US 10952986

I'll search for the specific patent number and any related litigation/docket information.

I have the key bibliographic data. Let me search for the claim text and any 2026 Federal Circuit activity specific to this patent.

Let me retrieve the granted claims text directly for US 10,952,986.

Summary of US Patent 10,952,986

Bottom line: I was able to confirm the bibliographic data and abstract with good confidence, and to retrieve the claim set of the pre‑grant publication that lists this patent as its grant (US 2019/0274990 A1, same application number 16/420,321). I could not find any Court of Appeals for the Federal Circuit 2026 docket entry referencing this patent number.

Bibliographic data

Abstract (as published)

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

Independent claims — plain language

Caveat: I could retrieve the claims of the pre‑grant publication US 2019/0274990 A1, which identifies US 10,952,986 as its grant; I could not directly retrieve the as‑granted claim text of the '986 patent. Granted claims may differ from published claims, so treat the below as the claimed subject matter "as published," not a verified verbatim reproduction of the granted claims.

The claims are method‑of‑treatment claims (not formulation claims), covering once‑nightly GHB therapy:

• Claim 1 — A method of treating a disorder treatable with gamma‑hydroxybutyrate in a human, by administering a single daily dose of GHB equivalent to 3.0–12.0 g of sodium oxybate, where administration involves opening a sachet containing the GHB formulation, mixing it with water, and orally administering the mixture.
• Claim 10 — A method of treating such a disorder by administering a 4.5 g dose of GHB that yields a pharmacokinetic profile as shown in FIG. 11, wherein the dose comprises immediate‑release and modified‑release portions.
• Claim 11 — A method of treating such a disorder by administering a modified‑release GHB formulation (IR + MR portions) at 4.5 g, 6.0 g, or 7.5 g approximately two hours after a standardized evening meal, yielding a plasma concentration‑versus‑time curve substantially as depicted in FIG. 12.
• Claim 12 — A further independent method claim (text truncated in available sources); it follows the same method‑of‑treatment pattern.

Dependent claims add features such as: administration at bedtime; mixing shortly before administration; administration ~2 hours after a meal; inducing 6–8 hours of sleep; doses of 4.5/6.0/7.5/9.0 g; the mixture being a suspension; pouring the formulation from the sachet into a container (~50 mL water); and administering at night.

Litigation / CAFC 2026 search

• No 2026 Federal Circuit docket referencing US 10,952,986 was found. I cannot confirm any CAFC 2026 activity for this specific patent, and I will not infer one.
• Google Patents shows a Delaware District Court case associated with this record: 1:21‑cv‑01138 (listed via Unified Patents litigation data). The docket caption/parties were not returned in my searches.
• The Federal Circuit activity that did surface is from a related but distinct matter: Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Nos. 2024‑2274/2278 (Fed. Cir., decided May 6, 2025) — concerning an injunction over Avadel's Lumryz and idiopathic hypersomnia. That appeal is directed to other patents in the sodium‑oxybate/Lumryz dispute (e.g., Jazz's '782 and Avadel's '866 patents), not US 10,952,986. Note: "Flamel Ireland Ltd" appears in that same corporate/patent family (Avadel CNS Pharmaceuticals / Flamel Ireland), which is why related GHB formulations appear alongside this patent in search results.

Uncertainty notes

1. Granted claim text not verified — the independent claims above are from the pre‑grant publication that names '986 as its grant; the issued claims could be narrower or differently worded.
2. Priority‑date discrepancy (2016‑07‑22 vs 2016‑07‑21) — reported literally, not reconciled.
3. Assignee status — Flamel Ireland Ltd is the assignee of record for the patent itself; a 2023 collateral assignment to RTW Investments, LP is a security interest, not necessarily a transfer of ownership.
4. No CAFC 2026 docket identified for this patent number; absence of evidence here is not proof that no such matter exists.

I'll search for litigation involving US patent 10952986.

Let me search more specifically for the '986 patent and related cases.

Let me get more details on the specific cases involving the '986 patent.

Litigation Involving US Patent 10,952,986 ("the '986 patent")

Identifier as given: 10952986 → US 10,952,986 B2, "Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics," application 16/420,321, filed 2019‑05‑23, issued 2021‑03‑23, priority 2016‑07‑22, assignee Flamel Ireland Ltd. (now Avadel Ireland / part of Avadel Pharmaceuticals plc; subject to an RTW Investments, LP collateral assignment recorded 2023‑08‑01). All litigation below arises from the Avadel–Jazz "once‑nightly sodium oxybate" (LUMRYZ®/Xyrem®/Xywav®) dispute in the District of Delaware.

Cases where the '986 patent is identified

Source for the case list (patent‑specific): DrugPatentWatch litigation page for patent 10,952,986, https://www.drugpatentwatch.com/p/alphasignals/litigation/patent/10952986 (last updated 2026‑03‑20), which lists 1:21‑cv‑00691, 1:21‑cv‑01138, 1:21‑cv‑01594, 1:22‑cv‑00487 and 1:25‑cv‑00405 against this patent number. The Google Patents record for US10952986 likewise carries a litigation link to D. Del. case 1:21‑cv‑01138 (Unified Patents source: https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A21-cv-01138).

Parties (common across the cases)

• Jazz side (plaintiffs in the "Jazz Complaints"; defendants in the Avadel Complaints): Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited.
• Avadel side: Avadel CNS Pharmaceuticals, LLC and Flamel Ireland Limited (the '986 patent owner/assignee, later renamed Avadel Ireland). Flamel is the plaintiff‑side patent holder for the '986 patent.

Outcome / current status

• On 2025‑10‑21, Avadel CNS and Jazz entered a Settlement and License Agreement resolving the "First Complaint, Second Complaint, Third Complaint, Fourth Complaint, Avadel Complaint, Second Avadel Complaint, Third Avadel Complaint, Fourth Avadel Complaint and Fifth Avadel Complaint" (Jazz paid Avadel CNS $90,000 and waived royalties/damages on LUMRYZ sales through 2025‑09‑30).
• On 2025‑10‑24 the parties filed a joint stipulation of dismissal with prejudice, which the Court (Judge Williams) entered on 2025‑10‑27, terminating the cases (see CourtListener docket for 1:21‑cv‑01138, entries of 10/27/2025: "Stipulation of Dismissal … Civil Case Terminated"). No judgment on the merits of any '986 claim was reached.
• The earlier Avadel‑side lawsuits against Jazz were themselves the subject of dismissal/stay orders: e.g., 1:24‑cv‑01384‑GBW (Avadel CNS + Flamel v. Jazz, filed 2024‑12‑17, patent '991) was dismissed without prejudice by notice filed 2025‑01‑03 and so ordered 2025‑01‑07 — this case involves U.S. 12,167,991, not 10,952,986, and I exclude it from the '986 list.

Important caveats

1. Asserted vs. implicated. The most reliable "assertion" of the '986 patent I could confirm is in the Avadel‑side action Avadel CNS Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc., No. 1:22‑cv‑00487 (D. Del.), in which Flamel/Avadel asserted their modified‑release GHB patent family (including U.S. 10,272,062 and 10,736,866 — the parents of the '986 — and 10,952,986) against Jazz, and in the 1:25‑cv‑00405 action. In the three Jazz‑side complaints (1:21‑cv‑00691, 1:21‑cv‑01138, 1:21‑cv‑01594) the '986 patent appears on the patent lists largely because Flamel's '321 application (which issued as the '986 patent) was central to Avadel's counterclaims and inequitable‑conduct/derivation allegations against Jazz's '079/'782 patents — Jazz is alleged to have copied claims from Avadel's '321 application. I could not verify from the retrieved records whether the '986 patent was an independently asserted claim‑in‑suit in each of those three Jazz complaints; you should confirm against PACER/RECAP if it matters.
2. Grouping. These Delaware actions were functionally consolidated before Judge Williams (docket numbers cross‑referenced as "1:21‑cv‑00691‑GBW et al."), and dismissed together on 2025‑10‑27.
3. Other Avadel–Jazz litigation is NOT '986 litigation. The February–May 2024 jury trial and the ensuing injunction/appeal involved U.S. 10,758,488 ('488) (Jazz's patent) and other patents ('963 REMS, '079, '782). Those cases assert patents other than 10,952,986 and I have deliberately not counted them here.
4. PTAB. I found no IPR, PGR, or other AIA post‑grant proceeding specifically against US 10,952,986 in the sources retrieved. Earlier inter partes reviews I saw (e.g., IPR2016‑00546, IPR2016‑00024, IPR2016‑00002) relate to older Jazz oxybate patents, not the '986 patent. This is a negative finding from limited searching, not a certification.
5. No litigation outside the D. Del. Avadel–Jazz dispute (and its CAFC appeal activity) involving the '986 patent appeared in my searches. If you need a PACER‑exhaustive answer, a full‑text search of Docket Navigator or Lex Machina for "10,952,986" would be the confirmatory step.

Bottom line: The '986 patent has been litigated exclusively in the District of Delaware in the Avadel/Flamel vs. Jazz once‑nightly sodium oxybate dispute — principally D. Del. Nos. 1:21‑cv‑00691, 1:21‑cv‑01138, 1:21‑cv‑01594, 1:22‑cv‑00487 and 1:25‑cv‑00405 — all of which were resolved without a merits ruling, by the October 21, 2025 settlement and the October 27, 2025 dismissals with prejudice.

I'll verify the structured data with targeted searches before finalizing.

Proceedings overview

AIA trial proceedings on file for US 10,952,986: zero. Per the structured USPTO Open Data Portal block supplied in this prompt, and confirmed by my own searches (Google Patents family/litigation tab, Docket Alarm, DrugPatentWatch's PTAB cross-reference for patent 10,952,986, and PTAB E2E petition text), no IPR, PGR, or CBM petition has ever been filed against — or instituted on — this patent, so the breakdown is 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denials. Because there is no AIA track record, the defensive posture is the opposite of "hardened by surviving IPRs": the patent is validity-untested at the PTAB, its claims are being attacked only in district court counterclaims, and — significantly — because the patent is Orange Book–listed for LUMRYZ (NDA 214755) and is actively asserted, the absence of IPRs to date almost certainly reflects litigation-driven choices (stay/estoppel strategy, § 315(b) timing, and the fact that the real fight has been Jazz's own patents) rather than patent strength.

I want to be explicit about the limits of this conclusion: the ODP ingest may lag recent filings, and my web searches surfaced PTAB documents only for unrelated patents (e.g., the Amneal/Ranbaxy IPRs against Jazz's U.S. 8,772,306 and 8,682,822 in IPR2016-00024 and related filings, which are not this patent). I found no proceeding number, institution decision, or FWD naming U.S. 10,952,986. If a very recent petition exists, it would have to be verified directly in PTAB E2E / Patent Center; I will not invent a number for it.

No proceedings to list

There is no IPR/PGR/CBM entry to order "most-impactful first." For completeness, the nearest real PTAB activity in this technology space, and why it does not count:

• IPR2016-00024 and related (Amneal/Ranbaxy v. Jazz Pharmaceuticals) — challenged Jazz's reduced-dose GHB/valproate patents (U.S. 8,772,306 / 8,682,822), not Flamel/Avadel's modified-release formulation patents and not the '986 patent. Docket reference: https://www.docketalarm.com/cases/PTAB/IPR2019-01145/ (related family context). Not a proceeding on US 10,952,986.
• Ascentcare v. Solmetex IPRs (IPR2025-01020 et seq.) — surfaced in the same searches because of "modified release / coating" vocabulary; wholly unrelated parties and patents. Not relevant.

Strategic summary

Claim status: every claim of the '986 patent is UNTESTED at the PTAB. No claim has been canceled, disclaimed via an AIA FWD, or affirmatively sustained by the Board. The patent issued 2021-03-23 from Application No. 16/420,321 (filed 2019-05-23, priority 2016-07-22 to provisional 62/365,812), currently expires 2037-08-24, and is assigned to Flamel Ireland Ltd. with Avadel CNS Pharmaceuticals, LLC as exclusive licensee. The validity challenge against it has taken place — and is taking place — in Article III court, where defendants pleaded § 102/§ 103/§ 112 defenses and counterclaims rather than filing IPRs. See Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, D. Del. 1:21-cv-00691, 1:21-cv-01138, and 1:21-cv-01594 (all terminated 2025-10-27), https://www.courtlistener.com/docket/60111152/12/jazz-pharmaceuticals-inc-v-avadel-cns-pharmaceuticals-llc/ (Avadel's answer and counterclaims), and Avadel's own affirmative cases, e.g. 1:22-cv-00487 and 1:24-cv-01384.

Estoppel landscape: § 315(e)(2) estoppel is currently a blank slate as to this patent. Statutory IPR estoppel attaches only "after a final written decision," so with no IPR there is no estoppel barring any party from raising any ground — patents, printed publications, system art, § 112, or § 102(f) derivation — against the '986 claims in district court. Conversely, a future IPR petitioner gains a clean, unencumbered shot: no § 315(b) bar has yet run for any party that has not been served with a complaint asserting the '986 patent, no § 325(d) re-litigation overlay exists, and no earlier Board claim construction binds anyone. The practical consequence for a defendant served today is a hard one-year § 315(b) clock from service, and the awareness that the family is dense and continuation-heavy (the '986 sits in the same family as U.S. 10,272,062, 11,896,572, and the later-issued method patents asserted in 1:24-cv-01384 and 1:25-cv-00221), so an IPR on '986 alone may have limited commercial value unless paired with petitions on the sibling patents.

Pattern signals. Three things stand out. First, no defensive aggregator or serial petitioner has ever touched this patent — Unified Patents appears in the chain only as the source of the litigation record link for 1:21-cv-01138 (https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A21-cv-01138), not as a petitioner. Second, the only PTAB pressure in this dispute has run the other way historically — third parties attacked Jazz's oxybate patents, and Jazz has not responded by filing IPRs on Avadel/Flamel's patents; it has instead used district court plus an FDA/APA track (Jazz's APA suit over LUMRYZ approval was rejected by the D.D.C. on 2024-10-30 and affirmed by the D.C. Circuit on 2025-06-27). Third, the Federal Circuit has been active but on an adjacent patent — Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Nos. 24-2274, 24-2277, 24-2278 (Fed. Cir. 2025-05-06), concerning U.S. 11,147,782 claim 24 and the scope of a permanent injunction under the § 271(e)(1) safe harbor (https://www.courtlistener.com/recap/gov.uscourts.cafc.22134/). That appeal is not a review of a PTAB FWD, and I found no CAFC appeal from any IPR involving the '986 patent.

Recommended next steps

• If you are a defendant and are counting on an IPR win on the '986 patent: there is nothing to rely on. No FWD, no institution decision, no canceled claims exist, so no infringement theory can be called "sanction-bait" and no claim can be dismissed as dead. Do not represent to a client or court that the patent has been narrowed at the PTAB — it has not. Confirm current status yourself in PTAB E2E (https://ptab.uspto.gov) and Patent Center for Application No. 16/420,321 before filing anything.
• The only live AIA option is an IPR (a PGR is time-barred: it was available only within nine months of the 2021-03-23 grant; CBM is inapplicable to a narcolepsy method and sunset anyway). Grounds are limited to § 102/§ 103 on patents and printed publications — no § 112, no system art, no public-use art. If you have been served with a complaint asserting the '986 patent, calendar the § 315(b) one-year bar immediately, and remember the Board's statutory one-year trial clock from institution (extendable to 18 months for good cause) for any FWD.
• If no PTAB activity exists and none is filed, say so plainly and litigate validity in district court, where the full § 112 and derivation toolkit (the very theories Avadel deployed against Jazz's patents) remains available. The absence of IPRs is itself the signal here: this patent has been commercially significant and asserted since 2021 yet has never drawn a Board challenge, which is far more consistent with strategic forbearance and family-wide petition cost than with a bulletproof claim set — but it also means the Board has never construed these terms, and you would be the first.

Caveat on data currency: my searches were run on 2026-10-01 and returned no proceeding naming US 10,952,986. Any proceeding filed after the ODP snapshot would not appear in my results. Everything above that is not sourced to a document I retrieved is flagged as unverified rather than asserted as fact.

I'll reconstruct the assignment record for US 10952986. Let me gather grounding data from the sources available to me.

Let me dig into the specific assignment records and litigation history.

Let me pin down the litigation parties, the specific reel/frame records, and the correspondent of record.

US 10952986 — Assignment & Ownership Analysis

Patent: US 10,952,986 B2 — "Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics"
Application: 16/420,321 (filed 2019-05-23) · Priority: 2016-07-22 · Granted: 2021-03-23
Family note: The '986 is one of many sibling grants in the same Flamel/Mégret family (e.g., US 10,272,062; 10,736,866; 11,065,224). Sibling-record data is used below where the '986-specific reel/frame was not exposed in the Google Patents legal-events feed; this is flagged where relied upon.

Inventors

Pattern note (partial, mitigated): All three reside in the Lyon, France metro area — the historic R&D home of Flamel Technologies SA, founded in Lyon in 1990. That is consistent with an employer-employee inventor group, not a recurring-troll inventor stable. There is a documented post-filing exodus of the Flamel scientific staff: per the Jazz v. Avadel trial record, after the Flamel→Avadel integration, consultant Dr. Thorsteinn Thorsteinsson recommended firing the Flamel research staff and CEO Greg Divis "fired all of those employees," including named inventor Guillard. Critically, however, this was a corporate R&D consolidation, not a fire-sale precondition — the patents stayed with Flamel Ireland Ltd and the product was subsequently commercialized.

Original assignee

Flamel Ireland Limited (Dublin, Ireland), operating under the trade name "Avadel Ireland"; named on the face of the patent as assignee.

• Line of business: Irish IP-holding subsidiary. Per Avadel's 10-Q, "Flamel Ireland Limited … since December 16, 2014, has been the owner of substantially all of Avadel's intellectual property." It is a wholly-owned subsidiary of Avadel Pharmaceuticals plc (Nasdaq: AVDL), the successor to Flamel Technologies SA via the France→Ireland redomestication merger completed 2016-12-31.
• Product embodying the claims: Yes. The patent family covers Avadel's LUMRYZ (once-at-bedtime extended-release sodium oxybate oral suspension), FDA-approved 2023-05-01 for cataplexy/EDS in narcolepsy. LUMRYZ generated $77.5M net revenue in Q3 2025 and is Avadel's only commercial product.
• Current status: Operating; acquired by Alkermes plc, completed 2026-02-12 (~$2.1–2.37B). Ancillary history: an Avadel affiliate (Avadel Specialty Pharmaceuticals, LLC) was deconsolidated / subject to a Chapter 11-adjacent restructuring around 2019, but the '986 and its Flamel Ireland IP were not disposed of in that event.

Assignment timeline

Records retrieved from USPTO Assignment Center (https://assignmentcenter.uspto.gov/) via the Google Patents legal-events feed for US 10,952,986 and the parallel sibling record for US 11,065,224. Live Assignment Center / PEDS did not surface the filed-correspondent field in the data available to me — see Signal 3.

• 2019-08-22 (recorded) — Reel 050132/0351 (reel/frame taken from the parallel Flamel Ireland family record; the '986-specific reel was not exposed in the legal-events feed)

  • Conveyance: Assignment (Assignment of Assignors Interest)
  • Assignor: Mégret, Claire; Guillard, Hervé; Dubuisson, Jean-François
  • Assignee: Flamel Ireland Limited
  • Correspondent: not exposed in retrieved records — do not rely on any named attorney here (see Signal 3).
  • Context: Standard inventor-to-employer assignment at/around original filing; no consideration suggests anything other than routine IP perfection.

• 2023-08-01 (recorded) — Reel 064463/0907 (same caveat as above)

  • 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 exposed in retrieved records.
  • Context: Securitization / royalty financing. Ties to the 2023-03-29 Purchase and Sale Agreement between Avadel CNS Pharmaceuticals, LLC and RTW Royalty II DAC (RTW-managed), in which Avadel sold a Revenue Participation Right and granted a "Back-Up Security Interest" over the Product Rights (per Avadel's 8-K). The patent is encumbered as collateral; ownership does not transfer.

• 2026-05-21 (recorded) — Reel 074729/0205 (reel/frame taken from the parallel Flamel Ireland family record)

  • Conveyance: Release of Security Interest
  • Assignor: RTW Investments, LP, as Collateral Agent
  • Assignee/Owner restored: Flamel Ireland Ltd. and Avadel CNS Pharmaceuticals, LLC
  • Correspondent: not exposed in retrieved records.
  • Context: Lien release — collateral released back to the Avadel/Flamel entities following the RTW royalty-financing arrangement.

Net effect: The '986 has never left the Flamel Ireland / Avadel control block. The only registered third-party interest (RTW, 2023) was a financing lien, now released (2026). No assignment to a licensing-only LLC was recorded.

Timeline diagram

timeline
    title Ownership of US 10952986
    2016 : Priority date
    2019 : Application filed by Flamel Ireland
         : Inventors assign to Flamel Ireland
    2021 : US 10952986 granted
         : Delaware litigation begins
    2023 : Patent collateral to RTW Investments
         : LUMRYZ approved by FDA
    2026 : Security interest released by RTW
         : Avadel acquired by Alkermes

NPE / troll-pattern signals

Related litigation context (not an assignment signal): The '986 patent was caught in the Jazz–Avadel oxybate war; Avadel pleaded that Jazz copied the '321 application's claims into Jazz's '041 application (issued as the '079 patent). The '986 is Avadel's own asserted asset — consistent with an operating-company enforcement posture.

Verdict

Operating-company assertion.

The chain runs inventors → Flamel Ireland Ltd (2019-08-22, reel 050132/0351) → a purely financing lien to RTW Investments, LP (2023-08-01, reel 064463/0907), later released (2026-05-21, reel 074729/0205). There is no transfer to a licensing-only shell, no known asserter, and no cascading LLC relay. Flamel Ireland Ltd and its parent Avadel Pharmaceuticals plc commercialize LUMRYZ, the very product embodying the '986 claims, and asserted the patent family directly against competitor Jazz — the signature of an operating-company patent holder, not an NPE.

Verification: https://assignmentcenter.uspto.gov/ (search patent number 10952986). Cross-check reels 050132/0351, 064463/0907, and 074729/0205 directly for the correspondent-of-record field, which is the one unresolved item in this file.

Confidence caveat: The reel/frame numbers for the 2019 and 2026 events were read from the parallel Flamel-Ireland family record for US 11,065,224 rather than the literal '986 entry; the Google Patents legal-events feed for the '986 confirms the same dates and parties for the 2019-08-22 and 2023-08-01 events but did not print reel/frame. Treat the reel numbers as family-level identifiers pending direct Assignment Center confirmation.

I'll research the prior art citations for US 10,952,986 (application 16/420,321). Let me run several targeted searches.

Let me get the specific cited references (the "References Cited" / § 102 prior art) listed on the face of US 10,952,986.

I found the face-of-patent reference list. Let me retrieve the complete citation list (including U.S. patent publications, foreign references, and the examiner's "Other Publications") from the granted patent PDF.

Prior-Art Analysis — US 10,952,986 B2

Important scope caveat up front: The "prior art for a patent" is conventionally the set of references cited on the patent's face under (56) References Cited, plus any reference the examiner applied in a rejection. I was able to retrieve the "U.S. Patent Documents" list from the face of the granted patent PDF (patentimages.storage.googleapis.com/35/8c/d6/fb64dd296ad985/US10952986.pdf, surfaced via the Google Patents record at https://patents.google.com/patent/US10952986). I was not able to retrieve, within the tool budget: (a) the full foreign-patent-document list, (b) the examiner's "Other Publications" (NPL) list, or (c) the examiner's actual § 102/§ 103 rejections from the file wrapper. The U.S. list below is verbatim and reliable; the foreign/NPL portions are flagged as incomplete, not asserted.

I cannot verify the full disclosure content of each cited reference, so the "potentially anticipates which claims" column is a reasoned screening analysis, not a legal conclusion.

1. The face-of-patent citation list (U.S. Patent Documents)

Retrieved verbatim from the granted patent's (56) section:

(The list continues with further U.S. patent publications after 2003/009163…, which the retrieved snippet cut off. The Megret '062 and '866 entries are marked with an asterisk on the face of the patent, which conventionally denotes a reference supplied by / considered relative to the applicant.)

Contradiction flag with the earlier section: The previously generated section characterized the '986 claims as method-of-treatment claims only (based on pre-grant pub US 2019/0274990 A1). The granted-patent bibliographic data retrieved here, however, shows heavy claim-level reliance on "immediate-release (IR) formulation" / "modified release portion" terminology, which is consistent with composition/formulation claims as well. I could not verify the as-granted claim set, so this discrepancy is unresolved and matters for the § 102 element-by-element mapping below.

2. Most relevant prior art and screening § 102 analysis

Tier 1 — Directly on-point GHB modified-release art

A. US 8,591,922 B1 — Allphin et al., issued 11/2013

• Description: Modified/extended-release sodium oxybate formulations (the "Allphin" once-nightly GHB family). The '986 specification itself discusses Allphin's formulations at length, reporting that Allphin's MR doses gave severely reduced AUCinf (56–63% of IR) and excessive residual drug at 8 h.
• § 102 relevance: This is the closest conceptual reference to claims drawn to "a modified release formulation comprising IR and MR portions." If any single Allphin reference disclosed the full combination of (i) IR+MR portions, (ii) the once-nightly dose range, and (iii) the recited PK endpoints, it could potentially anticipate the IR/MR-formulation claims. On the record, however, the '986 specification affirmatively distinguishes Allphin on the PK parameters (higher AUCinf, lower C8h), which suggests Allphin was § 103 art, not a clean § 102 reference.

B. US 8,901,173 B2 — Allphin et al., issued 12/2014 — same family/analysis as 8,591,922.

C. US 9,132,107 B2 — Allphin et al., issued 9/2015 — same family/analysis as 8,591,922.

D. US 8,193,211 B2 — Liang et al., issued 6/2012 ("Supernus/Liang")

• Description: Enterically coated delayed-release sodium oxybate; the '986 specification overlays Liang's FIG. 3 dissolution curve and notes Liang's MR microparticles "do not release more than 80% at 3 hours."
• § 102 relevance: Potentially relevant to claims reciting a "modified release portion," but the '986 spec distinguishes Liang on the release-rate limitation (>80% at 3 h). Likely § 103 art for the MR-portion limitations, not anticipatory of the granted claims.

E. US 8,101,209 B2 — Legrand, issued 1/2012 (Flamel)

• Description: Time-dependent + pH-dependent ("dual mechanism") modified-release coating system. The '986 specification expressly states Legrand "did not describe any dosage forms for delivering sodium oxybate or other forms of gamma-hydroxybutyrate."
• § 102 relevance: Relevant only to the coating/structural limitations (methacrylic acid copolymer + hydrophobic compound). Because Legrand is not GHB, it cannot anticipate any GHB method/formulation claim; it is at most § 103 art against coating limitations.

Tier 2 — Jazz sodium-oxybate (Xyrem®) patents — the IR "reference product"

These recite sodium oxybate dosing regimens (dose ranges, twice-nightly administration, titration). They are relevant as the immediate-release reference product against which many '986 claims are defined, and could bear on method claims that recite administering sodium oxybate at a recited dose:

• Reardan et al. family: US 7,668,730; 7,765,106; 7,765,107; 7,895,059; 8,457,988; 8,589,182.
• Cook et al. family: US 6,472,431; 6,780,889; 7,262,219; 7,851,506; 8,263,650; 8,324,275; 8,461,203; 8,859,619; 9,539,330.
• Others: US 7,797,171 & 8,731,963 (Reardon); US 8,772,306 & 9,486,426 (Eller).
• § 102 relevance: These disclose twice-nightly, divided-dose IR liquid sodium oxybate therapy. They do not disclose a single once-nightly dose from a sachet mixed with water, nor the recited MR dissolution/PK profile, so they do not anticipate the sole-source-of-novelty claims. They are relevant principally as evidence of the known dosing range (3–9 g/day) and as the comparator product.

Tier 3 — Formulation/coating and platform art (background)

• US 5,426,120 (Crepaldi, 6/1995) and US 5,594,030 (Conte, 1/1997) — microparticle/controlled-release coating platform art.
• US 6,913,768 (Couch, 7/2005); US 8,461,197 & 8,759,394 (Tung); US 8,529,954 (Lebon); US 8,771,735 & 8,778,398 (Rourke); US 8,778,301 (Mamelak); US 8,999,392 (Suplie) — general MR/oral dosage-form and excipient art.
• § 102 relevance: None of these, on their titles/known subject matter, discloses a gamma-hydroxybutyrate IR+MR formulation with the recited dissolution/PK behavior. They are background/§ 103 art only.

Tier 4 — Applicant's own earlier family members (alert)

• US 10,272,062 B2 (Megret, 4/2019) and US 10,736,866 B2 (Megret, 8/2020) — these are earlier granted patents in the same Flamel GHB family (the '986 is a continuation-in-part lineage member; its own specification cross-references the '062/'866 chain and provisional 62/365,812).
• § 102 relevance: Under § 102(a)(2)/102(e), a U.S. patent naming another inventor and effectively filed before the claimed invention can be prior art. Because these share inventors/owner with '986, the common-ownership or obligation-of-assignment exception (§ 102(b)(2)(C)) likely removes them as prior art. They are the most subject-matter-relevant citations but are almost certainly disqualified as prior art, and they would anticipate only if the claims were identical — which the continuation structure implies they are not. These should be flagged for any validity challenge rather than treated as anticipatory art.

Unretrieved / uncertain items

• US 2002/0077334 A1 (Cook, 6/2002) — a Jazz/Cook publication relevant to oxybate salt/composition disclosure; exact § 102 bearing not verifiable here.
• US 2003/009163… — the retrieval was truncated mid-number; I will not guess the full identifier.
• Foreign references and NPL ("Other Publications"): not retrieved for '986. I saw WO 1996040105 A1 cited as a foreign reference in a related Flamel continuation (US 2023/0172892), but I have not confirmed it appears on the '986 face — treat as unverified.

3. Bottom line

• The most relevant prior art for US 10,952,986 falls into two clusters: (1) the Allphin once-nightly MR sodium-oxybate family (US 8,591,922; 8,901,173; 9,132,107) and (2) the Liang enteric-coated DR sodium-oxybate reference (US 8,193,211), with Legrand US 8,101,209 supplying the coating technology. Together with the Jazz Xyrem® dosing patents, these define the field the '986 is attempting to distinguish.
• No single cited reference appears to disclose every element of the granted claims (notably the recited in vitro dissolution window — 10–65% at 1 h and 3 h in 0.1N HCl, >80% at 3 h in pH 6.8 buffer — combined with the recited AUCinf/C8h targets and sachet/mix-with-water once-nightly administration). On the available record, the cited art reads as § 103 (obviousness) art, not clean § 102 anticipation art — consistent with the patent having issued.
• Highest-priority references for a validity/invalidity review: US 8,591,922 / 8,901,173 / 9,132,107 (Allphin) and US 8,193,211 (Liang) — with the caveat that the '986 specification affirmatively distinguishes each on dissolution/PK parameters.
• Watch item: the same-family Megret '062 and '866 patents are the closest in subject matter but are likely excepted from prior-art status under common ownership; confirm the assignment record before relying on or attacking them.

Confidence/limitations: The face-of-patent U.S. citation list (Section 1) is grounded in retrieved primary text and is high-confidence. The per-reference descriptions and § 102 screening are lower-confidence inferences because I could not retrieve the full disclosures or the examiner's rejections, and I could not verify the as-granted claim language (see the method-vs-formulation-claim discrepancy flagged in Section 1).

I'll ground this analysis by searching for the key prior-art references identified in the patent's own discussion, plus the granted claim text.

Let me verify the identities of the prior-art references and retrieve the full granted claim set including claims 9–12.

Obviousness Analysis of US 10,952,986 B2 under 35 U.S.C. § 103

Status note: This is a technical patent-analysis work product, not a legal opinion or freedom-to-operate conclusion. Claim construction of terms such as "single daily dose," "sachet," and "substantially as depicted in FIG. 12" would materially change the analysis below. Where I could not verify a fact, I say so.

Date of analysis: April 26, 2026 (per task). Google Patents record fetched 2026-10-01.

1. What the claims actually require

Verified verbatim (two independent sources: the DrugPatentWatch claims database for 10,952,986 and the claims listing of family member AU 2023203055 B2, which reproduces the same claim 1 and the same dependent claims 2–8 — https://www.drugpatentwatch.com/p/patent-claims/10952986 ; https://patents.google.com/patent/AU2023203055B2/en#25). The identical text also appears in the Jazz v. Avadel pleadings, where Avadel quotes it as the claim Avadel says Jazz "copied" (https://storage.courtlistener.com/recap/gov.uscourts.ded.77089/gov.uscourts.ded.77089.238.0.pdf).

1. A method of treating a disorder treatable with gamma‑hydroxybutyrate in a human in need thereof, the method comprising: administering a single daily dose to said human, the single daily dose comprising an amount of gamma‑hydroxybutyrate equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein the administering comprises opening a sachet containing a gamma‑hydroxybutyrate formulation, mixing the formulation with water, and orally administering the mixture.

2. … the orally administering occurs at bedtime.
3. … the mixing occurs shortly before the orally administering.
4. … the orally administering occurs approximately 2 hours after said human has eaten a meal.
5. … said administering results in inducing said human to sleep for 6 to 8 hours.
6. … the amount … is equivalent to 4.5 g, 6.0 g, 7.5 g, or 9.0 g of sodium oxybate.
7. … the mixture is a suspension.
8. … the mixing comprises pouring the gamma‑hydroxybutyrate formulation from the sachet into a container containing the water.

Critical observation for § 103: As granted, claim 1 recites no modified‑release limitation whatsoever, no pharmacokinetic limitation, and no dissolution limitation. The "gamma‑hydroxybutyrate formulation" is unconstrained. The only features distinguishing claim 1 from the prior art are (i) once‑daily (rather than twice‑nightly) dosing of the full daily amount, and (ii) the packaging/administration ritual — sachet, water, oral administration. Every MR/IR, coating, dissolution and PK feature that dominates the specification's "principal embodiments" appears only in claims 10–12 (and possibly claim 9), which I could not retrieve verbatim.

Contradiction flag (minor, against the earlier-generated summary): The earlier summary described claim 10 as a method yielding a PK profile "as shown in FIG. 11." Search results from the AU family member show the corresponding claim 10 there begins "A method of treating narcolepsy Type 1 or Type 2…" (https://patents.google.com/patent/AU2023203055B2/en#25). The US and AU claims are not required to be identical. I therefore treat claims 10–12 as unverified and analyze them only conditionally.

Effective filing date caveat: The Google Patents record lists the priority date as 2016‑07‑22 (UN 2016‑07‑21 for the parent handling); the parent application 15/655,924 was filed 2017‑07‑21 (PCT/EP2017/068552 → WO 2018/015563). Independently, the Jazz v. Avadel pleadings show that the sachet/mixing claim language was added to application 16/420,321 and amended as late as the October 1, 2020 Response to Office Action. If it is later determined that the 2016 priority document does not provide written description for the sachet‑method claims, the effective filing date of those claims would shift forward, enlarging the prior‑art field. This is a live issue — Jazz has argued that its own copied claims lacked written‑description support in the Jazz application, which cuts symmetrically.

2. Person of ordinary skill in the art (POSA)

For the purposes of this analysis, a POSA would be a formulator with a B.S. or M.S. in pharmacy, pharmaceutical sciences, or chemical engineering and 2–5 years of experience developing oral immediate‑ and modified‑release solid dosage forms, working in a team that includes a clinician in sleep medicine. This is the level of skill implied by the references themselves: the art is an engineering art (coatings, dissolution test methods, multiparticulates) applied to a known drug with a known clinical problem.

3. The prior art of record

These are the references identified on the face of / in the body of US 10,952,986, plus the references actually applied by the examiner during prosecution of the same family (confirmed from the Jazz v. Avadel record, https://litigationtracker.law.georgetown.edu/wp-content/uploads/2025/01/Jazz-Pharmaceuticals-Inc._2022.02.25_JAZZ-PHARMACEUTICALS-INC.S-FIRST-AMENDED-ANSWER-TO-AVADEL-CNS-PHARAMCEUTICALS-LLCS-COUNTERCLAIMS.pdf).

Note on Allphin's coating: the applicant's own submission distinguishes Allphin on the ground that Allphin's ethylcellulose coatings "exhibited slow, steady release … from the onset (i.e., there is no lag period)," whereas the invention requires a lag. That distinction is fatal to obviousness only if the claim requires the lag. Claim 1 does not. And Legrand expressly supplies the lag phase (1–5 h at pH 1.4, then burst on pH shift to 6.8).

4. Grounds of rejection

Ground 1 (strongest): Liang 2006 in view of Cook 2002, further in view of Legrand and the Xyrem label — claims 1–8

This is not a hypothetical. The USPTO already made essentially this rejection. The record shows:

"In 2020, the USPTO rejected this pending claim of the '321 Application as unpatentable over Liang 2006 in view of U.S. Patent App. Pub. No. 2002/0077334 to Cook et al. ('Cook 2002')." — Jazz v. Avadel, D. Del. (https://storage.courtlistener.com/recap/gov.uscourts.ded.77089/gov.uscourts.ded.77089.238.0.pdf)

Element map for claim 1:

Dependents: claim 2 (bedtime) — Xyrem label; claim 3 (mix shortly before) — conventional for a suspension; claim 4 (~2 h after a meal) — Xyrem label food‑effect study and Borgen et al. 2003, J Clin Pharmacol 43(1), which is cited on the face of the Allphin/Jazz GHB patents; claim 5 (sleep 6–8 h) — Xyrem label's twice‑nightly regimen is expressly designed to provide ~8 h of sleep, and the '986 specification itself states "the ideal dose will provide an effective eight hours of sleep"; claim 6 (4.5/6/7.5/9 g) — literally the Xyrem dosing table; claims 7–8 — routine.

Motivation to combine (KSR v. Teleflex; Graham v. John Deere):

1. Same field of endeavor, same problem, same drug. Liang, Allphin and the Xyrem label all address once‑nightly sodium oxybate for narcolepsy; the '986 specification admits all three are prior art in this exact field.
2. The prior art itself states the objective. Both Liang and Allphin are expressly directed at converting twice‑nightly Xyrem into a once‑nightly product — that is the stated problem in each reference.
3. Cook 2002 supplies the recognized need for stable, microbiologically sound, water‑based GHB formulations — i.e., it teaches away from the alleged "instability/microbial growth/GBL degradation" objection and enables a sachet‑reconstituted aqueous dose.
4. Legrand supplies a known, patented solution to the exact engineering problem stated in the '986 specification: a coating that gives a lag phase in acid and then rapid release at intestinal pH, using a methacrylic acid copolymer plus a ≥ 40 °C‑melting hydrophobic compound at a defined weight ratio. Legrand is directed to drugs with a limited upper‑GI absorption window — precisely GHB's known pharmacokinetic profile (rapid absorption, short t½).
5. Same corporate family, same laboratory. Legrand is assigned to Flamel Technologies; the '986 patent is assigned to Flamel Ireland Ltd. A POSA at Flamel Ireland in 2016 would have had Legrand's coating technology in‑house. That is a classic "combination of prior art elements according to known methods" with the additional, strong incentive of an existing internal platform.
6. Predictable result. Combining a known IR multiparticulate population with a known lag‑then‑burst MR population in a known IR/MR ratio (the '986 specification itself contemplates a ~50/50 split) is the routine "mix two bead populations" approach.

Ground 2 (independent alternative): Xyrem label + Allphin 2012 + Legrand — claims 1–8

Same reasoning, substituting Allphin 2012 for Liang 2006 as the once‑nightly GHB framework. Allphin 2012 expressly discloses "controlled release dosage forms … [that] may incorporate both controlled release and immediate release formulations in a single unit dosage form," for GHB. The Xyrem label supplies the dose/disease/dosing‑time elements; Legrand supplies the lag‑coating. This avoids any argument that Liang 2006's specific chemistry differs.

Ground 3 (conditional): claims 10–12 (FIG‑based PK method claims)

Not verified verbatim. If, as the earlier summary indicates, they require a PK curve "substantially as depicted in FIG. 11/FIG. 12" for a 4.5/6.0/7.5 g dose given ~2 h after a standardized evening meal:

• Allphin 2012 discloses the same kind of data for the same drug, same doses, same fasting/fed conditions, including plotted mean plasma GHB concentration curves (FIGS. 12 and 14) and AUC/Cmax/Tmax values. A claim to a result that the prior art indicates is achievable (as the Jazz v. Avadel record puts it: "Because Allphin 2012 alleges that it achieves this plasma concentration, a POSA would have understood that this plasma concentration could be achieved") is vulnerable under In re Kao / KSR.
• The "standardized evening meal" is defined in the specification as 25.5% fat / 19.6% protein / 54.9% carbohydrate — i.e., the FDA‑recommended high‑fat test meal, which is a standardized regulatory convention, not an invention.
• Caution: "substantially as depicted in FIG. X" claims are notoriously difficult to invalidate on § 103 because a fact‑finder must compare curves, and they are also difficult to infringe. Do not over‑claim confidence here.

5. Reasonable expectation of success

The strongest non‑obviousness argument the patentee will press is unpredictability — and Avadel made it explicitly to the examiner:

"[T]he unpredictability of GHB formulations is not merely academic … there is no reasonable predictability with respect to GHB formulations, even if a skilled artisan were trying to copy a formulation exactly. It's simply too unpredictable." — App. No. 16/420,321, Oct. 1, 2020 Response at 9 (quoted in Jazz v. Avadel pleadings).

That argument fails against claim 1, because claim 1 requires no formulation performance at all. It also weakens materially because the same party argued the opposite in litigation — that as of February 2015 a POSA "would have been motivated to develop a method for treating narcolepsy by administering a single daily dosage…" using a sachet — and because the same party asserted that Liang 2006 discloses a sachet and stirring into water. Those positions are irreconcilable with the prosecution argument that the art "teaches away from a sachet as currently claimed." At minimum, this creates a prosecution‑history/estoppel problem on the two limitations that distinguish claim 1 (single daily dose; sachet + water).

6. What would defeat or blunt the obviousness case — secondary considerations

Under Graham and WBIP, these are the patentee's realistic defenses, and they are not trivial:

1. Unexpected and superior results across a dose range. The specification reports RBA > 80% (up to > 90–100% at 6.0/7.5/9.0 g) versus Allphin's dose‑adjusted 33–61% and Liang's lower bioavailability; and a C₈ₕ that mimics Xyrem's without the "excess residual" the specification attributes to Allphin. If this data is reproducible and the claims are limited to formulations exhibiting it, this is a serious non‑obviousness case (In re Soni).
   • Nexus problem: claim 1 has no PK or dissolution limitation. The unexpected‑results argument is barely available for claim 1.
2. Teaching away. Avadel's prosecution statements (sachet instability, microbial growth, GBL degradation) plus Allphin's and Liang's failure to achieve adequate bioavailability are the classic "failure of others" + "teaching away" combination.
3. Long‑felt need and failure of others — Allphin, Liang, and Supernus all tried once‑nightly GHB and, on the specification's account, failed on bioavailability or residual drug at 8 h.
4. Copying / industry recognition. The Jazz v. Avadel record contains allegations that Jazz copied Avadel's claims, which the patentee will characterize as copying of the invention.
5. Commercial success (Lumryz).

These are all weighty — but note the sequencing the courts apply: the prima facie case above should be established first, and then each secondary consideration must be weighed with nexus.

7. Assessment

Bottom line: Claim 1 of US 10,952,986 is, on this record, a strong § 103 candidate — it is a method‑of‑treatment claim to dosing a known drug to a known patient population at a label‑disclosed dose, packaged in a conventional sachet and mixed with water, with its only arguable novelty resting on once‑daily (rather than twice‑nightly) administration that the prior art expressly sought. Grounds 1 and 2 each supply a complete teaching‑suggestion‑motivation chain, and the motivation is unusually well documented because the market incentive (once‑nightly GHB) was stated in the prior art itself and because the coating technology came from the same corporate family (Legrand/Flamel). The MR/PK‑limited claims (particularly 10–12) are materially harder to invalidate, which is presumably why the claims were drafted with those limitations in the first place.

8. Explicit uncertainties

1. Claims 9–12 of the '986 patent were not retrieved verbatim. The earlier-generated summary's description of claims 10–12 comes from the pre‑grant publication (US 2019/0274990 A1 / WO 2018/015563), and the AU family member's claim 10 begins differently ("A method of treating narcolepsy Type 1 or Type 2…"). Grant‑date claim text should be pulled from USPTO PatentCenter before relying on any claim 10–12 conclusion.
2. Priority/effective filing date for the sachet claims is unresolved in this record; the claim language was amended in October 2020. If the 2016 priority is not available, the prior‑art field widens.
3. Conte US 5,594,030, Liang 2006 (US 2006/0210630) and Cook 2002 (US 2002/0077334) are confirmed as having been cited/applied by the examiner from the litigation record (https://litigationtracker.law.georgetown.edu/…FIRST-AMENDED-ANSWER…), but I did not independently open each document in this session; their precise teachings are characterized from the secondary sources cited above.
4. No IPR/PTAB or Federal Circuit 2026 activity specific to US 10,952,986 was identified. The Google Patents record lists a Delaware case 1:21‑cv‑01138 for this record but I could not retrieve its caption; the Jazz v. Avadel pleadings I cite concern D. Del. 1:21‑cv‑00691‑GBW and 1:21‑cv‑01594‑GBW, which is a related but distinct docket. Absence of evidence is not proof of absence.
5. The 2016‑07‑22 vs. 2016‑07‑21 priority‑date discrepancy noted in the prior section stands uncorrected, as instructed.