DCT

1:17-cv-00118

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-00118, D. Del., 02/03/2017
  • Venue Allegations: Venue in the District of Delaware is asserted based on Defendant Teva USA’s incorporation in Delaware, its regular business operations and distribution of generic drugs within the district, and its previous litigation activity in the forum.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic buprenorphine buccal film constitutes an act of infringement of two patents related to transmucosal drug delivery technology.
  • Technical Context: The technology concerns bioerodable polymer films designed for delivering pain medication through the mucosal tissues of the mouth, a method intended to provide rapid drug uptake while avoiding first-pass metabolism in the liver.
  • Key Procedural History: This litigation was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a notice letter regarding Defendants' ANDA submission. The complaint alleges this notice letter contained a Paragraph IV certification asserting the patents-in-suit are invalid, but that the letter did not contest that the proposed generic product would infringe claims of the asserted patents.

Case Timeline

Date Event
1996-10-18 U.S. Patent No. 7,579,019 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
2012-04-03 U.S. Patent No. 8,147,866 Issues
2015-10-23 FDA approves NDA for Belbuca®, Plaintiff's buprenorphine product
2016-12-22 Defendants send Notice Letter to Plaintiffs regarding ANDA No. 209807
2017-02-03 Complaint Filing Date

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, issued August 25, 2009

The Invention Explained

  • Problem Addressed: The patent describes the difficulty of delivering drugs topically to wet mucosal tissues, as natural bodily fluids tend to wash away medications quickly. It notes that prior art solutions like gels, pastes, and tablets suffered from short residence times, user discomfort due to bulkiness, or were not water-erodable, requiring manual removal. (’019 Patent, col. 1:24-34, col. 2:15-23). The stated goal is a "water-erodable pharmaceutical delivery device which provides good adhesion and localized delivery of a pharmaceutical with minimal discomfort to the patient" (’019 Patent, col. 2:36-41).
  • The Patented Solution: The invention is a layered, water-erodable film disk, typically composed of an adhesive layer that contacts the mucosa and a non-adhesive backing layer. (’019 Patent, col. 3:50-54, Fig. 1). The composition of these layers can be adjusted to control the rate of erosion and drug release, providing a longer residence time than gels or pastes while being more comfortable and flexible than tablets. (’019 Patent, col. 5:7-39).
  • Technical Importance: The technology offered a method to improve the effectiveness of mucosal drug delivery by creating a vehicle that was long-lasting, comfortable for the user, and bioerodable, thereby enhancing patient compliance and therapeutic outcomes. (’019 Patent, col. 2:36-48).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-7 (Compl. ¶ 23). Independent claim 1 is a method claim.
  • Essential elements of independent claim 1 include:
    • 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.
    • Directionally delivering the pharmaceutical to achieve a fast onset of activity in the subject within about 30 minutes.
    • The device has a residence time of less than 1 hour or about 1 hour.
    • The device comprises a thin and flexible adherent and bioerodable polymeric film containing the pharmaceutical.
  • The complaint does not explicitly reserve the right to assert other claims but infringement allegations are made as to "one or more claims" (Compl. ¶ 24).

U.S. Patent No. 8,147,866 - Transmucosal Delivery Devices with Enhanced Uptake, issued April 3, 2012

The Invention Explained

  • Problem Addressed: The patent background discusses prior art that controls drug absorption by buffering the environment upon dissolution, implying a need to overcome variability in drug uptake caused by factors in the oral cavity, such as the pH of a patient's saliva. (’866 Patent, col. 1:40-44).
  • The Patented Solution: The invention is a transmucosal delivery device comprising a "mucoadhesive polymeric diffusion environment" that contains the drug and is buffered to a specific pH optimized for that drug's absorption. For buprenorphine, a weakly basic drug, the patent teaches that a pH between about 4 and 6 is desirable. (’866 Patent, col. 26:54-col. 27:3). The device also includes a "barrier environment" to ensure a unidirectional gradient for drug delivery into the mucosa. (’866 Patent, Fig. 4A; col. 6:51-62).
  • Technical Importance: This approach sought to enhance the efficiency and consistency of transmucosal drug delivery by actively controlling the chemical micro-environment at the site of absorption, thereby increasing bioavailability and reducing inter-patient variability. (’866 Patent, col. 11:43-54).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-12 (Compl. ¶ 37). Independent claims 1 and 8 are analyzed.
  • Essential elements of independent claim 1 (method claim) include:
    • A method for providing enhanced uptake of buprenorphine by applying a mucoadhesive bioerodable device to an oral mucosal surface.
    • The device has a bioerodable mucoadhesive layer with buprenorphine in a polymeric diffusion environment.
    • The polymeric diffusion environment is a "buffered environment" with a pH between about 4 and about 6.
    • The device has a barrier layer to provide a unidirectional gradient.
  • Independent claim 8 is a device claim with elements substantially mirroring the device used in method claim 1.
  • The complaint notes that Defendants' notice letter does not contest infringement of claims 1-5 and 8-10. (Compl. ¶ 37).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' "Buprenorphine Buccal Film, 75 mcg and 150 mcg," for which Defendants filed Abbreviated New Drug Application (ANDA) No. 209807. (Compl. ¶ 21).

Functionality and Market Context

The complaint alleges that the accused product is a generic version of Plaintiffs' FDA-approved drug, Belbuca®, which is used for the treatment of pain via transmucosal delivery of buprenorphine. (Compl. ¶¶ 20, 34). As a buccal film, it is designed to adhere to the inside of the cheek to deliver its active ingredient. The complaint alleges that Defendants seek approval to market this generic product in the United States before the expiration of the patents-in-suit. (Compl. ¶¶ 21, 35). The complaint does not provide further technical details on the operation of the accused product itself, focusing instead on the statutory act of infringement by filing the ANDA.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The infringement allegations are statutory in nature, based on the filing of an ANDA under 35 U.S.C. § 271(e)(2). The complaint asserts that the product described in ANDA No. 209807, if approved and marketed, would infringe the asserted claims. A central allegation is that Defendants' pre-suit notice letter did not contest infringement of key asserted claims of either patent, suggesting the primary dispute may relate to validity. (Compl. ¶¶ 23, 37).

'019 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the transmucosal delivery of a systemic pharmaceutical ... comprising: adhering a bioerodable device to an oral mucosa surface of a subject... The complaint alleges that Defendants' proposed label and instructions for their generic buprenorphine buccal film will instruct users to apply the device to an oral mucosal surface. ¶26 col. 24:50-53
...directionally delivering an amount of a systemic pharmaceutical from the bioerodable device to mucosal tissue of the subject such that an effective amount... is delivered to the subject achieving a fast onset of activity...within about 30 minutes... The complaint alleges that the use of Defendants' generic film, a bioequivalent to Belbuca®, would result in the delivery of buprenorphine to achieve a fast onset of activity. ¶24 col. 24:54-60
...wherein the bioerodable device has a residence time of less than 1 hour or about 1 hour... The use of Defendants' generic film is alleged to meet the claimed residence time. The notice letter is alleged not to contest infringement of this claim. ¶¶23, 24 col. 24:60-62
...and the device comprises a thin and flexible adherent and bioerodable polymeric film containing a systemic pharmaceutical... Defendants' product is identified as a "Buprenorphine Buccal Film," which the complaint alleges is a thin, flexible, and bioerodable film as claimed. ¶¶21, 24 col. 24:62-64

'866 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for providing enhanced uptake of buprenorphine ... by application of a mucoadhesive bioerodable drug delivery device to an oral mucosal surface of the subject... Defendants' proposed product is a buprenorphine buccal film intended for application to the oral mucosa, which the complaint alleges would infringe. ¶¶35, 38 col. 26:55-59
...a bioerodable mucoadhesive layer comprising an effective amount of buprenorphine disposed in a polymeric diffusion environment... The complaint alleges Defendants' film contains buprenorphine in a mucoadhesive layer as claimed. ¶38 col. 26:60-62
...wherein the polymeric diffusion environment is a buffered environment having a pH of between about 4 and about 6... The complaint alleges that the use of Defendants' generic film would infringe this limitation, and that Defendants' notice letter did not contest infringement of this claim. ¶¶37, 38 col. 26:63-65
...and a barrier layer comprising a polymeric barrier environment disposed adjacent to the mucoadhesive layer to provide a unidirectional gradient... The complaint alleges Defendants' film contains a barrier layer that provides for unidirectional delivery as claimed. ¶38 col. 27:1-3

Identified Points of Contention

  • Validity vs. Infringement: The primary point of contention is expected to be patent validity. The complaint repeatedly highlights that Defendants' notice letter allegedly did not contest infringement of the core asserted claims (Compl. ¶¶ 23, 37), framing Defendants' Paragraph IV certification as being based solely on invalidity arguments which Plaintiffs characterize as baseless (Compl. ¶¶ 30, 44).
  • Technical Questions: Should infringement be contested, a key technical question for the ’866 patent would be whether Defendants' product formulation creates a "buffered environment" that maintains a pH "between about 4 and about 6" as required by the claims. However, the alleged non-contest of infringement suggests this may not be a point of dispute.

V. Key Claim Terms for Construction

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

  • Context and Importance: This term is central to the novelty of the ’866 Patent, distinguishing it from prior art that may have a particular pH but lacks an active buffering capacity. Its construction is critical to defining the scope of protection and determining whether a formulation that simply possesses an acidic character, without a system designed to resist pH change, would infringe.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification suggests that adjusting the pH can be achieved through various components, not just traditional buffer systems. For example, it notes that the amount of an anti-oxidant like citric acid "will adjust the pH of the device" (’866 Patent, col. 12:1-4). This may support a construction where any formulation that achieves and holds the target pH qualifies.
    • Evidence for a Narrower Interpretation: The specification also provides a list of conventional buffering agents, such as monobasic and dibasic phosphates and citrates, and describes the goal as creating a "stabilized pH" (’866 Patent, col. 12:21-38). This language could support a narrower construction requiring a formal chemical buffer system capable of resisting pH changes upon exposure to saliva.

VI. Other Allegations

Indirect Infringement

The complaint alleges that Defendants will induce infringement by providing instructions and/or a product label with their generic film that will direct physicians and patients to use the product in a manner that directly infringes the method claims of the patents-in-suit. (Compl. ¶¶ 26, 40). Contributory infringement is also alleged on the basis that the accused product is a material part of the claimed methods and is not a staple article of commerce suitable for substantial noninfringing use. (Compl. ¶¶ 27, 41).

Willful Infringement

Willfulness is alleged based on Defendants' knowledge of the patents, which is evidenced by their ANDA filing and notice letter. The complaint asserts that Defendants "acted without a reasonable basis for believing that they would not be liable" and that their invalidity contentions "are devoid of any objective good-faith basis." (Compl. ¶¶ 31, 45, 53, 62).

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

  • A foundational issue will be the focus of the dispute: given the complaint's assertion that Defendants have not contested infringement for the core claims, the case appears poised to be primarily a battle over patent validity. The central question is whether Defendants can prove by clear and convincing evidence that the asserted claims are invalid, as stated in their Paragraph IV certification.
  • A key legal and technical question for the ’866 patent, should infringement become a contested issue, will be one of claim scope: how should the term "buffered environment" be construed? Will the court determine that it requires a formal chemical system that actively resists pH change, or can it be satisfied by any formulation that is merely acidic within the claimed range upon dissolution?
  • A final question will be one of culpability: can Plaintiffs demonstrate that Defendants' invalidity positions are so objectively baseless as to render this an "exceptional" case under 35 U.S.C. § 285, which could expose Defendants to an award of Plaintiffs' attorney fees?