 6:20-50).
    • Evidence for a Narrower Interpretation: The specification provides specific examples, including the apparatus disclosed in U.S. Pat. No. 4,631,837 (Magoon) and the nozzle arrangement in Figure 7, which both emphasize applying heat to the bottom of the film (col. 6:22-25; col. 11:36-41). A party may argue that the term should be limited to processes embodying this specific principle of bottom-up drying, rather than any process that achieves a uniform result.

  • The Term: "substantially uniform distribution"

  • Context and Importance: This term is critical for defining the quality of the final film product. While Claim 95 provides its own lexicography ("not vary by more than 10%"), its practical application and relationship to the patent's teachings on avoiding particle aggregation will be a likely point of dispute.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim itself provides a clear, quantitative metric (10% variance), which mirrors the regulatory standard discussed in the specification (col. 2:15-20). A party could argue that if the final product meets this objective test, it satisfies the limitation, regardless of the micro-level particle arrangement.
    • Evidence for a Narrower Interpretation: The patent's background extensively criticizes prior art for causing "aggregation or conglomeration of particles" (col. 2:60-62). A party could argue that "substantially uniform" requires more than passing a final dosage test; it implies a physical state of non-aggregation within the film matrix, linking the term to the problem the invention claims to solve.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced and contributory infringement in a separate count (Compl. ¶¶35-37). The factual basis for inducement rests on the allegation that Defendant knowingly encourages others to use BELBUCA in an infringing manner, though specific facts demonstrating intent to induce, beyond knowledge of the patent, are not detailed (Compl. ¶36).
  • Willful Infringement: The complaint alleges willful infringement based on Defendant’s long-standing knowledge of the '167 patent (Compl. ¶33). The specific facts cited are Defendant’s receipt of service in a prior lawsuit involving the same patent in October 2014 and Defendant's subsequent, unsuccessful IPR petitions, which were denied in May 2015, predating the FDA approval and launch of BELBUCA (Compl. ¶¶4-5, 32).

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

  • A core issue will be one of process verification: can Plaintiff produce evidence through discovery to demonstrate that Defendant's proprietary and undisclosed method for manufacturing BELBUCA falls within the scope of the patent's "controlled drying process" claims? The outcome of the infringement analysis for key claims will likely depend on the answer.
  • A second key question will be the strategic impact of the prior IPR history: to what extent will the PTAB's 2015 refusal to institute IPR on the '167 patent influence the current litigation? While not preclusive on the issue of validity in district court, it may be presented by Plaintiff as evidence of the patent's strength and a cornerstone of its willfulness argument.
  • Finally, the case may turn on a question of definitional scope: does the term "substantially uniform distribution," as defined in the patent, simply require meeting a final-product dosage-variance test, or does it impose a stricter requirement on the physical non-aggregation of particles within the film matrix itself?