DCT

1:25-cv-01443

Neurelis Inc v. Lupin Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01443, D. Del., 11/26/2025
  • Venue Allegations: Venue is alleged to be proper as to the domestic defendants because they are Delaware corporations, and as to the foreign defendant because it is a non-resident of the United States.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application for a generic version of VALTOCO® (diazepam nasal spray) infringes patents related to pharmaceutical compositions for nasal administration of benzodiazepines.
  • Technical Context: The technology concerns non-aqueous nasal spray formulations for delivering benzodiazepine drugs, such as diazepam, to provide rapid, non-invasive treatment for acute repetitive seizures.
  • Key Procedural History: The action arises under the Hatch-Waxman Act, triggered by Defendant’s submission of an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification. The complaint notes three prior, consolidated actions filed by Plaintiff against Padagis LLC concerning the same branded drug, and suggests this matter is appropriate for consolidation with those actions.

Case Timeline

Date Event
2011-06-14 ’852 and ’061 Patents Priority Date
2024-05-27 Lupin sends First Notice Letter (re: other patents)
2025-06-10 U.S. Patent No. 12,324,852 issues
2025-06-24 U.S. Patent No. 12,337,061 issues
2025-07-02 Plaintiff commences Padagis II Action
2025-10-17 Lupin sends Second Notice Letter (re: Asserted Patents)
2025-11-26 Complaint filed

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

U.S. Patent No. 12,324,852 - "Administration of Benzodiazepine Compositions"

  • Patent Identification: U.S. Patent No. 12,324,852 ("Administration of Benzodiazepine Compositions"), issued June 10, 2025 (the "’852 Patent"). (Compl. ¶24).

The Invention Explained

  • Problem Addressed: The patent's background section describes the drawbacks of existing methods for administering benzodiazepine drugs to treat conditions like seizures. Oral administration can have a slow onset of action, intravenous administration is often limited to clinical settings, and rectal administration is inconvenient. (’852 Patent, col. 1:54–2:18).
  • The Patented Solution: The invention is a non-aqueous pharmaceutical solution for nasal administration, designed to provide rapid drug delivery. The solution uses a carrier system comprising a tocopherol (e.g., vitamin E), one or more alcohols, and an alkyl glycoside to dissolve a benzodiazepine drug, such as diazepam, enabling fast absorption through the nasal mucosa. (’852 Patent, Abstract; col. 2:21-46).
  • Technical Importance: This technical approach is designed to provide a rapid, effective, and non-invasive rescue treatment for seizures that can be administered by caregivers outside of a hospital, overcoming the practical limitations of other delivery routes. (Compl. ¶23; ’852 Patent, col. 2:11-18).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-31, with Claim 1 being the sole independent claim. (Compl. ¶37; ’852 Patent, col. 63:9-64:2).
  • The essential elements of independent Claim 1 include:
    • A method of treating bouts of intermittent and stereotypic episodes of increased seizure activity in an epilepsy patient.
    • The method comprises administering a single 100 µL spray to one nasal mucosal membrane.
    • The spray is of a pharmaceutical solution "consisting of" specified amounts of vitamin E USP (+/-5%), diazepam, dodecyl maltoside, benzyl alcohol (+/-5%), and a sufficient quantity of ethanol.
    • Administration of the single spray achieves a bioavailability of 92.5% to 107.5% of an equivalent dose of diazepam administered intravenously.
    • Administration of the single spray results in a specified therapeutic outcome, such as a reduction in seizure severity or frequency.

U.S. Patent No. 12,337,061 - "Administration of Benzodiazepine Compositions"

  • Patent Identification: U.S. Patent No. 12,337,061 ("Administration of Benzodiazepine Compositions"), issued June 24, 2025 (the "’061 Patent"). (Compl. ¶26).

The Invention Explained

  • Problem Addressed: The ’061 Patent addresses the same technical problem as the ’852 Patent: the need for a benzodiazepine delivery method that is both fast-acting and convenient for administration by non-professionals in an acute setting. (’061 Patent, col. 1:58–2:21).
  • The Patented Solution: The invention claims a method of treating seizures by administering a "stable" non-aqueous nasal spray. The formulation contains specific amounts of diazepam, vitamin E, dodecyl maltoside, benzyl alcohol, and ethanol, designed to achieve high bioavailability comparable to intravenous injection. (’061 Patent, Abstract; col. 2:25-50).
  • Technical Importance: The claimed solution provides a rescue medication for epilepsy patients that combines the rapid onset needed for acute seizure intervention with a non-invasive delivery method suitable for caregiver use. (Compl. ¶23; ’061 Patent, col. 2:13-21).

Key Claims at a Glance

  • The complaint asserts infringement of at least claims 1-62 and specifically recites independent Claim 21. (Compl. ¶¶45-46).
  • The essential elements of independent Claim 21 include:
    • A method of treating bouts of intermittent and stereotypic episodes of increased seizure activity in an epilepsy patient.
    • The method comprises administering a single spray of 100 µL +/-5% of a "stable pharmaceutical solution" to a nostril.
    • The solution "containing" specified amounts of vitamin E USP (+/-5%), diazepam, dodecyl maltoside (+/-5%), benzyl alcohol (+/-5%), and a sufficient quantity of ethanol.
    • Administration achieves a bioavailability of 92.5% to 107.5% of an equivalent dose of intravenously administered diazepam.
    • Administration is safe and effective and results in a specified therapeutic outcome.

III. The Accused Instrumentality

Product Identification

The accused products are generic versions of VALTOCO® (diazepam nasal spray) at dosages of 5 mg/spray, 7.5 mg/spray, and 10 mg/spray, for which Defendant Lupin submitted Abbreviated New Drug Application (ANDA) No. 220394 to the FDA. (Compl. ¶1).

Functionality and Market Context

The Lupin ANDA Products are intended to be generic equivalents of Plaintiff’s VALTOCO® product, which is a prescription nasal spray used for the short-term treatment of "seizure clusters" in epilepsy patients. (Compl. ¶¶1, 23). The act of infringement alleged in the complaint is the submission of the ANDA itself, which seeks FDA approval to manufacture, use, and sell the generic nasal spray before the expiration of the asserted patents. (Compl. ¶¶37, 45).

IV. Analysis of Infringement Allegations

The complaint alleges that Lupin’s ANDA and the products that will be marketed thereunder will infringe the asserted patents, based on information contained in a notice letter sent by Lupin to Neurelis. (Compl. ¶¶39, 47). The complaint does not include a claim chart exhibit. No probative visual evidence provided in complaint.

’852 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating bouts of intermittent and stereotypic episodes of increased seizure activity... The Lupin ANDA Products are alleged to be for the same indication as the claimed method. ¶39 col. 4:26-28
...administering a single spray of 100 µL to one nasal mucosal membrane of the patient of a pharmaceutical solution... The Lupin ANDA Products are alleged to be nasal sprays administered in a manner that satisfies this limitation. ¶39 col. 4:30-34
...consisting of: 56.47 mg of vitamin E USP +/-5%; 10 mg of diazepam; 0.25 mg of dodecyl maltoside; 10.50 mg of benzyl alcohol +/-5%, and a sufficient quantity of ethanol; The formulation specified in Lupin's ANDA is alleged to contain the recited ingredients in the claimed amounts. ¶39 col. 39:48-63
...achieves 92.5% to 107.5% of the bioavailability of an equivalent dose of diazepam administered intravenously... The Lupin ANDA Products are alleged to achieve the claimed pharmacokinetic profile. ¶39 col. 4:50-55
...results in a treatment selected from the group consisting of a reduction in the severity of the seizure...and combinations thereof. The Lupin ANDA Products are alleged to achieve the claimed therapeutic outcomes. ¶39 col. 22:30-39

’061 Patent Infringement Allegations

Claim Element (from Independent Claim 21) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating bouts of intermittent and stereotypic episodes of increased seizure activity... The Lupin ANDA Products are alleged to be for the same indication as the claimed method. ¶47 col. 4:33-35
...administering a single spray of 100 µL +/-5% of a stable pharmaceutical solution to a nostril of the patient... The Lupin ANDA Products are alleged to be stable nasal sprays administered in a manner that satisfies this limitation. ¶47 col. 4:37-39
...the pharmaceutical solution containing: 56.47 mg of vitamin E USP +/-5%; 10 mg of diazepam; 0.25 mg of dodecyl maltoside +/-5%; 10.50 mg of benzyl alcohol +/-5%; and a sufficient quantity of ethanol; The formulation specified in Lupin's ANDA is alleged to contain the recited ingredients in the claimed amounts. ¶47 col. 39:48-63
...achieves 92.5% to 107.5% of the bioavailability of an equivalent dose of diazepam administered intravenously; The Lupin ANDA Products are alleged to achieve the claimed pharmacokinetic profile. ¶47 col. 4:57-62
...results in a treatment selected from the group consisting of a reduction in the severity of the seizure...and combinations thereof. The Lupin ANDA Products are alleged to achieve the claimed therapeutic outcomes. ¶47 col. 10:47-56
  • Identified Points of Contention:
    • Scope Questions: Claim 1 of the ’852 Patent uses the restrictive transitional phrase "consisting of" to define the formulation. A central issue may be whether the proposed generic product described in Lupin's ANDA contains any unrecited ingredients that would place it outside the literal scope of this claim. Claim 21 of the ’061 Patent uses the less restrictive phrase "containing," which may lead to different infringement arguments.
    • Technical Questions: A key technical dispute will likely center on the functional limitations of the claims. The complaint alleges Lupin's product meets the specific bioavailability range of "92.5% to 107.5%" relative to intravenous administration. (Compl. ¶¶38, 46). A primary question for the court will be whether the bioequivalence data submitted in Lupin’s ANDA supports or refutes this allegation.

V. Key Claim Terms for Construction

  • The Term: "consisting of" (’852 Patent, Claim 1)
  • Context and Importance: This term introduces the list of ingredients in the pharmaceutical solution. Practitioners may focus on this term because it is a legal term of art that creates a "closed" claim, meaning the solution cannot contain any other active or inactive ingredients beyond those listed. If Lupin's ANDA specifies any additional excipients, it may have a direct path to arguing non-infringement of this claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party seeking a broader scope might argue that the term does not exclude impurities normally present in the recited ingredients or substances that do not materially alter the basic and novel characteristics of the invention, though this is a difficult argument for "consisting of."
    • Evidence for a Narrower Interpretation: The plain meaning of the term strongly supports a narrow interpretation. The specification provides specific formulations that list only the claimed components, reinforcing the closed nature of the list. (’852 Patent, col. 3:5-14; Table at col. 39).
  • The Term: "bioavailability" (’852 Patent, Claim 1; ’061 Patent, Claim 21)
  • Context and Importance: The claims require achieving a specific bioavailability relative to an "equivalent dose" administered intravenously. This is a critical functional limitation, and its definition will determine whether Lupin's product infringes. The dispute may turn on the proper methodology for measuring bioavailability and for calculating dose equivalence.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification suggests bioavailability can be determined by "a suitable pharmacodynamic method, such as comparison of area under the blood plasma concentration curve (AUC)." (’852 Patent, col. 4:54-59). A party could argue that this allows for any standard, accepted method of AUC calculation.
    • Evidence for a Narrower Interpretation: The specification explains how to compare different dosages (e.g., 10 mg nasal vs. 5 mg IV) by "taking into consideration the difference in dose." (’852 Patent, col. 4:60-65). A party could argue this requires a specific normalization protocol. The patent also provides detailed pharmacokinetic data from a clinical trial, which could be cited to define the precise conditions under which bioavailability must be measured to fall within the claim scope. (’852 Patent, Table 11-3, col. 63).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval of its ANDA, Lupin will actively induce infringement by marketing and selling its generic product with instructions for use that correspond to the patented methods. (Compl. ¶¶40, 48).
  • Willful Infringement: The complaint alleges that Lupin has acted with full knowledge of the asserted patents, citing Lupin's pre-suit notice letter as evidence. (Compl. ¶¶41, 49). This alleged pre-suit knowledge is the stated basis for the willfulness claim.

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

  • A core issue will be one of compositional identity: does the formulation in Lupin’s ANDA contain only the specific ingredients recited in Claim 1 of the ’852 Patent, which uses the closed-ended term "consisting of," or does it include other excipients that would place it outside the claim's literal scope?
  • A key evidentiary question will be one of functional performance: do the pharmacokinetic data submitted in Lupin's ANDA demonstrate that its product will achieve the narrow bioavailability range (92.5% to 107.5% of an equivalent intravenous dose) required by the claims, or will the data support a finding of non-infringement?
  • A central legal and factual question, stemming from Lupin's Paragraph IV certification, will be one of validity: are the asserted claims, which define the invention by specific compositional components and functional outcomes, anticipated by or obvious over prior art related to nasal spray formulations for benzodiazepines?