Neurelis Inc v. Strides Pharma Global Pte Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Neurelis, Inc. (Delaware)
  • Defendant: Strides Pharma Global PTE Limited (Singapore) and Strides Pharma Inc. (New Jersey)
  • Plaintiff's Counsel: McDermott Will & Schulte LLP
• Case Identification: 1:26-cv-00947, D. Del., 07/31/2026
• Venue Allegations: Venue is alleged to be proper as Strides Pharma Inc. sells products in Delaware and holds a contract with the State, and Strides Pharma Global PTE Limited is a foreign corporation subject to suit in any judicial district where personal jurisdiction is established.
• Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for approval to market generic versions of Plaintiff's VALTOCO® (diazepam nasal spray) constitutes an act of infringement of seven U.S. patents.
• Technical Context: The technology involves pharmaceutical formulations of diazepam for intranasal delivery, designed as a non-invasive rescue treatment for epilepsy patients experiencing seizure clusters.
• Key Procedural History: This is a Hatch-Waxman action initiated in response to Defendants' Paragraph IV certification asserting that the asserted patents are invalid, not enforceable, or not infringed by their proposed generic product. Plaintiff filed this suit within the 45-day statutory window, triggering an automatic 30-month stay on FDA approval of the Defendants' ANDA. The complaint notes that seven related cases are pending in the same court against other generic drug manufacturers, indicating a broad enforcement strategy by Neurelis to protect its VALTOCO® franchise. The asserted patents are listed in the FDA's "Orange Book" as covering VALTOCO®.

Case Timeline

Date	Event
2008-03-28	Earliest Priority Date for '414, '786, '664, and '400 Patents
2011-06-14	Earliest Priority Date for '852 and '061 Patents
2021-06-10	Priority Date for '611 Patent
2022-02-08	U.S. Patent No. 11,241,414 Issues
2023-10-24	U.S. Patent No. 11,793,786 Issues
2025-04-08	U.S. Patent No. 12,268,664 Issues
2025-06-10	U.S. Patent No. 12,324,852 Issues
2025-06-24	U.S. Patent No. 12,337,061 Issues
2025-12-15	Neurelis sought certificate of correction for '664 Patent
2026-01-13	U.S. Patent No. 12,521,400 Issues
2026-02-10	Certificate of correction issued for '664 Patent
2026-04-14	U.S. Patent No. 12,599,611 Issues
2026-06-17	Strides sends Paragraph IV Notice Letter to Neurelis
2026-07-31	Complaint Filed

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

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

• Patent Identification: U.S. Patent No. 11,241,414, "Administration of Benzodiazepine Compositions," issued February 8, 2022 Compl. ¶18

The Invention Explained

• Problem Addressed: The patent's background describes significant drawbacks with existing methods of administering benzodiazepine drugs like diazepam for conditions such as seizures Compl. ¶19 '414 Patent, col. 1:24-28 Oral administration has a slow onset, intravenous administration is often impractical outside of a clinical setting, and rectal suppositories are inconvenient and socially awkward '414 Patent, col. 1:51-2:9
• The Patented Solution: The patent discloses a pharmaceutical solution for nasal administration, which provides a rapid and convenient delivery method '414 Patent, abstract The formulation consists of diazepam dissolved in a non-aqueous carrier system comprising tocopherols (a form of Vitamin E), specific alcohols (ethanol and benzyl alcohol), and an absorption enhancer (n-dodecyl beta-D-maltoside) to facilitate uptake through the nasal mucosa '414 Patent, col. 2:11-21 Compl. ¶19
• Technical Importance: This technology offers a non-invasive, rapid-onset alternative to injections or suppositories, enabling caregivers or patients themselves to administer a rescue dose of diazepam in an out-of-hospital setting to treat acute seizure episodes '414 Patent, col. 15:8-14

Key Claims at a Glance

• The complaint asserts infringement of claims 1-18, highlighting independent claim 1 Compl. ¶40 Compl. ¶41
• Essential elements of Claim 1 include:
  • A pharmaceutical solution for nasal administration consisting of:
  • diazepam or a pharmaceutically acceptable salt thereof;
  • one or more natural or synthetic tocopherols or tocotrienols...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.
• The complaint reserves the right to assert other claims, including dependent claims, by alleging infringement of claims 1-18 Compl. ¶40

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

• Patent Identification: U.S. Patent No. 11,793,786, "Administration of Benzodiazepine Compositions," issued October 24, 2023 Compl. ¶20

The Invention Explained

• Problem Addressed: The patent addresses the same problems as the '414 Patent: the practical limitations of delivering benzodiazepines via oral, intravenous, or rectal routes for the acute treatment of seizures '786 Patent, col. 1:24-2:9
• The Patented Solution: The '786 Patent also claims a pharmaceutical solution for nasal administration using a carrier system of tocopherols and alcohols '786 Patent, abstract The claims are more specific than in the '414 Patent, defining a particular Markush group for the tocopherols and requiring that the alcohol component "comprises benzyl alcohol" '786 Patent, col. 55:10-27
• Technical Importance: The invention provides a convenient and rapid-acting formulation for out-of-hospital seizure rescue, addressing a significant unmet need for patients and caregivers '786 Patent, col. 15:10-16

Key Claims at a Glance

• The complaint asserts infringement of claims 1-27, highlighting independent claim 1 Compl. ¶48 Compl. ¶49
• Essential elements of Claim 1 include:
  • 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 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.
• The complaint reserves the right to assert other claims by alleging infringement of claims 1-27 Compl. ¶48

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

• Patent Identification: U.S. Patent No. 12,268,664, "Administration of Benzodiazepine Compositions," issued April 8, 2025 Compl. ¶22
• Technology Synopsis: The '664 patent claims a pharmaceutical composition for intranasal administration comprising specific amounts of diazepam dissolved in a carrier of tocopherols and alcohols, further defined by being a solution with less than 1% water and in a pharmaceutically-acceptable spray formulation Compl. ¶57
• Asserted Claims: Claims 1-18 are asserted, with Claim 1 being independent Compl. ¶56 Compl. ¶57
• Accused Features: The Strides ANDA Products are alleged to meet the limitations of the asserted claims Compl. ¶58

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 (Compl. ¶25).
• Technology Synopsis: The '852 patent claims a method of treating specific types of seizures by nasally administering a pharmaceutical solution with defined quantities of vitamin E, diazepam, dodecyl maltoside, and benzyl alcohol. The claim further requires achieving specific pharmacokinetic (bioavailability relative to IV) and pharmacodynamic (reduction in seizure severity, frequency, etc.) outcomes (Compl. ¶65).
• Asserted Claims: Claims 1-19 and 24-31 are asserted, with Claim 1 being an independent method claim (Compl. ¶64; Compl. ¶65).
• Accused Features: The Strides ANDA Products are alleged to meet the limitations of the asserted claims, implying the proposed product label will instruct infringing use (Compl. ¶66).

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 (Compl. ¶27).
• Technology Synopsis: The '061 patent claims a method of treating seizures similar to the '852 patent, defining the administered formulation as a "stable" solution with components specified with a "+/-5%" tolerance. The claim also recites specific pharmacokinetic and pharmacodynamic outcomes (Compl. ¶73).
• Asserted Claims: A wide range of claims are asserted, including 1-2, 5-6, 9-22, etc., with Claim 21 being an independent method claim (Compl. ¶72; Compl. ¶73).
• Accused Features: The Strides ANDA Products are alleged to meet the limitations of the asserted claims (Compl. ¶74).

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

• Patent Identification: U.S. Patent No. 12,521,400, "Administration of Benzodiazepine Compositions," issued January 13, 2026 (Compl. ¶29).
• Technology Synopsis: The '400 patent claims a pharmaceutical composition for intranasal administration comprising diazepam in a carrier of tocopherols and alcohols. The claim specifies that the composition is a solution of 50 µL to 150 µL in a pharmaceutically-acceptable spray formulation (Compl. ¶81).
• Asserted Claims: Claims 1-6, 8-15, and 17-21 are asserted, with Claim 1 being independent (Compl. ¶80; Compl. ¶81).
• Accused Features: The Strides ANDA Products are alleged to meet the limitations of the asserted claims (Compl. ¶82).

U.S. Patent No. 12,599,611 - "Methods and Compositions for Treating Seizure Disorders in Pediatric Patients"

• Patent Identification: U.S. Patent No. 12,599,611, "Methods and Compositions for Treating Seizure Disorders in Pediatric Patients," issued April 14, 2026 (Compl. ¶31).
• Technology Synopsis: The '611 patent claims a method of treating seizure episodes specifically in a pediatric subject population (2 to 5 years old, 23 to 33 kg body weight). The claim recites administering a specific formulation of diazepam nasal spray (Compl. ¶89).
• Asserted Claims: Claims 1-33 are asserted, with Claim 1 being an independent method claim (Compl. ¶88; Compl. ¶89).
• Accused Features: The Strides ANDA Products are alleged to infringe, with the complaint specifically pointing to prescribing information that allegedly "instructs physicians regarding treating pediatric patients" (Compl. ¶91).

III. The Accused Instrumentality

Product Identification

• The accused instrumentalities are the "Strides ANDA Products" detailed in Abbreviated New Drug Application (ANDA) No. 221329 Compl. ¶1 Compl. ¶35

Functionality and Market Context

• The Strides ANDA Products are proposed generic versions of Neurelis's VALTOCO® (diazepam nasal spray) Compl. ¶1 They are formulated as a nasal spray with dosages of 5 mg/spray, 7.5 mg/spray, and 10 mg/spray Compl. p.2, lines 1-2 Compl. ¶35 The filing of the ANDA with a Paragraph IV certification challenging the Asserted Patents represents a statutory act of infringement under 35 U.S.C. § 271(e)(2)(A), creating the basis for this lawsuit prior to any commercial launch Compl. ¶40 Defendants are generic pharmaceutical companies seeking to enter the market for seizure rescue medications upon FDA approval Compl. ¶¶6-7

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the Strides ANDA Products will infringe the asserted patents, but provides limited detail on the specific formulation of the accused products. The analysis below is based on the complaint's general allegations that the accused products meet each claim limitation literally or under the doctrine of equivalents.

11,241,414 Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A pharmaceutical solution for nasal administration consisting of:	The complaint alleges Strides' ANDA is for a diazepam nasal spray, which if approved will be sold as a pharmaceutical product.	¶42	col. 2:11-21
diazepam or a pharmaceutically acceptable salt thereof;	The complaint alleges Strides' ANDA Products contain diazepam.	¶42	col. 2:12
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 Strides ANDA Products satisfy this limitation.	¶42	col. 2:13-16
ethanol and benzyl alcohol in a combined amount from 10% to 70% (w/w); and	The complaint alleges the Strides ANDA Products satisfy this limitation.	¶42	col. 2:16-18
n-dodecyl beta-D-maltoside.	The complaint alleges the Strides ANDA Products satisfy this limitation.	¶42	col. 13:25-33

Identified Points of Contention

• Scope Questions: A central issue will be whether the term "consisting of" precludes the presence of any other excipients in the Strides ANDA product. The court may need to determine if any unlisted ingredients in the accused product materially alter the basic and novel properties of the claimed solution.
• Technical Questions: An evidentiary question will be whether the Strides ANDA product formulation contains each of the four listed components (diazepam, tocopherols, specific alcohols, and n-dodecyl beta-D-maltoside) within the claimed weight-per-weight percentage ranges. The presence and amount of the absorption enhancer, n-dodecyl beta-D-maltoside, may be a particular point of dispute.

11,793,786 Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A pharmaceutical solution for nasal administration consisting of:	The complaint alleges Strides' ANDA is for a pharmaceutical nasal spray solution.	¶50	col. 2:11-12
a therapeutically effective amount of diazepam or a pharmaceutically acceptable salt thereof;	The complaint alleges the Strides ANDA Products contain a therapeutically effective amount of diazepam.	¶50	col. 2:12-13
one or more natural or synthetic tocopherols or tocotrienols selected from the group consisting of a-tocopherol, β-tocopherol, γ-tocopherol, δ-tocopherol, a-tocotrienol, β-tocotrienol, γ-tocotrienol, δ-tocotrienol, tocophersolan, any isomers thereof, any esters thereof, and any combinations thereof, in an amount from 30% to 95% (w/w);	The complaint alleges the Strides ANDA Products satisfy this limitation.	¶50	col. 2:14-23
one or more alcohols in an amount from 10% to 70% (w/w), wherein the one or more alcohols comprises benzyl alcohol; and	The complaint alleges the Strides ANDA Products satisfy this limitation.	¶50	col. 2:23-25
n-dodecyl beta-D-maltoside.	The complaint alleges the Strides ANDA Products satisfy this limitation.	¶50	col. 13:40-48

Identified Points of Contention

• Scope Questions: The infringement analysis may turn on the scope of "one or more alcohols...comprises benzyl alcohol." This raises the question of whether the alcohol component must contain benzyl alcohol in addition to other alcohols (like ethanol), or if benzyl alcohol alone would suffice.
• Technical Questions: A key factual question will be whether the specific form of tocopherol or tocotrienol in the Strides ANDA product falls within the extensive Markush group recited in the claim.

V. Key Claim Terms for Construction

For the '414 Patent

• The Term: "consisting of"
• Context and Importance: This transitional phrase is highly restrictive and is central to the scope of the composition claim. Practitioners may focus on this term because infringement will depend on whether the Strides product contains only the listed ingredients or if it includes additional, unlisted excipients. The court's interpretation will determine whether any additional components in the accused product are permissible.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification discloses embodiments that comprise additional ingredients, such as enhancers and excipients, which "may be advantageous" '414 Patent, col. 29:39-43 This may support an argument that "consisting of" should be interpreted under the standard that it does not exclude ingredients that do not materially affect the basic and novel properties of the invention.
  • Evidence for a Narrower Interpretation: The plain meaning of "consisting of" creates a strong presumption that the claim is closed to any unrecited elements. The patent repeatedly uses the phrase to define a specific, four-component solution '414 Patent, claim 1 This may support an argument that the claim is exhaustive.

For the '786 Patent

• The Term: "wherein the one or more alcohols comprises benzyl alcohol"
• Context and Importance: The construction of "comprises" in this context is critical for defining the alcohol component of the formulation. Practitioners may focus on this term because it will determine whether the alcohol component must include benzyl alcohol in addition to other potential alcohols (e.g., ethanol) or if it can consist of benzyl alcohol alone.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: "Comprises" is generally interpreted as an open-ended term, meaning "includes at least." This could support a reading that the alcohol component must contain benzyl alcohol but may also contain other alcohols. The specification's description of alcohols includes a list where benzyl alcohol is one of several options '786 Patent, col. 2:65-3:2
  • Evidence for a Narrower Interpretation: The claim's structure, which separately recites "one or more alcohols" and then adds the "wherein" clause, could be argued to impose a specific requirement that benzyl alcohol must be part of any alcohol mixture used. Embodiments described in the patent often feature both ethanol and benzyl alcohol, which may be used to argue that the phrase requires a combination '786 Patent, col. 43:1-15

VI. Other Allegations

Indirect Infringement

• The complaint alleges that upon FDA approval, Defendants will indirectly infringe by inducing and contributing to infringement Compl. ¶43 Compl. ¶51 The factual basis for inducement is the allegation that Defendants' product labeling will instruct physicians and patients to administer the generic nasal spray in a manner that performs the steps of the asserted method claims Compl. ¶¶91-93 Contributory infringement is alleged on the basis that the accused products are not staple articles of commerce suitable for substantial noninfringing use Compl. ¶96

Willful Infringement

• The complaint alleges willful infringement based on Defendants' pre-suit knowledge of the Asserted Patents, as evidenced by their sending of a Paragraph IV Notice Letter to Neurelis Compl. ¶35 Compl. ¶44 Compl. ¶52 It is alleged that Defendants acted "without a reasonable basis for believing that it would not be liable" for infringement Compl. ¶44

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

• A central factual question will be one of compositional identity: Once the formulation of the Strides ANDA product is revealed, does it contain every component recited in the asserted composition claims-specifically tocopherols, ethanol, benzyl alcohol, and an alkyl maltoside-in the claimed concentrations? The absence of any single component or a deviation from the claimed ranges could be dispositive of literal infringement.
• A core legal issue will be one of claim scope and construction: Can the term "consisting of" in the '414 patent be interpreted to allow for additional, unlisted excipients in the accused product without avoiding infringement? Similarly, how will the court construe the specific pharmacokinetic and pharmacodynamic limitations in the method claims (e.g., '852, '061), and what level of evidence will be required to prove that the proposed generic product will meet these criteria in practice?
• A key issue for the method-of-use patents, particularly the pediatric-focused '611 patent, will be inducement: Does the proposed product label for the Strides ANDA product, directly or indirectly, encourage or instruct physicians to prescribe the drug for the patented pediatric use (ages 2-5), even if that specific indication is "carved out" of the label? This will likely involve a close analysis of the language in the proposed label and its potential to lead to infringing uses by end-users.