DCT

3:25-cv-16717

Braintree Laboratories Inc v. Strides Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-16717, D.N.J., 10/17/2025
  • Venue Allegations: Venue is based on Defendant Strides Pharma Inc.'s principal place of business in New Jersey and its regular business activities within the state. Jurisdiction over the foreign parent, Strides Pharma Global PTE Ltd., is alleged based on its acting in concert with its U.S. affiliate and its previous submissions to the jurisdiction of the court in other matters.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's SUFLAVE® colonoscopy preparation product constitutes an act of infringement of a patent covering the product's specific formulation.
  • Technical Context: The technology concerns oral solutions for cleansing the colon prior to medical procedures, designed to balance efficacy, patient tolerability, and safety by avoiding significant electrolyte shifts.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following a notice letter from Strides informing Braintree of its ANDA filing seeking FDA approval for its generic product. The asserted patent is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") as covering the SUFLAVE® product.

Case Timeline

Date Event
2023-06-15 ’529 Patent Priority Date
2023-06-15 Plaintiff's SUFLAVE® product approved by FDA
2025-05-06 U.S. Patent No. 12,290,529 Issued
2025-09-03 Defendants' ANDA Notice Letter sent to Plaintiff
2025-10-17 Complaint Filed

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

U.S. Patent No. 12,290,529 - Methods of Administering Safe Colon Cleansing Compositions

The Invention Explained

  • Problem Addressed: The patent describes a need for a colon cleansing preparation that overcomes the drawbacks of prior art solutions. These drawbacks included poor patient compliance due to the large volume and unpleasant salty taste of traditional polyethylene glycol (PEG) solutions, and safety risks such as renal failure associated with phosphate-based alternatives (’529 Patent, col. 1:10-47). Off-label preparations combining PEG with sports drinks raised concerns about electrolyte imbalances and the need for adjunct stimulant laxatives (’529 Patent, col. 1:48-54).
  • The Patented Solution: The invention is a specific, multi-component formulation that combines PEG with a balanced mixture of sulfate salts (sodium sulfate, magnesium sulfate), electrolytes (potassium chloride, sodium chloride), and a flavoring system. This combination is designed to induce effective purgation in a lower total volume, maintain a safe electrolyte balance, and improve taste to enhance patient compliance, thereby eliminating the need for separate adjunct laxatives (’529 Patent, Abstract; col. 2:10-28). The formulation is provided as a split-dose kit with certain components separated to be mixed by the user before administration, which the patent suggests helps maintain product stability and flavor (’529 Patent, col. 12:26-51).
  • Technical Importance: The claimed solution seeks to improve the quality of and compliance with colonoscopy preparation, a critical factor for the effectiveness of colorectal cancer screening and other important diagnostic procedures (’529 Patent, col. 1:12-20).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims, "including at least claim 1" (Compl. ¶28).
  • Independent Claim 1 requires:
    • A colon cleansing product supplied in four containers for a split-dose regimen.
    • A first and third container each comprising specific amounts of polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride.
    • A second and fourth container each comprising malic acid and citric acid.
    • The product further comprising lemon-lime flavor, sucralose, and neotame.
    • A functional limitation wherein the combined doses "cleanse a colon of a subject without causing a sodium balance of -50.00 mEq/L or greater in the subject."

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' proposed generic drug product, which is the subject of ANDA No. 220202 (Compl. ¶1).

Functionality and Market Context

  • The complaint alleges that the accused product is a generic version of Braintree's SUFLAVE® drug, intended for cleansing the colon before a colonoscopy (Compl. ¶¶1, 15). The complaint asserts that Defendants have represented to the FDA that their proposed product has the "same active ingredients, the same route of administration, the same dosage form, and the same strengths as the corresponding components of SUFLAVE®" and is bioequivalent to it (Compl. ¶22).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that by filing ANDA No. 220202, Defendants seek approval to market a product that will infringe the ’529 Patent (Compl. ¶23). The infringement theory relies on the assertion that the proposed generic product is bioequivalent and compositionally identical to the patented SUFLAVE® product (Compl. ¶22).

’529 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A colon cleansing product comprising: (a) a first container comprising a first portion of a first dose...comprising about 178.7 grams of polyethylene glycol 3350, about 7.3 grams of sodium sulfate, about 1.12 grams of potassium chloride, about 0.9 grams of magnesium sulfate, 0.5 grams of sodium chloride; The proposed generic product is alleged to contain the same active ingredients at the same strengths as the patented SUFLAVE® product. ¶¶22, 28 col. 18:27-35
(b) a second container comprising a second portion of the first dose...comprising malic acid and citric acid; The proposed generic product is alleged to be the same as SUFLAVE®, which is covered by the claims of the patent, implying the presence of all claimed components. ¶¶16, 28 col. 18:36-39
(c) a third container comprising a first portion of a second dose... [repeating ingredients from (a)]; and (d) a fourth container... [repeating ingredients from (b)] The proposed generic is alleged to have the same dosage form and administration as SUFLAVE®, implying a split-dose kit structure as claimed. ¶¶22, 28 col. 18:40-49
wherein the colon cleansing product further comprises lemon-lime flavor, sucralose, and neotame; The infringement allegation against the composition as a whole implies the presence of the claimed flavoring agents necessary for bioequivalence. ¶¶22, 28 col. 18:50-52
wherein the colon cleansing product is formulated so that the combination of the first dose and second dose cleanse a colon of a subject without causing a sodium balance of -50.00 mEq/L or greater in the subject. The allegation that the proposed generic is bioequivalent to SUFLAVE® implies that it will have the same clinical safety profile and effects. ¶¶22, 28 col. 18:53-57

Identified Points of Contention

  • Scope Questions: A central question may be the interpretation of the term "about" as it applies to the specific weight of each ingredient. The analysis will turn on whether the formulation described in Defendants' confidential ANDA falls within the scope of the claimed weights, even with minor variations.
  • Technical Questions: A key evidentiary dispute may arise over the negative functional limitation regarding sodium balance. The question will be whether the clinical data submitted in Defendants' ANDA demonstrates that their product meets this specific safety threshold, or if it can be shown to perform differently from the claimed invention.

V. Key Claim Terms for Construction

  • The Term: "about"

    • Context and Importance: This term modifies every recited weight in claim 1 (e.g., "about 178.7 grams"). Its construction will be dispositive for literal infringement, as any deviation in the accused product's formulation from the exact numbers will require the court to determine the permissible range of variance.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification discusses ingredient amounts in ranges (e.g., "from about 10.00 grams to about 25.00 grams of sodium sulfate"), suggesting the inventors contemplated some variability around specific values (’529 Patent, col. 6:30-34).
      • Evidence for a Narrower Interpretation: The claim recites quantities with high precision (e.g., "178.7," "1.12"). Parties may argue that this precision, especially when derived from a specific formulation example in the patent (Formulation BLI4900-5), implies that "about" should be construed narrowly to encompass only minor variations due to standard manufacturing tolerances (’529 Patent, col. 13, Table 1).

  • The Term: "without causing a sodium balance of -50.00 mEq/L or greater in the subject"

    • Context and Importance: This functional limitation defines the invention partly by its clinical effect on a patient's electrolytes. Infringement requires that the accused product achieves this specific safety outcome. The dispute will likely center on the evidence required to prove or disprove this clinical effect.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent's own clinical data distinguishes a preferred embodiment (BLI4900-5, sodium balance of -13.00) from a prior formulation (BLI4900-4, sodium balance of -61.9), framing this threshold as a key inventive feature tied to the overall composition (’529 Patent, col. 17, Table 2). A plaintiff may argue that any bioequivalent formulation necessarily meets this criterion.
      • Evidence for a Narrower Interpretation: The term "a subject" raises the question of whether this condition must be met in all subjects, an average subject, or a statistically significant portion of subjects. A defendant could argue that if its product causes a greater sodium loss in a identifiable patient subgroup, it does not meet this limitation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, Defendants will induce and contribute to infringement by providing a product with labeling that instructs medical professionals and patients to use it in an infringing manner. It further alleges the product is especially made for this use and lacks a substantial non-infringing use (Compl. ¶31).
  • Willful Infringement: The complaint does not explicitly plead "willful infringement" but alleges that Defendants possessed "actual and constructive knowledge of the '529 Patent prior to filing ANDA No. 220202" (Compl. ¶29). This allegation of pre-suit knowledge could form the basis for a later claim for enhanced damages.

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

  • A core issue will be one of compositional identity: Does the precise formulation contained within Defendants' confidential ANDA filing literally meet every quantitative limitation of claim 1, and how broadly will the court construe the term "about" in the context of the patent's highly specific examples?
  • A key evidentiary question will be one of clinical equivalence: How will the parties use the clinical data from the ANDA and the patent's specification to prove or disprove that the accused product satisfies the claimed safety profile, specifically the negative limitation on sodium balance loss?