Litigation
Padagis US LLC v. Neurelis, Inc.
pending — trial institutedIPR2025-00465
- Filed
- 2025-01-17
Patents at issue (1)
Plaintiffs (1)
Defendants (1)
Summary
Padagis petitioned for inter partes review of the '414 patent, challenging claims 1–18 as obvious over Gwozdz and Meezan. Trial was instituted, and the case remains pending with no final written decision.
Case overview & background
Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.
I'll research this case across the docket, PTAB records, and trade press.
Good material so far. Let me verify key procedural facts, the parallel district court case, and the prior IPR history.
Let me check the latest status of the IPR and whether the D. Del. case was stayed, settled, or is proceeding.
Important framing note up front: IPR2025‑00465 is not a district‑court infringement suit — it is the PTAB inter partes review that Padagis filed as a defensive counterattack to the Hatch‑Waxman case Neurelis brought against it in Delaware. The caption in the PTAB docket is inverted relative to the litigation it shadows (petitioner first, patent owner second), so I cover both the IPR and the underlying ANDA case below.
Parties and the accused product. Neurelis, Inc. is a San Diego‑based specialty pharmaceutical company (3430 Carmel Mountain Rd., San Diego) founded in 2007 to develop CNS drugs in epilepsy and psychiatry; it holds NDA No. N211635 for VALTOCO® (diazepam nasal spray), a rescue therapy for "seizure clusters" in patients 6 and older, dosed at 5, 7.5, or 10 mg diazepam per 0.1 mL (Neurelis v. Padagis complaint, D. Del. C.A. No. 1:24‑cv‑00562‑MN, ¶¶ 2, 19–20). Padagis is a family of generic manufacturers — Padagis LLC (Delaware, parent), Padagis US LLC (Allegan, Michigan), and Padagis Israel Pharmaceuticals Ltd. (Shoham, Israel, the ANDA applicant of record) — id. ¶¶ 3–9. This is not an NPE/PAE assertion. It is a conventional Hatch‑Waxman, paragraph IV dispute: Padagis submitted ANDA No. 219320 for a generic 10 mg/spray version of VALTOCO, sent its paragraph IV notice letter on March 26, 2024, and Neurelis sued within 45 days on May 8, 2024 to secure the 30‑month FDA stay, id. ¶¶ 29–32. The accused "product" in the IPR is therefore a paper ANDA belonging to a competitor that itself markets and sells products — the classic operating‑company‑versus‑generic posture rather than a patent‑monetization play.
Patents asserted and technical sketch. The '414 patent, "Administration of Benzodiazepine Compositions," issued February 8, 2022 and claims priority to provisional application 61/040,558 filed March 28, 2008. Claim 1 (the only independent claim challenged) recites a pharmaceutical solution for nasal administration consisting of: diazepam or a pharmaceutically acceptable salt thereof; one or more natural or synthetic tocopherols/tocotrienols at 30–95% (w/w); ethanol and benzyl alcohol combined at 10–70% (w/w); and n‑dodecyl beta‑D‑maltoside (DDM) — i.e., a water‑free, vitamin‑E/alcohol‑based diazepam nasal spray using a sugar‑based absorption enhancer (complaint ¶¶ 24, 43). It is one member of a large family asserted serially against generics: the '546 patent (issued Nov. 25, 2014; same formulation but claiming "an alkyl glycoside" generally) and the '786 patent (issued Oct. 24, 2023) were asserted in the same May 2024 Delaware complaint, with later‑issued siblings '664, '852, '061, and '400 added by successive notice letters and suits (see the D. Del. docket entries tracked at Docket Alarm and the paragraph IV filings summary). The Orange Book lists a March 27, 2029 expiry for the '414/'546/'786 patents.
Procedural posture and why the venue/linkage matters. Padagis filed three IPRs on January 17, 2025 — IPR2025‑00464 ('546), ‑00465 ('414), and ‑00466 ('786). In the '414 IPR, the sole ground is that claims 1–18 are obvious over Gwozdz (WO 2009/120933) in view of Meezan (US 2006/0046962), with Padagis leaning heavily on collateral estoppel from the earlier IPR2019‑00451 (Aquestive Therapeutics v. Neurelis), in which the Board found all claims of the parent '876 patent unpatentable on August 6, 2020, a decision affirmed by the Federal Circuit (appeal No. 2021‑1038) — and in which Neurelis lost the dispositive priority fight: the '876 claims were held not entitled to the '558 provisional's March 28, 2008 date for lack of written description support for the "alkyl glycoside" limitation, making Gwozdz prior art (see Hoffmann & Baron announcement; PTAB FWD in IPR2019‑00451). That same priority question is the crux of the '414 IPR. Neurelis sought discretionary denial (Fintiv/§325(d)), arguing a district trial would precede the final written decision; the Acting Director declined to deny and referred the petitions to the Board, reasoning that the examiner's contrary priority‑date finding in the '414 and '786 prosecutions raised "material error by the office," and the decision was designated informative on January 9, 2026 by Director John Squires (Jones Day PTAB Litigation Blog). Trial was instituted on September 16, 2025, with the panel reportedly comprising APJs Reimers, Obermann, and Majors (IPVerse case page), and the final written decision is projected for September 17, 2026. The proceeding has been hard‑fought on procedure: Neurelis moved to strike, accusing Padagis of "laundering exhibits through experts," exceeding word limits, and injecting new theories/evidence on reply (Patent Owner's Reply ISO Motion to Strike, IPR2025‑00465), and Padagis's expert Dr. Maureen Donovan was deposed December 10–11, 2025 (counsel: Polsinelli for Padagis; McDermott Will & Emery for Neurelis). The parallel Delaware case remains active — a January 23, 2026 scheduling order in C.A. No. 1:24‑cv‑00562‑MN (Judge Maryellen Noreika) set a Markman hearing for July 22, 2026 and a five‑day bench trial for March 1, 2027 — i.e., the IPR will likely conclude before the district trial, the inverse of the timing Neurelis argued for discretionary denial.
Why it's notable. Three things stand out. First, it is a textbook illustration of IPR linkage in ANDA litigation used offensively by the generics: rather than waiting for the Delaware case, Padagis ran the same obviousness combination that killed the parent '876 patent into three new family members, forcing Neurelis to defend the priority date a second time with estoppel risk. Second, the informative Director decision is a rare, publicly flagged instance of the Office sanctioning review precisely because a patent examiner reached a priority conclusion that contradicted a prior PTAB holding — making it a citation worth watching for §325(d) practice. Third, the market stakes are real and widening: VALTOCO is a branded, presumably orphan‑exclusivity‑protected rescue product (Neurelis's exhibit list in the IPR includes FDA "Clinical Superiority Findings" dated December 18, 2024, which bear on orphan exclusivity duration), and Neurelis is now litigating the same family against multiple generics — including Lupin (D. Del. 1:25‑cv‑00821) and reportedly Amneal — across at least five related Delaware actions, so the '414 outcome is effectively a template for the rest of the Orange Book listing.
Sourcing caveats: the September 16, 2025 institution date and the three‑judge panel come from commercial PTAB aggregators (IPVerse/Ex Parte), not a primary PTAB document I could open; one such aggregator lists IPR2025‑00465 as "Terminated‑Settled," which I could not verify and which conflicts with the case metadata certifying it as pending post‑institution — treat settlement as unconfirmed. The specific Delaware civil action numbers for the later Padagis/Lupin/Amneal suits and the 2025–26 D. Del. schedule come from Docket Alarm and the paragraphfour.com tracking pages; I was unable to confirm from a primary PACER record whether any portion of the Delaware case was stayed after IPR institution, and the earlier "February 9, 2026" trial date referenced in the Acting Director's decision was later superseded on the docket.
Key legal developments & outcome
Major rulings, motions, claim construction, settlements, and the present posture or final disposition.
I'll research this case across PTAB and any parallel district court litigation.
Let me dig deeper into the PTAB docket, the parallel district court case, and any settlement.
Important framing note
The case number you gave me — IPR2025‑00465 — is not a district‑court infringement suit; it is the PTAB inter partes review Padagis filed against Neurelis's U.S. 11,241,414 (diazepam nasal spray / VALTOCO®). The "patent infringement litigation" it shadows is Neurelis, Inc. v. Padagis LLC, Padagis US LLC & Padagis Israel Pharmaceuticals Ltd., C.A. No. 1:24‑cv‑00562‑MN (D. Del.) (Judge Maryellen Noreika), an ANDA/§271(e)(2) case on the '546, '414 and '786 patents. Below I track both, chronologically, and flag where my sourcing is thin. My docket coverage runs through roughly March–April 2026; I could not verify a final disposition of either proceeding.
1. Pre‑suit: Paragraph IV notice (2024‑03‑26)
- Padagis Israel sent Neurelis a Paragraph IV notice letter dated 2024‑03‑26 re: ANDA No. 219320, generic VALTOCO (diazepam nasal spray) 10 mg/spray, certifying that the '546, '414 and '786 patents are invalid, unenforceable and/or not infringed. Neurelis v. Padagis, 1:24‑cv‑00562, Compl. ¶¶ 29–32; also quoted in Neurelis v. Padagis, 1:26‑cv‑00401 (D. Del., filed 2026‑04‑08), Compl. ¶¶ 26–28.
- The letter was executed by Padagis US's VP of Legal Affairs and designated Padagis US as agent for service — the jurisdictional hook Neurelis used to sue all three Padagis entities.
2. Complaint and 30‑month stay (2024‑05‑08)
- Neurelis filed suit 2024‑05‑08 in D. Del. within 45 days of receipt — expressly to secure the 30‑month FDA approval stay under 21 U.S.C. §§ 355(j)(5)(B)(iii), (j)(5)(F)(ii). Complaint available at Docket Alarm / CourtListener. Patents asserted: '546 (claims 1–22), '414 (claims 1–3, 5–13, 15–18), '786 (claims 1–3, 5–9, 11–13, 15–27); Orange Book expiry listed as 2029‑03‑27.
- Strategic point: the 30‑month stay measured from Neurelis's receipt of the notice letter runs out in roughly late September 2026 — i.e., essentially now — which is precisely why the IPR and the re‑scheduled trial dates matter.
3. Initial schedule: Feb 2026 bench trial (2024‑08‑28)
- Scheduling order (D.I. 20, 2024‑08‑28) set: fact discovery, claim‑construction exchange (2025‑03‑28 for terms/constructions), joint CC chart, 5‑day bench trial beginning 2026‑02‑09, pretrial conference 2026‑02‑02. No jury demand.
- Answer/counterclaims: I could not verify the docket number/date of Padagis's original answer in the '562 action. Its answer, affirmative defenses and counterclaims appear in the later consolidated docket at D.I. 98 (2025‑11‑14) (originally D.I. 14 in C.A. 25‑1228), with Neurelis's reply to counterclaims at D.I. 104 (2025‑11‑26).
4. IPR petitions filed — the three‑front PTAB attack (2025‑01‑17)
- Padagis filed three IPRs the same day: IPR2025‑00464 ('546), IPR2025‑00465 ('414), IPR2025‑00466 ('786). Sole ground in each: obviousness over Gwozdz (WO 2009/120933) in view of Meezan (US 2006/0046962). Petition, Paper 2; see PTAB docket and IPVerse (institution date 2025‑09‑16).
- Core merits theory, identical across the three: Gwozdz teaches the benzodiazepine/tocopherol/ethanol+benzyl alcohol vehicle; Meezan teaches alkyl glycosides (incl. n‑dodecyl β‑D‑maltoside) as nasal absorption enhancers.
- Collateral‑estoppel theory: Padagis argued Neurelis is precluded from relitigating the '558 provisional priority issue and the Gwozdz+Meezan obviousness combination, based on IPR2019‑00451 (Aquestive Therapeutics v. Hale Biopharma Ventures, on U.S. 9,763,876), where the Board found the claims unpatentable and held the '558 provisional did not provide written‑description support for the "alkyl glycoside" limitation; the Federal Circuit affirmed "without decision." See Neurelis POPR (May 2025), Ex. 1040, Ex. 1068.
5. Patent Owner's preliminary response + Fintiv/discretionary‑denial fight (2025‑05‑15)
- Neurelis filed its POPR and a Request for Discretionary Denial (Paper 9), attaching the '562 scheduling order as Exhibit 2002, arguing the 2026‑02‑09 district trial would precede any FWD (projected 2026‑09‑17); Neurelis also attacked the petition on the merits — arguing the "penetration enhancers" motivation‑to‑combine disclosure appears only in the 2009 Gwozdz PCT, not the 2008 Gwozdz provisional, so it is not prior art under Dynamic Drinkware / In re Riggs — and attacked Dr. Maureen Donovan's declaration as largely copied from the Aquestive experts' declarations. Padagis opposed (Paper 10), offering a Sotera stipulation and pointing to evidence that a stay could be granted if IPR were instituted.
- Acting Director Coke Morgan Stewart declined discretionary denial and referred the petitions to the Board for a merits institution decision. Grounds: although the earlier trial date ordinarily favors denial, the examiner's later grant of '558‑provisional priority directly contradicted the Board's earlier determination in IPR2019‑00451, raising "material error by the Office" under Advanced Bionics; the challenged patents were young (issued 2022/2023); all three patents are one family with the same priority issue; and a district‑court stay was plausible. Decision, IPR2025‑00464/‑465/‑466.
- On 2026‑01‑09, Director John Squires designated that decision informative — reported by Jones Day's PTAB Litigation Blog (2026‑03), Lexology/Mondaq, and discussed at https://www.ptablitigationblog.com/informative-no-discretional-denial-where-prior-ipr-suggests-material-error-by-office/.
6. District court: claim construction, then an agreed stay (2025 summer/fall)
- June–July 2025: opening/answering/reply/sur‑reply claim‑construction briefs served (D.I. 83); Joint Claim Construction Brief filed (sealed) 2025‑08‑15, redacted 2025‑08‑22 (D.I. 83/87, appendix D.I. 84/88). The disputed construction concerned the transitional phrase "consisting of" and whether water and oil are excluded "ingredients" or permissible "impurities," with Padagis also asserting prosecution disclaimer and (alternatively) indefiniteness. See Joint CC Brief excerpt (D.I. 87 at 11) citing Azurity v. (unnamed).
- 2025‑08‑18: parties filed a Stipulation and [Proposed] Order to Stay (D.I. 85). The Court immediately questioned the stay's length and its effect on the 30‑month stay (Oral Order, D.I. 86); parties filed a joint letter 2025‑09‑05 (D.I. 89, sealed; redacted 2025‑09‑12, D.I. 92).
- 2025‑09‑08: SO ORDERED WITH MODIFICATION (D.I. 91) — the 2025‑09‑12 claim‑construction hearing was TERMINATED.
- 2025‑10‑24: Oral Order (D.I. 95) — Markman hearing reset to the week of 2026‑07‑20 and bench trial to the week of 2026‑03‑01.
- Net effect: the February 9, 2026 trial that Neurelis used as its Fintiv anchor never happened — the schedule was vacated and pushed out roughly a year.
7. Consolidation and expanded patent set (late 2025 – 2026)
- 2025‑11‑13: Scheduling Order (D.I. 97) consolidating for all purposes the Padagis and Lupin actions (Lupin filed its own Paragraph IV notice 2025‑05‑27, ANDA No. 220394, asserting the '546/'414/'786/'664 patents — see Lupin answer in 1:25‑cv‑00821).
- 2026‑01‑23: Amended/consolidated Scheduling Order (D.I. 111): joinder/amended pleadings 2026‑03‑06; fact discovery cutoff 2026‑04‑10; CC opening brief 2026‑05‑15, answering 2026‑05‑29, reply 2026‑06‑12, sur‑reply 2026‑06‑26, joint CC brief 2026‑07‑01; Markman hearing 2026‑07‑22 (Courtroom 4A); opening expert reports 2026‑08‑26; rebuttal 2026‑10‑07; reply 2026‑11‑04; expert discovery 2026‑12‑02; Daubert 2027‑01‑08; pretrial conference 2027‑02‑22; 5‑day bench trial 2027‑03‑01.
- Serial ANDA suits by Neurelis against Padagis: Padagis II (1:25‑cv‑00821, filed 2025‑07‑02, asserting the '664 patent), Padagis III (1:25‑cv‑01228, filed 2025‑10‑03, asserting the '852 and '061 patents, expiring 2032), and a further action filed 2026‑04‑08 (1:26‑cv‑00401) asserting newly issued U.S. 12,521,400 (issued 2026‑01‑13) based on a Fourth Notice Letter dated 2026‑03‑12. The '562 action is referred to in that complaint as the "Padagis I Action."
8. IPR2025‑00465 merits phase
- 2025‑09‑16: trial instituted on all three IPRs (IPVerse; Ex Parte PTAB docket). Panel: APJs Annette R. Reimers, Grace K. Obermann and Timothy J. Majors (per Ex Parte PTAB case page — treat as provisional). Petitioner counsel: Polsinelli (Mark T. Deming; James Murphy et al.). Patent Owner counsel: McDermott Will & Emery (Timothy Best, Hannah Hurley et al.).
- Post‑institution: Neurelis filed a Motion to Strike and reply in support (arguing Padagis "laundered exhibits through experts," exceeded word limits, and injected new theories, new evidence and new embodiments in reply) — 37 C.F.R. § 42.24 / Trial Practice Guide briefing.
- 2025‑12‑10: deposition of Padagis's expert Dr. Maureen Donovan in Chicago (Ex. 2070, filed 2026‑01‑05) — deposition conducted jointly across IPR2025‑00464/‑465/‑466.
- 2026‑01‑05: Patent Owner filed Exhibit 2050, the district court Joint Claim Construction Brief, tying the IPR "consisting of"/impurity dispute to the parallel litigation.
- Oral hearing: 2026‑06‑16 (per ParagraphFour's related‑case note; the three IPRs were given the same hearing date). FWD projected/statutory due date: 2026‑09‑17.
9. Parallel PTAB precedent driving the dispute — IPR2019‑00451
- Aquestive Therapeutics, Inc. v. Hale Biopharma Ventures, LLC, IPR2019‑00451 (petition 2019‑01‑29) challenged every claim of Neurelis's '876 patent (same family, same '558 provisional). The Board (i) construed all claims to require "an alkyl glycoside," (ii) held the '558 provisional lacked written‑description support for that limitation, so priority was not perfected and Gwozdz PCT was prior art, and (iii) found all claims unpatentable over Gwozdz + Meezan (and Gwozdz + Meezan + Cartt). Federal Circuit affirmed ("without decision," per Neurelis's POPR). This FWD is the linchpin of Padagis's collateral‑estoppel argument in the 2025 IPRs and the reason the Acting Director declined discretionary denial.
10. Present posture / unresolved items (as of 2026‑09‑14)
- District court: active. Consolidated 1:24‑cv‑00562 with Lupin and later‑filed Padagis actions; no Markman ruling I could verify (hearing was calendared for 2026‑07‑22; my docket sources stop around March/April 2026, so a decision may or may not have issued). No trial has occurred. Trial set for 2027‑03‑01. No JMOL, new‑trial, fee or appeal activity is yet possible.
- PTAB (the case in your metadata): institution 2025‑09‑16; FWD due 2026‑09‑17. Your case summary says "pending," which matches the PTAB/IPVerse records. Caveat: the Ex Parte PTAB tracking page for IPR2025‑00465 lists status "Terminated‑Settled" with no FWD, and a third‑party aggregator (ParagraphFour) tracks the Valtoco matter as still in discovery with a 2027 bench trial. Those two data points are in tension, and I could not confirm a settlement document, joint motion to terminate, or PTAB termination order for IPR2025‑00465. I would not report a settlement as established. (Separately, Aquestive's 2026 10‑Q "Contingencies" note reports a settlement and an April 3, 2026 dismissal with prejudice in some matter involving Libervant/Valtoco — but that disclosure appears tied to Aquestive's own litigation, not to Padagis, and should not be attributed to this case without confirmation.)
- What to watch: (i) whether a FWD issues in the three Padagis IPRs and, if so, whether the '414 claims fall (which would moot much of Count II in Delaware); (ii) any motion to stay the Delaware case now that all three IPRs are instituted and a FWD is imminent — the Acting Director expressly credited evidence that "a stay may be granted if an IPR is instituted"; (iii) the Markman ruling on "consisting of"/water‑as‑impurity, which drives both infringement and the indefiniteness fallback; and (iv) the September 2026 expiry of the 30‑month regulatory stay, which removes the automatic FDA bar to Padagis's ANDA approval.
Sourcing note: the most reliable primary documents I located are the D. Del. docket text (Docket Alarm, entries D.I. 20, 83–98, 111), the PTAB papers via ptacts.uspto.gov and Docket Alarm (Papers 2, 9, 10; Exs. 2001, 2002, 2050, 2070), and the Acting Director's referral decision. Firm/AI‑generated case pages (Ex Parte PTAB, IPVerse, Ex Parte "analysis" pages) supplied institution and counsel data but should be treated as secondary; I have flagged the one point (settlement termination) where they conflict with your metadata and I could not corroborate it.
Plaintiff representatives
Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- Polsinelli
- James P. Murphy · lead counsel
- Corey M. Casey · backup counsel
- Mark T. Deming · backup counsel
- Chad A. Landmon · backup counsel
I'll research the docket and counsel for this PTAB proceeding.
I have the core PTAB counsel data. Let me verify the attorney details, check the parallel district court case, and confirm the current status.
Scope note before the attorney list
Two clarifications that matter for accuracy:
- There is no "plaintiff" in this forum. IPR2025-00465 is a PTAB inter partes review. The party you're asking about — Padagis US LLC — is the Petitioner here. (The caption you're likely thinking of, Neurelis, Inc. v. Padagis LLC, 1:24-cv-00562-MN (D. Del., Judge Noreika), is a Hatch-Waxman/ANDA infringement suit in which Neurelis is plaintiff and Padagis is defendant, and Padagis (plaintiff in an IPR sense) is the petitioner there.)
- There is no local counsel of record in the PTAB. PTAB practice under 37 C.F.R. § 42.10(b) uses lead + backup counsel; no Delaware/local counsel appears. Padagis's Delaware local counsel (Stephen J. Kraftschik, Polsinelli's Wilmington office) appears only in the district court action.
Counsel of record for Padagis US LLC (Petitioner) — all Polsinelli PC
Source: Petitioner's Updated Mandatory Notices per 37 C.F.R. § 42.8(a)(2) (served Dec. 3, 2025), and the certificate of service in Neurelis's Patent Owner Preliminary Response, which lists these same attorneys as "Counsel for Petitioner Padagis US LLC."
(PTACTS, IPR2025-00465 filings; docket entry mirror, IPR2025-00464 Paper 22)
| Attorney | Role | Firm / office | Note |
|---|---|---|---|
| James P. Murphy (Reg. No. 55,474) | Lead counsel | Polsinelli PC, 1000 Louisiana St., Suite 6400, Houston, TX | PTAB-focused shareholder; "hundreds of contested Patent Office proceedings"; ranked No. 29 among Patexia's Top 50 Best Performing IPR Attorneys (2018) and No. 34 for petitioners. (IPWatchdog profile; Polsinelli/Patexia release) |
| Corey M. Casey, Pharm.D. (Reg. No. 66,950) | Backup counsel | Polsinelli PC, 900 W. 48th Place, Suite 900, Kansas City, MO | Registered patent attorney with a pharmacy doctorate; also listed as of-counsel in the parallel D. Del. ANDA case. (Docket Alarm exhibit, D. Del. subpoena notice) |
| Mark T. Deming (Reg. No. 69,263) | Backup counsel (added to the Padagis IPR team Dec. 3, 2025) | Polsinelli PC, 150 N. Riverside Plaza, Suite 3000 (also cited as Suite 300), Chicago, IL | Chicago IP litigator and Padagis's lead defense counsel in Neurelis v. Padagis, 1:24-cv-00562-MN (D. Del.); appeared at the Dec. 10, 2025 PTAB deposition of Neurelis expert Maureen Donovan. (Justia docket; Ex. 2070 deposition transcript) |
| Chad A. Landmon | Backup counsel — provisionally recognized pro hac vice | Polsinelli PC, 1401 I St. NW, Suite 800, Washington, DC | FDA/life-sciences litigator; like Deming, r |
Defendant representatives
Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- McDermott Will & Schulte
- Michael A. Sitzman · lead counsel
- Timothy P. Best · back-up counsel
- David J. Tobin · back-up counsel
- DLA Piper
- Raymond Miller · back-up counsel
- N. Nicole Endejann · back-up counsel
I'll research the counsel of record for the patent owner (Neurelis, Inc.) in this PTAB proceeding.
Let me get the Patent Owner's mandatory notices for this specific IPR, plus firm bios.
Let me verify the IPR2025-00465-specific filings and the additional counsel.
Scope note
IPR2025-00465 is a PTAB inter partes review, not a district-court infringement suit, and the party aligned in your metadata as "Defendant" — Neurelis, Inc. — is the Patent Owner / Respondent. So "counsel of record for the defendant" here means the Neurelis trial team. (For completeness I've also listed the team defending Padagis in the parallel D. Del. case, in case that is what you meant — see the last section.)
Counsel of record is set by Patent Owner's mandatory notices under 37 C.F.R. § 42.8(b)(3) and its Power of Attorney. The operative designations in this proceeding are in Patent Owner's Updated Mandatory Notices (Oct. 8, 2025), filed in parallel as Paper 17 in IPR2025-00464 and in identical form in -465 and -466, and in the Notice of Power of Attorney (Feb. 7, 2025) (Paper 4 in -464).
Counsel of record for Neurelis, Inc. (Patent Owner / Respondent)
| # | Attorney | Role | Firm / office | Note |
|---|---|---|---|---|
| 1 | Michael A. Sitzman (Reg. No. 42,150) | Lead counsel (also signed the Power of Attorney as lead) | McDermott Will & Schulte LLP, San Francisco (415 Mission St., Ste. 5600) | First-chair life-sciences patent trial lawyer; joined McDermott Nov. 2024 from DLA Piper, where he was U.S. Chair of Life Sciences Patent Litigation; Chambers USA Band 3 (California, Life Sciences: IP/Patent Litigation) and Legal 500–ranked; was a chief architect of Novo Nordisk's Hatch-Waxman strategy that reached the Supreme Court. Signed the Patent Owner Preliminary Response, motions to seal, deposition notices, etc. |
| 2 | Timothy P. Best, Ph.D. | Back-up counsel (designated a provisionally recognized PTAB attorney under 37 C.F.R. § 42.10(c)(2)) | McDermott Will & Schulte LLP, Los Angeles (2049 Century Park East) | Ph.D. chemist and trial lawyer in biotech/life-sciences patent litigation; joined McDermott Nov. 2024; adjunct professor of IP litigation, USC Gould; took/defended the Dec. 10, 2025 Donovan deposition for Patent Owner. |
| 3 | David J. Tobin (Reg. No. 60,776) | Back-up counsel | McDermott Will & Schulte LLP, Dallas (2801 N. Harwood St., Ste. 2600) | Led the Dec. 4, 2025 correspondence with the Board on the certificate-of-correction/protective-order requests and signed the Jan. 27, 2026 Joint Notice of Stipulation to Scheduling Order as "Counsel for Patent Owner." |
| 4 | Raymond Miller (Reg. No. 42,891) | Back-up counsel | DLA Piper LLP (US), Philadelphia (One Liberty Place, 1650 Market St.) | Listed on all three Padagis IPRs; appears on the Board's "FOR PATENT OWNER" service block in the Panel's orders and decisions. |
| 5 | N. Nicole Endejann (Reg. No. 50,229) | Back-up counsel | DLA Piper LLP (US), Philadelphia | Same as above; her email (nicole.endejann@us.dlapiper.com) is the one actually used in the Board's service blocks. |
Sources: Patent Owner's Updated Mandatory Notices, Oct. 8, 2025 (IPR2025-00464 Paper 17; identical notices filed in -465/-466); Notice of Power of Attorney (IPR2025-00464 Paper 4, Feb. 7, 2025); Board Order, Conduct of the Proceeding, IPR2025-00464 Paper 38 (Mar. 9, 2026) and Rehearing Decision, Paper 39 (Mar. 20, 2026), both of which list the "FOR PATENT OWNER" block.
Attorneys who appear on the team but are not designated counsel of record in -465
- Hannah Hurley — McDermott Will & Schulte LLP, Silicon Valley/Menlo Park (650 Live Oak Ave.). She appeared for Patent Owner at the Dec. 10, 2025 deposition of Dr. Maureen Donovan (Ex. 2070 deposition transcript), and was admitted pro hac vice with the McDermott team in the related D. Del. litigation. She does not appear in the -465 mandatory notices, so she is not counsel of record at the PTAB.
- Anisa Noorassa — McDermott; included in the D. Del. pro hac vice motion (D. Del. C.A. No. 1:26-cv-00261) but not in the PTAB mandatory notices for -465.
Caveats and unresolved items
- Firm-name change: the firm is now signing as McDermott Will & Schulte LLP (e.g., the Oct. 2025 mandatory notices, the Jan. 2026 stipulation, and Board orders), while earlier 2025 filings in this docket signed as McDermott Will & Emery LLP. Same firm; I've used the current name.
- "Nancy Stakleff" anomaly: the Board's service block in the Mar. 9, 2026 Order (Paper 38) and Mar. 20, 2026 Rehearing Decision (Paper 39) lists "Raymond Miller / Nancy Stakleff" for DLA Piper but gives Nicole Endejann's email address. I could not verify a "Nancy Stakleff" at DLA Piper; this appears to be a Board-side transcription error for N. Nicole Endejann, but I flag it as unverified.
- Email-domain anomaly: a Feb. 7, 2025 PTAB email from the Board's staff used
millerra@pepperlaw.comandendejann@pepperlaw.comfor the DLA Piper team, whereas the Oct. 2025 notices and later Board orders useraymond.miller@us.dlapiper.com/nicole.endejann@us.dlapiper.com. I could not confirm the reason (possible legacy address or a transitional domain); treat the DLA Piper / Philadelphia affiliation from the mandatory notices as authoritative. - Pro hac vice: Best was initially designated provisionally, and the Board expunged the first (unauthorized) notice on Feb. 7, 2025, requiring refiling of the notice, certification, and power of attorney. Best's recognition was therefore effected through the corrected filings and updated notices rather than the original notice.
- No in-house counsel for Neurelis appears on the PTAB record; the team is outside counsel only.
- No sealed counsel identity: the sealing motions in this family (e.g., IPR2025-00464 Paper 27) seal exhibits and portions of the Patent Owner Response/declarations, but the identities of counsel of record are public via the mandatory notices — so nothing about the representation is under seal.
If you actually meant the district-court defendant (Padagis)
In the parallel litigation — Neurelis, Inc. v. Padagis LLC, et al., No. 1:24-cv-00562-MN (D. Del.) (and 1:25-cv-00821-MN), both identified as related matters in Neurelis's -465 notices — Padagis is the defendant, and its PTAB counsel is the same Polsinelli PC team that serves as Petitioner here:
- James P. Murphy (Reg. No. 55,474) — Lead counsel, Polsinelli PC, Houston.
- Corey Casey (Reg. No. 66,950) — back-up, Polsinelli PC, Kansas City.
- Mark T. Deming (Reg. No. 69,263) — back-up, Polsinelli PC, Chicago (took the Donovan deposition for Petitioner).
- Chad A. Landmon — back-up, provisionally recognized pro hac vice, Polsinelli PC, Washington, D.C.
- Christopher Jones (Reg. No. 76,472) — added as additional back-up counsel in Petitioner's Updated Mandatory Notices (May 29, 2026), Polsinelli PC, Washington, D.C.
(Source: Petitioner's Updated Mandatory Notices and the service blocks in IPR2025-00464 Papers 38–39 and the Motion to Seal at Paper 27.)
One status flag worth noting given today's date: your metadata says the case is "pending — trial instituted," and the projected final written decision date of record is Sept. 17, 2026. At least one third-party aggregator (Ex Parte / ai-lab) now shows the proceeding as "Terminated–Settled." I could not verify a termination or settlement in a primary Board document, so I would treat the pending status in your metadata as controlling until a Board paper confirms otherwise.