US 10213400

I'll search for authoritative information on this specific patent and check for any CAFC 2026 activity.

Let me get the actual granted claim text and check for any 2026 CAFC activity.

US 10,213,400 B2 — Analyst Summary

Method note / caveats: I queried the open web for the specific identifier "10213400" and did not return results for similar numbers. However, my tooling is web search, not a credentialed login to USPTO PatentCenter/PAIR or the CAFC docket system, so the litigation and appeal statements below are grounded in third-party dockets/aggregators (Google Patents, CourtListener/Unified Patents, DrugPatentWatch, TheraRadar) rather than a direct PACER/CAFC query. Where sources conflict, I say so. Where I cannot confirm verbatim text, I flag it explicitly rather than reconstruct it.

1. Bibliographic data

2. Abstract (verbatim)

"One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition."

3. Independent claims — plain language

The '400 patent contains 20 claims, of which claims 1, 8, and 15 are independent (per Jazz's assertion of claims 1–20 and the breakdown in the N.D.N.J. consolidated ANDA litigation).

Claim 1 (verbatim, as reproduced in the N.D.N.J. invalidity contentions)

"1. A method for reducing adverse effects caused by a combination of gamma-hydroxybutyrate (GHB) or a salt thereof and divalproex sodium in a patient comprising:
administering a reduced daily dosage amount of GHB or a salt thereof to the patient of between about 5% to about 35%, compared to a daily dosage amount of GHB or salt thereof administered to the patient in the absence of concomitant administration of divalproex sodium;
wherein the patient is concomitantly administered divalproex sodium;
wherein the patient is a patient suffering from cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy and currently taking GHB or salt thereof;
wherein the daily dosage amount of GHB or salt thereof administered to the patient in the absence of concomitant administration of divalproex sodium is between 4.5 g to 9 g."

Plain language: A method of reducing adverse effects when GHB and divalproex sodium (valproate) are used together. The patient (a narcolepsy patient with cataplexy or excessive daytime sleepiness who is already on GHB) is given a daily GHB dose reduced by about 5–35% relative to the daily GHB dose the same patient would take without divalproex, where that reference daily dose is 4.5 g–9 g. The point is to offset the increased GHB exposure caused by valproate's inhibition of GHB metabolism.

Claims 8 and 15

• My sources (court filings identifying the independent claims and Litigation aggregators) confirm claims 8 and 15 are independent and are asserted, but I could not verify their verbatim claim text from an authoritative source in this session.
• Based on the specification and the sibling/child patents in the same family (e.g., US 10,864,181; US 11,253,494, whose independent claims recite a reduced GHB daily dose "about 15% to about 35% lower" with a reference dose of "between 4.5 g and 9 g" — or "between 1 g and 6 g" in the pediatric variant), claims 8 and 15 are most plausibly parallel reduced-dose divalproex-coadministration methods with different claim architecture (e.g., different dosage-reduction ranges, different reference-dose bands, or "recommending/administering" formulation). Treat this as an inference, not verified fact.
• Importantly, the specification's "Summary of Invention" is much broader than the granted claims (it recites diclofenac dose increases, ibuprofen cessation, pharmacy/REMS distribution methods, and diclofenac-for-GHB-toxicity methods). The granted independent claims appear to be limited to the valproate/divalproex reduced-dose method, the narrowest commercial embodiment. I could not confirm whether any diclofenac or pharmacy-distribution claim survived into the '400 patent.

4. Family / related patents (for context)

Same family (Google Patents "Family Members," 56 docs; BigQuery family 51031733): US 8,772,306; US 9,050,302; US 9,486,426; US 10,213,400; US 10,864,181; US 11,253,494; US 11,986,446; plus EP 2,961,399 / EP 3,335,708, CA 2,902,948, JP 6,433,440, CN 105073106, and others. These are the "oxybate co-therapy / divalproex concomitant-use" patents in the Xyrem®/Xywav® Orange Book stack.

5. Litigation status (including 2026)

• N.D.N.J. consolidated ANDA litigation (e.g., 2:23‑cv‑03182 Jazz Pharms. Ireland Ltd. v. Alkem Labs. et al.; also 2:23‑cv‑00329, 2:23‑cv‑01617, 2:21‑cv‑14271, 2:25‑cv‑14606, and 2026-filed 2:26‑cv‑01739 / 2:26‑cv‑01740): the '400 patent is asserted, with claims 1–20 in suit. Generics (Lupin, etc.) have advanced invalidity contentions (obviousness over Maitre, Okun, Cook, and the Xyrem® PI/titration schedule).
• D. Del. — Jazz v. Avadel (2021) and Avadel v. Jazz (2025) list US 10,213,400 among the patents-in-suit; press/analyst reporting through 2026 indicates a global Jazz–Avadel settlement dismissing the oxybate patent litigation.
• Antitrust/Paragraph IV follow-on cases (D. Minn., N.D. Cal., ~2020–2021) reference the '400 patent as part of the Xyrem patent stack.
• PTAB: prior IPRs targeted earlier family members (7,668,730; 7,765,106; 7,765,107) and IPR petitions were filed against the '302/'306 patents. I found no PTAB proceeding specifically captioned against the '400 patent in the results reviewed.

CAFC 2026 docket — explicit finding: I found no 2026 Federal Circuit appeal specifically involving US 10,213,400. The only "appeal" signal returned was a Patexia record showing the related application 17/216,540 (which issued as US 11,253,494) is "Not Appealed." I cannot rule out a 2026 CAFC docket that my web-search tooling did not surface — a direct CAFC/PACER query would be required to confirm a negative.

6. Uncertainty summary (per the strict-interpretation rule)

1. I interpreted the identifier literally as US 10,213,400 and did not substitute the visually similar 10,213,410 or the earlier family member 8,772,306.
2. Verbatim claim text is confirmed only for claim 1; claims 8 and 15 are confirmed only as independent claims being asserted, not by text.
3. Filing/issue dates have minor source conflicts (Jan 11 vs. Jan 12, 2018; Feb 25 vs. Feb 26, 2019) that I flag rather than silently reconciling.
4. No CAFC 2026 activity was located for this patent; this is a search limitation, not proof of absence.

I'll research litigation involving US patent 10213400. Let me start with the patent's own litigation records and then verify via litigation databases.

Let me gather detail on the specific cases identified.

Litigation Involving U.S. Patent No. 10,213,400

Patent identifier (literal): U.S. 10,213,400 B2 ("the '400 patent"), titled "Method of administration of gamma hydroxybutyrate with monocarboxylate transporters," inventor Mark Eller, current assignee Jazz Pharmaceuticals Ireland Limited. It is Orange Book–listed against Xywav® (calcium/magnesium/potassium/sodium oxybates oral solution, NDA No. 212690), use code U‑2499, nominal expiry 2033‑03‑15.

Below is what I could confirm from the litigation records surfaced in searching. A key limitation: many of these are consolidated multi‑patent ANDA cases in which the '400 patent is one of a dozen or more asserted patents, so the '400 patent is not always the sole or lead patent. Case numbers marked "unconfirmed" could not be verified in the sources reached.

A. ANDA / patent infringement suits (D.N.J. — Jazz Pharmaceuticals Ireland Ltd. as plaintiff)

These arise from generic/branded applicants seeking approval of oxybate products (Xywav or Xyrem versions) and are the principal cases in which the '400 patent is asserted.

B. Suits in which Jazz is plaintiff against Avadel (D. Del.)

DrugPatentWatch lists the '400 patent in the following Avadel matters (case numbers not confirmed):

Note: Jazz's public filings describe the Avadel litigation as directed to patents on sustained‑release oxybate formulations and distribution; the '400 patent appears in the DrugPatentWatch record for these dockets. I could not independently confirm the exact case numbers or that the '400 patent was actually asserted (rather than merely listed).

C. Antitrust / class actions (Xyrem "patent thicket" MDL) — '400 patent cited, not asserted

In these matters the '400 patent appears in the pleadings as part of the alleged Xyrem patent/settlement thicket; Jazz is a defendant, and these are not infringement assertions of the '400 patent.

The consolidated Xyrem antitrust MDL (N.D. Cal.) includes a $145 million class settlement granted preliminary approval May 16, 2025 (final‑approval hearing Oct 23, 2025), with remaining claims set for trial March 2, 2026.

D. PTAB proceedings

I found no IPR/CBM/PGR proceeding against the '400 patent in the PTAB records surfaced. The listed PTAB challenges in the Xyrem family were directed to different patents (e.g., 7,668,730 and 7,765,106 — petitioners Par, Amneal, Roxane, Wockhardt).

Caveats on completeness

• Case numbers I could not independently verify: 2:23‑cv‑03182 (defendant unknown) and the Avadel D. Del. case numbers. The '400 patent's Google Patents/Unified Patents page also lists several D.N.J. case links (2:26‑cv‑01740, 2:26‑cv‑01739, 2:25‑cv‑14606, 2:23‑cv‑03182, 2:23‑cv‑01617, 2:23‑cv‑00329, 2:21‑cv‑14271) but does not name defendants or outcomes for all of them.
• These cases are multi‑patent; the '400 patent is one asserted patent among many, so the "outcome" generally attaches to the case, not to the '400 patent individually.
• This is a best‑effort survey from publicly available dockets/databases as of the source dates shown; it should not be treated as a substitute for a PACER/Unified Patents or Darts‑IP family check. Where you need a definitive answer (e.g., the identity of the 2:23‑cv‑03182 defendant or whether the '400 patent was actually asserted against Avadel), that requires direct docket retrieval.

Primary sources consulted: Google Patents (US10213400), Unified Patents patent/litigation portal, DrugPatentWatch (sodium oxybate / Xyrem litigation tables), CourtListener and Justia dockets (2:26‑cv‑01740; 2:21‑cv‑14271), Law360, and Jazz Pharmaceuticals SEC/investor filings.

I'll start by verifying the structured data and then searching for any PTAB activity that may not be indexed.

Let me probe specifically for IPRs on the '400 patent and its immediate family members ('302, '426, '306).

Let me run targeted queries to confirm whether any AIA trial was ever filed against the '400 patent itself.

AIA Trial Proceedings — US Patent 10,213,400

Bottom line up front: The structured "PTAB proceedings on file" block is the canonical source here, and it reports no AIA trial proceedings. My web searches corroborate that: the extensive PTAB activity in the Xyrem/sodium-oxybate franchise sits on sibling patents in the same specification family (the '306/'302/'426 patents and the distribution-system patents), not on the '400 patent itself. I could not find any IPR, PGR, or CBM naming US 10,213,400 as the challenged patent. I flag below what I can and cannot verify.

Proceedings overview

Total AIA trial proceedings on US 10,213,400: 0 — zero active, zero with claims invalidated, zero with claims sustained, zero settled, zero institution denials. This yields an unusual defensive posture: the patent is completely untested at the PTAB, so there is no canceled claim to exploit and no estoppel record to inherit — a defendant must build its own invalidity case from scratch, but the absence of any challenge over ~7 years of public assertion (and 5+ years of litigation) is itself a signal that generic challengers have chosen the district court and Hatch-Waxman paths rather than an AIA trial.

Family-level context (proceedings on the same specification ancestry, NOT on the '400)

The '400 patent (App. 15/869,792, filed 2018-01-12, granted 2019-02-26) is the last continuation in a chain that runs:

15/869,792 ('400) ← 15/343,806 ← 14/707,914 ('426) ← 13/837,714 ('302) ← provisionals 61/771,557 and 61/777,873 (2013-03-01 / 2013-03-12).

That ancestry matters because the '306/'302/'426 patents share the '400's specification and were subjected to IPRs. These are not proceedings on US 10,213,400 and must not be cited as if they were.

IPR2016-00738 — Ranbaxy Inc. v. Jazz Pharmaceuticals, Inc. / Jazz Pharmaceuticals Ireland Ltd.

• Type: Inter Partes Review
• Patent challenged: US 9,050,302 (the '302 patent) — not the '400
• Filed: 2016-03-10 (accorded; petition filed by Knobbe Martens for Ranbaxy)
• Status: Terminated pre-institution on settlement — Institution Denied / Terminated
• Judge panel: Erica A. Franklin, Jacqueline Wright Bonilla, Zhenyu Yang (APJs)
• Petition grounds: § 103 over the prior art (Rotella declaration, Ex. 1002) against claims 1–31 of the '302 patent, directed to reducing the GHB dose in patients also receiving valproate.
• Institution decision: Never reached. On 2016-05-12 the parties filed a joint motion to terminate under 35 U.S.C. § 317(a); the Board entered judgment terminating the proceeding on 2016-05-23, granted the request to keep the settlement agreement confidential (Ex. 2002), and Ranbaxy's post-institution fees were refunded (notice of refund 2016-05-26). Source: PTAB E2E / Docket Alarm, Case IPR2016-00738.
• Settlement / termination: Yes — the '302 IPR was swept into Jazz's broader ANDA settlement with Ranbaxy (May 2016), which also resolved the district court case against Ranbaxy (Jazz v. Amneal, 13-391-ES-JAD (D.N.J.)). Terms confidential. Jazz disclosed the settlement granted Ranbaxy a license to sell generic Xyrem on or after 2025-12-31 (or earlier on certain events).
• Appeal: None — terminated before institution, so no appealable FWD.
• Defensive value for the '400: None directly. It shows Jazz settled rather than litigated the valproate-dosing claims, but it produced no ruling on any claim.

IPR2016-00002 / IPR2016-00024 / IPR2016-00546 — Par / Ranbaxy / Amneal v. Jazz

• Patent challenged: US 8,772,306 (the '306 patent) — not the '400
• Filed: October 2015 (Par, Ranbaxy) and February 2016 (Amneal) per Jazz's SEC disclosures.
• Status: Par's petition was denied in its entirety; Ranbaxy's petition was partially instituted (16 of 34 claims instituted, 18 denied); the instituted Ranbaxy trial was then terminated on the May 2016 settlement. Amneal's outcome is not something I can confirm from the sources retrieved.
• Defensive value for the '400: The '306 matters are frequently cited in third-party complaints as evidence that institution was denied on a "teaching-away" rationale tied to Jazz's 2005 Xyrem label. Treat that narrative — advanced in False Claims Act / antitrust complaints — as an unadjudicated allegation, not a PTAB finding.

Distribution-system patents (7,668,730; 7,765,106/107; 7,895,059; 8,457,988; 8,589,182; 8,731,963)

• Type: Covered Business Method (CBM2014-00149, CBM2014-00161, etc.) and Inter Partes Review
• Petitioners: Par, Amneal, Roxane/Wockhardt, plus a hedge-fund petitioner (Coalition for Affordable Drugs III LLC).
• Result: On 2016-07-27 the PTAB issued FWDs holding claims of six Xyrem distribution patents unpatentable; Jazz appealed to the Federal Circuit.
• Defensive value for the '400: Irrelevant to the '400's validity — different statutory subject matter, different claims, different patent family branch. Cite these only for franchise background.

Caveat on my search: I could not exhaustively confirm whether a fourth family IPR was filed on the '426 patent (Jazz's March 2016 SEC disclosure references a Ranbaxy petition on "the second of our patents covering a method for prescribing Xyrem when it is being co-administered with divalproex sodium"). That proceeding, if filed, again targets a sibling — not the '400. I did not confirm any such number, so I do not state one.

Strategic summary

Claim status on the '400. No claim of US 10,213,400 is canceled, and none is "sustained" in the AIA-trial sense. Every claim is UNTESTED before the PTAB. The precedential-looking outcomes that generics cite in Xyrem disputes belong to the '302/'306/'426 "valproate" patents and to the distribution-system patents — none of which is the '400. Practically, this means you cannot tell a court "the PTAB already killed these claims," but you also have no adverse FWD to distinguish.

Estoppel landscape. Because no IPR/PGR ever reached the '400, § 315(e)(2) estoppel attaches to nothing on this patent. Estoppel is patent- and claim-specific: a judgment in the '302 or '306 proceedings estops those petitioners and their privies only as to that patent, not as to the '400. So there is no prior-art ground that is foreclosed against the '400 by any past AIA trial — the full prior-art landscape (including the December 2012 Xyrem label, which third parties allege Jazz withheld) remains available to a new petitioner or a district court defendant. The flip side: past petitioners' wins/losses give you no preclusive benefit either. Separately, note the § 315(b) one-year bar — Lupin (served 2021), Teva and Alkem (2023), and other early-served defendants are time-barred from filing an IPR on the '400; Tris (2:26-cv-01740 / 2:26-cv-01739), Granules (2:25-cv-14606), and any not-yet-served competitor retain a live § 315(b) window (subject to privity/RPI analysis and current Federal Circuit doctrine on dismissed parties).

Pattern signals. Repeat petitioners ran the table on the franchise: Ranbaxy/Par/Amneal filed multiple IPRs across the '306, '302, and distribution patents, and Jazz's response pattern was to settle (Ranbaxy and Wockhardt in April–May 2016) rather than litigate the valproate-dosing claims to a FWD on the '306/'302 family. Jazz has litigated aggressively in district court on the same franchise (asserting the '400 against Lupin, Teva, Alkem, Granules, Tris and others in D.N.J.), and its patents have been the subject of antitrust and FCA suits. I found no defensive aggregator (e.g., Unified Patents) in the chain for the '400; the Unified Patents portal appearances in the patent record are litigation-docket mirrors, not petitioner filings.

Recommended next steps

1. Do not treat the '400 as previously invalidated. There is no FWD to cite. If a demand letter asserts the '400, your invalidity case must be built independently — you cannot lean on the '302/'306 IPR histories as claim-preclusive, though you can mine those petitions' prior-art combinations (Rotella declaration, Ex. 1002; the Vayer 1988 and label references) as a roadmap.
2. If you are a defendant within a year of service, decide fast on an IPR. The '400 is an untested patent with the same specification the PTAB never reached on the valproate claims — that is a genuine (if unexplored) opportunity. If you were served more than a year ago, assume § 315(b) bars you and litigate validity in the district court instead.
3. Verify the null result before relying on it. Because the ODP block is the canonical source and is periodically re-ingested, re-run a PTAB E2E search on "10,213,400" and check the Federal Circuit docket for any appeal from a family FWD (the 2016-07-27 distribution-patent FWDs were appealed; confirm no '400 appeal exists) before finalizing a non-infringement/invalidity opinion or a freedom-to-operate memo.
4. Sourcing for any opinion you write. PTAB E2E: https://ptacts.uspto.gov/ptacts/ (Case IPR2016-00738, IPR2016-00002, IPR2016-00024, IPR2016-00546). Patent text and family: https://patents.google.com/patent/US10213400/en. Litigation docket mirrors: Unified Patents portal, https://portal.unifiedpatents.com/patents/patent/US-10213400-B2.

Confidence statement: I am confident that the ODP records and available public sources disclose no AIA trial proceeding on US 10,213,400 as of 2026-10-01. I could not independently verify every outcome in the sibling '306 IPRs (particularly Amneal's IPR2016-00546 and any '426 petition), and I have not invented proceeding numbers to fill that gap.

I'll research this patent's assignment record across the sources you've specified.

Let me dig into the specific assignment records and the security agreement.

Let me try to find the specific reel/frame numbers and correspondent for the 2018 recordings on this patent.

US 10,213,400 B2 — Assignment / Ownership Reconstruction

Patent: Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters
App. No.: 15/869,792 (continuation of 15/343,806 → 14/707,914 → 13/837,714) · Filed: 2018-01-12 · Granted: 2019-02-26
Priority: 2013-03-01 (Google Patents) / 2013-02-28 (Unified Patents) · Anticipated expiry: 2033-03-15

Data-quality note up front. I could not open the interactive USPTO Assignment Center records (the search UI is JavaScript-driven and not directly retrievable here). The timeline below is reconstructed from the Google Patents legal-events block on the patent page, corroborated by PTAB real-party-in-interest filings that recite the reel/frame citations for the sibling patents in the family. The specific reel/frame numbers for the '400 patent's own recordings were not retrieved, so I flag them as unverified rather than supplying them. Nothing below is inferred from naming alone.

Inventors

Unusual-pattern check: No anomaly. There is a single inventor, he did not depart to a new entity, and the inventor-to-company assignment was executed and recorded contemporaneously with prosecution (see below). There is no evidence of an inventor walk-out preceding a portfolio sale.

Original assignee

Jazz Pharmaceuticals Ireland Ltd. (Connaught House, One Burlington Road, Dublin, Ireland).

• Product embodying the claims: Yes. The patent is Orange-Book listed against Xyrem® (sodium oxybate, NDA 21-196) and Xywav® (mixed-salt oxybate, NDA 212690). The claims cover a method of administration of GHB — i.e., the commercial dosing/drug-interaction management of the marketed product, not a bare research compound.
• Primary line of business: Specialty pharmaceutical company (neuroscience/sleep, oncology). Jazz Ireland is the Irish IP-holding and operating subsidiary of Jazz Pharmaceuticals plc (NASDAQ: JAZZ), the entity formed when Jazz Pharmaceuticals, Inc. combined with Azur Pharma and re-domiciled to Ireland in 2012.
• Current status: Operating. Publicly traded parent; active commercial manufacturer and seller of Xyrem/Xywav; active brand-side plaintiff in ANDA litigation. No Chapter 7/11 proceeding. (The 2021 U.S. Bank security interest, discussed below, is ordinary secured-debt financing, not distress.)

Assignment timeline

The Assignment Center does show records for this patent via the Google Patents legal-events mirror. Chronological chain:

• 2018-07-16 (recorded; execution date not shown) — Reel/frame not retrieved (unverified)

  • Conveyance: Assignment
  • Assignor: Mark Eller (inventor)
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: Not retrievable from the sources available to me — not stated rather than guessed.
  • Context: Internal confirmatory assignment of the inventor's rights to the operating parent (matches the pattern used for sibling patents, e.g., '302 at Reel 30652/0164 recorded 2013-05-24 and '306 at Reel 30836/0953 recorded 2013-07-09).

• 2018-07-16 (recorded; execution date not shown) — Reel/frame not retrieved (unverified)

  • Conveyance: Assignment
  • Assignor: Jazz Pharmaceuticals, Inc.
  • Assignee: Jazz Pharmaceuticals Ireland Limited
  • Correspondent: Not retrievable — not stated.
  • Context: Internal corporate reorganization — transfer of title into the Irish IP-holding subsidiary. Same structure as the sibling filings ('302 Reel 33480/0135 and '306 Reel 33480/0220, both recorded 2014-07-29).

• 2021-05-05 (recorded) — Reel/frame not retrieved (unverified)

  • Conveyance: Security Agreement (grant of security interest — not a title transfer)
  • Assignor/Grantors: Cavion, Inc.; Celator Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Limited; Jazz Pharmaceuticals, Inc.
  • Assignee/Secured party: U.S. Bank National Association
  • Correspondent: Not retrievable — not stated.
  • Context: Securitization/collateral grant supporting the 2021 credit facility (Bank of America as administrative agent, U.S. Bank as collateral trustee — Credit Agreement dated 2021-05-05, per Jazz plc SEC filings). A lender collateral-agent interest, not an ownership transfer.

No further recorded assignments. The chain terminates at Jazz Pharmaceuticals Ireland Ltd. (with U.S. Bank holding a security interest).

Repeat-correspondent finding: Cannot be made. Cross-checking the family's PTAB filings, the 37 CFR 3.73(b) ownership statement for the '306 patent was signed by Francis Dominic Cerrito (Reg. No. 38,100) on 2015-10-27 — but that is a power-of-attorney / standing signer, not the recording correspondent, and a single appearance is not the recurrence the signal requires. I will not manufacture a correspondent-of-record name I could not verify.

Timeline diagram

timeline
    title Ownership of US 10213400
    2013 : Priority date 1 Mar
    2018 : Application filed by Jazz Ireland
         : Inventor Eller assigns to Jazz Inc
         : Jazz Inc assigns to Jazz Ireland
    2019 : Patent granted
    2021 : Security interest granted to US Bank
         : First ANDA suit naming the patent
    2023 : Additional ANDA suits filed

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT.
The only title transfers are Eller → Jazz Pharmaceuticals, Inc. → Jazz Pharmaceuticals Ireland Ltd. — an intra-family reorganization into an existing operating subsidiary of a public company, not a transfer to a licensing-only LLC. No "IP/Holdings/Ventures" shell, no registered-agent-service address, no single-member Delaware/Texas LLC appears anywhere in the chain.

2. Known asserter in the chain — NOT PRESENT.
No assignee matches any NPE list (Acacia, Marathon, IV, Wi-LAN/Conversant, Vringo, Pendrell, Round Rock, etc.). Jazz Pharmaceuticals is a high-frequency plaintiff, but as a brand manufacturer defending its Orange-Book exclusivity against generic filers (Lupin, Teva, Amneal, Roxane/Hikma, Par, Ranbaxy, Watson) — the opposite of the NPE model. Unified Patents lists the '400 patent's assignee simply as "Jazz Pharmaceuticals Ireland Ltd," not an asserter.

3. Repeat correspondent across the chain — UNCLEAR / NOT VERIFIABLE.
I could not retrieve the correspondent-of-record for any of the three recordings, so recurrence cannot be assessed. Reported as unverified rather than assumed.

4. Cascading transfers — NOT PRESENT.
Two assignments were recorded on the same day (2018-07-16), both internal to the Jazz corporate family, with no chained LLCs and no shared third-party correspondent address. There is no <24-month sequence of unrelated assignees.

5. Pre-litigation transfer — NOT PRESENT.
The 2018-07-16 recordings predate the first suit naming the '400 patent (Jazz Pharmaceuticals Ireland Ltd. v. Lupin Inc., D.N.J. 2:21-cv-14271, filed 2021-07-28) by roughly three years, and they are corporate-housekeeping transfers, not assignments to an assertion vehicle. No standing/venue-engineered transfer is evident.

6. Bankruptcy fire-sale — NOT PRESENT.
No insolvency event. Jazz Pharmaceuticals plc is a going concern (Xyrem/Xywav revenue; 2021 GW Pharmaceuticals acquisition; active credit facility). The 2021 U.S. Bank entry is a security agreement, explicitly a grant of collateral — not a sale of assets in a bankruptcy estate.

7. Privateering — NOT PRESENT.
No operating-company-to-NPE transfer, and no evidence Jazz is asserting through a proxy. Jazz sues in its own name as the patent owner (Jazz Pharmaceuticals Ireland Ltd. is the named plaintiff).

8. Defensive aggregator — NOT PRESENT.
The chain does not terminate at RPX, AST, LOT, Unified, or OIN. The patent remains with the operating owner and is actively asserted, so it is not neutralized.

Verdict

Operating-company assertion.

Justification: The complete recorded chain is an internal reorganization — inventor Mark Eller → Jazz Pharmaceuticals, Inc. → Jazz Pharmaceuticals Ireland Ltd. (both recordings dated 2018-07-16) — followed only by a security agreement to U.S. Bank National Association on 2021-05-05, which grants collateral and transfers no title. The current assignee is an operating subsidiary of NASDAQ-listed Jazz Pharmaceuticals plc, which ships the Xyrem®/Xywav® products the claims cover and asserts the '400 patent in its own name against actual generic competitors (e.g., D.N.J. 2:21-cv-14271, filed 2021-07-28). Every NPE signal is either absent or unverifiable-for-benign-reason; none is present.

Caveat: Reel/frame numbers for the '400 patent's own recordings and the correspondent-of-record could not be retrieved through the available sources — I have flagged those gaps explicitly rather than filling them. Verify directly at the USPTO Assignment Center (https://assignmentcenter.uspto.gov/) by patent number 10,213,400; the Google Patents mirror of the same events is at https://patents.google.com/patent/US10213400/en, and the family reel/frame citations used for corroboration are recited in the PTAB RPI notices (e.g., IPR2016-00738 for the '302 patent; IPR2016-00002 and IPR2016-00546 for the '306 patent).

I'll research the prior art cited against US 10,213,400. Let me run several targeted searches.

Let me get the specific patent citation lists from authoritative sources.

Method note / verification caveat (read first)

Two things to flag before the analysis:

1. Date discrepancy. The task header says current date April 26, 2026, while my working environment reports October 1, 2026. I'm flagging this rather than silently reconciling it; it does not affect the citation analysis below.
2. Scope of what I could verify. I could not retrieve the complete verbatim front‑page "(56) References Cited" list from an authoritative USPTO/PAIR or issued‑PDF source within this session. My tooling is web search, not a credentialed PACER/PatentCenter query. The patent‑document list below is drawn from (a) the Unified Patents "Patent Art (57)" aggregation for US‑10213400‑B2 and (b) the specification's own incorporations‑by‑reference, cross‑checked against the PubChem US‑10213400‑B2 non‑patent‑literature list. Where I could not independently confirm a date or description, I say so. Treat this as a reconstruction, not a certified USPTO citation list.

This builds on the earlier-generated summary (claim 1 = reduced‑dose GHB/divalproex method; reference dose 4.5–9 g; 5–35% reduction). I do not repeat that section.

1. How the citations break down

The face of US 10,213,400 carries roughly 57 "Patent Art" entries (per Unified Patents), split among:

• US patent documents / publications (~20 discernible),
• Foreign patent documents (EP, WO, DE, GB),
• Non‑patent literature ("Other Publications") — the large majority (PubChem lists dozens: Lammers 1993, Vayer 1987/1988, Snead, Harvey 1975, Halestrap 2004, Hasan 2005, the Xyrem® PI and SmPC, etc.).

Critical structural point: US 10,213,400 is a continuation (→ 15/343,806 → 14/707,914 → 13/837,714). Most of its front‑face patent references were carried over from the parent '714/'302 family and are directed to GHB formulations, salts, and REMS/distribution systems — not to the GHB–valproate dose‑reduction method that the granted independent claims recite.

2. Cited US patent documents

Dates are the publication/issue or priority dates as reported by the aggregator; where I am uncertain I mark it.

(Additional US entries appear in the Unified list — e.g., US 8,560,460, US 8,495,880, US 8,719,055, US 9,047,487, US 9,805,004 — but these are overwhelmingly REMS/pharmacy‑informatics or divisional‑sibling art, not GHB‑co‑therapy art.)

3. Cited foreign patent documents

4. The citations that are substantively most relevant (the real § 102 story)

None of the cited patent documents discloses every element of granted claim 1 (or independent claims 8/15). Anticipation under 35 U.S.C. § 102 requires a single reference disclosing all claimed elements arranged as in the claim. The granted claims require, in combination: (a) GHB + divalproex sodium co‑administration; (b) a 5–35% reduction; (c) a patient with cataplexy‑in‑narcolepsy or EDS‑in‑narcolepsy; (d) a reference daily dose of 4.5–9 g. No cited patent supplies element (a)+(b).

The references that actually bear on the inventive concept are non‑patent literature, and they are the ones the examiner and litigants treated as the operative art:

• Vayer et al., Life Sci. 41(5):605–610 (1987) — "3′‑5′ cyclic‑GMP increase after GHB administration: prevention by valproate and naloxone." (Cited, e.g., in Ranbaxy IPR Ex. 1021.)
• Vayer et al., Trends Pharmacol. Sci. 9(4):127–129 (1988) — valproate's anticonvulsant mechanism linked to the cerebral GHB system.
• Snead & Gibson / Snead 1980 — effect of anticonvulsants on endogenous GHB in rat brain.
• Harvey et al., FEBS Ltrs 52(2):251–254 (1975) — valproate inhibition of GABA‑shunt degradative enzymes.
• Lammers et al., Sleep 16(3):216–220 (1993) — GHB in narcolepsy (double‑blind).
• Xyrem® US PI (2005/2012) and EU SmPC (2013 download) — printed publications teaching GHB dosing (4.5–9 g/day) and narcolepsy indications.
• Halestrap & Meredith, Pflugers Arch. 447(5):619–628 (2004) — MCT/SLC16 family review (the transporter rationale).
• Gonzalez & Tukey, "Drug Metabolism," Goodman & Gilman (11th ed., 2006) — DDI background.

These NPL references are the ones with § 102(a)(1) "printed publication" character. Individually they do not anticipate — each lacks the recited reduction percentage plus the specific reference‑dose band and indication combination. Their real force is § 103 obviousness (that is precisely how Ranbaxy/Lupin/Amneal framed it: valproate was known to inhibit GHB dehydrogenase → higher GHB exposure → motivate a dose reduction).

5. Bottom line

• No cited patent anticipates claims 1, 8, or 15 under § 102. The patent citations are directed to (i) GHB salt chemistry, (ii) GHB/Xyrem® formulations (concentration/pH), and (iii) REMS/pharmacy‑distribution systems — none discloses the GHB + divalproex reduced‑dose method.
• The closest patent citation for formulation‑type dependent claims is US 8,263,650 (Cook et al., Jazz) and its siblings (US 8,324,275, US 7,851,506), but these address concentration/pH, not co‑therapy dose adjustment.
• Anticipation exposure, if any, lies in the NPL (Vayer 1987/1988, Snead, the Xyrem PI/2012) — and even there, only as § 103 obviousness art, because no single reference recites the full claimed combination (valproate co‑administration + 5–35% reduction + 4.5–9 g reference dose + the specific narcolepsy indications).
• Same‑family patents (US 8,772,306; 9,050,302; 9,486,426; 10,864,181; 11,253,494) share inventor Mark Eller and the Jazz chain and are not § 102 prior art to the '400 patent in the ordinary sense.

Confidence/limits: The patent‑document roster above is reconstructed from the Unified Patents "Patent Art (57)" aggregation and the specification's incorporations‑by‑reference; I could not verify the exact verbatim "(56) References Cited" face list. Specific issue dates for a few entries (e.g., US 6,356,873; US 2014/0249222) are approximate and marked. A PAIR/PatentCenter pull of the '400 prosecution file wrapper would be required to certify the examiner's actual § 102/§ 103 rejections and the exact citations applied.

I'll ground this analysis in the actual prior-art references surfaced for this patent and its family, then build the §103 combinations.

Let me pull the specific prior-art references cited on the face of the '400 patent and the Teva/Lupin contentions directed to it.

Obviousness Analysis — U.S. Patent No. 10,213,400 B2 under 35 U.S.C. § 103

Patent: US 10,213,400 B2 ("the '400 patent"), Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters, inventor Mark Eller, assignee Jazz Pharmaceuticals Ireland Limited. Priority 2013‑03‑01; filed 2018‑01‑12; issued 2019‑02‑26.

Prior-art basis used. The "Prior Art" block on the patent page supplies the keyword set (ghb, patient, salt, dosage amount, dose) and the reference set indexed to the family, which I have supplemented with (a) the family's own "References Cited" lists appearing in sibling members (US 11,253,494; US 11,147,782; US 11,400,065), and (b) the operative prior-art identifications in the N.D.N.J. consolidated litigation (Lupin/Teva contentions, Dkt. 244) and the '306-family IPR petitions. I flag every reference I could not pin to a verbatim bibliographic entry rather than inventing a citation.

I. The governing framework and the person of ordinary skill

Preliminary strict-interpretation note. One source in the record (a Joint Claim Construction Appendix) mis-tabulates "10,213,400 B2 2/2019 Megret et al." That attribution is a source error — the '400 patent's front page, every N.D.N.J. complaint (e.g., Jazz Pharms. Ireland Ltd. v. Alkem Labs. Ltd., 2:23‑cv‑03182, Count IV), and the Litigation record all name Mark Eller. I do not propagate the "Megret" attribution.

II. Claim 1 — the limitation ladder

Per the previously generated claim analysis (verbatim claim text confirmed only for claim 1, from the N.D.N.J. contentions):

This is the crucial structural point for §103: claim 1 is a dosing-adjustment claim whose entire numerical content (5–35% reduction of a 4.5–9 g baseline) sits on top of the pre-existing Xyrem® label. That makes the case turn almost entirely on (a) whether the art motivated a reduction at all, and (b) whether the magnitude was a matter of routine optimization or a critical, unexpected range.

III. Primary §103 combinations

Combination A (lead theory): Xyrem® 2005 PI + Depakote® 2011 Label + Cagnin 2011 + Okun

This is essentially the Par/Ranbaxy/Amneal '306 theory transplanted onto the '400's narrower claim.

Element-by-element under Combination A

• L3 (co-administration) and L4 (population/on-drug): Xyrem 2005 PI + Okun. Oral sodium oxybate for EDS and cataplexy in narcolepsy, patients already maintained on it.
• L1 (reducing adverse effects): Depakote label's additive-CNS-depression warning + Cagnin's documented human harm supply the "adverse effects" that the method is said to reduce.
• L5 (4.5–9 g reference dose): Xyrem 2005 PI, verbatim.
• L2 (5–35% reduction): the Xyrem Titration Schedule's 1.5 g increments yield exactly the claimed range from the label's own dose ladder: 9 → 7.5 g = 16.7%; 7.5 → 6 g = 20%; 6 → 4.5 g = 25%; 4.5 → 3.0 g = 33.3%. Every one lands inside "about 5% to about 35%."

Motivation to combine (KSR flexible test).

1. Same field, same problem. Both references address the same clinical population (epilepsy patients are frequently narcoleptic-adjacent; valproate is a common anticonvulsant), and the Art recognized that co-prescription was possible, not exotic.
2. A POSA knew valproate elevates GHB exposure (Okun: GHB-DH inhibition; Hechler 1997: GHB→GABA conversion displaced by valproate; Weiss: "GHB dehydrogenase is the main route of GHB metabolism … inhibited by antiepileptic drugs such as valproate and ethosuximide").
3. A POSA reduces dose when exposure rises, especially when the label already teaches that the starting dose should be halved in hepatic impairment (reduced clearance → increased exposure) — Winkelman ¶79. That is a direct, in-label template for "reduce dose when clearance falls."
4. Cagnin supplies the human safety signal, and the Xyrem label plus Depakote label together flag the additive CNS-depression risk.

Reasonable expectation of success. Not a new chemical entity: the POSA is re-titrating an approved drug along the drug's own approved titration grid, using "start low and go slow" (also endorsed in the FDA drug-interaction guidance relied on in the petitions). A 1.5 g decrement from a 9 g/night maximum is a routine, label-sanctioned step.

Weaknesses of Combination A (and this is where the record is unfavorable to the challenger): the PTAB rejected substantially this theory against the '306 patent. In IPR2016‑00002 (Par), the Board found "Petitioner has not demonstrated a reasonable likelihood of prevailing," reasoning that Petitioner "does not account for the prior art's teaching away" — specifically the Xyrem black-box warning against CNS depressants (when valproate is itself a CNS depressant), the label's contraindication in patients with SSADH deficiency (when valproate inhibits SSADH), and Cagnin's own conclusion that only GHB discontinuation resolved the events. The Board also held that Par failed to establish a reasonable expectation that the reduced doses would remain therapeutically effective, given the label's teaching that doses below 6 g/night are ineffective while Cagnin showed side effects at 3.5 g/night — a "pincer" the challenger never escaped. See the petition/Patent Owner materials at https://ptacts.uspto.gov/ptacts/public-informations/petitions/1463743/ and .../1463786/ and .../1463792/.

Combination B: Xyrem® 2005 PI + Hechler 1997 + Shinka + Depakote 2011 Label (+ Cagnin, Waszkielewicz)

This is Amneal's IPR2016‑00546 ground, redirected at the '400.

Motivation. Where Combination A relies on the pharmacodynamic warning, Combination B supplies the pharmacokinetic mechanism (enzyme inhibition → higher GHB levels) and then applies the ordinary practitioner's rule that exposure-raising co-therapy requires down-titration. Petitions at https://www.docketalarm.com/cases/PTAB/IPR2016-00546/ and https://www.docketalarm.com/cases/PTAB/IPR2016-00546/Inter_Partes_Review_of_U.S._Pat._8772306/docs/02-02-2016-Petitioner/Exhibit-1003-Declaration_of_John_R_Horn,_PharmD,_FCCP.pdf.

Weaknesses. Same teaching-away record; and the Board/Patent Owner response in the sibling proceeding developed that the art discloses valproate lowering GHB in at least two ways — via renal effects and via MCT inhibition increasing renal clearance and reducing oral absorption (the Horn/Winkelman "conflicting pathways" argument, drawing on Kaufman and the Maitre pathway figure showing SSA can route to GABA rather than back to GHB). Where the art shows the analyte going in both directions, In re Cyclobenzaprine and the Board's "no established PK/PD relationship" reasoning cut hard against a reasonable expectation of success.

Combination C (the patent's own thesis): Xyrem 2005 PI + Okun + Wang MCT art + Halestrap & Meredith + Depakote Label + Cagnin/Weiss

This is the theory that most directly tracks the '400's title and specification — and it is the one the patent itself hands to a challenger.

(These Wang/Halestrap entries are verified as cited references in the family — e.g., the reference list of US 11,400,065 — and Halestrap is quoted in the '400 specification.)

Why this combination is potent. The '400 specification admits the operative facts: "Valproate, diclofenac, and ibruprofen are monocarboxylate transporter inhibitors"; "MCT inhibition caused renal clearance to be increased 30% … GHB dehydrogenase inhibition caused systemic exposure (plasma AUC) to be increased 26%." Under In re Nomiya/Standard Oil, a patentee's own characterization of the prior art can be treated as an admission of what the art disclosed. If MCT-inhibition of GHB was known (Wang), and valproate was known to be an MCT inhibitor and a GHB-DH inhibitor (Okun/Hechler/Weiss), then "valproate alters GHB exposure" was a known, quantified proposition before March 2013, and the only remaining question is the arithmetic of the adjustment — which the titration grid supplies.

Additional lever for Combination C: the specification's own working examples here are not a valproate dose-response study. One figure set compares diclofenac + Xyrem vs. Xyrem alone vs. diclofenac + placebo (FIGS. 1–4; Xyrem co-dosed with diclofenac "produced significantly less impairment than Xyrem alone" at 1 and 2.5 h), and the other compares Xyrem vs. Xyrem placebo vs. valproate (FIGS. 5–10) showing the combination "produced greater deficits than Xyrem alone." A challenger will argue that FIGS. 5–10 demonstrate nothing more than the predictable additive CNS-depressant effect already warned of in the Depakote label, i.e., the claimed benefit ("reducing adverse effects") is achieved by the same dose-lowering the label's cross-warning already implies.

Weaknesses. Wang establishes transport, not the clinically relevant direction/magnitude of a valproate–GHB interaction in humans; the Board's "no known PK/PD relationship" reasoning again applies.

Combination D (for any claim reaching the diclofenac/ibuprofen embodiments)

If any independent claim of the '400 reaches the diclofenac or ibuprofen aspects recited in the specification (my earlier analysis flagged that I could not verify the maturity of claims 8 and 15, and the granted claims appear confined to the divalproex reduced-dose method), the corresponding theory is:

Xyrem 2005 PI + Wang MCT art + Okun/Hechler + a diclofenac NSAID label + FDA Guidance for Industry (drug-interaction studies) + Hansten (drug-interaction compendium).

• Motivation: Wang shows GHB renal clearance is MCT-dependent; NSAIDs are carboxylic-acid MCT substrates/inhibitors; therefore a POSA would expect increased renal clearance and reduced exposure on co-administration, and would compensate by increasing the GHB dose or discontinuing the NSAID.
• This is a weaker theory for unexpected results purposes: "increasing the dose to compensate for reduced exposure" is the most routine of clinical reflexes, and the FDA Guidance reference supplies the "conduct a PK interaction study / adjust" motivation.
• The '400's own data support the direction (diclofenac co-dosing produced less impairment), so the challenger can argue the patent merely quantifies a predictable interaction.

IV. Motivation-to-combine — the general case

Across Combinations A–D a POSA had, at minimum, five independent motivations, each sufficient under KSR:

1. Explicit label warning of additive CNS depression when GHB meets another CNS depressant (Depakote 2011 Label).
2. Explicit human safety report of psychosis/seizures on GHB + valproate (Cagnin 2011).
3. Explicit enzymatic mechanism (GHB dehydrogenase and SSADH inhibition by valproate; Hechler, Shinka, Okun, Weiss).
4. Explicit instruction to be careful — Weiss: "we suggest using such combinations only with great care," which the petitions construe as including dose reduction and monitoring.
5. A label-provided titration grid (Xyrem Titration Schedule, 1.5 g increments) that converts "reduce the dose" into a finite set of numeric answers, all inside the claimed 5–35% band — the KSR "finite number of identified, predictable solutions" scenario.

Reasonable expectation of success rests on the fact that this is dose optimization of an approved drug within its own approved dosing envelope, not de novo drug discovery.

V. The claims beyond claim 1

• Claims 8 and 15 (independent, text unverified in my sources). My prior analysis could confirm only that they are independent and asserted; the sibling patents US 10,864,181 / US 11,253,494 recite reduced GHB daily doses "about 15% to about 35% lower" against a reference dose "between 4.5 g and 9 g" (adult) or "between 1 g and 6 g" (pediatric).
• If claims 8/15 recite narrower percentage bands or sub-ranges of g/day, they are more, not less, vulnerable to §103: a narrower range wholly within a range disclosed or suggested by the prior art is prima facie obvious absent a showing of criticality (In re Peterson; In re Aller; In re Merck & Co.). The 1.5 g titration ladder generates 16.7%, 20%, 25% and 33.3% reductions from a 9 g, 7.5 g, 6 g and 4.5 g baseline respectively — meaning that almost any sub-range a drafter might claim between ~15% and ~35% is numerically derivable from the prior art's own grid.
• Dependent claims reciting concentration (350–750 mg/mL; 450–550 mg/mL), pH (6–10; 6.5–8), salt selection (Na/K/Mg/Ca GHB), before-bed + 1–2 h dosing, and the "no hazardous machinery for 6–9 hours" warnings map directly onto the Xyrem 2005 PI (500 mg/mL, pH 7.5 with malic acid; twice-nightly dosing; the label's own driving warning) — these are disclosed elements arranged according to their established functions.

VI. Objective indicia and the strongest rebuttal — and why the analysis is contested

Jazz's defensive posture (built from the sibling '306 record):

1. Teaching away. The Xyrem label's black-box warning against other CNS depressants and its SSADH-deficiency contraindication are, on the Board's reasoning, "criticiz[ing], discredit[ing], or otherwise discourag[ing]" the very combination the claims require (In re Fulton). A POSA reading both labels would more naturally avoid co-administration than titrate around it — and indeed the '400 specification itself lists "avoiding concomitant administration of diclofenac or valproate" as an embodiment.
2. Unpredictability / no PK-PD link. The prior art contains opposing directionality evidence (valproate raising GHB via GHB-DH inhibition; lowering it via MCT inhibition, renal clearance, and decreased absorption; Kaufman showing decreased endogenous GHB in kidney). Without a known PK/PD relationship, the POSA cannot predict which direction dominates, or whether any change warrants a dosing change (In re Cyclobenzaprine).
3. Known inefficacy floor vs. known toxicity ceiling. The label teaches <6 g/night is ineffective; Cagnin reports toxicity at 3.5 g/night. A POSA reducing a 4.5–9 g dose by 5–35% risks landing in the gap — which is the Board's core "no reasonable expectation of success" holding.
4. Unexpected results. The '400 specification asserts an "unexpected discovery that drugs change the PD profile of GHB," and FIGS. 5–10 purport to show that the valproate combination "produced greater deficits than Xyrem alone."

Why a challenger can still attack (and where the '400 is arguably weaker than the '306):

• The '400's claim 1 requires a bounded 5–35% reduction, which is easier to meet with the prior art's titration arithmetic than the '306's open-ended "at least 5% decrease." A bounded range that reads on the prior art's disclosed decrements is classic prima facie obviousness.
• The stated purpose, "reducing adverse effects," is arguably satisfied by the additive CNS-depression already warned of in the Depakote label and by the "start low, go slow" convention — i.e., the claim may recite a result that the prior art's cautionary instruction already produced (In re Montgomery; "obvious to try" / method-of-treatment result limitations).
• The '400 specification's own data are thin on valproate dose-response: the diclofenac arm tests 50 mg QID with 3 g Xyrem doses, while the valproate arm's PK findings (renal clearance +30%; AUC +26%) are asserted, and the "26% AUC" figure sits close to a routine-titration magnitude.
• The litigation contentions have already assembled a large, tiered combination library for the '400 specifically, including the express Rothman v. Target "evidentiary cornucopia" framing: Tier 1 (GHB use in narcolepsy — Cook patent, Bhattacharya 2004, Broughton 1979/1980, Feldman 2006/2010, Frucht, Mamelak 1986/1989, Okun, Priori, Scharf 1985/1988, Scrima, Xyrem 2005 PI, Xyrem 2012 PI, Xyrem PDR, Xyrem 2002/2005 approval letters, Xyrem Titration Schedule) × Tier 2 (mechanism — Bernasconi, Bhattacharya 2006, Borgen, Cash, Chateauvieux, Depakote Label, Divry, Harvey, Hechler, Kaufman 1987/1988/1991, Knerr, Laan, Löscher 1999/2002, Maitre, Mathivet, Morris 2011, Rumigny, Schep, Shinka, Snead 1980/2005, Vayer 1987/1988, Waszkielewicz, Wedin) × Tier 3 (human toxicity — Cagnin, Weiss) + optional (FDA Guidance, Hansten). See https://storage.courtlistener.com/recap/gov.uscourts.njd.478299/gov.uscourts.njd.478299.244.2.pdf.

Important cross-reference correction. The earlier Litt section of this analysis attributed Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 895 F.3d 1347 (Fed. Cir. 2018), to the oxybate patent stack generally. On the full opinion, that decision concerns the drug-distribution-system patents ('730, '106, '107, '059, '988, '182, '963) and the public-accessibility of the FDA Advisory Committee materials — it is not a §103 ruling on the '400 or any '302-family "drug-drug interaction" patent. Its only relevance here is jurisprudential (KSR motivation-to-combine does not require subsidiary findings of a "problem to be solved" plus a "finite universe"). Source: https://www.govinfo.gov/content/pkg/USCOURTS-ca13-17-01675/pdf/USCOURTS-ca13-17-01675-0.pdf.

VII. Bottom line

Claims 1, 8, and 15 are, in my assessment, subject to strong prima facie §103 challenges — but the challenges are genuinely contested, because the most natural combination has already been tested against the sibling '306 claims and rejected on teaching-away and reasonable-expectation grounds.

Where the challenger should focus: (i) attack the bounded 5–35% range as a range reading directly on the label's 1.5 g titration arithmetic (In re Peterson); (ii) use the '400 specification's own admissions about MCT inhibitors and the 26%/30% figures as prior-art admissions; (iii) press that the "reducing adverse effects" preamble recites a result the Depakote cross-warning already motivated; and (iv) if claims 8/15 recite narrower percentage bands, seek a prima facie case with no criticality showing.

Where Jazz should focus: the Fulton/KSR teaching-away record built in the '306 IPRs; the lack of any established PK/PD relationship for a valproate–GHB interaction (Cyclobenzaprine); the inefficacy-floor / toxicity-ceiling pincer; and the absence (to date) of any AIA trial ever instituted on the '400 itself — meaning no unpatentability finding exists against these claims.

Confidence and limitations.

• High confidence in the reference identities and teachings I quote from the PTAB petitions and the N.D.N.J. contentions (Xyrem 2005 PI, Xyrem Titration Schedule, Depakote 2011 Label, Cagnin, Hechler AMN1006, Shinka AMN1007, Waszkielewicz, Weiss).
• Medium confidence in the bibliographic details of "Okun" (I relied on the petition's pinpoint cites at pp. 169–70 rather than a full citation) and in the identity/number of the "Cook patent" — I did not verify a patent number and do not state one.
• Lower confidence on the precise status of claims 8 and 15 of the '400: I can confirm they are independent and asserted, but not their verbatim text; the analysis of those claims is necessarily inferential.
• I could not retrieve the '400 patent's own front-page "References Cited" list in full, so the reference set above is drawn from the family listings and the litigation/IPR record rather than a certified copy of the '400 face.
• Minor date discrepancy noted: the task prompt states April 26, 2026; the session context states October 1, 2026. The analysis is date-insensitive in substance but I flag the inconsistency rather than silently reconciling it.

Primary sources cited: Google Patents US10213400 (https://patents.google.com/patent/US10213400/en); PTAB IPR2016‑00002 / ‑00024 / ‑00546 petition and Patent Owner papers (https://ptacts.uspto.gov/ptacts/public-informations/petitions/1463743/, .../1463786/, .../1463792/; https://www.docketalarm.com/cases/PTAB/IPR2016-00546/); Winkelman Decl. Ex. 1003; Horn Decl. AMN1003; N.D.N.J. Dkt. 244 (Lupin/Teva invalidity contentions) https://storage.courtlistener.com/recap/gov.uscourts.njd.478299/gov.uscourts.njd.478299.244.2.pdf; Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347 (Fed. Cir. 2018); Alkem complaint (2:23‑cv‑03182) https://paragraphfour.com/wp-content/uploads/2010/11/njdc23cv3182C.pdf; Unified Patents patent page https://portal.unifiedpatents.com/patents/patent/US-10213400-B2.