Litigation
Neurelis, Inc. v. Strides Pharma Global PTE Ltd. et al.
pending1:26-cv-00947-MN
- Filed
- 2026-07-31
Patents at issue (1)
Plaintiffs (1)
Defendants (2)
Summary
ANDA case against Strides relating to ANDA No. 221329 and identified as a related action consolidated under lead case 1:24-cv-00562-MN. The Strides complaint expressly asserts the '414 patent among the asserted patents.
Case overview & background
Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.
I'll research this case thoroughly using web search.
Good initial results. Let me dig deeper into the patents, the related consolidated case, and the parties.
Neurelis, Inc. v. Strides Pharma Global PTE Ltd. et al., No. 1:26-cv-00947-MN (D. Del.)
Parties and what they do. Neurelis, Inc. is a private, commercial‑stage neuroscience company (organized in Delaware, principal place of business at 3430 Carmel Mountain Rd., Suite 300, San Diego, CA) founded in 2007 to develop and commercialize CNS therapies for epilepsy and psychiatry. It is not an NPE — it is the innovator/NDA holder for the branded product at issue, VALTOCO® (diazepam nasal spray), approved under NDA No. N211635 (FDA approval Jan. 10, 2020; label expanded in April 2025 to patients ages 2 and older). Neurelis reported estimated 2025 net revenue of $295–300M (more than double 2024) with a 30%+ EBITDA margin and no bank debt, and its Rule 7.1 disclosure in this case identifies China Medical System Holdings Limited (a Chinese pharma that commercializes the product in greater China) as an affiliate — see Neurelis business update, Jan. 12, 2026 and the docket's Rule 7.1 filing at CourtListener docket 73702976. The defendants are Strides Pharma Global PTE Ltd. (a Singapore corporation, The Central, Singapore) and Strides Pharma Inc. (a New Jersey corporation in Bridgewater, NJ), affiliates of the Indian generics group Strides Pharma Science Ltd. The complaint pleads that Strides Inc. is an "agent or affiliate" of Strides Global acting on its behalf with respect to the accused ANDA (Compl. ¶¶ 3–7, via CourtListener).
Accused product. This is a Hatch‑Waxman ANDA case under 35 U.S.C. § 271(e)(2). The accused instrumentality is ANDA No. 221329, a generic diazepam nasal spray in the 5 mg/spray and 7.5 mg/spray strengths (the CourtListener text excerpt truncates the dosage list), which Neurelis alleges is a generic version of VALTOCO. Strides served a Paragraph IV notice letter that Neurelis received June 18, 2026 (per the docket's ANDA supplemental‑information sheet); Neurelis filed within the 45‑day window on July 31, 2026, triggering a 30‑month FDA‑approval stay running to December 18, 2028 (docket entry for the ANDA form, CourtListener). Strides Pharma Global was served Aug. 5, 2026; answer was originally due Aug. 26, 2026, and a stipulation to extend appears on the docket around Aug. 25, 2026, so the case remains in its earliest pleading phase.
Patents asserted and posture. The complaint's Patent/Trademark Report lists seven U.S. patents — Nos. 11,241,414; 11,793,786; 12,268,664; 12,324,852; 12,337,061; 12,521,400; and 12,599,611 — so although the case metadata and the prior summary center on the '414 patent, the '414 is one of a broader asserted set (CourtListener docket; DrugPatentWatch). Technical sketch of each: the '414 ('Administration of Benzodiazepine Compositions,' issued Feb. 8, 2022, 2008 priority, Orange Book expiry Mar. 27, 2029) claims a nasal solution "consisting of" diazepam plus tocopherols/tocotrienols (30–95% w/w), ethanol and benzyl alcohol (10–70% w/w combined) and n‑dodecyl β‑D‑maltoside (DDM); the '786 (issued Oct. 24, 2023, same 2008 family) is the sibling composition claim with the alcohol component required to comprise benzyl alcohol plus DDM; the '664 claims a low‑water (<1%) intranasal solution of ~1–20 mg diazepam in 45–85% tocopherol/tocotrienol, 25–40% alcohol and 0.01–1% w/v DDM in a spray formulation; the '852 and '061 are method‑of‑treatment claims covering intranasal diazepam for acute seizure clusters (Orange Book expiries Oct. 16, 2032 and June 13, 2032, respectively — the patents Neurelis credits with extending exclusivity past 2032); the '400 (issued Jan. 13, 2026) claims an intranasal diazepam composition in a 50–150 µL solution of defined tocopherol/alcohol ranges; and the '611 is listed by DrugPatentWatch as a VALTOCO patent but I could not independently verify its claim scope. Notably, the earlier, soon‑to‑expire '546 patent (8,895,546) asserted against Padagis and Lupin is not on the Strides docket report — consistent with Strides targeting the newer/lower‑strength filings.
Venue and why it matters. The case sits before Judge Maryellen Noreika (the "MN" suffix) in the District of Delaware — the dominant forum for ANDA litigation because so many generic sponsors are Delaware‑organized or registered there (as are Strides' U.S. affiliates' competitors), and because § 1400(b) venue is easy to establish. It has been designated related to and consolidated under lead case No. 1:24-cv-00562-MN (Neurelis v. Padagis), alongside a cluster of related Neurelis actions: Padagis II (1:25-cv-00821), Padagis III (1:25-cv-01228), 1:25-cv-01443, Lupin (1:26-cv-00258‑MN), Amneal (1:26-cv-00261‑MN) and Padagis (1:26-cv-00401‑MN) (Compl. ¶ on related actions; see the complaint text and the Padagis '401 complaint analysis). The case is notable on three fronts: (1) it is a bet‑the‑company franchise defense — VALTOCO is essentially Neurelis's only commercial product, and Neurelis is running parallel litigations against every significant ANDA filer while layering on new Orange Book patents; (2) it is IPR‑linked — Padagis filed three IPRs against the '546, '414 and '786 patents (IPR2025‑00464/‑465/‑466); the Board instituted all three and set an oral‑hearing/trial date of June 16, 2026 (paragraphfour.com aggregator), which means final written decisions on the '414 should be issuing around now (Sept. 2026) — a validity loss on the '414 could reshape the Strides case, whereas a Neurelis win would harden the asserted family; and (3) it is a market‑context case, with a branded intranasal benzodiazepine franchise growing rapidly against legacy rectal gel (Diastat) and competing intranasal entrants.
Sourcing caveats. Party identities, service dates, the June 18, 2026 notice date, the Dec. 18, 2028 thirty‑month stay, the judge assignment and the seven‑patent list come from the complaint/docket via CourtListener (docket 73702976) and DrugPatentWatch. The IPR institution/trial‑date facts come from a secondary aggregator and PTAB filings (Petitions 1557269–1557271 on PTACTS); I could not confirm the outcome or exact FWD dates for IPR2025‑00464/‑465/‑466. Plaintiff‑side Delaware counsel appears to be DLA Piper (Michael Sitzman, Brian A. Biggs, Stephanie O'Byrne) per the related Padagis complaints, while the Strides‑case summons was filed by Ethan H. Townsend, whose Law360 profile associates him with McDermott Will & Emery — I have not verified the full counsel lineup or any defense counsel, so treat those attributions as tentative. The metadata supplied for this matter lists only the '414 patent; the docketed complaint lists seven, and I have flagged that discrepancy rather than resolve it.
Key legal developments & outcome
Major rulings, motions, claim construction, settlements, and the present posture or final disposition.
I'll research this case across multiple sources. Let me start with broad searches.
Let me get the full docket and explore the related consolidated litigation.
Now let me dig into the PTAB proceedings and the lead consolidated case.
Neurelis v. Strides Pharma Global PTE Ltd., No. 1:26-cv-00947-MN (D. Del.)
Bottom line up front: This case is roughly six weeks old. It is in the pleading stage — the complaint is on file, both Strides entities have been served and have appeared, and the answer deadline has been extended by stipulation. No pre-trial motions, no Markman, no discovery, no trial, and no disposition exist yet in this docket. The most consequential developments so far are (1) the 30-month FDA stay triggered on 2026-06-18, and (2) the fact that this case rides into a consolidated Neurelis/Valtoco litigation family in which claim construction and instituted PTAB proceedings on overlapping patents (including the '414) are already well advanced.
1. Pre-suit chronology — the litigation family this case joins
| Date | Development | Source |
|---|---|---|
| 2024-03-26 | Padagis Notice Letter (ANDA No. 219320) on '546, '414, '786 | Complaint, Neurelis v. Padagis, 1:24-cv-00562 |
| 2024-05-08 | Lead case filed: Neurelis, Inc. v. Padagis LLC et al., 1:24-cv-00562-MN (Hon. Maryellen Noreika) — '546, '414, '786 | D. Del. docket |
| 2025-05-21 / 2025-09-02 | Padagis 2d and 3d Notice Letters ('664; then '852 and '061) | Neurelis v. Padagis, 1:26-cv-00401, ¶¶29–33 |
| 2025-06-16 (approx.) | Padagis files IPR2025-00464 ('546), -465 ('414), -466 ('786); all instituted, trial set 2026-06-16 | paragraphfour case trackers |
| 2025-08-15 / 2025-08-22 | Markman briefing in the lead case: Joint Claim Construction Brief (D.I. 87) and Defendants' Responsive CC Brief (D.I. 88) — disputed terms include "consisting of" and "in a combined amount," plus an indefiniteness fight over whether water is excluded | PTAB exhibit lists (EX-2050, EX-2051, EX-2069–2071) |
| 2026-03-11 | Neurelis v. Lupin Inc., 1:26-cv-00258-MN; Neurelis v. Amneal Pharm. LLC, 1:26-cv-00261-MN | Complaint, related-filings notice |
| 2026-04-08 | Neurelis v. Padagis LLC, 1:26-cv-00401-MN ('400 patent) | D. Del. docket |
| 2026-06-17 | Strides Notice Letter re ANDA No. 221329 (diazepam nasal spray, 5 / 7.5 / 10 mg per spray), executed by Timothy H. Kratz; Paragraph IV certification against the '546, '414, '786, '664, '852, '061 and '400 patents | Compl. ¶¶35–36 |
The Strides complaint lists the related actions as consolidated under the first-filed number (the 1:24-cv-00562-MN lead case) pursuant to L.R. 3.1.
2. Filing & initial pleadings (2026-07-31 → present)
- 2026-07-31 — Complaint (D.I. 1). Seven counts, Exhibits A–G, one exhibit per asserted patent. The '414 patent ('414) is asserted at least as to claims 1–18, with the § 271(e)(2)(A) theory pleaded against the Strides ANDA and § 271(a)/(b)/(c) theories pleaded against post-approval commercial activity. Neurelis also moved for a Rule 7.1 disclosure identifying China Medical System Holdings Limited as an affiliate.
- 2026-07-31 — ANDA form / 30-month stay. Patentee received notice 2026-06-18; docket records the thirty-month stay deadline as 2028-12-18. The complaint was filed within the 45-day window, so Neurelis is entitled to the statutory stay under 21 U.S.C. § 355(j)(5)(B)(iii).
- 2026-07-31 — Summonses issued; 2026-08-05 — both defendants served (returns filed 2026-08-10 by Ethan H. Townsend, McDermott Will & Emery — Neurelis's Delaware counsel); answers originally due 2026-08-26.
- 2026-08-11 / 2026-08-13 — pro hac vice appearances (six out-of-state attorneys admitted, orders entered 2026-08-11 and 2026-08-13).
- 2026-08-25 — Defendants' appearance and Rule 7.1 disclosure (D.I. 14, 15), and a stipulation to extend the answer deadline (D.I. 16), so ordered the same day. Note: I am inferring that D.I. 14–15 are Strides-side filings from the docket feed; confirm against PACER.
- No answer, no counterclaims, and no amended pleadings appear on the docket as of the last RECAP update (2026-08-25). Any invalidity/unenforceability/non-infringement counterclaims would be expected in the answer, in the ordinary ANDA-defendant pattern.
Record discrepancy worth flagging: the complaint narrative describes seven Paragraph IV patents including the '546 patent, but the court's Patent/Trademark Report form lists 7 patents including U.S. 12,599,611 ('611) and not the '546. I could not resolve which is correct; the metadata's single-patent field ('414) is narrower still than either list.
3. Pre-trial motions of substance
None filed. There is no motion to dismiss, transfer, stay pending IPR, or summary judgment in this docket. Because this case is consolidated into a family where fact discovery is ongoing and a bench trial is scheduled for 2027-03-01 in the lead case, any stay or coordination motion would most likely be addressed in the lead case rather than here. I found no public evidence of a stay having been granted in the lead case despite the instituted IPRs.
4. Claim construction
Not reached here (case is weeks old). In the lead case, Markman was briefed in August 2025 and the parties have disputed, among other things, the closed transitional phrase "consisting of" and the meaning of "in a combined amount" (whether each of ethanol and benzyl alcohol must be >0%). I could not confirm a claim construction order or hearing transcript in the time available — treat the outcome of Markman in 1:24-cv-00562-MN as an open item that will likely be adopted or adapted for the Strides case.
5. Discovery
Not commenced. No scheduling order, Rule 26(f) report, or discovery dispute appears on the 1:26-cv-00947 docket. Strategically, note that in the lead case the parties already extended fact discovery deadlines by stipulation (order entered 2025-05-15), which suggests the family's discovery timeline is a moving target.
6. Trial, verdict, post-trial motions
None. The consolidated family is set for a bench trial on 2027-03-01; the docket shows no jury demand (consistent with the other Neurelis/Valtoco cases, which list "Jury Demand: None"). No JMOL, new-trial, or fee motions exist.
7. Disposition / present posture
Active and pending. No settlement, dismissal, consent judgment, or appeal. Key dates to track: defendants' extended answer deadline (reset by D.I. 16), the 2028-12-18 expiry of the 30-month stay, and the 2027-03-01 bench trial in the lead consolidated case.
8. Parallel PTAB proceedings
- IPR2025-00465 — U.S. 11,241,414 ('414, the patent flagged in the case metadata). Petitioned by Padagis US LLC, instituted for trial with a 2026-06-16 hearing date. Neurelis's preliminary response attacked institution on discretionary-denial grounds (invoking the Director's Stewart memorandum and a Sotera-style stipulation argument), attacked petitioner's § 120 priority theory, and argued the expert declaration (Donovan) was substantially copied from Aquestive's expert (Peppas) in IPR2019-00451. Whether a final written decision has issued — which would be roughly contemporaneous with today's date, given the June 2026 hearing — is the single most important open question; I could not confirm it.
- IPR2025-00464 ('546) and IPR2025-00466 ('786) — also Padagis-filed, also instituted, same 2026-06-16 trial date.
- IPR2019-00451 — Aquestive Therapeutics v. Neurelis on U.S. 9,763,876, the earlier, closely related Neurelis patent; its record (including the '558 provisional / Gwozdz priority dispute) is being re-litigated in the 2025 IPRs.
- No Strides-filed IPR on the '414 or its siblings appears in the sources I reviewed. Under 35 U.S.C. § 315(b), Strides's one-year window measured from service (2026-08-05) closes on approximately 2027-08-05 — the natural next pressure point in this case.
Effect on the litigation: the instituted '414 IPR is a genuine existential risk to the asserted claims and a plausible basis for a stay motion, yet the Neurelis family has proceeded to full Markman briefing and a trial setting rather than pausing for the Board. A cancellation of '414 claims in an FWD would likely narrow or moot the corresponding counts in this case; survival would strengthen Neurelis's hand modestly and, combined with any § 315(b) estoppel, constrain Strides's invalidity case in the district court.
Sourcing caveats
- Well-sourced: filing date, parties, counsel, ANDA number and strengths, notice-letter date, service and answer dates, the 2028-12-18 stay deadline, the seven-patent list in the court's PTO report, and the related-case family. (D. Del. docket via CourtListener: https://www.courtlistener.com/docket/73702976/neurelis-inc-v-strides-pharma-global-pte-limited/; complaint at Document 1.)
- Reasonably sourced but secondary: the IPR numbers, institution decisions and 2026-06-16 trial date, the 2027-03-01 bench trial, and the Markman briefing dates — these come from paragraphfour.com case trackers and PTAB exhibit lists rather than from primary docket entries I retrieved directly.
- Not verified (do not treat as fact): the identity of Strides's Delaware counsel; whether D.I. 14–15 are defendants' filings; any Markman order in the lead case; any FWD in IPR2025-00464/-465/-466; any Strides IPR petition; and whether the complaint asserts the '611 rather than the '546. I hit my search-call ceiling before I could query PACER/PTAB for the June–September 2026 Board decisions and the current docket sheet — those are the first things I would pull next.
Plaintiff representatives
Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- McDermott Will & Schulte
- Ethan H. Townsend · local counsel
I'll research the docket and counsel for this case. Let me run several searches in parallel.
Let me dig into the docket entries and counsel appearances.
Bottom line
I could confirm that Neurelis, Inc. is represented in this case by McDermott Will & Schulte LLP, with Delaware counsel appearing of record, and that Neurelis's long-running Valtoco/Hatch‑Waxman team (formerly at DLA Piper, now at McDermott) is the same group handling this Strides action. However, the full counsel list cannot be stated with certainty from public sources — the complaint's signature block and the text of the pro hac vice entries (D.I. 9, 12) and the Aug. 25 Notice of Appearance (D.I. 14) were not retrievable in full, so I am reporting confirmed names and flagging the rest as inference.
What the docket shows
Case: Neurelis, Inc. v. Strides Pharma Global PTE Ltd., No. 1:26‑cv‑00947‑MN (D. Del.), assigned to Judge Maryellen Noreika; complaint filed 7/31/2026 (CourtListener docket).
Relevant entries (per CourtListener/RECAP and the docket feed):
| Entry | Date | Description |
|---|---|---|
| D.I. 1 | 7/31/2026 | Complaint for patent infringement + Exs. A–G, Notice of Related Filings, Civil Cover Sheet |
| D.I. 3 | 7/31/2026 | Rule 7.1 Disclosure Statement (identifies China Medical System Holdings Ltd. as affiliate) |
| D.I. 7 | 8/10/2026 | Summons returned executed — Strides Pharma Global served 8/5/2026 — filed by "Townsend, Ethan" |
| D.I. 8 | 8/10/2026 | Summons returned executed — Strides Pharma, Inc. |
| D.I. 9 | 8/11/2026 | Motion to Appear Pro Hac Vice (SO ORDERED); minute entries reflect "Add Attorneys – PHV only" and pro hac vice fee payments listed as "05 Attorneys" and "01 Attorney" |
| D.I. 12 | 8/13/2026 | Motion to Appear Pro Hac Vice (SO ORDERED); additional PHV fee minute entry |
| D.I. 14 | 8/25/2026 | Notice of Appearance (party not confirmed in the retrieved text); Stipulation to Extend Time also docketed late Aug. 2026 |
Source: CourtListener docket feed for 1:26‑cv‑00947.
Counsel identified
1. Ethan H. Townsend — Delaware counsel (local counsel of record)
- Firm / office: McDermott Will & Schulte LLP, Wilmington, Delaware.
- Basis of identification: He is the filer of record on the summons returns in this case (D.I. 7–8, 8/10/2026), which is the signature that appears for plaintiff Neurelis. Law360's attorney profile for Ethan H. Townsend (Wilmington, DE) / McDermott Will lists the Neurelis v. Strides Pharma Global case (filed July 31, 2026, D. Del., ANDA) among his matters, alongside Neurelis, Inc. v. Padagis LLC (Apr. 8, 2026, D. Del.).
- Note on role: Delaware practice in this district requires a member of the Delaware bar to appear; his filing of the service returns indicates he is Neurelis's Delaware counsel of record. He is the only attorney name I could confirm appearing for Neurelis in this specific docket.
2. Michael Sitzman — lead counsel / trial counsel (inferred, not confirmed on this docket)
- Firm / office: McDermott Will & Schulte LLP, 415 Mission St., Suite 5600, San Francisco, CA.
- Basis: In the parallel PTAB proceeding Padagis US, LLC v. Neurelis, Inc., IPR2025‑00464, Neurelis's mandatory notices under 37 C.F.R. § 42.8(b)(3) designate Michael Sitzman (Reg. No. 42,150) of McDermott Will & Schulte LLP as Lead Counsel (dated October 8, 2025), with McDermott and DLA Piper attorneys as back‑up (PTAB filing, Patent Owner's mandatory notices). He was previously identified as Neurelis's lead plaintiff-side lawyer in the Valtoco ANDA litigation (paragraphfour.com lists "Plaintiff Lawyer/Firm: Michael Sitzman" for Neurelis v. Padagis, 1:24‑cv‑00562‑MN — then at DLA Piper).
- Relevant experience: Sitzman has led Neurelis's Valtoco® (diazepam nasal spray) Hatch‑Waxman campaign against Padagis, Lupin, and others, and Neurelis's Patent Owner-side defense of the '546, '414, and '786 patents in IPR2025‑00464/‑00465/‑00466.
- Caveat: I did not confirm Sitzman's appearance on the 1:26‑cv‑00947 docket itself. His connection to this case is by (a) firm continuity with the filer of record, (b) his designation on the related IPR covering the same '414 patent, and (c) Law360's firm-level listing of McDermott on this case.
3. Timothy P. Best — back‑up counsel (same family of cases)
- Firm / office: McDermott Will & Schulte LLP, 2049 Century Park East, Suite 3200, Los Angeles, CA. Designated in IPR2025‑00464 as a provisionally recognized PTAB attorney / back‑up counsel for Neurelis.
4. David J. Tobin — back‑up counsel
- Firm / office: McDermott Will & Schulte LLP, 2801 N. Harwood St., Suite 2600, Dallas, TX (Reg. No. 60,776). Listed in the same Neurelis mandatory notices.
5. DLA Piper team still listed in Neurelis's PTAB notices (role in this case unconfirmed)
- Raymond Miller (Reg. No. 42,891) and N. Nicole Endejann (Reg. No. 50,229), both DLA Piper LLP (US), One Liberty Place, 1650 Market Street, Suite 5000, Philadelphia, PA 19103 — designated back‑up counsel for Neurelis in IPR2025‑00464.
- Brian A. Biggs (DE Bar No. 5591) and Stephanie E. O'Byrne (DE Bar No. 4446), DLA Piper LLP (US), 1201 N. Market Street, Wilmington, DE — the Delaware counsel block on Neurelis's May 8, 2024 complaint in the parent case, Neurelis, Inc. v. Padagis LLC, C.A. No. 1:24‑cv‑00562‑MN (complaint signature block, Ex. 1063 to IPR2025‑00464).
- Catherine Huang (DLA Piper, San Diego) and Stephanie Piper (DLA Piper, New York) — "of counsel" on that same 2024 complaint.
- Note: These DLA Piper names appear on the 2024 Padagis complaint and on the IPR notices, not on the 1:26‑cv‑00947 docket. Neurelis's principal outside patent team appears to have migrated from DLA Piper to McDermott Will & Schulte between 2024 and late 2025 (Sitzman's IPR designation moved to McDermott by Oct. 2025), and the Strides case is being handled out of McDermott.
In-house counsel
I found no publicly available record identifying Neurelis in-house counsel of record in this action. The Rule 7.1 disclosure statement (D.I. 3) was filed by outside counsel and does not name in-house attorneys. Paragraph IV notice letters in the related cases were executed by counterparty (Strides/Padagis) legal personnel, not Neurelis's.
Important caveats and gaps
- The complaint's signature block was not retrievable. The CourtListener text of D.I. 1 for 1:26‑cv‑00947 that I obtained ends at the prayer for relief; the signature block attributing the pleading was not captured. So I cannot state with certainty who signed the Strides complaint.
- D.I. 9 and D.I. 12 (pro hac vice motions) were not retrieved in full text. The docket feed shows a "05 Attorneys" PHV fee payment on 8/11 and "01 Attorney" payments on 8/11 and 8/13, which suggests roughly five to seven out-of-state Neurelis attorneys were admitted pro hac vice shortly after filing — but I could not read the names. This is where the bulk of the Neurelis-side roster most likely sits.
- D.I. 14 (Notice of Appearance, 8/25/2026) is unattributed in my sources. Given the Aug. 26 answer deadline and the simultaneously docketed stipulation to extend time, that notice is at least as likely to be defense counsel (Strides) as plaintiff counsel. I therefore do not attribute it to Neurelis.
- No sealed filings affecting the analysis were identified, but PACER/RECAP coverage for this new case is incomplete ("This item is not yet in the RECAP collection" appears for several attachments), so the record may not be complete.
- The metadata in the case prompt controls: I've used Neurelis, Inc. v. Strides Pharma Global PTE Ltd., No. 1:26‑cv‑00947‑MN, D. Del., with the '414 patent among the asserted patents. Note that the docket's Patent/Trademark Report lists seven patents (11,241,414; 11,793,786; 12,268,664; 12,324,852; 12,337,061; 12,521,400; 12,599,611), not just the '414.
How to close the remaining gaps
- Pull the PACER docket for 1:26‑cv‑00947, D.I. 9, 12, and 14 — the pro hac vice motions will list every out-of-state Neurelis attorney name, firm, and office address, and the PHV orders will confirm admission.
- Pull the last page of D.I. 1 (complaint signature block) for the as-filed attribution and "Attorneys for Plaintiff Neurelis, Inc." designation.
- Check the lead case, 1:24‑cv‑00562‑MN, for the operative Neurelis-side roster and any substitution/withdrawal filings (e.g., a DLA Piper → McDermott withdrawal), which would explain the firm transition.
If you want, I can draft the counsel-identification section for the case memo using only the confirmed name (Ethan H. Townsend / McDermott Wilmington) plus the IPR-designated Neurelis team, with the unconfirmed names held as "to be verified against D.I. 9/12."
Defendant representatives
Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- Kratz & Barry
- Timothy H. Kratz · lead counsel
I'll research the docket and counsel appearances for this case.
Let me pull the full docket sheet and look for defense appearances.
Answer
Bottom line: I could only partially verify defense counsel from public sources. The complaint itself supplies one hard name — Timothy H. Kratz — and the docket shows defense-side appearances began in mid-to-late August 2026, but the text of the key docket entries (D.I. 11–14) is not in the RECAP collection, so the precise roster on the Notice of Appearance could not be confirmed. Rather than guess, here is what is sourced, what is inference, and what remains unverified.
1. Verified from the complaint itself (D.I. 1, ¶ 36)
| Name | Role | Firm / Location | Note |
|---|---|---|---|
| Timothy H. Kratz | Named in the complaint as the individual who executed the Strides Paragraph IV Notice Letter (dated June 17, 2026) on behalf of Strides Pharma Inc./Strides Pharma Global PTE Ltd, and expressly designated as "an agent authorized to accept service of process" | Kratz & Barry LLP — Atlanta, GA (1050 Crown Pointe Parkway, Suite 500); firm also has Wilmington, DE and Philadelphia offices | Veteran Hatch-Waxman trial lawyer; per his firm bio, 25+ years first-chair experience and lead counsel on 65+ ANDA Paragraph IV matters for generic manufacturers; Georgia bar since 1989. (firm bio, Kratz & Barry firm profile) |
Kratz's designation as service agent strongly signals he is lead counsel for Strides in this ANDA action, though the complaint itself does not say so and I could not confirm his formal appearance from the docket.
2. Kratz & Barry personnel likely to appear (inference — not confirmed in this docket)
Kratz & Barry litigates ANDA matters as a team, typically with an Atlanta-based trial team plus a Delaware-barred local attorney. In a closely analogous case (Pfizer v. Dexcel Pharma, D. Del. 1:23-cv-00879, D.I. 115), the same firm moved for pro hac vice admission of Kratz, George J. Barry III, Michael P. Hogan, and John Thallemer (Atlanta), with R. Touhey Myer (Delaware bar #5939, 800 N. West Street, Wilmington) as local counsel. (D.I. 115 PDF; docket)
| Name | Likely role | Firm / office | Note |
|---|---|---|---|
| George J. Barry III | Partner / co-lead (if appearing) | Kratz & Barry LLP, Atlanta | Firm co-founder; moved from an international firm with Kratz in 2017 |
| Michael P. Hogan | Partner | Kratz & Barry LLP, Atlanta | Routine ANDA team member in the Dexcel/Aurobindo matters |
| John D. Thallemer | Associate/partner | Kratz & Barry LLP, Atlanta | Same |
| R. Touhey Myer | Local (Delaware) counsel | Kratz & Barry LLP, Wilmington, DE | Member of the Delaware bar; has served as local counsel for generic ANDA defendants |
Caveat: These four are listed as the firm's standard ANDA team as evidenced in other cases. I found no source naming them in 1:26-cv-00947. Treat as probable, not confirmed.
3. What the docket shows (but the content is not retrievable)
From the CourtListener/RECAP docket sheet (1:26-cv-00947):
- Aug 5, 2026 – Case assigned to Judge Maryellen Noreika.
- Aug 5, 2026 – Both Strides entities served; answer due Aug 26, 2026 (D.I. 10).
- Aug 11 and Aug 13, 2026 – Pro hac vice fee payments received for one attorney (Aug 11) and five attorneys (Aug 13) — i.e., six PHV admissions sought in this matter to date. I could not determine from available sources whether these belong to plaintiff Neurelis (McDermott Will & Emery) or to the Strides defendants; the docket text of the corresponding motions is not in RECAP.
- ~Aug 14, 2026 – A Notice of Appearance minute entry appears in the docket feed.
- Aug 25, 2026 – Additional Notice of Appearance and a Stipulation to Extend Time (consistent with defendants answering rather than defaulting).
So: counsel has appeared; the case is not in a "no appearance yet" posture. But the names are locked in unretrieved PDFs.
4. Plaintiff's Delaware counsel (for contrast / identification)
Not asked, but for docket reference: Ethan H. Townsend (McDermott Will & Emery, Wilmington, DE) filed the summons returns and signed filings for Neurelis. (Law360 attorney page, docket)
5. What I could NOT verify — and why
- The exact defense appearance roster. D.I. 11–14 (the pro hac vice motions and notices of appearance) are not in the RECAP collection; only the minute-entry captions and fee payments are visible. PACER direct access would resolve this in one query.
- Whether Strides Global and Strides Inc. are jointly or separately represented. Singapore parent + New Jersey subsidiary in Delaware ANDA cases are usually jointly represented, but I have no filing confirming that here.
- In-house counsel. The complaint's ¶ 36 references the notice letter's execution but names no Strides in-house attorney. Strides Pharma Inc. legal is based in Bridgewater, NJ; I found no sourced name.
- No sealed filings confirmed. I cannot confirm or rule out sealed defense filings; the docket entries I reviewed contain no sealing orders.
Recommended verification step: pull the PACER docket for 1:26-cv-00947-MN, entries 11–14 and 15–18, and the D.I. 14 Notice of Appearance — that document will name every defense attorney of record and their firm/office, which is the authoritative answer to your question.
I have deliberately not named any attorney I could not source; the Kratz identification is grounded in the complaint text and his firm's public ANDA practice, and the Barry/Hogan/Thallemer/Myer names are flagged as inference from parallel cases only.