Neurelis Inc v. Amneal Pharma LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Neurelis, Inc. (Delaware)
  • Defendant: Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, Inc. (Delaware)
  • Plaintiff's Counsel: McDermott Will & Schulte LLP
• Case Identification: 1:26-cv-00261, D. Del., 03/11/2026
• Venue Allegations: Venue is alleged as proper in the District of Delaware on the basis that both Defendant entities are organized under the laws of Delaware and are subject to personal jurisdiction in the district.
• Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) seeking FDA approval for generic versions of VALTOCO® (diazepam nasal spray) constitutes an act of infringement of six U.S. patents.
• Technical Context: The technology relates to pharmaceutical formulations for the nasal administration of benzodiazepines, such as diazepam, intended for the rapid treatment of acute repetitive seizures or "seizure clusters" in epilepsy patients.
• Key Procedural History: The complaint notes this action is related to four prior, consolidated patent infringement cases filed by Neurelis against Padagis LLC and Lupin Inc. concerning the same VALTOCO® product. The asserted patents are listed in the FDA's "Orange Book" as covering VALTOCO®. This action was filed within 45 days of Neurelis's receipt of Amneal's Paragraph IV notice letter, triggering a 30-month statutory stay of FDA approval for Amneal's generic product.

Case Timeline

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

U.S. Patent No. 11,241,414 - "Administration of Benzodiazepine Compositions"

The Invention Explained

• Problem Addressed: The patent describes significant limitations with existing methods of administering benzodiazepine drugs for conditions like seizures Compl. ¶18 '414 Patent, col. 1:22-25 Oral administration is slow due to digestive tract absorption and liver metabolism; intravenous administration is fast but requires trained professionals and is impractical outside clinical settings; and suppository (rectal) administration is inconvenient and socially difficult Compl. ¶19 '414 Patent, col. 1:51-col. 2:8
• The Patented Solution: The invention is a pharmaceutical solution designed for nasal administration, which allows for rapid drug absorption through the nasal mucosa Compl. ¶19 '414 Patent, col. 2:11-20 The solution uses a non-aqueous carrier system "consisting of" specific components: a benzodiazepine drug (diazepam), a high concentration of tocopherols (e.g., vitamin E), a combination of ethanol and benzyl alcohol, and an alkyl glycoside (n-dodecyl beta-D-maltoside) as a penetration enhancer '414 Patent, abstract '414 Patent, col. 55:7-14 This formulation is designed to dissolve the typically poorly soluble benzodiazepine and facilitate its transport across the nasal membranes, bypassing the digestive system '414 Patent, col. 15:64-col. 16:5
• Technical Importance: This approach provides a method for rapid, convenient, and non-invasive administration of a rescue medication for seizures that can be used by caregivers or patients themselves in an out-of-hospital setting '414 Patent, col. 16:6-14

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claims 2-3, 5-13, and 15-18 Compl. ¶37
• Independent Claim 1 requires a pharmaceutical solution for nasal administration "consisting of" the following elements:
  • 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 Compl. ¶38 '414 Patent, col. 55:7-14

U.S. Patent No. 11,793,786 - "Administration of Benzodiazepine Compositions"

The Invention Explained

• Problem Addressed: The '786 Patent, from the same family as the '414 Patent, addresses the same technical problems of slow or inconvenient administration of benzodiazepines for acute seizures Compl. ¶20 '786 Patent, col. 1:22-25
• The Patented Solution: The patent discloses a similar pharmaceutical solution for nasal administration comprising diazepam dissolved in a carrier system of tocopherols and alcohols Compl. ¶21 '786 Patent, abstract Claim 1 specifies a "therapeutically effective amount" of diazepam and defines the tocopherol and alcohol components with specific Markush groups and concentration ranges '786 Patent, col. 55:1-18 The solution is designed for rapid absorption to bypass the issues associated with oral and parenteral routes '786 Patent, col. 15:65-col. 16:5
• Technical Importance: Like the '414 Patent, this technology enables rapid and non-invasive seizure treatment outside of a clinical setting '786 Patent, col. 16:6-14

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claims 2-3, 5-9, 11-13, and 15-27 Compl. ¶45
• Independent Claim 1 requires a pharmaceutical solution for nasal administration "consisting of":
  • a therapeutically effective amount of diazepam or a pharmaceutically acceptable salt thereof;
  • one or more tocopherols or tocotrienols selected from a specified Markush group, in an amount from 30% to 95% (w/w);
  • one or more alcohols in an amount from 10% to 70% (w/w), wherein the one or more alcohols comprises benzyl alcohol; and
  • n-dodecyl beta-D-maltoside Compl. ¶46 '786 Patent, col. 55:1-18

U.S. Patent No. 12,268,664 - "Administration of Benzodiazepine Compositions"

Technology Synopsis

The '664 Patent claims a pharmaceutical composition for intranasal administration comprising specific weight percentages of diazepam, tocopherols, one or more alcohols, and dodecyl β-D-maltoside Compl. ¶¶23, 54 The claims further require the composition to be a solution containing less than 1% water and to be in a pharmaceutically-acceptable spray formulation Compl. ¶54

Asserted Claims

Claims 1-18 are asserted Compl. ¶53

Accused Features

The complaint alleges Amneal's ANDA Products meet the limitations of the asserted claims Compl. ¶55

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

Technology Synopsis

The '852 Patent claims a method of treating specific types of epileptic seizures by administering a single 100 µL spray of a pharmaceutical solution Compl. ¶¶25, 62 The claim specifies exact quantities (with a +/-5% tolerance) of vitamin E, diazepam, dodecyl maltoside, and benzyl alcohol, with a sufficient quantity of ethanol. The claim also includes functional limitations requiring the achievement of a specific bioavailability relative to an intravenous dose and resulting in specific treatment outcomes (e.g., reduction in seizure severity) Compl. ¶62

Asserted Claims

Claims 1-9, 14-21, 23-25, 27-29, and 31 are asserted Compl. ¶61

Accused Features

The complaint alleges Amneal's ANDA Products satisfy the limitations for the claimed method of treatment Compl. ¶63

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

Technology Synopsis

The '061 Patent, similar to the '852 Patent, claims a method of treating specific seizure episodes by administering a 100 µL spray of a stable pharmaceutical solution to a nostril Compl. ¶¶27, 70 The asserted claim recites specific quantities of vitamin E, diazepam, dodecyl maltoside, and benzyl alcohol, and includes limitations on bioavailability and treatment outcomes Compl. ¶70

Asserted Claims

Claims 1-52 are asserted, with claim 21 specifically identified Compl. ¶¶69-70

Accused Features

The complaint alleges Amneal's ANDA Products meet the limitations for the claimed method of treatment Compl. ¶71

U.S. Patent No. 12,521,400 - "Administration of Benzodiazepine Compositions"

Technology Synopsis

The '400 Patent claims a pharmaceutical composition for intranasal administration comprising diazepam dissolved in a carrier of tocopherols and alcohols Compl. ¶¶29, 78 The claim specifies weight percentage ranges for the components, a solution volume of 50 µL to 150 µL, and requires the composition to be in a spray formulation. Unlike other asserted patents, claim 1 of the '400 patent does not recite dodecyl maltoside Compl. ¶78

Asserted Claims

Claims 1-21 are asserted Compl. ¶77

Accused Features

The complaint alleges Amneal's ANDA Products meet the limitations of the asserted claims Compl. ¶79

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the "Amneal ANDA Products," which are the subject of Amneal's Abbreviated New Drug Application (ANDA) No. 219109 submitted to the FDA Compl. ¶1

Functionality and Market Context

• The Amneal ANDA Products are identified as generic versions of VALTOCO®, which is a diazepam nasal spray Compl. ¶1 The ANDA covers two dosage strengths: 7.5 mg/spray and 10 mg/spray Compl. ¶1
• The complaint alleges that Amneal is seeking approval to commercially manufacture, use, offer for sale, and sell these generic products prior to the expiration of the Asserted Patents Compl. ¶1 The submission of the ANDA itself is the statutory act of infringement under the Hatch-Waxman Act Compl. ¶37

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that Amneal's ANDA Products will infringe the asserted claims either literally or under the doctrine of equivalents Compl. ¶39 Compl. ¶47 The allegations are based on "information and belief" derived from Amneal's notice letter regarding its ANDA filing Compl. ¶39 Compl. ¶47

'414 Patent Infringement Allegations

'786 Patent Infringement Allegations

Identified Points of Contention

• Scope Questions: The independent claims of the '414 and '786 Patents use the transitional phrase "consisting of," which is strictly limiting and closes the claim to any elements not explicitly recited. A primary legal question will be whether Amneal's ANDA formulation contains any additional, unrecited components (e.g., other solvents, stabilizers, or excipients) that would place it outside the literal scope of these claims.
• Factual and Technical Questions: The infringement analysis will depend on the precise formulation disclosed in Amneal's ANDA. A central factual question for the court will be whether the weight-per-weight (w/w) or weight-per-volume (w/v) percentages of each component in the Amneal ANDA Products fall within the specific ranges required by the asserted claims of the patents-in-suit.

V. Key Claim Terms for Construction

For U.S. Patent Nos. 11,241,414 and 11,793,786

• The Term: "consisting of"
• Context and Importance: This transitional phrase appears in the preamble of independent claim 1 of both the '414 and '786 Patents and is legally distinct from "comprising." Its construction is critical because it presumptively excludes any elements not specified in the claim. If Amneal's ANDA product contains any additional excipients, the interpretation of this term could be dispositive of literal infringement. Practitioners may focus on this term to determine if the claim is closed to any additional, unlisted ingredients.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (or to support equivalence): The complaint alleges infringement "literally or through the doctrine of equivalents" Compl. ¶39 Compl. ¶47 Plaintiff may argue that even if an additional, immaterial ingredient is present, the Amneal product is equivalent to the claimed invention. The patents' specifications describe various additional ingredients, such as other enhancers or agents to adjust pH, which could be argued to be contemplated by the inventors, even if not recited in these specific claims '414 Patent, col. 3:41-46
  • Evidence for a Narrower Interpretation: Case law establishes that "consisting of" creates a strong presumption that the claim is closed. The '664 Patent, by contrast, uses the term "comprising," which may suggest the patentee deliberately chose the more restrictive "consisting of" in the '414 and '786 Patents to capture a specific formulation Compl. ¶54 Defendants may argue this choice was a deliberate surrender of claim scope.

VI. Other Allegations

Indirect Infringement

The complaint alleges that upon FDA approval, Amneal will actively induce infringement by marketing and distributing its ANDA Products with instructions for use that direct users (patients and caregivers) to administer the product in an infringing manner Compl. ¶40 Compl. ¶48 It also alleges contributory infringement on the basis that the ANDA products are not staple articles of commerce suitable for substantial non-infringing use Compl. ¶40 Compl. ¶48

Willful Infringement

The complaint alleges that Amneal has acted with full knowledge of the asserted patents and their claims, based on its Paragraph IV certification and notice letter Compl. ¶41 Compl. ¶49 It further alleges that Amneal has no reasonable basis for believing its products would not be liable for infringement and that it "specifically intends infringement" upon approval and commercialization Compl. ¶41 Compl. ¶49

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

• A central issue will be one of claim scope and construction: Does the term "consisting of," as used in the independent claims of the '414 and '786 patents, strictly preclude the presence of any unrecited ingredients in the accused generic product, and if so, does Amneal's formulation contain such additional ingredients?
• A key evidentiary question will be one of factual correspondence: Does the specific formulation detailed in Amneal's confidential ANDA submission meet the precise quantitative limitations-including component concentrations and weight percentages-recited in the various asserted composition and method claims?
• For the method of treatment patents ('852 and '061), a critical question will be one of bioequivalence and functionality: Assuming Amneal's product is formulated to be bioequivalent to VALTOCO®, will its administration inherently result in the specific bioavailability and treatment outcomes (e.g., "92.5% to 107.5% of the bioavailability of an equivalent dose of diazepam administered intravenously") as required by the functional language in those claims?