DCT

1:23-cv-02853

Braintree Laboratories Inc v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-02853, D.N.J., 07/05/2023
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because Defendant entities Lupin Pharmaceuticals, Inc. and Lupin Inc. maintain a regular and established place of business in Somerset, New Jersey, and that parent company Lupin Limited acts in concert with and controls its New Jersey-based affiliates.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs' SUTAB® colonoscopy preparation product infringes four patents related to solid oral sulfate salt formulations.
  • Technical Context: The technology concerns solid tablet formulations for colon cleansing, which aim to improve patient compliance and safety compared to traditional large-volume liquid preparations or phosphate-based tablets.
  • Key Procedural History: The asserted patents are listed in the U.S. Food and Drug Administration's (FDA) "Orange Book" for SUTAB®. The lawsuit was triggered by notice letters from Defendant Lupin Limited, dated April 13, 2023, and June 16, 2023, informing Plaintiffs of its ANDA submission seeking to market a generic version of SUTAB® prior to the expiration of the asserted patents.

Case Timeline

Date Event
2017-08-04 Priority Date ('656, '498, '864, '697 Patents)
2018-12-04 Issue Date (U.S. Patent No. 10,143,656)
2020-11-10 SUTAB® FDA Approval Date
2021-06-15 Issue Date (U.S. Patent No. 11,033,498)
2022-07-12 Issue Date (U.S. Patent No. 11,382,864)
2023-04-13 Lupin Notice Letter sent to Plaintiffs
2023-05-02 Issue Date (U.S. Patent No. 11,638,697)
2023-06-16 Lupin Supplemental Notice Letter sent to Plaintiffs
2023-07-05 Complaint Filing Date

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

U.S. Patent No. 10,143,656 - “Solid Oral Sulfate Salt Formulations For Cleansing A Colon And Methods Of Using Same”

The Invention Explained

  • Problem Addressed: The patent's background section describes issues with prior art colon cleansing preparations, noting that large-volume liquid solutions lead to poor patient compliance, while earlier tablet forms based on phosphate salts created risks of renal failure (Compl. Ex. A, '656 Patent, col. 1:12-55).
  • The Patented Solution: The invention is a solid oral dosage formulation, such as a tablet, that combines three specific sulfate salts: sodium sulfate, magnesium sulfate, and potassium chloride. This combination of osmotically active salts is designed to induce purgation (cleansing diarrhea) effectively while being balanced to "reduce the likelihood of electrolyte shifts" in the patient, thereby improving the safety profile (Compl. Ex. A, '656 Patent, Abstract; col. 2:48-55).
  • Technical Importance: This approach provided an effective colon cleansing method in a more patient-friendly tablet form, avoiding both the large liquid volumes of polyethylene glycol (PEG)-based solutions and the renal safety risks associated with phosphate-based tablets (Compl. Ex. A, '656 Patent, col. 1:56-col. 2:6).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶45).
  • Essential elements of claim 1:
    • A solid oral formulation for cleansing a colon of a subject;
    • The formulation comprises from about 34.0 grams to about 38.0 grams of sodium sulfate;
    • about 4.0 grams to about 8.5 grams of magnesium sulfate; and
    • about 3.0 grams to about 5.0 grams of potassium chloride.
  • The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation of infringement of "one or more claims" (Compl. ¶44).

U.S. Patent No. 11,033,498 - “Solid Oral Sulfate Salt Formulations For Cleansing A Colon And Methods Of Using Same”

The Invention Explained

  • Problem Addressed: As with the '656 Patent, this patent addresses the need for a safe and effective colon cleansing preparation that overcomes the patient compliance and safety issues of prior liquid and solid formulations (Compl. Ex. B, '498 Patent, col. 1:14-col. 2:14).
  • The Patented Solution: This patent claims a method of cleansing the colon by administering the three-sulfate-salt composition in a specific split-dosing regimen. The method involves administering a first dose of the formulation, followed by a volume of liquid, and then later administering a second dose of the formulation, also followed by liquid, to complete the cleansing process (Compl. Ex. B, '498 Patent, Claim 1; col. 5:1-4).
  • Technical Importance: The split-dosing methodology allows a large total dosage to be administered in a manner that is more tolerable for patients, improving the likelihood of a successful colon cleansing while maintaining the safety benefits of the specific salt combination (Compl. Ex. B, '498 Patent, col. 5:1-4).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶53).
  • Essential elements of claim 1:
    • A method of cleansing the colon comprising:
    • Administering a first dose of a colon cleansing composition "consisting essentially of" an oral dosage form with about 17.75g sodium sulfate, 2.7g magnesium sulfate, and 2.25g potassium chloride;
    • Administering a first volume of liquid within two hours of the first dose;
    • Administering a second dose of the same composition; and
    • Administering a second volume of liquid within two hours of the second dose.
  • The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation of infringement of "one or more claims" (Compl. ¶52).

U.S. Patent No. 11,382,864 - “Solid Oral Sulfate Salt Formulations For Cleansing A Colon And Methods Of Using Same”

  • Patent Identification: U.S. Patent No. 11,382,864, "Solid Oral Sulfate Salt Formulations For Cleansing A Colon And Methods Of Using Same," issued July 12, 2022 (Compl. ¶29).
  • Technology Synopsis: This patent claims a highly specific method for cleansing a colon using a solid oral sulfate salt formulation. The invention requires administering the composition in two separate doses, with multiple, specified volumes of water administered at specific times both during and after each drug dose (Compl. Ex. C, '864 Patent, Claim 1).
  • Asserted Claims: The complaint asserts at least independent claim 1 (Compl. ¶61).
  • Accused Features: The infringement allegation is based on the likelihood that the proposed labeling for Defendants' generic product will instruct patients and physicians to follow the detailed administration protocol recited in the claims, thereby inducing infringement (Compl. ¶¶61, 64).

U.S. Patent No. 11,638,697 - “Solid Oral Sulfate Salt Formulations For Cleansing A Colon And Methods Of Using Same”

  • Patent Identification: U.S. Patent No. 11,638,697, "Solid Oral Sulfate Salt Formulations For Cleansing A Colon And Methods Of Using Same," issued May 2, 2023 (Compl. ¶33).
  • Technology Synopsis: This patent protects a solid oral formulation for colon cleansing comprising a specific combination of sulfate salts. The claims recite precise quantities of sodium sulfate, magnesium sulfate, and potassium chloride that constitute the full therapeutic dose (Compl. Ex. D, '697 Patent, Claim 1).
  • Asserted Claims: The complaint asserts at least independent claim 1 (Compl. ¶69).
  • Accused Features: The composition of Defendants' proposed generic drug product, which is alleged to contain the same active ingredients at the same strengths as SUTAB®, is accused of infringing the patent's formulation claims (Compl. ¶¶69, 72).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the Defendants' proposed generic drug product that is the subject of ANDA No. 216095 (Compl. ¶1).

Functionality and Market Context

  • The complaint alleges that the accused product is a generic version of Braintree's SUTAB® drug product, designed for cleansing the colon prior to a colonoscopy (Compl. ¶1).
  • The product is a solid oral tablet formulation containing 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride per tablet (Compl. ¶¶37, 45). The complaint alleges that under its proposed use, the generic product will have the same active ingredients, route of administration, dosage form, and strengths as SUTAB®, and is represented to the FDA as being bioequivalent to SUTAB® (Compl. ¶¶39-40).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

10,143,656 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A solid oral formulation for cleansing a colon of a subject Defendants' proposed product is a solid tablet formulation intended for colon cleansing. ¶¶39, 45 col. 2:40-41
the formulation comprising from about 34.0 grams to about 38.0 grams of sodium sulfate The proposed total therapeutic dose of 24 tablets contains 35.5 g of sodium sulfate (24 x 1.479 g). ¶¶44, 45 col. 2:42-47
about 4.0 grams to about 8.5 grams of magnesium sulfate The proposed total therapeutic dose of 24 tablets contains 5.4 g of magnesium sulfate (24 x 0.225 g). ¶¶44, 45 col. 2:42-47
and about 3.0 grams to about 5.0 grams of potassium chloride. The proposed total therapeutic dose of 24 tablets contains approximately 4.5 g of potassium chloride (24 x 0.188 g). ¶¶44, 45 col. 2:42-47

11,033,498 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of cleansing the colon, the method comprising: Defendants' proposed product labeling allegedly instructs a method of use for cleansing the colon. ¶¶53, 56 col. 1:1-4
administering a first dose of a colon cleansing composition consisting essentially of an oral dosage form that comprises about 17.75 grams of sodium sulfate, about 2.7 grams of magnesium sulfate, and about 2.25 grams of potassium chloride The proposed label allegedly instructs a first dose of 12 tablets, containing approximately 17.75 g sodium sulfate, 2.7 g magnesium sulfate, and 2.25 g potassium chloride. ¶¶53, 56 col. 5:1-4
administering a second dose of the colon cleansing composition... The proposed label allegedly instructs a second dose of 12 tablets with the same composition as the first dose. ¶¶53, 56 col. 5:1-4
administering a first volume of liquid within two hours of the first dose... [and] a second volume of liquid within two hours of the second dose The proposed label allegedly instructs the patient to consume liquid with each of the two doses as part of the cleansing regimen. ¶¶53, 56 col. 11:22-40

Identified Points of Contention:

  • Scope Questions: The infringement analysis for the '656 and '697 Patents may depend on the construction of the term 'about' as applied to the quantitative ranges of the ingredients. For the method claims in the '498 and '864 Patents, a key question will be the scope of the transitional phrase 'consisting essentially of,' and whether any excipients in the Defendants' formulation materially alter the basic and novel properties of the claimed invention.
  • Evidentiary Questions: For the method claims, infringement hinges on the specific instructions included in the Defendants' proposed product labeling. A primary evidentiary question will be whether the final, FDA-approved label for the generic product instructs users to perform the exact dosing and administration steps recited in the claims of the '498 and '864 patents.

V. Key Claim Terms for Construction

  • The Term: 'about' (e.g., "about 34.0 grams" in '656 Patent, Claim 1)

    • Context and Importance: This term's construction is critical for determining literal infringement of the composition claims in the '656 and '697 Patents. The analysis will focus on whether the precise quantities in the accused generic product fall within the claimed numerical ranges, which are modified by 'about.'
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides an explicit definition: "As used herein, the term 'about' means within +/-10% of the recited value" ('656 Patent, col. 2:50-53). This provides strong support for a construction that is not strictly limited to the recited numbers.
      • Evidence for a Narrower Interpretation: The patent provides specific examples of formulations with precise weights (e.g., 35.5 g of sodium sulfate) ('656 Patent, col. 8, Table 1). A party could argue that these embodiments exemplify the intended scope and that 'about' should not be construed so broadly as to cover formulations that differ significantly from those proven effective in the patent's own studies.

  • The Term: 'consisting essentially of' ('498 Patent, Claim 1)

    • Context and Importance: This transitional phrase is legally distinct from "comprising" and "consisting of." Its interpretation is central to the scope of the method claims in the '498 and '864 Patents. The dispute will likely center on whether unlisted ingredients in the accused product, such as excipients, materially alter the "basic and novel properties" of the invention—namely, cleansing the colon without causing significant electrolyte shifts.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation (Plaintiff's View): The patent describes the core inventive concept as the specific three-salt combination that balances electrolytes ('498 Patent, col. 2:54-61). A party may argue that standard pharmaceutical excipients (e.g., binders, lubricants) do not affect this fundamental property and thus fall within the scope of the claim.
      • Evidence for a Narrower Interpretation (Defendant's View): The patent discusses the importance of dissolution characteristics and the potential for other agents like PEG to be included ('498 Patent, col. 5:1-col. 6:2). A party could argue that specific excipients in its formulation (e.g., those affecting dissolution rate or bioavailability) do materially alter the invention's properties, thus taking the product outside the scope of claims with this transitional phrase.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce infringement of the method patents ('498 and '864 Patents) because their proposed product labeling will instruct physicians and patients to perform the claimed cleansing methods (Compl. ¶¶ 56, 64). It further alleges contributory infringement, stating the proposed product is especially made for infringing use and is not suitable for a substantial non-infringing use (Compl. ¶¶ 48, 56).
  • Willful Infringement: The complaint alleges that Defendants had "actual and constructive knowledge" of the asserted patents prior to filing their ANDA, and that the filing itself constituted an act of infringement (Compl. ¶¶ 46, 54, 62, 70). This forms the basis for the willfulness allegation, which is predicated on alleged pre-suit knowledge.

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

  • A key question will be one of claim construction: The dispute over the composition claims will likely turn on the interpretation of 'about.' The court must decide whether to apply the patent’s explicit "+/- 10%" definition or a narrower construction based on the disclosed embodiments, a decision that will directly impact the literal infringement analysis.
  • A second core issue will be the scope of the method claims: The interpretation of the transitional phrase 'consisting essentially of' will be critical. The case may hinge on an evidentiary finding of whether any unlisted excipients in the Defendants' generic formulation materially alter the fundamental properties of the patented colon cleansing method.
  • Finally, a central evidentiary question for the inducement claims will be the content of the accused product's label: The ultimate infringement finding for the method patents will depend on whether the final, FDA-approved instructions for use direct physicians and patients to perform the specific, multi-step administration protocols recited in the claims.