DCT

3:17-cv-00246

MonoSol RX LLC v. BioDelivery Sciences Intl Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:17-cv-00246, D.N.J., 01/13/2017
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant transacts business in the district and has committed acts of patent infringement there.
  • Core Dispute: Plaintiff alleges that Defendant’s BELBUCA (buprenorphine) buccal film product infringes a patent related to uniform, rapid-dissolve oral films with anti-tacking compositions.
  • Technical Context: The technology concerns oral film drug delivery systems, which serve as an alternative to conventional tablets and pills for administering pharmaceutical agents.
  • Key Procedural History: The complaint alleges a significant history between the parties concerning the patent-in-suit. Plaintiff previously sued Defendant for infringement of the same patent over a different product (Bunavail) in 2014. Subsequently, Defendant filed inter partes review (IPR) petitions challenging numerous claims of the patent, which the Patent Trial and Appeal Board (PTAB) declined to institute. The complaint notes that Defendant is now statutorily barred from filing further IPRs on the asserted claims, potentially limiting its invalidity defenses in this forum.

Case Timeline

Date Event
2001-10-12 ’167 Patent Priority Date
2014-07-01 ’167 Patent Issue Date
2014-10-13 Defendant served with complaint in prior litigation involving the ’167 Patent
2014-10-28 Defendant files IPR petitions against the ’167 Patent
2015-05-20 PTAB denies institution of Defendant's IPR petitions
2015-10-23 FDA approves Defendant's BELBUCA New Drug Application
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"

  • Patent Identification: 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 issues with prior art oral films, where active ingredients and other components tend to "self-aggregate" during manufacturing (’167 Patent, col. 1:61-63). This leads to non-uniform distribution of the active ingredient, making accurate and consistent dosing difficult, a critical failure for pharmaceutical products (’167 Patent, col. 2:6-12). A related problem is the "tackiness" of films, which causes them to stick to each other in packaging (’167 Patent, col. 4:1-9).
  • The Patented Solution: The invention is an oral film formulation that combines a water-soluble polymer matrix with an active ingredient and an anti-tacking agent (’167 Patent, Abstract). The patent teaches that using a "controlled drying process" that rapidly forms a viscoelastic matrix "lock[s]-in" the active components, preventing aggregation and ensuring a "substantially uniform distribution" throughout the film (’167 Patent, col. 5:20-35). This uniformity allows for reliable, repeatable dosing.
  • Technical Importance: The claimed invention aims to overcome key manufacturing hurdles, enabling the production of oral films with the dosage consistency required for regulatory approval and commercial use as a pharmaceutical delivery system (’167 Patent, col. 2:12-21).

Key Claims at a Glance

  • The complaint asserts independent claims 13 and 95, among numerous other dependent claims (Compl. ¶¶ 2, 28).
  • Independent Claim 95 requires:
    • 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).
    • An anti-tacking agent comprising sodium benzoate.
    • A substantially uniform distribution of the active component.
    • Formation by a "controlled drying process" that rapidly creates a viscoelastic matrix to maintain uniformity.
    • The film must be self-supporting, with the uniform distribution measured by unit doses not varying by more than 10%.
  • Independent Claim 13 is similar but recites a broader list of polymers (including polyethylene oxide) and anti-tacking agents (including Vitamin E and Vitamin E TPGS).
  • The complaint reserves the right to assert additional claims (Compl. ¶28).

III. The Accused Instrumentality

Product Identification

The accused product is BELBUCA®, a buccal film containing the active pharmaceutical ingredient buprenorphine hydrochloride (Compl. ¶¶ 2, 21).

Functionality and Market Context

  • BELBUCA is a prescription drug product designed for transmucosal delivery of buprenorphine, an opioid analgesic (Compl. ¶21). It is sold in various dosage strengths, from 75 mcg to 900 mcg (Compl. ¶20). The complaint provides a table detailing the various dosage strengths and corresponding film sizes for BELBUCA (Compl. ¶22, Table 6).
  • Crucially, the complaint lists the ingredients of BELBUCA, which include "carboxymethylcellulose sodium USP," "hydroxyethylcellulose NF," "hydroxypropylcellulose NF," and "sodium benzoate NF" (Compl. ¶23). These ingredients correspond directly to elements recited in the asserted claims.
  • The complaint alleges that Defendant has received payments and milestones totaling at least $125 million for the development and manufacture of BELBUCA, suggesting significant commercial activity (Compl. ¶26).

IV. Analysis of Infringement Allegations

’167 Patent Infringement Allegations

Claim Element (from Independent Claim 95) Alleged Infringing Functionality Complaint Citation Patent Citation
an ingestible, water-soluble polymer matrix comprising a polymer selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose and carboxymethyl cellulose and combinations thereof; The accused BELBUCA product contains hydroxyethylcellulose NF, hydroxypropylcellulose NF, and carboxymethylcellulose sodium USP. ¶23 col. 12:40-50
at least one anti-tacking agent comprising sodium benzoate; The accused BELBUCA product contains sodium benzoate NF. ¶23 col. 19:25-33
wherein said active component is selected from the group consisting of... pharmaceutical agents... The active ingredient in BELBUCA is buprenorphine hydrochloride, a pharmaceutical agent. ¶¶21, 23 col. 12:45-48
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 infringes this limitation, asserting that the active component is substantially uniformly distributed. ¶¶17, 28 col. 2:15-21
said film being formed by a controlled drying process which rapidly forms a viscoelastic matrix to lock-in said active in place... The complaint alleges infringement of this process limitation. ¶¶17, 28 col. 6:20-41

Identified Points of Contention

  • Scope Questions: A central question will be whether the accused BELBUCA product meets the quantitative uniformity requirement of Claim 95, i.e., that unit doses "do not vary by more than 10% of said desired amount of said active component." The complaint makes a conclusory allegation of infringement but does not provide specific test data for BELBUCA, making this a likely point of factual dispute.
  • Technical Questions: The complaint does not describe Defendant's manufacturing process. Therefore, a key question for discovery will be whether the process used to make BELBUCA meets the "controlled drying process" limitation as described in the patent. The patent specification details specific drying methods, such as bottom-up heating, to avoid prior art problems (’167 Patent, col. 6:31-41), and infringement may turn on whether Defendant's process is equivalent.

V. Key Claim Terms for Construction

  • The Term: "controlled drying process"

    • Context and Importance: This term is critical because it describes the method step allegedly responsible for achieving the claimed "substantially uniform distribution." Its construction will determine what types of manufacturing processes fall within the scope of the claims. Practitioners may focus on this term because the patent contrasts it with conventional drying methods that cause non-uniformity.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: Plaintiff may argue the term should be understood by its function—any process that rapidly forms a viscoelastic matrix and maintains uniformity—and not be limited to specific apparatuses.
      • Evidence for a Narrower Interpretation: Defendant may argue the term is defined by the specific problems it solves and the solutions offered in the specification. The patent describes avoiding "rippling" by "drying the bottom surface of the film first" or using balanced air flow (’167 Patent, col. 6:31-54). This language may support a narrower construction limited to processes with these specific characteristics.

  • The Term: "substantially uniform distribution"

    • Context and Importance: This term lies at the heart of the invention's purported advance over the prior art. The infringement analysis for every asserted claim will depend heavily on its definition.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: Plaintiff may argue that "substantially" imparts a degree of flexibility, and the term should be understood in the context of what one of ordinary skill in the art would consider uniform for a pharmaceutical product.
      • Evidence for a Narrower Interpretation: Defendant may argue that the term is explicitly defined by the quantitative limitation that follows it in Claim 95: "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" (’167 Patent, cl. 95). This suggests "substantially uniform" is not a vague standard but is tied to a specific, measurable outcome.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced infringement and contributory infringement (Compl. ¶¶ 36-37). Inducement is based on allegations that Defendant knowingly and intentionally encourages others to use BELBUCA in an infringing manner (Compl. ¶36). Contributory infringement is based on the allegation that BELBUCA is not a staple article of commerce suitable for a substantial non-infringing use (Compl. ¶37).
  • Willful Infringement: The complaint makes a detailed allegation of willfulness based on Defendant's alleged pre-suit knowledge of the ’167 patent (Compl. ¶33). The basis for this knowledge is specific: Defendant was served in a prior lawsuit on the same patent for a different product on October 13, 2014, and subsequently filed (unsuccessful) IPR petitions challenging the patent's validity (Compl. ¶¶ 4, 32).

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

  • A core issue will be one of process and product conformity: as the complaint lacks specific evidence on Defendant's manufacturing methods and product testing, a key evidentiary question will be whether discovery reveals that (a) the BELBUCA manufacturing process meets the definition of a "controlled drying process," and (b) the final BELBUCA product meets the patent's quantitative "10% variance" uniformity requirement.
  • A second central question will concern willfulness and damages: given the complaint's specific and documented allegations of pre-suit knowledge stemming from prior litigation and IPR proceedings, a crucial issue will be whether Defendant's conduct rises to the level of willful infringement, which could expose it to enhanced damages if infringement is found.