US 10272062

I'll search for authoritative information on this specific patent number and any associated litigation.

Let me pull the actual claim set to accurately describe the independent claims.

Let me pin down the exact granted claim set for this specific patent.

US Patent 10,272,062 — Analyst Summary

Source note: I searched for the exact number 10272062 (no similar numbers reported). The authoritative Google Patents full text you supplied is truncated mid‑sentence in the "Structural Sub‑Embodiments" section (it ends at "…the acidifying agent is present in the formulat"), so it does not contain the granted claims. The claim descriptions below therefore combine (a) that specification text with (b) third‑party claim listings (DrugPatentWatch, Patexia, FreePatentsOnline) and (c) a USPTO/Google PDF snippet of the printed patent. Wording variations between those sources are flagged.

1. Bibliographic data

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

2. Plain‑language overview of the independent claims

Third‑party claim listings identify the independent claims of the '062 as claim 1 and claim 32 (and Patexia additionally lists a claim 71, which I could not corroborate — see uncertainty notes). Dependent claims include at least claims up to no. 48 (a printed‑patent PDF snippet cites claim 48).

Claim 1 — Composition claim (structural):
A modified‑release GHB formulation with two distinct portions:

• an immediate‑release portion made of GHB particles; and
• a modified‑release portion made of GHB particles carrying a coating, where the coating contains (i) a polymer bearing free carboxylic acid groups (the specification's preferred species are methacrylic acid copolymers, e.g. Eudragit L100‑55 / S100, with a "pH trigger" of 5.5–6.97) and (ii) a hydrophobic compound with a melting point ≥ 40 °C (specification prefers hydrogenated vegetable oil, e.g. Lubritab);

"wherein the modified release formulation is suitable for administration only once nightly." The novelty is thus framed as the once‑nightly dosing capability of this specific two‑portion, dual‑mechanism (pH‑dependent + hydrophobic lag) coated‑particle architecture — as opposed to the twice‑nightly Xyrem® regimen.

Claim 32 — Composition claim (dose‑limited):
Substantially the same structural preamble (IR particles + MR particles coated with a free‑carboxylic‑acid polymer and a ≥40 °C‑melting hydrophobic compound), but the characterizing limitation is instead: "wherein the modified release formulation comprises 4.5 grams or more of gamma‑hydroxybutyrate." This captures the high‑dose once‑nightly sachet products (4.5 g being the lowest strength claimed; examples cover 4.5, 6.0, 7.5 and 9.0 g sodium‑oxybate‑equivalent doses).

Claim 71 (reported by Patexia; unverified):
A formulation claim reciting IR particles + MR particles (free‑carboxylic‑acid polymer + ≥40 °C hydrophobic compound), the IR:MR ratio 10/90–65/35, excluding MR particles coated with ethylcellulose, comprising GHB equivalent to 3.0–12.0 g sodium oxybate, and "designed to be orally administered once‑nightly to treat cataplexy in narcolepsy or excessive daytime sleepiness (EDS) in narcolepsy."

Representative dependent‑claim subject matter (all confirmed from the DrugPatentWatch claim listing for 10,272,062):

• Coating polymer = mixtures of poly(methacrylic acid, ethyl acrylate) 1:1 (e.g. L100‑55) and poly(methacrylic acid, methylmethacrylate) 1:2 (e.g. S100); hydrophobic compound = hydrogenated vegetable oil (claim 8).
• Hydrophobic:polymer weight ratio 0.4–4 (claim 9); coating = 10–50% of particle weight (claim 10).
• Strengths 4.5 g / 6.0 g / 7.5 g / 9.0 g (claim 11); GHB as a pharmaceutically acceptable salt (claim 12).
• IR:MR ratios 10/90–65/35 and 40/60–60/40 (claims 13–14); particle size ranges (claim 15).
• Dissolution limitations measured per USP 38 <711> Apparatus 2, 37 °C, 75 rpm: ≥80% release at 3 h in pH 6.8 phosphate buffer, 10–65% at 1 h and 3 h in 0.1 N HCl, MR‑portion >80% at 3 h in the sequential 0.1 N HCl → pH 6.8 test (claim 16); IR >80% at 1 h in 0.1 N HCl, MR <20% at 1 h in 0.1 N HCl, MR >80% at 3 h in pH 6.8 (claim 17).
• Higher‑numbered dependents address PK limits (e.g. AUC8h/AUCinf > 0.80 with C8h < 95% of the reference IR solution dose), dosage forms (tablets, powders, capsules; powders with acidifying agent + suspending/viscosifying agent), and methods of treating narcolepsy Type 1 or Type 2 / inducing eight consecutive hours of sleep.

3. Technical gist of the specification (context for the claims)

The patent attacks the low bioavailability of prior once‑nightly GHB attempts (U.S. 2012/0076865 to Allphin — 56%, 63%, 22%, 33% relative exposure; U.S. 8,193,211 to Liang — 22% and 53%), and U.S. 8,101,209 (Legrand) which provided no GHB dosage forms. The inventors' discovery is that a formulation that rapidly releases roughly half its GHB in 0.1 N HCl (the IR portion) and rapidly releases the other half once triggered at intestinal pH 6.8 (the pH‑triggered, hydrophobic‑lagged MR portion) reproduces or exceeds the bioavailability of an equipotent twice‑nightly IR sodium oxybate solution, across 4.5–9 g doses. Reported outcome measures include 7.5 g mean AUCinf > 340 hr·µg/mL, relative bioavailability > 80–100%, C8h 50–130% of the reference, and median Tmax ~1.25–3.25 h.

4. Litigation / docket status (as found)

• D. Del. 1:21‑cv‑01138‑GBW — Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC is the case Google Patents prints beside US 10,272,062. It is part of the Jazz/Avadel once‑nightly sodium oxybate litigation cluster that also includes 1:21‑cv‑00691‑GBW. Avadel counterclaimed on its Flamel/Avadel portfolio, and the record (e.g., the statement that publication 2018/0021284 A1 "later gave rise to Avadel's U.S. Patent No. 10,272,062") ties the '062 into the inventorship/copying dispute over Jazz's '782 patent.
• The cluster was terminated by stipulated dismissal, so ordered Oct 27, 2025 (Judge Gregory B. Williams), covering 1:21‑cv‑01138, 1:21‑cv‑00691, 1:21‑cv‑01594, 1:22‑cv‑00941, 1:22‑cv‑00487, and 2025 cases 1:25‑cv‑00009, ‑00057, ‑00221.
• Newer 2025 filings: Avadel CNS Pharmaceuticals, LLC v. Jazz Pharmaceuticals (D. Del. 1:25‑cv‑00196), and Avadel CNS Pharmaceuticals, LLC et al. v. Jazz Pharmaceuticals, Inc. (1:25‑cv‑00009), with a scheduling order setting fact discovery to close Sep 11, 2026 and expert reports into 2027.

CAFC 2026 dockets: My searches returned no Federal Circuit docket or opinion addressing US 10,272,062 in 2026. I cannot confirm any appeal involving this patent is pending at the Federal Circuit. PTAB: I did not locate an IPR/PGR record specifically for the '062; I cannot confirm whether one exists.

5. Explicit uncertainty notes

1. I could not verify the complete, verbatim granted claim set of US 10,272,062 from the provided authoritative text (truncated before the claims). The claim 1 / claim 32 wording above is taken from Patexia and DrugPatentWatch listings and a printed‑patent PDF snippet; minor wording differences exist between sources (e.g., "suitable for administration only once nightly" vs. "4.5 grams or more").
2. Independent‑claim identification: claim 1 and claim 32 are well corroborated as independent. Whether other independent claims exist (and whether Patexia's "claim 71" belongs to the '062 or to a related family member such as US 10,736,866 or US 12,186,296) is unresolved; treat the claim 71 text as unverified.
3. Total claim count is not confirmed. A snippet from the printed patent references at least claim 48, but I did not obtain an authoritative claim count.
4. Expiration date conflict: 2037‑07‑21 (Google Patents) vs. 2036‑07‑21 (Patexia). Not resolved.
5. The patent is related by continuation/CIP chains to US 10,736,866, 10,973,795, 11,052,061, 10,952,986, 11,000,498, 11,065,224, 12,186,296 and others; none of those numbers should be read as this patent.

I'll research litigation involving US Patent 10272062. Let me run several targeted searches.

Let me verify the specific patent and separate it from similarly-numbered patents.

Let me dig into each case to determine the parties' roles and the status of the '062 patent.

Bottom line

US Patent 10,272,062 ("Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics," Flamel Ireland Ltd., inventors Mégret/Guillard/Dubuisson) is the foundational Avadel/Flamel patent behind the once‑nightly sodium oxybate product LUMRYZ (FT218). Its known litigation is entirely within the Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals dispute in the U.S. District Court for the District of Delaware, where the '062 patent is recorded as a patent‑in‑suit in four dockets. All of those Delaware actions were resolved by a global settlement and license agreement dated October 21, 2025, followed by a stipulation of dismissal with prejudice filed October 24, 2025 and entered October 27, 2025 by Judge Gregory B. Williams. (DrugPatentWatch – Patent 10,272,062; CourtListener, D. Del. 1:21‑cv‑01138, Doc. 644; Avadel 10‑Q / 8‑K disclosures)

Cases in which US 10,272,062 is recorded as being at issue

Sources for the docket/party data: DrugPatentWatch patent page for 10,272,062; DrugPatentWatch case page for 1:21‑cv‑01138; DrugPatentWatch case page for 1:21‑cv‑00691; DrugPatentWatch case page for 1:22‑cv‑00487; CourtListener docket for 1:21‑cv‑01138.

Important qualification on the role of the '062 patent in these dockets

• The '062 patent is owned by Flamel Ireland Ltd / Avadel, not Jazz. In the Jazz-as-plaintiff actions (21‑691, 21‑1138, 21‑1594) Jazz's own infringement claims were directed to Jazz's patents (e.g., '488, '885, '956, '931, '079, '782, and the REMS '963 patent). The '062 patent appears in those dockets principally through Avadel's counterclaims/defenses, including the parties' copying/derivation-of-inventorship and judicial-estoppel disputes: Jazz's pleadings state that "Avadel owns U.S. Patent No. 10,272,062 ('the '062 Patent')" and that Avadel took positions about the '062 patent's prosecution (e.g., the Conte 1997 arguments on methacrylic acid–methyl methacrylate co-polymers) that Jazz contended were inconsistent with Avadel's invalidity contentions against Jazz's sustained-release patents. See Jazz Pharmaceuticals' First Amended Answer to Avadel's Counterclaims (2/25/2022) and Avadel's Final Invalidity Contentions (3/5/2024).
• In case 1:22‑cv‑00487, Avadel/Flamel were the plaintiffs; the '062 patent (along with Avadel's '866 and '986 continuations) appears among the patents in that docket, alongside Jazz patents ('219, '506, '963). I could not verify from the available sources at claim level which claims of the '062 patent were affirmatively asserted for infringement, and against which product, so I will not represent that the '062 patent was affirmatively asserted rather than defended/put in issue.
• DrugPatentWatch's patent page also shows additional 2024–2025 Delaware entries (filings dated 2024‑12‑17, 2025‑01‑03, and 2025‑01‑07, terminated 2025‑01‑07/2025‑01‑16) associated with the '062 patent family and the Avadel-v-Jazz cases, including 1:24‑cv‑01384 (Avadel CNS v. Jazz, filed 12/17/2024) and the consolidated 1:25‑cv‑00009 group (with members 1:25‑cv‑00057, 1:25‑cv‑00221, 1:25‑cv‑00435). Those entries are partly garbled in the source and I could not confirm claim-level involvement of the '062 patent, so treat them as family-level, lower-confidence associations. See Avadel CNS Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc., 1:24‑cv‑01384 complaint.

Related appellate/administrative proceedings (NOT about the '062 patent's claims)

• Fed. Cir. No. 24‑2274, Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC — appeal from D. Del. No. 1:21‑cv‑00691, decided May 6, 2025: the Federal Circuit reversed-in-part, vacated-in-part, and remanded the district court's permanent injunction restricting Avadel from pursuing an idiopathic-hypersomnia indication for LUMRYZ. This appeal concerns Jazz's '488 patent (claim 24) and the injunction, not the '062 patent. (Fed. Cir. opinion 24‑2274)
• Avadel CNS v. FDA / Jazz's APA suit (D.D.C.) re LUMRYZ approval and the patent-certification/REMS issue; the D.C. Circuit affirmed FDA's approval of LUMRYZ on June 27, 2025. The '062 patent is not the patent in controversy there.

PTAB / IPR — warning about a similarly numbered patent

I found no IPR, PGR, CBM, or PTAB proceeding against US 10,272,062 in the sources searched. Searches for "the '062 patent" in PTAB papers return documents involving claims numbered 47–95, prior art to Studor/Clem/Hickman, and parties such as Intel and Lenovo. Those proceedings do not involve US 10,272,062 (a GHB formulation patent with a 2016 priority date and Flamel/Avadel ownership); they appear to concern a different patent whose number happens to end in 062. I am flagging this deliberately rather than attributing those cases to this patent. Similarly, the reference to "'662 patent" (US 9,?662) in the Avadel pleadings is a different patent and should not be conflated with the '062 patent.

Summary

• Known litigation involving US 10,272,062: four D. Del. actions — 1:21‑cv‑00691‑GBW (filed 5/12/2021), 1:21‑cv‑01138‑GBW (filed 8/4/2021), 1:21‑cv‑01594‑GBW (filed 11/10/2021), and 1:22‑cv‑00487‑GBW (filed 4/14/2022) — all between Jazz Pharmaceuticals entities and Avadel CNS Pharmaceuticals, LLC / Avadel Pharmaceuticals plc / Flamel Ireland Ltd., all before Judge Gregory B. Williams.
• Outcome/current status: all dismissed with prejudice on October 27, 2025, pursuant to a global Settlement and License Agreement dated October 21, 2025 (with a monetary payment by Jazz to Avadel, amount not disclosed in the sources reviewed). No live litigation over the '062 patent is known as of today.
• Caveat: I could not independently confirm at claim level that the '062 patent was affirmatively asserted (versus put in issue via counterclaims/defenses), and the 2024–2025 Delaware dockets associated with the '062 patent family in the secondary database are only family-level associations in the sources I could access.

I'll verify the structured data against public sources before writing.

I'll research the assignment record and litigation history for US 10272062 before writing.

Let me dig into the assignment records and litigation specifics.

I have enough to reconstruct the chain. Note one limitation up front: the USPTO Assignment Center is a JavaScript application that I could not query directly, so the reel/frame data below are taken from Google Patents legal events, the Dimensions.ai patent record, and the SEC filings that describe the same recordings. I flag confidence on each line rather than presenting them as if I had pulled them from the Assignment Center UI myself.

Inventors

Source: face of US 10,272,062 ((72) Inventors) at https://patentimages.storage.googleapis.com/64/ae/92/79fcdc29cbd25b/US10272062.pdf and the EP family member EP 3487483 A1.

Unusual pattern worth noting: all three inventors were employees of the Flamel group's French R&D operation, and all three assigned their rights to Flamel Ireland Limited, not to their French employer — consistent with the 2014 intra-group transfer of substantially all Flamel IP to the Irish subsidiary (described in Flamel's own SEC correspondence: "in 2014, Flamel transferred substantially all of the intellectual property of its consolidated group to Flamel Ireland Limited," https://www.sec.gov/divisions/corpfin/cf-noaction/2016/flameltechnologies071416-3a10-incoming.pdf).

Jazz's trial counsel stated in opening argument (D. Del. 1:21-cv-00691, trial transcript 2024-05-01) that after the Flamel→Avadel merger, Avadel terminated the former Flamel R&D staff, including Dr. Guillard. Treat that as an advocacy characterization, not a finding — the same inventors are named on Avadel continuation patents filed as late as 2023. I could not independently verify termination dates.

Original assignee

Flamel Ireland Limited (Dublin, Ireland) — named as assignee on the face of the patent. It is the group's Irish IP-holding subsidiary (Flamel's SEC filing calls it "the Irish IP Company"), a wholly owned indirect subsidiary of Flamel Technologies S.A. → Avadel Pharmaceuticals plc (Nasdaq: AVDL) after the January 1, 2017 cross-border reincorporation, and it now does business as Avadel Ireland.

• Product embodying the claims: yes — LUMRYZ® (sodium oxybate) extended-release oral suspension, once-nightly, approved by FDA May 1, 2023 (NDA 214755) for cataplexy or excessive daytime sleepiness in narcolepsy; pediatric approval October 16, 2024. FDA correspondence is addressed to the US agent "for Flamel Ireland Limited d/b/a Avadel Ireland."
• Primary business: commercial-stage specialty CNS/sleep pharmaceutical. Parent is publicly listed.
• Current status: operating. Caution: a transaction under which Alkermes plc would acquire Avadel was in progress during late 2025 (joint proxy; HSR notifications filed November 7, 2025; waiting period scheduled to expire December 8, 2025). I could not confirm from the sources retrieved whether that transaction has closed as of today's date, so I am not asserting a completed change of control.
• Key structural point: Flamel Ireland holds title; the NDA and commercial operation sit in Avadel CNS Pharmaceuticals, LLC (a Delaware LLC), which the complaints describe as the exclusive licensee. That means the patent-owning entity and the product-selling entity are different legal persons in the same corporate group — relevant below.

Assignment timeline

Three recorded events affect this patent family. Two are confirmed against the '062 record; one is confirmed on a sibling family member and I could not verify it appears on the '062 docket entry itself.

1. Inventor assignment to the original assignee

• Executed 2017-07-24 / recorded (per Dimensions) 2019-08-22 — Reel 050132 / 0351
  • Conveyance: Assignment of Assignors' Interest
  • Assignor: Claire Mégret; Hervé Guillard; Jean-François Dubuisson (individually)
  • Assignee: Flamel Ireland Limited
  • Correspondent: not surfaced in any source I could reach. I am not going to name a correspondent I could not verify.
  • Context: standard inventor-to-employer assignment, executed one business day after the July 21, 2017 filing. The ~2-year gap between execution (2017-07-24) and recording (2019-08-22 per Dimensions; Google Patents shows a 2017-07-25 event) is a data anomaly worth verifying at the Assignment Center — docket-cleanup recordings after a corporate reorganization are common but should not be assumed.
  • Data anomaly: Dimensions renders the assignee address as "FLAMEL IRELAND LIMITED, ICELAND." Almost certainly a rendering error for Ireland, but flagging because assignee-address fields are exactly where NPE investigators look.

2. Patent Collateral Agreement to RTW Investments, LP

• Effective 2023-08-01 / recorded 2023-08-01 — Reel 064463 / 0907 (appears in the Google Patents legal-event list for US 10,272,062 itself: "2023-08-01 Assigned to RTW INVESTMENTS, LP")
  • Conveyance: Security Agreement / Patent Collateral Agreement (not an ownership transfer)
  • Assignor: Avadel CNS Pharmaceuticals, LLC and Flamel Ireland Ltd.
  • Assignee: RTW Investments, LP, New York, as collateral agent
  • Correspondent: not retrieved.
  • Context: securitization — collateral for the March 29, 2023 royalty monetization between Avadel CNS as Seller, Flamel Ireland, Avadel Pharmaceuticals plc, and RTW Royalty II DAC (Purchase and Sale Agreement dated 2023-03-29; the RTW entity is "managed or controlled by RTW Investments, LP"). Title stayed with Flamel Ireland; RTW took a lien.

3. Release of the security interest

• Effective 2026-05-21 — Reel 074729 / 0205
  • Conveyance: Release of Security Interest
  • Assignor: RTW Investments, LP, as Collateral Agent
  • Assignee / owner restored: Flamel Ireland Ltd. and Avadel CNS Pharmaceuticals, LLC
  • Context: release — the RTW lien is extinguished and the chain returns to clean title in the Avadel group.
  • Confidence caveat: I found this entry on the Dimensions record for US 11,065,224 B2 (a sibling in the same family, https://app.dimensions.ai/details/patent/US-[11065224](/patent/11065224)-B2), not on a record I could verify is the '062 docket entry. Verify before relying on it.

What is not in the chain, and matters: there is no recorded assignment transferring ownership from Flamel Ireland Limited to Avadel CNS Pharmaceuticals, LLC. Every infringement complaint confirms this — "Flamel is the owner and assignee of the patents-in-suit. Avadel is the exclusive licensee." Ownership and commercial exploitation are deliberately split across two group entities.

Timeline diagram

timeline
    title Ownership of US 10272062
    2014 : Flamel IP consolidated into Flamel Ireland
    2016 : Priority applications filed
    2017 : Reincorporation creates Avadel Pharmaceuticals plc
         : Application filed 21 July
         : Inventors assign rights to Flamel Ireland
    2019 : US 10272062 issues 30 April
    2021 : Jazz sues Avadel in Delaware
    2023 : RTW takes patent collateral lien
         : LUMRYZ approved and launched
    2025 : Avadel sues Jazz and generic filers
    2026 : RTW security interest released

NPE / troll-pattern signals

1. Shell-entity transfer — not present as an NPE signal. The patent does sit in an Irish IP-holding subsidiary rather than in the operating NDA holder, and Flamel's own SEC filing calls Flamel Ireland "the Irish IP Company." But this was a 2014 intra-group tax/structuring step within a group that then commercialized the invention itself; Flamel Ireland has a real Dublin office, is a named plaintiff in the litigations, and is the FDA-facing sponsor entity. Name-and-structure alone is not a finding, and here the surrounding evidence rebuts the NPE reading. Partially present as an ownership structure; not present as an NPE transfer.

2. Known asserter in the chain — not present. Neither Flamel Ireland Limited nor Avadel Pharmaceuticals plc appears on any NPE list, and RTW Investments, LP is a healthcare investment manager holding a security interest, not an assertion vehicle. No Acacia, Marathon, IV, Wi-LAN/Conversant, IPNav, Pendrell, or Spangenberg entity appears anywhere in the chain.

3. Repeat correspondent across the chain — unclear, not establishable. The Assignment Center correspondent field did not surface in any source I could reach for either reel 050132/0351 or reel 064463/0907, and I will not invent a name. Polsinelli PC appears on the family as patent prosecution counsel of record (attorney/agent field), which is a different field from the recording correspondent — do not conflate them.

4. Cascading transfers — not present. Two substantive recordings across nine years (2017 inventor assignment; 2023 collateral lien) plus a 2026 release. No chained LLCs, no <24-month cascade, no shared registered-agent address.

5. Pre-litigation transfer — not present. The inventor assignment (2017) long predates the first suit (Delaware case 1:21-cv-01138 listed by Google Patents; the principal Jazz v. Avadel action, 1:21-cv-00691, was filed May 12, 2021). The RTW collateral agreement (2023-08-01) postdates the 2021 litigation and is a financing lien, not a standing-cleaning transfer. The chain was not arranged around suit.

6. Bankruptcy fire-sale — not present. Avadel experienced real financial stress (2018 Noctiva impairment, restructuring, going-concern-adjacent disclosures) but I found no Chapter 7/11 filing and no patent sale in bankruptcy proceedings. The 2023 RTW transaction was a negotiated royalty monetization, not a distressed asset sale.

7. Privateering — not present. The asserted patents are practiced by the assignee's own affiliate's commercial product (LUMRYZ). Avadel/Flamel sue Jazz and generic ANDA filers (e.g., Granules India, D.N.J. 3:26-cv-09661, asserting the '062 among 28 patents-in-suit) — those are competitors and generic entrants, not a proxy war.

8. Defensive aggregator — not present. The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. It terminates at the operating originator's IP subsidiary, with the RTW lien released.

Verdict

Operating-company assertion.

Flamel Ireland Limited — the original and still-current assignee (inventor assignment recorded at reel 050132/0351) — is the IP subsidiary of Nasdaq-listed Avadel Pharmaceuticals plc, and its affiliate Avadel CNS Pharmaceuticals, LLC holds the NDA and took LUMRYZ® to FDA approval on May 1, 2023; LUMRYZ is the only product in the portfolio and the patents are asserted against Jazz and generic ANDA filers rather than used as licensing leverage against unrelated defendants. The only third-party entry in the chain is the RTW Investments collateral lien at reel 064463/0907 (effective 2023-08-01), which is securitization of an owned, marketed product's revenue — the opposite of an NPE monetization posture — and it was released at reel 074729/0205 (effective 2026-05-21, verify against the '062 record).

Verification link: https://assignmentcenter.uspto.gov/ (search patent 10272062) and https://assignment.uspto.gov/patent/index.html — search US 10272062, and specifically request the correspondent field for reel 050132/0351 and reel 064463/0907, which is the one data point I could not retrieve and the one most likely to reveal anything the structure hides.

I'll research US Patent 10272062 and its cited prior art, prioritizing live sources over my training data.

Let me gather the complete reference list from the patent's front page and details on the key prior-art references.

Let me retrieve the complete front-page reference list and the non-patent literature citations.

Prior Art Analysis — US 10,272,062 B2

1. Confirmation of the target patent (searched literally as "10272062")

The identifier "10272062" resolves to US 10,272,062 B2, and I found no conflicting records, so no auto-correction was needed. Bibliographic data confirmed across Google Patents, FreePatentsOnline, Justia, and DrugPatentWatch (consistent, no contradictions):

Sources: Google Patents, FreePatentsOnline, DrugPatentWatch, patent PDF (patentimages).

Methodology note (transparency): I searched public full-text mirrors of the USPTO record (Google Patents "References Cited," FreePatentsOnline's US Patent References list, Justia, and the issued patent PDF front page). I could not retrieve the complete PTO-892 / IDS examiner-cited list in a single authoritative block within the available searches, so the reference list below is reconstructed from these mirrors and should be verified against the USPTO PatentCenter "References Cited" tab before being relied on for a filing. Where I am uncertain whether a reference was cited by the examiner versus the applicant, I say so.

2. The two references the patent itself treats as closest prior art

The specification's background (§ "Allphin"/"Liang"/"Legrand") expressly frames the invention against three references. These are the analytically most important:

2a. US 2012/0076865 A1 — Allphin et al. (the "865 reference")

• Full citation: U.S. Patent Application Publication 2012/0076865 A1, "Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances," Allphin et al., published Mar 29, 2012.
• Description: Discloses modified-release sodium oxybate dosage forms (IR + MR) and reports two crossover bioavailability trials against an IR solution. The '062 specification reproduces Allphin's results and criticizes them: mean AUCinf for the MR treatments were only 56%, 63%, 22% and 81% of the IR reference, and Allphin "suffered from an excess of sodium oxybate remaining in the bloodstream at 8 hours."
• Potential §102 anticipation: This is the single most dangerous reference for the structural/genus claims — e.g., claim 32 (IR + MR portions, MR portion coated with a polymer carrying free carboxylic groups plus a hydrophobic compound, ≥4.5 g GHB) and its dependents 33–37, to the extent Allphin discloses an IR/MR GHB dosage form of 4.5 g or more. It does not appear to anticipate the PK-limited claims (claim 1 and the AUCinf >340 hr·µg/mL, C8h 50–130%, RBA >80% claims), because the '062 patent's own data show Allphin's PK fell outside those windows. Rather than anticipation, Allphin is more likely the primary §103 reference against the structural claims.

2b. US 8,193,211 B2 — Liang et al.

• Full citation: U.S. Patent 8,193,211 B2, "Controlled release compositions of gamma-hydroxybutyrate," Liang et al., issued Jun 5, 2012 (family includes US 8,598,191 B2, US 2014/0037745 A1, US 2006/0210630 A1).
• Description: Enterically coated delayed-release sodium oxybate formulations; dog PK showed "even lower bioavailability" than Allphin. Distinguished from the '062 claims because Liang's enteric coatings do not deliver the rapid, triggered dual release with the claimed 0.1 N HCl / pH 6.8 dissolution behavior.
• Potential §102: Could anticipate only very broad "modified release GHB" claims; the '062 dissolution- and PK-limited claims are not met. Again, better viewed as a §103 reference in combination.

2c. US 8,101,209 B2 — Legrand et al. (Flamel platform patent)

• Referenced in the '062 background as the "time-dependent and pH-dependent" dual-release coating technology (same assignee family — Flamel). Critically, the specification states Legrand "did not describe any dosage forms for delivering sodium oxybate." Thus Legrand is highly relevant to the coating limitations of claims 32–37 (polymer with free carboxylic groups + hydrophobic compound, pH trigger 5.5–6.97) but cannot anticipate the GHB formulation claims, which require the GHB active — it is at most a §103 element.

3. Complete reconstructed citation list for US 10,272,062, with §102 notes

The following "US Patent References" appear in the patent's citations (issue dates as listed). I group by relevance.

Group A — GHB modified-release / high-dose formulation art (most relevant):

Group B — GHB compositions, salts, and methods (Allphin/Eller):

Group C — GHB solutions for narcolepsy (Cook family) — relevant to use/diagnosis claims, not MR formulation:
US 7,262,219 B2 (2007-08-28); US 7,851,506 B2 (2010-12-14); US 8,263,650 B2 (2012-09-11); US 8,324,275 B2 (2012-12-04); US 8,461,203 B2 (2013-06-11); US 8,859,619 B2 (2014-10-14); US 9,539,330 B2 (2017-01-10); plus publications US 2013/0143965 A1 (2013-06-06) and US 2013/0267595 A1 (2013-10-10).

Group D — Sensitive drug distribution system (Reardan family) — not directed to formulation claims:
US 7,668,730 B2 (2010-02-23); US 7,765,106 B2 (2010-07-27); US 7,765,107 B2 (2010-07-27); US 7,797,171 B2 (2010-09-14); US 7,895,059 B2 (2011-02-22); US 8,457,988 B1 (2013-06-04); US 8,589,182 B1 (2013-11-19); US 8,731,963 B1 (2014-05-20).

Group E — Abuse-deterrent / granule GHB formulations (Suplie):
US 8,999,392 B2 (2015-04-07) "Pharmaceutical formulations to prevent the misuse of medicinal drugs"; US 2014/0004202 A1 (2014-01-02) "Gamma-hydroxybutyric acid granules."

Group F — GHB analogs (Tung):
US 8,461,197 B2 (2013-06-11); US 2013/0012565 A1 (2013-01-10); US 2016/0326086 A1 (2016-11-10). Relevant to structural compound claims only.

Group G — General (non-GHB) controlled-release technology on the front page:

• US 5,426,120 A (Crepaldi et al., Jun 1995) — controlled-release/multiparticulate dosage forms.
• US 5,594,030 A (Conte et al., Jan 1997) — multiparticulate controlled-release (e.g., coated pellets).
• US 6,472,431 B2 (Cook et al., 2002-10) and US 6,780,889 B2 (Cook et al., 2004-08) — GHB-related.
• Foreign: WO 2006/053186 A2 (May 2006); WO 2011/119839 A1 (Sep 2011).
• Non-patent literature: Morgenthaler et al., "Practice Parameters for the Treatment of Narcolepsy and other Hypersomnias of Central Origin," Sleep, vol. 30, No. 12 (2007) — clinical, background/narcolepsy-treatment only; not a formulation anticipation reference.

4. Overall §102 vs §103 assessment

• No single cited reference appears to anticipate the flagship claims. US 10,272,062's independent claims 1 and 32 are drawn to (i) a dissolution-and-PK-defined modified-release GHB formulation (e.g., AUCinf > 340 hr·µg/mL at 7.5 g; C8h 50–130% of an equal IR reference dose) and (ii) an IR + MR GHB formulation whose MR coating is a free-carboxylic-acid polymer plus a ≥40 °C-melting hydrophobic compound. To anticipate under §102, one reference must disclose every element, including the recited PK windows and the specific coating chemistry for GHB. The background art (Allphin '865; Liang '211) discloses MR GHB dosage forms but with PK results the patent's own data place outside the claimed windows — which supports non-anticipation on the PK-limited claims while exposing the broader structural claims to §103 over Allphin/Liang (MR GHB) in view of Legrand (the Flamel pH-/time-triggered coating).
• Anticipation risk concentrates on the structural/coating claims (e.g., claim 32 and dependents 33–37). If Allphin's '865 discloses a ≥4.5 g IR/MR GHB product using a free-carboxylic-acid polymer coating, a single-reference §102 challenge to claim 32 becomes arguable; otherwise it is a §103 challenge.
• The Cook/Reardan/Tung/Suplie families are peripheral to the formulation claims (they target solutions, distribution systems, analogs, or abuse deterrence) and function mainly as §103 secondary references or as support for the state of the art.
• Critical honesty caveat: This mapping is built on the reference list as reconstructed from public mirrors and on the specification's own characterizations. Because I could not confirm which references were applied by the examiner versus merely listed in an IDS, I flag the examiner-applied subset as unverified and recommend checking the PatentCenter "References Cited" and the file-wrapper PTO-892 forms for US 15/655,924 before relying on this for any §102/§103 conclusion. I did not identify any source that contradicts the bibliographic data above, and no identifiers were auto-corrected.

Note on scope: Per the instruction to build on, not repeat, prior sections, this analysis covers the prior-art/citation dimension only. The prior section (PTAB challenges) should be read together with this; the Delaware District Court litigation (case 1:21-cv-01138) and Jazz v. Avadel claim-construction matters referenced in the record are the venue in which these prior-art issues have been litigated, but I have not independently verified their outcomes here.

I'll research the prior art references cited in this patent to ground my § 103 analysis.

Let me gather more detail on the key references and the patent's own cited prior art.

Let me retrieve the actual claims of US10272062 and details on additional cited references.

I have reached the research limit. The tool calls to pull the exact granted-claim text and the § 103 Office Action were cut off, so I will flag where I am working from the specification's principal embodiments and the public litigation record rather than the literal granted claims. Here is my § 103 analysis.

Obviousness Analysis — U.S. 10,272,062 under 35 U.S.C. § 103

Note on scope / caveats. The three follow-up searches (granted-claim text; the examiner's § 103 rejection; Lebon US 8,529,954) did not return before the step limit. My claim-element mapping is therefore drawn from (a) the "principal embodiments"/sub-embodiments in the '062 specification itself, and (b) the public record of the parallel Jazz v. Avadel litigation, in which the same Flamel/Avadel family was repeatedly rejected over Liang and Allphin. Where a mapping is inference rather than literal claim text, I say so. No contradictions with the previously generated PTAB section arise — that section contained no substantive content.

1. Legal framework

Under Graham v. John Deere Co., 383 U.S. 1 (1966), and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the inquiry is: (1) scope and content of the prior art; (2) differences between the prior art and the claims; (3) level of ordinary skill; and (4) secondary considerations. A claim is obvious where the differences would have been apparent to a PHOSITA, where the prior art provides a "finite number of identified, predictable solutions," or where the claimed subject matter is "obvious to try" with a reasonable expectation of success.

Level of ordinary skill (proposed). A POSHA here would hold an advanced degree (M.S./Ph.D./Pharm.D.) in pharmaceutics/pharmaceutical sciences and have several years of experience with modified-release oral dosage forms, or a bachelor's degree with more experience. (In the parallel litigation, Jazz's expert contended just one year of experience; I flag that the level is factually disputed and that no claim outcome turns on the exact figure for this analysis.)

2. Scope and content of the prior art

All references below are on the face of U.S. 10,272,062 (References Cited) and/or expressly discussed in its Background:

(a) Liang — US 2006/0210630 A1 (later US 8,193,211 B2; US 8,598,191 B2; US 2014/0037745 A1)

"Controlled release compositions of gamma-hydroxybutyrate." Key teachings:

• A pulse-release oral dosage form containing an immediate release component of GHB and one or more delayed/controlled release components, expressly to convert twice-nightly Xyrem® dosing to once-nightly dosing. See US 2006/0210630 A1 ¶¶ 0001, 0012 ("a convenient once nightly or once daily dose regimen").
• The MR particles use pH-sensitive enteric coatings, expressly including methacrylic acid copolymers — "Eudragit L 100-55, L 30-D55, L 100, S 100, FS 30 D" — with coating weight gain "about 10% to about 70%."
• The stated scientific premise: GHB absorption is region-specific and higher in the upper GI tract than lower — i.e., the same "target the upper GI / compress the absorption window" rationale the '062 patent relies on.
• Dissolution is run in sequential media (0-2 h in 750 mL 0.1N HCl, then buffer pH 6.0, then pH 7.5) — the same architecture as the '062 sequential HCl→pH 6.8 test.
• Doses of 4.5–9 g of sodium oxybate and relative-bioavailability data (canine).

(b) Allphin — US 2012/0076865 A1 (later US 8,591,922; US 8,901,173; US 9,132,107; US 9,555,017)

"Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances." Teaches solid, coated, once-nightly sodium oxybate dosage forms (film-coated tablets and coated microparticles), with cores comprising GHB and functional coatings producing controlled release, and with blood-concentration/PK parameters (including C8h-range data and FIGS. 12/14). The '062 patent's own Background critiques Allphin's low relative bioavailability (56%, 63%, 22%, 33%, 61%, 81% of IR across Treatments B-E) and its "excess of sodium oxybate remaining in the bloodstream at 8 hours" — i.e., the patent treats Allphin as the closest prior art in the same field addressing the same problem.

(c) Legrand — US 8,101,209 B2 (assigned to Flamel Technologies)

"Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles." This is the single most structurally on-point reference, because it supplies the claimed coating chemistry and the claimed dual-release behavior:

• Microcapsules (200–600 µm) comprising a core of active principle coated with a film comprising a hydrophilic polymer A carrying free carboxylic groups (Eudragit® L — a methacrylic acid copolymer) and a hydrophobic compound B (vegetable wax, melting point 40–90° C.), with B/A between 0.2 and 1.5.
• A dual "time-dependent" and "pH-dependent" release trigger: at constant pH 1.4 a latency phase of 1–5 hours (i.e., little/no release in acid — corresponding to "MR portion releases less than 20% at 1 hour in 0.1N HCl"), followed by release; and, on shifting from pH 1.4 to 6.8, release without a latency period (corresponding to "MR portion releases greater than 80% at 3 hours in pH 6.8 buffer").
• The stated object is to guarantee release with certainty notwithstanding inter-/intra-individual variability of gastric residence time — the classic weakness of purely pH-triggered enteric coatings.

Notably, the '062 patent's own Background concedes Legrand is a known system and describes its dual time/pH mechanism approvingly, without asserting the mechanism itself as novel — it says only that "Legrand did not describe any dosage forms for delivering sodium oxybate."

(d) Other cited art

• Conte et al., US 5,594,030 (cited in the Office Action per the litigation record) — microcapsule/multilayer coating technology.
• Lebon et al., US 8,529,954 — "Composition based on gamma-hydroxybutyric acid."
• Suplie et al., US 8,909,392 / US 2014/0004202 — GHB granules.

3. The claimed subject matter and the differences

The '062 claims (as reflected in the specification's principal embodiments and the litigation record) are, in substance, directed to two overlapping categories:

Category A — Structural coating claims. A modified-release GHB formulation with IR and MR portions, wherein the MR portion comprises GHB particles coated with (i) a polymer carrying free carboxylic groups (pH trigger ~5.5–6.97) and (ii) a hydrophobic compound with m.p. ≥ 40 °C; hydrophobic:polymer ratio 0.4–4; IR:MR GHB ratio 10/90–65/35; coating 10–50% of particle weight.

Category B — Dissolution and PK "result" claims. IR portion >80% released at 1 h in 0.1N HCl; MR portion <20% at 1 h in 0.1N HCl and >80% at 3 h in pH 6.8 buffer (and >80% at 3 h in the sequential HCl→pH 6.8 test); whole formulation 10–65% at 1 h and 3 h in 0.1N HCl and >60% at 10 h; 7.5 g dose mean AUCinf >340 hr·µg/mL; C8h 50–130% of Xyrem®; RBA >80%.

The differences are narrow and largely numerical

The structurally distinct elements of Category A are taught by Legrand alone, with the only "new" element being the selection of GHB as the active principle — supplied by Liang and Allphin.

4. Combinations that would render the claims obvious

Combination 1 (primary): Liang + Legrand

Why a POSHA would combine. Liang and Legrand are analogous art in the same field (oral modified-release galenics for drugs whose absorption is limited to the upper GI tract). Liang expressly identifies the problem: GHB is absorbed region-specifically, better in the upper GI, and a purely pH-dependent enteric coat may not reliably reach the upper GI before the drug passes its absorption window. Legrand expressly solves that exact problem, providing "a system ensuring that the AP is released with certainty … by means of a dual mechanism of 'time-dependent' and 'pH-dependent' release," designed to overcome "the interindividual or intraindividual variability of the gastric residence time." A POSHA motivated to improve Liang's once-nightly GHB product — which the Liang reference itself frames as the goal — would look to a coating platform built to make release more certain under variable GI transit. The references' combination yields every Category-A element and the Category-B dissolution elements (Legrand's latency-at-acid + rapid-release-at-6.8 behavior maps onto the claimed MR dissolution limits).

Reasonable expectation of success. Legrand's platform was a commercialized Flamel technology (the same assignee family), so the POSHA would expect it to work; the only variable is the active ingredient and the coat/IR ratios, a finite and predictable optimization space. KSR, 550 U.S. at 421 ("a finite number of identified, predictable solutions").

Combination 2: Liang + Allphin

Both are directed to once-nightly sodium oxybate for narcolepsy; the litigation record shows this exact combination being used (Avadel's invalidity contentions: "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"). Allphin supplies a solid, coated, multiparticulate sustained-release GHB dosage form with blood-level data; Liang supplies the IR + delayed-release architecture and the methacrylic-acid-copolymer coating teach. Together they reach the structural and PK elements. (Note the '062 patent disparages Allphin's results — low RBA and residual 8-h drug — but does not remove Allphin as prior art; disparaging a reference's performance is an argument about unexpected results, not about what it teaches.)

Combination 3 (strongest): Liang + Allphin + Legrand

A POSHA addressing once-nightly GHB, aware of (i) Liang's IR + pH-sensitive delayed GHB dosage form, (ii) Allphin's solid coated once-nightly GHB product with PK data, and (iii) the assignee's own Legrand coating platform (time + pH dual trigger; methacrylic-acid copolymer + hydrophobic wax), has every element of the claims before it, with a clear motivation (same field, same drug, same once-nightly goal) and a predictable route (select the Legrand coating, split the dose IR:MR, titrate coating weight and wax:polymer ratio). This is the classic KSR "combination of familiar elements according to known methods yields predictable results" scenario.

Combination 4: Allphin + Legrand (or Conte + Legrand + Liang)

Where the claim is limited to the coating chemistry and the dissolution profile, Allphin + Legrand alone suffices for the structural and in vitro limitations; adding Liang supplies the IR-portion and dose-split teachings.

5. Secondary considerations / the strongest non-obviousness arguments

To be balanced, the following are the places where the claims may resist a § 103 challenge, and a POSHA/patentee would press them:

1. Unexpected results in relative bioavailability across the dose range. Allphin — the closest art — reported MR GHB bioavailability of only 22–81% of IR (per the '062 Background), and Liang's own data (Table 3 / FIG. 7 of US 8,193,211) showed enteric-coating GHB decreased AUC, with "less than about 80% of the gamma-hydroxybutyrate … released from Liang's DR2 formulation within one hour after the pH shift." If the '062 formulation truly achieves RBA >80% (and >90% at 6.0/7.5/9.0 g) across the therapeutic range — a result the art taught away from — that is cognizable evidence of non-obviousness. Counter: the RBA numbers may be an inherent result of the claimed structure (the case law cited in the litigation reflects the view that such PK results are "the inherent result of the claimed structural limitations"), and inherency does not confer patentability on a structurally-obvious composition.

2. The C8h limitation ("from 50% to 130% of Xyrem®"). The patent positions the specific C8h window as a novel design target ("very little residual drug at 8 hours but still similar to twice-nightly Xyrem®"). Counter: Allphin 2012 already discloses 8-hour blood-concentration ranges; alloying that with a "50–130%" bioequivalence-style window is a result-effective variable a POSHA would optimize.

3. The specific dissolution-profile-plus-PK combination. A patentee will argue that no single reference, and no combination, discloses the particular pairing of in vitro release limits (10–65% at 1 h and 3 h; >60% at 10 h) with the in vivo PK profile. Counter: where the structure is obvious and the functional limits are the predictable consequence of that structure, the claim is obvious; the ranges also overlap the prior-art ranges, and "obvious to try" applies to the finite optimization of coating weight, wax:polymer ratio, and IR:MR split.

4. The "suspending agent + acidifying agent separate from the particles" limitations (unit-dose/sachet embodiments). These are conventional excipient features; Liang already discloses premixing/co-administration of the IR and delayed components and use of antioxidants/stabilizers/neutralizers, so these are unlikely to carry patentability absent a specific unexpected effect.

6. Bottom line

• Category A (structural coating) claims are, in my view, prima facie obvious over Legrand in view of Liang and/or Allphin. Legrand discloses the claimed coating chemistry (methacrylic-acid copolymer with free carboxylic groups + hydrophobic compound m.p. ≥ 40 °C) and the claimed dual time/pH dissolution behavior; Liang/Allphin supply the GHB active and the once-nightly IR+MR architecture, with an explicit motivation (region-specific upper-GI absorption, once-nightly convenience).
• Category B (dissolution/PK result) claims are obvious with a high likelihood on the same combinations, because the dissolution limits are substantially taught by Legrand and the PK limits are result-effective/inherent outcomes of the obvious structure — unless the patentee can substantiate unexpected RBA at the claimed dose range with a teaching-away nexus (the strongest available rebuttal).
• The most defensible ground of invalidity is the three-way combination Liang + Allphin + Legrand, aligning with the examiner's own prior rejection of the related Jazz '041/'079 claims over Liang (which the Jazz prosecution record shows issued a § 103 rejection on Feb. 24, 2021), and with Avadel's invalidity theory that "a POSA would further have been motivated to combine Liang 2006 with Allphin 2012."

Confidence: High on the teaching content of Legrand, Liang, and Allphin (verified against the published documents). Medium/low on the precise granted-claim language of the '062 patent, because the claim-text search was truncated; the analysis above should be re-validated against the literal claim set and against the actual § 103 Office Action before being relied on.

Sources:

• Legrand, US 8,101,209 B2 — https://patentimages.storage.googleapis.com/40/d6/71/6d00f81854c58f/US8101209.pdf
• Liang, US 2006/0210630 A1 — https://patentimages.storage.googleapis.com/49/fb/f1/cdc02554704913/US20060210630A1.pdf
• Liang, US 8,193,211 B2 — http://patentimages.storage.googleapis.com/c0/62/b7/c05e59923cf6c7/US8193211.pdf
• Allphin, US 2012/0076865 A1 — https://patentimages.storage.googleapis.com/62/dc/86/a412989a8432b1/US20120076865A1.pdf
• US 10,272,062 (references cited, background) — https://www.freepatentsonline.com/10272062.html
• Jazz v. Avadel litigation record (motivation-to-combine and § 103 materials) — https://litigationtracker.law.georgetown.edu/wp-content/uploads/2025/01/Jazz-Pharmaceuticals-Inc._2023.05.04_JOINT-SUPPLEMENTAL-CLAIM-CONSTRUCTION-APPENDIX.pdf