Neurelis, Inc. v. Padagis LLC et al.

I'll research this case thoroughly across legal news sources, the docket, and patent databases.

I have substantial primary-source material. Let me verify docket status, the IPR outcomes, and the trial schedule.

Let me confirm the current trial schedule, IPR final written decisions, and the consolidated case structure.

Case Overview — Neurelis, Inc. v. Padagis LLC, No. 1:24-cv-00562-MN (D. Del.)

The parties and the accused product. Neurelis, Inc. is a San Diego–based specialty pharmaceutical company (founded 2007, Delaware corporation, HQ at 3430 Carmel Mountain Road, San Diego) that develops and commercializes CNS drug candidates in epilepsy and psychiatry. Neurelis is not an NPE — it is the brand manufacturer and NDA holder (NDA No. N211635) for VALTOCO® (diazepam nasal spray), the first FDA-approved nasal rescue therapy for "seizure clusters" (acute repetitive seizures), launched January 2020 in 5 mg and 10 mg strengths with a 7.5 mg strength added later and a pediatric indication down to age 2 added in the 04/2025 labeling revision. VALTOCO received Orphan Drug Exclusivity for clinical superiority, a point Neurelis has stressed in the parallel PTAB proceedings. See FDA labeling, https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1a8bcc90-68fa-474d-832c-0df01e825f39. The defendants are the Padagis entities: Padagis LLC (Delaware LLC, Allegan, Michigan), its wholly owned subsidiary Padagis US LLC (also a Delaware LLC), and Padagis Israel Pharmaceuticals Ltd. (Shoham, Israel), a generic-drug manufacturer whose Israeli affiliate prepared and submitted the ANDA. Padagis is widely reported to be the former Perrigo prescription-pharmaceuticals business spun out under Altaris Capital ownership in 2021, though I could not verify that lineage in the sources retrieved here. The accused instrumentality is Padagis's ANDA No. 219320, seeking approval to market a generic diazepam nasal spray (initially 10 mg/spray; the dispute later expanded to the 5 mg and 7.5 mg strengths) as a bioequivalent, lower-cost VALTOCO alternative prior to patent expiry, based on Paragraph IV certifications.

Patents asserted. All seven asserted patents descend from a common family (earliest provisional filed March 28, 2008, originating with Questcor Pharmaceuticals and successor-in-interest Hale BioPharma Ventures, now Neurelis) and share the title "Administration of Benzodiazepine Compositions," except the method-of-treatment claims. One-line sketches, drawn from the complaints and claim texts reproduced therein:

• U.S. 8,895,546 ('546, issued Nov. 25, 2014; OB expiry 3/27/2029) — nasal solution of a benzodiazepine + tocopherol(s)/tocotrienol(s) 30–95% w/w + ethanol and benzyl alcohol 10–70% w/w + an alkyl glycoside.
• U.S. 11,241,414 ('414, issued Feb. 8, 2022) — same carrier system narrowed to diazepam plus n-dodecyl beta-D-maltoside (DDM).
• U.S. 11,793,786 ('786, issued Oct. 24, 2023) — diazepam + a specified tocopherol/tocotrienol genus + alcohol(s) comprising benzyl alcohol + DDM.
• U.S. 12,268,664 ('664) — "about 1–20 mg diazepam dissolved in about 45–85% w/w tocopherols/tocotrienols, about 25–40% w/w alcohols, about 0.01–1% w/v DDM, <1% water, in a spray formulation."
• U.S. 12,324,852 ('852, OB expiry 10/16/2032) and U.S. 12,337,061 ('061, issued June 24, 2025, priority June 2011/Dec. 2011; OB expiry 6/13/2032) — the '061 claims a method of treating intermittent, stereotypic seizure-cluster episodes by nasal administration of diazepam/tocopherol/alcohol/ethanol/DDM.
• U.S. 12,521,400 ('400, issued January 13, 2026, claiming priority to the 2008 provisional) — 1–20 mg diazepam in 45–85% tocopherols/tocotrienols plus 25–40% alcohols, as a 50–150 µL spray solution.

Posture, venue, and why it matters. Filed May 8, 2024 in the District of Delaware before Judge Maryellen Noreika (Courtroom 4A, Wilmington), the case began as a three-patent action ('546, '414, '786) and has since been consolidated for all purposes with successive Padagis actions adding the '664 (Padagis II, filed 7/2/2025), the '852 and '061 (Padagis III, filed 10/3/2025), and the '400 (Padagis IV, filed 4/8/2026) patents — see D.I. 97 (Nov. 13, 2025 consolidation order) and D.I. 111 (Jan. 23, 2026 consolidated scheduling order), https://www.docketalarm.com/cases/Delaware_District_Court/1--24-cv-00562/. The governing schedule (as reset in the consolidated order, https://dockets.justia.com/docket/delaware/dedce/1:2025cv01228/90733) sets a Markman hearing for July 22, 2026, a pretrial conference on February 22, 2027, and a 5-day bench trial beginning March 1, 2027 — notably, there is no jury demand, and the earlier February 2026 trial date referenced in the PTAB briefing was superseded. Delaware is the natural and, practically, unavoidable venue: two Padagis entities are Delaware LLCs that consented to personal jurisdiction and venue "for purposes of this action only," Padagis Israel is a nonresident foreign defendant reachable under § 1391(c)(3)/Rule 4(k)(2), and Delaware is the nation's dominant Hatch-Waxman forum with a deep ANDA bench.

The case is notable on several fronts. First, it is one multi-front generic campaign: Neurelis has also sued Lupin, Amneal, and (as of July 31, 2026) Strides over the same VALTOCO franchise, and Padagis appears in more than one of those actions, so the seven-patent Padagis consolidation functions as the lead vehicle. Second, it is tightly linked to an earlier PTAB loss: in Aquestive Therapeutics v. Hale Biopharma Ventures, IPR2019-00451, the Board invalidated the related '876 patent after holding the '558 provisional did not provide written-description support for the "alkyl glycoside" limitation, a decision affirmed by the Federal Circuit. Padagis timely filed IPR2025-00464/-00465/-00466 (Jan. 17, 2025) against the '546, '414, and '786 patents on a single ground — obviousness over Gwozdz PCT in view of Meezan — invoking collateral estoppel from that earlier decision and relying on substantially identical expert declarations from Dr. Maureen Donovan. Neurelis's preliminary responses (June 17, 2025) attacked both the estoppel theory and the Gwozdz-PCT priority chain, and argued Fintiv discretionary denial. The Director declined discretionary denial and referred the merits to the Board, which instituted all three IPRs on September 16, 2025; the Director's decision was then designated informative on January 9, 2026 — a decision widely covered as a post-Fintiv-rescission guidepost for when examiner "material error" justifies institution. See https://www.ptablitigationblog.com/informative-no-discretionary-denial-where-prior-ipr-suggests-material-error-by-office/. The IPRs are scheduled with oral hearing/ Due Date 8 on June 16, 2026 and final written decisions due roughly one year after institution (mid-September 2026); I have not confirmed whether those final written decisions have issued as of today, and Padagis has taken the position that a district-court stay may follow institution. Third, two developments materially reshape the merits: Neurelis statutorily disclaimed claims 1–16 and 18–21 of the '546 patent, leaving only claims 17 and 22 (the specific diazepam/vitamin E/ethanol/benzyl alcohol/dodecyl maltoside formulation), and Neurelis moved on December 23, 2025 for leave to seek a certificate of correction adding a joint research agreement disclosure (the 2007 Questcor–Particle Sciences master services agreement) to invoke the pre-AIA § 103(c)(2) safe harbor against Gwozdz-PCT, which is asserted only as § 102(e) art. Finally, the '400 patent's issuance in January 2026 — years after Padagis filed its ANDA — raises a live § 271(e)(2) question about how later-issuing, same-family claims apply to an already-submitted ANDA, and the Orange Book listing from the complaint (see https://www.courtlistener.com/docket/67119/1/neurelis-inc-v-padagis-llc/) reflects these dynamics.

Sourcing caveats: party identities, addresses, ANDA number, notice-letter dates, patent claim texts, and the consolidation/Markman/trial dates are drawn from the complaints, Padagis's answer and counterclaims (https://paragraphfour.com/wp-content/uploads/2024/05/dedc24cv0562A.pdf), the consolidated scheduling orders, and the PTAB papers reproduced at Docket Alarm and the USPTO PTACTS portal. Counsel: Neurelis's complaint was signed by DLA Piper attorneys (Brian A. Biggs, Stephanie E. O'Byrne, Michael Sitzman, Catherine Huang, Stephanie Piper), with Sitzman appearing for Neurelis at McDermott Will & Emery in the IPRs; Padagis is represented by Polsinelli (James P. Murphy, Corey Casey, and, per Paragraph Four, Mark Deming). I did not independently verify current appearances against PACER, and I could not confirm VALTOCO's precise annual net sales figure for market context.

I'll research this case systematically across dockets, PTAB, and legal press.

Substantial material found. Let me dig into the IPRs' institution decisions, the stay, and the current claim construction posture.

Let me pin down the stay, institution decisions, claim construction status, and the certificate-of-correction/disclaimer developments.

Neurelis, Inc. v. Padagis LLC — Key Legal Developments and Present Posture

Bottom line up front: This case has not reached trial, verdict, or final judgment. It remains an active, consolidated ANDA action before Judge Maryellen Noreika (D. Del.), with a 5-day bench trial set for 2027-03-01, Markman held on 2026-07-22, and three parallel IPRs against the three earliest patents (the '546, '414 and '786) now post-hearing with a projected final written decision deadline of 2026-09-17. The single most consequential development to date is the PTAB's institution of those three IPRs on a Gwozdz/Meezan obviousness ground buttressed by collateral estoppel from Aquestive v. Hale Biopharma, IPR2019-00451.

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1. Filing & initial pleadings (2024)

No motion to dismiss, no § 1404(a) transfer motion, and no motion to strike were filed. Padagis also did not move to stay the district court case — a point Neurelis weaponized before the Director (see § 4). Padagis contested neither venue nor personal jurisdiction; it had previously submitted to jurisdiction in Delaware in Hikma v. Padagis.

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2. Claim construction — round one (2025), then reset (2026)

• 2025-03-28: parties exchanged claim terms; 2025-04-18 final infringement/invalidity contentions.
• 2025-05-23 → 2025-07-11: opening/answering/reply/sur-reply CC briefs served.
• 2025-08-15: Joint Claim Construction Brief filed under seal (D.I. 83; redacted at D.I. 87 on 2025-08-22). Remarkably, only one disputed term: the transitional phrase "consisting of" in the '546, '414 and '786 claims.
  • Neurelis's position: no construction needed; settled law (Conoco; Phillips; MPEP § 2111.03) means "consisting of" still permits impurities, residual solvents and incidental elements — so trace water in Padagis's ANDA product doesn't avoid infringement.
  • Padagis's position: the applicants replaced "comprising" with "consisting of" and repeatedly told the examiner the invention "excludes water and oil," a clear and unmistakable disavowal under Azurity Pharms. v. Alkem Labs., 133 F.4th 1359 (Fed. Cir. 2025). In the alternative, if water is not excluded, the claims are indefinite under § 112(b) — supported by Dr. Maureen Donovan's unrebutted declaration.
• The 2025-09-12 Markman hearing was terminated when the case was stayed (see § 3).
• After consolidation, the consolidated scheduling order (D.I. 97, 2025-11-13; D.I. 111, 2026-01-23) reset claim construction: opening brief 2026-05-15, answering 2026-05-29, reply 2026-06-12, sur-reply 2026-06-26, joint brief 2026-06-29/07-01, and a Markman hearing on 2026-07-22 at 10:00 a.m. in Courtroom 4A. I did not find a publicly reported Markman ruling or memorandum order as of 2026-09-14; given Judge Noreika's practice of issuing constructions within ~60 days of the hearing, an order would be expected in roughly the September–October 2026 window. Treat the outcome as still open.

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3. The stipulated stay and the reset schedule (2025-08 → 2025-11)

This is the most procedurally distinctive stretch of the case:

• 2025-08-18: The parties filed a joint stipulation and proposed order to stay (D.I. 85). Judge Noreika immediately questioned it by oral order (D.I. 86), asking the parties to address the estimated length of the stay and its impact on the 30-month stay — a pointed concern, since the '546/'414/'786 30-month stay ran out on approximately 2026-09-26.
• 2025-09-05: Joint letter response (D.I. 89, sealed; redacted 2025-09-12 at D.I. 92).
• 2025-09-08: "SO ORDERED WITH MODIFICATION" (D.I. 91) — the stay was granted as modified, and the 2025-09-12 claim construction hearing was terminated. The docket does not reflect an indefinite stay: the parties filed a joint status report on 2025-10-07 (D.I. 93) and a proposed consolidated schedule on 2025-10-23 (D.I. 94), and the Court on 2025-10-24 (D.I. 95) ordered a Markman hearing the week of 2026-07-20 and trial the week of 2027-03-01.
• 2025-11-13 (D.I. 97): Consolidated scheduling order — "These matters are consolidated for all purposes," fact discovery to 2026-04-10, opening expert reports 2026-08-26, rebuttal 2026-10-07, reply 2026-11-04, expert discovery 2026-12-02, Daubert motions 2027-01-08, pretrial conference 2027-02-22, 5-day bench trial 2027-03-01.

Practical read: the stay was sufficiently narrow/short (or effectively superseded by the new consolidations) that the case is now fully litigating on a schedule whose trial date is roughly six months after the IPR final written decision date — inverting the timing that drove Neurelis's Fintiv argument. I could not verify from the public docket the precise scope of the modification (e.g., whether the stay applied only to the '546/'414/'786 claims). Flag this as an evidentiary gap.

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4. Parallel PTAB proceedings — the center of gravity

Three petitions: IPR2025-00464 ('546), IPR2025-00465 ('414), IPR2025-00466 ('786), all filed 2025-01-17 by Padagis US LLC. Sole ground in each: obviousness of the challenged claims over Gwozdz PCT (WO 2009/120933) in view of Meezan (US 2006/0046962), with a supporting declaration from Dr. Maureen Donovan (largely overlapping across the three).

Key chain of events:

1. Neurelis's request for discretionary denial (Fintiv). Neurelis argued the district court trial (then 2026-02-09) would precede the projected FWD by ~7 months, that Padagis had delayed, and that Padagis's proposed Sotera stipulation should not save the petitions. Neurelis also attacked the merits: Gwozdz's "penetration enhancer" disclosure first appeared in the 2009 Gwozdz PCT, not in the Gwozdz provisional, so under In re Riggs, 131 F.4th 1377 (Fed. Cir. 2025), the motivation-to-combine theory lacks prior-art support.
2. 2025-07-16 — Acting Director Coke Morgan Stewart decision (Paper 12), declining discretionary denial and referring the petitions to the Board. Reasoning: the examiner's contrary priority-date finding "directly contradicts" the Board's IPR2019-00451 determination, raising material error by the Office under Advanced Bionics — an appropriate use of Office resources notwithstanding the earlier trial date. The '414 and '786 patents had been in force only since 2022 and 2023, so Neurelis had weak "settled expectations." The Director also cited evidence that a stay "may be granted" in the district court case if an IPR is instituted — which pairs directly with the D.I. 85 stay stipulation filed a month later.
3. 2026-01-09 — USPTO Director John Squires designated that decision informative (part of a batch of four precedential and nine informative discretionary-denial rulings). See Jones Day's analysis at https://www.ptablitigationblog.com/informative-no-discretionary-denial-where-prior-ipr-suggests-material-error-by-office/.
4. 2025-09-16 — Board instituted trial in all three IPRs (IPR2025-00464 Paper 13, Decision Granting Institution). Importantly, the Board found that collateral estoppel applies to the '558-provisional priority issue for the '546 patent, comparing claim 1 of the '876 patent (held unpatentable in IPR2019-00451) with claim 1 of the '546 patent — both requiring "an alkyl glycoside." Neurelis did not contest the estoppel argument on priority, instead taking the position that the '546 claims claim priority only to the '439 application (2009-03-27).
5. 2025-11-18 → 2026-01-27: Revised IPR schedule; Patent Owner's Response filed (Due Date 1, 2026-01-05); Petitioner's Reply/oral argument dates confirmed. Oral hearing (Due Date 8): 2026-06-16. Projected statutory FWD deadline: 2026-09-17.

The certificate-of-correction gambit (a notable near-miss for Neurelis):

• The patents' specifications allegedly omit a 2007 Joint Research Agreement (JRA) disclosure. Adding it would let Neurelis invoke the pre-AIA § 103(c)(2)(C) safe harbor and knock out Gwozdz as prior art — effectively case-dispositive across all three IPRs.
• 2025-12-15: Board authorized a motion for leave; 2025-12-23: Neurelis filed it (Paper 26).
• 2026-01-02: Neurelis filed a statutory disclaimer on the '546 patent (Ex. 2075) — noted in the record but not considered on the motion because it post-dated the filing.
• 2026-02-06: Board denied leave (Paper 36), citing Neurelis's ~7-year delay (it knew of the JRA issue since at least the 2019 '451 IPR), failure to allege or substantiate "good faith," and substantial prejudice to Padagis, which is now statutorily time-barred from filing a non-Gwozdz IPR.
• 2026-03-20: Request for rehearing denied (Paper 39). The Board rejected Neurelis's Honeywell argument that the Board lacked authority to assess § 255 merits, distinguishing CSIRO (PGR2020-00033) on prejudice.
• 2026-02-10: The Director nevertheless granted a certificate of correction on the related '664 patent (Ex. 2078) — a fact Neurelis argued before the Board in the rehearing request.

Collateral consequence in the district court: the '664 patent has a § 103(c) safe-harbor correction, while the '546/'414/'786 do not — an asymmetry Padagis will press if the IPRs come back adverse.

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5. Serial ANDA suits and consolidation

Neurelis did not litigate the family piecemeal — it filed successive ANDA actions as new patents issued and Padagis served new notice letters:

• The '852 and '061 patents claim priority to provisionals filed 2011-06-14 and 2011-12-13 — a different chain than the '414/'786/'546 family (which traces to the 2008-03-28 '558 provisional). Orange Book expirations: '852 → 2032-10-16; '061 → 2032-06-13.
• On 2025-11-13 the Court consolidated the matters "for all purposes" into the lead case, 24-562-MN (see D.I. 97, 98, 103, 104). Padagis's answer/counterclaims in the '852/'061 case were docketed at D.I. 98, and Neurelis answered the counterclaims at D.I. 104 (2025-11-26).
• Lupin is now a co-defendant in the consolidated matter (e.g., D.I. 112, 118).
• Related, not-yet-confirmed-as-consolidated: Neurelis v. Lupin (25-1443, filed 2025-11-26), Neurelis v. Amneal, and Neurelis v. Strides Pharma Global (1:26-cv-00947, filed 2026-07-31, asserting '414, '786, '664, '852, '061, '400 and a new '599,611 patent).
• I could not confirm whether 1:26-cv-00401 (the '400 case) has been formally consolidated into 24-562; the drugpatentwatch listing for 24-562 does now include 12,521,400 among the patents, suggesting consolidation or relation.

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6. Discovery milestones of strategic significance

• 2026-02-06: Neurelis's preliminary infringement contentions to Padagis (D.I. 113).
• 2026-02-20: Padagis's preliminary invalidity contentions (D.I. 114).
• 2026-02-27 → 2026-03-13: Stipulated extensions of the responses to preliminary contentions and substantial completion of document production (D.I. 115). Original consolidated cutoffs: joinder/amended pleadings 2026-03-06; fact discovery 2026-04-10.
• 2025-12-22 / 2026-01-22: Neurelis's first and second sets of RFPs (Nos. 1-40 to Lupin; Nos. 40-64 to Padagis) and the responses.
• Expert discovery is the live phase now: opening expert reports were due 2026-08-26; rebuttal 2026-10-07; reply 2026-11-04; expert discovery cutoff 2026-12-02; Daubert motions due 2027-01-08 (with answer/reply briefs 2027-01-22 and 2027-01-29).
• Cross-proceeding discovery: documents produced under the district court protective order were designated and relied on in the IPRs (e.g., Particle Sciences, Questcor and Aegis agreements designated "HIGHLY CONFIDENTIAL" in 24-562 and filed in the IPRs as Exs. 2035, 2037, 2040-2043 to support the § 103(c) safe harbor). Dr. Maureen Donovan was deposed 2025-12-10 and 2025-12-11 in the district court matter, and that transcript was later filed as an IPR exhibit (Ex. 2070).

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7. Trial, verdict, post-trial motions, and disposition

• No trial has occurred. The original 2026-02-09 bench trial date was vacated; the current bench trial is set for 2027-03-01 (5 days, Courtroom 4A, Judge Noreika), with a pretrial conference on 2027-02-22.
• No summary judgment practice: the operative scheduling orders provide that the Court "will not hear case dispositive motions in ANDA cases" absent agreement or prior approval.
• No verdict, no JMOL, no new-trial motion, no fee motion, no settlement, no dismissal, and no appeal. The case is active and undecided.

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8. Parallel/adjacent PTAB matter worth noting

A separate precedential-generation proceeding, IPR2019-00451 (Aquestive Therapeutics v. Hale Biopharma Ventures), invalidated all claims of the related '876 patent over Gwozdz + Meezan and held the '558 provisional lacked written-description support for "an alkyl glycoside" limitation. That FWD was affirmed by the Federal Circuit. It is the estoppel predicate driving both the Padagis petitions and the Board's institution decisions, and the earlier ArtUnit/examiner's contrary priority finding is what the Director labelled material error. Neurelis's position in the current case is that its later-issued claims ('414, '786, etc.) were narrowed after the '451 IPR and therefore do not carry the same defect — a position the Board rejected at institution and will resolve on the merits.

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9. Where this stands (as of 2026-09-14) and what to watch

1. Imminent: the IPR final written decisions in IPR2025-00464/-465/-466 (projected 2026-09-17). If the Board cancels the '546, '414 and/or '786 claims, the district court case shrinks to the later-issued '852, '061, '664 and '400 patents — a materially different case, given the '664 patent's § 103(c) safe-harbor correction and the '852/'061's separate 2011 priority chain.
2. A Markman ruling expected imminently (hearing 2026-07-22). The linchpin term remains "consisting of" (Neurelis: impurities included; Padagis: water and oil excluded, or indefinite), with the newer claims adding "about X% to about Y%" and "less than 1% water" (the '664/'400 patents) as scope-defining terms.
3. Whether the stay/modification of 2025-09-08 is revisited if the FWDs go Padagis's way, and the FDA 30-month stay timing (approximately 2026-09-26 for the '546/'414/'786 patents) — the Court's D.I. 86 concern.
4. Expert/Daubert phase (2026-08-26 through 2027-01-29) — Dr. Donovan for Padagis and Neurelis's expert will define the infringement and validity cases.

Caveats: the exact terms of the modified stay (D.I. 91), the filing date/D.I. of Padagis's answer in 24-562, the status of 1:26-cv-00401, and any Markman order issued after mid-August 2026 are not confirmed in the public sources reviewed and should be verified against PACER. Dates drawn from the docket alarms, PTAB papers, and the parties' briefs are cited above; the "approximately 2026-09-26" 30-month date is my calculation from the 2024-03-26 notice letter (the Delaware ANDA form in the related case lists 2026-09-27).

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

Let me pull the docket sheet and complaint signature block for this specific case.

I have the key ECF notice and stipulation. Let me verify individual attorneys' roles, firm moves, and any later appearances/withdrawals.

Plaintiff's Counsel of Record — Neurelis, Inc. v. Padagis LLC, No. 1:24-cv-00562-MN (D. Del.)

Sourcing note up front: The most reliable primary evidence I found is (a) the CM/ECF Notice of Electronic Filing for D.I. 47 (Mar. 11, 2025) in 1:24-cv-00562, which reproduces the court's full e-mail service list for the case, and (b) the executed stipulation filed at D.I. 46/65 (May 15, 2025), which carries the signature blocks of plaintiff's counsel. Both were obtained through the PTAB record (Neurelis Exhibits 2012–2013 in IPR2025-00464/65/66). I could not independently open the live PACER docket sheet, so I cannot guarantee the list is complete as of today or that no appearances/withdrawals have occurred since.

The representation is co-counseled by two firms: McDermott Will & Emery LLP (national lead, life-sciences patent litigation) and DLA Piper LLP (US) (Delaware filings and patent-side support).

Attorneys appearing for Neurelis, Inc.

In-house

• Jennifer Alonso, General Counsel & Chief Compliance Officer, Neurelis, Inc. — signed the 37 C.F.R. § 42.10(b) power of attorney in the IPRs (Feb. 7, 2025). In-house counsel; no indication she has entered an appearance in the district court case.

Caveats and things I could not verify

• Firm transition is the source of a common error in third-party databases. ParagraphFour and Ex Parte both still list plaintiff's counsel as "Michael Sitzman / DLA Piper." That reflects the firm where the complaint was drafted (Sitzman was at DLA Piper until late 2024). The IPR papers and the D. Del. service list show him at McDermott Will & Emery, with DLA Piper continuing as Delaware/local and PTAB back-up counsel. Do not rely on the DLA Piper attribution alone.
• The docket is a consolidated lead case. By the Apr. 23, 2026 "Second Consolidation Order" (entered in member case 1:26-cv-00401), all filings are made in lead case No. 24-562 (MN), and the consolidated action now includes the Padagis II/III, Lupin I/II, and Amneal I actions. The plaintiff-side roster above is the Padagis I team; the same core attorneys (Sitzman, Townsend, O'Byrne, Endejann) appear in the related Neurelis filings, but I have not verified every additional appearance in the member actions.
• No sealed-counsel issue identified. I found no indication that counsel identities are under seal; the concern is simply that I could not retrieve a current full appearance list from PACER directly.
• Opposing counsel (for context only, not asked): Padagis is represented by Polsinelli PC — Mark T. Deming (lead), Chad A. Landmon, Stephen J. Kraftschik (D. Del.), Dominique E. Smith, and Corey M. Casey.

Primary sources: D.I. 47 ECF Notice of Electronic Filing (Mar. 11, 2025) reproduced at Neurelis Ex. 2013 (IPR2025-00466); D.I. 46/65 stipulation (May 15, 2025) reproduced at Neurelis Ex. 2013 (IPR2025-00464); Neurelis Power of Attorney under 37 C.F.R. § 42.10(b), IPR2025-00464 (Feb. 7, 2025); D.I. 20 Scheduling Order (Aug. 28, 2024) via Neurelis Ex. 2002; Docket Alarm docket sheet for 1:24-cv-00562.

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

I have strong initial leads. Let me verify and check for any later appearances or changes of counsel.

Let me check the consolidated docket for the full list of defense counsel appearances, including any later pro hac vice admissions.