DCT

2:18-cv-01775

Indivior Inc v. DR Reddy's Laboratories SA

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-01775, D.N.J., 04/27/2018
  • Venue Allegations: Venue is alleged to be proper based on Defendant Dr. Reddy’s Laboratories, Inc. being incorporated and having its principal place of business in New Jersey, and Plaintiff Aquestive Therapeutics, Inc. having its principal place of business in the District.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs' Suboxone® sublingual film constitutes an act of infringement of a patent related to anti-tacking agents in dissolvable films.
  • Technical Context: The technology concerns thin, dissolvable oral films used for drug delivery, specifically formulations designed to prevent the films from becoming sticky or adhering to each other or to the user's mouth.
  • Key Procedural History: The complaint notes that the ANDAs were originally filed by Teva Pharmaceuticals and subsequently transferred to Defendants. It also references separate, ongoing litigation between the parties in the same district concerning a different patent related to the same drug product.

Case Timeline

Date Event
2001-10-12 ’221 Patent Priority Date
2010-08-30 FDA approves Plaintiffs’ NDA for Suboxone® sublingual film
2016-08-05 Teva transfers ownership of ANDAs to Defendants
2018-01-02 ’221 Patent Issue Date
2018-02-15 Plaintiffs receive Paragraph IV Notification Letters from Defendants
2018-04-27 Complaint Filing Date

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

U.S. Patent No. 9,855,221 - Uniform Films for Rapid-Dissolve Dosage Form Incorporating Anti-Tacking Compositions

The Invention Explained

  • Problem Addressed: The patent's background section describes technical challenges with earlier orally dissolving films. These include the tendency of components to clump together during drying, leading to non-uniform films and inaccurate drug dosing (Compl. ¶17; ’221 Patent, col. 2:1-30). A separate problem is that finished film strips can become tacky, causing them to stick to each other in packaging or to the roof of a user's mouth (Compl. ¶17; ’221 Patent, col. 4:5-12).
  • The Patented Solution: The invention is an edible, water-soluble film that incorporates at least one "anti-tacking agent" to solve these problems. These agents are described as lubricants, glidants, or antiadherants that improve the film's surface properties, prevent sticking, and promote a uniform distribution of the active pharmaceutical ingredient (Compl. ¶17; ’221 Patent, Abstract; col. 19:26-34).
  • Technical Importance: This technical approach aims to improve the manufacturability, packaging stability, and patient experience of oral film drug delivery systems, thereby making them a more reliable alternative to traditional tablets (Compl. ¶17; ’221 Patent, col. 1:44-54).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 6, 8, and 25 (Compl. ¶25).
  • Independent Claim 1 requires:
    • A continuously cast film for delivery of an active in individual self-supporting oral unit doses.
    • The film comprises an ingestible, water-soluble, polymer matrix.
    • The film comprises at least one anti-tacking agent selected from a specified group that includes stearates, waxes, silicon dioxide, and Vitamin E, among others.
    • The film has a substantially uniform distribution of the active ingredient, such that equally sized unit doses do not vary by more than 10% of the desired amount of the active.
  • The complaint does not explicitly reserve the right to assert additional dependent claims.

III. The Accused Instrumentality

Product Identification

The accused products are Defendants' generic Buprenorphine and Naloxone Sublingual Films as described in ANDA Nos. 205299 and 205806 (Compl. ¶21).

Functionality and Market Context

  • The accused products are generic versions of Plaintiffs’ Suboxone® sublingual film, used for the treatment of opioid dependence (Compl. ¶1, ¶19).
  • The complaint alleges the accused generic product contains three grades of polyethylene oxide (PEO) sold under the trademark POLYOX™. It further alleges that all grades of this commercially sourced PEO contain silicon dioxide (Compl. ¶25). This presence of silicon dioxide forms the central basis for the infringement allegation.
  • The complaint alleges that by filing the ANDAs, Defendants seek approval to commercially manufacture and sell their generic product before the expiration of the ’221 Patent (Compl. ¶23).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 9,855,221 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A continuously cast film for delivery of an active... The complaint does not provide sufficient detail for analysis of Defendants' manufacturing process. ¶31 col. 41:9-13
an ingestible, water-soluble, polymer matrix; The accused product is a sublingual film containing polyethylene oxide, a water-soluble polymer. ¶25 col. 13:1-10
at least one anti-tacking agent selected from the group consisting of... silicon dioxide... and combinations thereof; The accused product contains polyethylene oxide (POLYOX™), which itself contains silicon dioxide. The claim identifies silicon dioxide as an anti-tacking agent. ¶25 col. 41:17-24
a substantially uniform distribution of said active... wherein said active is substantially uniformly distributed... such that equally sized individual self supporting oral unit doses... do not vary by more than 10% of said desired amount of said active. The ANDA filings purport to contain data showing bioequivalence with Plaintiffs' Suboxone® sublingual film, which requires dosage uniformity. ¶24 col. 41:26-36

Identified Points of Contention

  • Scope Questions: The primary dispute may center on the "anti-tacking agent" limitation. A central question for the court could be whether the presence of silicon dioxide as a component within a commercially sourced bulk ingredient (polyethylene oxide) meets the claim limitation, or if the term requires the agent to be added for the purpose of, and to actually perform, an anti-tacking function in the final product.
  • Technical Questions: The complaint does not describe Defendants’ manufacturing process. A key factual question will be whether that process constitutes "continuously cast[ing]" as required by the claim. The complaint's allegations regarding the uniformity of the accused product are based on its purported bioequivalence to Suboxone®, which may raise questions about the direct evidence of uniformity in the accused product itself.

V. Key Claim Terms for Construction

  • The Term: "anti-tacking agent"
  • Context and Importance: This term is the lynchpin of the infringement allegation. The complaint alleges infringement because the accused product contains silicon dioxide, which is an enumerated "anti-tacking agent" in the claim's Markush group (Compl. ¶25). The definition of this term will determine whether the mere presence of a listed substance is sufficient for infringement, or if a functional requirement is implied.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that the claim language "selected from the group consisting of" is dispositive. Because "silicon dioxide" is explicitly listed, its presence in the accused product, regardless of its source or primary purpose, could be argued to satisfy the limitation ('221 Patent, col. 41:17-24).
    • Evidence for a Narrower Interpretation: The specification repeatedly describes the purpose and function of these agents. The abstract states they "reduce the problem of film adhering to a user's mouth or to other units of film" ('221 Patent, Abstract). The detailed description explains they "assist in the flow characteristics of the material" and reduce "sticking to the roof of the mouth" ('221 Patent, col. 19:28-34). A party might argue this context implies a functional requirement—that the silicon dioxide must actually perform an anti-tacking function in the accused product to meet the claim limitation.

VI. Other Allegations

  • Indirect Infringement: The complaint does not plead separate counts for induced or contributory infringement. The prayer for relief includes a request for an injunction against "inducing and/or encouraging the use of methods, claimed in the patent-in-suit," but the factual allegations in the complaint focus on infringement under 35 U.S.C. § 271(e)(2) via the ANDA submission (Compl. ¶32; Prayer for Relief ¶C).
  • Willful Infringement: The complaint does not contain allegations of willful infringement.

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

  • A core issue will be one of definitional scope and function: does the term "anti-tacking agent," as used in the patent, read on a substance (silicon dioxide) that is allegedly present not as a separately added ingredient but as a component of a commercially sourced polymer, or must Plaintiffs prove the substance was included to perform, and actually performs, the claimed anti-tacking function?
  • A key evidentiary question will be one of manufacturing process: what evidence will be presented to establish that Defendants’ method for producing their generic film constitutes a "continuously cast film" process as required by the asserted independent claim? The complaint's focus on the product's composition leaves this element open for dispute.