DCT

2:17-cv-07111

Indivior Inc v. DR Reddy's Laboratories SA

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-07111, D.N.J., 11/06/2017
  • Venue Allegations: Venue is based on Defendant Dr. Reddy's Laboratories, Inc.'s incorporation in New Jersey, its principal place of business in the state, and its continuous and systematic business activities, including the distribution and sale of pharmaceutical products within the judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of Plaintiff’s Suboxone® sublingual film constitutes an act of patent infringement under the Hatch-Waxman Act.
  • Technical Context: The technology concerns an abuse-deterrent, dissolvable oral film for delivering a combination of buprenorphine (an opioid agonist) and naloxone (an opioid antagonist) to treat narcotic dependence.
  • Key Procedural History: This action was triggered by Defendant’s Paragraph IV certification asserting that the patent-in-suit is invalid, unenforceable, or will not be infringed by its proposed generic product. The complaint notes that Defendant acquired the relevant ANDAs from a third party, Teva Pharmaceuticals. Subsequent to the complaint's filing, an Inter Partes Review (IPR) proceeding (IPR2019-00329) resulted in the cancellation of all asserted claims of the patent-in-suit except for dependent claim 8, significantly narrowing the scope of the dispute.

Case Timeline

Date Event
2009-08-07 '454 Patent Priority Date
2010-08-30 FDA approves Plaintiff's Suboxone® sublingual film (NDA)
2016-08-05 Defendant DRL acquires ANDAs from Teva Pharmaceuticals
2017-06-27 '454 Patent Issue Date
2017-09-22 Plaintiff receives Defendant's Paragraph IV Notice Letter
2017-11-06 First Amended Complaint Filing Date
2022-09-30 IPR Certificate issues, cancelling all claims except 8

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

  • Patent Identification: U.S. Patent No. 9,687,454, "Sublingual and Buccal Film Compositions", issued June 27, 2017.

The Invention Explained

  • Problem Addressed: The patent describes the potential for abuse of tablet-based opioid dependence treatments. A patient could pretend to swallow a tablet, later remove it, and extract the opioid agonist for injection, bypassing the co-formulated abuse-deterrent antagonist ('454 Patent, col. 2:1-8).
  • The Patented Solution: The invention is a self-supporting, orally dissolvable film designed to adhere to the buccal or sublingual mucosa, making it difficult to remove once administered ('454 Patent, col. 2:11-17). The film contains a polymeric matrix, the opioid agonist buprenorphine, the antagonist naloxone, and a buffer. The buffer controls the local pH to optimize the absorption of buprenorphine while simultaneously inhibiting the absorption of naloxone, which is intended to be swallowed and neutralized in the stomach ('454 Patent, col. 12:8-25).
  • Technical Importance: This film-based drug delivery system was developed to provide a bioequivalent alternative to existing tablets for treating opioid dependence, with the added benefit of features intended to reduce the potential for illicit diversion and abuse ('454 Patent, col. 2:15-19).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the '454 patent (Compl. ¶30).
  • A post-filing IPR proceeding cancelled all claims except for dependent claim 8. The case therefore now centers on this single surviving claim. Claim 8 depends from claims 7 and 1, incorporating all of their limitations.
  • The essential elements of the asserted claim combination (Claims 1, 7, and 8) are:
    • An oral, self-supporting, mucoadhesive film comprising:
    • (a) about 48.2 wt % of a water-soluble polymeric matrix;
    • (b) about 2 mg to about 16 mg of buprenorphine;
    • (c) about 0.5 mg to about 4 mg of naloxone;
    • (d) an acidic buffer;
    • Wherein the film is mucoadhesive to the sublingual or buccal mucosa;
    • Wherein the weight ratio of buprenorphine to naloxone is about 4:1;
    • Wherein the weight ratio of the acidic buffer to buprenorphine is from 2:1 to 1:5; and
    • Wherein application of the film results in specific pharmacokinetic profiles for both buprenorphine and naloxone.

III. The Accused Instrumentality

Product Identification

  • Defendant's generic Buprenorphine and Naloxone Sublingual Film, for which it seeks FDA approval via ANDA Nos. 205299 and 205806 (Compl. ¶¶1, 23).

Functionality and Market Context

  • The accused product is a generic version of Plaintiff's Suboxone® sublingual film, designed for the treatment of opioid dependence (Compl. ¶¶1, 17). The ANDAs filed by Defendant assert that the generic product is bioequivalent to the branded Suboxone® film (Compl. ¶26). The complaint does not provide specific details on the formulation of the accused product beyond its identification as a generic equivalent in the ANDA submission.

IV. Analysis of Infringement Allegations

The complaint, filed under 35 U.S.C. § 271(e)(2), alleges that Defendant’s act of submitting its ANDAs to the FDA constitutes infringement of the '454 Patent (Compl. ¶31). The pleading does not contain a detailed claim chart or an element-by-element breakdown of its infringement theory. The infringement analysis will turn on whether the formulation described in Defendant's confidential ANDA meets every limitation of the surviving claim.

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Scope Questions: A central dispute will likely involve the construction of "about 48.2 wt %" from Claim 8. The court will need to determine the permissible range of deviation from the "48.2 wt %" value for the water-soluble polymeric matrix. The interpretation of "about" will be critical to the infringement analysis.
    • Technical Questions: A key question is whether achieving the bioequivalence alleged in the ANDA (Compl. ¶26) necessarily requires the accused product to have the specific compositional and structural limitations recited in Claim 8. This includes not only the precise "about 48.2 wt %" matrix concentration but also the claimed 4:1 drug ratio, the specified buffer-to-drug ratio, and the resulting pharmacokinetic parameters.

V. Key Claim Terms for Construction

  • The Term: "about 48.2 wt %"
  • Context and Importance: This term, found in the sole surviving claim, precisely defines the weight percentage of the water-soluble polymeric matrix. The outcome of the infringement analysis for the entire case hinges on whether the accused product's formulation falls within the scope of this limitation. Practitioners may focus on this term because its specificity, qualified by "about," creates a focal point for claim construction disputes.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discloses polymer concentrations in broad ranges, such as "from about 20% to 100% by weight" ('454 Patent, col. 8:36-39), which may support an argument that the numbers are not intended to be rigidly exact and should accommodate standard manufacturing variability.
    • Evidence for a Narrower Interpretation: The patentee drafted claim 8 to specify "about 48.2 wt %," narrowing from the range of "about 48.2 wt % to about 58.6 wt %" in its parent claim 7. This express narrowing could be argued to give the specific number heightened significance. The patent's examples also provide detailed formulations with precise percentages (e.g., '454 Patent, Table 1), which could be used to argue that the quantities are critical to the invention's function.

VI. Other Allegations

  • Indirect Infringement: The prayer for relief seeks to enjoin Defendant from "inducing and/or encouraging the use of methods, claimed in the patent-in-suit" (Compl., Prayer for Relief ¶C). However, the complaint's substantive counts focus on infringement under 35 U.S.C. § 271(e)(2) based on the ANDA submission and do not plead specific facts to support a claim for induced infringement, such as details from product labeling or instructions for use.
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. It does request a finding that the case is "exceptional" to warrant an award of attorneys' fees under 35 U.S.C. § 285, but it does not detail the factual basis for this assertion (Compl., Prayer for Relief ¶E).

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

  • A core issue will be one of claim scope: can the term "about 48.2 wt %," which defines a specific compositional element in the patent's sole surviving claim, be construed to read on the formulation disclosed in Defendant's confidential ANDA? The resolution of this construction will likely be dispositive.
  • A second key question relates to the impact of the IPR: with the case narrowed to a single, highly specific dependent claim, the litigation risk for both parties is concentrated. The central evidentiary battle will be to compare the precise formulation in the accused ANDA against the narrow limitations of this surviving claim.
  • Finally, a key evidentiary question will be whether the accused product's asserted bioequivalence to Suboxone® film is sufficient to prove infringement, or if Plaintiff must show that the accused product also meets the specific, non-functional compositional limitations required by the claim language, such as the exact polymer weight percentage and buffer ratio.