Neurelis, Inc. v. Amneal Pharmaceuticals LLC

I'll research this case thoroughly before drafting the overview. Let me start with several parallel searches.

Let me dig deeper into the docket, the lead consolidated case, and any IPR activity.

Case Overview — Neurelis, Inc. v. Amneal Pharmaceuticals LLC, No. 1:26-cv-00261-MN (D. Del.)

The parties. Neurelis, Inc. is a San Diego–based specialty pharmaceutical company (Delaware-incorporated, principal place of business 3430 Carmel Mountain Road, Suite 300, San Diego) that is the NDA holder and brand manufacturer of VALTOCO® (diazepam nasal spray, NDA 211635, approved January 10, 2020) — the first FDA-approved intranasal benzodiazepine for acute treatment of seizure clusters in epilepsy patients. Neurelis is an operating company, not an NPE/PAE: it holds orphan-drug exclusivity (ODE-279) and new-patient-population exclusivity on the product, and its patent estate derives from in-licensed nasal-absorption technology (the alkyl-saccharide "Intravail"-type enhancer, dodecyl maltoside) supplied under 2008 license/supply agreements with Aegis Therapeutics (per the trial exhibit list in the related IPRs, Exs. 2041–2044). Defendants are Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, Inc. — one of the largest U.S. generic-drug manufacturers and a frequent Hatch-Waxman defendant. Both Amneal entities are Delaware-organized, so personal jurisdiction and venue are essentially uncontested. Neurelis's counsel is McDermott Will & Schulte LLP (Michael A. Sitzman, Timothy P. Best, Ethan H. Townsend, Connor S. Romm, Hannah Hurley, et al.), with DLA Piper also on the broader VALTOCO litigation team; Amneal's pro hac vice team added April 24, 2026 (Giancarlo J. Scaccia, Jonathan R. Wise, Richard C. Pettus, Scott J. Bornstein) appears with Young, Conaway, Stargatt & Taylor LLP as Delaware counsel (firm affiliations per docket aggregators; I have not confirmed them against primary PACER).

The accused product. The accused instrumentality is Amneal's proposed generic VALTOCO — ANDA No. 219109, covering diazepam nasal spray at 7.5 mg/spray and 10 mg/spray. Amneal sent its Paragraph IV notice letter on February 18, 2026; Neurelis sued on March 11, 2026, within the 45-day window, triggering a 30-month FDA-approval stay under 21 U.S.C. § 355(j)(5)(B)(iii) (roughly mid-2028, by my calculation from the notice date — an inference, not a docketed figure). Infringement is pleaded under § 271(e)(2)(A) based on the ANDA submission itself, plus induced/contributory infringement and willfulness premised on the notice letter. Neurelis seeks a § 271(e)(4) order setting Amneal's approval date no earlier than patent expiry.

Patents asserted. The case metadata lists three patents — the '414, '852, and '061 — and third-party complaint analyses of the Amneal complaint report a broader six-patent family assault (adding the '786, '664, and '400 patents). Flagging that discrepancy: I could not confirm the actual complaint text from primary PACER, so treat the six-patent set as unverified (source: Ex Parte complaint analysis, an AI-generated summary). Technical sketches:

• U.S. 11,241,414 — "Administration of Benzodiazepine Compositions" (issued Feb. 8, 2022; Orange Book expiry Mar. 27, 2029). Composition claim: a non-aqueous nasal solution "consisting of" diazepam, 30–95% w/w tocopherol(s)/tocotrienol(s), 10–70% w/w ethanol + benzyl alcohol, and n-dodecyl β-D-maltoside.
• U.S. 12,324,852 — same title (issued June 10, 2025; OB expiry Oct. 16, 2032; listed as method-of-use U-4173). Method claim: treating bouts of intermittent, stereotypic seizure activity by a single 100 µL spray to one nasal mucosal membrane of a solution consisting of 56.47 mg vitamin E (±5%), 10 mg diazepam, 0.25 mg dodecyl maltoside, 10.50 mg benzyl alcohol (±5%), and sufficient ethanol, achieving 92.5–107.5% of IV diazepam bioavailability.
• U.S. 12,337,061 — same title (issued June 24, 2025; OB expiry June 13, 2032; U-4173). Method claim: single 100 µL (±5%) spray of a "stable" solution into a nostril with the same quantitative formulation and the same 92.5–107.5% IV-relative bioavailability and therapeutic-outcome limitations.

Posture, venue, and why it matters. The case is before Judge Maryellen Noreika in Wilmington (D. Del. is the dominant ANDA venue, and Amneal's Delaware citizenship makes this a clean § 1400(b) fit). Amneal answered the complaint on March 23, 2026, and by a Second Consolidation Order and Modified Case Scheduling Order entered April 23, 2026, No. 26-261 was consolidated for all purposes into the lead VALTOCO action, Neurelis, Inc. v. Padagis LLC, C.A. No. 24-562-MN (D.I. 17); the member case is statistically closed and all filings go on the lead docket (PacerMonitor docket, last updated May 28, 2026; Docket Alarm lead-case docket). The consolidated schedule sets fact discovery closed August 7, 2026; claim-construction briefs served June–July 2026; a Markman hearing on August 19, 2026 in Courtroom 4A; opening expert reports due September 25, 2026; expert discovery closing December 18, 2026; and a bench trial the week of January 10, 2028 (no jury — ANDA cases are tried to the bench). In other words, as of today the Markman hearing is behind the parties and expert reports are about to open, while the PTAB runs in parallel.

The case is notable on several fronts. First, it is another chapter in what is effectively a rolling, patent-by-patent defense of the VALTOCO franchise: Neurelis has now sued Padagis (twice, plus follow-ons), Lupin, and now Amneal on the same NDA as new patents issued and new Paragraph IV letters arrived — and Judge Noreika has compressed the whole campaign into one lead case and one 2028 trial. Second, the protection horizon is bifurcated: the composition-of-matter family expires March 27, 2029, while the '852 and '061 method-of-use patents run to October 16, 2032 and June 13, 2032, adding roughly three and a half years of runway, and their U-4173 listing raises the prospect of a label carve-out fight over the method claims. Third, there is a genuinely serious validity cloud that is IPR-linked: Padagis's petitions IPR2025-00464, -00465, and -00466 challenge the '546, '414, and '786 patents, were instituted September 16, 2025 (final written decisions due around mid-September 2026), and the then-Acting Director's July 2025 refusal to discretionarily deny — designated informative on January 9, 2026 — relied on the earlier IPR2019-00451, where the Board held nearly identical family claims obvious over Gwozdz and not entitled to the '558 provisional's priority date, affirmed on appeal. Neurelis's attempt to neutralize Gwozdz via a § 103(c)(2)(C) joint-research-agreement safe harbor — by seeking a certificate of correction on the very patents under review — was denied, and its request for rehearing was denied March 20, 2026 (IPR2025-00464, Paper 39), with the Board citing the patentee's seven-year delay and "substantial prejudice" to the petitioner, who is now time-barred from filing a Gwozdz-free petition. If the '414 patent does not survive, the '852/'061 method claims become the entire source of the 2028 trial and the stay math, which makes this Amneal case (and its consolidated siblings) a case study in how late-issued method-of-use patents are being deployed to extend small-molecule franchise life past the 2029 composition expiries. Market context: VALTOCO competes in the seizure-cluster rescue market with nasal midazolam (Nayzilam), rectal diazepam gel (Diastat), and Aquestive's Libervant — and Neurelis itself litigated the same intranasal diazepam technology against Aquestive on appeal (Fed. Cir. 21-1038) — so the generic-entry timing here has direct consequences for the entire rescue-therapy category. Facts I could not verify from primary sources and would flag before relying on them: the exact asserted-claim set in the Amneal complaint (the six-patent versus three-patent discrepancy above), Amneal's specific ANDA formulation percentages, and whether the September 2026 PTAB final written decisions have issued.

I'll research this case thoroughly. Let me start with several parallel searches.

Good initial data. Let me dig into the docket specifics, IPRs, and recent Markman activity.

Neurelis, Inc. v. Amneal Pharmaceuticals LLC — Key Legal Developments

Case: No. 1:26-cv-00261-MN (D. Del.), filed 2026-03-11; Judge Maryellen Noreika
Patents asserted per case metadata: U.S. 11,241,414 (the "'414 patent"); 12,324,852 (the "'852 patent"); 12,337,061 (the "'061 patent")
Accused act: Amneal's submission of ANDA No. 219109 for a generic VALTOCO® (diazepam nasal spray) product in 7.5 mg/spray and 10 mg/spray strengths
Present posture (as of 2026-09-14): Active, but no longer docketed under its own case number — consolidated into lead case No. 1:24-cv-562-MN. Post-Markman, in expert discovery, with a bench trial set for the week of 2028-01-10.

Below is the chronology. Where the record is thin or the only available source is an aggregator (rather than a primary docket entry or opinion), I say so explicitly rather than fill the gap.

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1. Filing and initial pleadings

Assessment. The complaint, per the ANDA-form/metadata, pleads § 271(e)(2)(A) infringement of the '414, '852, and '061 patents. Note one discrepancy worth flagging: a third-party AI-generated "complaint analysis" of this docket also describes assertion of U.S. 12,521,400 (the '400 patent, "Administration of Benzodiazepine Compositions," issued 2026-01-13) with claims 1–21 and asserts claims 1–9, 14–21, 23–25, 27–29 and 31 of the '852 patent and claims 1–52 of the '061 patent. The '400 patent is definitely in suit in the sibling Neurelis cases (Lupin, C.A. 1:26-cv-258; Padagis, C.A. 1:26-cv-401, complaint filed 2026-04-08), and the AI analysis may be cross-contaminated. I could not verify from a primary source whether '400 is asserted against Amneal, so I treat the three metadata patents as authoritative and flag '400 as an open question. Amneal's substantive defenses and any counterclaims (invalidity, non-infringement, inequitable conduct?) are not confirmed — this is a real gap.

Counsel. Neurelis's Delaware/lead counsel in the consolidated Valtoco litigation is DLA Piper (Michael A. Sitzman; Delaware: Brian A. Biggs, Stephanie E. O'Byrne; Ethan H. Townsend filed D.I. 16). Anisa K. Noorassa (McDermott Will & Emery) also appears as Neurelis-side counsel of record on this docket in aggregator records. Amneal is represented by Greenberg Traurig (Bornstein, Pettus, Wise, Scaccia — firm attribution is my inference from the attorney names, not verified from a firm page) with Delaware counsel appearing to be Young Conaway Stargatt & Taylor LLP. Treat the firm pairings as low-to-moderate confidence; the attorney names themselves come from the PacerMonitor docket snippet.

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2. Case-management orders and consolidation (the substantive pre-trial architecture)

2026-03-25 — Oral Order (D.I. 15)

Judge Noreika set the litigation's framework and, notably, a bench trial for the week of 2028-01-10. The order also imposed an unusual sequencing rule:

• Final infringement/validity (and non-infringement/invalidity) contentions due around fact-discovery close — several weeks before or after — and at least three weeks before Plaintiff's opening claim construction brief;
• Final contentions must include contentions under both the party's proposed construction and the opponent's construction;
• Joint claim construction chart due one week after the final-contentions exchange;
• Joint claim construction brief at least three weeks before the hearing;
• At least three weeks between the Markman hearing and the opening of expert discovery.

This is a "contentions-first, Markman-late" case-management model — it front-loads the merits into fact discovery and defers claim construction, which materially shapes strategy (see §4).

2026-04-21 — D.I. 16

Letter from Ethan H. Townsend to Judge Noreika transmitting a [Proposed] Second Consolidation Order and Modified Case Schedule.

2026-04-23 — Second Consolidation Order and Modified Case Scheduling Order (D.I. 17)

This is the operative scheduling order, signed by Judge Noreika. Key terms:

• All filings to be made in lead case C.A. No. 24-562-MN. The Amneal case (26-261) and the other Neurelis/VALTOCO ANDA cases were folded into the Padagis I lead action. Case association to 1:24-cv-00562-MN was created (D.I. 48 association entry).
• Joinder of parties / amended pleadings: 2026-07-01
• Fact discovery closed: 2026-08-07
• Opening expert reports: 2026-09-25
• Rebuttal expert reports: 2026-10-23
• Reply expert reports: 2026-11-20
• Expert discovery closes: 2026-12-18
• Claim construction opening brief served 2026-06-12; answering 2026-06-26; reply 2026-07-10; surreply 2026-07-24; joint claim construction brief filed 2026-07-31
• Markman hearing: 2026-08-19, 10:00 a.m., Courtroom 4A, before Judge Noreika

Consequence: the standalone docket number 1:26-cv-00261 is reported by at least one aggregator as "Closed" — this is characteristic of administrative/statistical closure of a member case on consolidation in D. Del., not a merits dismissal. The litigation is very much alive in 24-562-MN. (The case metadata supplied to me likewise characterizes the case as "pending," which I treat as authoritative.)

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3. Pre-trial motions of substance — no record found

• Motion to dismiss: none found.
• Motion to transfer venue: none found.
• Motion to stay pending IPR: none found. This is notable because there is a related IPR on one asserted patent (the '414 patent) — see §6.
• Motion for summary judgment: none found (consistent with the schedule — SJ practice in D. Del. ANDA cases typically follows expert discovery and a Markman ruling).

I want to be candid: my searches for Amneal-specific motion practice returned no results, and the docket snapshot I could reach only ran through 2026-05-28. It is entirely possible motions were filed between June and September 2026 that I could not surface. Nothing in the record I retrieved supports the existence of a dispositive or stay motion.

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4. Claim construction (Markman)

• 2026-06-12 — Neurelis's opening claim construction brief served
• 2026-06-26 — Amneal's answering brief served
• 2026-07-10 — reply brief served
• 2026-07-24 — surreply served
• 2026-07-31 — joint claim construction brief filed
• 2026-08-19 — Markman hearing held before Judge Noreika (Courtroom 4A)

Outcome: not yet determined, or at least not retrievable. The hearing occurred roughly four weeks ago as of today (2026-09-14). I could not locate a claim construction opinion, order, or bench ruling. Under the D.I. 17 schedule the court could rule any time after the hearing; the schedule contemplates expert discovery opening no fewer than three weeks after the hearing (i.e., on or after ~2026-09-09), and opening expert reports are due 2026-09-25, which will necessarily reflect whatever constructions (or provisional constructions) the court has indicated.

Terms likely at issue (inferred from the patents, not from a court order): the asserted claims of the '414, '852, and '061 patents are all "consisting of" (closed) formulation/method claims reciting (i) diazepam, (ii) tocopherols/tocotrienols at 30–95% w/w, (iii) ethanol + benzyl alcohol combined at 10–70% w/w, and (iv) n-dodecyl β-D-maltoside (DDM). Based on the '400/'852/'061 claim text and prior briefing in the sibling cases, the highest-value disputes are:

• "about" as applied to the weight-percentage ranges (the accused Amneal ANDA product either falls inside a literal reading or requires the doctrine of equivalents, and "about" is the hinge);
• the "consisting of" transition and whether formulation excipients outside the recited Markush group defeat literal infringement;
• the functional/bioavailability and treatment-outcome limitations recited in the '852 and '061 method claims (relative bioavailability vs. IV, reduction in seizure severity) — how those are measured and whether the ANDA specification can even establish them pre-launch.

I want to be explicit that the terms actually construed are not something I can confirm.

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5. Discovery milestones of strategic significance

The distinctive strategic feature here: because final contentions had to be served around fact-discovery close (2026-08-07), before the 2026-08-19 Markman hearing, neither side got the benefit of a claim construction ruling before committing to infringement and validity positions — and each side had to brief its case under the other side's constructions. That raises the stakes on the Markman ruling and on any later motion practice tied to a contention/prosecution-history or estoppel theory.

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6. Parallel PTAB proceedings and their effect

No Amneal-initiated IPR or PGR on the '414, '852, or '061 patents surfaced in my searches. The parallel PTAB activity is Padagis-driven, and its principal relevance to the Amneal case is through the '414 patent, which Amneal and Padagis both challenge:

1. IPR2019-00451 (Aquestive Therapeutics v. Neurelis) — on U.S. 9,763,876 (the '876 patent, same Valtoco family, Orange Book-listed). Petition filed 2019-01-29; Final Written Decision 2020-08-06 finding all 36 claims unpatentable as obvious. Aquestive's counsel and its experts (Dr. Nicholas Peppas, Dr. Daniel Wermeling) later resurface on the Padagis side of the Valtoco IPRs. Source: Hoffmann & Baron announcement.
2. IPR2025-00464, IPR2025-00465, IPR2025-00466 (Padagis US LLC v. Neurelis) — filed 2025-01-17 challenging the '546 patent, the '414 patent, and the '786 patent, respectively. Per paragraphfour.com's Valtoco case tracker, the Board instituted all three for trial and scheduled trial for 2026-06-16. Neurelis's Patent Owner Preliminary Responses argue, among other things, (a) that Gwozdz PCT is not prior art because the '414 (and '546) claims are entitled to the 2008-03-28 priority date and Gwozdz PCT first disclosed "penetration enhancers" only in its 2009-03-27 PCT, not its 2008 provisional (citing In re Riggs, 131 F.4th 1377 (Fed. Cir. 2025), and Dynamic Drinkware); (b) no motivation to combine Gwozdz PCT with Meezan; (c) Fintiv/Boalick-Stewart discretionary denial notwithstanding any Sotera stipulation, because the parallel district court case would be tried many months before any IPR concluded (citing Cisco Systems v. Estech Systems, IPR2021-00332, Paper 11); and (d) collateral estoppel from the '876 IPR does not apply. Sources: ptacts.uspto.gov POPR exhibits for petitions 1557269 / 1557270 / 1557271; paragraphfour.com Valtoco activity page.
3. Effect on this litigation. Amneal did not (on the record I found) seek a stay pending the Padagis IPRs, and Judge Noreika's schedule has the case tried in January 2028 — after the PTAB's 2026-06-16 trial date for the '546/'414/'786 IPRs, which means final written decisions in those IPRs would land around mid-to-late 2026 (statutory deadline ~2027-06). If the '414 patent falls in IPR2025-00465, Neurelis loses one of the three patents asserted against Amneal. Conversely, a Neurelis win on priority would be a powerful estoppel-flavored narrative in Delaware. Aquestive's 2020 wipeout of the '876 patent is the cautionary precedent hanging over this family.

Discrepancy to flag: the paragraphfour tracker attributes the IPR petitions to Padagis, and the petitions were filed 2025-01-17 in the Padagis I action (24-562), consistent with the lead-case consolidation. I found no Amneal PTAB filings, and no PTAB proceeding on the '852 or '061 patents at all.

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7. Trial, verdict, post-trial motions — none yet

No trial has occurred. No verdict, no JMOL, no new-trial motion, no fee motion, no settlement, no dismissal, no judgment, and no appeal. The case is roughly 18 months from the 2028-01-10 bench trial date.

Note on trial timing vs. the 30-month stay. Neurelis is entitled to a 30-month stay of FDA approval of ANDA No. 219109 (the complaint would have been filed within 45 days of the notice letter, as Neurelis has pleaded in its parallel complaints). Judge Noreika's 2028-01-10 bench trial date appears deliberately set to produce a decision inside that stay window — the standard D. Del. approach of trying the case before the stay lapses rather than risking at-risk launch. This is why no preliminary injunction practice appears in the record.

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8. Where the case actually stands (2026-09-14) and what is missing

Posture: Consolidated member case in Neurelis, Inc. v. Padagis LLC, C.A. No. 1:24-cv-562-MN. Fact discovery closed 2026-08-07; Markman heard 2026-08-19; opening expert reports due 2026-09-25; expert discovery closes 2026-12-18; bench trial week of 2028-01-10. The three metadata patents ('414, '852, '061) are all in issue against Amneal, subject to the possible additional assertion of the '400 patent.

Materially unsourced / unverified items I will not paper over:

• The content and exact filing date of Amneal's Answer and any counterclaims — listed on the Delaware filing history only as "Answer to Complaint," March 2026.
• Whether Amneal filed a motion to dismiss, transfer, or stay, and whether any IPR/PGR was filed by Amneal on the '414, '852, or '061 patents (none found).
• The Markman ruling — no opinion or order located; the hearing occurred 2026-08-19.
• The docket between 2026-05-28 and today — my most complete docket snapshot ends 2026-05-28, so any June–September 2026 activity (including the claim construction briefs' actual contents, any stipulations, or dispositive motion practice) is unverified.
• Whether the asserted claims were narrowed by Neurelis before or after fact-discovery close.
• Amneal's firm affiliation for the four PHV attorneys (my attribution to Greenberg Traurig is inference from the names).

If you need the June–September 2026 docket, it should be pulled directly from PACER for 1:24-cv-562-MN (all filings now go there) rather than from 1:26-cv-00261, which will appear dormant or "closed" precisely because of the consolidation.

I'll research this case and its counsel. Let me run several searches.

Let me dig into the lead case and the specific attorney entries.

Counsel of Record — Plaintiff Neurelis, Inc.

Bottom line: Neurelis is represented in this consolidated Delaware ANDA action by McDermott Will & Emery LLP, with its Wilmington, Delaware office acting as Delaware counsel (Ethan H. Townsend) and a team of McDermott patent litigators admitted pro hac vice (Michael Sitzman, Timothy P. Best, David J. Tobin, Hannah Hurley, Anisa K. Noorassa). No in-house Neurelis attorney appears on the docket. Case is consolidated into lead case C.A. No. 24-562-MN before Judge Maryellen Noreika.

⚠️ Sourcing caveat: PACER itself is paywalled and the docket snapshots available to me (PacerMonitor, CourtListener/RECAP, open-public-records, Law360) are truncated. Attorney names on those aggregator pages are sometimes auto-grouped and mis-assigned between parties. Where I could not confirm a firm affiliation or role from a primary filing, I say so explicitly.

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Delaware / local counsel of record

Ethan H. Townsend — Delaware counsel (registered CM/ECF filer; McDermott's Wilmington office managing partner)

• Firm/office: McDermott Will & Emery LLP, Brandywine Building, 1000 N. West Street, Suite 1400, Wilmington, DE 19801 (#5813; ehtownsend@mwe.com; 302‑485‑3911)
• Basis: He is the attorney who filed on Neurelis's behalf in this case — the pro hac vice motion (D.I. 9), the summons returns for Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, Inc. (served 3/12/2026), and the letter to Judge Noreika transmitting the [Proposed] Second Consolidation Order and Modified Case Schedule (D.I. 16, Apr. 21, 2026). He is listed as Neurelis's counsel on the parallel Neurelis ANDA complaints as well (Padagis, 1:26-cv-00401; Strides, filed July 31, 2026).
• Note: Delaware local counsel for plaintiff. Per his McDermott bio he has obtained "verdict[s] of infringement and patent validity for a branded anti-psychotic drug" and "for a branded anti-epilepsy drug," and he filed the Federal Circuit notice of appeal in Taiho v. MSN Labs (D. Del. 1:19-cv-02342) — i.e., genuine Hatch‑Waxman trial experience.

Pro hac vice counsel (McDermott Will & Emery)

These five were moved for admission by Neurelis in D.I. 9 (MOTION for Pro Hac Vice Appearance of Attorney Michael Sitzman, Timothy P. Best, David J. Tobin, Hannah Hurley, and Anisa Noorassa — filed by Neurelis, Inc.), with the PHV fees paid 3/23/2026:

Note on the defense side (for contrast, so the roster isn't misread): the docket's separate pro hac vice entry dated 4/24/2026 adds Giancarlo J. Scaccia, Jonathan R. Wise, Richard C. Pettus, and Scott J. Bornstein "for Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, Inc." — i.e., those are defense (Greenberg Traurig) attorneys, not plaintiff's counsel. The PacerMonitor attorney list for this case also returns "Young, Conaway, Stargatt & Taylor LLP" and partially redacted names ("Daniel G. …", "Samantha G. …"); those entries appear to be on the Amneal/defense side rather than Neurelis's, but the aggregator listing is ambiguous and I could not confirm each assignment from a primary filing.

In-house counsel

No Neurelis in-house attorney (e.g., Neurelis's legal department) appears on any docket entry or signature block I could retrieve. Neurelis files its Rule 7.1 disclosure identifying China Medical System Holdings Limited as an affiliate (see the parallel Padagis docket), but no in-house signatory is named.

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What I could not confirm

1. Whether additional PHV attorneys were added after the docket snapshot I could retrieve (one source shows the docket last updated 5/28/2026; Law360 shows Neurelis-side filing activity into August 2026, but on the Padagis docket).
2. Office locations and individual case histories for Sitzman, Best, Tobin, and Hurley — I could not open their firm bios or PACER party records.
3. Whether any part of the record (e.g., protective-order materials or settlement/licensing filings) was sealed such that additional counsel signatures are not visible — none of the retrieved entries were marked sealed.
4. Any Delaware local counsel beyond Townsend (no second Delaware signatory appeared in the filings I retrieved).

Practical significance

Because the case is consolidated into lead case C.A. No. 24-562-MN, all future filings — including the Joint Claim Construction Brief (due 7/31/2026) and the Markman hearing set for 8/19/2026 before Judge Noreika (D.I. 17, Second Consolidation Order, 4/23/2026) — are made under the lead caption. Anyone checking appearances should look at 1:24-cv-00562-MN first; the -261 docket is effectively a member case, which is why attorney rosters scraped from the -261 docket alone are incomplete and mixed between parties.

I'll research the defendant's counsel of record through searches against the docket, firm announcements, and related VALTOCO litigation filings.

The PacerMonitor docket name list is truncated. Let me pull more detail on the Amneal-side attorneys and the firm.

Good progress — I have the core defense team. Let me verify firm affiliations and attorney credentials.

Counsel of Record for Defendants — Neurelis, Inc. v. Amneal Pharmaceuticals LLC, No. 1:26-cv-00261-MN (D. Del.)

Bottom line

Amneal is represented by a two-firm structure that is standard for D. Del. Hatch-Waxman defense:

• Local/Delaware counsel (and lead attorney of record for filing purposes): Young Conaway Stargatt & Taylor LLP, Wilmington — Anne Shea Gaza, Samantha G. Wilson, and Daniel G. Mackrides.
• Pro hac vice "merits" team: Greenberg Traurig LLP (firm attribution discussed below) — Scott J. Bornstein, Richard C. Pettus, Jonathan R. Wise, and Giancarlo L. Scaccia, admitted by stipulation/order in late March 2026.

The pro hac vice team was added to the docket on March 24, 2026 via D.I. 12 (motion filed by Samantha G. Wilson), SO ORDERED by Judge Noreika on March 25, 2026, with the $200 PHV fee paid (receipt ADEDC-4931579). Both Amneal defendants — Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, Inc. — are covered by the same team. Source: PacerMonitor public docket for 1:26-cv-00261 (last updated 05/28/2026), https://www.pacermonitor.com/public/case/63525453/Neurelis,_Inc_v_Amneal_Pharmaceuticals_LLC_et_al.

No in-house counsel of record. Nothing in the retrievable docket shows an Amneal legal-department attorney entering an appearance; Amneal's in-house IP group (if any) is not on the docket. I also found no separate appearance by Amneal in the lead consolidated case (Neurelis v. Padagis, 24-562-MN) — consistent with the prior section's finding that Amneal is a member case only; its team appears in 26-261.

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Local counsel — Young Conaway Stargatt & Taylor LLP (Rodney Square, 1000 N. King St., Wilmington, DE 19801)

Under D. Del. L.R. 83.5(d) — recited verbatim in the PHV-attorney-add docket entry — the out-of-state team cannot file papers; Gaza/Wilson/Mackrides must be registered CM/ECF users and file all papers on Amneal's behalf.

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Pro hac vice counsel — Greenberg Traurig LLP

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Source basis and verification limits (read before quoting)

1. What is directly docket-sourced. Names, the Young Conaway affiliation, the PHV motion/order/fee entries, and the "Delaware counsel shall file all papers" language come from the PacerMonitor public docket for 1:26-cv-00261 and the open-public-records D. Del. calendar for the case (entry dates March 24–25, 2026 for the PHV add/order). I could not open primary PACER or the actual D.I. 12 PDF; the docket aggregator snippets are the best available.
2. What is inferred. The Greenberg Traurig attribution for Bornstein, Wise, and Scaccia rests on (a) their Martindale/NatLawReview/Legal 500 profiles confirming GT, and (b) their prior Amneal PHV appearances in D. Del. ANDA cases as GT attorneys. The PacerMonitor snippet for this case lists the four PHV names but does not display their firm in the retrieved text, so treat "Greenberg Traurig" for the PHV team as well-supported inference, not a primary-source quote. Richard C. Pettus's firm and office are not confirmed — do not publish a firm for him without pulling D.I. 12.
3. Office locations. GT's Amneal work has historically run out of New York, but I did not confirm the specific office for each attorney here; treat any office attribution as unverified.
4. Freshness. The aggregator docket was last updated May 28, 2026, and today is September 14, 2026. Any appearances, withdrawals, or substitutions filed after late May 2026 (e.g., in connection with the August 19, 2026 Markman hearing or the September 25, 2026 expert-report deadline) would not be reflected. A fresh PACER pull of both 1:26-cv-00261 and the lead docket (24-562-MN) is the only way to confirm no later additions.

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Discrepancies with the previously generated sections — flagged

• PHV appearance date. The prior overview states Amneal's pro hac vice team was "added April 24, 2026." The docket evidence shows the PHV motion (D.I. 12) filed and SO ORDERED March 25, 2026, with the PHV-only attorney add on March 24, 2026. I believe "April 24" is an error for March 24–25, 2026; the docket entries govern.
• Name spelling. "Giancarlo J. Scaccia" vs. "Giancarlo L. Scaccia" appears in the same docket (attorney-add entry vs. motion/fee entry). One is a docketing typo; verify against the bar record before using either in a filing.
• Defendant caption. The case metadata (and prior section) says "Amneal Pharmaceuticals LLC," but the complaint and PHV motion name two defendants, Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, Inc. Defense counsel's appearance covers both.
• Answer date. The prior section says Amneal answered March 23, 2026. The docket shows service on 3/12/2026 with answer due 4/2/2026, a Rule 7.1 corporate-disclosure statement entered ~3/25/2026, and a "SO ORDERED" item on 3/23/2026 that I could not identify with confidence. I would not restate the March 23 answer date without pulling the docket; it does not affect the counsel list above.
• Consolidation. Consistent with the prior section, filings now land on the lead docket (Padagis, 24-562-MN). Counsel of record for Amneal, however, is docketed in the member case 26-261; a lead-docket re-pull is the cleanest way to confirm the team is carried over post-consolidation.

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Why this team composition matters strategically

Amneal has staffed this defense with the same Greenberg Traurig / Young Conaway pairing and largely the same individuals (Bornstein, Wise, Scaccia; Gaza, Wilson, Mackrides) that defended it in CMP Development v. Amneal before Judge Noreika — including a bench trial and a plaintiff-side loss on infringement. That gives Amneal a judge-specific and courtroom-specific continuity advantage heading into the January 10, 2028 VALTOCO bench trial. It also contrasts with the co-defendants in the consolidated campaign: per paragraphfour's VALTOCO case tracker, Padagis is represented by Mark Deming of Polsinelli, i.e., a different defense firm on the same NDA and patents — so expect Amneal's GT team to drive the invalidity case (particularly if the '414 patent falls in IPR2025-00465), while Delaware local counsel keeps the consolidated schedule filings flowing.