DCT

1:13-cv-01674

Reckitt Benckiser Pharma Inc v. Watson Laboratories Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:13-cv-01674, D. Del., 06/04/2015
  • Venue Allegations: Venue is alleged to be proper based on Defendants' incorporation in Delaware, as well as their continuous and systematic business contacts, marketing, and sales activities within the district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of Abbreviated New Drug Applications (ANDAs) with the FDA to market a generic version of Suboxone® sublingual film constitutes an act of infringement of three U.S. patents related to pharmaceutical film compositions and drug delivery systems.
  • Technical Context: The technology concerns orally dissolvable films for delivering pharmaceutical compounds, specifically a combination of an opioid agonist (buprenorphine) and an antagonist (naloxone) for the treatment of opioid dependence.
  • Key Procedural History: The action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of "Paragraph IV certification" letters from Defendants, which asserted that the patents-in-suit are invalid, unenforceable, and/or would not be infringed by the proposed generic products. The provided complaint is a Second Amended Complaint. An inter partes review (IPR) proceeding, IPR2014-00325, resulted in the cancellation of claims 15-19 of U.S. Patent No. 8,475,832.

Case Timeline

Date Event
2001-10-12 ’514 Patent Priority Date
2002-04-11 ’150 Patent Priority Date
2009-08-07 ’832 Patent Priority Date
2010-08-30 FDA approves Plaintiff RBP's Suboxone® sublingual film
2011-09-13 ’150 Patent Issued
2013-07-02 ’832 Patent Issued
2013-08-27 Plaintiffs receive Watson's ANDA Notification Letter for ’832 and ’150 Patents
2013-12-10 ’514 Patent Issued
2014-02-04 Plaintiffs receive Watson's ANDA Notification Letter for ’514 Patent
2015-04-22 Plaintiffs receive Actavis's ANDA Notification Letter for all patents-in-suit
2015-06-04 Second Amended Complaint Filed

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

U.S. Patent No. 8,475,832 - "Sublingual and Buccal Film Compositions"

The Invention Explained

  • Problem Addressed: The patent describes the challenge of co-administering two therapeutic agents where one (an opioid agonist, buprenorphine) is intended for absorption into the body, while the other (an antagonist, naloxone) should remain substantially unabsorbed to prevent abuse (Compl. ¶14; ’832 Patent, col. 1:21-34). Existing tablet forms of such combinations are susceptible to abuse, as a user could separate the agonist from the tablet for injection ('832 Patent, col. 1:53-64).
  • The Patented Solution: The invention is a self-supporting, orally dissolvable film containing both buprenorphine and naloxone within a polymeric matrix. The key feature is a buffer system designed to create a "local pH" of about 3 to 3.5 in the presence of saliva ('832 Patent, col. 2:7-14). This acidic environment optimizes the buccal absorption of the buprenorphine while simultaneously inhibiting the absorption of the naloxone, thereby ensuring the antagonist is effective primarily if the drug is misused ('832 Patent, col. 11:46-56).
  • Technical Importance: This approach provides a dosage form for opioid dependence treatment that is bioequivalent to tablets but offers enhanced abuse-deterrent properties by chemically controlling the differential absorption of its active ingredients ('832 Patent, col. 1:65-col. 2:3).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims of the ’832 Patent (Compl. ¶27). Independent claim 1 is representative.
  • Essential elements of Independent Claim 1:
    • A film dosage composition comprising:
    • a. A polymeric carrier matrix;
    • b. A therapeutically effective amount of buprenorphine or a pharmaceutically acceptable salt thereof;
    • c. A therapeutically effective amount of naloxone or a pharmaceutically acceptable salt thereof; and
    • d. A buffer in an amount to provide a local pH for said composition of a value sufficient to optimize absorption of said buprenorphine, wherein said local pH is from about 3 to about 3.5 in the presence of saliva.

U.S. Patent No. 8,017,150 - "Polyethylene Oxide-Based Films and Drug Delivery Systems Made Therefrom"

The Invention Explained

  • Problem Addressed: The patent's background section details how conventional methods for creating drug-delivery films can lead to "aggregation or conglomeration of particles," resulting in a non-uniform distribution of the active ingredient ('150 Patent, col. 2:15-18). This non-uniformity prevents accurate and consistent dosing, a critical failure for pharmaceutical products ('150 Patent, col. 2:35-44).
  • The Patented Solution: The invention claims a water-soluble film with a polymer component based on polyethylene oxide (PEO), optionally blended with a hydrophilic cellulosic polymer ('150 Patent, Abstract). The solution to the uniformity problem lies not just in the composition but in the manufacturing process, which involves controlled, rapid drying to "lock-in" the components and prevent aggregation, avoiding the "ripple effect" seen in conventional, slower drying methods ('150 Patent, col. 3:9-19; col. 7:1-8).
  • Technical Importance: This technology enables the production of homogenous, rapidly dissolving films that provide a consistent dose of a pharmaceutical active per unit area, a fundamental requirement for regulatory approval and safe administration of medication ('150 Patent, col. 2:35-44).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims of the ’150 Patent (Compl. ¶31). Independent claim 1 is representative.
  • Essential elements of Independent Claim 1:
    • A mucosally-adhesive water-soluble film product comprising:
    • an analgesic opiate pharmaceutical active;
    • at least one water-soluble polymer component consisting of polyethylene oxide in combination with a hydrophilic cellulosic polymer;
    • wherein the polymer component comprises greater than 75% polyethylene oxide and up to 25% hydrophilic cellulosic polymer;
    • wherein the polyethylene oxide comprises specified combinations of low and high molecular weight polyethylene oxides; and
    • wherein the low molecular weight polyethylene oxide is about 60% or more of the polymer component.

U.S. Patent No. 8,603,514 - "Uniform Films for Rapid Dissolve Dosage Form Incorporating Taste-Masking Compositions"

Technology Synopsis

  • This patent addresses the technical challenge of delivering active ingredients with unpleasant tastes in a rapid-dissolve film format ('514 Patent, col. 14:4-9). The invention discloses coating particles of the active ingredient with a taste-masking agent before incorporating them into the film-forming matrix, thereby preventing the release of unpleasant taste during dissolution in the mouth while ensuring uniform distribution ('514 Patent, Abstract).

Asserted Claims & Accused Features

  • Asserted Claims: The complaint asserts infringement of one or more unspecified claims of the ’514 Patent (Compl. ¶35).
  • Accused Features: The complaint alleges that the Defendants' generic sublingual film, which is a rapid dissolve dosage form incorporating buprenorphine and naloxone, infringes the ’514 patent (Compl. ¶¶ 1, 18, 35).

III. The Accused Instrumentality

Product Identification

  • The accused products are the generic buprenorphine hydrochloride and naloxone hydrochloride sublingual films for which Defendants Watson and Actavis submitted ANDA Nos. 204383 and 20-7087, respectively (Compl. ¶¶ 18, 24).

Functionality and Market Context

  • The products are generic versions of Plaintiff RBP's Suboxone® sublingual film, intended for the maintenance treatment of opioid dependence (Compl. ¶¶ 1, 15). The ANDA filings purport to contain data showing the bioequivalence of the Defendants' generic product with the branded Suboxone® film, and seek FDA approval for commercial manufacture and sale prior to the expiration of the patents-in-suit (Compl. ¶¶ 18, 24).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for analysis of a specific infringement theory. It alleges infringement under 35 U.S.C. § 271(e)(2), where the submission of an ANDA for a generic drug is itself the statutorily defined act of infringement (Compl. ¶¶ 28, 32, 36). The complaint makes conclusory allegations that the generic product is "covered by one or more claims" of each patent-in-suit without identifying specific claims or mapping claim elements to the accused product's features (Compl. ¶¶ 27, 31, 35). A detailed infringement analysis would require access to the Defendants' confidential ANDA filings, which are typically produced during discovery.

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Scope Questions: For the ’150 Patent, a potential dispute may arise over the scope of "mucosally-adhesive." The parties may contest the degree of adhesion required to meet this limitation and the proper methodology for measuring it.
    • Technical Questions: For the ’832 Patent, a central factual question will be whether the Defendants' generic product formulation, including its specific excipients and buffer system, actually produces a "local pH... from about 3 to about 3.5 in the presence of saliva" as required by claim 1. For the ’150 Patent, a key question will be whether the specific types and ratios of polymers used in the generic film (e.g., the percentage of polyethylene oxide and the ratio of low-to-high molecular weight variants) fall within the claimed ranges.

V. Key Claim Terms for Construction

  • The Term: "local pH" (’832 Patent, claim 1)

  • Context and Importance: The claimed invention's ability to optimize buprenorphine absorption while inhibiting naloxone absorption is entirely dependent on achieving this specific pH range. The definition of "local pH" is therefore critical to determining infringement, as it dictates how and where the pH of the accused product will be measured.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim language "in the presence of saliva" may support a view that the term refers generally to the pH environment created as the film dissolves in the mouth, not necessarily a property of the dry film itself (’832 Patent, col. 24:65-67).
    • Evidence for a Narrower Interpretation: The specification provides a specific definition: "The term 'local pH' refers to the pH of the region of the carrier matrix immediately surrounding the active agent as the matrix hydrates and/or dissolves" (’832 Patent, col. 3:36-39). This definition may support a narrower construction focused on the micro-environment at the particle-polymer interface.

  • The Term: "non-self-aggregating uniform heterogeneity" (’150 Patent, specification context)

  • Context and Importance: While not in the asserted independent claim, this phrase from the specification defines the core technical problem the patent purports to solve and is used to characterize the resulting film ('150 Patent, col. 5:26-47). Practitioners may focus on this term because Defendants could argue that the asserted claims, when read in light of this objective, should be interpreted narrowly to cover only films made by processes that actively prevent aggregation, or that the term renders the patent's scope indefinite.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes this as a "substantial absence of aggregates or conglomerates as is common in conventional mixing and heat drying methods" ('150 Patent, col. 5:39-42), which could be argued to cover any film that is merely uniform, regardless of the process used.
    • Evidence for a Narrower Interpretation: The patent repeatedly links this property to a "controlled, and desirably rapid, drying process" that avoids the "ripple effect" of conventional top-down drying ('150 Patent, col. 3:12-14; col. 5:51-65). This could support a narrower construction where the claims are limited to films possessing uniformity specifically achieved through such unconventional drying methods.

VI. Other Allegations

The complaint does not contain allegations of willful or indirect infringement. It requests attorneys' fees for an exceptional case under 35 U.S.C. § 285 (Compl. p. 8, ¶D).

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

  • A core issue will be one of factual infringement: will empirical testing of the Defendants' generic film formulation, once disclosed from the ANDAs, show that it meets the specific quantitative limitations of the asserted claims, such as the polymer ratios and molecular weights required by the ’150 Patent and, most critically, the "local pH" of 3.0-3.5 required by the ’832 Patent?
  • A second key issue will be claim construction: how will the court define the operative technical terms of the patents, particularly "local pH"? The outcome of this legal determination will establish the standard against which the accused product's characteristics are measured.
  • A final central question will be one of patent validity. The Defendants' Paragraph IV certifications allege invalidity and unenforceability, and the cancellation of several claims of the ’832 Patent in a prior IPR proceeding suggests that validity, likely on grounds of obviousness or anticipation, will be a significant focus of the litigation.