DCT

1:17-cv-00293

Braintree Laboratories Inc v. Lannett Co Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00293, D. Del., 03/20/2017
  • Venue Allegations: Venue is asserted based on Defendant being a Delaware corporation with a registered agent in the state, its continuous transaction of business in Delaware, and its previous litigation in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff’s SUPREP® bowel preparation kit constitutes an act of infringement of a patent related to low-volume, sulfate-based colon cleansing solutions.
  • Technical Context: The technology involves osmotic laxative formulations designed to cleanse a patient's colon prior to medical procedures, such as a colonoscopy, while minimizing adverse side effects.
  • Key Procedural History: The patent-in-suit, U.S. Patent No. 6,946,149, was the subject of an ex parte reexamination requested by the Plaintiff in 2008. A reexamination certificate was issued in 2009, which cancelled several original claims and confirmed the patentability of other claims in amended form. This history may be relevant to construing the scope of the asserted claims, which were amended during that proceeding. The current lawsuit was triggered by Defendant's 2017 notice letter regarding its ANDA filing.

Case Timeline

Date Event
2002-04-30 '149 Patent Priority Date
2005-09-20 '149 Patent Issue Date
2008-10-15 Ex Parte Reexamination of '149 Patent Requested
2009-06-30 '149 Patent Reexamination Certificate Issued
2010-08-05 Plaintiff's SUPREP® NDA Approved by FDA
2017-02-08 Defendant's ANDA Notice Letter Sent to Plaintiff
2017-03-20 Complaint Filing Date

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

U.S. Patent No. 6,946,149 - "Salt Solution for Colon Cleansing"

The Invention Explained

  • Problem Addressed: The patent's background section describes a trade-off in colon cleansing preparations existing at the time. Large-volume (e.g., four-liter) iso-osmotic solutions were safe regarding patient electrolyte balance but were difficult for patients to consume, leading to poor compliance ('149 Patent, col. 2:5-12). In contrast, small-volume, hyper-osmotic preparations, particularly those based on phosphate salts, were more convenient but carried risks of causing "clinically significant electrolyte disturbances and fluid shifts" ('149 Patent, col. 2:56-64).
  • The Patented Solution: The invention is a low-volume, hyper-osmotic purgative solution that uses a combination of sulfate salts (specifically, sodium, potassium, and magnesium sulfate) instead of phosphates ('149 Patent, col. 4:49-57). This formulation is designed to achieve effective colon cleansing without producing the "clinically significant changes in bodily function" associated with prior small-volume, phosphate-based solutions ('149 Patent, Abstract).
  • Technical Importance: The technology aimed to combine the patient convenience of a small-volume preparation with the superior safety profile of large-volume solutions, addressing a long-standing challenge in the field of bowel preparation for diagnostic procedures ('149 Patent, col. 3:12-23).

Key Claims at a Glance

  • The complaint asserts independent claims 15 and 18, and dependent claims 19, 20, and 23 (Compl. ¶24).
  • The essential elements of independent claim 15, as amended during reexamination, are:
    • A composition for inducing purgation of the colon of a patient,
    • the composition comprising from about 100 ml to about 500 ml of an aqueous hypertonic solution
    • comprising an effective amount of Na₂SO₄, an effective amount of MgSO₄, and an effective amount of K₂SO₄,
    • wherein the composition does not produce any clinically significant electrolyte shifts
    • and does not include phosphate.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Lannett’s proposed generic sodium sulfate, potassium sulfate, and magnesium sulfate oral solution, as described in ANDA No. 209941 (Compl. ¶17).

Functionality and Market Context

  • The product is an oral solution intended for colon cleansing, designed to be a generic equivalent of Braintree’s SUPREP® Bowel Prep Kit (Compl. ¶¶1, 18).
  • The complaint alleges, based on Lannett's notice letter, that the product consists of two 6-ounce bottles, each containing 17.5 g of sodium sulfate, 3.13 g of potassium sulfate, and 1.6 g of magnesium sulfate (Compl. ¶27).
  • For administration, the solution is diluted with water to a final volume of 16 ounces (473 ml) (Compl. ¶27).
  • The complaint asserts that Lannett has represented to the FDA that its product has the same active ingredients, dosage form, and strengths as SUPREP® and is bioequivalent to it (Compl. ¶18).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'149 Patent Infringement Allegations

Claim Element (from Independent Claim 15) Alleged Infringing Functionality Complaint Citation Patent Citation (Reexam Cert.)
A composition for inducing purgation of the colon of a patient... The accused product is alleged to be for the same approved indications as SUPREP®, namely bowel cleansing, and will induce purgation when administered. ¶¶26-27 col. 2:23-24
...the composition comprising from about 100 ml to about 500 ml of an aqueous hypertonic solution... The accused product is administered as a 473 ml solution (16 ounces), which falls within the claimed volume range, and is alleged to be a hypertonic solution like SUPREP®. ¶27 col. 2:25-26
...comprising an effective amount of Na₂SO₄, an effective amount of MgSO₄, and an effective amount of K₂SO₄... The product is alleged to contain 17.5 g of sodium sulfate, 1.6 g of magnesium sulfate, and 3.13 g of potassium sulfate per bottle, which are asserted to be effective amounts for purgation. ¶27 col. 2:26-28
...wherein the composition does not produce any clinically significant electrolyte shifts... This is alleged to be met because the accused product will be administered using the same dosing regimen as SUPREP®, which is designed not to cause such shifts. ¶27 col. 2:28-30
...and does not include phosphate. The complaint anticipates a non-infringement defense that the accused product contains phosphate, but alleges that any such phosphate is not "phosphate within the meaning of the claims" and that the product's active ingredients do not include phosphate. ¶¶28-29 col. 2:30
  • Identified Points of Contention:
    • Scope Questions: The complaint frames the primary dispute around the negative limitation "does not include phosphate" (Compl. ¶¶28-29). This raises a critical claim construction question: does this limitation require the absolute absence of any detectable phosphate, or does it mean the composition is not formulated with phosphate as a functional or active ingredient? The resolution of this question will likely define the scope of the claim.
    • Technical Questions: A key factual question will be whether Defendant's proposed generic product formulation contains any phosphate. If it does, evidence regarding the quantity, chemical form, and source (e.g., impurity vs. intentional ingredient) of that phosphate will be central to the infringement analysis.

V. Key Claim Terms for Construction

  • The Term: "does not include phosphate"
  • Context and Importance: This term, appearing in both asserted independent claims 15 and 18, appears to be the central point of the infringement dispute as framed by the complaint (Compl. ¶28). Practitioners may focus on this term because its construction will determine whether the presence of any amount of phosphate, regardless of its source or function, is sufficient to place the accused product outside the claim scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (Plaintiff's likely view): The patent specification repeatedly contrasts the claimed sulfate-based invention with prior art phosphate-based solutions and their associated dangers, such as hyperphosphatemia ('149 Patent, col. 4:5-28). An interpreter could find that the purpose of this limitation was to exclude formulations that rely on phosphate salts for their osmotic effect, suggesting the term targets functionally significant amounts of phosphate, not necessarily trace impurities.
    • Evidence for a Narrower Interpretation (Defendant's likely view): The plain language is an absolute negative limitation. The patentee added this term during reexamination, which could be interpreted as a clear and deliberate surrender of any composition containing any amount of phosphate to secure patentability. An interpreter could find that if the patentee had intended to permit trace amounts, it could have used qualified language such as "substantially free of phosphate" or "does not include phosphate as an active ingredient."

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, Lannett will induce and contribute to infringement by others (Compl. ¶33). The factual basis alleged is that Lannett's proposed product labeling will instruct physicians and patients to mix and administer the solution in a manner that directly infringes the patent's claims, and that the product is not suitable for a substantial noninfringing use (Compl. ¶¶31-32).
  • Willful Infringement: While the complaint does not use the term "willful," it alleges pre-suit knowledge of the patent and awareness that filing the ANDA constituted an act of infringement (Compl. ¶30). In the context of an ANDA litigation, this allegation is foundational, as the statutory act of infringement itself (35 U.S.C. § 271(e)(2)) is predicated on the ANDA filer's knowledge of the patent listed in the FDA's Orange Book.

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

  • A core issue will be one of definitional scope: The case appears poised to turn on the construction of the claim term "does not include phosphate," which was added during reexamination. The central legal question is whether this creates an absolute bar against any detectable amount of phosphate, or whether it only excludes formulations where phosphate is a functional or active ingredient.
  • A key evidentiary question will be one of compositional fact: Assuming the claim is construed, the case will require factual evidence establishing the precise chemical composition of Lannett's proposed generic product. The presence, quantity, and nature of any phosphate in that formulation will be dispositive for the infringement analysis.