DCT

2:26-cv-11566

CMP Development LLC v. MSN Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:26-cv-11566, D.N.J., 09/16/2026
  • Venue Allegations: Venue is based on Defendant MSN Inc.'s principal place of business in Piscataway, New Jersey, its continuous transaction of business in the state, and its stated intent to market and sell the accused product in the judicial district. Plaintiff also notes that Defendants have previously invoked the jurisdiction of this court as counterclaim plaintiffs in other patent matters.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's TADLIQ® oral suspension constitutes an act of infringement of four U.S. patents directed to liquid oral formulations of tadalafil.
  • Technical Context: The technology concerns ready-to-use liquid suspensions of tadalafil, a PDE V inhibitor used to treat conditions such as pulmonary arterial hypertension, designed for patients who have difficulty swallowing solid dosage forms.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 221209 and a corresponding Paragraph IV certification notice letter. The complaint notes a related litigation is pending in the same court involving earlier patents from the same family (Civil Action No. 2:26-cv-02653), and states that the patents-in-suit are continuations of those earlier patents.

Case Timeline

Date Event
2017-12-26 Earliest Priority Date for '626, '849, '175 Patents
2017-12-29 Earliest Priority Date for '338 Patent
2022-06-17 FDA approves Plaintiff's TADLIQ® New Drug Application
2026-01-23 Defendants send Paragraph IV Notice Letter to Plaintiff
2026-01-30 Plaintiff receives Defendants' Notice Letter
2026-03-16 Related litigation (2:26-cv-02653) filed
2026-07-28 Amended Complaint filed in related litigation
2026-08-04 U.S. Patent No. 12,697,338 issues
2026-08-18 U.S. Patent No. 12,708,626 issues
2026-09-01 U.S. Patent No. 12,721,849 issues
2026-09-15 U.S. Patent No. 12,734,175 issues
2026-09-16 Complaint filed in present action

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

U.S. Patent No. 12,697,338 - "Liquid Oral Formulations for PDE V Inhibitors"

  • Issued: August 4, 2026

The Invention Explained

  • Problem Addressed: The patent's background section describes that PDE V inhibitors like tadalafil have very low water solubility, which results in poor bioavailability when administered orally '338 Patent, col. 7:10-14 Furthermore, ready-to-use liquid formulations are needed for patients with dysphagia (difficulty swallowing), as existing powder-for-suspension products are inconvenient and difficult for patients or caregivers to prepare correctly '338 Patent, col. 10:21-39
  • The Patented Solution: The invention is a ready-to-use liquid oral pharmaceutical composition, specifically a suspension, that overcomes these challenges '338 Patent, abstract The formulation combines particulate tadalafil with a "means for maintaining the particulate tadalafil uniformly dispersed," which includes a viscosity modifying agent like xanthan gum, and a "means for maintaining the composition at a pH" between 4 and 8, all within a water-based vehicle '338 Patent, claim 1 The specification highlights that using glycerin as a wetting agent is surprisingly effective for dispersing the poorly wettable drug, allowing a stable suspension to be made '338 Patent, col. 13:38-44
  • Technical Importance: This technology provides a stable, palatable, and ready-to-use liquid dosage form that ensures consistent and accurate dosing for patients unable to swallow tablets, such as pediatric and geriatric populations '338 Patent, col. 10:46-54

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims without specifying them Compl. ¶50 Independent claim 1 is representative of the invention as it applies to tadalafil.
  • Essential elements of independent claim 1 include:
    • A liquid oral pharmaceutical composition comprising about 4 mg/mL particulate tadalafil with a d90 particulate size of from about 5 to 200 microns.
    • A means for maintaining the tadalafil uniformly dispersed in a liquid vehicle, which comprises xanthan gum (2 mg/mL to 6 mg/mL) as a viscosity modifying agent.
    • A means for maintaining the composition at a pH of from about 4 to 8.
    • A vehicle comprising water.
  • The complaint reserves the right to assert other claims, which may include dependent claims Compl. ¶50

U.S. Patent No. 12,708,626 - "Liquid Oral Formulations for Tadalafil"

  • Issued: August 18, 2026

The Invention Explained

  • Problem Addressed: The '626 Patent addresses the same core problems as its parent patents: the very low solubility and bioavailability of tadalafil, and the need for a convenient, ready-to-use liquid dosage form for patients who cannot swallow tablets ('626 Patent, col. 7:4-14; col. 7:20-29).
  • The Patented Solution: The patent discloses a liquid oral tadalafil suspension characterized by a specific performance metric: a rapid dissolution rate. The claimed composition, which includes about 4 mg/mL of particulate tadalafil in a water-based vehicle at a pH of 4 to 8, "exhibits a dissolution rate of at least about 90% in 10 minutes when measured in 0.5% sodium lauryl sulfate" '626 Patent, claim 1 This functional limitation defines the invention.
  • Technical Importance: Achieving a rapid dissolution rate from a suspension formulation is significant because it is expected to lead to faster drug absorption, a more rapid onset of therapeutic action, and potentially greater bioavailability '626 Patent, col. 30:35-39

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims Compl. ¶58 Independent claim 1 is representative.
  • Essential elements of independent claim 1 include:
    • A liquid oral pharmaceutical composition comprising about 4 mg/mL particulate tadalafil.
    • A pharmaceutically acceptable excipient.
    • A vehicle comprising water.
    • The composition has a pH of from about 4 to 8.
    • The composition exhibits a dissolution rate of at least about 90% in 10 minutes when measured in 0.5% sodium lauryl sulfate.
  • The complaint reserves the right to assert additional claims Compl. ¶58

Multi-Patent Capsule: U.S. Patent No. 12,721,849

  • Patent Identification: U.S. Patent No. 12721849, "Liquid Oral Formulations for PDE V Inhibitors," issued September 1, 2026.
  • Technology Synopsis: The '849 patent is also directed to ready-to-use liquid oral suspensions of tadalafil. It claims a composition containing 4 mg/mL tadalafil with a d90 particulate size between 5 and 100 microns, a wetting agent, and a water-based vehicle, maintained at a pH between 4 and 8 '849 Patent, claim 1 The invention focuses on the combination of a specified particle size range and a wetting agent to achieve a stable and effective liquid formulation.
  • Asserted Claims: The complaint makes a general allegation of infringement; independent claim 1 is representative '849 Patent, claim 1
  • Accused Features: The complaint alleges that the MSN ANDA Product contains tadalafil and excipients that perform the functions recited in the '849 patent's claims Compl. ¶65

Multi-Patent Capsule: U.S. Patent No. 12,734,175

  • Patent Identification: U.S. Patent No. 12734175, "Liquid Oral Formulations for PDE V Inhibitors," issued September 15, 2026.
  • Technology Synopsis: The '175 patent claims a liquid oral tadalafil composition with a more narrowly defined d90 particle size of 5 to 10 microns. The claims also positively require the presence of a preservative, a sweetener, and a flavorant, with the formulation maintained at a pH of 4 to 8 '175 Patent, claim 1 This patent focuses on a specific particle size combined with excipients for palatability and stability.
  • Asserted Claims: The complaint makes a general allegation of infringement; independent claim 1 is representative '175 Patent, claim 1
  • Accused Features: The complaint alleges the MSN ANDA Product contains tadalafil and excipients that perform "substantially the same function" as the excipients recited in the '175 patent's claims Compl. ¶73

III. The Accused Instrumentality

Product Identification

  • The "MSN ANDA Product," a generic drug proposed in Abbreviated New Drug Application (ANDA) No. 221209 Compl. ¶¶2-3

Functionality and Market Context

  • The accused product is a generic version of Plaintiff's TADLIQ®, a ready-to-use oral liquid suspension of tadalafil Compl. ¶3 Compl. ¶38
  • It is formulated at the same strength as TADLIQ®, 20 mg/5 mL (equivalent to 4 mg/mL) Compl. ¶35
  • The complaint alleges that by submitting its ANDA, Defendant has represented to the FDA that its product has the same active ingredient, dosage form, route of administration, and is bioequivalent to TADLIQ® Compl. ¶34
  • The product is intended for the treatment of pulmonary arterial hypertension and is positioned as an option for patients with dysphagia who cannot swallow tablets Compl. ¶39 Compl. ¶41

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 12,697,338 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
about 4 mg/mL tadalafil or a pharmaceutically acceptable salt thereof, wherein the tadalafil comprises particulate tadalafil having a d90 particulate size of from about 5 microns to about 200 microns; The MSN ANDA Product is alleged to contain the same active ingredient, tadalafil, at the same 4 mg/mL strength as TADLIQ®. ¶35; ¶49 col. 36:47-52
means for maintaining the particulate tadalafil uniformly dispersed in a liquid vehicle, which comprises a viscosity modifying agent that comprises xanthan gum in an amount of from about 2 mg/mL to about 6 mg/ml; The complaint alleges on information and belief that the MSN ANDA Product contains excipients that perform the same function as the recited means for maintaining uniform dispersion. ¶49 col. 36:53-58
means for maintaining the composition at a pH of from about 4 to about 8; and It is alleged that the MSN ANDA Product contains excipients that perform the same function as the recited means for maintaining the claimed pH range. ¶49 col. 36:59-60
a vehicle comprising water. The MSN ANDA Product is described as an oral liquid suspension, which implies a water-based vehicle. ¶36 col. 36:61

U.S. Patent No. 12,708,626 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
about 4 mg/mL tadalafil or a pharmaceutically acceptable salt thereof, wherein the tadalafil comprises particulate tadalafil; The MSN ANDA Product is alleged to contain 4 mg/mL of the active ingredient tadalafil. ¶35; ¶57 col. 34:47-50
a pharmaceutically acceptable excipient; and The MSN ANDA Product is alleged to contain "the same or substantially similar inactive ingredients as TADLIQ®." ¶37 col. 34:51
a vehicle comprising water; The product is an oral liquid suspension, implying an aqueous vehicle. ¶36 col. 34:52
wherein the pharmaceutical composition has a pH of from about 4 to about 8; and The complaint alleges the product contains excipients that perform the recited functions to achieve the claimed properties. ¶57 col. 34:55-56
wherein the composition exhibits a dissolution rate of at least about 90% in 10 minutes when measured in 0.5% sodium lauryl sulfate. The complaint alleges on information and belief that the MSN ANDA Product contains excipients that perform the function of achieving the recited dissolution rate. ¶57 col. 34:57-60
  • Identified Points of Contention:
    • Scope Questions: Claim 1 of the '338 Patent recites two "means-plus-function" limitations. A central issue will be construing these terms under 35 U.S.C. § 112(f). The analysis will require identifying the specific structures disclosed in the patent's specification that perform the claimed functions (e.g., specific buffering agents) and then determining whether the accused product contains identical or structurally equivalent components.
    • Technical Questions: The infringement allegations rely heavily on the assertion that the MSN ANDA Product is bioequivalent to TADLIQ® and contains "substantially similar" excipients Compl. ¶34 Compl. ¶37 A key technical question for the court will be whether this alleged similarity is sufficient to meet the specific quantitative limitations of the claims, such as the d90 particle size ranges and the dissolution rate profile '626 Patent, claim 1 Evidence from the ANDA filing and product testing will be required to resolve this.

V. Key Claim Terms for Construction

The Term: "means for maintaining the particulate tadalafil uniformly dispersed in a liquid vehicle" '338 Patent, claim 1

  • Context and Importance: This is a means-plus-function term, and its construction is central to infringement of the '338 Patent. The court must identify the function (maintaining uniform dispersion) and the corresponding structure(s) disclosed in the specification. Practitioners may focus on this term because infringement will depend on a finding that the accused product's formulation contains a structure that is identical or equivalent to the specific structures disclosed in the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim itself recites that the means "comprises a viscosity modifying agent that comprises xanthan gum." A party could argue the "means" is not limited only to xanthan gum but can include other agents used in combination with it, as long as xanthan gum is present.
    • Evidence for a Narrower Interpretation: The specification discloses specific exemplary formulations, such as combinations of xanthan gum with HPMC or with microcrystalline cellulose (Avicel) '338 Patent, col. 20:58-66 A party may argue that the "corresponding structure" is limited to these specific disclosed combinations, narrowing the scope of equivalents.

The Term: "dissolution rate of at least about 90% in 10 minutes when measured in 0.5% sodium lauryl sulfate" '626 Patent, claim 1

  • Context and Importance: This performance-based limitation defines the '626 Patent's invention. The infringement analysis will likely turn on test results of the accused product. Practitioners may focus on this term because the dispute will be factual and evidentiary, centering on whether the accused product meets this specific quantitative threshold under the prescribed test conditions.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of "at least about 90%" provides a floor but includes a degree of flexibility with the word "about." A party could argue this covers results that are scientifically and statistically close to 90%.
    • Evidence for a Narrower Interpretation: The patent provides an example of a formulation that achieves over 94% dissolution in 10 minutes '626 Patent, Table 7, TIDL3010 A party could argue that this example helps define what the inventors contemplated and that "about 90%" should not be interpreted to cover results significantly lower than this demonstrated performance.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all four patents-in-suit Compl. ¶50 Compl. ¶58 Compl. ¶66 Compl. ¶74 The basis for inducement is the allegation that Defendants intend to market the product for the patented uses and that the product's label will instruct physicians and patients to use it in an infringing manner Compl. ¶51 The basis for contributory infringement is the allegation that there are "no substantial non-infringing uses" for the MSN ANDA product Compl. ¶52
  • Willful Infringement: While not pleaded as a separate count, the complaint lays the groundwork for a willfulness claim by alleging that Defendants have "actual and constructive knowledge" of the patents and a "specific intent to infringe" by seeking FDA approval before patent expiration Compl. ¶47 Compl. ¶51 This knowledge is likely predicated on the listing of the patents in the FDA's Orange Book and the filing of this lawsuit.

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

  • A core issue will be one of evidentiary proof: Does the accused generic product, as described in its ANDA and as manufactured, actually meet the specific, quantitative limitations recited in the asserted patent claims? This includes the d90 particle size ranges claimed in the '338, '849, and '175 patents and, critically, the rapid dissolution rate of "at least about 90% in 10 minutes" required by the '626 patent. The plaintiff's case, as pleaded, relies on the regulatory assumption of similarity, which must be substantiated with technical evidence.
  • A key legal question will be one of claim scope under § 112(f): For the means-plus-function claims in the '338 patent, what specific formulation components disclosed in the specification constitute the "corresponding structure" for the functions of maintaining dispersion and pH? The resolution of this question will define the scope of infringement and determine whether the defendant's formulation, once revealed, contains an identical or equivalent structure.
  • The case will likely involve a significant validity challenge based on the patents' relationship to one another. Given that all four patents-in-suit issued in 2026 as continuations from a common lineage, a defendant is likely to argue that the claims are invalid for obviousness-type double patenting over earlier-expiring patents in the family or are obvious in light of the prior art and the disclosures in the parent applications.