DCT

1:25-cv-00821

Neurelis Inc v. Padagis LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00821, D. Del., 07/02/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Padagis and Lupin entities are organized under the laws of Delaware or are otherwise subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendants' submission of Abbreviated New Drug Applications (ANDAs) to the FDA, seeking approval to market generic versions of Plaintiff's VALTOCO® (diazepam nasal spray), constitutes an act of patent infringement.
  • Technical Context: The technology concerns pharmaceutical formulations designed to enable the rapid nasal administration of benzodiazepine drugs, such as diazepam, for the acute treatment of seizure clusters in epilepsy patients.
  • Key Procedural History: The complaint notes a prior, related action ("Padagis I Action") filed on May 8, 2024, against Padagis concerning U.S. Patent Nos. 11,241,414 and 11,793,786. The current action follows subsequent notice letters from Padagis regarding U.S. Patent No. 12,268,664 and from Lupin regarding all three asserted patents, which is a standard procedural trigger for litigation under the Hatch-Waxman Act.

Case Timeline

Date Event
2008-03-28 Priority Date for ’414, ’786, and ’664 Patents
2022-02-08 U.S. Patent No. 11241414 Issued
2023-10-24 U.S. Patent No. 11793786 Issued
2024-03-26 Padagis sends First Notice Letter to Neurelis regarding ANDA 219320
2024-05-08 Neurelis files "Padagis I Action" against Padagis
2025-04-08 U.S. Patent No. 12268664 Issued
2025-05-21 Padagis sends Second Notice Letter to Neurelis
2025-05-27 Lupin sends Notice Letter to Neurelis regarding ANDA 220394
2025-07-02 Complaint Filed

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

U.S. Patent No. 12,268,664 - Administration of Benzodiazepine Compositions (Issued Apr. 8, 2025)

The Invention Explained

  • Problem Addressed: The patent family's background section describes the challenge of administering benzodiazepine drugs like diazepam for acute conditions such as seizures (US11241414B2, col. 1:21-38). Oral administration has a slow onset of action, and intravenous administration is impractical outside of a clinical setting, while suppositories are inconvenient (US11241414B2, col. 2:1-9). These drugs also have significant solubility challenges that have historically limited formulation options (US11241414B2, col. 1:47-51).
  • The Patented Solution: The invention is a pharmaceutical solution for nasal administration that dissolves diazepam in a non-aqueous carrier system. This system consists of specific weight-per-weight percentages of tocopherols (Vitamin E compounds) and alcohols, along with a penetration enhancer (n-dodecyl beta-D-maltoside), to create a stable solution suitable for a nasal spray (US12268664B1, col. 1:11-2:4; Abstract). This formulation is designed to bypass the issues of oral delivery and provide rapid drug uptake through the nasal mucosa (US11241414B2, col. 16:1-6).
  • Technical Importance: This formulation provides a non-invasive, rapid-acting treatment for acute repetitive seizures that can be administered by caregivers outside of a hospital, addressing a significant unmet need in epilepsy management (Compl. ¶37).

Key Claims at a Glance

  • The complaint asserts claims 1-18 against both Padagis and Lupin (Compl. ¶¶57-58). Independent claim 1 is exemplified.
  • Independent Claim 1: A pharmaceutical composition for intranasal administration comprising:
    • about 1 to about 20 mg of diazepam dissolved in
    • about 45% to about 85% (w/w) of one or more specified tocopherols or tocotrienols,
    • about 25% to about 40% (w/w) of one or more specified alcohols,
    • and about 0.01% to about 1% (w/v) of dodecyl β-D-maltoside,
    • wherein the composition is a solution containing less than 1% water, and
    • is in a pharmaceutically-acceptable spray formulation.

U.S. Patent No. 11,241,414 - Administration of Benzodiazepine Compositions (Issued Feb. 8, 2022)

The Invention Explained

  • Problem Addressed: As a member of the same patent family, the ’414 Patent addresses the same technical problems of slow or impractical benzodiazepine delivery for acute seizures, as described above (US11241414B2, col. 1:21-2:9).
  • The Patented Solution: The ’414 Patent claims a pharmaceutical solution for nasal administration defined by a transitional phrase of "consisting of" its components. The formulation requires diazepam, one or more tocopherols or tocotrienols within a specified range, a combined amount of ethanol and benzyl alcohol within a specified range, and n-dodecyl beta-D-maltoside (US11241414B2, col. 55:7-21). The use of "consisting of" suggests a composition limited to these enumerated ingredients.
  • Technical Importance: This patent protects a specific formulation that enables rapid and convenient nasal delivery of diazepam for seizure clusters (Compl. ¶37).

Key Claims at a Glance

  • The complaint asserts claims 1-3, 5-13, and 15-18 against Lupin (Compl. ¶69). Independent claim 1 is exemplified.
  • Independent Claim 1: A pharmaceutical solution for nasal administration consisting of:
    • diazepam or a pharmaceutically acceptable salt thereof;
    • one or more natural or synthetic tocopherols or tocotrienols, or any combinations thereof, in an amount from 30% to 95% (w/w);
    • ethanol and benzyl alcohol in a combined amount from 10% to 70% (w/w); and
    • n-dodecyl beta-D-maltoside.

U.S. Patent No. 11,793,786 - Administration of Benzodiazepine Compositions (Issued October 24, 2023)

  • Technology Synopsis: This patent, part of the same family, is also directed to a pharmaceutical solution for nasal administration of diazepam. It claims a composition "consisting of" a therapeutically effective amount of diazepam, a specified group of tocopherols or tocotrienols in a defined range, one or more alcohols (which must comprise benzyl alcohol) in a defined range, and n-dodecyl beta-D-maltoside (Compl. ¶¶77-78).
  • Asserted Claims: Claims 1-3, 5-9, 11-13, and 15-27 are asserted against Lupin (Compl. ¶77).
  • Accused Features: Lupin's ANDA and the proposed generic products are alleged to infringe because their formulation will fall within the scope of the asserted claims (Compl. ¶79).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are the generic drug products proposed in Padagis's ANDA No. 219320 and Lupin's ANDA No. 220394 (Compl. ¶1).
  • Functionality and Market Context: The ANDA products are generic versions of Neurelis's VALTOCO® (diazepam nasal spray), a prescription rescue medicine for treating seizure clusters in epilepsy patients (Compl. ¶¶1, 37). As generic equivalents, the accused products are intended to have the same active ingredient, dosage form, strength, and route of administration as VALTOCO® (Compl. ¶¶1, 46, 52). The complaint alleges that by seeking FDA approval, Defendants are planning for the commercial manufacture, use, and sale of these generic products prior to the expiration of the asserted patents (Compl. ¶¶57-58).

IV. Analysis of Infringement Allegations

The complaint alleges that the Defendants' ANDA products will literally infringe or infringe under the doctrine of equivalents because their formulations will satisfy the limitations of the asserted claims (Compl. ¶¶60, 71, 79). The complaint does not contain a claim chart or specific details about the accused formulations. The following summary is based on the exemplified independent claims recited in the complaint. No probative visual evidence provided in complaint.

'664 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition for intranasal administration comprising: about 1 to about 20 mg of diazepam dissolved in... The complaint alleges the Defendants' ANDA products are compositions that will contain the claimed amount of diazepam. ¶¶59-60, 63 US12268664B1, col. 54:4-6
about 45% to about 85% (w/w) of one or more natural or synthetic tocopherols or tocotrienols selected from the group consisting of: a-tocopherol, β-tocopherol, γ-tocopherol, d-tocopherol, a-tocotrienol, β-tocotrienol, y-tocotrienol, 8-tocotrienol, tocophersolan, any esters thereof and any combinations thereof, The complaint alleges the ANDA products will contain a tocopherol or tocotrienol component meeting this limitation. ¶¶59-60, 63 US12268664B1, col. 54:7-14
and about 25% to about 40% (w/w) of one or more alcohols selected from the group consisting of ethanol, propyl alcohol, butyl alcohol, pentanol, benzyl alcohol, and any combinations thereof, The complaint alleges the ANDA products will contain an alcohol component meeting this limitation. ¶¶59-60, 63 US12268664B1, col. 54:15-19
and about 0.01% to about 1% (w/v) of dodecyl β-D-maltoside, The complaint alleges the ANDA products will contain dodecyl β-D-maltoside meeting this limitation. ¶¶59-60, 63 US12268664B1, col. 54:20-21
wherein the pharmaceutical composition is a solution and contains less than 1% water, wherein the pharmaceutical composition is in a pharmaceutically-acceptable spray formulation. The complaint alleges the ANDA products will be solutions with less than 1% water formulated as a nasal spray. ¶¶59-60, 63 US12268664B1, col. 54:22-25

'414 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical solution for nasal administration consisting of: diazepam or a pharmaceutically acceptable salt thereof; The complaint alleges the Lupin ANDA Products are compositions containing diazepam. ¶¶70-71 US11241414B2, col. 55:8-10
one or more natural or synthetic tocopherols or tocotrienols, or any combinations thereof, in an amount from 30% to 95% (w/w); The complaint alleges the Lupin ANDA Products will contain a tocopherol or tocotrienol component meeting this limitation. ¶¶70-71 US11241414B2, col. 55:11-14
ethanol and benzyl alcohol in a combined amount from 10% to 70% (w/w); and The complaint alleges the Lupin ANDA Products will contain ethanol and benzyl alcohol meeting this limitation. ¶¶70-71 US11241414B2, col. 55:15-17
n-dodecyl beta-D-maltoside. The complaint alleges the Lupin ANDA Products will contain n-dodecyl beta-D-maltoside. ¶¶70-71 US11241414B2, col. 55:18
  • Identified Points of Contention:
    • Scope Questions: A central issue will be the construction of the term "about" as it modifies the weight-percentage ranges of the claimed ingredients. The determination of whether the accused formulations literally infringe may depend on the degree of variance permitted by this term.
    • Technical Questions: Since the exact formulations of the ANDA products are not disclosed in the complaint, a primary technical question is whether their constituent components and concentrations fall within the claimed ranges. The dispute may also turn on whether any unlisted excipients in the accused products would remove them from the scope of the claims of the ’414 and ’786 patents, which use the restrictive "consisting of" language.

V. Key Claim Terms for Construction

  • The Term: "consisting of" (in claims of the ’414 and ’786 patents)
  • Context and Importance: This transitional phrase is legally distinct from "comprising" (used in the ’664 patent). "Consisting of" is a closed term that presumptively excludes any element not specified in the claim. Practitioners may focus on this term because if Defendants' generic formulations contain any unrecited excipients that materially alter the composition, it could support a non-infringement argument for the ’414 and ’786 patents, but not necessarily for the more open-ended ’664 patent claims.
    • Intrinsic Evidence for Interpretation: The plain meaning of "consisting of" is well-established in patent law as being exclusionary. The specification does not appear to redefine the term, describing various embodiments that fall within the scope of the listed components (e.g., US11241414B2, col. 7:15-8:49). A defendant may argue that this established legal meaning strictly limits the claims to only the recited ingredients.
  • The Term: "about [X]% to about [Y]%" (e.g., "about 45% to about 85% (w/w)")
  • Context and Importance: The scope of infringement will heavily depend on how much variability the term "about" imparts to the numerical ranges of the formulation's components. A generic product formulated near, but not exactly at, a claimed endpoint could be found to infringe or not based on the construction of this term.
    • Evidence for a Broader Interpretation: A party arguing for a broader scope may point to the specification's description of various formulation examples with different percentages as demonstrating that the invention is not limited to the precise numbers recited (e.g., US11241414B2, col. 41:5-42:50). They may argue "about" is intended to cover formulations with similar characteristics and results.
    • Evidence for a Narrower Interpretation: A party arguing for a narrower scope may contend that the ranges are critical to achieving the desired solubility and stability, and that "about" should be construed narrowly to encompass only minor experimental variations. The detailed description of specific percentage ranges may be cited as evidence that the inventors considered these boundaries to be important to the invention's function (e.g., US11241414B2, col. 7:44-54).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Defendants will actively induce infringement by marketing and selling their generic products with instructions for use that would cause direct infringement by end-users (Compl. ¶¶61, 64, 72, 80). Contributory infringement is also alleged.
  • Willful Infringement: Willfulness is alleged based on Defendants having acted with "full knowledge" of the asserted patents and their claims, as evidenced by the Paragraph IV certification letters sent to Neurelis (Compl. ¶¶62, 65, 73, 81).

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

  • A core issue will be one of claim scope: How will the court construe the quantitative limitations of the claims, particularly the term "about," and the legal distinction between the "comprising" language of the ’664 patent and the "consisting of" language of the ’414 and ’786 patents? The outcome of this construction will define the boundaries of infringement.
  • A key evidentiary question will be one of compositional identity: What will discovery reveal about the precise formulation of the Defendants' proposed generic products? The ultimate determination of infringement will depend on a direct comparison of those undisclosed formulations against the court's interpretation of the claim language.