US 7765107

I'll verify current litigation/docket status via search while relying on the authoritative patent text provided.

Let me check specifically for any 2026 appellate activity.

US Patent 7,765,107 B2 — Analyst Summary

Verification note: The USPTO/Google Patents record for 7,765,107 was retrieved and cross-checked. I found no 2026 Court of Appeals for the Federal Circuit docket involving this patent number; the appellate activity on the '107 patent occurred earlier (see Litigation/PTAB history below). If you need a definitive 2026 docket confirmation, the CAFC PACER docket and the PTAB APIs would need to be queried directly — my search results did not surface one, and I will not infer one exists.

Bibliographic Data

Uncertainty flags: The "current assignee" listing is expressly qualified on the source page ("may be inaccurate"); the real party in interest in the litigation record is Jazz Pharmaceuticals, Inc. The status line saying "Expired – Fee Related" alongside an "adjusted expiration 2026-09-16" is internally odd (20 years from the 2002-12-17 priority date would normally lapse in December 2022 unless patent term adjustment applies), so I report both literally rather than reconciling them.

Abstract (verbatim)

"A drug distribution system and method utilizes a central pharmacy and database to track all prescriptions for a sensitive drug. Information is kept in the database regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving the drug. Abuses are identified by monitoring data in the database for prescription patterns by physicians and prescriptions obtained by patients. Further verification is made that the physician is eligible to prescribe the drug by consulting a separate database, and optionally whether any actions are taken against the physician. Multiple controls beyond those for normal drugs are imposed on the distribution depending on the sensitivity of the drug."

Plain-Language Overview of the Independent Claims

Claim 1 — Computerized method to control abuse of a prescription drug

A computer-implemented method with four operative steps:

1. Centralized, exclusive distribution control. A computer processor controls distribution through an exclusive central pharmacy that maintains a central database tracking all prescriptions for the drug and analyzing for potential abuse.
2. Single intake point. All prescription requests, for any and all patients, are received only at the exclusive central pharmacy, from any and all medical doctors permitted to prescribe the drug.
3. Single processing point. All prescriptions are processed only by the exclusive central pharmacy using only the central database.
4. Pattern detection. The processor determines current and anticipated patterns of potential abuse from periodic reports generated only by the central database, based on (a) prescription request data from a particular physician and (b) filling of prescriptions by a particular patient; the request data must identify the patient, the prescribed drug, and the physician's credentials.
5. Selection of "multiple controls." The processor selects a long enumerated list of distribution controls — essentially a closed-universe checklist — including: physician→pharmacy prescription communication; capturing physician name, license, and DEA registration; prescription verification; patient information collection; verifying prescriber eligibility by consulting the National Technical Information Services to confirm an active DEA number and check pending actions against the physician; printed physician materials; insurance contact; patient registry verification; patient education and verification the patient reviewed it; home-address verification; shipping via USPS or commercial carrier; an 18-or-older designee to receive the drug; confirming receipt of the initial shipment; return of the drug after two failed delivery attempts; investigation of lost shipments; shipping to another pharmacy for delivery; single-location manufacture; controlled inventory release; questioning early refills; flagging repeat lost/stolen/destroyed/spilled prescriptions; one-month supply limit; periodic prescription rewriting; and making the database available to the DEA to check abuse patterns, cash payments, and inappropriate questions.

Claim 4 — The same method, but limited to gamma hydroxy butyrate (GHB)

Claim 4 is a parallel independent claim whose steps are substantively identical to claim 1, with GHB substituted as the controlled substance (e.g., "controlling… the distribution of GHB"; "receiving… all prescription requests… for… GHB"; "all prescriptions for GHB"). It does not merely depend on claim 1 — it is a separate, drug-specific independent claim.

Dependent claims (all narrow, not independent)

• Claims 2 and 5 designate an "initially selected" subset of the controls (the earlier-stage controls such as physician credential verification via NTIS, patient education and review verification, USPS shipping, initial-shipment confirmation, controlled inventory release, flagging repeat loss reports, and DEA database access). Claim 2 depends from claim 1; claim 5 depends from claim 4.
• Claims 3 and 6 add consulting a separate database to verify the physician is eligible to prescribe (claim 3 from claim 1, re GHB; claim 6 from claim 4).

Practical reading: The claims are written as a closed, highly specific bundle of administrative and logistics controls implemented with a processor, all anchored on a single exclusive pharmacy and a single central database. That drafting style (a "consisting of"-flavored laundry list of controls plus a processor element) is what later became the vulnerability in PTAB proceedings.

Litigation / PTAB History Relevant to the '107 Patent

These are from the retrieved record and search results, not from the patent text itself:

• PTAB IPR2015-00547 — [Amneal Pharmaceuticals, LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%2C%20LLC) and Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc., IPR of US 7,765,107 B2. Filed 2015-01-08; instituted 2015-07-28; Final Written Decision 2016-07-27: "claims 1–6 of the '107 patent are unpatentable" under 35 U.S.C. § 103 over the FDA Advisory Committee Art ("ACA") materials (Xyrem advisory committee transcript/slides, preliminary clinical safety review, briefing booklet, and Xyrem distribution-system video).
• PTAB IPR2015-01820 — Wockhardt Bio AG et al. v. Jazz Pharmaceuticals, Inc., IPR of the same patent; filed 2015-08-27; instituted 2015-10-30; joined with IPR2015-00547 and terminated 2016-07-27 by the same Final Written Decision.
• CBM2014-00175 — Roxane Laboratories, Inc. et al., covered business method review of the '107 patent; filed 2014-08-18; not instituted (procedural).
• Federal Circuit appeal — Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC (Fed. Cir. 2018). The court addressed, among other things, the Board's claim constructions of "periodic reports," "information identifying patients," and "credentials" (construed as at least two different types of credentials), and the public accessibility of the ACA materials; the Board's obviousness determinations were affirmed. The same appeal resolved the parallel IPRs on the '106, '730, '988, '963, '059, and '182 patents.
• District court litigation naming the '107 patent includes numerous D.N.J. actions (e.g., 2:10-cv-06108 vs. Roxane; 2:13-cv-07884 vs. Par; 2:13-cv-00391 vs. Amneal; 2:14-cv-04467 vs. Ranbaxy; 2:14-cv-07757 vs. Watson) and later antitrust/REMES-related actions in N.D. Cal. (3:20-cv-04056, 3:20-cv-04064) listing 7,765,107 among the patents at issue.
• Note the FTC/REMS context: after Jazz v. Avadel (Fed. Cir., May 6, 2025, Nos. 2024-2274/-2277/-2278), the "computerized access-control system is not a method of using the drug" line of reasoning is frequently invoked against REMS-type distribution patents. That decision involved different patents, not the '107 patent, but is relevant background for the enforceability trajectory of this patent family.

Bottom Line

US 7,765,107 is the divisional sibling of US 7,668,730, claiming a computerized, single-exclusive-pharmacy/single-database method for distributing a sensitive drug (claim 1 generically; claim 4 specifically GHB/sodium oxybate) with a mandatory enumerated set of diversion controls. It issues out of the Xyrem restricted-distribution program and is part of the Jazz/Orphan Medical "sensitive drug distribution" patent family. Its independent claims were held unpatentable as obvious by the PTAB on 2016-07-27 in IPR2015-00547 (joined with IPR2015-01820), a result affirmed on appeal to the Federal Circuit. The listed status is expired/fee-related with a recorded adjusted expiration of 2026-09-16.

Confidence: High for bibliographic data, abstract, claim text, and PTAB filings (sourced directly). Medium-high for the Federal Circuit affirmance (well-corroborated but the exact citation year/month should be confirmed). No 2026 CAFC docket for patent 7,765,107 was found in my searches — treat that as "not located," not as positive proof of none.

I'll research litigation involving US patent 7765107. Let me start with searches on litigation databases.

Let me search for the specific district court cases listed for this patent.

Based on my research (the Google Patents family data for US 7,765,107 and targeted searches of litigation databases), here is what I can confirm about litigation involving US Patent No. 7,765,107 ("Sensitive drug distribution system and method"). The patent issued July 27, 2010 (priority Dec. 17, 2002), assignee Jazz Pharmaceuticals, Inc. (originally JPI Commercial LLC / Orphan Medical). It is one of the "'730 patent family" of Xyrem (sodium oxybate) REMS/distribution patents.

Important caveat: Some docket numbers listed on the patent page carry no caption in the extracted record. Where I could not independently verify a caption, plaintiff/defendant, or outcome, I say so rather than guess.

A. PTAB proceedings (directly challenging the '107 patent)

The '107 patent's claims were invalidated as obvious; the PTAB found the claimed distribution system had been publicly disclosed by Orphan Medical (e.g., June 6, 2001 FDA Advisory Committee meeting). The Federal Circuit affirmed in July 2018, which eviscerated Jazz's REMS distribution patent portfolio.

B. District court litigation (Hatch-Waxman / ANDA infringement actions)

These are consolidated in the District of New Jersey (Jazz's preferred forum). The '107 patent was asserted in the initial wave.

Settlements/outcomes of the district court wave: Jazz settled with Wockhardt (Apr 2016), Ranbaxy (May 2016), Par (Jan 2018), and Teva (Mar 2018), and with the first filer West-Ward/Hikma. The settlements granted generic-entry dates starting July 1, 2023 and Dec 31, 2025. The consolidated case against Amneal and Lupin, and later Mallinckrodt, remained pending at the time of the last-Jazz 10-K descriptions I reviewed.

C. Follow-on antitrust / class-action litigation (where '107 is cited)

US 7,765,107 is listed among the patents at issue in the Xyrem antitrust litigation, which challenges the patent-settlement and REMS conduct rather than asserting the patent:

• In re Xyrem (Sodium Oxybate) Antitrust Litigation, N.D. Cal., 3:20-md-02966 (RS) — consolidated MDL.
• New York State Teamsters Council Health & Hospital Fund v. Jazz Pharmaceuticals, Inc., N.D. Cal., 3:20-cv-04056 (filed June 18, 2020).
• City of Providence, Rhode Island v. Jazz Pharmaceuticals PLC, N.D. Cal., 3:20-cv-04064-LB (filed June 18, 2020).
• UFCW Local 1500 Welfare Fund v. Jazz Pharmaceuticals Ireland Ltd., N.D. Ill., 1:20-cv-03852 (filed June 30, 2020; terminated July 22, 2020 — transferred to MDL).
• Blue Cross & Blue Shield of Florida, Inc. v. Jazz Pharmaceuticals, Inc., N.D. Fla., 3:23-cv-01453 (filed Dec 11, 2023).
• United HealthCare Services, Inc. v. Jazz Pharmaceuticals plc, D. Minn., 0:21-cv-00737 (filed 2021).

In each, '107 appears in the listed patents-in-suit alongside '730, '106, '059, '988, '182, '963, and others.

D. Summary

• Confirmed litigation specifically naming US 7,765,107: the D.N.J. Hatch-Waxman cases (led by Jazz v. Roxane, 2:10-cv-06108, and including Amneal, Par, Ranbaxy, Watson, Wockhardt, Lupin) and the three PTAB proceedings (IPR2015-00547, IPR2015-01820, CBM2014-00175).
• Key outcome: The '107 patent's claims were held unpatentable in IPR2015-00547 (FWD July 27, 2016), affirmed by the Federal Circuit in 2018 — effectively ending its ability to block generic Xyrem.
• Antitrust MDL and related class actions cite '107 as part of Jazz's Xyrem patent portfolio but do not assert it.

Things I could not confirm (and therefore am flagging rather than guessing): exact captions, plaintiffs/defendants, filing dates, and dispositions for a few docket numbers the patent record lists (e.g., 2:14-cv-04467, 2:14-cv-07757, 2:15-cv-05619, 2:17-cv-05487, and E.D.N.Y. 2:17-cv-04439). A PACER or Bloomberg Law/Law360 docket pull for each of those case numbers would be needed to state their parties and outcomes with confidence. If you'd like, I can research those specific docket numbers one at a time.

I'll reconcile the structured ODP block against the patent record and then verify the PTAB details via search.

Let me pin down the CBM denial and the joined-Wockhardt resolution.

Let me confirm the Federal Circuit docket/citation and the claim-level disposition.

AIA Trial Proceedings — US 7,765,107 B2 ("Sensitive drug distribution system and method")

⚠️ Contradiction flagged up front. The structured "PTAB proceedings on file" block you supplied states: "The USPTO ODP API returns no AIA trial proceedings for this patent as of the most recent ingest." That is wrong for this patent. The patent record itself (Google Patents litigation block, retrieved 2026-10-01) lists three AIA proceedings by number — IPR2015-00547, IPR2015-01820, and CBM2014-00175 — and each is independently corroborated by PTAB docket data and the Federal Circuit's published opinion. I am treating the ODP ingest as stale/incomplete and proceeding on the verified record. I flag this because "no proceedings on file" would be a catastrophically wrong signal to a defendant: it implies the patent is untested, when in fact all six claims have been canceled. Do not rely on the ODP block for this patent.

Proceedings overview

Three AIA proceedings touch US 7,765,107: two IPRs (one of which is claims-invalidated and one of which is a joined copy that settled out) and one CBM (institution denied). Breakdown: 0 active, claims invalidated: all of claims 1–6 (IPR2015-00547, affirmed), claims sustained: none, settled/terminated as to one petitioner (IPR2015-01820, Wockhardt), institution denied (CBM2014-00175). Bottom-line defensive posture: this patent is dead, not hardened. Claims 1–6 were held unpatentable under § 103 over the FDA Advisory Committee Art (ACA materials), and the Federal Circuit affirmed in Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347 (Fed. Cir. 2018). If a demand letter cites claims 1–6 of the '107 patent, the sender is asserting canceled claims — that is potentially sanctionable conduct, not merely a weak case.

IPR2015-00547 — Amneal Pharmaceuticals LLC and Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc.

• Type: Inter Partes Review (Tech Center 3600)
• Filed: 2015-01-08
• Status: Final Written Decision — claims unpatentable (terminated 2016-07-27)
• Judge panel: Brian P. Murphy, Jacqueline Wright Bonilla, Jon B. Tornquist, Susan L. C. Mitchell (APJs)
• Petition grounds (two grounds, all of claims 1–6, both under 35 U.S.C. § 103(a)):
  • Ground 1 — ACA materials (FDA Advisory Committee transcript & slides (Ex. 1003), preclinical safety review (Ex. 1004), briefing booklet (Ex. 1005), Xyrem distribution-system video & transcript (Ex. 1006)), supported by the Valuck declaration (Ex. 1007).
  • Ground 2 — Talk About Sleep (Ex. 1033) in view of Honigfeld (Ex. 1034), Elsayed (Ex. 1035), and Lilly (Ex. 1010).
• Institution decision: 2015-07-28. Partially instituted as to grounds: review was instituted on Ground 1 only (ACA materials, § 103). Ground 2 (Talk About Sleep combination) was not instituted. Review was instituted as to all challenged claims 1–6. The Board also rejected Patent Owner's threshold § 312(a)(2)/§ 315(b) attack — Jazz had argued Amneal/Par failed to name Par's parents (Par Pharmaceutical Companies, Par Holdings, Sky Growth Intermediate Holdings I & II) as real parties-in-interest, and that the petition was therefore untimely.
• Final Written Decision: 2016-07-27 — "claims 1–6 of the '107 patent are unpatentable." All six claims, including both independent claims 1 and 4, were held obvious over the ACA materials alone or in combination with Korfhage, Information Storage and Retrieval (1997). No claim was held patentable.
  • The Board found the ACA materials publicly accessible on an FDA website no later than 2001-10-04 (via the 2001-05-14 Federal Register notice), more than two months before the 2001-12-17 critical date, and that a POSA (a pharmacist or computer scientist familiar with computerized drug distribution) would have been motivated to and capable of locating them.
  • Key constructions (later reviewed on appeal): "periodic reports" = reports "generated at regular intervals or intermittently" (rejecting Jazz's regularity-only reading); "information identifying patients" = "information identifying a patient," not all listed categories; "credentials" = "information identifying various credentials, i.e., at least two different types of credentials, of the prescribing physician."
  • The FWD also rejected Jazz's secondary-considerations evidence (commercial success, long-felt need), attributing Xyrem's success to the active ingredient and FDA-imposed regulatory barriers.
• Settlement / termination: No global settlement in this case — Amneal and Par litigated to FWD. (Par separately settled with Jazz during the pendency of the appeal, per the Federal Circuit opinion, and was dismissed from the appeal; the docket reflects that.)
• Appeal: Yes. Consolidated appeal, lead No. 2017-1671 (with Nos. 2017-1673, -1674, -1675, -1676, -1677, and -2075), Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347 (Fed. Cir. 2018-07-13) (Newman, Lourie (opinion author), Reyna, JJ.). Issues: (i) public accessibility of the ACA materials as § 102(b) printed publications (Jazz demanded an indexing/searchability requirement); (ii) the "periodic reports," "information identifying patients," and "credentials" constructions; (iii) the obviousness analysis. Disposition: AFFIRMED — substantial evidence supported accessibility; no indexing requirement imposed; obviousness affirmed. Opinion: https://www.courtlistener.com/opinion/[4516711](/patent/4516711)/jazz-pharmaceuticals-inc-v-amneal-pharmaceuticals-llc/
• Defensive value: Decisive. Claims 1–6 are canceled. A defendant can move to dismiss or for sanctions if a plaintiff asserts them. Because the winning ground was § 103 over FDA Advisory Committee Art, and the Federal Circuit endorsed that agency-published materials linked from the Federal Register are printed publications even without indexing, this opinion is itself a sword against other REMS-style Orange Book patents in the same family.

IPR2015-01820 — Wockhardt Bio AG (et al.) v. Jazz Pharmaceuticals, Inc.

• Type: Inter Partes Review (Tech Center 3600) — joined to IPR2015-00547
• Filed: 2015-08-27
• Status: Final Written Decision / terminated (docket terminated 2016-07-27). Gloss: the FWD entered in this file is a copy of the IPR2015-00547 FWD (Paper 12); Wockhardt itself had already settled out.
• Judge panel: Same as IPR2015-00547 — Brian Murphy, Jacqueline Wright Bonilla, Jon Tornquist, Susan Mitchell (APJs). The joinder conference call was held 2015-09-14.
• Petition grounds: § 103(a) over the same ACA materials, challenging all claims 1–6. Wockhardt's petition was expressly an "almost verbatim copy of the petition in IPR2015-00547," dropping the uninstituted Ground 2. Wockhardt sought joinder to IPR2015-00547; the same petitioner filed parallel, joined petitions on the sibling patents (IPR2015-01813, -01814, -01815, -01816, -01818, and IPR2016-00370 for the '797 patent).
• Institution decision: 2015-10-30 — Decision Instituting Inter Partes Review and Granting Motion for Joinder.
• Final Written Decision: 2016-07-27 — the joined FWD (copy of the IPR2015-00547 decision) holding claims 1–6 unpatentable. As to Wockhardt specifically, it had been terminated from the proceeding before the FWD; the merits determination ran against the remaining petitioners.
• Settlement / termination: Yes. By Order dated 2016-05-05 (Paper 11), the Board granted a joint motion (filed 2016-04-26, authorized 2016-04-19) to terminate the proceeding as to Petitioner Wockhardt Bio AG under 37 C.F.R. §§ 42.72/42.74, based on a confidential settlement agreement (Ex. 2061) filed "Board Only" and treated as business confidential under 35 U.S.C. § 317(b). Per Jazz's public 10-K disclosures, the company settled with Wockhardt on 2016-04-18, granting a license to market a generic Xyrem on or after 2025-12-31 (or earlier on certain triggers); terms otherwise confidential. Wockhardt also stipulated to dismissal in the district court.
• Appeal: No — Wockhardt settled and was not a party to the Federal Circuit appeal (the Duane Morris/Lexology commentary confirms Wockhardt settled before the appeal).
• Defensive value: Low standalone value, but important estoppel/redundancy context: it shows a second, well-financed petitioner was unable to get a different result, and that the joinder route was available. The § 317(a) termination means the settlement did not stay the primary proceeding — the FWD still issued three months later.

CBM2014-00175 — Roxane Laboratories, Inc. and Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc.

• Type: Covered Business Method review (AIA § 18 / 35 U.S.C. § 321)
• Filed: 2014-08-18 (petition; part of a June–August 2014 wave of CBM petitions against Jazz's Orange Book patents)
• Status: Not Instituted — Procedural (decision denying institution, 2015-01-13)
• Judge panel: Not confirmed in the sources retrieved (likely the same APJ panel as the companion CBMs; I will not guess names).
• Petition grounds: Challenged claims 1–6 under § 101 (abstract idea; Mayo invoked), § 102(b) (anticipation), and § 103 (obviousness), contending the claims recited "the abstract idea of centralizing retail drug distribution using an exclusive central pharmacy that encompasses the non-technical steps of interfacing with financial businesses."
• Institution decision: Denied on 2015-01-13 — the Board held the '107 patent is not a "covered business method patent" under § 18(d)(1) because the claims do not recite a method "for performing data processing or other operations used in the practice, administration, or management of a financial product or service." The claims were "checks" and "controls" on shipping/mailing/providing a prescription drug, not financial activity; the claims do not require movement of money or extension of credit. The Board rejected the "used in commerce" theory as an improper expansion of CBM, and rejected the Class 705/Subclass 2 classification argument. The same reasoning denied institution in the companion CBMs (CBM2014-00149, -00150, -00151, -00153, -00161).
• Final Written Decision: None — never instituted (a denial of institution is not appealable, per Versata and the AIA).
• Settlement / termination: N/A.
• Appeal: None (institution decisions are non-appealable).
• Defensive value: A closed door, but a useful one to know about. You cannot get this patent (or its family siblings) reviewed as a CBM. Post-Alice, however, the substantive § 101 argument the petitioners raised (and that this panel never reached on the merits) remains available in district court as an invalidity defense — the denial was purely about CBM eligibility, not patentability. Note this panel construed the claims narrowly as drug-distribution controls, which cuts against a § 101 "abstract idea" theory in litigation; the ACA/§ 103 route proved far more effective.

Strategic summary

Claim status. Every claim of US 7,765,107 — independent claims 1 and 4 and dependent claims 2, 3, 5, and 6 — was held unpatentable in IPR2015-00547 (FWD 2016-07-27) and that judgment was affirmed in Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347 (Fed. Cir. 2018-07-13). No claim is sustained. No claim is untested. There is no surviving claim scope to design around. (One record inconsistency to note: the Google Patents status line reads "Expired – Fee Related," adjusted expiration 2026-09-16, which is a maintenance-fee-derived status and does not reflect the claim cancellations; the rights died in 2018, not 2026. Treat the "2026-09-16" date as an artifact.)

Estoppel landscape. Under § 315(e)(2), Amneal, Par, and Wockhardt — and their privies and real parties-in-interest (including Par's parent entities) — are estopped from asserting in district court any ground they raised or reasonably could have raised in these IPRs. Because the FWD invalidated all claims on Ground 1 (ACA materials, § 103), the estoppel is largely academic for the patent itself. Practically: a defendant facing a fresh assertion can rely on the FWD directly under Blonder-Tongue/collateral estoppel principles — a final judgment of invalidity, affirmed on appeal, is generally conclusive against the patent owner as to those claims against the world. You do not need your own IPR. And because the patent claims are canceled, a new IPR on the '107 is unavailable — you cannot IPR a canceled claim.

Pattern signals. (i) This is a co-ordinated generic-industry attack — Amneal, Par, Roxane, Wockhardt, Ranbaxy, Watson, and Lupin all filed/triggered proceedings and Hatch-Waxman litigation against the '730-family "sensitive drug distribution" patents (US 7,668,730; 7,765,106; 7,765,107; 7,895,059; 8,589,182; 8,457,988; 8,731,963). (ii) Jazz litigated hard and appealed aggressively — it appealed all six adverse FWDs and lost across the board. (iii) No defensive aggregator (e.g., Unified Patents) appears in these PTAB proceedings; the petitioners were generic ANDA filers with direct Hatch-Waxman standing, not a defensive aggregator. (iv) The '107 family has continued to attract antitrust/REMS scrutiny in district court (N.D. Cal. 3:20-cv-04056 and 3:20-cv-04064, which list 7,765,107 among patents at issue), and the later Jazz v. Avadel line of reasoning (a computerized access-control system is not a method of using the drug) further undercuts REMS-style Orange Book listings generally.

Recommended next steps

1. If you are a defendant and the demand cites claims 1–6: quote the disposition directly. The FWD (IPR2015-00547, Paper 32, 2016-07-27) stated that "claims 1–6 of the '107 patent are unpatentable," affirmed at 895 F.3d 1347. Link the opinion: https://www.courtlistener.com/opinion/4516711/jazz-pharmaceuticals-inc-v-amneal-pharmaceuticals-llc/ and the PTAB record via PTAB E2E: https://ptacts.uspto.gov/ptacts/. Move to dismiss and consider a Rule 11 / § 285 motion.
2. Do not file an IPR. The claims are canceled; an IPR on the '107 is not a viable vehicle. If the same plaintiff family is asserting a sibling/continuation (e.g., the '730 family or a later Jazz "sensitive drug distribution systems and methods" patent, such as the '814/REMS-era filings), check that patent's own PTAB history — the ACA-materials § 103 theory is transferable and the Jazz v. Amneal accessibility holding is binding precedent on similar FDA/agency-published art.
3. Pull the primary documents yourself (I have not independently pulled the PDFs): IPR2015-00547 FWD (Paper 32) and Institution Decision (07-28-2015, Paper 20); IPR2015-01820 Papers 11 (termination order, 2016-05-05) and 12 (FWD, 2016-07-27); CBM2014-00175 institution denial (2015-01-13). These are retrievable at PTAB E2E / PTAB API v2 (https://developer.uspto.gov/api-catalog), by proceeding number.
4. Verify the ODP gap. The structured block returned "no proceedings" for this patent. That is plainly inaccurate for a patent with a precedential Federal Circuit affirmance. Escalate the ingest discrepancy — an automated system that reports "no proceedings on file" for US 7,765,107 will give clients dangerously wrong go/no-go advice.
5. No 2026 appellate activity on the '107 was located. Consistent with the earlier section of this analysis, I found no Federal Circuit docket in 2026 involving patent 7,765,107; the appeal concluded in 2018. I treat this as "not located," not as affirmative proof of none.

Confidence: High for proceeding numbers, dates, panels, petitioner identities, grounds, the CBM denial reasoning, and the Federal Circuit affirmance (multiple independent, mutually corroborating sources, including the court's own opinion text). Medium for the exact sub-docket number within the consolidated 2017 appeal that corresponds specifically to the '107 FWD — I confirmed the consolidated set (2017-1671, -1673, -1674, -1675, -1676, -1677, -2075) but not the one-to-one mapping to the '107. Low/none for the CBM2014-00175 panel names — not surfaced, and I have declined to guess.

I'll begin by attempting to locate the actual recorded assignment data (reel/frame, correspondent) for US 7,765,107 and related entities, then cross-check corporate history.

Now let me try to pull the actual reel/frame and correspondent data from assignment-specific sources.

Ownership Reconstruction — US 7,765,107 B2

Source limitation (read first). The USPTO Assignment Center (https://assignmentcenter.uspto.gov/) and the legacy https://assignment.uspto.gov/patent/index.html are JavaScript applications whose record-level detail (reel/frame, execution date, correspondent of record) is not exposed to the retrieval methods available in this session. I was therefore unable to retrieve a single verified reel/frame number or correspondent name for this patent. Everything below that is labeled as recorded is taken from the USPTO-sourced assignment/legal-events data mirrored on the Google Patents page for US 7,765,107 (provided as authoritative in this task), which reports conveyance type, assignor, assignee, and date but not reel/frame or correspondent. I have not filled the gaps with invented numbers. Where the prior section and this section overlap, I flag the reconciliation explicitly at the end.

Inventors

What the record does show: the three inventors are identical across the whole family (confirmed in the PTAB/docket records for IPR2015-00547 and IPR2015-01820, which list "Dayton T. Reardan, Patti A. Engel, Bob Gagne"). The claimed subject matter is the Xyrem® restricted-distribution program — the drug was Orphan Medical, Inc.'s NDA product (FDA approval July 2002), and the parent application was filed 2002-12-17, i.e. ~2.5 years before Jazz Pharmaceuticals, Inc. acquired Orphan Medical. Yet the as-issued assignee on the face of the patent is JPI Commercial LLC, a Jazz subsidiary. That juxtaposition is the strongest available inference that the inventors were Orphan Medical personnel whose invention passed to Jazz through the 2005 merger.

Pattern notes (as requested):

• Inventor-departure data: not available. I found no source (assignment cover sheets, SEC filings, or news) evidencing when any inventor left the original assignee. I am explicitly recording this as "no data," not as "no departures." Do not treat the absence as a negative finding.
• Real anomaly observed — applicant/business reality mismatch: an application filed 2002-12-17 and a divisional filed 2005-04-01 both carry JPI Commercial LLC as the applicant/filer, even though the merger agreement between Jazz Pharmaceuticals, Inc., Twist Merger Sub, Inc. and Orphan Medical, Inc. is dated 2005-04-18 (i.e. 17 days after the divisional filing) and closing was expected June 2005 (Simpson Thacher press release, 2005-05-11). Either (a) a pre-closing intra-group assignment existed that is not shown in the indexed event list, or (b) the indexed "application filed by" attribution is back-filled from the later-recorded assignment. This is unresolved and is worth pulling the actual reel/frame to settle, because it determines whether the recorded chain begins pre- or post-closing.

Original assignee

JPI Commercial LLC (named on the issued patent). Per Jazz's own SEC filings, JPI Commercial, LLC was "a wholly-owned subsidiary of Jazz Pharmaceuticals, Inc." (Jazz 8-K dated February 10, 2009, re the Solvay LUVOX CR license; also the Senior Secured Note and Warrant Purchase Agreement dated March 14, 2008 "by and among the Registrant, JPI Commercial, LLC and the Purchasers named therein," listed as Exhibit 4.5A in the FY2008 10-K/A).

• Product embodying the claims: Yes — the claims describe the Xyrem® (sodium oxybate) restricted-distribution system. Xyrem was commercialized through a single exclusive central pharmacy (referred to in the spec as "SDS"), and Jazz later launched the successor Xywav® (JZP-258) in November 2020.
• Primary line of business: specialty biopharmaceutical (neuroscience; now also oncology).
• Current status: the original assignee (JPI Commercial LLC) is/was an operating subsidiary inside a public company group, not a standalone entity. The group chain of custody is: Orphan Medical, Inc. (public, Minnetonka MN) → acquired by Jazz Pharmaceuticals, Inc. (private, KKR-backed) for $10.75/share, ~$140M, merger agreement 2005-04-18, closed June 2005 → Jazz Pharmaceuticals, Inc. combined with Azur Pharma to form Jazz Pharmaceuticals plc (Irish holding company, NASDAQ: JAZZ) in 2012 → Jazz Pharmaceuticals, Inc. continues as the US subsidiary that owns the Xyrem distribution patents (confirmed by the D. Del. complaint, which states the '488/'885/'956/'931 patents "are owned by Jazz Pharmaceuticals, Inc."). No bankruptcy, no dissolution, no wind-up of the original assignee or its parents was found.
• One caveat on JPI Commercial LLC's current existence as a separate legal entity: not verified. It appears as an obligor/assignor through the 2010 recordings but I did not find a 2020s-era reference.

Assignment timeline

Global caveat for this section: every entry below is an encumbrance or intra-group transfer recorded against the patent family, as listed in the authoritative record supplied for this task (Google Patents legal events, sourced from USPTO assignment data). Reel/frame: not retrieved. Correspondent: not retrieved — for any entry. Dates shown are the dates carried in that record (in Google's convention these are typically the recordation dates reported by the assignment database, which may differ from the execution date on the cover sheet). Conveyance types are quoted as recorded, including the "Assigned to X" phrasing, which for security interests means lien recorded, not title transferred.

• 2005-04-01 / recorded 2005-04-01 — Reel/Frame not retrieved

  • Conveyance: Application filed by JPI Commercial LLC (ownership baseline, not an assignment)
  • Assignor: n/a
  • Assignee/applicant: JPI Commercial LLC
  • Correspondent: not retrieved
  • Context: anomaly — divisional filed 17 days before the April 18, 2005 merger agreement, yet attributed to a Jazz subsidiary; see Inventors section.

• 2005-07-29 / recorded 2005-07-29 — Reel/Frame not retrieved

  • Conveyance: Security Interest (see document for details)
  • Assignor: Twist Merger Sub, Inc.
  • Assignee: LB 1 Group Inc.
  • Correspondent: not retrieved
  • Context: securitization — collateral grant tied to the KKR/LB-backed financing of the Orphan Medical acquisition. Record anomaly: Twist Merger Sub, Inc. was the merger sub that by the merger agreement's own terms "shall cease" its separate corporate existence at the effective time, so its appearance as assignor/grantor is either a cover-sheet naming artifact or a pre-effective-time document; worth verifying on the face of the recorded instrument.

• 2008-04-04 / recorded 2008-04-04 — Reel/Frame not retrieved

  • Conveyance: Security Agreement
  • Assignor: JPI Commercial, LLC
  • Assignee: LB I Group Inc.
  • Correspondent: not retrieved
  • Context: securitization — corroborated by the SEC-listed "Senior Secured Note and Warrant Purchase Agreement, dated as of March 14, 2008, by and among the Registrant, JPI Commercial, LLC and the Purchasers."

• 2010-06-30 / recorded 2010-06-30 — Reel/Frame not retrieved

  • Conveyance: Security Agreement
  • Assignor: Jazz Pharmaceuticals, Inc.
  • Assignee: Silicon Valley Bank
  • Correspondent: not retrieved
  • Context: securitization (venture-debt style blanket lien).

• 2010-06-30 / recorded 2010-06-30 — Reel/Frame not retrieved

  • Conveyance: Release by Secured Party
  • Assignor: LB I Group, Inc.
  • Assignee: JPI Commercial, LLC
  • Correspondent: not retrieved
  • Context: lien release — the 2008 LB I Group security interest is discharged.

• 2010-11-12 / recorded 2010-11-12 — Reel/Frame not retrieved

  • Conveyance: Merger
  • Assignor: Orphan Medical, Inc.
  • Assignee: Orphan Medical, LLC
  • Correspondent: not retrieved
  • Context: internal reorganization / merger — conversion of the acquired Orphan entity into an LLC form.

• 2010-11-12 / recorded 2010-11-12 — Reel/Frame not retrieved

  • Conveyance: Assignment of Assignors Interest
  • Assignor: Orphan Medical, LLC
  • Assignee: JPI Commercial, LLC
  • Correspondent: not retrieved
  • Context: internal reorganization — consolidation of the Xyrem IP into Jazz's commercial subsidiary.

• 2010-11-17 / recorded 2010-11-17 — Reel/Frame not retrieved

  • Conveyance: Assignment of Assignors Interest
  • Assignor: JPI Commercial, LLC
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrieved
  • Context: internal reorganization — cleanup of record ownership to the ultimate US parent.
  • Note: this recording post-dates the first infringement suit naming the '107 patent (Roxane, D.N.J. 2:10-cv-06108, filed 2010-11-22 was the first of the series; the '107 was also asserted in the earlier-filed '730-family actions). See NPE signal 5.

• 2010-11-26 / recorded 2010-11-26 — Reel/Frame not retrieved

  • Conveyance: Merger (same parties as the 2010-11-12 merger)
  • Assignor: Orphan Medical, Inc. → Assignee: Orphan Medical, LLC
  • Correspondent: not retrieved
  • Context: duplicate recordation / bookkeeping cleanup — identical conveyance recorded a second time 14 days later.

• 2010-11-26 / recorded 2010-11-26 — Reel/Frame not retrieved

  • Conveyance: Assignment of Assignors Interest (same parties as the 2010-11-12 assignment)
  • Assignor: Orphan Medical, LLC → Assignee: JPI Commercial, LLC
  • Correspondent: not retrieved
  • Context: duplicate recordation / bookkeeping cleanup.

• 2010-12-22 / recorded 2010-12-22 — Reel/Frame not retrieved

  • Conveyance: Assignment of Assignors Interest (same parties as the 2010-11-17 assignment)
  • Assignor: JPI Commercial, LLC → Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrieved
  • Context: duplicate recordation / bookkeeping cleanup — third pass at the same intra-group transfer; effect is that title of record sits with Jazz Pharmaceuticals, Inc.

• 2011-12-30 / recorded 2011-12-30 — Reel/Frame not retrieved

  • Conveyance: Release
  • Assignor: Silicon Valley Bank → Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrieved
  • Context: lien release — discharges the 2010-06-30 SVB security agreement.

• 2012-08-06 / recorded 2012-08-06 — Reel/Frame not retrieved

  • Conveyance: Security Interest
  • Assignors: EUSA Pharma (USA), Inc.; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals, Inc. → Assignee: Barclays Bank PLC, as Collateral Agent
  • Correspondent: not retrieved
  • Context: securitization — group-wide collateral package in connection with the Azur Pharma/plc transaction financing; the '107 rides along on a schedule.

• 2015-06-19 / recorded 2015-06-19 — Reel/Frame not retrieved

  • Conveyance: Security Agreement
  • Assignors: Jazz Pharmaceuticals International III Limited; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals Ireland Limited; Jazz Pharmaceuticals, Inc. → Assignee: Bank of America, N.A., as Collateral Agent
  • Correspondent: not retrieved
  • Context: securitization — refinancing; Barclays replaced by BofA as collateral agent.

• 2015-07-09 / recorded 2015-07-09 — Reel/Frame not retrieved

  • Conveyance: Release by Secured Party
  • Assignor: Barclays Bank PLC, as Collateral Agent → Assignees: EUSA Pharma (USA), Inc.; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals, Inc.
  • Correspondent: not retrieved
  • Context: lien release.

• 2021-05-05 / recorded 2021-05-05 — Reel/Frame not retrieved

  • Conveyance: Release by Secured Party
  • Assignor: Bank of America, N.A. → Assignees: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals International III Limited; Celator Pharmaceuticals, Inc.; Cavion, Inc.; Jazz Pharmaceuticals Ireland Limited
  • Correspondent: not retrieved
  • Context: lien release — the last recorded event touching the patent; title unaffected.

• 2026-09-16 — Adjusted expiration (legal-status event, not an assignment).

Ownership conclusion from the timeline: title of record for US 7,765,107 has never left the Jazz corporate family. No recorded assignment to any third party, licensing entity, or assertion vehicle exists in the retrieved record. Every post-2010 entry is either a group security interest or its release.

Timeline diagram

timeline
    title Ownership of US 7765107
    2002 : Parent application filed
    2005 : Divisional filed by JPI Commercial LLC
         : LB 1 Group security interest
    2008 : LB I Group security agreement
    2010 : SVB security agreement
         : Release of LB I Group lien
         : Orphan Medical merger chain
         : Title recorded to Jazz Pharmaceuticals Inc
    2011 : SVB lien released
    2012 : Barclays collateral security interest
         : Jazz Inc folded under Jazz plc
    2015 : Bank of America security agreement
         : Barclays lien released
    2021 : Bank of America lien released
    2026 : Adjusted expiration recorded

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The only LLCs in the chain are Orphan Medical, LLC and JPI Commercial, LLC, both recorded on 2010-11-12/2010-11-26/2010-11-17/2010-12-22, and both are Jazz's own corporate family: SEC filings describe JPI Commercial, LLC as "a wholly-owned subsidiary of Jazz Pharmaceuticals, Inc." (Exhibit 4.5A, Jazz FY2008 10-K/A; Jazz 8-K of 2009-02-10). Neither entity has the licensing-vehicle tell (no "IP/Holdings/Ventures" naming, no registered-agent address of record surfaced, no third-party assertions). The chain ends at an operating company.

2. Known asserter in the chain — NOT PRESENT. Nothing in the chain matches Acacia, Marathon Patent Group, Intellectual Ventures, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, or any Spangenberg entity. The plaintiff of record across the D.N.J. actions (2:10-cv-06108 Roxane; 2:13-cv-07884 Par; 2:13-cv-00391 Amneal; 2:14-cv-04467 Ranbaxy; 2:14-cv-07757 Watson) is Jazz Pharmaceuticals, Inc. itself — the product company.

3. Repeat correspondent across the chain — UNVERIFIABLE / unclear. The correspondent-of-record field was not retrievable in this session for any of the 15 recorded events. This is the one classic NPE tell that cannot be run here, and I will not simulate it. If the correspondent recurs across the 2005-07-29 and 2008-04-04 LB I Group lien records and the 2010 releases, that would be ordinary lender's-counsel behavior (Simpson Thacher & Bartlett LLP acted for Jazz on the 2005 acquisition per its own 2005-05-11 release; Dorsey & Whitney LLP is named as the closing venue in the merger agreement, consistent with Orphan Medical's Minnesota counsel), i.e. operating-company/deal counsel, not NPE-assertion counsel. That is an expectation, not a finding — mark it unclear pending reel/frame pull.

4. Cascading transfers through chained LLCs in <24 months — NOT PRESENT as an NPE cascade; PRESENT as a record anomaly. Four ownership-type recordings land inside a 40-day window (2010-11-12, 2010-11-12, 2010-11-17, 2010-11-26, 2010-11-26, 2010-12-22), tracing Orphan Medical, Inc. → Orphan Medical, LLC → JPI Commercial, LLC → Jazz Pharmaceuticals, Inc. But (a) they are all within one corporate family, (b) there is no change of correspondent address or principal attributable to them on the record available, and (c) the 11-12/11-26 duplication looks like re-recordation of the same 2005 merger/assignment paper to cure a chain-of-title gap before assertion — i.e. pre-litigation title cleanup, not NPE formation. Flag: the duplicate pairs should be checked for a "Correction" or "corrective assignment" conveyance on the underlying cover sheets.

5. Pre-litigation transfer — NOT PRESENT. The last title-changing recordation (to Jazz Pharmaceuticals, Inc.) is 2010-12-22; the first suits naming the '107 patent in the retrieved record are the 2010 Roxane action (D.N.J. 2:10-cv-06108, consolidated, filed 2010-11-22 — i.e. before the 12-22 recording, which actually cuts against the "arranged transfer to enable suit" theory) and then the 2013-2014 actions — years after the transfer. The chain was not re-papered in the six months before any suit.

6. Bankruptcy fire-sale — NOT PRESENT. No Chapter 7/11 filing by Orphan Medical, Jazz Pharmaceuticals, Inc., or Jazz Pharmaceuticals plc appears in the record or in the SEC/court material retrieved. Note as counter-context: Orphan Medical did enter a 2007 deferred-prosecution/plea arrangement (criminal fine $5M + $12,262,078 restitution, Non-Prosecution Agreement with Jazz Pharmaceuticals, Inc., 2007-07-13) — that is a criminal/off-label-marketing matter, not an insolvency event, and it did not put the portfolio into play.

7. Privateering — NOT PRESENT. Jazz asserts its own REMS/distribution patents against actual ANDA competitors and does not appear to have handed them to an outside monetization vehicle. The Xyrem litigation economics (reverse-payment settlements with Par, Hikma, Amneal, Lupin; authorized-generic royalties) run through Jazz, per the N.D. Cal. / D. Minn. antitrust complaints (e.g., 3:20-cv-04056/04064; D. Minn. 0:21-cv-00577), which pleads Jazz as the sole beneficiary — the opposite of privateering.

8. Defensive aggregator (anti-NPE) — NOT PRESENT. Nothing terminates at RPX, AST, LOT, Unified Patents, or OIN.

Economic neutralizer worth recording: the asset was killed by validity, not by transfer. IPR2015-00547 (Amneal/Par v. Jazz) ended in a Final Written Decision on 2016-07-27 holding claims 1–6 of the '107 patent unpatentable under § 103 over the FDA Advisory Committee Art; IPR2015-01820 (Wockhardt Bio AG et al.) was joined and terminated the same day; and the Board's determinations were *affirmed in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 895 F.3d 1347 (Fed. Cir. 2018)* (addressing "periodic reports," "information identifying patients," and "credentials," plus public accessibility of the ACA materials). A CBM review, CBM2014-00175 (Roxane et al.), was not instituted (decision 2015-02-09). Any monetization value in this specific patent was extinguished in 2016–2018.

Verdict

Operating-company assertion.

Justification: Title of record never leaves the Jazz corporate family — JPI Commercial LLC (the as-issued assignee) is described in Jazz's own SEC filings as a wholly-owned subsidiary of Jazz Pharmaceuticals, Inc., and every post-2010 recorded event is either an intra-group merger/assignment (2010-11-12 through 2010-12-22) or a group lien and its release (SVB 2010-06-30/2011-12-30; LB I Group 2008-04-04/2010-06-30; Barclays 2012-08-06/2015-07-09; Bank of America 2015-06-19/2021-05-05). No NPE-list entity appears anywhere in the chain, and the asserting plaintiff is Jazz Pharmaceuticals, Inc. against actual ANDA competitors (D.N.J. 2:10-cv-06108; 2:13-cv-07884; 2:13-cv-00391; 2:14-cv-04467; 2:14-cv-07757) for a product Jazz commercially sells (Xyrem®, later Xywav®). The litigation volume is high and the settlement/authorized-generic behavior is antitrust-controversial, but that is brand-vs-generic exclusivity warfare, not NPE monetization. The single residual "troll-tell" — repeat correspondent of record — could not be tested because reel/frame and correspondent data were unretrievable in this session; that gap does not change the verdict but does leave signal 3 unresolved.

Verification link: USPTO Assignment Center — search by patent number 7765107 / application 11/097,985: https://assignmentcenter.uspto.gov/ (patent-page cross-reference: https://patents.google.com/patent/US7765107/en)

Cross-reference against the previously generated section (contradictions / clarifications)

• Consistent, no contradiction: inventors; filing 2005-04-01; priority 2002-12-17; issue 2010-07-27; divisional of 10/322,348; the IPR2015-00547 FWD date 2016-07-27; Wockhardt IPR2015-01820 filed 2015-08-27 and terminated 2016-07-27; CBM2014-00175 not instituted; the "no 2026 CAFC docket located" statement. The retrieved PTAB records independently confirm the 7/27/2016 FWD and the Wockhardt termination date.
• New detail added, not a contradiction: the earlier section described the ownership history only as "original assignee JPI Commercial LLC / current assignee Jazz Pharmaceuticals Inc." The record actually contains ~15 recorded events, including an Orphan Medical, Inc. → Orphan Medical, LLC → JPI Commercial, LLC → Jazz Pharmaceuticals, Inc. chain recorded in late 2010, plus a LB 1 Group Inc. / LB I Group Inc. lien pair and Silicon Valley Bank, Barclays, and Bank of America lien/release pairs. The earlier summary omitted these because the assignment data was not its focus.
• Flagged discrepancy (already noted in the prior section, now sharpened): the record shows status "Expired – Fee Related" alongside adjusted expiration 2026-09-16, while the Orange Book listing reflected in Par's 2013 Paragraph IV notice letter states the '107 expires June 16, 2024. Cross-check: the family sibling US 7,797,171 ('651, filed the same day as the '107) is listed Active with adjusted expiration 2026-07-19 — a date in the same ~2026 ballpark as the '107's 2026-09-16, which suggests both reflect the same PTA-adjusted term and that the "Expired – Fee Related" status line may be a data artifact. The June 16, 2024 OB date is not reconcilable with either. I report all three literally and do not resolve them.
• Flagged anomaly not in the prior section: the "filed by JPI Commercial LLC on 2005-04-01" attribution versus the 2005-04-18 merger agreement date (see Inventors section) — a genuine chain-of-title question that only the underlying reel/frame documents can settle.
• Excluded evidence (for transparency): a web search surfaced reel/frame strings 4667/0065 and 4671/0001 (a "Release of Security," recorded 2011-11-03 and shortly after) inside a TTAB opposition exhibit. Those records involve different, unnamed parties and I could not tie them to Jazz, JPI Commercial, or Orphan Medical. They are excluded and must not be cited as this patent's reel/frame.

I'll verify the specific patent record and key cited references via search, then build the prior-art analysis. Let me run several targeted searches.

I have strong confirmation of the record, the IPR prior-art set, and the Celgene references. Let me verify a few more of the most arguably-relevant cited references.

Prior-Art Analysis — US Patent No. 7,765,107 B2

"Sensitive drug distribution system and method" — App. 11/097,985; filed 2005‑04‑01; earliest effective filing 2002‑12‑17; issued 2010‑07‑27; inventors Reardan, Engel, Gagne; original assignee JPI Commercial LLC (now listed as Jazz Pharmaceuticals, Inc.).

Provenance of this analysis. Every reference below is taken from the citation lists printed on the '107 record itself (the "Citations (41)" and "Patent Citations (49)" IDS lists retrieved from the USPTO/Google Patents record at https://patents.google.com/patent/[US7765107](/patent/US7765107)/en), cross‑checked against the PubChem patent record (https://pubchem.ncbi.nlm.nih.gov/patent/US-7765107-B2) and against the IPR record for the '107 patent. I have not auto‑corrected any number, date, or assignee; where the record is internally inconsistent I report it literally.

1. Threshold legal framing (read this before the table)

Two points govern the answer, and I want to be explicit rather than dress up the result:

(a) No cited patent reference anticipates claims 1–6 under §102. Anticipation requires a single reference disclosing every element of a claim as arranged. Claims 1 and 4 each require, in combination: (i) an exclusive central pharmacy, (ii) a single central database that processes all prescriptions, (iii) pattern detection from reports generated only by that database, and (iv) selection of a long enumerated bundle of "multiple controls" — including the very specific limitation that physician eligibility is verified "by consulting the National Technical Information Services" (NTIS). No patent in the IDS discloses that full combination. Accordingly, the honest answer for each reference is "no single‑reference §102 anticipation of claims 1/4"; the references are relevant as §103 obviousness art and as partial §102(a)/(b)/(e) art against sub‑elements.

(b) The art that actually invalidated the '107 claims was not any patent citation. In IPR2015‑00547 ([Amneal Pharmaceuticals, LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%2C%20LLC) et al. v. Jazz Pharmaceuticals, Inc.), FWD 2016‑07‑27 (claims 1–6 unpatentable), the Board relied exclusively on the FDA Advisory Committee materials ("ACA") — non‑patent literature — under 35 U.S.C. §103, not on the patents cited on the '107 face. Confirmed by the FWD and by the Federal Circuit's affirmance in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC (Fed. Cir. July 13, 2018), which held the ACA materials were §102(b) printed publications (Federal Register notice May 14, 2001, with a public FDA hyperlink). The ACA exhibits were:

Critical date applied: the Board used a §102(b) critical date of December 17, 2001 (one year before the 2002‑12‑17 effective filing). Publications before that date are §102(b) bars; publications between 2001‑12‑17 and 2002‑12‑17 are candidates only under §102(a)/(e).

2. Master table of cited references

"Claims" = the claim(s) each reference is most pertinent to; the §102 note records whether it could singly anticipate.

Tier 1 — Closest patent‑type art (drug‑distribution control / registry systems)

Tier 2 — Pharmacy dispensing, order execution, and fulfillment infrastructure

Tier 3 — Peripheral / non‑analogous art

Additional IDS entries appearing on some versions of the record

PubChem's citation list for US‑7765107‑B2 adds US 4,847,764 C1 (reissue of the Meditrol '764 patent), US 6,347,329 B1, and US 2002/0042725 A1. I could not re‑run full‑text verification of '329 and 2002/0042725 before reaching the tool limit; I flag them rather than characterize them from memory. '329 appears to be a records/database‑type reference; treat its description as unverified.

3. Deep dive on the four references that matter most

1. US 6,045,501 A (Celgene, Elsayed et al.), filed 1998‑08‑28, issued 2000‑04‑04.
Discloses the canonical restricted‑distribution architecture: a computer‑readable storage medium registering prescribers, pharmacies, and patients; verification that prescriber/pharmacy/patient are registered and qualified; counseling/education of the patient; and authorization of the pharmacy to dispense only in response to a computer‑determined eligibility check. This maps onto claim 1 elements: "verifying the physician is eligible," "verifying patient registry information," "providing comprehensive education information to the patient," and "verifying the patient has reviewed the educational materials." §102: cannot anticipate claim 1 or claim 4 because it lacks the exclusive central pharmacy, the single central database processing all prescriptions, the NTIS verification step, and the shipping/logistics controls. Strong §103 art.

2. US 6,315,720 B1 (Celgene, Williams et al.), filed 2000‑10‑23, issued 2001‑11‑13.
Adds risk‑group assignment, periodic surveys/diagnostic tests to reassess ongoing risk, and generation of a prescription approval code before filling. The "periodic" re‑assessment is directly pertinent to the "periodic reports generated … by the central database" element (a term the Board and the Federal Circuit expressly construed in the '107 IPR), and the approval‑code concept maps to the verification controls. §102: no anticipation, for the same structural reasons as '501. Very high §103 relevance.

3. US 2003/0093295 A1 (Lilly), filed 2001‑11‑14, published 2003‑05‑15.
A central, independent information utility aggregating prescriptive‑medication data to control abuse, with specified access by government oversight bodies (DEA et al.). Pertinent to claims 1/4's "central database that tracks all prescriptions … and analyzes for potential abuse" and to the "making the database available to the DEA" control. §102: no anticipation. Note the prosecution remark quoted in the file record for this family — the applicant distinguished Lilly on the ground that "distribution of a sensitive drug by an exclusive central pharmacy" is not disclosed — which is itself the reason the reference cannot anticipate.

4. US 2003/0229519 A1 (Eidex), filed 2002‑05‑16, published 2003‑12‑11.
Fraud‑and‑abuse analytics on prescription claims — the closest cited art to the claims' pattern‑detection step ("current and anticipated patterns of potential prescription abuse"). §102: no anticipation; it is claim‑data analytics without a controlled distribution channel. Useful §103 art on the detection element.

Reference the IPR cited that is outside the '107 IDS: the petitioner also cited US 2004/0176985 A1 (Lilly et al.), "Controlled substance tracking system and method," filed 2004‑03‑18, published 2004‑09‑09 (Ex. 1010). Literal date check: its filing and publication are after the '107's 2002‑12‑17 effective filing, so it is not §102 prior art to the '107 and could not itself anticipate any claim. It appears to have been offered as context/state‑of‑the‑art, not as an anticipatory reference.

4. Bottom line

Confidence / caveats. High confidence on the identity, dates, and assignees of the Tier‑1 references (verified via Google Patents/PubChem and the IPR exhibits), and high confidence that no cited patent anticipates (structural analysis of the claim language). Medium confidence on the one‑line characterizations of the Tier‑2/Tier‑3 references, several of which I characterized from the record short titles rather than full text because the tool budget was exhausted mid‑verification; those are flagged in the tables. Two IDS entries (US 6,347,329 B1 and US 2002/0042725 A1) remain uncharacterized and should be pulled individually if they are material to your purpose.

One inconsistency to flag against the prior sections: the earlier summary describes the '107 independent claims as a "closed‑universe checklist" and reads claim 1's control list as "consisting of"‑flavored. That is accurate for the pre‑grant published claim 26 ("selected from the group consisting of …"), but the granted claim 1 reads "the controls comprising …", which is an open recitation. The distinction matters for §102/§103 scope and should be carried forward.

I'll research the specific prior-art grounds used against this patent family and verify the reference combinations, then build the obviousness analysis grounded in the Prior Art section.

Let me pin down the exact grounds and secondary references from the '107 Final Written Decision.

Obviousness Analysis — US 7,765,107 B2 under 35 U.S.C. § 103

Scope note / cross-reference to earlier sections. This analysis builds on the previously generated Patent summary and Litigation summary and does not restate them. Two refinements should be flagged up front because they affect the § 103 picture:

1. The prior summaries describe the Final Written Decision (FWD, July 27, 2016) as resting on the Advisory Committee Art ("ACA"). That is correct, but it was Ground 1 only. The Petitioners also pleaded a second, independent § 103(a) ground — Talk About Sleep in view of Honigfeld, Elsayed and Lilly — and the Board instituted on Ground 1 only. The earlier summaries did not mention Ground 2; this is a refinement, not a contradiction.
2. The earlier summary's PTAB table is corroborated: the IPR2015-00547 institution decision caption reads Par Pharmaceutical, Inc. and [Amneal Pharmaceuticals, LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%2C%20LLC) v. Jazz Pharmaceuticals, Inc., and the FWD issued as Paper 12 on July 27, 2016. Wockhardt Bio AG's IPR2015-01820 is described in its own petition as an "almost verbatim copy" of the '547 petition, filed with a motion for joinder.

1. Legal framework applied

Pre-AIA § 103(a) governs (priority date December 17, 2002; critical date December 17, 2001 for § 102(b) purposes). The analysis follows Graham v. John Deere Co., 383 U.S. 1 (1966) (scope/content of prior art; differences; level of ordinary skill; secondary considerations) and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).

Notably, the Federal Circuit in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 895 F.3d 1347 (Fed. Cir. 2018) (appeal no. 2017-1675) rejected Jazz's argument that KSR imposes a rigid two-part "problem to be solved + finite universe of options" test, holding that such an approach is "the exact sort of 'rigid preventative rule that denies factfinders recourse to common sense' the Court rejected." That holding directly governs the motivation-to-combine question for the '107 patent.

Level of ordinary skill. Consistent with the Petitioner's expert (Robert J. Valuck, Ph.D., R.Ph., Ex. 1007) and the Board's POSA framing as of December 17, 2002, the POSA is a person with a pharmacy or healthcare-informatics background (e.g., a Pharm.D. or R.Ph. with several years in drug distribution practice, or equivalent) who is familiar with: (i) DEA/state controlled-substance controls, (ii) FDA restricted-distribution/Subpart H risk-management programs, and (iii) then-conventional computerized prescription and registry databases. This is a low-to-moderate skill level, which cuts against nonobviousness of an administrative/logistics checklist.

2. The invention as a whole (what must be shown)

Claims 1 and 4 are independent; claims 2/3 depend from 1, and 5/6 depend from 4 (GHB-specific). The independent claims are, in substance, a closed enumerated bundle of diversion controls executed with a computer processor, anchored on (a) a single exclusive central pharmacy, (b) a single central database, and (c) periodic reports used to detect "current and anticipated patterns" of abuse. As the earlier summary and the Federal Circuit's claim-construction discussion show, the key constructions are "exclusive central database," "information identifying [patients]," "periodic reports," and "credentials" (construed to require at least two different types of credentials).

3. Ground 1 — The Advisory Committee Art (as adjudicated; claims 1–6 unpatentable)

The four ACA documents (Exs. 1003–1006) were treated as one publicly accessible body of prior art:

Prior-art status. Accessibility was established from the May 14, 2001 Federal Register Notice (66 Fed. Reg. 24,391), which hyperlinked the FDA docket site and told readers to "Click on the year 2001 and scroll down to the Peripheral and Central Nervous Systems Drugs meetings." The Board found the materials accessible no later than October 4, 2001 — more than one year before the '107 critical date. The Federal Circuit affirmed, holding that "public accessibility" is the touchstone; that indexing/searchability is not independently required; and that "there is no requirement to show that particular members of the public actually received the information."

Element mapping (claim 1):

Claim 1 step 1.5 control-by-control mapping to the ACA:

• physician → central pharmacy communication; identifying name/license/DEA; verifying the prescription; obtaining patient information — the ACA's closed system requires prescriber enrollment and prescription verification calls.
• verifying physician is eligible (NTIS check for active DEA number and pending actions) — the ACA discloses prescriber eligibility verification. Flag: the specific "National Technical Information Services" element is the limitation for which I have the least direct visibility into the Board's mapping; the operative substance (confirming active DEA registration / no adverse actions) is what the art supplies. Treat this element as the one most vulnerable to a renewed written-description/claim-construction attack rather than as squarely adjudicated.
• printed materials to physician; patient education; verifying patient reviewed materials — ACA educational/enrollment materials.
• insurance contact; patient registry verification; home-address verification — ACA enrollment/verification steps.
• shipping via USPS or commercial carrier; 18-year-old designee; confirming receipt of initial shipment; return after two failed deliveries; lost-shipment investigation — ACA home-delivery/signature controls.
• shipping to another pharmacy for delivery; single-location manufacture; controlled inventory release — ACA's specialty-pharmacy network and single-site manufacture.
• questioning early refills; flagging repeat lost/stolen/destroyed/spilled prescriptions; one-month supply; periodic rewriting — Ex. 1004 flagging language; refill controls.
• DEA database access for abuse patterns, cash payments, inappropriate questions — ACA's abuse-pattern reporting to regulators.

Claim 4 (GHB-specific) adds nothing beyond the drug identity: the ACA is about Xyrem®/sodium oxybate/GHB. Claim 4 is therefore obvious for the same reasons as claim 1.

Claim 2 (from claim 1) and claim 5 (from claim 4) — the "initially selected controls." These recite a subset of the claim-1 controls. Selecting a subset of a disclosed set is the paradigm of an obvious narrowing; the choice is also dictated by the regulatory sequence (what must happen before first shipment). Such an "initial set" designation involves no patentable weight beyond the ordering of the same already-obvious steps.

Claim 3 (from claim 1) and claim 6 (from claim 4) — "consulting a separate database to verify that the medical doctor is eligible to prescribe the drug." A POSA routinely cross-checks prescriber licensure/DEA status against an external source (state boards of medicine/pharmacy, DEA registrant data). This limitation is obvious over the ACA in view of, e.g., US 7,467,113 (Walgreen, "License verification system and method," cited in the '107 family's citing-art list), US 6,687,676 (Prescription verification system), or US 2001/0047281 A1 (Secure on-line authentication system for processing prescription drug fulfillment) — all listed on the face of the patent/family record. Motivation: independent confirmation of a regulatory credential is a stated goal of every restricted-distribution program (Accutane, Clozaril, thalidomide S.T.E.P.S.), and it is trivially enabled by then-existing networked databases.

Result: claims 1–6 unpatentable as obvious over the ACA. Affirmed, 895 F.3d 1347.

4. Ground 1-a — ACA modified by a distributed/networked database reference

In the sibling '107-family IPRs (the '730/'988 decision, 2016 WL 7985458), the Board found a POSA "would have been motivated to modify the [ACA] distribution system to include multiple computers in a distributed database system for reasons of cost, efficiency, and the anticipated volume of prescription-related information to be received, entered, and queried" (per Korfhage). The Federal Circuit expressly approved that reasoning. Because '107 claim 1 requires only a "central database" (not a distributed one), this ground is a fortiori available: any conceivable "computerization" gap in the ACA is filled by the ordinary, well-motivated use of a multi-computer implementation of the same registry. This is the cleanest answer to Jazz's argument that "the ACA doesn't say 'computerized.'"

5. Ground 2 — TAS + Honigfeld + Elsayed + Lilly (pleaded; not instituted)

Why the Board refused institution. The Board found "an essential difference between TAS and Honigfeld, Elsayed or Lilly is the use by Honigfeld, Elsayed, and Lilly of (i) a centralized registration database, and (ii) de-centralized systems that permit multiple registered pharmacies to dispense the prescription drug directly to patients." Honigfeld's database is controlled by the manufacturer, not a pharmacy, and the physician sends the Rx to a registered pharmacy rather than to an exclusive central pharmacy. The Board therefore found the pleaded combination did not teach an "exclusive central pharmacy that maintains a central database."

Analyst's view. The failure was one of pleading and reference characterization, not of technical unpatentability:

• TAS does disclose a single central pharmacy; Honigfeld/Elsayed supply the computerized central registry, credential capture and eligibility gating; Lilly supplies the abuse-pattern flagging (the "aberrant use flag" and multi-pharmacy comparison) that maps onto claim 1's "current and anticipated patterns of potential prescription abuse."
• The motivation to combine is strong and non-hindsight: TAS itself states the system "was designed by Orphan Medical with assistance and input from State Scheduling authorities, experts in specialty distribution, drug diversion investigators, field law enforcement, narcolepsy patient groups, and pharmacists experienced in dealing with" controlled distribution — i.e., the prior art itself points a POSA to the diversion-control references.
• A POSA seeking to keep a single-point-of-dispensing system (TAS) would look precisely to the Clozaril registry (Honigfeld) and the Celgene '501 S.T.E.P.S.-type registration system as the two dominant, FDA-accepted models for restricted distribution of a hazardous drug.

I flag, however, that the Board was not persuaded by the version presented, and I do not assert that a re-pleaded Ground 2 would necessarily have succeeded — the "exclusive central pharmacy, not a manufacturer, controlling the database" distinction is a real limitation and cannot be hand-waved.

6. Ground 3 — Generic restricted-distribution programs + a prescription-tracking database (built from the patent's own cited art)

This ground matters because it uses only references appearing in the "Prior Art"/Citations sections of the '107 record (plus the ACA for the product-specific core):

Primary/secondary distribution-program art:

• US 6,045,501 (Elsayed, Celgene) — cited on the face of the '107 patent — registered prescriber/pharmacy/patient model with authorization gating.
• US 6,315,720 (Celgene) — listed in the '107 family's citing-art record — the "Enhanced S.T.E.P.S.®" methodology (risk groups, affirmative risk assessment, approval code before dispensing).
• Clozaril CPMS / Honigfeld and Accutane Pregnancy Prevention Program ("PPP") — the federally-required, pre-2002 restricted-distribution programs; the Celgene v. Peter line (IPR2015-01092/01096/01102/01103; aff'd 931 F.3d 1342 (Fed. Cir. 2019)) shows these programs were ordinary prior art in the REMS space, and the Celgene patents themselves were held obvious over Powell, Mitchell (isotretinoin pregnancy-prevention), and Dishman (Clozapine at a VA medical center).

Computerized prescription-tracking art (supplies "computerized," "abuse patterns," "periodic reports"):

• US 2002/0042762 A1 (Mcquade), "Tracking the distribution of prescription drugs and other controlled articles"
• US 2003/0093295 A1 (Lilly Ralph B.), "Controlled substance tracking system and method"
• US 2003/0229519 A1 (Eidex), "Systems and methods for identifying fraud and abuse in prescription claims"
• US 5,845,255 (Prescription management system); US 5,924,074 (Electronic medical records system); US 6,021,392 (System and method for drug management); US 6,112,182 (Integrated management of pharmaceutical and healthcare services); US 6,055,507 (Dispensing, tracking and managing pharmaceutical trial products)
• US 2002/0032581 A1 (Reitberg), "Single-patient drug trials used with accumulated database: risk of habituation" — directly on point for monitoring accumulated data for habituation/abuse.
• US 2003/0197366 A1 (Kusterbeck), "Method and system for prescription distribution security"
• US 2001/0047281 A1 (Secure on-line authentication for prescription drug fulfillment); US 6,687,676 (Prescription verification system); US 2003/0160698 A1 (tracking pharmaceuticals within a facility)

The combination: Celgene '501/'720 + Clozaril CPMS/Accutane PPP (controls/architecture) in view of Eidex, Lilly, Mcquade and Reitberg (computerized abuse-pattern detection, aberrant-use flags, DEA-number capture, physician-level and patient-level pattern reports), in view of the ACA (the Xyrem®-specific single-national-pharmacy implementation).

Motivation to combine (this is the crux and where § 103 is won or lost):

• Same field, same problem. All references address restricting access to drugs with severe abuse/adverse-event profiles while preserving patient access — a unitary "endeavor."
• Regulatory compulsion, not hindsight — Subpart H (21 C.F.R. § 314.520) required a distribution restriction as a condition of approval; the Celgene record shows the FDA required other manufacturers to copy an approved program. The prior art supplies a strong, non-hindsight reason to assemble a REMS-style system.
• Predictable result. Combining a known single-central-pharmacy delivery model with a known computerized patient/prescriber registry and known abuse-pattern reports yields nothing more than the expected sum of the parts — the hallmark of KSR obviousness.
• No technical barrier. The Board/experts in the parallel Celgene and Jazz proceedings repeatedly found "no inadequacies in the technical knowledge that prevented the development of the claimed distribution program."

7. Secondary considerations (and why they did not save the claims)

Jazz's anticipated objective indicia, and the record responses:

Critically, Orphan itself told the FDA that the risk-management program would "eliminate[] the opportunity to 'fill the retail distribution pipeline'" — undercutting the commercial-success nexus.

8. Bottom line

Yes — claims 1–6 are obvious under § 103, and were so held. The strongest, cleanest combination is the ACA materials (Exs. 1003–1006), viewed as a single body of prior art, optionally modified by the ordinary networked/distributed-database teachings approved in the parallel Jazz v. Amneal proceedings. That ground alone invalidated all six claims (FWD July 27, 2016; aff'd 895 F.3d 1347).

Alternative, independently sufficient combinations:

1. TAS + Honigfeld + Elsayed ('501) + Lilly — technically strong on every element except the "exclusive central pharmacy" character of the database controller; as pleaded, the Board distinguished the references' decentralized multi-pharmacy dispensing and declined to institute.
2. Celgene '501/'720 + Clozaril CPMS/Honigfeld + Accutane PPP + Eidex/Lilly/Mcquade/Reitberg (computerized abuse-pattern tracking) — drawn almost entirely from references already of record on the '107 face; motivation supplied by FDA Subpart H compulsion and the unitary endeavor of anti-diversion drug distribution.
3. For dependent claims 3/6, add a prescriber-credential verification reference (US 7,467,113; US 6,687,676; US 2001/0047281) for the "separate database" element.

Confidence: High for the ACA ground and the claims 1–6 outcome (directly sourced from the institution decision, the FWD docket entry, and the Federal Circuit opinion). Medium-high for the alternative combinations (element mappings are corroborated from the '547/'106/'182 petition and institution-decision excerpts; I have not independently re-derived each cell of the claim charts). Element-specific caution: the "consulting the National Technical Information Services" limitation is the one element for which I could not locate a specific Board finding; I have treated it as supplied by the generic prescriber-eligibility/DEA-verification disclosures and flagged it rather than asserting a mapping.