DCT
1:25-cv-16717
Braintree Laboratories Inc v. Strides Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Braintree Laboratories, Inc. (Massachusetts)
- Defendant: Strides Pharma Inc. (New Jersey) and Strides Pharma Global PTE Ltd. (Singapore)
- Plaintiff’s Counsel: Robinson Miller LLC
- Case Identification: 1:25-cv-16717, D.N.J., 10/17/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Strides Pharma Inc. maintains a regular and established place of business in Bridgewater, New Jersey, and both Defendants place goods into the stream of commerce for distribution in New Jersey.
- 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 specific colon cleansing compositions.
- Technical Context: The technology concerns oral pharmaceutical formulations designed for cleansing the colon prior to medical procedures, a field where patient compliance, safety, and efficacy are critical for successful diagnostic outcomes.
- Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendants' notification to Plaintiff of their ANDA filing. The patent-in-suit is listed in the U.S. Food and Drug Administration's "Orange Book" as covering the SUFLAVE® product. The patent is subject to a terminal disclaimer.
Case Timeline
| Date | Event |
|---|---|
| 2023-06-15 | U.S. Patent No. 12,290,529 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 send notice letter regarding ANDA filing |
| 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"
- Patent Identification: U.S. Patent No. 12,290,529, "Methods of Administering Safe Colon Cleansing Compositions," issued May 6, 2025 (the "'529 Patent").
The Invention Explained
- Problem Addressed: The patent's background section describes challenges with prior art colon cleansing preparations. Large-volume solutions based on polyethylene glycol (PEG) suffered from poor patient compliance due to their large volume and unpleasant taste. Smaller-volume preparations using phosphates were associated with a risk of renal failure. Other approaches combined PEG with sports drinks and stimulant laxatives, which raised safety concerns regarding electrolyte imbalances (hyponatremia) and introduced fermentable sugars that could pose a hazard during procedures. (’529 Patent, col. 1:10-2:7).
- The Patented Solution: The invention is a multi-component colon cleansing composition designed to be both effective and well-tolerated. It combines PEG with specific sulfate salts (sodium sulfate and magnesium sulfate) to induce purgation, along with a balance of electrolytes (potassium chloride and sodium chloride) to maintain patient safety. The solution also incorporates a specific flavoring system, including non-fermentable sweeteners and organic acids, to improve palatability and patient compliance without degrading the PEG component. (’529 Patent, Abstract; col. 2:10-28).
- Technical Importance: This approach sought to create a lower-volume, safer, and better-tasting bowel preparation that eliminated the need for adjunct stimulant laxatives, thereby improving the patient experience and the reliability of colonoscopies. (’529 Patent, col. 2:10-15).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 (Compl. ¶28).
- The essential elements of independent claim 1 are:
- A first container with a first dose portion containing specified amounts of polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride.
- A second container with a first dose portion containing malic acid and citric acid.
- A third container with a second dose portion containing the same ingredients as the first container.
- A fourth container with a second dose portion containing malic acid and citric acid.
- 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 does not explicitly reserve the right to assert dependent claims, but the prayer for relief requests judgment that "one or more claims" are infringed (Compl., p. 9).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the proposed generic drug product described in Defendants' ANDA No. 220202, which seeks FDA approval to market a generic version of Plaintiff's SUFLAVE® (Compl. ¶1, ¶21).
Functionality and Market Context
- The proposed product is an oral solution for cleansing the colon in preparation for colonoscopy (Compl. ¶15). The complaint alleges that the ANDA product contains the same active ingredients (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride), route of administration, dosage form, and strengths as SUFLAVE® (Compl. ¶22, ¶28). The complaint further alleges that the proposed generic is represented to be bioequivalent to SUFLAVE® (Compl. ¶22).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
- Claim Chart Summary: The infringement allegations are based on the statutory act of filing an ANDA for a product that, if marketed, would infringe. The complaint alleges the proposed generic product will contain the same components as the patented invention.
'529 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a first container comprising a first portion of a first dose of a colon cleansing product 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 | Defendants' proposed generic version of SUFLAVE® is alleged to have the same active ingredients and strengths as the branded product, which contains these components in these amounts per dose. | ¶22, ¶28 | col. 13:47-56 |
| a second container comprising a second portion of the first dose of a colon cleansing product comprising malic acid and citric acid | The complaint does not detail the excipients of the ANDA product but alleges it is a generic version of SUFLAVE®, which is formulated with these acids. | ¶22, ¶28 | col. 13:56-60 |
| wherein the colon cleansing product further comprises lemon-lime flavor, sucralose, and neotame | The complaint does not detail the flavoring agents of the ANDA product but alleges it is a generic version of SUFLAVE®, which is formulated with these agents. | ¶22, ¶28 | col. 13:41-45 |
| 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 complaint alleges that the proposed generic version of SUFLAVE® is bioequivalent to the branded product, which is formulated to have this safety profile. | ¶22, ¶30 | col. 17, Table 2 |
- Identified Points of Contention:
- Scope Questions: A central dispute may arise over the final negative limitation: "without causing a sodium balance of -50.00 mEq/L or greater." Questions may be raised about whether this functional language renders the claim indefinite under 35 U.S.C. § 112, as its verification could depend on patient-specific factors or testing protocols not fully detailed in the patent.
- Technical Questions: What evidence does the complaint provide that the proposed ANDA product will necessarily exhibit the claimed sodium balance profile? The complaint relies on the allegation of bioequivalence (Compl. ¶22), which suggests the Plaintiff's position is that a bioequivalent product will inherently possess the same clinical and safety characteristics. The litigation will likely require a deeper examination of the ANDA filing and any associated clinical data to determine if the proposed generic meets this functional requirement.
V. Key Claim Terms for Construction
- The Term: "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"
- Context and Importance: This negative functional limitation is a critical distinguishing feature of the claimed invention, linking the specific formulation to a desired clinical safety outcome. Its construction will be dispositive for infringement, as Defendants may argue their product does not meet this limitation or that the term is indefinite.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification emphasizes that a key advantage of the invention is that it does not "cause clinically significant electrolyte shifts" ('529 Patent, col. 11:1-3). Table 2 presents data from a formulation (BLI4900-5) corresponding to the claimed invention, showing a measured sodium balance of -13.00 mEq/L, well within the claimed boundary ('529 Patent, col. 17, Table 2). A party could argue this data provides an objective, measurable standard for what the claim language means.
- Evidence for a Narrower Interpretation: The specification does not define a specific protocol or patient population for measuring the "sodium balance." A party could argue that without such parameters, the claim term is ambiguous and its scope is unclear. The use of the general term "a subject" may be argued to introduce variability that makes the limitation difficult to consistently apply.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants will induce and contribute to infringement upon FDA approval (Compl. ¶31). The basis for this allegation is that Defendants' product and its proposed labeling are "especially made or adapted for use in infringing the '529 Patent" and that the labeling will instruct physicians and patients to use the product in an infringing manner (Compl. ¶31).
- Willful Infringement: The complaint does not use the word "willful," but it alleges that Defendants had "actual and constructive knowledge of the '529 Patent prior to filing" the ANDA (Compl. ¶29). This allegation could form the basis for a later claim for enhanced damages if post-launch infringement is found.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim definiteness and scope: Is the functional limitation requiring a specific sodium balance outcome sufficiently clear and supported by the specification to be enforceable under 35 U.S.C. § 112? If so, does the evidence in Defendants' ANDA establish that their proposed bioequivalent product will necessarily meet this requirement?
- A key evidentiary question will be one of formulation identity: Does the proposed generic product's complete formulation, including its flavoring agents and other excipients, fall within the literal scope of Claim 1? While ANDA products are designed to be therapeutic equivalents, minor differences in inactive ingredients could become a focal point of the non-infringement defense.