DCT

1:25-cv-13133

Braintree Laboratories Inc v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-13133, D.N.J., 07/10/2025
  • Venue Allegations: Venue is based on allegations that Lupin Pharmaceuticals, Inc. and Lupin Inc. maintain a regular and established place of business in Somerset, New Jersey, which includes a manufacturing facility encompassing research and development, production, and regulatory affairs.
  • Core Dispute: Plaintiff alleges that Defendants' Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's SUFLAVE® drug product constitutes an act of infringement of two patents covering colon cleansing compositions and methods of administration.
  • Technical Context: The technology relates to oral solutions for cleansing the colon prior to medical procedures such as colonoscopies, a market where patient compliance, safety, and comfort are significant factors.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following a notice letter from Lupin Limited, dated May 27, 2025, informing Braintree of its ANDA filing. The Asserted Patents are listed in the FDA's "Orange Book" for Braintree's SUFLAVE® product. The complaint notes that the Lupin entities have previously submitted to the jurisdiction of the District of New Jersey in other patent litigation.

Case Timeline

Date Event
2023-06-15 Earliest Priority Date for '659 and '529 Patents
2023-06-15 FDA Approval Date for SUFLAVE®
2025-03-04 U.S. Patent No. 12,239,659 Issue Date
2025-05-06 U.S. Patent No. 12,290,529 Issue Date
2025-05-27 Date of Lupin's ANDA Notice Letter
2025-07-10 Complaint Filing Date

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

U.S. Patent No. 12,239,659 - Methods of Administering Safe Colon Cleansing Compositions

  • Patent Identification: U.S. Patent No. 12,239,659, Methods of Administering Safe Colon Cleansing Compositions, issued March 4, 2025. (Compl. ¶20; '659 Patent, (45)).

The Invention Explained

  • Problem Addressed: The patent describes challenges with prior art colon cleansing preparations. Large-volume polyethylene glycol (PEG) solutions are noted for poor patient compliance due to their large volume and unpleasant taste, while smaller-volume phosphate-based solutions were associated with safety risks like renal failure. Common "off-label" preparations combining laxatives like MiraLax® with sports drinks require adjunct stimulant laxatives and can present safety and compliance issues. (’659 Patent, col. 1:21-col. 2:6).
  • The Patented Solution: The invention is a method for administering a colon cleansing composition containing PEG and specific sulfate salts. This combination is designed to induce purgation effectively without requiring adjunct stimulant laxatives, while also incorporating a flavoring system to improve palatability and specific electrolyte balancing to enhance safety. (’659 Patent, Abstract; col. 2:10-28). The method involves a split-dosing regimen where the formulation is prepared from separate containers of active ingredients and acids before consumption. (’659 Patent, col. 18:22-63).
  • Technical Importance: The claimed method aims to provide a colon cleansing option that balances efficacy, safety, and patient tolerability, potentially improving patient compliance with screening colonoscopies. (’659 Patent, col. 1:12-20).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1. (Compl. ¶35).
  • Independent Claim 1 of the ’659 Patent recites a method with the essential steps of:
    • Providing separate containers for a first dose, one with the active ingredients (PEG, salts, flavors) and another with acids (malic and citric acid).
    • Mixing the contents of the two containers with water to form the first dose.
    • Consuming the first dose.
    • Repeating the providing and mixing steps to form and consume a second dose.
    • Wherein the consumption of the two doses cleanses the colon sufficiently for medical procedures and "does not cause a sodium balance of -50.00 mEq/L or greater in the patient." (’659 Patent, col. 18:22-col. 19:2).

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

  • Patent Identification: U.S. Patent No. 12,290,529, Methods of Administering Safe Colon Cleansing Compositions, issued May 6, 2025. (Compl. ¶24; ’529 Patent, (45)).

The Invention Explained

  • Problem Addressed: The technical problems described are identical to those in the parent ’659 Patent, focusing on the taste, volume, and safety drawbacks of previous colonoscopy preparations. (’529 Patent, col. 1:21-col. 2:6).
  • The Patented Solution: Unlike the method claim of the ’659 Patent, this patent claims a colon cleansing product. The product is defined as comprising a multi-container kit (four containers total for two doses) with the active ingredients and acids separated. The patent claims the product as being "formulated" to achieve effective cleansing without causing a significant negative sodium balance in the patient. (’529 Patent, Abstract; col. 2:10-28; col. 18:23-53).
  • Technical Importance: This patent protects the physical product kit itself, complementing the method-of-use protection provided by the ’659 Patent. (’529 Patent, col. 1:12-20).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1. (Compl. ¶43).
  • Independent Claim 1 of the ’529 Patent recites a product comprising:
    • A first container with a first portion of a dose (PEG 3350, sodium sulfate, potassium chloride, magnesium sulfate, sodium chloride).
    • A second container with a second portion of the dose (malic acid and citric acid).
    • A third container and fourth container repeating the formulations of the first and second.
    • Wherein the product further comprises specific flavoring agents and is formulated so that the combined doses "cleanse a colon of a subject without causing a sodium balance of -50.00 mEq/L or greater in the subject." (’529 Patent, col. 18:23-53).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the proposed generic drug product that is the subject of Defendants' Abbreviated New Drug Application (ANDA) No. 220363. (Compl. ¶1, ¶14).

Functionality and Market Context

  • The complaint alleges that Defendants' ANDA filing represents that their proposed generic product contains the "same active ingredients, the same route of administration, the same dosage form, and the same strengths" as Braintree's SUFLAVE®. (Compl. ¶29). The active ingredients are identified as polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride. (Compl. ¶34). The product is intended for cleansing the colon before a colonoscopy and is alleged to be "bioequivalent to SUFLAVE®." (Compl. ¶18, ¶29). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the act of filing ANDA No. 220363 constitutes infringement under 35 U.S.C. § 271(e)(2). The theory is that the product described in the ANDA, if commercially manufactured and sold, would infringe the asserted patents. The infringement allegations for both patents rest on the assertion that the proposed generic product is a copy of SUFLAVE® in its composition, dosage, and administration, and that its proposed labeling will instruct for an infringing use. (Compl. ¶¶35, 38, 43, 46).

’659 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
(a) providing a first container comprising a first portion of a first dose... comprising about 178.7 grams of polyethylene glycol, about 7.3 grams of sodium sulfate... The proposed generic product, as described in the ANDA, will be supplied in a multi-container kit with these specified ingredients and amounts. ¶29, ¶34, ¶35 col. 18:25-33
(c) mixing the contents... with about 0.5 liters to about 1.0 liters of water... The proposed labeling for the generic product will allegedly instruct patients and physicians to mix and administer the product in this manner. ¶38 col. 18:37-41
(h) consuming the second dose, wherein consumption... cleanses the colon... and... does not cause a sodium balance of -50.00 mEq/L or greater... The proposed generic product is alleged to be bioequivalent to SUFLAVE® and intended for the same use, which Braintree alleges will result in the claimed cleansing and safety profile. ¶29, ¶35 col. 18:59-col. 19:2

’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... about 178.7 grams of polyethylene glycol 3350... Defendants' ANDA allegedly describes a product supplied in a multi-container kit that contains the claimed ingredients at the specified strengths. ¶29, ¶42, ¶43 col. 18:24-32
wherein the colon cleansing product further comprises lemon-lime flavor, sucralose, and neotame; The proposed generic product is alleged to have the same composition as SUFLAVE®, which would include the claimed flavoring agents. ¶29, ¶43 col. 18:47-48
and wherein the colon cleansing product is formulated so that the combination... cleanse a colon... without causing a sodium balance of -50.00 mEq/L or greater... The filing of an ANDA for a bioequivalent product allegedly constitutes the creation of a product that is formulated to meet this efficacy and safety profile. ¶29, ¶43 col. 18:49-53

Identified Points of Contention

  • Scope Questions: The negative limitation "does not cause a sodium balance of -50.00 mEq/L or greater" (in the ’659 Patent) and the corresponding formulation limitation in the ’529 Patent will be a central focus. The dispute will question whether Lupin's ANDA submission contains data demonstrating that its product meets this specific safety parameter.
  • Technical Questions: A key evidentiary question will be whether the data within Lupin's ANDA, once produced in discovery, confirms that its generic product is in fact "formulated" to meet every claimed limitation. The complaint relies on the legal presumption flowing from the ANDA filing and bioequivalence assertion, but the underlying technical data will be subject to scrutiny.

V. Key Claim Terms for Construction

  • The Term: "sodium balance of -50.00 mEq/L or greater"
  • Context and Importance: This quantitative negative limitation appears in the independent claims of both asserted patents and defines a key safety feature of the invention. Practitioners may focus on this term because infringement depends on the accused product not causing a sodium loss at or beyond this threshold. Its precise meaning and the protocol for its measurement are critical.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party could argue the term should be understood in the context of standard clinical practice for measuring electrolyte balance, without being strictly limited to the patent's specific test protocol.
    • Evidence for a Narrower Interpretation: The patent specification provides specific clinical trial data in Table 2, which details the "Gastric Electrolyte Balance" for several formulations. (’659 Patent, col. 17-18, Table 2). Formulation "BLI4900-4" is shown with a sodium balance of -61.9 mEq/L, while the improved "BLI4900-5" has a balance of -13.00 mEq/L. A party will argue that these examples, in conjunction with the detailed study protocol described, explicitly define the scope and measurement method for this term. (’659 Patent, col. 15:3-col. 16:65).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement to infringe. The factual basis for this claim is the allegation that Defendants know their product is especially adapted for an infringing use and that the "proposed labeling" for the generic product will instruct patients and healthcare providers to use it in a manner that directly infringes the method claims of the ’659 Patent. (Compl. ¶38, ¶46).
  • Willful Infringement: The complaint does not contain an explicit count for willful infringement. However, it alleges that Defendants had "actual and constructive knowledge" of the Asserted Patents prior to filing their ANDA. (Compl. ¶36, ¶44). These allegations may provide a foundation for a later claim of willfulness, particularly concerning any commercial activity that occurs post-filing.

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

  • A core issue will be one of clinical and factual proof: Does the defendants' proposed generic product, as defined by the data in their ANDA, actually meet the quantitative safety limitation of not causing a "sodium balance of -50.00 mEq/L or greater"? The case may turn on a "battle of the data" between the parties' respective clinical findings for the generic formulation.
  • A second key question will be one of validity: Assuming the generic product falls within the scope of the claims, the defense will likely focus on arguing that the asserted claims are invalid as obvious over prior art combinations of PEG, sulfate salts, and flavorings used for colon cleansing. The patentability of this specific formulation, particularly its claimed safety profile, will be a central point of contention for the court.