US 10736866

I'll verify this patent against external sources before summarizing.

Verification note on method

I searched Google Patents (mirrors USPTO bibliographic/claim data), DrugPatentWatch (FDA Orange Book + USPTO-derived claim text), CourtListener/RECAP dockets, the D. Del. claim‑construction record in Jazz v. Avadel, and Avadel/Alkermes SEC filings. I did not directly query USPTO Patent Center/PAIR or the Federal Circuit's own docket system, so where I say "no 2026 CAFC docket found," that reflects the coverage of the sources above, not a negative result from the CAFC's own docket. Caveats are flagged inline.

1. Bibliographic data — US 10,736,866 B2

Familial provenance (continuation chain). The '866 application is a continuation of Ser. No. 15/655,924, filed 2017‑07‑21, now US 10,272,062 ("the '062 patent"), and claims priority to U.S. provisionals 62/365,812 (2016‑07‑22), 62/399,413 (2016‑09‑25), and 62/474,330 (2017‑03‑21). It in turn spawned a large continuation family (e.g., US 10,952,986; US 10,973,795; US 11,065,224; US 11,602,513; US 11,766,418; US 11,896,572, etc.). Note that later continuations name an additional inventor, Jordan Dubow, but the '866 patent itself lists only the three inventors above — the user should not conflate the two.

Assignee nuance (important). Per the Google Patents front page and an Aug. 1, 2023 assignment record, RTW Investments, LP appears as an assignee in a "Patent Collateral Agreement," with assignors Avadel CNS Pharmaceuticals, LLC and Flamel Ireland Ltd. That is a security interest, not a transfer of title; and Avadel is the NDA holder/commercializer. Any statement that "RTW owns the patent" would be over‑reading the record. The commercially relevant owner/patentee is Flamel Ireland Ltd (the Avadel group).

Orange Book / product linkage. DrugPatentWatch lists US 10,736,866 as protecting LUMRYZ (sodium oxybate, extended‑release oral suspension), NDA 214755 (approved 2023‑05‑01), as a "product" patent. That is the Avadel once‑nightly sodium oxybate product.

2. Abstract

"Modified release formulations of gamma‑hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof."

This abstract is confirmed by multiple independent sources (Google Patents, DrugPatentWatch, PubChem patent record, EPO family record for EP3487483A1).

3. Disclosure — plain‑language overview of the invention

The specification addresses narcolepsy treatment with sodium oxybate (Xyrem®), which is dosed twice nightly (at bedtime and again 2.5–4 h later) as an immediate‑release (IR) liquid. The inventors set out to make a once‑nightly, modified‑release (MR) formulation that (i) roughly matches or exceeds the bioavailability of an equal dose of the twice‑nightly IR solution, (ii) does so across the dose range, and (iii) leaves little residual drug at 8 h but still approximates the 8‑hour concentration of the reference regimen. The specification is highly critical of prior art once‑nightly attempts — Allphin (US 2012/0076865) and Liang et al. (US 8,193,211) — alleging low relative bioavailability (e.g., 22–63% of IR for various treatments).

The structural solution disclosed is a particulate (dry‑powder) formulation containing:

• an IR portion (gamma‑hydroxybutyrate particles releasing >80% in 1 h in 0.1N HCl), and
• an MR portion — microparticles of GHB coated with (a) a polymer carrying free carboxylic groups (methacrylic acid copolymers; pH dissolution trigger 5.5–6.97) and (b) a hydrophobic compound with melting point ≥ 40 °C (e.g., hydrogenated vegetable oil), at a hydrophobic:polymer weight ratio of 0.4–4, with the coating being 10–50% of particle weight;
• plus a suspending/viscosifying agent and an acidifying agent (preferably malic acid), physically separate from the IR and MR particles — the acidifying agent stabilizes the 0.1N HCl dissolution profile after reconstitution;
• an IR:MR GHB ratio of 10/90 to 65/35 (preferably ~50/50);
• intended to be dispersed in ~50 mL tap water and swallowed once at bedtime.

The claimed/described performance targets include: 7.5 g dose producing mean AUCinf > 340 hr·µg/mL; mean C8h within 50–130% of the equal‑dose twice‑nightly IR reference; relative bioavailability > 80% at 4.5 g, 6 g, 7.5 g and 9 g; and a specific multi‑point dissolution fingerprint (e.g., 40–65% released at 1 h and at 3 h in 0.1N HCl; >80% at 3 h in pH 6.8 phosphate buffer). The specification contains 90 figures, largely dissolution (FIGS. 1–89) and PK (FIGS. 12–14, 22, 90) profiles.

4. Independent claims — overview

Caveat on completeness: The Google Patents page I retrieved truncated before the claims, and I could not retrieve a full verbatim claim set. The following is built from (a) DrugPatentWatch's USPTO‑derived claim text, (b) direct quotations of the '866 claim language in the Jazz v. Avadel D. Del. record (e.g., ¶¶984–987 of the Aug. 29, 2023 expert declaration, Doc. 357, and Doc. 316‑1), and (c) the observation in Jazz's briefs that the '866 patent contains four claims (1–4) that Jazz's '782 patent copied. I flag where I am reconstructing rather than quoting.

Claim 1 (composition — the principal independent claim). A modified release gamma‑hydroxybutyrate formulation comprising:

• an immediate release portion comprising gamma‑hydroxybutyrate;
• a modified release portion comprising gamma‑hydroxybutyrate;
• a suspending or viscosifying agent "selected from the group consisting of xanthan gum, carrageenan gum, gellan gum, guar gum, sodium alginate, calcium alginate, agar, sodium carboxymethyl cellulose, microcrystalline cellulose, hydroxyethyl cellulose, hydroxypropylmethyl cellulose, and mixtures thereof" (quoted in the D. Del. record); and
• an acidifying agent selected from the group consisting of malic acid, citric acid, tartaric acid, adipic acid, boric acid, maleic acid, phosphoric acid, ascorbic acid, oleic acid, capric acid, caprylic acid, and benzoic acid (quoted verbatim from the DrugPatentWatch claim text).

I am not fully confident that this is the entirety of claim 1 — the D. Del. record also refers to claim 1 reciting a suspending/viscosifying agent being "separate from the immediate release particles and the modified release particles," and Jazz/Avadel litigated whether claim 1 (as reflected in the copied '782 claim) requires "modified release particles." Treat the above as a high‑confidence reconstruction, not a certified copy.

Claim 4 (dependent, notable). Recites a list of lubricants; per the litigation record, four of these overlap with the lubricant list in Avadel's '064 application/§, and one (stearic acid) appears in the '866 specification at col. 34:4–10.

Claim 20 (independent — formulation/use‑oriented). DrugPatentWatch gives this text: a formulation comprising an IR portion and an MR portion; 1%–15% of a suspending or viscosifying agent; and 1.2%–15% of an acidifying agent; wherein the suspending/viscosifying agent and the acidifying agent are separate and distinct from the IR and MR portions; wherein the IR:MR GHB ratio is 10/90 to 65/35; wherein the formulation comprises GHB equivalent to 3.0 g to 12.0 g of sodium oxybate; and wherein the formulation is designed to be orally administered once‑nightly to treat cataplexy in narcolepsy or excessive daytime sleepiness (EDS) in narcolepsy.

Claims 39 and 40 (independent). Both open "A formulation of gamma‑hydroxybutyrate comprising: …". Claim 40 additionally recites "from 1% to 15% of a suspending or viscosifying agent for improving the formulation's viscosity." I could not verify the full body of claims 39 and 40 from the sources retrieved; the full text of these two claims is the largest gap in my retrieval.

Representative dependent claims (verified in the DrugPatentWatch text):

• Claim 13 — PK limitation: dose achieves mean AUCinf > 80% of the equal‑dose twice‑nightly IR reference and mean C8h < 95% of that reference.
• Claim 14 — ≥80% release at 3 h in pH 6.8 phosphate buffer (USP 38 <711> Apparatus 2).
• Claim 15 — 10–65% release at 1 h and at 3 h in 0.1N HCl.
• Claim 16 — MR portion >80% released at 3 h in pH 6.8 buffer.
• Claim 17 — MR portion <20% released at 1 h in 0.1N HCl.
• Claim 18 — MR portion >80% released at 3 h in the sequential 0.1N HCl → pH 6.8 test.
• Claim 19 — IR portion >80% released at 1 h in 0.1N HCl.

Therapeutic method claims: I did not retrieve method claims in the '866 claim set from my sources. Note that Avadel's later family members do contain method‑of‑treatment claims (e.g., mixed‑salt, once‑nightly, titration‑based claims asserted against XYWAV® in Avadel CNS Pharma v. Jazz, D. Del. 1:25‑cv‑00221, involving US 12,226,388 / 12,226,389), but those are different patents, not the '866.

5. Litigation / docket status relevant to the '866 patent

• D. Del. 1:21‑cv‑01594 (Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals) — this is the case hyperlinked from the Google Patents page. Jazz asserted its US 11,147,782 ('782) patent; in that complaint Jazz characterized the '866 patent as Avadel's patent and alleged Avadel's FT218 (now LUMRYZ) is an embodiment of the '866 claims. Jazz also alleged its '782 claims were copied from Avadel's '866 claims 1–4.
• D. Del. 1:21‑cv‑00691 (Jazz v. Avadel) — the '866 patent figures heavily as prior disclosure/written‑description support for Jazz's asserted '488/'885/'956/'931 ("sustained release") and '079/'782 ("resinate") patents; it was not, on the record I retrieved, a patent asserted by Avadel in that case.
• D. Del. 1:22‑cv‑00487 (Avadel CNS Pharmaceuticals v. Jazz Pharmaceuticals) — patents in suit include 10,272,062; 10,736,866; 10,952,986 alongside Jazz patents 7,262,219; 7,851,506; 8,731,963.
• Federal Circuit: the appeals I can confirm are Nos. 2024‑2274, 2024‑2277, 2024‑2278, argued and decided May 6, 2025 (Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals), concerning the permanent injunction barring Avadel from pursuing an idiopathic‑hypersomnia indication for Lumryz. Those appeals turned on Jazz's REMS patent and the §271(e)(1) safe harbor — not on the '866 patent. The DC Circuit separately affirmed FDA's approval of LUMRYZ (June 27, 2025).
• Settlement: On 2025‑10‑21 Avadel CNS and Jazz entered a Settlement and License Agreement resolving the various First–Fifth Complaints (including Avadel's counterclaims), and a joint stipulation of dismissal with prejudice was entered 2025‑10‑27.

On "CAFC 2026 dockets" for this patent specifically: I found no Federal Circuit appeal docketed in 2026 that asserts or adjudicates US 10,736,866. The '866‑relevant district court litigation settled in October 2025, which makes a pending 2026 appeal over this patent unlikely but not impossible (e.g., a case could name it as background art or in a later‑filed action). I do not have high‑confidence, authoritative negative coverage of the 2026 CAFC docket, so this conclusion should be treated as "not found in the sources searched" rather than "confirmed absent."

6. Summary of uncertainties

1. Full claim text: Claims 1, 39 and 40 are only partially verified; claim 1 is a reconstruction from quoted fragments. Any definitive claim chart should be built from the USPTO/Google Patents full‑text claims or the issued patent PDF, not from this summary.
2. Assignee: Flamel Ireland Ltd is the patentee; RTW Investments, LP appears only in a collateral/security agreement (Aug. 2023) whose assignors include Avadel CNS Pharmaceuticals, LLC. Do not treat RTW as the owner of record absent the actual assignment document.
3. Litigation: The judicial record is dense and partially redacted/sealed; the litigation history above is drawn from RECAP filings, law‑firm trackers, and Avadel/Alkermes investor disclosures, which are secondary as to docket status.
4. CAFC 2026: I cannot certify that no 2026 CAFC activity exists; I can only report that none surfaced.

Sources: Google Patents US10736866B2; DrugPatentWatch patent/claim pages for 10,736,866 (updated Apr. 24, 2026); PubChem patent record US-10736866-B2; EPO family record for EP3487483A1 / WO2018/017522; freepatentsonline continuations (US 2024/0148685, US 2023/0172892); CourtListener/RECAP D. Del. 1:21‑cv‑00691 Docs. 314, 357, 581, and 1:21‑cv‑01594 Doc. 1; Federal Circuit slip opinion in Nos. 2024‑2274/‑2277/‑2278 (decided May 6, 2025); Avadel Pharmaceuticals plc and Alkermes plc periodic filings describing the Jazz/Avadel litigation and the October 2025 settlement.

I'll search for litigation involving US patent 10736866 across patent litigation sources.

Let me search more specifically for the litigation referenced on the patent page and related cases.

Let me search for the specific patent number as asserted in litigation, and check the Unified Patents litigation portal entry.

Litigation involving US Patent 10,736,866

Caveats up front: US 10,736,866 ("Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics," Flamel Ireland Ltd., Mégret et al.) is the subject of a dense, multi-case patent war in the District of Delaware over once‑nightly sodium oxybate products (Avadel's LUMRYZ/FT218 vs. Jazz's XYREM/XYWAV). Two independent indicators exist, and they do not fully agree:

• The Google Patents page for US 10,736,866 lists exactly one litigation entry: Delaware District Court, case 1:21‑cv‑01594 (link: https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A21-cv-01594).
• DrugPatentWatch's "Litigation for Patent 10,736,866" page (updated 2026‑03‑18) lists a larger set of D. Del. cases in which the '866 patent appears.

I report both, and flag where I am uncertain whether '866 was an asserted patent or merely listed/cited in the case.

Cases reported for US 10,736,866 (DrugPatentWatch; all D. Del. unless noted)

Important interpretation note (STRICT rule applied): I am not auto‑correcting anything, but the DrugPatentWatch table's captions for rows 4–7 are truncated/misaligned in the retrieved text — only one party ("Jazz Pharmaceuticals, Inc.") is legible, so I cannot reliably state plaintiff vs. defendant for those dockets. Rows 1–3 are legible as captioned. I also caution that for several of these dockets DrugPatentWatch may be listing '866 because it was referenced (e.g., as a continuation of Avadel's '062 patent in the 1:22‑cv‑00487 pleadings) rather than because it was asserted.

Additional case asserting the '866 patent (found separately)

• Avadel CNS Pharmaceuticals, LLC v. Granules India Limited, No. 3:26‑cv‑09661‑GC‑JBD (D.N.J.) — complaint pleads infringement of, inter alia, the '866 patent (and the '062 patent) arising from Granules' ANDA/Paragraph IV certification.
  • Flag: the retrieved complaint bears a filing stamp of 07/30/26 and references a notice letter dated June 17, 2026 — i.e., dates after today's stated date of 2026‑04‑26. I am reporting the identifier literally per the search result, but this date inconsistency means either the search index is showing a future‑dated/anticipated filing or there is an indexing artifact. Verify against PACER before relying on it.

Key factual/relational points (from the pleadings themselves)

• Ownership: Flamel Ireland Ltd. is the owner/assignee of the '866 patent; Avadel CNS Pharmaceuticals, LLC is the exclusive licensee (stated in the Flamel/Avadel complaints, e.g., the '388/'389 and '991 patent complaints).
• The Delaware '866‑related cases are all in the District of Delaware, before Judge Gregory B. Williams (‑GBW dockets).
• The dispute centers on Hatch‑Waxman (35 U.S.C. § 271(e)) claims over Avadel's once‑nightly LUMRYZ (FT218) NDA, and on parallel declaratory‑judgment/validity counterclaims by Avadel against Jazz.

What I could NOT confirm

• No PTAB/IPR record for US 10,736,866 appeared in my searches. I did not find an IPR/PGR/CBM docket for the '866 patent; treat that as "not found," not as "none exists."
• Outcomes: I could not verify a final judgment specifically on the '866 patent. The broader Delaware oxybate litigation culminated in a 2024 jury trial (in 1:21‑cv‑00691) and 2025 injunction/settlement activity, but I cannot tie a specific '866 disposition to it. Do not assume the '866 patent was adjudged valid/infringed based on these results.
• Exact filing dates for the earlier '866‑relevant complaints (e.g., 1:21‑cv‑00691, 1:21‑cv‑01594) may differ by a few days from the DrugPatentWatch table; PACER/ CourtListener control.

Recommendation: these dockets should be verified directly on PACER (or the Unified Patents litigation portal) because (a) the Google Patents page lists only one case while DrugPatentWatch lists seven, and (b) several captions and at least one filing date could not be reconciled.

I'll start by verifying the structured block against live sources before drafting.

No PTAB hits yet. Let me probe more specifically for any petition naming this patent, and check the Unified Patents portal entry.

Let me check whether the patent owner/assignee has ever been a PTAB respondent, and whether any IPR names the '866 patent's family.

Proceedings overview

Total AIA trial proceedings on US 10,736,866: zero (0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denials). The USPTO Open Data Portal structured block returns no AIA trial proceedings for this patent, and my independent web searching found no IPR, PGR, or CBM ever filed naming US 10,736,866 — which means the defensive bottom line is the opposite of a "hardened" patent: every claim stands exactly as issued on 2020-08-11, un-narrowed and un-adjudicated, and any challenger still has a completely clean § 315(e) slate and a fully available IPR window.

That said, "no PTAB activity" is a fact about the record, not a fact about the patent's strength — and for this patent the absence is mostly explained by who owns it, not by whether anyone could challenge it (see below).

No proceedings to report

The canonical list is empty, so there is no FWD to quote, no claim to mark canceled, no panel to name, and no appeal to track. I am explicitly not inventing proceeding numbers, petitions, or panels to fill the template. Verification performed:

Caveat, stated plainly: I could not run a live query against USPTO PTAB E2E / PatentCenter in this session. "No PTAB activity" reflects the ODP block plus absence of any indexed proceeding in public sources, not a direct E2E confirmation. Treat it as high-confidence but verify in E2E before relying on it in a brief or an opinion letter.

Related proceedings that are NOT proceedings on the '866 (do not conflate)

These came up in searching and are worth knowing, but none of them involve Patent No. 10,736,866 as the challenged patent:

• IPR2016-00002, IPR2016-00024, IPR2016-00546 — Petitions against Jazz's U.S. Pat. No. 8,772,306 (Eller, GHB + valproate dosing), not the '866. IPR2016-00002 was denied institution. Source: PTAB petition document. Different patent, different owner, different family — useful only as background on how the Board has treated oxybate art.
• The Jazz v. Avadel District of Delaware war, including D. Del. 1:21-cv-00691 (tried to jury verdict in Feb. 2024 — Jazz's '782 patent held valid and infringed by LUMRYZ), the parties' 2025 cross-assertion of Avadel/Flamel patents (e.g., 1:25-cv-00009, 1:25-cv-00221 re U.S. 12,167,991 and 12,226,388/12,226,389), and the 2025-10-24 stipulated dismissal with prejudice of the Avadel-v.-Jazz actions. Sources: CourtListener docket 1:25-cv-00009, Georgetown Litigation Tracker trial transcripts. These are § 271 district-court actions, not AIA trials, and they are invalidity/validity fights about Jazz's patents plus Avadel's later patents — not about the '866.
• Litigation flagged against the '866 itself: the structured block links D. Del. 1:21-cv-01594 as a US case filed in Delaware District Court. I could not retrieve the complaint or confirm which of the parties is plaintiff on that docket from available sources, so I am flagging it without characterizing it.

Strategic summary

Claim status: 100% SUSPENDED IN AMBER — untested, not canceled, not sustained. No claim of the '866 has ever been construed by the Board, canceled by a certificate, or confirmed in an FWD. The complete claim set as issued on 2020-08-11 remains live and is scheduled to expire 2037-07-21 (priority 2016-07-22; status Active per ODP; current assignee Flamel Ireland Ltd, with a 2023-08-01 collateral-security assignment recorded to RTW Investments, LP that is a lien, not a transfer of title). Because the patent is one of Avadel's own product patents on the Orange Book listing for LUMRYZ (NDA 214755), the realistic challenger class is generic/505(b)(2) entrants and would-be competitors — not the patent owner — which is exactly why a zero-IPR record is unsurprising for a patent that has mainly been used offensively within the Avadel–Jazz dispute rather than against an ANDA filer.

Estoppel landscape: nothing is barred, and that cuts both ways. With no instituted trial, no petitioner is subject to § 315(e)(2) estoppel on this patent, and there are no IPR-created admissions, no narrowed substitute claims, and no Board claim constructions to inherit. A defendant today can (a) raise any § 102/§ 103/§ 112 defense in district court without an estoppel shadow, and (b) file a first IPR on this patent without facing General Plastic serial-petition headwinds from an earlier petitioner — though the same factors will bite that defendant if it later wants a second, follow-on petition. Watch one asymmetry: because the '866 sits at the head of a very large continuation family (the ODP block shows repeated continuations issuing from this lineage, e.g., 10,952,986, 10,973,795, 11,000,498, 11,052,061, 11,065,224, 11,504,347, 11,602,512/513, 11,666,418, 12,128,621, 12,226,388/389, 12,263,150 …), an IPR knocking out the '866 alone does not clear the field — the family's later-issued claims are a separate challenge set with their own (and in some cases later, 2042) expirations.

Pattern signals. No serial filer on this patent (there is no filer at all). No Unified Patents or other defensive aggregator in the chain — I checked the Unified Patents portal entry for this family and found the patent listed in the portfolio, but no unified-filed IPR. The patent owner has not had to defend this patent at the Board. Note for context: PGR is dead (its 9-month window closed 2021-05-11) and CBM is dead (program sunset), so IPR under §§ 102/103 is the sole AIA path left — and § 112 grounds are unavailable in an IPR.

Recommended next steps

If you are a defendant (or prospective defendant) facing assertion of the '866:

1. There is no FWD to hand you. Unlike a patent with a canceled claim, you cannot say "claims 1–N are dead." Your invalidity case must be built from scratch. Start with the substantive art the owner itself distinguished: the '866 specification discusses Allphin (US 2012/0076865) and Liang, and disparages Allphin's modified-release formulations for (i) mean AUCinf of only 56–63% of an equal immediate-release dose across Treatments B/C/E, with Treatment D at 22–33%, and (ii) excess residual sodium oxybate at 8 hours. That self-identified gap — "modified release that actually matches twice-nightly IR bioavailability" — is the natural § 103 attack surface, and the same art was litigated against Avadel's family in the district courts (see the Lupin invalidity contentions at CourtListener N.J. recap 478299).
2. File within one year of service. § 315(b) bars an IPR petition more than one year after service of a complaint alleging infringement of the '866. The D. Del. docket flagged in the structured block (1:21-cv-01594, 2021-11-10) plus the 2021–2025 Avadel/Jazz dockets mean any party served in those actions is already time-barred on this patent; a newly served party is not.
3. Attack the priority chain, not just the art. Priority is 2016-07-22 with a 2019-02-21 filing and 2020-08-11 grant. If you can push the effective filing date later, you unlock intervening prior art under § 102(a)(1)/(a)(2) — the same move the district courts have litigated heavily in this family (Dynamic Drinkware priority challenges to the '168/'922 patents). Also consider whether the disclosure dates in the specification are internally inconsistent, which can be an enablement/written-description argument for a district-court count even though IPR can't take § 112.
4. Mind the family, not the patent. Because the '866 is one node in a continuation thicket of ~30+ Orange Book-listed relatives all claiming priority to 2016-07-21/22 and many expiring 2037-07-21, plan your challenge across the family (and consider whether Avadel's own later patents, e.g., 12,226,388/389 and 12,263,150 with 2042 expirations, are the real gatekeepers before you spend on an IPR against the '866).
5. Procedural posture to verify before filing: any ongoing inter partes or district-court challenge to the '866 that post-dates the ODP ingest would change the § 315(a)/(b) and Fintiv-style calculus. Re-run USPTO PTAB E2E, the PTAB "Patent Trial and Appeal Board" tab on Google Patents US10736866, and the Unified Patents litigation portal entry immediately before filing, and confirm the assignment record (the RTW collateral agreement may affect who has standing to settle or license).

If you are the patent owner: the clean record is an asset — no estoppel, no Board construction, no narrowed claims. The corresponding risk is that the '866 has never been tested, so its validity is an open question and the first IPR petition will define the patent's litigation value for the remainder of its term.

Reported on 2026-10-01. The proceedings list in the structured block is authoritative and was treated as the canonical set; the related matters above are labeled as unrelated to US 10,736,866 and are not presented as AIA trials on this patent. Where a fact could not be verified in public sources, it is flagged as unverified rather than asserted.

I'll research the assignment record for US 10736866 across the sources available.

Good — I found family-level assignment data. Let me pin down the records specific to US 10736866 and the litigation.

Let me verify the specific reel/frame for US 10,736,866 itself and hunt for the assignment correspondent of record.

Ownership Reconstruction — US 10,736,866 B2

Patent: US 10,736,866 B2 — "Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics"
App. No. 16/281,235 · filed 2019-02-21 · granted 2020-08-11 · priority 2016-07-22 · anticipated expiry 2037-07-21
Verification sources: Google Patents legal events · USPTO Assignment Center / assignment.uspto.gov (search by patent number) · Unified Patents litigation record

Data-quality note: The Google Patents legal-events feed for the '866 patent does not expose reel/frame strings. The reel/frame numbers below were recovered from the parallel assignment record of same-family sibling US 11,065,224 B2 (Dimensions legal-events extract). Reel 064463/0907 and reel 074729/0205 are family-wide security/release instruments and almost certainly cover the '866 patent; reel 050132/0351 is the inventors' assignment as recorded on the sibling, and I could not independently confirm the identical reel/frame string on the '866 record itself. Treat the '866-specific reel/frame as reported-by-family, not personally verified at Assignment Center.

Inventors

All three are listed on the sibling US 11,065,224 front page as Flamel Ireland-applicant inventors, and all three are named as assignors on the employees' assignment (reel 050132/0351) — i.e., they were Flamel staff, not licensors or third-party inventors.

Unusual pattern — noted but not a fire-sale signal: the entire Lyon formulation team subsequently left the assignee. Jazz's trial counsel stated in the Delaware courtroom (D. Del. 1:21-cv-00691-GBW, trial transcript 2024-05-01, pp. 47–48) that after Flamel became Avadel, a consultant reviewed the Flamel work, found no "secret ingredient," recommended all Flamel employees be fired for that reason, and Avadel CEO Greg Divis "fired all of those employees… one of those that they fired was Dr. Guillard." This is a post-merger, post-commercialization R&D consolidation — the departure came roughly five years after the 2017-07-24 assignment, not within 12 months of filing, and the portfolio was retained and commercialized rather than sold. It does not match the "departures precede a portfolio fire-sale" pattern.

Original assignee

Flamel Ireland Limited (Dublin, Ireland; 10 Earlsfort Terrace, Dublin 2 per the 2022 Recipharm manufacturing agreement). Named as applicant on the '866 and on all family members; the Canadian-examination and Orange Book records show Flamel Ireland Limited d/b/a Avadel Ireland.

• Line of business: Specialty pharmaceutical company — the Irish operating/R&D-holding subsidiary of Flamel Technologies SA (Lyon, France; NASDAQ: FLML), which renamed itself Avadel Pharmaceuticals plc (NASDAQ: AVDL). Flamel's platform was Micropump® oral modified-release microparticles; this patent family is the Micropump® sodium oxybate program (FT218).
• Did it ship a product embodying the claims? Yes. FT218 became LUMRYZ™ (sodium oxybate) extended-release oral suspension, approved by FDA 2023-05-01 and commercialized in the U.S. by Avadel CNS Pharmaceuticals, LLC, the declared exclusive licensee of the family (see the '991-patent pleading in D. Del.: "Flamel is the owner and assignee… Avadel CNS Pharmaceuticals, LLC is the exclusive licensee… The parties collectively hold all rights, title, and interest"). The patent family was listed in the Lumryz Orange Book listing and was the subject of the Hatch-Waxman/§271(e)(2) fights with Jazz.
• Current status: Operating. Flamel Ireland Limited remains an active Avadel subsidiary; Avadel Pharmaceuticals plc is a listed, revenue-generating company (no bankruptcy, no dissolution). Note the collateral lender RTW Investments, LP recorded a release of its security interest effective 2026-05-21 (reel 074729/0205), indicating the secured financing has been discharged.

Assignment timeline

• 2017-07-24 (executed) / recorded 2019-08-22 — Reel 050132/0351 (reel/frame as recorded on sibling US 11,065,224; see data-quality note)

  • Conveyance: Assignment of Assignors' Interest
  • Assignor: Mégret, Claire; Guillard, Hervé; Dubuisson, Jean-François (individually)
  • Assignee: Flamel Ireland Limited
  • Correspondent: not retrievable from the sources available to me (see Signal 3 below); the Assignment Center record shows this field and should be pulled directly.
  • Context: routine employer/employee assignment perfecting title in the applicant a week after the parent PCT/US filing — not a monetization event.

• 2023-08-01 (executed) / recorded 2023-08-01 — Reel 064463/0907

  • Conveyance: Patent Collateral Agreement (security interest, not a title transfer)
  • Assignors: Avadel CNS Pharmaceuticals, LLC and Flamel Ireland Ltd.
  • Assignee: RTW Investments, LP (New York, NY), as collateral agent
  • Correspondent: not retrievable from the sources available to me.
  • Context: securitization — the patent family pledged as collateral for a healthcare-investor financing facility; equitable/security interest only, legal title retained by Flamel/Avadel.

• ~2026-05-21 (effective) / recorded 2026-05-21 — Reel 074729/0205 (shown on sibling US 11,065,224; not yet reflected in the '866 Google Patents legal-events capture)

  • Conveyance: Release of Security Interest
  • Assignor: RTW Investments, LP, as Collateral Agent
  • Assignee/owner of record: Flamel Ireland Ltd. and Avadel CNS Pharmaceuticals, LLC
  • Correspondent: not retrievable from the sources available to me.
  • Context: lien discharge — collateral released back to the operating entities; confirms the 2023 pledge was financing, not a disposition.

There is no recorded assignment to any licensing-only LLC, no merger/change-of-name recordation, and no post-issuance sale of the patent. Legal title has never left the Flamel/Avadel operating group.

Timeline diagram

timeline
    title Ownership of US 10736866
    2016 : Priority date for the oxybate family
    2017 : Inventors assign rights to Flamel Ireland
    2019 : Application filed as 16 281 235
         : Inventors assignment recorded at USPTO
    2020 : Patent 10736866 issues
    2023 : Family pledged to RTW Investments
         : Lumryz approved and launched
    2026 : RTW releases security interest

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The only title transfer is reel 050132/0351 (2017-07-24 / recorded 2019-08-22), from the three individual inventors to Flamel Ireland Limited — the same operating group that employed them and that holds the product NDA. The 2023-08-01 entry (reel 064463/0907) is styled a Patent Collateral Agreement, i.e. a security interest granted to RTW Investments, LP, with legal title retained. No "IP Holdings / Ventures / Licensing" assignee appears anywhere in the chain, and no registered-agent-service address is used for any assignee.

2. Known asserter in the chain — not present. Assignees are Flamel Ireland Limited and RTW Investments, LP. Neither appears on the RPX/Unified high-frequency-plaintiff lists, and RTW is a New York healthcare investment manager acting as lender/collateral agent, not as an asserting entity. Avadel CNS Pharmaceuticals, LLC (exclusive licensee) is a drug marketer that was sued by Jazz Pharmaceuticals (D. Del. 1:21-cv-00691 and 1:21-cv-01594, first filed 2021-05-13 and 2021-11-10) — it is the target of assertion in this technology, not an asserter of it.

3. Repeat correspondent across the chain — unclear. The recording correspondent (attorney/agent of record on the assignment cover sheets) is the single most probative field for this test, and I was unable to retrieve it for reels 050132/0351, 064463/0907 or 074729/0205 from the sources available to me; not from Google Patents (legal events suppress correspondence), not from Dimensions, and the Assignment Center requires an interactive lookup. I therefore cannot run the recurrence test and will not infer a finding from the firm names that appear in unrelated litigation. Recommended next step: pull the correspondent field for those three reel/frame entries directly at assignmentcenter.uspto.gov. Note that because two of the three entries are borrower/lender instruments, a shared correspondent here would most likely indicate transactional counsel, not an NPE operator.

4. Cascading transfers — not present. Three recorded events over nine years (2017/2019, 2023, 2026), and two of the three are the grant and the release of the same security interest. There is no chained-LLC sequence, no shared-principal cluster, and no sub-24-month relay.

5. Pre-litigation transfer — not present. The family's first appearance in litigation is Jazz's 2021 filings (D. Del. 1:21-cv-00691 filed 2021-05-13; 1:21-cv-01594 filed 2021-11-10). The only assignments nearby are (a) the 2017/2019 employer assignment, ~2 years before suit and unrelated to it, and (b) the 2023-08-01 collateral pledge, which post-dates the first suit by ~20 months. Nothing was moved within six months ahead of an assertion.

6. Bankruptcy fire-sale — not present. No Chapter 7/11, no receivership, no §363 sale appears in the record for Flamel Technologies SA, Flamel Ireland Limited, or Avadel Pharmaceuticals plc. Flamel's transition to Avadel was a name change/reorganization of a solvent NASDAQ-listed company, and Avadel remains listed and revenue-generating.

7. Privateering — not present. The inverse of privateering is visible here: the operating company (Avadel) kept the patents in-house and used them to protect its own product, Lumryz. There is no NPE asserting on Flamel/Avadel's behalf; Avadel's related offensive case against Jazz (D. Del., filed 2022-04-14) is a trade-secret and contract action, not an NPE-style patent assertion.

8. Defensive aggregator (anti-NPE) — not present. The chain terminates at Flamel Ireland Ltd. / Avadel CNS Pharmaceuticals, LLC after the 2026-05-21 release (reel 074729/0205). RPX, AST, LOT Network, Unified Patents and OIN appear nowhere in the chain.

Verdict

Operating-company assertion.

Legal title has never left the Flamel/Avadel operating group: the only title assignment is the routine employee→employer recordation at reel 050132/0351 (executed 2017-07-24, recorded 2019-08-22), and the only other recorded instruments are the RTW Investments Patent Collateral Agreement at reel 064463/0907 (2023-08-01) and its Release of Security Interest at reel 074729/0205 (2026-05-21) — a financing pledge and its discharge, not a disposition. The assignee is a solvent operating subsidiary of a NASDAQ-listed specialty pharma company whose product, LUMRYZ, embodies the claims and was approved 2023-05-01, and the family is being actively contested in D. Del. (1:21-cv-00691 and 1:21-cv-01594) rather than monetized by a shell. Caveats: (i) this patent's owner is a defendant in that litigation, so no offensive assertion of the '866 patent itself by its owner is evidenced; and (ii) the recording-correspondent field, the key input for Signal 3, could not be verified and should be pulled directly from Assignment Center.

I'll research this patent carefully. Let me start with searches on the patent itself and its citation records.

Let me dig deeper into the specific citation records for this patent.

Prior-Art Analysis — U.S. Patent No. 10,736,866

1. Confirmation of the record (interpreted literally, no auto-correction)

The patent is directed to a GHB (sodium oxybate) formulation having an immediate-release (IR) portion and a modified-release (MR) portion, defined by (a) in vitro dissolution profiles in 0.1 N HCl and in pH 6.8 phosphate buffer, and (b) in vivo PK parameters (mean AUCinf, C₈ₕ, relative bioavailability vs. twice-nightly Xyrem®).

2. Important sourcing note before the citations

I want to be explicit about what I could and could not verify, because the request turns on the "References Cited" front-page list of US 10,736,866:

• The authoritative full text of US 10,736,866 was supplied to me. Its front-page bibliographic citation list (the "References Cited / Cited By" table) is not reproduced in that text, and my attempts to pull the raw examiner-cited list from USPTO Patent Public Search / PatentCenter did not return the machine-readable citation table before I exhausted my search budget.
• What I can ground with confidence are the prior-art references expressly named and relied upon inside the specification body of US 10,736,866 (and its sibling continuations), plus references confirmed in the parallel D. Del. litigation (Jazz Pharmaceuticals v. Avadel CNS, No. 1:21-cv-00691-GBW) and the published family.
• Where a reference's identity as a § 102 art citation rather than a background citation is uncertain, I say so explicitly rather than fabricate a citation class.

3. The prior art identified

A. Liang et al. — U.S. Patent No. 8,193,211 (and its publication US 2006/0210630 A1)

• Full citation: U.S. Pat. No. 8,193,211 B2 (also published as US 2006/0210630 A1, "Gamma-hydroxybutyrate compositions," Liang et al.; commonly attributed to Supernus Pharmaceuticals).
• Dates: U.S. 2006/0210630 A1 published 21 September 2006; U.S. Pat. No. 8,193,211 granted 5 June 2012. (Both pre-date the 2016-07-22 priority date, so both are § 102(b)/§ 102(a)(1) art.)
• Description: Controlled-release GHB compositions comprising an immediate-release component plus one or more pH-sensitive delayed/controlled-release components, optionally pre-mixed, presented as pellets/beads or a sachet. It reports the canine PK data (Table 3) showing the IR component had the highest relative bioavailability (AUClast = 601 µg·h/mL) and that enteric/delayed coating depressed BA.
• How it is used in the '866 record: This is the single most relevant prior-art reference. It is cited inside the '866 specification itself as the comparator whose FIG. 3 dissolution profile is overlaid against the invention's MR-microparticle profile (FIG. 4). The '866 applicant expressly disparages it: "any of the envisioned combinations of immediate release (IR) components and delayed release (DR) components as described in col. 5 lines 3 to 28 of U.S. Pat. No. 8,193,211 will not give a relative bioavailability greater than 78%," and reports that the Liang-type comparative Example 7 gave only ~67% RBA.
• Anticipation (§ 102) relevance — claim mapping: Liang discloses the architectural claim elements — "immediate release particles comprising gamma-hydroxybutyrate" + "modified release particles comprising gamma-hydroxybutyrate," in a unit dose/sachet, for narcolepsy (the elements recited in the preamble/structural claims of the '866 family and of Jazz's later '782 patent). It does not disclose, on the face of the specification's own analysis, the recited quantitative dissolution limits (e.g., ≥80 % release at 3 h in pH 6.8 buffer under the specified USP 38 <711> Apparatus 2 conditions) or the recited PK limits (mean AUCinf >340 hr·µg/mL at a 7.5 g dose; RBA >80 %). Conclusion: Liang is strong § 102 art against a structural independent claim (IR+MR GHB particles), but the '866 specification is written to avoid anticipation by Liang on the dissolution/PK claims. It is best characterized as the primary § 102/§ 103 reference, not a clean anticipatory reference for the issued dissolution- and PK-limited claims.

B. Allphin et al. — U.S. Patent Publication No. 2012/0076865 A1 ("Allphin 2012")

• Full citation: US 2012/0076865 A1, Allphin et al. (Gamma-hydroxybutyrate controlled-release formulation).
• Dates: Published 29 March 2012 — well before the 2016 priority date; § 102(a)(1)/102(b) art.
• Description: Controlled-release sodium oxybate dosage forms with a functional (ethylcellulose/pore-former) coating on an IR core; an "integrated dosage form" containing an immediate-release component plus a controlled-release component. It reports USP 2 dissolution and PK (beagle) data.
• How it is used in the '866 record: The '866 specification overlays its FIG. 2 (deionized-water) release profile against the invention's finished-composition profile (FIG. 6 / FIG. 19) and states the profiles "are different" because the prior art lacks a lag phase after IR dissolution. Note also that Allphin 2012 is incorporated by reference "in its entirety" into the related Jazz '079/'782 patents, and Avadel's expert testimony (D. Del.) refers to Allphin as "USP 2012/0076865."
• Anticipation (§ 102) relevance — claim mapping: Allphin 2012 discloses an IR+CR GHB product and controlled-release dissolution testing, and it discloses plasma concentrations in the range recited in dependent PK claims (the litigation record contains arguments that a plasma level "above 10 µg/mL" limitation is disclosed by Allphin 2012). It is therefore potential § 102 art against claims reciting an IR+CR oxybate dosage form and against blood-concentration/PK-range claims, but not against claims requiring the specific 0.1 N HCl and pH 6.8 dissolution windows of the '866 patent, which the applicant distinguished on the lag-phase difference.

C. Legrand et al. — U.S. Patent No. 8,101,209 B2

• Full citation: U.S. Pat. No. 8,101,209 B2, Legrand, Castan, Meyrueix & Soula, "Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles," assigned to Flamel Technologies (application US 10/826,690; also published WO 2005/099671 A3).
• Dates: Filed 19 April 2004; WO publication 27 October 2005; U.S. grant 24 January 2012. Well before the priority date.
• Description: Microcapsules (200–600 µm) comprising an AP core coated with a film (≤40 wt %) of a hydrophilic polymer A (Eudragit® L, i.e., methacrylic-acid copolymer) and a hydrophobic compound B (vegetable wax, m.p. 40–90 °C), B/A = 0.2–1.5, providing a dual "time-dependent" + "pH-dependent" release trigger.
• How it is used in the '866 record: Cited in the '866 background as prior art for formulation technique — "Legrand provides a system ensuring that the active ingredient is released with certainty… by means of a dual mechanism of 'time-dependent' and 'pH-dependent' release. Legrand did not describe any dosage forms for delivering sodium oxybate or other forms of gamma-hydroxybutyrate." (Legrand is also the same assignee family, Flamel.)
• Anticipation (§ 102) relevance — claim mapping: Legrand is a coating-technology reference, not a GHB reference. It discloses the coating chemistry recited in the '866 dependent claims (methacrylic-acid copolymer + hydrophobic compound m.p. ≥40 °C), but it does not disclose gamma-hydroxybutyrate as the active principle and cannot anticipate any claim reciting GHB. Its § 102 value is limited to claims that recite only the microparticulate coating architecture without a GHB limitation (unlikely in an issued claim of this patent). Properly it is a § 103 (obviousness) reference, not an anticipation reference.

D. WO 1996/040105 A1 (foreign reference)

• Full citation: WO 1996/040105 A1 (published 19 December 1996).
• Status: Appears in the "Foreign References" list of the related '866-family continuation (US 2023/0172892 A1), per FreePatentsOnline. I could not independently confirm that this specific document appears on the front-page "References Cited" list of US 10,736,866 itself.
• Description/dates: Pre-1996 priority art in the oral modified-release/oxybate space; publication date is decades before the priority date, so it is § 102(b)/102(a)(1) art if relied upon.
• Anticipation (§ 102) relevance: Cannot be responsibly mapped to a claim without the document itself and the claim text; flag as unconfirmed / needs verification rather than assert an anticipation position.

E. Supernus / "Liang 2006" as cited in the parallel litigation

The D. Del. record confirms the same reference set is the operative prior art in the Jazz v. Avadel dispute, naming Liang 2006 (US 2006/0210630), Allphin 2012 (US 2012/0076865), Lebon 2013, and the Xyrem® label. In that litigation the '866 patent is used as anticipatory art against Jazz's own later patent (Jazz's '782 patent) rather than the reverse — i.e., Avadel contends the '866 patent's specification discloses the subject matter Jazz later claimed.

4. Overall § 102 assessment

1. No clean anticipatory reference exists in the identified set for the issued dissolution-and-PK-limited claims of US 10,736,866. The closest reference, Liang (US 8,193,211 / US 2006/0210630), discloses the IR+MR GHB architecture but, on the '866 specification's own data, yields RBA ≤78 % and a materially different dissolution profile — so it anticipates, at most, a broad structural claim, not the quantitative dissolution/PK claims.
2. The most likely § 102 targets of the identified art are structural/general claims (an IR portion plus an MR portion of GHB, in unit dose or sachet form) — Liang and Allphin 2012 both disclose these elements.
3. Legrand (US 8,101,209) is not anticipation art for this patent (no GHB disclosure) and functions only as § 103 coating-technology art.
4. To provide a definitive § 102 mapping you need (i) the exact issued claim text of US 10,736,866 and (ii) the certified front-page "References Cited" table from USPTO PatentCenter / the IFW. I was unable to retrieve either the complete examiner-cited list or the verbatim claim set within the available search steps, and I will not invent claim numbers or citation classes.

5. What I would still verify (honest unknowns)

• The complete examiner-cited U.S. and foreign patent list on the '866 front page (I confirmed only the references relied on in the specification body and in the related litigation).
• The verbatim claims of US 10,736,866 (the specification sets out "principal embodiments," which are strong but not identical to the issued claims).
• Whether WO 1996/040105 A1 and the other "Foreign References" belong to the '866 record or to a continuation.
• Non-patent literature cited (the PubChem patent record shows a long NPL list — e.g., Johnson et al. 2013; Liechti et al. 2016; Maitre et al. 2016; the Xyrem® NDA 21-196 review) which would also be § 102(b)/§ 103 art and which I did not enumerate.

If you can supply the USPTO "References Cited" table or the issued claim text, I can convert the above into a reference-by-reference, element-by-element § 102 anticipation chart.

I'll research the prior art references identified in this patent before building the obviousness analysis.

Let me gather details on the specific prior-art references and the claims of the '866 patent.

Let me obtain the actual claims of the '866 patent and its cited prior art.

Obviousness Analysis — U.S. Patent No. 10,736,866 B2

Important scope note (read first): The page content I was given contains the specification/summary of the invention and the "Prior art keywords" field, but not the issued claim text nor the full "Citations" list of the patent. Accordingly, the claim characterization below is drawn from (i) the "principal embodiments" recited on the page (which the specification expressly states are the basis of the claims: "the invention can be described in terms of principal embodiments, which in turn can be recombined…") and (ii) the elements of the '866 claims quoted in the co-pending Avadel/Jazz litigation record. The specific claim numbers and exact claim language should be verified against the printed claim set before being relied on. Everything else below (references, dates, disclosures) is grounded in the page and in the search results cited.

1. The reference point: what the '866 patent claims

• Patent: US 10,736,866 B2, "Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics"; App. No. 16/281,235, filed 2019-02-21; priority 2016-07-22; granted 2020-08-11; assignee Flamel Ireland Ltd; inventors Mégret, Guillard, Dubuisson.
• The claims (as reflected in the principal embodiments and as quoted in litigation) are directed to a modified release formulation of GHB comprising an immediate release (IR) portion and a modified release (MR) portion, and are defined by one or more of:
  • Structural limitations: MR portion = coated GHB particles; coating = a polymer bearing free carboxylic groups (methacrylic acid copolymer, pH trigger ~5.5–6.97) plus a hydrophobic compound with m.p. ≥ 40 °C; hydrophobic:polymer weight ratio 0.4–4; coating = 10–50% of particle weight; IR/MR GHB ratio 10/90–65/35 (pref. 40/60–60/40); a suspending/viscosifying agent and an acidifying agent separate from the particles.
  • In vitro dissolution limitations: e.g., ≥80% released at 3 h in 0.05M monobasic potassium phosphate pH 6.8; 10–65% (pref. 40–60%) released at 1 h and 3 h in 0.1N HCl; >60% at 10 h in 0.1N HCl; MR portion <20% at 1 h in 0.1N HCl and >80% at 3 h in pH 6.8.
  • In vivo PK limitations: 7.5 g dose → mean AUCinf >340 hr·µg/mL; mean C8h 50–130% of an equal dose of IR liquid sodium oxybate given t0/t4h; RBA >80% at 4.5/6/7.5/9 g; mean Cmax >65–90 µg/mL; median Tmax 1.25–3.25 h; AUC8h/AUCinf >0.80.
  • Method/unit-dose claims: single nightly dose from a sachet, mixed with water, ~2 h after a standardized evening meal.

2. Level of ordinary skill

A POSA here would be a formulation scientist (Ph.D. or M.S. plus several years) with experience in oral modified-release multiparticulates, enteric/functional coatings, and clinical PK. The '866 specification itself assumes such skill (e.g., it treats routine dissolution testing under USP 38 <711> as conventional).

3. The prior art on this page

Two structural facts matter: (a) the '866 specification itself reproduces U.S. 8,193,211 FIG. 3 as "Comparative" Example 7, conceding it is the closest art; and (b) Legrand and Lebon are the same corporate family's own earlier work — a § 103 analysis does not treat "applicant's own prior art" differently.

4. Combination 1 (primary): Liang or Lebon, in view of Allphin 2012, in view of Legrand

Why the references combine:

1. Same field, same problem, same drug. Liang, Lebon, Allphin and the '866 patent all address oral GHB for narcolepsy and all expressly diagnose the same deficiency — GHB's short half-life and rapid elimination force a second middle-of-the-night dose. Motivation to combine is therefore not speculative; it is supplied by the references themselves (Lebon: "reduce…the number of times it is taken per day"; Allphin: a controlled-release GHB unit dose).
2. Liang/Lebon supply the architecture. An IR portion + an enteric/delayed MR portion of GHB, as pre-mixed multiparticulates, is disclosed in haec verba by Liang; Lebon supplies the same core/shell multiparticulate in a sachet. The IR/MR ratios (10/90–65/35, pref. ~50/50) are a design choice routinely optimized to shape a plasma curve — indeed, the dissolution limitations "40–60% at 1 h and 3 h" are little more than the arithmetic consequence of a ~50/50 IR:MR split in which the IR dissolves in acid and the MR does not.
3. Allphin supplies the "both IR and CR in one unit dose" and the PK endpoint. Allphin expressly discloses a single unit dosage form containing controlled-release and immediate-release GHB, and reports plasma concentration/time curves. That is the whole point of the claimed invention.
4. Legrand supplies the coating that achieves the recited dissolution behavior. The '866 coating (methacrylic acid copolymer with a pH trigger + a hydrophobic, m.p. ≥ 40 °C compound) is the Flamel time-plus-pH dual-trigger system of Legrand, applied to the GHB multiparticulate of Liang/Lebon/Allphin. Legrand's stated purpose — ensuring release with certainty by combining a time-dependent and pH-dependent mechanism — is precisely the property needed to convert a slow, incomplete enteric release (Liang's 22–53% RBA) into a delayed burst at intestinal pH, and thus to raise bioavailability. A POSA would adopt it for that reason.
5. The acidifying agent and the viscosifying/suspending agent are disclosed for GHB in Liang (malic/citric/tartaric acids; suspending/thickening/gelling agents). Placing a viscosifying agent and acid outside the IR/MR particles (to keep the suspension pourable and to hold gastric pH low while the MR coating stays intact) is the kind of arrangement the references render obvious; the specification supplies no non-obviousness for merely relocating a known excipient.

Claim-by-claim result: The structural claims (IR + MR portions; coating chemistry; coating weight 10–50%; IR/MR ratio; separate acid/viscosifier) read directly onto the combination. The dissolution claims read onto a Legrand-coated Liang/Lebon pellet (in acid, only the IR fraction dissolves → 10–65% at 1 h and 3 h; at pH 6.8 the coating triggers → ≥80% at 3 h). The PK claims are addressed in § 6 below.

5. Combination 2 (alternative): Liang in view of Allphin 2012

This is the combination actually pleaded in the related Jazz v. Avadel record: "a POSA would further have been motivated to combine Liang 2006 with Allphin 2012 because they are both specifically directed to a formulation of sodium oxybate useful for the treatment of narcolepsy and trying to formulate a once-nightly formulation" (Jazz's expert, Joint Supplemental Claim Construction Appendix). Liang supplies IR+DR GHB multiparticulates; Allphin supplies the single unit dose combining IR and CR GHB and the plasma-concentration data against which the claimed AUCinf/C8h/Tmax values were set. Combined, they render obvious the two-portion GHB formulation and its PK range; the numerical dissolution/PK endpoints are the result-effective variables a POSA would optimize by routine testing.

6. Why the numerical limitations do not rescue the claims

• In re Kao, 639 F.3d 1057 (Fed. Cir. 2011) is directly on point: claims to a known drug reciting specific PK parameters (AUC, Cmax, Tmax) were obvious where the art made the desired PK profile known and the parameters were obtainable by routine formulation. Here the "desired" profile is defined by the Xyrem® label — 50–130% of the reference C8h, >80% RBA, AUCinf >340 hr·µg/mL — which is exactly what the art set out to reproduce. Under KSR Int'l v. Teleflex, 550 U.S. 398 (2007), where a finite number of identified, predictable solutions exist, a POSA's "obvious to try" defeats patentability.
• Obvious ranges: once a ~50/50 IR:MR split and an enteric coating are selected, the recited 1 h/3 h/10 h dissolution windows follow arithmetically; the "10–65%" window is broad and overlaps the dissolution behavior disclosed in U.S. 8,193,211. Broad prior-art ranges encompass narrower claimed subranges. In re Peterson; Merck & Co. v. Biocraft Labs. Overlapping ranges are prima facie obvious. In re Woodruff.
• Routine optimization of recognized parameters: In re Boesch; In re Aller; KSR ("a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions").
• In re Huai-Hung Kao / In re Best logic: where the prior art teaches a formulation that apparently possesses the same properties, the burden shifts to applicant to show the claimed parameters are not inherently present.
• Materials choice: methacrylic acid copolymers (Eudragit L100-55/S100), hydrogenated vegetable oil, microcrystalline cellulose spheres, povidone, xanthan gum, HEC, carrageenan, malic acid, magnesium stearate — every one of these excipients is conventional, and the specification claims no unexpected property for any individual choice.

7. The patent's likely rebuttals — and the counterarguments

8. Conclusion

A practitioner could establish a prima facie case of obviousness under § 103 as follows:

1. Primary: Liang (U.S. 2006/0210630 A1 / U.S. 8,193,211) + Allphin 2012 (U.S. 2012/0076865 A1) + Legrand (U.S. 8,101,209) — Liang/Lebon for the IR+MR GHB multiparticulate architecture and the acid/viscosifier excipients, Allphin for the single-unit-dose IR+CR GHB concept and the PK target, and Legrand for the methacrylic-acid-copolymer/hydrophobic coating with a time-plus-pH dual trigger.
2. Alternative: Lebon 2013 (U.S. 2011/0293729 / U.S. 8,529,954) + Allphin 2012 ± Legrand — same result using Lebon's core/shell sachet granulate.
3. Add the Xyrem® label / NDA 21-196 review to establish the desired PK profile as a known design target for the AUCinf/C8h/RBA/Tmax limitations.

The structural claims (IR+MR portions, coating chemistry and weight, IR/MR ratio, separate acid and viscosifying agent) are the most vulnerable. The dissolution and PK parameter claims are vulnerable under In re Kao and KSR as result-effective variables optimized by routine experimentation, since every element is disclosed and the claimed numerical windows either overlap the prior art or follow arithmetically from an obvious ~50/50 IR:MR design. The principal obstacle is not the prior-art disclosures but the patentee's secondary-consideration evidence (long-felt need, commercial success, and recorded skepticism in the art), which a challenger must rebut for lack of nexus.

Sources: US 10,736,866 (Google Patents); publication US 2019/0183836 A1; Avadel's invalidity contentions (Liang 2006, Lebon 2013); Joint Supplemental Claim Construction Appendix (Liang 2006 + Allphin 2012 motivation); Jazz v. Avadel invalidity report (ded. 75471.357); Jazz concise statement re: Liang and the '079/'866 patents; Lebon US 2011/0293729 / US 8,529,954; Jazz trial transcript (skepticism evidence).