Neurelis, Inc. v. Lupin Inc. et al.

I'll research this case thoroughly across multiple sources.

Excellent initial results. Let me dig deeper into company backgrounds, the patents, and IPR linkage.

Let me verify counsel, any news coverage, and the IPR landscape for the newly asserted patents.

Case Overview — Neurelis, Inc. v. Lupin Inc. et al., No. 1:25-cv-01443-MN (D. Del.)

The parties. Neurelis, Inc. is a commercial-stage neuroscience company (Delaware-incorporated, principal place of business in San Diego, CA) founded in 2007, not a patent-assertion vehicle: it owns and markets the branded product at issue, VALTOCO® (diazepam nasal spray), under FDA NDA No. N211635, approved January 10, 2020 (FDA Orange Book, NDA 211635). Its Rule 7.1 disclosure in this action identifies China Medical System Holdings Limited as an "Other Affiliate" (D.I. 5, Nov. 26, 2025); CMS separately holds commercialization rights to diazepam nasal spray in mainland China, Hong Kong, Macao and Taiwan and obtained NMPA approval there in 2023 — the docket entry does not spell out the precise equity relationship, so I'd treat the exact ownership structure as unconfirmed. The defendants are three Lupin entities: Lupin Inc. (U.S.; Rule 7.1 discloses its corporate parent as Nanomi B.V.), Lupin Pharmaceuticals, Inc. (U.S.; parent Lupin Limited) (both per D.I. 10, Dec. 22, 2025), and Lupin Limited (India), a serial generic ANDA filer and frequent D. Del. ANDA defendant (see, e.g., the related-case citations to Neurocrine v. Lupin, Vertex v. Lupin and Galderma in the later Lupin complaint, paragraphfour.com, 1:26-cv-00258 complaint). Notably, only Lupin Inc. and Lupin Pharmaceuticals, Inc. answered and counterclaimed in this action (D.I. 9, Dec. 22, 2025); no appearance by Lupin Limited appears in the retrieved docket for this case. Neurelis's Delaware counsel of record includes Ethan H. Townsend (D.I. 11, 13); in the parallel Padagis litigation Neurelis has been represented by DLA Piper (Michael Sitzman), and Lupin's Delaware filings here are signed by Kenneth Dorsney (D.I. 9–10), per ParagraphFour's Valtoco case page and the Docket Alarm docket.

The accused product and the asserted patents. The accused instrumentality is Lupin's ANDA No. 220394, a generic diazepam nasal spray at 5, 7.5 and 10 mg/spray referencing VALTOCO. Lupin served a Paragraph IV notice letter dated October 17, 2025 ("Second Lupin Notice Letter"), and Neurelis filed this § 271(e)(2)(A) action within 45 days, on November 26, 2025, triggering a 30-month FDA-approval stay with a deadline of November 27, 2027 (D.I. 1; D.I. 3). The case metadata lists U.S. Patent 12,337,061 as the patent at issue; the complaint as filed reported both the '061 patent and U.S. Patent 12,324,852 (D.I. 4, Report to the Commissioner listing "12,324,852; 12,337,061"), consistent with the parallel Padagis action (1:25-cv-01228 complaint). Both patents are titled "Administration of Benzodiazepine Compositions," issued within weeks of each other in mid-2025 (the '852 on June 10, 2025; the '061 on June 24, 2025), claim priority to provisionals filed June 14, 2011 and December 13, 2011, and are Orange Book-listed with expirations of October 16, 2032 ('852) and June 13, 2032 ('061). Technically, both are method-of-treatment claims covering intranasal rescue of seizure clusters: claim 1 of the '852 recites administering a single 100 µL spray to one nasal mucosal membrane of a solution "consisting of" 56.47 mg vitamin E USP ±5%, 10 mg diazepam, 0.25 mg dodecyl maltoside, 10.50 mg benzyl alcohol ±5% and sufficient ethanol, achieving 92.5–107.5% of the bioavailability of IV diazepam and producing a defined therapeutic outcome (reduced severity, reduced recurrence probability, longer inter-seizure interval, or reduced frequency); claim 21 of the '061 is the parallel claim but uses the open transitional phrase "containing," which is likely to drive different infringement and claim-construction arguments (complaint text and claim analysis; Ex Parte complaint analysis).

Posture, venue and why it matters. The case sits before Judge Maryellen Noreika in the Wilmington division (Courtroom 4A) and was formally associated with the lead consolidated case, Neurelis v. Padagis, No. 1:24-cv-00562-MN, on January 23, 2026. The consolidated scheduling order (D.I. 14, Jan. 23, 2026) set fact discovery to close April 10, 2026, a Markman hearing for July 22, 2026, expert reports through late 2026, and a five-day bench trial beginning March 1, 2027 (an earlier oral order had flagged an outer trial date of April 26, 2027). Delaware venue is natural and essentially uncontested here — Neurelis is a Delaware corporation, the Lupin entities have previously submitted to the district's jurisdiction, and D. Del. is the dominant Hatch-Waxman forum. What makes the case notable is that it is one front in a coordinated multi-generic, multi-patent campaign over VALTOCO, a franchise Neurelis says produced $295–300 million in 2025 net sales (more than doubling 2024), backed by FDA findings of clinical superiority over rectal diazepam gel and orphan-drug exclusivity (Neurelis business update, Jan. 12, 2026). The earlier formulation patents — the '546, '414 and '786 patents, all expiring March 27, 2029 — are already under instituted PTAB review in Padagis's IPR2025-00464, -00465 and -00466 (filed Jan. 17, 2025; institution decisions in September 2025; oral argument June 2026; final written decisions projected around September 17, 2026), with Neurelis pressing Fintiv-style discretionary denial (PTAB docket via Docket Alarm; IPR2025-00466 proceeding record). The later-issuing method patents asserted here ('852/'061), plus the even newer '400 (12,521,400, litigated in 1:26-cv-00258-MN) and '611 (12,599,611) patents, function as Neurelis's later-expiring exclusivity layer through 2032 — which is precisely why the technical disputes over the "consisting of"/"containing" formulations and the claimed 92.5–107.5% relative-bioavailability limitation are commercially consequential.

Sourcing notes / confidence. (1) Party, court, case-number and judge facts above are confirmed by the docket summarized at Docket Alarm and Justia; I did not independently retrieve PACER images. (2) The complaint, notice-letter dates and 30-month stay come from the filed complaint text and the D. Del. ANDA supplemental-information form; the complaint PDF I relied on is the ParagraphFour mirror, not the PACER original. (3) I could not locate mainstream press coverage (Reuters, Law360, IPWatchdog, RPX) specifically on 1:25-cv-01443; the trade-press/analytics sources used are ParagraphFour, Docket Alarm, DrugPatentWatch, Justia and PTAB-derived pages, so attribution of specific counsel names to firms (beyond docket signatories) and the exact Neurelis–China Medical System relationship should be treated as unverified. (4) I have no confirmation that the July 22, 2026 Markman hearing occurred or of any claim-construction ruling, nor of any Lupin IPR petitions against the '852 or '061 patents — the PTAB activity I could verify is Padagis's, and only as to the '546, '414 and '786 patents.

I'll research this case systematically. Let me start with the docket and complaint.

Good start. Now let me dig into the docket events, Lupin's answer/counterclaims, and any PTAB proceedings.

Let me look for PTAB proceedings on the '852/'061 patents and the case's scheduling/consolidation events.

Neurelis, Inc. v. Lupin Inc. — 1:25-cv-01443-MN (D. Del.)

Bottom line: the case is still in pre-trial (active/pending). No Markman ruling, no summary-judgment decision, no trial, no verdict, no settlement and no appeal have been publicly reported as of 2026-09-16. Everything below is either docket/pleading-grounded (real, cited) or flagged as unconfirmed.

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1. Case context (short — builds on the prior section)

25-1443 is the second of at least four Neurelis Valtoco ANDA suits against Lupin, and it is not the first case asserting these patents:

Sources: Robins Kaplan Hatch‑Waxman bulletin, Q4 2025 new ANDA cases; paragraphfour ValtoCo entry.

Note a metadata discrepancy worth correcting: your case summary lists only the '061 patent, but D.I. 4 (Report to Commissioner) and D.I. 3 (ANDA form) in 25-1443 list 12,324,852 and 12,337,061, and both are asserted (see Justia docket).

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2. Chronology

2025-06-10 / 2025-06-24 — patents issue. '852 issues 2025-06-10; '061 issues 2025-06-24 (both in the "Administration of Benzodiazepine Compositions" family; '852 expires 2032-10-16, '061 expires 2032-06-13). Neurelis reported these as extending Valtoco exclusivity to October 2032 and bringing the Orange Book list to six patents.

2025-10-17 — Second Lupin Notice Letter. Lupin Inc. served a Paragraph IV certification on ANDA No. 220394 (5, 7.5 and 10 mg/spray), challenging '852 and '061 as invalid, unenforceable and/or not infringed. Signed by Deepro Mukerjee, designated as agent for service. (Compl. ¶¶33–34, complaint PDF).

2025-11-26 — Complaint filed (D.I. 1). Filed within 45 days of the notice letter, triggering a 30‑month FDA approval stay. Counts I–II assert infringement of '852 (claims 1–31) and '061 (claims 1–62) under § 271(e)(2)(A), plus §§ 271(a)/(b)/(c) for post-approval conduct. Same-day docket entries: ANDA form (D.I. 3, notice received 10/17/2025; thirty-month stay deadline 11/27/2027), Report to Commissioner (D.I. 4), Rule 7.1 disclosure identifying China Medical System Holdings Ltd. as affiliate (D.I. 5), summons issued (D.I. 6). Judge: Maryellen Noreika.

2025-12-01 — summons returned executed; 2025-12-03 — case assigned/reassigned.

Late December 2025 — Lupin Answer + Counterclaims. The answer denies that Lupin Limited (India) and Lupin Pharmaceuticals, Inc. are proper parties (Lupin Inc. alone submitted the ANDA), pleads invalidity under §§ 101/102/103/112 and other affirmative defenses, and (inferred) asserts declaratory-judgment counterclaims — exact filing date not confirmed; the inference comes from Neurelis's "Answer to Counterclaim" docketed 2026-01-12. (answer PDF)

2025-12-15 / 2026-02-10 — family-level defensive move. Neurelis sought a certificate of correction for the '664 patent (issued 2026-02-10) reciting a Joint Research Agreement so it could invoke 35 U.S.C. § 103(c)(2) — i.e., knock out prior-art combinations in the parallel IPRs. (Recited in the 2026-04-08 Padagis complaint; it is not an '852/'061 filing but it is the clearest signal of how Neurelis is defending the family.)

2026-01-12 — Oral Order; Neurelis files Answer to Counterclaim (docket entries). The same date carries the scheduling language that final infringement/invalidity contentions must be served by the close of fact discovery and at least three weeks before Neurelis's opening claim-construction brief.

2026-01-21 — Letter to the Court (docket); 2026-01-23 — Scheduling Order – Patent plus a "Create Case Association – dkt in member case for Consol or MDL" entry. The scheduling order sets:

• Claim construction opening brief 2026-05-15; answering brief 2026-05-29; reply thereafter;
• Answering brief (dispositive-motion/Daubert track) 2027-01-22; reply brief 2027-01-29;
• Bench trial the week of 2027-03-01 (jury demand: none).
  (Source: Docket Alarm docket page.)

Consolidation. The 2026-01-23 case-association entry and Neurelis's later complaints ("These related actions have been consolidated…") confirm the Valtoco ANDA cases are being coordinated before Judge Noreika. A fragment of the 2026-07-31 Strides complaint lists 25-1443-MN alongside 26-258-MN, 26-261-MN and 26-401-MN among the consolidated actions. I could not confirm the lead consolidated case number — treat that as open.

2026-03-11 — Neurelis v. Lupin ('400 patent), 1:26-cv-00258-MN — a third Lupin suit on the newly issued '400 patent.

2026-05-15 / 2026-05-29 — claim construction briefs served (per the 2026-01-23 scheduling order). A Markman hearing would fall in roughly June–August 2026, but no claim construction order or hearing transcript is publicly available in my searches. Dispositive practice in these consolidated cases suggests any Markman ruling has not yet been issued in a reported form.

2026-07-31 — Neurelis v. Strides Pharma Global, 1:26-cv-00947-MN — fourth ANDA defendant, asserting all seven Valtoco patents ('414, '786, '664, '852, '061, '400, '611).

Present posture (2026-09-16): fact discovery closing, claim construction briefing complete, expert/dispositive-motion phase ahead (briefing January 2027), bench trial set for the week of 2027-03-01.

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3. Pre-trial motions of substance

• No motion to dismiss, motion to transfer, motion to stay pending IPR, or summary-judgment motion is confirmed on the 25-1443 docket as of my searches. The Jan. 2026 entries are a letter and two case-management orders, not contested-motion practice.
• The one substantive recurring dispute is party propriety/jurisdiction: Lupin re-pleads in every answer that Lupin Ltd. and Lupin Pharmaceuticals, Inc. are not proper parties (only Lupin Inc. submitted ANDA 220394). Whether that was converted into a Rule 12 motion in 25-1443 is not confirmed — worth checking the docket for a Rule 12(b)(2) motion.
• Stay dynamics are asymmetric: in the parallel IPRs, Neurelis's patent-owner preliminary response expressly argued that "Padagis has not sought a stay of the district court case, and it would be unlikely to prevail if it did so." (POPR, IPR2025-00464). No Lupin stay motion has been reported.

4. Claim construction (Markman)

Reached the briefing stage — the 2026-01-23 order fixed opening/answering briefs for 2026-05-15 / 2026-05-29. Likely disputed terms include "stable pharmaceutical solution," the "consisting of"/"containing" transition in '852/'061 claims, the numeric vitamin E / benzyl alcohol / dodecyl maltoside amounts, and the "92.5%–107.5% bioavailability" limitation. No Markman order, hearing date, or construction ruling is publicly reported. Terms "vitamin E USP," "dodecyl maltoside," and the bioavailability/clinical-outcome limitations look like the pinch points given how the complaint maps them.

5. Discovery milestones with strategic significance

• Final infringement and invalidity contentions required by the close of fact discovery and at least three weeks before the opening claim-construction brief (Jan. 2026 orders) — this is the operative narrowing event.
• Fact discovery ran through 2026; expert discovery and dispositive briefing are set for late 2026 / January 2027 (answering brief 2027-01-22, reply 2027-01-29), which in turn implies a February 2027 pretrial conference ahead of the 2027-03-01 bench trial.
• The '664 certificate-of-correction (2026-02-10) and the earlier '664 claim-priority/§ 103(c)(2) JRA work are the discovery-sensitive items most likely to be contested across the consolidated cases, since Neurelis's priority chain (2008 provisional → 2009 non-provisional → 2011 provisionals) is the fault line in the IPRs.
• Nothing in the record indicates Lupin has produced the ANDA under the protective order, stipulated to infringement, or that any § 271(e)(4) stay has lifted.

6. Trial, verdict, post-trial motions

None. Bench trial is set for the week of 2027-03-01 (no jury demand — consistent with the typical ANDA posture where damages are not sought in the first phase). No JMOL, new-trial or fee motions exist to date.

7. Settlement / dismissal / judgment / appeal

None. The case remains pending and active; there is no final disposition to report. The FDA 30-month stay deadline docketed in the ANDA form is 2027-11-27.

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8. Parallel PTAB proceedings (the most consequential parallel track)

• IPR2025-00464, -00465, -00466 — Padagis US, LLC v. Neurelis, Inc., filed 2025-01-17 against the '546, '414 and '786 patents respectively (not '852/'061). Sole ground: obviousness over Gwozdz PCT in view of Meezan; all three rely on near-identical declarations from Dr. Maureen Donovan. All three were instituted for trial, with a trial/FWD target reported as 2026-06-16 (paragraphfour). Neurelis's POPR raised § 314(a) Fintiv denial (advanced district-court case, February 2026 trial then set, Sotera stipulation offered but not filed) and attacked the Donovan declaration as copied from the Aquestive expert declarations in the earlier '876 IPR — the Board declined those arguments and instituted.
• IPR2019-00451 (Aquestive Therapeutics v. Hale Biopharma Ventures) — earlier IPR on the '876 patent; all claims held unpatentable; affirmed by the Federal Circuit without opinion. This is the estoppel/priority backdrop Padagis leans on, and it is why the '558 provisional's support for "alkyl glycoside"/dodecyl maltoside is central.
• No IPR or PGR petition on either '852 or '061 has surfaced in my searches for either Padagis or Lupin. Given that '852 and '061 issued in June 2025 and are method-of-treatment claims with clinical-outcome limitations, the absence of a filed post-grant challenge (as of this search) is itself strategically notable — but treat "none filed" as unverified; I did not get a clean PTAB docket page for either patent number.

Effect on the litigation: the instituted IPRs on the earlier-issued composition patents are the near-term risk to the Valtoco estate; if any of '546/'414/'786 falls, Neurelis still has '852/'061/'400/'611 (2032–2042) as the backstop — which is precisely why Neurelis kept suing on each newly issued patent, and why Lupin's Paragraph IV strategy now runs through the method claims in 25-1443 and 26-258.

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9. Gaps / caveats (things I could not source)

1. Exact Lupin answer/counterclaim filing date in 25-1443 and the precise counterclaim counts (inferred invalidity/non-infringement DJ counts from the 2026-01-12 "Answer to Counterclaim" entry).
2. Whether the Rule 12(b)(2)/improper-party issue was formally moved in 25-1443 (it is pleaded as a defense in the answer).
3. Markman: no order, hearing date, or transcript located; briefing dates come from the 2026-01-23 scheduling order as reported by a docket aggregator, not from an opinion.
4. Lead consolidated case number for the Valtoco actions.
5. Institution/FWD dates in IPR2025-00464/465/466 — I have the POPR argument and reported 2026-06-16 FWD target, not the institution decisions themselves; the POPR frames the statutory FWD window as opening around September 2026, which conflicts with the reported June 2026 trial date. Verify on PTAB.
6. Counsel: Neurelis is now McDermott Will & Schulte (Michael Sitzman, Ethan H. Townsend, Timothy P. Best, Connor S. Romm, Hannah Hurley, Anisa Noorassa) per its 2026 complaints; paragraphfour still lists Sitzman/DLA Piper for the older case. Lupin's counsel of record is not confirmed — only Deepro Mukerjee as the notice-letter signatory/authorized agent.

I'll search for press coverage across multiple angles.

Let me search additional angles including trade press, company statements, and any settlement or launch news.

Let me try more specific outlets and company/investor angles.

Press coverage of Neurelis v. Lupin, No. 1:25-cv-01443-MN

Bottom line: there is essentially no press coverage of this specific case. My searches — the case caption, "Neurelis" + "Lupin," "Valtoco" + patent litigation, the asserted patent numbers 12,324,852 / 12,337,061, and the terms "settlement," "verdict," and "generic launch" — returned no dedicated article from Reuters, Bloomberg Law, Law360, IPWatchdog, Patently-O, Ars Technica, The Verge, EFF Deeplinks, or the wider trade press. What exists instead is docket-tracker and analytics-database entries plus one industry roundup table, all of which restate the court record rather than report independently on it. This confirms the caveat flagged in the earlier "Case overview" section: the 25-1443 filing was not covered as news. Note also that the search engine surfaced no case-specific article from § JD Supra beyond the Robins Kaplan bulletin discussed below, and no reported damages figure, settlement term, or verdict — consistent with the earlier sections' finding that the case remains pending with trial set for the week of 2027-03-01.

The one roundup mention. Robins Kaplan LLP included the case in its "Generically Speaking: Hatch-Waxman Bulletin — 2025 Q4 New ANDA Cases," which the firm also mirrors on JD Supra. The entry is a single table row — "Neurelis, Inc. v. Lupin Inc., 25-1443 (D. Del.) | Nov. 26, 2025 | Hon. Maryellen Noreika | Valtoco® (diazepam nasal spray) | 12,324,852 / 12,337,061" — with no narrative, no analysis, and no executive or analyst comment. Its significance for this memo is corroborative rather than reportorial: the bulletin confirms that both the '852 and '061 patents were asserted in 25-1443, which supports the metadata-discrepancy flag raised in the earlier sections (your case summary lists only the '061, while D.I. 3–4 list both). The same bulletin separately lists the parallel Neurelis v. Padagis, 25-1228 (D. Del.), which is why the two cases are sometimes conflated in trade sources.

Analytics-database coverage. DrugPatentWatch maintains a "VALTOCO Drug Patent Profile" that is the closest thing to independent industry commentary I located. Its "Last Updated: March 4, 2026" snapshot states that "Valtoco is a drug marketed by Neurelis Inc… There are nine patents protecting this drug and two Paragraph IV challenges"; its "Last Updated: June 24, 2026" snapshot says eight patents and the same two Paragraph IV challenges, with challenge submission dates listed as 2024-02-14 (10 mg/spray) and 2025-04-03 (5 and 7.5 mg/spray). The page also offers a "Litigation and Generic Entry Outlook" for the brand. Two caveats: this is a subscription data product, not journalism, and the nine-vs-eight patent count changes between snapshots without explanation — I could not verify what drove the delta (listing, delisting, or a data update), and the two Paragraph IV entries it counts appear to be brand-level ANDA submission dates rather than a count of this defendant's notices, so treat them as an entry-timing indicator, not a litigation tally. I found no outlet offering a market-impact estimate, a revenue-at-risk figure, or analyst commentary tied to 25-1443 specifically.

Why the silence — and one likely source of confusion. The litigation does not appear to have generated a news peg: no motion to dismiss, stay, or transfer has been publicly reported, no Markman ruling has issued, and there is no verdict or settlement to write up. The Neurelis matter that has drawn sustained attention is a different dispute — the orphan-drug-exclusivity fight over Aquestive's Libervant, Neurelis, Inc. v. Califf (D.D.C.), which Aquestive Therapeutics describes at length in its annual report and which has generated D.C. Circuit briefing and even a 2026 amendment to the Orphan Drug Act. Separately, the PTAB papers in the instituted Padagis IPRs (IPR2025-00464/-465/-466) against the earlier '546/'414/'786 patents reading on Valtoco — including Neurelis's Fintiv arguments and its critique of the Donovan declaration as copied from the Aquestive '876 IPR — are publicly accessible on PTACTS, but these are primary-source filings, not press. Likewise, the phrase "Valtoco" appears frequently in ParagraphFour and CourtListener results for the consolidated Neurelis family and the later Strides and Amneal suits — but those are complaint mirrors and docket records, not reported articles, and I have not treated them as press coverage.

Sources

• Patent Owner Neurelis solved that problem
• 33. Lupin notified Neurelis by letter dated October 17, 2025 (the "Second Lupin Notice Letter") that it had submitted the Lupin ...
• The Neurelis inventors also explored the use of absorption enhancers to enhance the transit of diazepam across the nasal mucosa
• 33. The Second Lupin Notice Letter was sent on behalf of Lupin Inc
• IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
• Aquestive would erase Dr
• Complaint – #1 in Neurelis, Inc. v. Padagis LLC (D. Del., 1:26-cv-00401) – CourtListener.com - 21 U
• Complaint – #1 in Neurelis, Inc. v. Strides Pharma Global PTE Limited (D. Del., 1:26-cv-00947) – CourtListener.com - 27. Neurelis is the owner of the ’061 patent, titled “Administration of Benzodiazepine
• 35. Strides' first notified Neurelis by letter dated June 17, 2026 (the "Strides Notice Letter") that it had submitted ANDA No
• Complaint – #1 in Neurelis, Inc. v. Padagis LLC (D. Del., 1:26-cv-00401) – CourtListener.com - Neurelis, Inc. v. Padagis LLC
• IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
• New ANDA Cases

I'll research the counsel of record for the plaintiff in this case.

Let me dig deeper into the counsel details and firm affiliations.

Let me verify the specific counsel appearances in this case and the firm affiliations.

Plaintiff's Counsel of Record — Neurelis, Inc. v. Lupin Inc. et al., No. 1:25-cv-01443-MN (D. Del.)

Important framing caveat: The public docket extracts I could retrieve for this specific case (Docket Alarm, Justia, open-public-records.com) run only through D.I. 14 (Jan. 23, 2026). Because Neurelis's Valtoco ANDA campaign is litigated as a consolidated family of cases before Judge Noreika, the fuller plaintiff-side team is visible from docket activity in the related actions (Padagis I/II, Amneal, Strides). I have flagged below what is confirmed on this docket versus confirmed only in related Neurelis cases versus inferred. I have not invented any names.

Attorneys appearing for Neurelis in 1:25-cv-01443

(The Best/Tobin/Hurley/Noorassa group is drawn from Neurelis's consolidated pro hac vice motion in the related Amneal case — PacerMonitor entry for 1:26-cv-00261, D.I. 9, granted by Judge Noreika on 3/23/2026. I did not locate an equivalent PHV entry on the 1:25-cv-01443 docket itself, so I cannot state definitively that all five have entered in this case.)

What the docket in 1:25-cv-01443 actually shows

• D.I. 1 (Compl. filed 11/26/2025): filed on behalf of Neurelis against Lupin Inc., Lupin Limited, and Lupin Pharmaceuticals, Inc.; the docket text does not carry an attorney signature, and I was not able to retrieve the complaint's signature block (the paragraphfour.com copy of the 1443 complaint was truncated before the signature page).
• D.I. 7, D.I. 8 (Summons Returned Executed, 12/1/2025): filed by "(Townsend, Ethan)" — the first attorney identified on the plaintiff side of this docket.
• D.I. 11 (Answer to Counterclaim, 1/12/2026): filed by Neurelis, "(Townsend, Ethan)."
• D.I. 13 (1/21/2026): "Letter to the Honorable Maryellen Noreika from Ethan H. Townsend, Esq. regarding [Proposed] Consolidated Scheduling Order."
• Justia's docket page for 1:25-cv-01443 lists plaintiff's representation as: "Represented By: Ethan Haller Townsend" (retrieved as of 11/26/2025).

In-house counsel

Not identified. I found no docket appearance or public filing identifying a Neurelis in-house attorney (e.g., general counsel) appearing in this matter. Neurelis, Inc. is a Delaware corporation headquartered in San Diego, CA (per the related complaint), but no in-house lawyer entry is documented.

Sealing / non-appearance notes

• Nothing in the publicly retrievable portions of this docket suggests counsel filings are sealed. The limitations are the recency of the free docket extracts (last public entry seen: 1/23/2026) and the fact that PACER itself was not queried directly — a PACER pull would confirm any later pro hac vice motions and the exact roster.
• The complaint PDF's signature block was not verified, so the filer(s) of record on D.I. 1 remain unconfirmed from primary source.

Claimed vs. sourced summary

• Well sourced: Ethan H. Townsend as the plaintiff's appearing attorney on this docket (Docket Alarm docket texts; Justia); the related-case pro hac vice group of Sitzman, Best, Tobin, Hurley, Noorassa (PacerMonitor docket for 1:26-cv-00261, D.I. 9); Sitzman's move from DLA Piper to McDermott (McDermott press release, Nov. 4, 2024; DLA Piper press release, Nov. 4, 2019).
• Conflicting/less certain: Townsend's current firm. PacerMonitor and Law360 both label him McDermott Will (Wilmington), while some records reference Young Conaway Stargatt & Taylor. I would not treat the Townsend firm affiliation as settled without a fresh PACER check.
• Explicitly not verified: any in-house Neurelis counsel; a signature-page attribution for D.I. 1; and whether all five McDermott attorneys have formally entered in this docket as opposed to the consolidated family of Valtoco cases.

Sources: Docket Alarm (1:25-cv-01443 docket sheet); Justia Dockets (1:25-cv-01443); Paragraph IV Disputes / paragraphfour.com Valtoco case page and Lupin complaint PDFs (dedc25cv1443C.pdf, dedc26cv0258C.pdf); PacerMonitor public entries for Neurelis, Inc. v. Amneal Pharmaceuticals LLC et al. (1:26-cv-00261) and Neurelis, Inc. v. Padagis LLC et al. (1:25-cv-01228); Law360 firm/attorney page for Ethan H. Townsend; McDermott Will & Emery press release (Nov. 4, 2024); DLA Piper press release (Nov. 4, 2019); Robbins Kaplan "New ANDA Cases" Q4 2025 bulletin.

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

Key docket leads found. Let me dig into the answer/counterclaim filing and the firms.

Let me pull the actual Answer/counterclaim filing and the docket for counsel signature blocks.

Counsel of Record — Defendants (Lupin Inc., Lupin Limited, Lupin Pharmaceuticals, Inc.)

Bottom line: The only defense attorney appearing by name on the public docket of Neurelis, Inc. v. Lupin Inc. et al., No. 1:25-cv-01443-MN (D. Del.) is Kenneth L. Dorsney of Morris James LLP (Wilmington, DE), who filed Lupin's Answer, Counterclaim and Rule 7.1 disclosure on December 22, 2025. Lupin's nationwide Hatch‑Waxman defense team is Katten Muchin Rosenman LLP, led by Deepro R. Mukerjee; Katten's involvement in this specific ANDA is confirmed by the October 17, 2025 Lupin Paragraph IV notice letter, which was executed by Mukerjee as Lupin's authorized agent for service. I could not retrieve the full signature block of D.I. 9, so the Katten attorneys are identified as the probable merits/lead team rather than confirmed appearances — see the sourcing caveats below.

Confirmed on the docket

Docket evidence: D.I. 9 (Dec. 22, 2025) — "ANSWER to [1] Complaint, COUNTERCLAIM against Neurelis, Inc. by Lupin Inc., Lupin Pharmaceuticals, Inc. (Dorsney, Kenneth)"; D.I. 10 (Dec. 22, 2025) — Rule 7.1 disclosure "filed by Lupin Inc., Lupin Pharmaceuticals, Inc. (Dorsney, Kenneth)."

Lead/merits counsel (Katten) — supported by Lupin's filings and firm disclosures, not yet confirmed in this docket snapshot

Important caveats

1. No Katten pro hac vice motion appears in the docket snapshot I retrieved. The docket I could access covers entries through January 23, 2026 (D.I. 1–14). The only defense attorney name tied to a filing is Kenneth Dorsney. It is common in D. Del. for the answer to be filed by local counsel with out-of-state "of counsel" listed in the signature block; I could not open the full text of D.I. 9, so I cannot confirm which Katten attorneys are formally of record in this case as of today.
2. Lupin Limited's appearance is unclear in this case. D.I. 9 and D.I. 10 name only Lupin Inc. and Lupin Pharmaceuticals, Inc.; the summons returns of service (D.I. 7, 8, Dec. 1, 2025) cover only those two entities. In the related later-filed case, Neurelis, Inc. v. Lupin Inc., No. 1:26-cv-00258-MN (D. Del.), all three Lupin entities appeared through Dorsney. Verify service status on Lupin Limited on PACER.
3. No in-house Lupin attorney is identified in the public record for this matter. The Paragraph IV letter was executed by outside counsel (Mukerjee), who also served as Lupin's designated agent for service.
4. Nothing is sealed in a way that hides counsel — the answer and counterclaim are public; the gap is only in the signature-block detail, which PACER would resolve.

Contrast: plaintiff's team (for completeness)

Neurelis is represented by McDermott Will & Schulte LLP — Michael Sitzman (San Francisco), Timothy P. Best (Los Angeles), Connor S. Romm (Boston), Hannah Hurley (Menlo Park), with Ethan H. Townsend as Delaware counsel (Wilmington).

Case context worth noting for the defense team's strategy

• Asserted patents here: U.S. 12,324,852 and 12,337,061 (the case metadata lists only the '061; the complaint and D.I. 3–4 identify both), both listed against VALTOCO® (diazepam nasal spray), Orange Book expirations Oct. 16, 2032 ('852) and June 13, 2032 ('061).
• Lupin's second notice letter (Oct. 17, 2025) executed by Mukerjee asserted invalidity/non-infringement of the '852 and '061 patents — the same posture Katten litigated in the Padagis and Vertex tracks.
• Scheduling order (D.I. 14, Jan. 23, 2026): fact discovery closed Apr. 10, 2026; Markman hearing July 22, 2026; 5-day bench trial set for Mar. 1, 2027 before Judge Noreika (with a separate bench-trial date of Apr. 26, 2027 noted and the case associated with lead case 1:24-cv-00562-MN). 30-month stay deadline: Nov. 27, 2027.