Neurelis, Inc. v. Amneal Pharmaceuticals

I'll research this case before drafting the overview.

Now let me pin down the '664 patent and the Amneal-specific docket details.

Let me find the actual Amneal complaint and its asserted patents.

I'll research this case thoroughly, starting with the docket and the patent itself.

Good, I have solid leads. Let me dig into the specific patent, the answer/counterclaims, and the consolidation.

Key legal developments — Neurelis, Inc. v. Amneal Pharmaceuticals LLC et al., No. 1:26-cv-00261-MN (D. Del.)

Bottom line as of 2026-09-16: This is an early-stage, consolidated Hatch-Waxman ANDA case. There has been no Markman ruling, no summary-judgment decision, no trial, no verdict, no settlement, and no appeal. The only substantive "events" to date are (i) the complaint and answer, (ii) an administrative consolidation into a long-running lead case, (iii) a scheduling order that has pushed the case into expert discovery, and (iv) parallel PTAB proceedings that sit on the older VALTOCO patents — not on the '664 patent that the case metadata identifies as the patent at issue.

I was able to reconstruct the docket only from aggregator sources (PacerMonitor, Justia, open-public-records.com, Law360, paragraphfour.com, ai-lab). I did not obtain direct PACER/RECAP access to the '261 docket, so docket-entry numbers and party-specific attributions below carry a sourcing caveat. Facts I could not corroborate are flagged explicitly rather than filled in.

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1. Filing and initial pleadings

Asserted patents / accused product. The case metadata identifies only U.S. Patent No. 12,268,664 ("Administration of Benzodiazepine Compositions," issued 2025-04-08, App. No. 18/782,666, filed 2024-07-24, assignee Neurelis, prosecution firm DLA Piper). The accused instrumentality is Amneal's ANDA No. 219109 for generic VALTOCO® (diazepam nasal spray) at 7.5 mg/spray and 10 mg/spray. Neurelis's NDA is N211635; VALTOCO is indicated for seizure clusters in epilepsy.

⚠️ Contradiction to flag. The complaint-analysis page for this very docket (1:26-cv-00261) walks through asserted claims of the '414, '852, '061 and '400 patents in addition to the composition claims of the VALTOCO family, i.e., it suggests the Amneal complaint is a multi-patent complaint, not a '664-only complaint (complaint analysis). That is consistent with Neurelis's practice of stacking newly issued VALTOCO patents into its ANDA suits as they issue. If you need the operative patent list for the Amneal case specifically, pull D.I. 1 and the ANDA Form from PACER — I could not verify whether the '664 patent was pleaded as a separate count against Amneal's ANDA.

Answer / counterclaims. The docket shows an Answer to Complaint filed in March 2026. In every parallel Neurelis ANDA answer I could locate (Padagis, Lupin in the 1:25-cv-00821 family), the generic defendant admitted ANDA submission and pleaded invalidity and non-infringement defensively. I could not confirm from a primary source whether Amneal pleaded counterclaims for declaratory judgment of invalidity/non-infringement, and I did not find a motion to dismiss or a Rule 12 challenge. Treat "counterclaims" as likely-but-unverified.

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2. Consolidation — the single most consequential development

Source: PacerMonitor docket; mirrored on the Padagis 1:26-cv-00401 docket.

⚠️ Contradiction with the case metadata. The prompt's status line says "active; awaiting consolidation." That is stale — the consolidation order issued 2026-04-23. Note also that an aggregator reports this docket's status as "Closed" (ai-lab/exparte). My read is that this reflects administrative closure of the member case upon consolidation into 24-562, not a dismissal of Neurelis's claims — the substantive deadlines continue to run in the lead case. Confirm on PACER before treating the case as terminated.

Why the consolidation matters strategically. The '261 case is now a member of a consolidated family with four-plus years of history and a docket in the 24-562 lead case, meaning Amneal's invalidity/non-infringement theories will be litigated against the same claim-construction record generated across the Padagis and Lupin branches (see §3 and §5). The lead case 1:24-cv-00562-MN (Neurelis v. Padagis et al., filed 2024-05-08, Judge Noreika) asserted the '546, '414 and '786 patents; the '664 patent was folded in later via the 1:25-cv-00821 branch (paragraphfour activity log).

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3. Claim construction (Markman)

No public Markman ruling or transcript order was located as of 2026-09-16. I searched for a § 112/claim-construction opinion in the lead case and found nothing reported. Flag as an open item.

Two construction disputes are worth tracking because they recur across the family:

• "about" as it modifies the weight-percentage ranges in the '664 claims (e.g., "about 45% to about 85% (w/w) tocopherols," "about 1 to about 20 mg of diazepam"). The complaint-analysis source identifies this as the central literal-infringement battleground, since the ANDA formulation's exact concentrations are not public.
• "consisting of" in the '414/'786 claims (closed transitional phrase) versus "comprising" in the '664 claim — a materially different infringement exposure if the accused product contains unrecited excipients.
• An earlier Markman in the lead case was already briefed by 2025-08-22 — Neurelis's brief is Case 1:24-cv-00562-MN Document 87 (78 pages), which was later filed into the IPR record as an exhibit (see §5). So the 2026-08-19 hearing is a second round covering the newer patents.

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4. Discovery milestones with strategic significance

From D.I. 17 (2026-04-23):

Post-consolidation activity I could confirm:

• 2026-08-17 — Defendants' First Supplemental Responses and Objections to Plaintiff's First Set of Interrogatories (Nos. 2–7 and 10–12) served by Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, Inc. (Samantha Wilson). This is the only Amneal-specific discovery filing I could source, and it confirms Amneal is actively participating in consolidated fact discovery. (Law360 Neurelis docket feed)
• 2026-08-19 — Notice to take deposition of Hardik Patel (set for 2026-08-25). This notice appears on the Padagis branch of the consolidated family, not the Amneal branch; I include it only to show the consolidated case was in active fact/third-party discovery in August 2026.
• A 2026-05-28 "docket last updated" timestamp on PacerMonitor is the outer edge of what the aggregator captured; anything filed after that date (including anything from the 2026-08-19 Markman hearing) is a gap in my sourcing.

Strategic note: the sequencing here is unusual and favorable to Neurelis — fact discovery closed (2026-08-07) before the Markman hearing (2026-08-19), and opening expert reports are due one week later (2026-09-25). Practically, the parties will be drafting expert reports without the benefit of a construction ruling, which is why the 2026-03-25 oral order pushed the parties to exchange proposed constructions and final contentions early and to include contentions under both sides' proposed constructions.

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5. Parallel PTAB proceedings (and why they don't touch the '664 patent)

The parallel IPRs were filed by Padagis US LLC, not Amneal:

Source: paragraphfour activity log, which links the petitions, preliminary responses, and institution decisions. A 2026-01-05 filing of Exhibit 2050 (Joint Claim Construction Brief) in IPR2025-00464 confirms the IPRs are importing the district-court claim-construction record — the exhibit is stamped "Case 1:24-cv-00562-MN Document 87 Filed 08/22/25."

Key points for the Amneal case:

1. No IPR/PGR on U.S. 12,268,664 was located. The '664 patent appears in the PTAB record only as an exhibit (EX2077, the printed patent, in IPR2025-00464) — i.e., as background/priority evidence, not as a challenged patent. So there is no PTAB estoppel or institution-decision risk hanging over the '664 patent as of 2026-09-16.
2. The IPRs are on the patents asserted in the lead case, and their final written decisions (statutorily due within 12 months of institution, i.e., likely around mid-2026) will land squarely inside the district court's expert-discovery window (2026-09-25 to 2026-12-18) and before the January 2028 bench trial. I could not confirm the outcomes of the § 316(a)(11) final written decisions — that is the single highest-value open item.
3. No stay appears on this docket. The scheduling order contemplates a full Markman and full expert discovery, which is inconsistent with a granted stay. I found no record of a motion to stay pending IPR in the '261 or lead docket.
4. A cross-cutting IPR theme: Neurelis's exhibit-2050 brief argues that the asserted claims are not indefinite for reciting water, and frames the invention as a non-aqueous tocol carrier system solving diazepam's aqueous solubility problem. That framing will echo into the '664 patent's own "contains less than 1% water" limitation.

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6. '664-patent-specific development worth its own heading: the certificate of correction

This is the one substantive, '664-specific legal event I found, and it is not reflected in the case overview:

• 2025-12-15 — Neurelis sought correction to the '664 patent to recite the existence of a Joint Research Agreement, so that it could invoke the protections of 35 U.S.C. § 103(c)(2) (disqualifying certain commonly-owned/JRA-derived prior art as prior art for obviousness).
• 2026-02-10 — the Director issued the certificate of correction.
• The '664 patent is also subject to a terminal disclaimer and claims priority to a non-provisional filed 2009-03-27 and a provisional filed 2008-03-28 (App. No. 61/040,558).

Source: a Neurelis D. Del. complaint reproduced at archive.org (¶¶22–24). ⚠️ I could not confirm which docket that complaint belongs to — its caption does not match the '261 case cleanly, and it references a seven-patent Orange Book listing ('414, '786, '664, '852, '061, '400, '611) that looks like a consolidated/amended complaint in the 24-562 family. Treat the JRA correction dates as reliable (they are quoted from the pleading) but the host docket as unconfirmed.

Why it matters: a § 103(c)(2) JRA correction is a direct counter to an obviousness defense built on a joint-research-agreement collaborator's work. If Amneal's invalidity contentions rely on such art, this certificate is Neurelis's anticipatory response — and the timing (correction issued 2026-02-10, complaint filed 2026-03-11) suggests it was obtained precisely to arm this round of ANDA litigation.

Also relevant to the '664 patent's scope/term: Orange Book sources list the '664 patent's expiration as 2029-03-27, i.e., tied to the earliest-family-date-driven term rather than the 2025 issue date (DrugPatentWatch).

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7. Final disposition / present posture

• Present posture (2026-09-16): Active and consolidated into C.A. No. 1:24-cv-00562-MN (D. Del., Noreika, J.). Markman hearing held/set 2026-08-19 with no published ruling located; fact discovery closed 2026-08-07; expert discovery running to 2026-12-18; bench trial the week of 2028-01-10.
• No trial events, verdict, JMOL/new-trial motions, fee motions, injunction, settlement, stipulated dismissal, or appeal were located for this docket. Given a January 2028 bench trial date, none would be expected.
• The 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii) is the operative commercial constraint on Amneal's ANDA No. 219109; I could not confirm the notice-letter date or the resulting stay expiry from the Amneal ANDA Form (the '261 docket's ANDA Form was not captured in the sources I retrieved).

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8. Sources to pull to close the gaps (ranked by value)

1. PACER 1:26-cv-00261 D.I. 1 (Complaint), ANDA Form, and the Answer — to settle which patents and claims Amneal actually faces, the notice-letter date, the 30-month stay date, and whether counterclaims were pleaded. This resolves the §1 contradiction.
2. The 2026-08-19 Markman transcript/order in 24-562 — the constructions of "about" (weight-percentage ranges) and "consisting of" vs. "comprising," both flagged by the complaint analysis as dispositive.
3. Final written decisions in IPR2025-00464/465/466 — and any IPR2026 petition against the '664 patent that may have been filed but not yet surfaced.
4. Amneal's invalidity contentions and any § 103(c)(2)/JRA-related briefing on the '664 patent.

Explicit non-findings / things I could not verify: no motion to dismiss, motion to transfer, motion to stay, § 101 challenge, or summary-judgment motion in this docket; no settlement or dismissal; no Federal Circuit activity; Amneal's counsel firms are only partially attributable from the PacerMonitor snapshot (the pro hac vice group added on Amneal's behalf is verified as acting for Amneal, but I did not confirm individual firm affiliations). Docket-entry numbers 1–17 are corroborated across two aggregators; entries after the 2026-05-28 PacerMonitor refresh are inferred from Law360 and open-public-records listings and should be re-verified against PACER.

I'll research the docket and counsel appearances for this case.

Good initial hits. Now let me confirm which attorneys are Neurelis's versus Amneal's, and pin down firm/office details.

Now let me verify each individual Neurelis attorney's firm, office, and background.

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

Bottom line: Neurelis is represented by McDermott Will & Emery LLP (shown on the docket and in trade-press listings as "McDermott Will & Schulte LLP"). The Delaware-registered filer of record is Ethan H. Townsend in McDermott's Wilmington office; Michael A. Sitzman (San Francisco) is the lead trial lawyer and is also Neurelis's lead counsel of record in the parallel Valtoco IPRs. The remaining Neurelis appearances are pro hac vice attorneys admitted in March 2026. No in-house attorney appearance is reflected on the public docket.

Note on search depth: I was able to pull the docket's attorney list, the PHV motion/fee entries, and firm-side biographical material, but my research run terminated before I could independently verify every individual attorney's firm office and practice history. Items I could not corroborate are flagged [unverified] rather than asserted.

Neurelis, Inc. — counsel of record

For contrast (so the two sides aren't conflated)

The same docket's attorney block also contains Amneal's team — those are not Neurelis's counsel: Delaware counsel Anne Shea Gaza, Samantha G. Wilson, and Daniel G. Mackrides of Young Conaway Stargatt & Taylor LLP (Wilmington), with pro hac vice counsel Scott J. Bornstein, Richard C. Pettus, Jonathan R. Wise, and Giancarlo J. Scaccia (these names are consistent with Greenberg Traurig's ANDA/life-sciences group — [firm affiliation for the Amneal PHV team not independently confirmed in this run]).

Docket anchors

• D.I. 1 — Complaint against Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, Inc. (filed 3/11/2026; fee receipt ADEDC-4920448). Summons returned executed 3/12/2026; answers initially due 4/2/2026.
• D.I. 9 — Motion for Pro Hac Vice Appearance of Attorneys Michael Sitzman, Timothy P. Best, David J. Tobin, Hannah Hurley, and Anisa Noorassa, filed by Neurelis (Ethan Townsend); PHV fees paid 3/23–3/24/2026; PHV attorneys added for electronic noticing.
• Townsend's letter to the Hon. Maryellen Noreika re: [Proposed] Second Consolidation Order and Modified Case Schedule — confirms McDermott as Neurelis's filing counsel here.
• Case assigned to Judge Maryellen Noreika (case suffix "MN" appears in the related Strides complaint).

Two flags for the case file

1. Consolidation status vs. the existing summary. The earlier section describes the case as "active; awaiting consolidation." Public filings indicate consolidation has been proposed and, per the Neurelis v. Strides complaint (1:26-cv-00947), the Amneal action ("C.A. No. 1:26-cv-00261MN") is among the related actions consolidated under the lead Neurelis Valtoco case (C.A. No. 1:24-cv-01443-MN), with all claims still pending. The Strides snippet is partial, so treat the lead-case number as high-confidence but not fully verified.
2. Patent-in-suit discrepancy. The prompt's metadata lists only U.S. Patent No. 12,268,664, whereas the 1:26-cv-00261 complaint analysis discusses the '414, '786, '852, '061, and '400 patents. The '664 patent does appear in the Valtoco litigated family (expiry 3/27/2029, per ParagraphFour's Neurelis v. Padagis entry), which is consistent with aggregator-level attribution of '664 to the consolidated family rather than to this specific complaint — worth resolving against the D.I. 1 Patent/Trademark Report.
3. Historical counsel note: ParagraphFour's entry for the earlier Neurelis v. Padagis case (1:24-cv-00562) lists "Plaintiff Lawyer/Firm: Michael Sitzman/DLA Piper." That is a stale attribution: Sitzman moved to McDermott in Nov. 2024, which matches the current McDermott appearances and the PTAB power of attorney.

Key sources: PacerMonitor docket page for Neurelis, Inc. v. Amneal Pharmaceuticals LLC et al (1:26-cv-00261); open-public-records docket index; Law360 attorney profile for Ethan H. Townsend (McDermott, Wilmington) and Law360 Neurelis Inc. docket feed; PTAB Power of Attorney in IPR2025-00464 (Sitzman, McDermott, San Francisco); Chambers USA and Legal 500 profiles for Michael Sitzman; Watanabe placement announcement (Sitzman join, Nov. 2024); CourtListener docket for Neurelis v. Strides (1:26-cv-00947, D.I. 1) re consolidation.

What's missing: No in-house/Neurelis legal-department appearance was found; if one appears later it would be on a corporate disclosure or answer signature block. The five PHV attorneys' individual office locations beyond Sitzman, and the Amneal PHV team's firm, should be confirmed from the PHV motion itself (D.I. 9) and the Amneal answer, which are the authoritative sources.

I'll research the defense counsel of record for this case. Let me start with several targeted searches.

Good initial hits. Let me dig into the specific defense counsel and the Delaware local counsel.

Let me verify each defense attorney's firm, office, and background, plus confirm the docket-level appearance details.

Defense Counsel of Record — Amneal Pharmaceuticals LLC & Amneal Pharmaceuticals, Inc.

Note on scope: This is a two-defendant ANDA action (both Amneal entities). All defense-side appearances I could confirm are a two-firm structure: Greenberg Traurig LLP as lead/outside patent counsel (admitted pro hac vice) and Young Conaway Stargatt & Taylor LLP as Delaware local counsel. My confirmation of the names comes from the PacerMonitor docket page and Law360 docket entries for 1:26-cv-00261; I was unable to pull the underlying docket documents themselves, so I flag confidence levels and one open item below.

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Delaware Local Counsel — Young Conaway Stargatt & Taylor LLP

Rodney Square, 1000 North King Street, Wilmington, DE 19801

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Outside/Lead Patent Counsel (pro hac vice) — Greenberg Traurig LLP

Amneal filed D.I. 12, Motion for Pro Hac Vice Appearance of Attorney Scott J. Bornstein, Richard C. Pettus, Jonathan R. Wise, and Giancarlo Scaccia, SO ORDERED by Judge Maryellen Noreika on 3/25/2026; the four were added for electronic noticing 3/24/2026, so all four are attorneys of record (subject to L.R. 83.5(d), under which Delaware counsel must file all papers).

In-house counsel: No in-house attorney appearance is reflected on the docket excerpt I could retrieve. Amneal appeared through outside counsel only.

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Cross-checks, gaps, and contradictions with the case metadata

1. "Awaiting consolidation" is now outdated. Per D.I. 17, Second Consolidation Order and Modified Case Scheduling Order (signed by Judge Noreika 4/23/2026), this action was consolidated into lead case C.A. No. 24-562-MN, with all filings to be made in the lead case. The scheduling order sets fact discovery closed 8/7/2026, opening expert reports 9/25/2026, a Markman hearing 8/19/2026, and a bench trial for the week of 1/10/2028.
2. Counsel-of-record distribution. PacerMonitor's attorney roll for this docket mixes both sides. Plaintiff Neurelis is represented by McDermott Will & Emery LLP (Delaware filer Ethan H. Townsend; PHV: Michael A. Sitzman, Timothy P. Best, David J. Tobin, Hannah Hurley, Anisa K. Noorassa). I list this only to prevent mis-attribution — none of these are defense counsel.
3. Pro hac vice order dates. Two dates appear in the excerpts: the Neurelis PHV motion (D.I. 9) was ordered 3/23/2026, and the Amneal PHV motion (D.I. 12) was ordered 3/25/2026. The Amneal-side date is the one relevant here.
4. Unverified items. (a) Firm office locations for Pettus, Wise, and Scaccia; (b) the full name of the second/third Young Conaway attorney ("Daniel G. ___"); (c) whether Robert M. Vrana is on this roster. I did not fabricate any of these.
5. Docket access caveat. Primary docket documents (the PHV motion, Answer, and any notices of appearance) are behind PACER; my confirmations rest on PacerMonitor and Law360 docket extracts rather than the filings themselves. If a Notice of Withdrawal/Substitution or additional appearance was filed after 5/28/2026 (the last docket update I could see), it would not be reflected above.

Bottom line: Defendant Amneal is represented of record by Young Conaway Stargatt & Taylor LLP in Delaware (Anne Shea Gaza, Samantha G. Wilson, plus at least one further Young Conaway name I could not verify) and by Greenberg Traurig LLP as outside counsel — Scott J. Bornstein, Richard C. Pettus, Jonathan R. Wise, and Giancarlo J. Scaccia, all admitted pro hac vice by Judge Noreika's 3/25/2026 order on D.I. 12.