DCT
1:25-cv-01228
Neurelis Inc v. Padagis LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Neurelis, Inc. (Delaware)
- Defendant: Padagis LLC (Delaware), Padagis US LLC (Delaware), and Padagis Israel Pharmaceuticals Ltd. (Israel)
- Plaintiff’s Counsel: McDermott Will & Schulte LLP
- Case Identification: 1:25-cv-01228, D. Del., 10/03/2025
- Venue Allegations: Venue is alleged to be proper in the District of Delaware based on Padagis LLC and Padagis US LLC being organized under Delaware law and subject to personal jurisdiction, and Padagis Israel being a non-resident defendant. The complaint also notes that venue has not been contested in two prior related actions.
- Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of VALTOCO® (diazepam nasal spray) constitutes an act of infringement of two U.S. patents covering methods of treating seizures with specific diazepam formulations.
- Technical Context: The technology concerns non-aqueous pharmaceutical formulations for nasal delivery of benzodiazepines, designed to provide a rapid, non-invasive treatment for acute repetitive seizures, also known as seizure clusters.
- Key Procedural History: This action was filed under the Hatch-Waxman Act following a notice letter from Padagis informing Neurelis of its ANDA filing, which included a "Paragraph IV Certification" alleging the asserted patents are invalid, not enforceable, or would not be infringed. The complaint notes two prior, pending infringement actions between the same parties involving different patents related to the same VALTOCO® product, designated the "Padagis I Action" and "Padagis II Action."
Case Timeline
| Date | Event |
|---|---|
| 2011-06-14 | Earliest Priority Date for ’852 and ’061 Patents |
| 2024-05-08 | Padagis I Action Filed |
| 2025-06-10 | ’852 Patent Issued |
| 2025-06-24 | ’061 Patent Issued |
| 2025-07-02 | Padagis II Action Filed |
| 2025-09-02 | Third Padagis Notice Letter Sent to Neurelis |
| 2025-10-03 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,324,852 - “Administration of Benzodiazepine Compositions”
The Invention Explained
- Problem Addressed: The patent’s background describes the challenges associated with existing methods of administering benzodiazepines for conditions like seizures. Oral administration can be too slow, while intravenous administration is impractical outside of a clinical setting and can be associated with respiratory depression. Rectal administration, while effective, is noted as inconvenient ( Compl. ¶23; ’852 Patent, col. 1:56–col. 2:18).
- The Patented Solution: The invention is a non-aqueous pharmaceutical solution for nasal administration. The formulation uses one or more tocopherols (such as Vitamin E) and alcohols as a solvent system to dissolve the benzodiazepine drug (e.g., diazepam). It also includes an alkyl glycoside, which acts as a penetration enhancer to facilitate rapid absorption through the nasal mucosal membranes (’852 Patent, Abstract; col. 2:21-44).
- Technical Importance: This approach provides a method for rapid, non-invasive delivery of a rescue medication for seizures that can be administered by caregivers outside of a hospital setting, addressing the limitations of both oral and intravenous routes ( Compl. ¶23; ’852 Patent, col. 2:7-18).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-31, with independent claim 1 detailed explicitly (Compl. ¶¶37-38).
- Claim 1 is a method of treatment claim with the following essential elements:
- 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 to one nasal mucosal membrane."
- The spray is of a pharmaceutical solution "consisting of" specific quantities of vitamin E, diazepam, dodecyl maltoside, benzyl alcohol, and ethanol.
- The administration "achieves 92.5% to 107.5% of the bioavailability of an equivalent dose of diazepam administered intravenously."
- The method is "safe and effective."
- The administration results in a treatment outcome selected from a group including reduction in seizure severity, probability, or frequency.
U.S. Patent No. 12,337,061 - “Administration of Benzodiazepine Compositions”
The Invention Explained
- Problem Addressed: As a continuation of the same patent family, the ’061 Patent addresses the same technical problems as the ’852 Patent: the need for a rapid and convenient non-clinical method for administering benzodiazepines for acute seizures ( Compl. ¶25; ’061 Patent, col. 1:56–col. 2:20).
- The Patented Solution: The patented solution is likewise a non-aqueous, nasally administered pharmaceutical composition containing a benzodiazepine, tocopherols, alcohols, and an alkyl glycoside to achieve rapid drug absorption (’061 Patent, Abstract; col. 2:25-48).
- Technical Importance: The technology provides a practical rescue treatment for seizure clusters that can be administered by non-professionals, improving upon the speed of oral drugs and the convenience of rectal suppositories ( Compl. ¶25; ’061 Patent, col. 2:12-20).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-62, with independent claim 21 detailed explicitly (Compl. ¶¶45-46).
- Claim 21 is a method of treatment claim with the following essential elements:
- 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 pharmaceutical solution "containing" specified quantities of vitamin E, diazepam, dodecyl maltoside, benzyl alcohol, and ethanol.
- The administration "achieves 92.5% to 107.5% of the bioavailability of an equivalent dose of diazepam administered intravenously."
- The method is "safe and effective."
- The administration results in a specified treatment outcome, such as reduction in seizure severity or frequency.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the "Padagis ANDA Product," which is a generic version of VALTOCO® (diazepam nasal spray), 10 mg diazepam/spray, for which Padagis submitted Abbreviated New Drug Application (ANDA) No. 219320 to the FDA (Compl. ¶¶1, 28).
Functionality and Market Context
- The Padagis ANDA Product is described as a generic version of VALTOCO®, which is a prescription nasal spray used for the short-term treatment of "seizure clusters" in epilepsy patients (Compl. ¶¶1, 21). The complaint alleges that Padagis is seeking FDA approval to manufacture, use, and sell this product in the United States prior to the expiration of the Asserted Patents, which are listed in the FDA's "Orange Book" as covering VALTOCO® (Compl. ¶¶1, 26, 28).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges infringement based on Padagis's submission of its ANDA, asserting that the product described therein will, upon approval, meet all limitations of the asserted claims (Compl. ¶¶39, 47). The specific details of the accused formulation are not public but are inferred from its nature as a generic equivalent to VALTOCO®.
12,324,852 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 in an epilepsy patient... | The Padagis ANDA Product is a generic version of VALTOCO®, a rescue medicine for treating seizure clusters. | ¶¶1, 21, 39 | col. 63:8-29 |
| administering a single spray of 100 µL to one nasal mucosal membrane of the patient... | The Padagis ANDA Product is a nasal spray delivering 10 mg diazepam per spray, intended for nasal administration. | ¶¶1, 28, 39 | col. 64:11-13 |
| ...of a pharmaceutical solution 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 complaint alleges the product described in the Padagis ANDA contains a formulation that satisfies these specific compositional limitations. | ¶39 | col. 64:14-19 |
| wherein administering the single spray...achieves 92.5% to 107.5% of the bioavailability of an equivalent dose of diazepam administered intravenously... | As a generic product seeking approval under an ANDA, the Padagis product is required to be bioequivalent to VALTOCO®, which the complaint alleges meets this functional limitation. | ¶39 | col. 64:20-23 |
12,337,061 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 in an epilepsy patient... | The Padagis ANDA Product is a generic version of VALTOCO®, a rescue medicine for treating seizure clusters. | ¶¶1, 21, 47 | col. 63:6-23 |
| administering a single spray of 100 µL +/-5% of a stable pharmaceutical solution to a nostril of the patient... | The Padagis ANDA Product is a nasal spray delivering 10 mg diazepam per spray, intended for nasal administration. | ¶¶1, 28, 47 | col. 66:44-46 |
| ...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 complaint alleges the product described in the Padagis ANDA contains a formulation that satisfies these specific compositional limitations. | ¶47 | col. 65:47-51 |
| wherein administering the single spray...achieves 92.5% to 107.5% of the bioavailability of an equivalent dose of diazepam administered intravenously; | As a generic product seeking approval under an ANDA, the Padagis product is required to be bioequivalent to VALTOCO®, which the complaint alleges meets this functional limitation. | ¶47 | col. 65:52-55 |
Identified Points of Contention
- Scope Questions: A primary question may arise from the transitional phrases in the claims. Claim 1 of the ’852 Patent uses "consisting of," which is highly restrictive and generally means the formulation can contain no other active or inactive ingredients. In contrast, Claim 21 of the ’061 Patent uses "containing," which is open-ended. The infringement analysis may turn on whether Padagis's ANDA formulation includes any unlisted excipients not present in the claims, which may support a non-infringement argument for the ’852 Patent but not necessarily the ’061 Patent.
- Technical Questions: Infringement of the functional limitation requiring "92.5% to 107.5% of the bioavailability" will be a central evidentiary question. The dispute may focus on the bioequivalence data submitted in Padagis's ANDA and whether it demonstrates that the accused product performs this function when measured according to the methods disclosed in the patent specifications.
V. Key Claim Terms for Construction
The Term: "consisting of" (’852 Patent, Claim 1)
- Context and Importance: This term is critical because it defines the scope of the claimed formulation as "closed." If the Padagis ANDA Product contains any material component not explicitly listed in Claim 1, it may fall outside the claim's scope. This term’s construction will be central to determining literal infringement of the ’852 Patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The complaint does not provide sufficient detail for analysis of evidence supporting a broader interpretation. Case law provides very limited exceptions to the closed nature of this term (e.g., for impurities).
- Evidence for a Narrower Interpretation: The plain and ordinary meaning of "consisting of" in patent law is that the claim is closed to any elements not recited. This established legal meaning serves as strong intrinsic evidence for a narrow interpretation.
The Term: "stable pharmaceutical solution" (’061 Patent, Claim 21)
- Context and Importance: The term "stable" is not defined with specific parameters in the claim. Practitioners may focus on this term because its definition could either broaden or narrow the scope of infringing formulations. The dispute will likely center on the required duration and conditions of stability (e.g., temperature, humidity, chemical degradation) for the solution to be considered "stable."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Parties may argue "stable" should be given its ordinary meaning in the pharmaceutical arts, i.e., a product that maintains its physical and chemical integrity during manufacturing, storage, and use for its intended shelf life.
- Evidence for a Narrower Interpretation: The patent specification includes extensive stability data for specific formulations under various conditions (e.g., 25°C/60% RH, 40°C/75% RH) over several months (’061 Patent, Tables 5-4 through 5-7). A party might argue that these examples implicitly define the required level and duration of stability.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that upon FDA approval, Padagis will actively induce infringement by marketing and selling its ANDA product with instructions for users to administer it in an infringing manner. It also alleges contributory infringement on the basis that the product is not a staple article of commerce suitable for substantial noninfringing use (Compl. ¶¶40, 48).
- Willful Infringement: Willfulness is alleged based on Padagis’s pre-suit knowledge of the patents, evidenced by the "Third Padagis Notice Letter" sent to Neurelis on September 2, 2025, which discussed both the ’852 and ’061 patents (Compl. ¶¶33, 41, 49).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of compositional scope: does the Padagis ANDA formulation contain any unlisted ingredients? If so, this fact may create a dispositive distinction between the infringement analysis for the ’852 Patent, with its restrictive "consisting of" language, and the ’061 Patent, which uses the broader term "containing."
- A key evidentiary question will be one of functional performance: does the data in Padagis's ANDA demonstrate that its product achieves the specific bioavailability range (92.5% to 107.5% of an equivalent IV dose) as required by the claims? The resolution will depend on the court's interpretation of how this comparison must be made.
- A central claim construction question will be one of definitional clarity: what are the specific technical criteria for a "stable pharmaceutical solution" as required by the ’061 patent? The case may turn on whether the specification’s stability testing examples are read as defining the term or merely illustrating one embodiment.