DCT

2:25-cv-15123

Ars Pharma Operations Inc v. Lupin Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-15123, D.N.J., 08/29/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because the Lupin defendants maintain a regular and established place of business in Somerset, New Jersey, which is described as Lupin's "first and only commercial manufacturing facility in the United States," encompassing R&D, manufacturing, and packaging operations.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking to market a generic version of Plaintiffs' neffy® (epinephrine nasal spray), constitutes an act of infringement of eight U.S. patents.
  • Technical Context: The technology relates to pharmaceutical formulations that enable the intranasal delivery of epinephrine for the emergency treatment of severe allergic reactions, offering a needle-free alternative to auto-injectors.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 220047 with a Paragraph IV certification, alleging that Plaintiffs' patents are invalid and/or not infringed. USPTO records indicate that an inter partes review (IPR) proceeding resulted in the cancellation of several claims of U.S. Patent No. 10,682,414, including independent claims 1 and 15, which may substantially impact the scope of that patent in this litigation.

Case Timeline

Date Event
2013-07-25 U.S. Patent No. 10,576,156 Priority Date
2018-12-21 U.S. Patent No. 10,682,414 Priority Date
2020-03-03 U.S. Patent No. 10,576,156 Issued
2020-06-16 U.S. Patent No. 10,682,414 Issued
2021-11-16 U.S. Patent No. 11,173,209 Issued
2021-12-07 U.S. Patent No. 11,191,838 Issued
2023-08-08 U.S. Patent No. 11,717,571 Issued
2023-09-05 U.S. Patent No. 11,744,895 Issued
2024-03-05 U.S. Patent No. 11,918,655 Issued
2025-06-10 U.S. Patent No. 12,324,838 Issued
2025-08-08 Lupin Notice Letter sent to Plaintiffs
2025-08-29 Complaint Filing Date

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

U.S. Patent No. 10,576,156 - “Compositions for drug administration”

  • Patent Identification: U.S. Patent No. 10,576,156, titled “Compositions for drug administration,” issued on March 3, 2020 (Compl. ¶24).

The Invention Explained

  • Problem Addressed: The patent addresses the challenge that many therapeutic agents, particularly peptides and proteins, have poor oral bioavailability due to their susceptibility to hydrolysis and poor absorption in the gastrointestinal tract, typically requiring administration by injection (ʼ156 Patent, col. 1:41-50).
  • The Patented Solution: The invention provides pharmaceutical compositions that increase the absorption and bioavailability of therapeutic agents by combining them with a specific type of non-toxic surfactant known as an alkylglycoside. These surfactants, such as dodecyl-beta-D-maltoside, act as absorption enhancers, allowing for non-invasive delivery (e.g., intranasal) of drugs like epinephrine (ʼ156 Patent, Abstract; col. 3:5-13).
  • Technical Importance: This technology enables the development of needle-free drug delivery systems for complex molecules, which can improve patient compliance and safety by avoiding injections (ʼ156 Patent, col. 2:60-65).

Key Claims at a Glance

  • The complaint does not identify specific claims but alleges infringement of one or more claims (Compl. ¶47). Independent claim 1 is representative of the patent's core composition claims.
  • Independent Claim 1 of the '156 Patent includes the following essential elements:
    • An intranasal pharmaceutical composition comprising epinephrine.
    • The composition comprises between about 0.05% and 0.5% (w/v) of an alkylglycoside.
    • The alkylglycoside is dodecyl-beta-D-maltoside.
    • The composition is an aqueous solution formulated for intranasal delivery.
    • The composition provides systemic absorption of epinephrine.
    • The composition has a pH of about 2.0 to 5.0.

U.S. Patent No. 10,682,414 - “Intranasal epinephrine formulations and methods for the treatment of disease”

  • Patent Identification: U.S. Patent No. 10,682,414, titled “Intranasal epinephrine formulations and methods for the treatment of disease,” issued on June 16, 2020 (Compl. ¶25).

The Invention Explained

  • Problem Addressed: The patent identifies a need for improved methods of administering epinephrine for emergency situations like anaphylaxis. It notes that currently approved auto-injectors (e.g., EpiPen®) are cumbersome, can cause fear of injection leading to reluctance to use, and exhibit highly variable pharmacokinetics depending on the injection site (’414 Patent, col. 2:1-24).
  • The Patented Solution: The invention provides intranasal epinephrine formulations and methods of use that offer a needle-free, non-invasive alternative to injection. The formulation is designed for administration with a sprayer device to ensure rapid, reliable, and consistent dosing for treating conditions like anaphylaxis (’414 Patent, Abstract; col. 2:41-48).
  • Technical Importance: This approach offers a more convenient, discrete, and less intimidating method for administering life-saving epinephrine, which may improve the clinical management of anaphylaxis in out-of-hospital settings (’414 Patent, col. 2:32-40).

Key Claims at a Glance

  • The complaint does not identify specific claims but alleges infringement of one or more claims (Compl. ¶53). An inter partes review proceeding cancelled independent claims 1 and 15. Independent claim 1 is analyzed here as it is representative of the patent's originally issued scope.
  • Independent Claim 1 of the '414 Patent (as issued) included the following essential elements:
    • A method of treating a type-1 hypersensitivity reaction in a mammal.
    • The method comprises intranasally administering an aqueous nasal spray pharmaceutical formulation.
    • The formulation comprises an anaphylaxis active ingredient.
    • The active ingredient consists of between about 0.1 mg and about 2.4 mg of epinephrine, or a salt thereof, in a single dose.

U.S. Patent No. 11,173,209 - “Compositions for drug administration”

  • Patent Identification: U.S. Patent No. 11,173,209, "Compositions for drug administration," issued November 16, 2021 (Compl. ¶26).
  • Technology Synopsis: This patent, like the '156 Patent, is directed to pharmaceutical compositions containing an alkylglycoside absorption enhancer to improve the bioavailability of a therapeutic agent for non-invasive administration (’209 Patent, Abstract; col. 1:41-50).
  • Asserted Claims: The complaint alleges infringement of one or more claims (Compl. ¶60).
  • Accused Features: The accused features are the components of the Lupin ANDA Product, alleged to be a generic equivalent of the neffy® nasal spray (Compl. ¶59).

U.S. Patent No. 11,191,838 - “Intranasal epinephrine formulations and methods for the treatment of disease”

  • Patent Identification: U.S. Patent No. 11,191,838, "Intranasal epinephrine formulations and methods for the treatment of disease," issued December 7, 2021 (Compl. ¶27).
  • Technology Synopsis: This patent, like the '414 Patent, is directed to intranasal epinephrine formulations and methods for treating conditions like anaphylaxis, providing a needle-free alternative to injection (’838 Patent, Abstract; col. 2:1-24).
  • Asserted Claims: The complaint alleges infringement of one or more claims (Compl. ¶67).
  • Accused Features: The accused features are the composition and intended use of the Lupin ANDA Product (Compl. ¶66).

U.S. Patent No. 11,717,571 - “Intranasal epinephrine formulations and methods for the treatment of disease”

  • Patent Identification: U.S. Patent No. 11,717,571, "Intranasal epinephrine formulations and methods for the treatment of disease," issued August 8, 2023 (Compl. ¶28).
  • Technology Synopsis: This patent continues the themes of the '414 patent family, describing intranasal epinephrine formulations designed to provide rapid and reliable dosing as an alternative to auto-injectors for anaphylaxis treatment (’571 Patent, Abstract; col. 2:1-24).
  • Asserted Claims: The complaint alleges infringement of one or more claims (Compl. ¶74).
  • Accused Features: The accused features are the composition and intended method of use of the Lupin ANDA Product (Compl. ¶73).

U.S. Patent No. 11,744,895 - “Intranasal epinephrine formulations and methods for the treatment of disease”

  • Patent Identification: U.S. Patent No. 11,744,895, "Intranasal epinephrine formulations and methods for the treatment of disease," issued September 5, 2023 (Compl. ¶29).
  • Technology Synopsis: This patent also relates to intranasal epinephrine formulations for treating severe allergic reactions, focusing on providing a convenient, needle-free method of administration (’895 Patent, Abstract; col. 2:1-24).
  • Asserted Claims: The complaint alleges infringement of one or more claims (Compl. ¶81).
  • Accused Features: The accused features are the composition and intended method of use of the Lupin ANDA Product (Compl. ¶80).

U.S. Patent No. 11,918,655 - “Intranasal epinephrine formulations and methods for the treatment of disease”

  • Patent Identification: U.S. Patent No. 11,918,655, "Intranasal epinephrine formulations and methods for the treatment of disease," issued March 5, 2024 (Compl. ¶30).
  • Technology Synopsis: This patent continues the description of intranasal epinephrine formulations intended to provide a safe and effective needle-free treatment for anaphylaxis (’655 Patent, Abstract; col. 2:1-24).
  • Asserted Claims: The complaint alleges infringement of one or more claims (Compl. ¶88).
  • Accused Features: The accused features are the composition and intended use of the Lupin ANDA Product (Compl. ¶87).

U.S. Patent No. 12,324,838 - “Intranasal epinephrine formulations and methods for the treatment of disease”

  • Patent Identification: U.S. Patent No. 12,324,838, "Intranasal epinephrine formulations and methods for the treatment of disease," issued June 10, 2025 (Compl. ¶31).
  • Technology Synopsis: This patent also relates to formulations and methods for the intranasal delivery of epinephrine as a non-invasive treatment for severe allergic reactions (’838 Patent, Abstract; col. 2:1-24).
  • Asserted Claims: The complaint alleges infringement of one or more claims (Compl. ¶95).
  • Accused Features: The accused features are the composition and intended method of use of the Lupin ANDA Product (Compl. ¶94).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "Lupin ANDA Product," a generic epinephrine nasal spray for which Defendant Lupin seeks FDA approval under ANDA No. 220047 (Compl. ¶1, 16, 37).

Functionality and Market Context

The Lupin ANDA Product is described as a 2 mg/spray epinephrine nasal spray intended for the emergency treatment of type I allergic reactions, including anaphylaxis (Compl. ¶34, 37). By filing its ANDA, Lupin has represented to the FDA that its product is bioequivalent to Plaintiffs' neffy® drug product (Compl. ¶39). The product is not yet on the market; this litigation arises from the statutory act of infringement created by the filing of the ANDA itself, which seeks approval to market the product before the expiration of the patents-in-suit (Compl. ¶44).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed infringement theory, claim chart, or specific mapping of the accused product's features to the elements of any asserted patent claim. The infringement allegation is statutory, based on 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA seeking approval to market a drug claimed in a patent as an act of infringement (Compl. ¶44, 47). The complaint alleges that Lupin's ANDA Product, if approved and marketed, would infringe one or more claims of each of the asserted patents (Compl. ¶49, 55). Lupin's Paragraph IV certification letter asserts that the patents are invalid and/or will not be infringed (Compl. ¶40, 42).

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

  • The Term: "alkylglycoside" ('156 Patent, Claim 1)

  • Context and Importance: This term defines the key absorption-enhancing excipient in the claimed formulation. The scope of this term is central to infringement, as any accused generic product must contain a compound meeting this definition. Practitioners may focus on this term to determine if the specific enhancer used in Lupin's ANDA falls within the scope of the claims, especially for claims that may not be as specific as claim 1.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a general definition, stating an alkylglycoside is "any sugar joined by a linkage to any hydrophobic alkyl" and lists numerous examples of different sugars (maltose, sucrose, glucose) and alkyl chain lengths (from octyl to octadecyl) (’156 Patent, col. 25:12-26:55).
    • Evidence for a Narrower Interpretation: The abstract specifies that the alkylglycoside has an alkyl chain length from "about 10 to about 16 carbon atoms" (’156 Patent, Abstract). Furthermore, claim 1 itself explicitly narrows the term for that claim by stating "wherein the alkylglycoside is dodecyl-beta-D-maltoside."

  • The Term: "about" (used with concentration and pH ranges in '156 Patent, Claim 1)

  • Context and Importance: The term "about" modifies the claimed numerical ranges for the concentration of the alkylglycoside ("about 0.05% and 0.5%") and the formulation's pH ("about 2.0 to 5.0"). The interpretation of this term will be critical for determining literal infringement, as it defines the boundaries of the claimed ranges. Practitioners may focus on this term because even a small deviation in Lupin's formulation from the recited numbers could avoid infringement if "about" is construed narrowly.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent uses the term repeatedly with numerical values, suggesting the inventors did not intend to be limited to the exact numbers recited. The specification shows data plots where effects are seen across a continuum of concentrations, which may support a broader interpretation that encompasses values with similar functionality just outside the stated range (’156 Patent, Fig. 1).
    • Evidence for a Narrower Interpretation: The patent provides specific working examples and embodiments with precise concentrations and pH values. A party might argue that "about" should be limited to the range of experimental error or minor variations that do not materially change the properties demonstrated in those specific examples.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Lupin's future commercial manufacture, use, or sale of its ANDA product will induce infringement of the patents-in-suit (Compl. ¶49, 56). This allegation is based on the premise that Lupin's proposed product labeling will instruct healthcare providers and patients to use the generic product in a manner that directly infringes the method claims of the asserted patents (Compl. ¶36). The prayer for relief also seeks a declaratory judgment of induced and contributory infringement (Prayer for Relief ¶c, d).
  • Willful Infringement: The complaint does not contain allegations of willful infringement.

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

  • A central issue will be one of claim construction and infringement: As the complaint lacks a detailed infringement analysis, the case will depend on the formulation details revealed from Lupin's ANDA submission. The key question will be whether Lupin's specific combination of epinephrine, excipients, concentrations, and pH, as defined in its confidential ANDA, falls within the scope of the asserted claims, particularly as the court construes terms like "alkylglycoside" and the numerical ranges modified by "about."
  • A second core issue will be patent validity, particularly obviousness. Lupin has certified that the patents are invalid. A likely question for the court will be whether it was obvious to a person of ordinary skill in the art at the time of the inventions to combine epinephrine with a known class of absorption enhancers, such as alkylglycosides, in an aqueous solution at the claimed pH and concentrations for intranasal administration to treat anaphylaxis.
  • A key procedural question will be the enforceability of U.S. Patent No. 10,682,414: Public USPTO records indicate that independent claims 1 and 15 of the ’414 Patent were cancelled in an inter partes review proceeding that concluded before the filing of this complaint. The court will need to determine which, if any, of the remaining dependent claims of the ’414 patent are viable for assertion in this litigation, which could significantly narrow or eliminate this patent from the case.