DCT

1:17-cv-00282

BioDelivery Sciences Intl Inc v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00282, D. Del., 03/16/2017
  • Venue Allegations: Venue is based on Defendant Teva USA being incorporated in Delaware, conducting regular business in the state, and having previously utilized the district for litigation. Venue over Teva Ltd. is alleged based on its contacts and business conducted in the district, directly or through its U.S. subsidiary.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic buprenorphine/naloxone buccal film constitutes infringement of four patents related to transmucosal drug delivery technology.
  • Technical Context: The technology concerns bioerodable polymer films for delivering drugs through the mucosal tissues of the mouth, specifically for the maintenance treatment of opioid dependence.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff’s receipt of a Paragraph IV notice letter dated January 31, 2017, in which Defendant asserted that the patents-in-suit are invalid or would not be infringed by its proposed generic product. The asserted patents are listed in the U.S. Food and Drug Administration's "Orange Book" as covering Plaintiff's commercial product, Bunavail®. The complaint notes that two of the patents received patent term adjustments for delays during prosecution at the U.S. Patent and Trademark Office.

Case Timeline

Date Event
1996-10-18 U.S. Patent No. 7,579,019 Priority Date
2005-12-13 U.S. Patent No. 9,522,188 Priority Date
2006-07-21 U.S. Patent No. 8,147,866 Priority Date
2009-08-25 U.S. Patent No. 7,579,019 Issues
2011-08-18 U.S. Patent No. 8,703,177 Priority Date
2012-04-03 U.S. Patent No. 8,147,866 Issues
2014-04-22 U.S. Patent No. 8,703,177 Issues
2014-06-06 FDA approves Plaintiff's Bunavail® (NDA No. 205637)
2016-12-20 U.S. Patent No. 9,522,188 Issues
2017-01-31 Defendant sends Paragraph IV Notice Letter to Plaintiff
2017-03-16 Complaint Filed

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

U.S. Patent No. 7,579,019 - "Pharmaceutical Carrier Device Suitable for Delivery of Pharmaceutical Compounds to Mucosal Surfaces"

The Invention Explained

  • Problem Addressed: The patent’s background section describes the difficulty of topical drug delivery to mucosal surfaces, such as the inside of the mouth, because bodily fluids quickly wash away medication. It notes that prior solutions like gels had poor residence time, while tablets were often bulky and uncomfortable, and non-soluble films required painful removal. (’019 Patent, col. 1:22-34; col. 2:16-23).
  • The Patented Solution: The invention is a water-erodable, layered film designed for mucosal delivery. It consists of an adhesive layer to stick to the tissue and a backing layer to protect the film and guide drug delivery. This structure aims to provide a comfortable, long-lasting application that erodes away naturally over time, eliminating the need for removal. (’019 Patent, Abstract; col. 4:45-54).
  • Technical Importance: The invention sought to create a drug delivery vehicle that combined the adhesion and residence time of laminated films with the convenience and comfort of a fully dissolvable product. (’019 Patent, col. 3:30-42).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims, referencing a notice letter that challenges claims 1-7 (Compl. ¶¶23-24). Independent claim 1 is a method claim with the following essential elements:
    • A method for transmucosal delivery of a systemic pharmaceutical for achieving a fast onset of activity.
    • Adhering a bioerodable device to an oral mucosa surface with minimal foreign body sensation.
    • Directionally delivering the pharmaceutical to achieve a fast onset of activity.
    • The device has a residence time of less than or about 1 hour.
    • The device comprises a thin, flexible, adherent, and bioerodable polymeric film containing the pharmaceutical.
    • The device comprises soluble polymers selected based on dissolution rates to achieve the desired residence time and release profile.

U.S. Patent No. 8,147,866 - "Transmucosal Delivery Devices with Enhanced Uptake"

The Invention Explained

  • Problem Addressed: The patent identifies a need to improve the efficiency of transmucosal drug delivery. The rate and extent of drug absorption through mucosal tissue are highly dependent on the local pH, which can be influenced by saliva and other factors, leading to inconsistent uptake. (’866 Patent, col. 1:22-44).
  • The Patented Solution: The invention is a bioerodable mucoadhesive device that incorporates a "buffered environment." This feature is designed to control the pH at the point of contact with the mucosa, maintaining it within a specific range optimal for the absorption of a particular drug (e.g., buprenorphine). The device also includes a barrier layer to ensure the drug is delivered unidirectionally into the tissue. (’866 Patent, Abstract; col. 2:50-64). Figure 4A illustrates the layered structure designed for unidirectional delivery to the mucosa.
  • Technical Importance: This technology focuses on actively manipulating the chemical microenvironment at the delivery site to enhance drug permeability and ensure more consistent and efficient bioavailability. (’866 Patent, col. 2:45-54).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims, referencing a notice letter that challenges claims 1-12 (Compl. ¶¶34-35). Independent claim 1 is a method claim with the following essential elements:
    • A method for providing enhanced uptake of buprenorphine via direct transmucosal delivery.
    • Administering a mucoadhesive bioerodable drug delivery device to an oral mucosal surface.
    • The device has a bioerodable mucoadhesive layer containing buprenorphine within a polymeric diffusion environment.
    • The polymeric diffusion environment is a "buffered environment" with a pH between about 4 and about 6.
    • The device also has a barrier layer adjacent to the mucoadhesive layer to provide a "unidirectional gradient" for drug delivery.

U.S. Patent No. 8,703,177 - "Abuse-Resistant Mucoadhesive Devices for Delivery of Buprenorphine"

  • Patent Identification: U.S. Patent No. 8,703,177, "Abuse-Resistant Mucoadhesive Devices for Delivery of Buprenorphine," issued April 22, 2014 (Compl. ¶41).
  • Technology Synopsis: This patent describes an abuse-deterrent transmucosal film. It teaches a multi-layer device where the buprenorphine (agonist) layer and the naloxone (antagonist) backing layer are buffered to different pH levels. This differential pH is designed to maximize buprenorphine absorption during normal use while impeding naloxone absorption, but would allow for antagonist release if the product were dissolved for illicit use. (’177 Patent, Abstract; col. 2:5-23).
  • Asserted Claims: The complaint references a notice letter challenging claims 1-7 (Compl. ¶45).
  • Accused Features: Defendants' proposed "generic buprenorphine/naloxone buccal film" is accused of infringement (Compl. ¶¶43, 46).

U.S. Patent No. 9,522,188 - "Abuse Resistant Transmucosal Drug Delivery Device"

  • Patent Identification: U.S. Patent No. 9,522,188, "Abuse Resistant Transmucosal Drug Delivery Device," issued December 20, 2016 (Compl. ¶51).
  • Technology Synopsis: This patent relates to abuse-resistant drug delivery, describing a solid dosage form containing an abusable drug and an antagonist. The antagonist is associated with an "abuse-resistant matrix" that prevents its release and absorption during normal transmucosal use but would not prevent its release if the product were tampered with (e.g., dissolved for injection). (’188 Patent, Abstract).
  • Asserted Claims: The complaint references a notice letter challenging claims 1-4, 8, 9, and 11-21 (Compl. ¶56).
  • Accused Features: Defendants' proposed "generic buprenorphine/naloxone buccal film" is accused of infringement (Compl. ¶¶54, 57).

III. The Accused Instrumentality

Product Identification

Defendants' generic buprenorphine and naloxone buccal film, for which Abbreviated New Drug Application (ANDA) No. 209831 was filed with the FDA (Compl. ¶21).

Functionality and Market Context

The accused product is a generic version of Plaintiff's Bunavail®, a buccal film for the maintenance treatment of opioid dependence (Compl. ¶¶20-21). The complaint identifies two dosage strengths: 4.2 mg buprenorphine / 0.7 mg naloxone and 2.1 mg buprenorphine / 0.3 mg naloxone (Compl. ¶21). The product is designed to be applied to the mucosal surface inside the cheek, where it adheres and releases the active ingredients for absorption into the bloodstream (Compl. ¶1). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for analysis of infringement on a claim-by-claim basis. As is common in initial complaints filed under the Hatch-Waxman Act, the infringement theory is stated generally. Plaintiffs allege that Defendants' act of filing ANDA No. 209831, seeking approval to market their generic buprenorphine/naloxone buccal film prior to the expiration of the patents-in-suit, constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶24, 35, 46, 57). The complaint further alleges that the future commercial manufacture, use, or sale of the product as described in the ANDA would directly infringe one or more claims of each asserted patent (Compl. ¶¶24, 35, 46, 57). A detailed infringement analysis will depend on the specific formulation and performance characteristics of the accused generic product, which are detailed in the confidential ANDA submission and not public in the complaint.

  • Scope Questions: A central question for the ’019 Patent will be whether the accused product exhibits the functional properties of "fast onset of activity" and a "residence time of less than...1 hour" as claimed. For the ’866 Patent, a key dispute may be whether the term "buffered environment" requires the presence of explicit buffering agents or can be met by the inherent pH properties of the film's excipients.
  • Technical Questions: The infringement analysis for the ’866, ’177, and ’188 patents will raise the question of whether the accused product's formulation creates the specific pH-controlled environment required by the claims to enhance buprenorphine uptake and/or deter abuse. The complaint does not provide the technical details of the accused product's formulation or mechanism of action.

V. Key Claim Terms for Construction

  • The Term: "bioerodable device" (from ’019 Patent, Claim 1)

    • Context and Importance: The scope of this term defines the fundamental nature of the infringing article. Its construction is critical because it determines whether the claim covers a broad class of dissolving films or is limited to more specific structures disclosed in the patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification defines the related term "water-erodable" as meaning that the component "erodes in water-based media such as saliva, over time," which could support a broad reading covering any device that dissolves or wears away in the mouth (’019 Patent, col. 4:48-50).
      • Evidence for a Narrower Interpretation: The summary of the invention and preferred embodiments consistently describe the device as a "layered film disk" with distinct adhesive and backing layers, which could support an argument that "bioerodable device" should be construed as being limited to such a multi-layer configuration (’019 Patent, col. 4:51-54; FIG. 1).

  • The Term: "buffered environment" (from ’866 Patent, Claim 1)

    • Context and Importance: This term is the central inventive concept of the ’866 Patent. Its definition will determine whether infringement requires the inclusion of specific buffering agents or can be satisfied by the overall pH characteristics of the film upon application.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claims require the environment to have a pH within a specific range ("between about 4 and about 6"), which a plaintiff may argue is the operative definition, regardless of how that pH is achieved.
      • Evidence for a Narrower Interpretation: The detailed description explicitly lists conventional buffering agents like phosphates and citrates as components for creating the buffered environment, which a defendant may argue limits the scope of the term to formulations containing such agents (’866 Patent, col. 11:20-32).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement for all four patents. The basis for these allegations is that Defendants, with knowledge of the patents, will sell their generic product with instructions and labeling that will inevitably lead physicians to prescribe and patients to use the product in a manner that directly infringes the asserted claims (Compl. ¶¶26, 37, 48, 59). Contributory infringement is also alleged for the ’019 and ’188 patents on the basis that the accused film is a material part of the claimed methods and is not a staple article of commerce suitable for substantial noninfringing use (Compl. ¶¶27, 60).
  • Willful Infringement: The complaint does not include an explicit allegation of willful infringement.

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

  • A core issue will be one of technical functionality: Does the specific formulation of Teva's generic buccal film, as detailed in its ANDA, create the precise "buffered environment" with the specific pH ranges required by the ’866 and ’177 patents, or does it operate via a different, non-infringing mechanism?
  • A second key issue will be one of claim scope and validity: Given that the notice letters challenge the validity of the patents, the case will likely involve a dispute over whether the claims, if construed broadly enough to cover Teva's product, are invalid in light of prior art related to transmucosal films and drug formulations.
  • A third question will relate to performance equivalence: For the ’019 patent, the dispute may center on evidence from clinical or bioequivalence studies to determine if the accused generic product meets the claimed functional limitations of "fast onset of activity" and a specific "residence time."