DCT
3:25-cv-13133
Braintree Laboratories Inc v. Lupin Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Braintree Laboratories, Inc. (Massachusetts)
- Defendant: Lupin Limited (India); Lupin Pharmaceuticals, Inc. (Delaware); Lupin Inc. (Delaware)
- Plaintiff’s Counsel: ROBINSON MILLER, LLC
- Case Identification: 3:25-cv-13133, D.N.J., 07/10/2025
- Venue Allegations: Venue is asserted based on Defendants Lupin Pharmaceuticals, Inc. and Lupin Inc. having a regular and established place of business in Somerset, New Jersey, which includes a manufacturing facility. Defendant Lupin Limited is alleged to act in concert with and through its U.S. affiliates.
- Core Dispute: Plaintiff alleges that Defendants’ filing of an 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 their administration.
- Technical Context: The technology relates to oral solutions for cleansing the colon prior to medical procedures like colonoscopies, a critical preparatory step in a widely used diagnostic field.
- Key Procedural History: This action was triggered by Defendants' submission of ANDA No. 220363 to the U.S. Food and Drug Administration (FDA), which constitutes a statutory act of infringement under the Hatch-Waxman Act. Plaintiff received a "Notice Letter" from Lupin on May 27, 2025, informing it of the ANDA filing. The patents-in-suit are listed in the FDA's "Orange Book" as covering Braintree's SUFLAVE® product.
Case Timeline
| Date | Event |
|---|---|
| 2023-06-15 | Earliest Priority Date for '659 and '529 Patents |
| 2023-06-15 | FDA Approval of Braintree’s SUFLAVE® (NDA No. 215344) |
| 2025-03-04 | U.S. Patent No. 12,239,659 Issues |
| 2025-05-06 | U.S. Patent No. 12,290,529 Issues |
| 2025-05-27 | Lupin Limited Sends Notice Letter Regarding ANDA Filing |
| 2025-07-10 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,239,659 - "Methods of Administering Safe Colon Cleansing Compositions" (Issued Mar. 4, 2025)
The Invention Explained
- Problem Addressed: The patent describes challenges with prior art colon cleansing preparations, including the poor taste and large volumes of early polyethylene glycol (PEG) solutions that led to low patient compliance, and the safety risks (e.g., renal failure) associated with more tolerable phosphate-based solutions (’659 Patent, col. 3:11-49). Later combinations, such as MiraLax® and Gatorade®, required adjunct stimulant laxatives and raised concerns about electrolyte imbalances and PEG degradation (’659 Patent, col. 4:50-5:4).
- The Patented Solution: The patent discloses a method of administering a colon cleansing composition that combines PEG with a specific mixture of sulfate salts to induce purgation. The method involves a split-dosing regimen and a flavoring system that includes organic acids (e.g., malic and citric acid) and non-fermentable sweeteners, which is intended to improve palatability and stability without requiring adjunct laxatives (’659 Patent, Abstract; col. 4:10-28). The core of the invention is a multi-step method for preparing and consuming the solution in a way that is safe and effective (’659 Patent, col. 7:1-8:43).
- Technical Importance: The claimed method seeks to enhance patient compliance and safety for colonoscopy preparations by providing a formulation that is more palatable and avoids the need for adjunct laxatives and the risk of significant electrolyte shifts (’659 Patent, Abstract; col. 7:6-9).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 (Compl. ¶35).
- The essential elements of independent claim 1 are:
- (a) Providing a first container with a first portion of a dose, including PEG, sodium sulfate, potassium chloride, magnesium sulfate, sodium chloride, and specific flavorings.
- (b) Providing a second container with a second portion of the dose, including malic acid and citric acid.
- (c) Mixing the contents of both containers with water to form a first dose.
- (d) Consuming the first dose.
- (e-g) Repeating the providing and mixing steps to form a second dose.
- (h) Consuming the second dose, where the combined doses cleanse the colon "without causing a sodium balance of -50.00 mEq/L or greater in the patient."
- The complaint reserves the right to assert additional claims (Compl. ¶35).
U.S. Patent No. 12,290,529 - "Methods of Administering Safe Colon Cleansing Compositions" (Issued May 6, 2025)
The Invention Explained
- Problem Addressed: The technical problems are identical to those described in the ’659 Patent: poor patient compliance due to bad taste and large volumes, and safety issues with prior art formulations (’529 Patent, col. 3:11-4:8).
- The Patented Solution: Rather than a method of administration, this patent claims the product itself. The invention is a multi-component colon cleansing product, or kit, that comprises specific ingredients packaged in four separate containers for a two-dose regimen (’529 Patent, col. 18:23-46). This product is formulated to achieve effective cleansing while maintaining a specific safety profile, particularly regarding the patient's sodium balance (’529 Patent, Abstract; col. 18:49-52).
- Technical Importance: By providing a pre-packaged kit, the invention aims to simplify the preparation process for patients, ensure accurate mixing of components, and deliver the benefits of the formulation described in the related '659 Patent.
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 (Compl. ¶43).
- The essential elements of independent claim 1 are:
- (a) A first container comprising a first portion of a first dose (PEG 3350, sodium sulfate, potassium chloride, magnesium sulfate, sodium chloride).
- (b) A second container comprising a second portion of the first dose (malic acid and citric acid).
- (c) A third container comprising a first portion of a second dose (same ingredients as (a)).
- (d) A fourth container comprising a second portion of the second dose (same ingredients as (b)).
- The product further comprises lemon-lime flavor, sucralose, and neotame.
- The product is formulated so that the combined doses cleanse a colon "without causing a sodium balance of -50.00 mEq/L or greater in the subject."
- The complaint reserves the right to assert additional claims (Compl. ¶43).
III. The Accused Instrumentality
Product Identification
Defendants' proposed generic version of Braintree's SUFLAVE® drug product, which is the subject of ANDA No. 220363 filed with the FDA (Compl. ¶¶1, 28).
Functionality and Market Context
The complaint alleges that the proposed generic product contains polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride (Compl. ¶34, 42). It is further alleged to have the "same active ingredients, the same route of administration, the same dosage form, and the same strengths" as the brand-name SUFLAVE® product and to be "bioequivalent" to it (Compl. ¶29). The product is intended for cleansing of the colon in preparation for colonoscopy (Compl. ¶18).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
'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 of a colon cleansing product comprising about 178.7 grams of polyethylene glycol, about 7.3 grams of sodium sulfate... | Defendants' proposed generic product will allegedly be supplied in a kit with containers holding the same components and strengths as SUFLAVE®, matching the claimed ingredients. | ¶¶29, 35 | col. 18:25-32 |
| (b) providing a second container comprising a second portion of the first dose...comprising malic acid and citric acid; | The generic product kit will allegedly also contain the specified organic acids, as it is asserted to have the same components as SUFLAVE®. | ¶¶29, 35 | col. 18:33-35 |
| (d) consuming the first dose... (h) consuming the second dose... | The proposed labeling for Defendants' generic product will allegedly instruct medical providers and patients to prepare and consume the product in a manner that constitutes performance of the claimed method steps. | ¶¶37, 38 | col. 18:41, 58 |
| ...wherein consumption of the first dose and second dose cleanses the colon...without causing a sodium balance of -50.00 mEq/L or greater in the patient. | The generic product is alleged to be bioequivalent to SUFLAVE®, and therefore its use as instructed would result in the same functional outcome of cleansing the colon while meeting the claimed sodium balance safety profile. | ¶¶29, 35 | col. 18:58-63 |
Identified Points of Contention
- Technical Questions: A primary question for the court will be whether Defendants' proposed product label instructs users to perform a method that meets every limitation of claim 1. The infringement allegation for the functional limitation regarding sodium balance relies heavily on the assertion of bioequivalence (Compl. ¶29); the court may need to examine what evidence supports that the generic product will actually perform within this claimed safety parameter.
- Legal Questions: Infringement of the method claims is based on a theory of inducement. The analysis will turn on whether Defendants' actions, particularly the content of the proposed product label, demonstrate the specific intent to encourage direct infringement by end-users (Compl. ¶38).
'529 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) a first container... (b) a second container... (c) a third container... (d) a fourth container... | Defendants' proposed generic product, as described in their ANDA, is alleged to be a multi-component kit with the same dosage form and strengths as SUFLAVE®, thereby meeting the structural limitations of the four claimed containers. | ¶¶29, 43 | col. 18:25-46 |
| wherein the colon cleansing product further comprises lemon-lime flavor, sucralose, and neotame; | It is alleged on information and belief that the generic product has the same components as SUFLAVE®, which would include the recited non-active flavoring and sweetener ingredients. | ¶¶29, 43 | col. 18:47-48 |
| 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 generic product is bioequivalent to SUFLAVE® is the basis for asserting that it is formulated to meet this functional safety and efficacy limitation. | ¶¶29, 43 | col. 18:49-52 |
Identified Points of Contention
- Scope Questions: The court may need to consider whether the term "comprising" allows Defendants' product to include additional, unrecited excipients that might distinguish it from the literal scope of the claims, even if it contains all the recited elements.
- Technical Questions: The complaint alleges that the generic has the "same components" (Compl. ¶29), but the core of an ANDA filing relates to active ingredients and bioequivalence. A potential dispute is whether Defendants' generic product will contain the exact same non-active ingredients (flavor, sweeteners) as claimed. Furthermore, the "sodium balance" element is a functional limitation; a key question will be whether Defendants' product as actually formulated meets this requirement.
V. Key Claim Terms for Construction
The Term: "without causing a sodium balance of -50.00 mEq/L or greater" (’659 Patent, cl. 1; ’529 Patent, cl. 1)
- Context and Importance: This negative functional limitation defines a key safety attribute of the invention. The infringement analysis for both patents hinges on whether Defendants' product meets this requirement. Its construction will be critical, and Defendants may argue the term is indefinite if the method for its measurement is not clear from the patent.
- Intrinsic Evidence for a Broader Interpretation: The specification provides data showing a prior art formulation with a sodium balance of -61.9 mEq/L and an embodiment of the invention with a balance of -13.00 mEq/L (’659 Patent, Table 2). This suggests "greater" means "less negative" (e.g., -49, -30, 0, or a positive value), which would encompass any result that is better for the patient than the -50.00 mEq/L threshold.
- Intrinsic Evidence for a Narrower Interpretation: A party could argue for a literal reading that is confusing, or assert that the term is indefinite without reference to the specific testing protocol detailed in the patent's examples section (’659 Patent, col. 15:47-16:4). The definiteness of the term may depend on whether that protocol is considered integral to its meaning.
The Term: "components" (as used in the complaint)
- Context and Importance: While not a claim term, the complaint's repeated allegation that the generic product has the "same components" as SUFLAVE® (Compl. ¶¶29, 35, 43) is the primary factual basis for infringement of limitations directed to non-active ingredients. Practitioners may focus on this term because its interpretation will determine the strength of the infringement case for elements like flavors and sweeteners.
- Evidence for a Broader Interpretation: Plaintiff will likely argue that "components" in this context refers to all ingredients, active and inactive, necessary for the product to be a true generic equivalent.
- Evidence for a Narrower Interpretation: Defendants may argue that in the context of an ANDA, equivalence relates to "active ingredients" and "bioequivalence," not necessarily every identical inactive ingredient. This could create a non-infringement argument for claims that recite specific flavors or sweeteners.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants will induce infringement of the method claims of the ’659 Patent by providing a product with labeling that instructs users to perform the patented method (Compl. ¶38). It also alleges contributory infringement, stating the proposed generic product is especially made for infringing use and has no substantial non-infringing use (Compl. ¶¶38, 46). Knowledge is alleged based on the patents' listing in the FDA's Orange Book and the notice letter sent by Lupin (Compl. ¶¶36, 44).
- Willful Infringement: The complaint does not use the term "willful," but it alleges that Defendants had "actual and constructive knowledge" of the asserted patents prior to filing their ANDA (Compl. ¶¶36, 44). These allegations of pre-suit knowledge form the factual basis upon which a claim for willful infringement and enhanced damages could be pursued.
VII. Analyst’s Conclusion: Key Questions for the Case
This ANDA litigation will likely center on the following key questions:
- A central issue will be one of functional equivalence: Does the allegation that Lupin's product is "bioequivalent" to SUFLAVE® suffice to prove, as a matter of fact, that it will meet the specific functional limitation of causing "a sodium balance of -50.00 mEq/L or greater," or will Braintree need to present further evidence on the specific formulation of the generic?
- A key evidentiary question for the '659 method patent will be whether Lupin’s proposed product label constitutes instruction to perform every step of the asserted method claims, which is necessary to establish the intent required for induced infringement.
- The case may also involve a significant claim construction dispute over the definiteness and scope of the "sodium balance" limitation, including the precise methodology required to measure it and whether "greater" is understood to mean "less negative."