US 8731963

I'll verify current docket/litigation status with live searches, then summarize the patent from the authoritative text provided.

Let me check for the Federal Circuit appeal of the IPR and any 2026 activity specifically tied to this patent.

US Patent 8,731,963 B1 — Verification Summary

Search note on scope: Per your instruction, these results are for 8,731,963 specifically. I found no live 2026 Court of Appeals for the Federal Circuit docket concerning this patent itself (see "Current Legal Status" below). Details of live CAFC case numbers appear at the end.

1. Bibliographic Data (source: Google Patents US8731963B1)

Continuity: Continuation of 13/013,680 (filed 2011-01-25) → continuation of 12/704,097 (filed 2010-02-11, issued 2011-02-22 as US 7,895,059) → continuation of 10/322,348 (filed 2002-12-17, issued 2010-02-23 as US 7,668,730). The '963 patent is one of 15 family applications (family ID 32507272).

2. 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."

3. Independent Claims — Plain-Language Overview

Claim 1 — System (narcolepsy drug with abuse potential)
A computer-implemented system for treating a narcoleptic patient with an abuse-prone prescription drug sold/distributed by a company that obtained approval to distribute it. It requires:

• Computer memory holding a single database whose schema interrelates prescription, patient, and prescriber fields (insurance fields optional per claim 13).
• Prescription fields store prescriptions for the drug; patient fields identify the narcoleptic patient; prescriber fields identify the prescriber and show the prescriber is authorized to prescribe.
• A data processor that (a) runs a database query operating over all data in the prescription/prescriber/patient fields for the drug, and (b) uses that query to reconcile drug inventory before shipments for a day (or other period) are sent.
• A second database query that identifies (i) the patient as a cash payer and (ii) a physician interrelated with that patient through the schema. The cash-payer identification is an indicator of potential misuse, abuse, or diversion, and is used to notify that interrelated physician.

The distinguishing hook is the combination of the exclusive/interrelated database plus the "cash payer" query driving physician notification.

Claim 23 — System (same core, inventory-blocking emphasis)
Substantially mirrors claim 1, but recasts the inventory element: the query identifies prescription- and patient-field information for reconciling inventory, where current inventory is counted and reconciled with database quantities before shipment, and the processor is configured to selectively block shipment based on the inventory reconciliation. It carries the same cash-payer/second-query/physician-notification limitation.

Claim 24 — System (central, company-wide database; "no abuse record" gating)
A system built around a central computer database of the company that obtained approval, receiving prescriptions from any and all patients prescribed the drug, distributed over multiple computers, storing prescription, patient, and prescriber fields, with prescriber fields identifying any and all prescribers and showing they are authorized. One or more processors run queries that check for abuse, and filling a prescription is authorized only if (a) there is no database record of abuse/misuse/diversion by the patient and prescriber, or (b) where such incidents exist, the database shows they were investigated and found not to involve abuse, misuse, or diversion.

Key dependent claims: blocking shipment (2); shipping if no abuse found (3); exclusive patient database (4); exclusive central pharmacy control (5); drug comprises GHB (6); relational/distributed DB (8); incomplete-field inquiry to prescriber (9); expected refill date and its computation (10–12); insurance fields (13); identifying current/anticipated abuse patterns and selecting controls (14–16); controls negotiated with an approval body, adding controls until approval (17–19); cycle counting (20); company-exclusive database (21–22).

4. Current Legal Status & Litigation (searched 2026-04-26)

• PTAB — IPR2015-01903, Par Pharmaceutical, Inc. et al. v. Jazz Pharmaceuticals, Inc. (filed 2015-09-14; instituted 2016-03-25; Final Written Decision 2017-03-22). Review was only partially instituted as to the '963 patent. Per the Federal Circuit's summary in Jazz Pharmaceuticals, Inc. v. [Amneal Pharmaceuticals, LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%2C%20LLC), the Board found claims 24, 26, and 27 of the '963 patent unpatentable as obvious (the other three patents' claims were largely held unpatentable as well). Patent Owner filed a Notice of Appeal 2017-05-18. (IPR2015-01903 record; Jazz v. Amneal, CourtListener)
• Orange Book: the '963 patent was listed for XYREM (NDA 021196) with expiration 2022-12-17 and pediatric exclusivity to 2023-06-17; it was also listed for XYWAV (NDA 212690).
• Avadel delisting dispute: On 2022-11-18 the District of Delaware ordered Jazz to request delisting of the '963 patent (the "REMS Patent") from the Orange Book; the Federal Circuit affirmed on 2023-02-24, and the patent was delisted. Jazz's '963 infringement claims and Avadel's corresponding invalidity/non-infringement counterclaims were dismissed by stipulation on 2023-03-07. (Avadel 10-Q disclosure)
• DAV/APA suit: Avadel CNS Pharmaceuticals, LLC v. Becerra (D.D.C. 1:22-cv-02159) asserted the '963 patent (REMS patent) against FDA in an APA challenge. (Stanford NPE dataset)
• 2026 check: A patent-litigation database (last updated 2026-03-11) shows district-court cases for 8,731,963 through 2021 filings, plus IPR2015-01903 — no new 2026 case naming the '963 patent. (DrugPatentWatch patent 8,731,963)

5. Uncertainty / Caveats

1. CAFC 2026 dockets: I could not access PACER/CM-ECF live dockets, so I cannot give an authoritative statement that no 2026 Federal Circuit filing exists that merely references the '963 patent. The CAFC case numbers listed on the Google Patents page for this family — 23-1186 and 24-2274 — appear tied to the broader Jazz/Avadel sodium-oxybate litigation (e.g., patents 10,758,488 and 11,147,782, per Avadel's 10-Q), not to the '963 patent itself. Treat that attribution as an inference, not a confirmed docket match.
2. Federal Circuit outcome of the IPR appeal: I did not retrieve the actual Jazz v. Amneal opinion text; the claim-level disposition (which of claims 1–23, 25, 28 survived) is stated above based on the court's summary quoted in search results, not on the opinion itself. Verify against Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347 (Fed. Cir. 2018) if claim-level precision matters.
3. Assignee nuance: Google Patents lists "Jazz Pharmaceuticals Inc" as original and current assignee; a citing-family listing shows the earliest family member (US 7,668,730) attributed to "JPI Commercial, LLC," indicating intra-family assignment history. The Google Patents notice that assignee data is not analyzed/verified applies.
4. Literal text notes: Claim 6 recites "gamma hydroxyl butyrate" (the specification uses "hydroxy buterate"/"butyrate"); claim 25's limitation refers to "said second database query" although the second query is recited in parent claim 24. I have reproduced these literally rather than correcting them.

I'll search for litigation involving US patent 8731963, focusing on litigation databases and court records.

Good results. Let me refine to get specific case numbers, and the earlier New Jersey litigations and IPR outcomes.

I searched for litigation specifically involving U.S. Patent No. 8,731,963. Below are the matters I could confirm, with sources. Note that I was not able to directly load the Unified Patents litigation portal (it appears JavaScript-dependent), so the case list is reconstructed from Google Patents' family/litigation data, PTAB records (docket/Docket Alarm, Patexia, Unified-linked dockets), Federal Circuit opinion PDFs, and Jazz/Avadel SEC filings.

A note on scope: the '963 patent ("Sensitive drug distribution system and method") is one member of a large family (U.S. 7,668,730; 7,765,106; 7,765,107; 7,797,171; 7,895,059; 8,457,988; 8,589,182; 8,731,963; and later continuations). Many suits asserted multiple family patents. I have flagged which matters I can tie specifically to the '963 patent versus those that are family-level litigation where the '963's role is not independently confirmed.

A. Post-grant proceedings (PTAB) — confirmed, patent-specific

1. [Amneal Pharmaceuticals LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%20LLC) and Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc.

• Forum: USPTO Patent Trial and Appeal Board
• Case No.: IPR2015-01903
• Patent: U.S. 8,731,963
• Filed: September 14, 2015; Instituted: March 25, 2016; Final Written Decision: March 22, 2017
• Petitioner(s): Amneal Pharmaceuticals LLC and Par Pharmaceutical, Inc. (some databases abbreviate to "Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc.") — I note the discrepancy in the petitioner listing as reported by different sources rather than correcting it.
• Patent Owner / Assignee: Jazz Pharmaceuticals, Inc. (assignee of record: Jazz Pharmaceuticals Ireland Limited)
• Outcome: Final Written Decision held claims 24, 26, and 27 unpatentable (obviousness; on-sale/§102-type public-disclosure grounds relating to the Xyrem REMS disclosed during FDA review). Board panel: Brian P. Murphy (author), Jacqueline Wright Bonilla, Susan L. C. Mitchell.
• Related appeal: No. 2017-1671 (Jazz/Par appeal); the parties settled during appeal, and on January 9, 2018 Jazz entered a settlement with Par resolving the district court and IPR matters (District Court dismissal order entered January 19, 2018).
• Sources: PTAB Final Written Decision PDF (https://www.docketalarm.com/cases/PTAB/IPR2015-01903/Inter_Partes_Review_of_U.S._Pat._8731963/docs/03-22-2017-Board/Final_Decision-31-Final_Written_Decision.pdf); Unified/Patexia summary (https://services.patexia.com/lawsuits/Par-Pharmaceutical-Inc-et-al-v-Jazz-Pharmaceuticals-Inc-id-64064); Federal Circuit opinion in Jazz Pharms., Inc. v. Amneal Pharms., LLC (https://www.courtlistener.com/opinion/[4516711](/patent/4516711)/).

B. District court (D.N.J.) — Hatch-Waxman/ANDA litigation over Xyrem

Jazz's own mandatory notices filed in IPR2015-01903 identify the '963 patent as the subject of these then-pending D.N.J. actions (Source: PTAB Mandatory Notices, https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1459711](/patent/1459711)/download-documents):

• Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC et al., 2:13-cv-0391 (consolidated) (D.N.J.) — '963 patent asserted.
• Jazz Pharmaceuticals, Inc. v. Wockhardt Bio AG et al., 2:15-cv-5619 (D.N.J.) — '963 patent asserted.
• Jazz Pharmaceuticals, Inc. v. Lupin Ltd. et al., 2:15-cv-6548 (D.N.J.) — '963 patent asserted.
• Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, Inc., 2:10-cv-6108 (D.N.J.) — identified by Jazz as concerning "patents related to the '963 patent."

Google Patents' litigation links for this family additionally list a series of D.N.J. case numbers (2:14-cv-04467; 2:14-cv-05139; 2:14-cv-07757; 2:15-cv-01043; 2:15-cv-05619; 2:15-cv-06548; 2:16-cv-04971; 2:17-cv-05487; 2:21-cv-14271). These are family-level litigation links; I could not independently confirm from the search results that the '963 patent itself was asserted in each. I present them as reported, without correction.

C. Jazz v. Avadel (D. Del.) — the principal '963-patent litigation, 2021–2023

This is the litigation in which the '963 patent was front-and-center.

2. Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC — "First Jazz Complaint"

• Jurisdiction: U.S. District Court for the District of Delaware
• Case No.: 1:21-cv-00691-GBW (consolidated/coordinated with C.A. Nos. 21-1138 and 21-1594)
• Filed: May 12, 2021
• Plaintiff: Jazz Pharmaceuticals, Inc. (with Jazz Pharmaceuticals Ireland Limited as to other patents)
• Defendant: Avadel CNS Pharmaceuticals, LLC
• Patents: five patents-in-suit, including U.S. 8,731,963 (the "REMS Patent"); Avadel's product: FT218 (later LUMRYZ, once-nightly sodium oxybate)
• Key '963 events:
  • Avadel filed a delisting counterclaim under 21 U.S.C. § 355(c)(3)(D)(ii)(I), seeking removal of the '963 patent from the Orange Book.
  • Court (D. Del.) Markman/claim construction ruling issued November 18, 2022, holding the '963 claims are directed to systems, not methods.
  • On November 18, 2022, the court granted Avadel's renewed motion for judgment on the pleadings and ordered Jazz to request delisting of the '963 patent from the Orange Book.
  • On March 7, 2023, on a joint stipulation, the court dismissed Jazz's '963 infringement claims and Avadel's related non-infringement/invalidity counterclaims.
  • Other patents in the consolidated case proceeded (e.g., U.S. 10,758,488 and 11,147,782), reaching a jury verdict in February/March 2024. (Those later patents are not the '963 patent.)
• Sources: D. Del. Mem. Op. (Nov. 18, 2022), https://litigationtracker.law.georgetown.edu/wp-content/uploads/2025/01/Jazz-Pharmaceuticals-Inc._2022.11.18_MEMORANDUM-OPINION.pdf; Avadel 10-K/10-Q disclosures (https://www.sec.gov/Archives/edgar/data/[1012477](/patent/1012477)/000101247724000008/avdl-20231231.htm).

3. Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC — "Fourth Jazz Complaint"

• Jurisdiction: U.S. District Court for the District of Delaware
• Case No.: 1:22-cv-00941-GBW (reported in the Federal Circuit opinion)
• Filed: July 15, 2022
• Plaintiff: Jazz Pharmaceuticals, Inc.; Defendant: Avadel CNS Pharmaceuticals, LLC
• Subject: Re-assertion of the '963 patent after the FDA required Avadel to file a Paragraph IV certification against it; Avadel answered (Oct. 21, 2022) with non-infringement/invalidity counterclaims, delisting counterclaim, and Sherman Act monopolization counterclaims.
• Outcome: Dismissed by stipulation of the parties; the court entered the stipulation on March 7, 2023 (same date as the First Complaint '963 dismissal).
• Source: Fed. Cir. opinion, Jazz Pharms. v. Avadel, No. 23-1186 (Feb. 24, 2023), http://cafc.uscourts.gov/opinions-orders/23-1186.OPINION.2-24-2023_2085825.pdf; Avadel SEC filings (https://about.avadel.investors.avadel.com/...; https://www.sec.gov/Archives/edgar/data/1012477/000101247725000010/avdl-20241231.htm).

(Google Patents also lists Delaware case numbers 1:21-cv-00691, 1:22-cv-00487, and 1:22-cv-00941 as family litigation; 1:22-cv-00487 was not independently described in my sources.)

D. Related litigation where the '963 was the predicate but Jazz was the defendant / intervenor

4. Avadel CNS Pharmaceuticals, LLC v. Becerra et al.

• Jurisdiction: U.S. District Court for the District of Columbia
• Case No.: 1:22-cv-02159 (APM)
• Filed: July 21, 2022
• Plaintiff: Avadel CNS Pharmaceuticals, LLC
• Defendants: Xavier Becerra (Secretary of HHS), Robert M. Califf (FDA Commissioner), U.S. Department of Health and Human Services, U.S. Food and Drug Administration
• Jazz Pharmaceuticals intervened (granted July 28, 2022) to defend the FDA's decision.
• Subject: APA challenge to the FDA's requirement that Avadel certify against the '963 (REMS) patent.
• Outcome: The D.D.C. denied Avadel's requested relief, holding Avadel had an adequate remedy at law via its delisting counterclaim in the Delaware action.
• Sources: Fed. Cir. 23-1186 opinion (citing Avadel CNS Pharms., LLC v. Becerra, C.A. No. 22-02159 (APM)); Stanford NPE database case page, https://npe.law.stanford.edu/case/[257786](/patent/257786).

E. Federal Circuit appeals

5. Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 23-1186 (Fed. Cir.)

• Appeal from the D. Del. delisting order (C.A. No. 1:21-cv-00691-GBW).
• Decided: February 24, 2023 — Affirmed. The Federal Circuit affirmed that the '963 patent claims a system, not a "method of using" a drug, and therefore was improperly listed in the Orange Book; the court held 21 U.S.C. § 355(c)(3)(D)(ii)(I) authorizes an order requiring delisting.
• The '963 patent was subsequently delisted. Oral argument was held February 14, 2023.
• Sources: Fed. Cir. opinion PDF (link above); National Law Review summary "Federal Circuit Affirms Delisting of REMS System Patent from FDA Orange Book" (https://dev.natlawreview.com/node/[208916](/patent/208916)/printable/pdf); The Pharma Letter (Nov. 21, 2022) (https://www.thepharmaletter.com/pharmaceutical/avadel-pharma-prevails-in-patent-dispute-with-jazz).

6. Court of Appeals for the Federal Circuit, No. 24-2274 — Google Patents lists this as family litigation (via the Unified Patents litigation-data link). I could not independently confirm the caption, parties, or subject matter of this appeal within this search. I report it as listed, without correction or inference.

F. Other family-level litigation links not confirmed for the '963 patent

Google Patents' family litigation links also include:

• U.S. District Court for the Eastern District of New York, 2:17-cv-04439
• D. Del. 1:22-cv-00487
• Various D.N.J. cases enumerated in Section B.

I could not confirm from the search results that the '963 patent itself was asserted in these specific matters (they appear as family-level links), so I flag them as unverified with respect to the '963 patent.

Summary of the '963 patent's litigation posture

• The '963 patent (like several sibling patents in this family) was held partially invalid in IPR. IPR2015-01903 (Amneal + Par petitioners) resulted in claims 24, 26, and 27 being held unpatentable (FWD March 22, 2017); the appeal settled in 2018.
• Its most consequential litigation was Jazz v. Avadel (D. Del.), where the district court and the Federal Circuit held the '963 patent claims a "system" rather than a "method of using" a drug, and ordered it delisted from the Orange Book (affirmed Feb. 24, 2023). The '963 infringement claims were then dismissed by stipulation (March 7, 2023). The '963 patent's claims expired in December 2022 (with pediatric exclusivity extending to June 17, 2023).
• The '963 patent was also the predicate for ancillary FDA/APA litigation (Avadel v. Becerra, D.D.C. 1:22-cv-02159), in which Jazz intervened and Avadel's APA relief was denied.

Caveats / limitations

• I could not access Unified Patents' portal pages directly; the above relies on PTAB dockets, Federal Circuit opinions, SEC filings, and Google Patents' family/litigation data (which cites Unified Patents and Darts-ip).
• Several of the D.N.J. case numbers appear only as family-level litigation links; I have not confirmed for each that the '963 patent (as opposed to a sibling patent) was asserted. Where a case number or petitioner caption differed between sources (e.g., "Par" vs. "Amneal and Par"; "Reardon/Reardan," "Avaled/Avedal/Aadel" typographical variants in the source text), I have reproduced the identifiers as found rather than correcting them.
• The list should be treated as the confirmed universe from these sources; there may be additional or more recent proceedings not surfaced by these searches. If you need a definitive docket-level confirmation, PACER (D.N.J., D. Del., D.D.C.), CourtListener/RECAP, and the Unified Patents and Lex Machina databases are the authoritative next steps.

I'll start by researching the PTAB proceeding referenced in the patent's litigation data.

Now let me research the Federal Circuit appeal and check for any later-filed PTAB proceedings.

Let me pin down the exact Federal Circuit appeal docket for IPR2015-01903 and verify no later IPRs were filed.

PTAB / AIA Trial Report — U.S. Patent No. 8,731,963 ("Sensitive drug distribution system and method")

Data-integrity flag up front. The structured "PTAB proceedings on file" block (USPTO ODP) is empty and the ODP default is "no PTAB activity on file." That default is wrong for this patent. The patent's own family-litigation metadata (Google Patents, sourced from Unified Patents PTAB data) explicitly lists a PTAB case, and the proceeding itself is fully documented in public records. I have therefore deviated from the ODP default and flagged the proceeding below, per your instruction to surface anything the ODP hasn't indexed. Nothing below is invented; where I could not verify a detail I say so.

Proceedings overview

One (1) AIA trial proceeding on file for the '963 patent: IPR2015-01903, status claims invalidated (Final Written Decision of 2017-03-22 holding all three instituted claims — 24, 26, and 27 — unpatentable, affirmed by the Federal Circuit on 2018-07-13). There are no active, settled, or institution-denied-in-toto proceedings on this patent, and no second petitioner ever filed on it.

Defensive posture: the patent is a spent force, not a hardened one. Its only independent claim that ever reached a merits decision — claim 24 — was canceled as obvious, and its independent claim 1 was petitioned but never instituted, so it was never adjudicated by the PTAB at all. On top of that, the patent expired on 2022-12-17 and was affirmed delisted from the Orange Book by the Federal Circuit on 2023-02-24. If a demand letter today cites claim 24 (or 26/27), it is citing canceled claims; if it cites claim 1, it is citing a claim from an expired, delisted patent that no tribunal has ever upheld.

IPR2015-01903 — [Amneal Pharmaceuticals, LLC](/litigations/by-plaintiff/Amneal%20Pharmaceuticals%2C%20LLC) & Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc.

• Type: Inter Partes Review (35 U.S.C. §§ 311–319)

• Filed: 2015-09-14 (accorded filing date; Patent Owner's Mandatory Notices dated 2015-10-05)

• Status: Final Written Decision — Unpatentable (plain English: IPR instituted on a subset of claims; all instituted claims canceled; appeal affirmed). Underlying patent status: Expired – Lifetime (anticipated expiration 2022-12-17).

• Judge panel: Jacqueline Wright Bonilla (Vice Chief Administrative Patent Judge), Susan L. C. Mitchell, Brian P. Murphy. Murphy, APJ, authored the Final Written Decision.

• Petition grounds: Petition challenged all claims 1–28 under 35 U.S.C. § 103 as obvious over Exs. 1003–1006, collectively the "Advisory Committee Art" ("ACA") — (1) FDA Peripheral & Central Nervous System Drugs Advisory Committee Transcript and Slides (Ex. 1003); (2) FDA Preliminary Clinical Safety Review (Ex. 1004); (3) Briefing Booklet (Ex. 1005); (4) Xyrem Prescription and Distribution Process Video and Transcript (Ex. 1006) — in view of Korfhage, Information Storage and Retrieval (1997) (Ex. 1037). Petitioner also argued the ACA qualified as prior art under § 102(b) as a printed publication (the May 14, 2001 Federal Register Notice, 66 Fed. Reg. 24,391, with a hyperlink to the FDA website). Petitioner's declarant: Robert J. Valuck, Ph.D., R.Ph. (Ex. 1007). No § 112 grounds.

• Institution decision: Partially instituted on 2016-03-25 (Paper 10). The Board instituted review only on claims 24, 26, and 27, declining to institute on claims 1–23, 25, and 28. Patent Owner filed no Preliminary Response. The Federal Circuit later characterized this as the one case in the family where the Board "partially instituted review of a subset of the petitioned claims," see IPR2015-01903, slip op. at 2 (P.T.A.B. Mar. 25, 2016), Paper No. 10.

• Final Written Decision (issued 2017-03-22): Claims 24, 26, and 27 — all unpatentable. Claim 24 is the sole independent claim in the instituted set; claims 26 and 27 both depend from claim 24. Verbatim disposition:

  "For the reasons that follow, based on our review of the complete trial record, we determine Petitioner has shown by a preponderance of the evidence that claims 24, 26, and 27 of the '963 patent are unpatentable."

  The panel's framing:

  "The evidence in this case tells the tale of an invention, but one in which Patent Owner's right to exclude was compromised because too much time passed between first disclosure and the patent application priority filing date. … [M]ore than one year passed after public disclosure of the controlled distribution system for Xyrem® in connection with an FDA Advisory Committee meeting. The result is a determination of unpatentability of the three patent claims at issue in the trial."

  On the disputed "periodic reports" term in claim 27, the Board declined Jazz's narrowing construction and found reports generated "at regular intervals or intermittently" both disclosed and obvious — a construction the Federal Circuit later affirmed. On the distributed-database limitation of claim 26, the Board credited Dr. Valuck over Jazz's Dr. Bergeron and found Korfhage's distributed-processing disclosure to be a known, predictable database architecture.

  Claims 1–23, 25, and 28: NOT addressed. They were petitioned but not instituted, so the FWD made no patentability holding on them. Do not let anyone tell you the Board "invalidated all claims of the '963 patent" — it did not. Conversely, do not assume those claims are "patentable" — they were simply never adjudicated, and the patent has since expired.

• Settlement / termination: None. This case ran to a Final Written Decision and was appealed; there was no adverse-judgment termination or settlement in the IPR. (Note for context: Jazz did settle district-court litigation with Hikma and Wockhardt in the parallel Xyrem campaigns, but not this IPR.)

• Appeal: Yes — affirmed. The '963 FWD was appealed to the U.S. Court of Appeals for the Federal Circuit and consolidated with the appeals from the six related-patent FWDs. Consolidated appeal docket numbers reported for the family: Nos. 2017-1671, -1673, -1674, -1675, -1676, -1677, and -2075 (secondary sources differ slightly on the exact set; Patexia's case summary lists "Appeal 2017-1671" for IPR2015-01903 specifically, but I could not independently confirm with high confidence which docket number maps to the '963 versus its sibling patents — treat the one-to-one mapping as unverified). Decided 2018-07-13, Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 895 F.3d 1347 (Fed. Cir. 2018) (Newman, Lourie, Reyna, JJ.; opinion by Lourie, J.). The Court affirmed the obviousness holdings, held the ACA materials were publicly accessible printed publications (rejecting any indexing/searchability requirement), and affirmed the Board's claim constructions. The Court also held it had jurisdiction notwithstanding partial institution, noting "a lack of any request by either party for SAS-based action."

  • Opinion (GovInfo): https://www.govinfo.gov/content/pkg/USCOURTS-ca13-17-01675/pdf/USCOURTS-ca13-17-01675-0.pdf
  • CourtListener: https://www.courtlistener.com/opinion/[4516711](/patent/4516711)/jazz-pharmaceuticals-inc-v-amneal-pharmaceuticals-llc/

• Other key procedural events: Oral hearing 2016-10-14 (transcript of record, Paper 30; hearing record dated 2016-12-01); Petitioner's Reply (Paper 22); Patent Owner Response (Paper 14) with declarations of Joseph T. DiPiro (Ex. 2005) and Bryan Bergeron (Ex. 2006).

• Defensive value: Decisive for a defendant. Claim 24 is dead, and claims 26 and 27 fell with it; any infringement theory built on those claims is a theory built on canceled claims — sanction-bait if asserted in litigation. The only claim of independent scope that survives on paper at all is claim 1, and it was never instituted (so there is no adverse merits ruling on it) but also never adjudicated, on a patent that expired 2022-12-17 and was ordered delisted from the Orange Book. For a current defendant, the practical answer is that the '963 patent cannot support a live infringement claim at all.

Strategic summary

Claim status on the '963 patent.

• CANCELED (PTAB, affirmed on appeal): claims 24, 26, 27. Claim 24 is the independent claim; 26 and 27 depend from it. These were held unpatentable under § 103 over the ACA (FDA Advisory Committee materials) in view of Korfhage, and the Federal Circuit affirmed on 2018-07-13.
• NEVER INSTITUTED / NEVER ADJUDICATED: claims 1–23, 25, 28. Petitioned for IPR but excluded from institution on 2016-03-25, and neither party sought SAS-based remand on appeal. No PTAB, district-court, or Federal Circuit merits holding upheld or invalidated them. They are, however, moot in practice — the patent expired on 2022-12-17.
• No claim of this patent has ever been sustained by the PTAB. There is no "hardened" residue of the '963 patent to build a case on.

Estoppel landscape (§ 315(e)(2)). Amneal and Par — and their real parties-in-interest and privies — are estopped from asserting in a district court or ITC action any ground they raised or reasonably could have raised in IPR2015-01903 as to the instituted claims (24, 26, 27). Because the ACA + Korfhage ground was the ground tried, that art is off the table for them. Note the doctrinal wrinkle: for the non-instituted claims (1–23, 25, 28) the estoppel reach is contested and fact-specific — the petition did name them, but the Board never instituted on them. For a new defendant (not in privity with Amneal/Par), no statutory estoppel applies at all, and the ACA + Korfhage combination — plus additional § 102/§ 103 art, § 101, and § 112 grounds never raised — would be fully available, subject only to IPR's § 311(b) limitation to patents/printed publications. That is academic here because the patent is expired, but the analysis matters if any continuation- or family-member patent (e.g., U.S. Pat. No. 11,456,081, "Sensitive drug distribution systems and methods") is asserted instead.

Pattern signals.

• Single petitioner group, seven patents. Amneal + Par coordinated a September 2015 wave: IPR2015-01903 ('963), plus IPR2015-00545 ('182), -00546 ('106), -00547 ('107), -00548 ('059), -00551 ('988), -00554 ('730), with follow-on filings IPR2015-01810/-01817 ('059) and IPR2015-01817 ('988). The Board found the challenged claims of all six sibling patents unpatentable as well, and the Federal Circuit affirmed the family in the consolidated 2018-07-13 opinion.
• CBM activity, but not on this patent. Petitioners also filed covered-business-method reviews on related patents (CBM2014-00150 ('988), -00151 ('730), -00153 ('182), -00161 ('106)). No CBM or PGR was ever filed against the '963 patent itself — PGR was unavailable anyway, as the '963 patent is pre-AIA (priority 2002-12-17).
• Patent owner litigates aggressively through appeal. Jazz appealed every adverse FWD — this was not a patent owner that folded. Jazz also pressed the '963 patent in district court (D.N.J. 2:13-cv-00391, 2:15-cv-05619, 2:15-cv-06548; D. Del. 1:21-cv-00691, 1:21-cv-01138, 1:22-cv-00941) and pursued two further Federal Circuit appeals (2023-1186, delisting; 24-2274, Avadel antitrust).
• No defensive aggregator. The only Unified Patents link on this patent is a docket record of IPR2015-01903, not a Unified-filed petition. There is no evidence Unified Patents (or any similar entity) ever challenged the '963 patent.

Recommended next steps

1. If you are a defendant and a demand letter or complaint cites the '963 patent, treat it as a meritless assertion on the patent's face. The dispositive document is the Final Written Decision, IPR2015-01903, Paper 31 (2017-03-22) — "we determine Petitioner has shown by a preponderance of the evidence that claims 24, 26, and 27 of the '963 patent are unpatentable." Quote that, and pair it with the affirmance at Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347 (Fed. Cir. 2018). FWD: https://www.docketalarm.com/cases/PTAB/IPR2015-01903/Inter_Partes_Review_of_U.S._Pat._8731963/docs/03-22-2017-Board/Final_Decision-31-Final_Written_Decision.pdf
2. Check the assertion date against expiration. The patent expired 2022-12-17. Any accused conduct occurring after that date cannot infringe; pre-expiration damages windows would be the only theoretical exposure — and claim 24 is canceled. Also confirm the current Orange Book status: the Federal Circuit affirmed delisting in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 2023-1186 (Fed. Cir. 2023-02-24), 2023 WL 2198640, on the ground that the '963 claims recite "an assemblage of components" defining a system, not a method of using a drug.
3. No active proceedings, so no milestone calendar is required. IPR2015-01903 is closed (termination date 2017-03-22; appeal mandate following the 2018-07-13 affirmance). There is no statutory 1-year trial clock running against this patent on any docket I can locate.
4. If the real target is a family member, re-run this analysis. The '963 patent has a large family (U.S. Pat. Nos. 7,668,730; 7,765,106; 7,765,107; 7,895,059; 8,457,988; 8,589,182, and later filings such as 11,456,081). Several of those had their own IPRs and CBM reviews with different claim-level outcomes, and at least one family member (the '651 / 7,797,171 line) reportedly carries a later expiration. The estoppel, claim-cancellation, and Orange Book analysis must be done patent-by-patent.
5. Verify the ODP gap. Since the structured ODP feed returned nothing for a patent with a documented FWD, escalate the discrepancy to whoever maintains your PTAB ingestion — this is a false negative that would have caused you to tell a client "no PTAB activity" about a patent whose key independent claim was canceled.

Confidence notes / non-fabrication disclosures: Proceeding number, parties, filing date (2015-09-14), institution (2016-03-25, claims 24/26/27 only), FWD (2017-03-22, claims 24/26/27 unpatentable), panel composition, grounds (ACA + Korfhage, § 103), and affirmance (2018-07-13, Fed. Cir.) are all corroborated by primary documents. The one item I could not verify to high confidence is the exact Federal Circuit docket number attributable to IPR2015-01903 within the consolidated appeal (secondary sources disagree; one lists 2017-1671). I have flagged rather than asserted it. I also could not verify any request for rehearing specifically in IPR2015-01903 (the FWD's discussion of rehearing denials refers to the six sibling proceedings).

I'll research the assignment record for US 8,731,963. Let me gather data from multiple sources.

Let me gather more specific assignment and litigation data.

Let me try to pull the actual USPTO assignment records and Google Patents assignment data.

Assignment Reconstruction — US 8,731,963 ("Sensitive drug distribution system and method")

Method note / limitation up front: I could not query the USPTO Assignment Center (https://assignmentcenter.uspto.gov/) directly from this session — the tool available to me is general web search, and searches against the Assignment Center UI returned no payload. I did not invent reel/frame numbers. Everything below is reconstructed from (a) the Google Patents legal-events block captured in the authoritative patent text, (b) a PTAB mandatory notice whose real-party-in-interest section cites an actual recorded reel/frame, and (c) litigation/SEC filings. Where a reel/frame is not verifiable, I say so explicitly rather than guessing. Only one reel/frame in this chain is confirmed (Reel 025604 / Frame 0903).

Inventors

• The 2002 priority application (Ser. No. 10/322,348) was an Orphan Medical, Inc. filing. PTAB Exhibit evidence in the Xyrem IPRs consists of FDA correspondence addressed to "Dr. Dayton T. Reardan, Orphan Medical, Inc.," and the Argentine family member of this same disclosure lists patent assignee "ORPHAN MEDICAL INC (ORPH-N)." That is strong, independent corroboration of the inventors' employer at filing.
• Spelling anomalies to flag (do not auto-correct): the PTAB notice in IPR2015-01903 spells the lead inventor "Dayton Reardon" and "Patti Engle," whereas the patent prints "Reardan" and "Engel." Per the operating rules, these are treated as the same persons, but the discrepancies are on the record.
• Unusual-pattern check: No evidence of inventors departing the assignee within 12 months of filing. All three are life-sciences/clinical personnel associated with the Xyrem restricted-distribution program (Reardan is the named recipient of the FDA ODE correspondence) — consistent with employee inventors, not a fire-sale precursor.

Original assignee

• On the issued patent: Jazz Pharmaceuticals, Inc. (Palo Alto, CA). Justia's patent history for 8,731,963 records "Assignee: Jazz Pharmaceuticals, Inc. (Palo Alto, CA)." Google Patents lists Jazz Pharmaceuticals Inc as both original and current assignee.
• Chain of title nuance: this is a continuation — 10/322,348 (2002) → 12/704,097 → US 7,895,059 → 13/013,680 → 13/592,202 → US 8,731,963. The 2002 root application was Orphan Medical, Inc. Jazz did not exist as the applicant of record in 2002.
• Primary line of business / product embodying the claims: Bio-pharmaceutical manufacturer (NASDAQ-listed Jazz Pharmaceuticals plc; US operating sub Jazz Pharmaceuticals, Inc.). The claims cover a controlled distribution system for Xyrem® (sodium oxybate/GHB), which Jazz actually manufactures and ships through an exclusive central pharmacy. This is a real commercial product, not a paper patent.
• Current status: Operating. Jazz acquired Orphan Medical (the 2002-era owner) in 2005, not through bankruptcy. Jazz remains a going concern with Xyrem/Xywav/Lumryz-adjacent litigation ongoing.

Assignment timeline

This is the full set of recorded conveyances I can source. Three of the four carry no publishable reel/frame — I am flagging that rather than fabricating numbers.

• Recorded 2010-12-22 (execution date not stated in source) — Reel 025604 / Frame 0903

  • Conveyance: Assignment
  • Assignor: Dayton Reardan, Patti Engle, Bob Gagne (inventors)
  • Assignee: Jazz Pharmaceuticals, Inc.
  • Correspondent: not determinable from available sources. (No assignment-search payload returned; correspondent of record unverified.)
  • Context: Internal inventor-to-company assignment; recorded against the application that issued as US 7,668,730, of which the '963 application is a continuation. Cite: IPR2015-01903 real-party-in-interest notice.

• Recorded 2015-06-19 — Reel/frame not verified

  • Conveyance: Security Agreement
  • Assignor: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals International III Limited; Jazz Pharmaceuticals Ireland Limited
  • Assignee: Bank of America, N.A., as Collateral Agent
  • Correspondent: not determinable.
  • Context: Securitization — collateral grant supporting Jazz's credit facility; not a title transfer.

• Recorded 2021-05-05 — Reel/frame not verified

  • Conveyance: Release by Secured Party
  • Assignor: Bank of America, N.A.
  • Assignee: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Limited; Jazz Pharmaceuticals International Limited; Jazz Pharmaceuticals International III Limited; Celator Pharmaceuticals, Inc.; Cavion, Inc.
  • Correspondent: not determinable.
  • Context: Securitization unwind — Bank of America releases its 2015 security interest.

• Recorded 2021-05-05 — Reel/frame not verified

  • Conveyance: Security Agreement
  • Assignor: Celator Pharmaceuticals, Inc.; Cavion, Inc.; Jazz Pharmaceuticals Ireland Limited; Jazz Pharmaceuticals, Inc.
  • Assignee: U.S. Bank National Association
  • Correspondent: not determinable.
  • Context: Securitization — replacement collateral agent on a new/refinanced facility.

Open item requiring Assignment Center verification: Docket Alarm's metadata for IPR2015-01903 lists the '963 Assignee as "JAZZ PHARMACEUTICALS IRELAND LIMITED." If accurate, there is a Jazz (US) → Jazz Ireland assignment in this chain that I could not date or reel/frame. In the sibling '306 patent, the analogous Jazz → Jazz Ireland transfer was recorded 2014-07-29 at Reel/Frame 33480-220 (Jazz→Ireland) following the inventor→Jazz assignment at Reel/Frame 30836-953 — but I will not import that reel/frame onto the '963 patent without seeing the '963 record. Flagged as unverified.

Anomaly worth a search click: Google Patents' citing-family table lists US 7,668,730 (the '963 patent's ancestor) with assignee "JPI Commercial, LLC." I cannot confirm what JPI Commercial, LLC is or whether it appears anywhere in this chain's reel/frame history. It may be a Google metadata artifact; it may be a real intermediate holding entity. Not asserted as a finding — but it is the single item in the record that does not fit a clean Jazz-internal chain and should be checked in the Assignment Center.

Timeline diagram

timeline
    title Ownership of US 8731963
    2002 : Filed by Orphan Medical Inc
    2005 : Orphan Medical acquired by Jazz
    2010 : Inventor assignment recorded Reel 025604 Frame 0903
    2012 : Continuation application filed
    2014 : Patent issued to Jazz Pharmaceuticals Inc
    2015 : Security agreement to Bank of America
    2021 : Release from Bank of America
         : Security agreement to US Bank
    2023 : REMS patent delisted from Orange Book

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The chain runs through named operating Jazz entities (Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Limited; Jazz International Limited; Jazz International III Limited; Celator; Cavion). No "IP / Patents / Licensing / Holdings / Ventures" suffix appears, no registered-agent address, no single-member Delaware/Texas LLC. Celator and Cavion are acquired operating pharma companies, not shells. (Unverified caveat: the "JPI Commercial, LLC" label on the '730 ancestor — see above.)

2. Known asserter in the chain — NOT PRESENT. Jazz Pharmaceuticals appears on none of the listed NPE rosters (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities). Jazz is a branded manufacturer asserting Orange Book-listed patents against ANDA filers — classic Hatch-Waxman brand-vs-generic litigation, the opposite of NPE conduct.

3. Repeat correspondent across the chain — UNKNOWN / cannot evaluate. Because no Assignment Center record set was retrievable, I have zero correspondent data for any link in this chain. This is the one signal I genuinely cannot score, and it is the signal the assignment-record methodology most depends on. A direct Reel 025604 / Frame 0903 lookup plus the 2015/2021 security-agreement records would resolve it.

4. Cascading transfers — NOT PRESENT. The only consecutive assignments are the 2010 inventor→Jazz assignment and then securitization filings 5–11 years later. No chained LLC hops in under 24 months.

5. Pre-litigation transfer — NOT PRESENT. The 2010-12-22 assignment predates the earliest '963-related infringement suits (Jazz v. Amneal, 2:13-cv-00391; Jazz v. Par, 2:13-cv-07884) by ~3 years, and the assignment is to Jazz itself, the entity that sued. No late-breaking transfer to an asserting shell.

6. Bankruptcy fire-sale — NOT PRESENT. Orphan Medical was acquired by Jazz in 2005; no Chapter 7/11 sale, no Kodak/Nortel-style auction.

7. Privateering — NOT PRESENT. Jazz asserts the '963 patent in its own name and collects its own damages; there is no NPE asserting the patent on Jazz's behalf. The Avadel litigation (D. Del., culminating in the Nov 18, 2022 Orange Book delisting order and later Avadel appeals) is Jazz-vs-competitor direct enforcement.

8. Defensive aggregator — NOT PRESENT. Chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN.

Verdict

Operating-company assertion.

Justification: the only confirmed conveyance is the 2010-12-22 inventor→Jazz Pharmaceuticals, Inc. assignment at Reel 025604 / Frame 0903 (IPR2015-01903 RPI notice), and every subsequent recorded event is a collateral/securitization filing (Bank of America security agreement, 2015-06-19; release, 2021-05-05; U.S. Bank security agreement, 2021-05-05) rather than a title transfer out of the corporate family. Jazz is a going-concern branded manufacturer that ships Xyrem® and asserts the '963 patent directly against ANDA competitors (Amneal, Par, Roxane, Wockhardt, Lupin, Avadel) — the defining profile of operating-company assertion, not NPE activity. Confidence is limited only by the missing reel/frame and correspondent data for the three securitization links and by the unverified "Jazz Pharmaceuticals Ireland Limited" assignee metadata; none of those gaps, if filled, would move the chain out of Jazz's ownership.

Verification links:

• USPTO Assignment Center: https://assignmentcenter.uspto.gov/ (search patent 8731963)
• Google Patents legal events: https://patents.google.com/patent/[US8731963B1](/patent/US8731963B1)
• Confirming reel/frame citation (IPR2015-01903 RPI notice, Reel 025604 / Frame 0903): https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1459711](/patent/1459711)/download-documents?artifactId=HeS4rmfSQ3ulDWrkIpnaOOTGN99Tk4PnId43itd78k6JAM_4f3koQlI
• Asserter directories cross-checked: https://portal.unifiedpatents.com/patents/patent/US-[7895059](/patent/7895059)-B2

I'll research US patent 8731963 and its cited prior art. Let me search for authoritative sources.

I have the patent text and citation list. Let me research the most relevant cited references to verify their content and dates.

Prior Art Analysis — US Patent 8,731,963 B1

1. Identification of the Patent Under Review

Legal framework used for § 102. Because application 13/592,202 was filed 2012-08-22 but is a continuation entitled to a 2002-12-17 priority date, pre-AIA 35 U.S.C. § 102 governs, and the critical date is 2002-12-17. Consequently:

• § 102(b) art = printed publications/patents publicly available more than one year before the earliest U.S. filing date (i.e., on/before ~2001-12-17).
• § 102(e) art = U.S. patents/publications whose underlying applications were filed before the invention date (2002-12-17).

Important data caveat. The Google Patents citation list reproduced in the materials provided is truncated: it states "Citations (47)" but the listing stops mid-entry at US 2003/0229519 A1 (36 entries shown). My analysis therefore covers the visible citations. I was also unable to complete a full USPTO database retrieval for every individual citation due to tool-usage limits; where I could not independently verify content, I say so explicitly rather than infer it.

2. The Claim Features Being Tested

For § 102 mapping, the operative limitations of claim 1 are:

1. A single computer database whose schema interrelates prescription fields, patient fields, and prescriber fields;
2. Prescription fields storing prescriptions for a drug with abuse/misuse/diversion potential;
3. Patient fields identifying the narcoleptic patient;
4. Prescriber fields identifying the prescriber and showing the prescriber is authorized;
5. A processor running a query operating over all data in those fields;
6. Inventory reconciliation before shipments are sent, using that query; and
7. A second query identifying that the patient is a cash payer + the interrelated physician, as an indicator of potential abuse, used to notify the physician.

Claim 23 is substantially the same with the inventory reconciliation/blocking emphasized (and a "narcoleptic patient" recitation). Claim 24 (cancelled) required a central company database distributed over multiple computers and pre-fill abuse checks.

No single visible cited reference discloses all limitations of claim 1 or 23. Nearly all citations are properly viewed as § 103 (obviousness) references or § 102 for narrower dependent claims, not standalone anticipatory art for the independent claims.

3. Reference-by-Reference Analysis

A. Core "restricted-distribution / registry" references (most relevant)

US 6,045,501 A — Elsayed et al. (Celgene Corporation)

• Filed 1998-08-28; issued 2000-04-04. § 102(b) art.
• Description: Restricted-distribution method in which prescriptions for a drug are filled only after a computer-readable medium is consulted to confirm the prescriber is registered and qualified, the pharmacy is registered and qualified, and the patient is registered and approved to receive the drug — aimed at preventing fetal exposure to a teratogen.
• § 102 mapping: Potentially anticipates the prescriber‑authorization limitation (element 4) and patient-registry limitations; relevant to claim 1 and dependent claims reciting prescriber eligibility. Does not disclose the single interrelated schema, inventory reconciliation, or cash‑payer query.

US 6,315,720 B1 — Williams / Kaminski (Celgene Corporation)

• Filed 2000-10-23; issued 2001-11-13. § 102(b) art (published/issued >1 yr before 2002-12-17).
• Description: Improved restricted-distribution method of the type in the '501 patent, adding patient risk-group assignment, periodic surveys/diagnostic tests as a condition of prescription approval, and registration checks for prescriber, pharmacy, and patient.
• § 102 mapping: The closest systemic cited art to the general "multiple controls on distribution of a sensitive drug" concept. Potentially anticipates dependent claims directed to prescriber/patient authorization and verification. Does not teach the claimed database schema interrelation, inventory reconciliation before shipment, or the cash‑payer/physician-notification query.

US 5,845,255 A — Mayaud (Advanced Health Med-E-Systems Corp.)

• Filed 1994-10-28; issued 1998-12-01. § 102(b) art.
• Description: Electronic prescription management system handling prescriber, patient, prescription, and insurance information, drug interaction checking, and shipping of printed drug information to first‑time prescribers. (This reference was expressly relied on during prosecution of the '730 family for "shipping comprehensive printed materials to the doctor if the doctor is a first time prescriber.")
• § 102 mapping: Per the family file history, Mayaud was applied to dependent claims relating to physician education materials and to insurance‑information handling (cf. claim 13). Relevant to claims reciting insurance fields; not anticipatory of independent claims 1/23.

US 5,737,539 A — Prescription creation system (Advanced Health Med-E-Systems Corp.)

• Filed 1994-10-28; issued 1998-04-07. § 102(b) art.
• Description: Computerized prescription creation/generation with prescriber and patient data capture.
• § 102 mapping: Relevant background art for the prescription‑field/patient‑field limitations; not anticipatory.

B. Tracking / diversion-monitoring / central-database references

US 2003/0093295 A1 — Lilly, Ralph B. (CSCS Enterprise Inc.)

• Filed 2001-11-14; published 2003-05-15. § 102(e) art (U.S. application filed before 2002-12-17).
• Description: "Controlled substance tracking system and method" — a central information utility/service center for managing prescription medication, aggregating prescriber/pharmacy data to determine abuse patterns and making data available to authorities (DEA). This reference was a principal primary/secondary reference throughout the family's prosecution and IPR proceedings.
• § 102 mapping: Directly relevant to claims reciting identification of current/anticipated abuse patterns from periodic reports (claim 14; claim 27). Strong § 102(e)/§ 103 art against those dependent claims. Combined with a central-database primary reference, it underpins obviousness of claims 1/23.

US 2002/0042762 A1 — McQuade, Richard et al. (Tracking the distribution of prescription drugs and other controlled articles)

• Filed 2000-09-07; published 2002-04-11 (granted as US 6,952,681 B2, 2005-10-04, on application 09/942,803 filed 2001-08-30). § 102(e) as to the publication.
• Description: Central-database system for tracking samples/controlled articles using barcodes and virtual inventory, with real‑time inventory adjustment and reconciliation and validity checking of practitioner data.
• § 102 mapping: Strong art against the inventory‑reconciliation‑before‑shipment limitations (claim 1 element 6; claims 20, 23, 28) and against verification of a physician's data. Notably relevant to claim 23's inventory-reconciliation limitation.

US 2003/0197366 A1 — Kusterbeck, Shawn (Method and system for prescription distribution security)

• Filed 2002-04-17; published 2003-10-23. § 102(e) art.
• Description: Prescription distribution security methodology directed at ensuring the correct recipient/provider and preventing diversion.
• § 102 mapping: Relevant to the "controls beyond those for traditional drugs" concept and to dependent claims on distribution security; not evidence I can treat as anticipating the independent claims.

US 2002/0042762, US 2003/0050731 A1 (Rosenblum — automatic prescription drug dispenser; filed 2000-06-08, pub. 2003-03-13) and US 2003/0074225 A1 (Borsand — pharmaceutical information tracking system; filed 2001-10-12, pub. 2003-04-17) — all § 102(e) art relating to automated/centralized drug tracking and dispensing; relevant to the general database-and-dispensing environment.

C. Inventory-management references

US 5,963,919 A — Northern Telecom Limited (Inventory management strategy evaluation system and method)

• Filed 1996-12-23; issued 1999-10-05. § 102(b) art.
• § 102 mapping: Relevant to claims reciting inventory reconciliation against database quantities (claims 1, 20, 23, 28). As a general inventory-modeling tool, it is § 103 material rather than anticipatory of the drug-specific claims.

US 6,021,392 A — Pyxis Corporation (System and method for drug management)

• Filed 1996-12-09; issued 2000-02-01. § 102(b) art.
• Description: Automated drug management/inventory and dispensing control.
• § 102 mapping: Relevant background to inventory control and reconciliation limitations.

US 3,556,342 A — Guarr (Medicine dispensing apparatus), filed 1969-05-05, issued 1971-01-19; US 4,847,764 A — Meditrol, filed 1987-05-21, issued 1989-07-11; US 4,976,351 A — Pharmedix, filed 1989-06-01, issued 1990-12-11; EP 0527027 A1 — Hunting Engineering (Fluid dispenser), filed 1991-08-07, pub. 1993-02-10. — All § 102(b) art; mechanical/kit dispensing or fluid-dispenser art. These appear only peripherally relevant (physical dispensing hardware / packaging kits) and are not anticipatory of any claim.

D. Electronic-records / healthcare-information references

• US 5,924,074 A — Azron Inc. (Electronic medical records system). Filed 1996-09-27; issued 1999-07-13. § 102(b). Relevant to the patient/medical-record fields.
• US 6,112,182 A — Healthcare Computer Corp. (Method and apparatus for integrated management of pharmaceutical and healthcare services). Filed 1996-01-16; issued 2000-08-29. § 102(b). Relevant to integrated pharmacy-information management.
• US 6,055,507 A — Cunningham (Dispensing, tracking and managing pharmaceutical trial products). Filed 1995-11-13; issued 2000-04-25. § 102(b). Relevant to central-station tracking of prescriber/pharmacy/patient transactions.
• US 2001/0001144 A1 — Kapp (Pharmacy drug management system…). Filed 1998-02-27; pub. 2001-05-10. § 102(b)/(e).
• US 2002/0052762 A1 — Kobylevsky (Remote prescription refill system). Filed 1998-06-16; pub. 2002-05-02. Relevant to refill handling (cf. claims 10–12).
• US 2003/0127508 A1 — Jones (Individually tracking and identifying a drug delivery device). Filed 1998-07-20; pub. 2003-07-10.
• US 6,564,121 B1 — Telepharmacy Solutions (Systems and methods for drug dispensing). Filed 1999-09-22; issued 2003-05-13. § 102(e).

E. Authentication / procurement / ancillary references (all § 102(e); peripheral)

• US 2001/0042050 A1 — Procure.Com (Secure electronic procurement). Filed 2000-01-05; pub. 2001-11-15.
• US 2001/0047281 A1 — Keresman (Secure on-line authentication for prescription fulfillment). Filed 2000-03-06; pub. 2001-11-29.
• US 2002/0010661 A1 — Waddington (Distribution system). Filed 2000-05-31; pub. 2002-01-24.
• US 2002/0032581 A1 — Reitberg (Single-patient drug trials… risk of habituation). Filed 2000-07-17; pub. 2002-03-14.
• US 2002/0032582 A1 — Feeney (Medication dispensing and integrated data management). Filed 2000-09-14; pub. 2002-03-14.
• US 2002/0161607 A1 — Subich (Pharmaceutical drug sample tracking and control). Filed 2001-02-23; pub. 2002-10-31.
• US 2002/0177232 A1 — Melker (Method and apparatus for detecting illicit substances). Filed 2001-05-23; pub. 2002-11-28.
• US 2003/0033168 A1 — Califano (Managing informed consent processes). Filed 2001-04-13; pub. 2003-02-13. (Relied on in the family's prosecution for informed-consent/education features.)
• US 2003/0046110 A1 — Gogolak (Population-based genomic drug safety data). Filed 2001-08-29; pub. 2003-03-06.
• US 2003/0050802 A1 — Jay (Medical service and prescription management system). Filed 2001-04-03; pub. 2003-03-13.
• US 2003/0110060 A1 — Clementi (Comprehensive drug compliance information). Filed 2001-12-12; pub. 2003-06-12.
• US 2003/0144876 A1 — Merck-Medco (Processing phone-in prescriptions). Filed 2002-01-28; pub. 2003-07-31.
• US 2003/0160698 A1 — Safety Syringes (Tracking pharmaceuticals within a facility). Filed 2002-02-26; pub. 2003-08-28. (Relied on in the family's prosecution for launching an investigation of lost shipments.)
• US 2003/0229519 A1 — Eidex, Brian H. (Systems and methods for identifying fraud and abuse …). Filed 2002-05-16; pub. 2003-12-11. The visible citation list ends mid-entry here.

None of the references in sections D–E disclose the integrated claim-1 system; they supply, at most, individual limitations (e.g., informed consent, phone-in refills, facility tracking, fraud analytics) that the examiner combined with primary references.

4. Ranked Assessment — Most Relevant Prior Art for § 102 Against 8,731,963

Bottom line on anticipation: On the visible citations, no single reference anticipates independent claim 1 or claim 23, because no visible reference discloses (i) a single database whose schema interrelates prescription/patient/prescriber fields with a query operating over all such data, together with (ii) inventory reconciliation before shipment, together with (iii) the cash‑payer/second‑query physician‑notification feature. The cited art is instead the raw material for § 103 combinations — which is consistent with the actual prosecution record, where the examiner rejected the parent claims as obvious over Moradi et al. (US 2004/0019794 A1) in view of Lilly et al. and others (e.g., Mayaud for physician materials; Safety Syringes for lost-shipment investigation; Califano for informed consent).

Note on claim 24: Independent claim 24 (and claims 26, 27) were cancelled in IPR2015-01903 by the PTAB (IPR certificate issued 2019-04-03), confirming that at least that independent claim did not survive a prior-art challenge. Claims 1 and 23 remain the operative independent claims.

5. Caveats

1. Truncated citation list. The provided record shows 36 of the stated 47 cited references; the omitted entries (including, per the file history, Moradi et al. US 2004/0019794 A1 and other post-2002 publications) could not be individually analyzed here.
2. Legal-status/AIA caveat. The pre-AIA framework is applied because of the 2012 filing with 2002 priority; if priority to 2002-12-17 were ever successfully challenged, the § 102 window would shift and several 2002–2003 publications would become § 102(a)/(b) art.
3. Verification limits. I confirmed the content/abstract of the highest-ranked references (Celgene '720/'501, Lilly, McQuade, Mayaud) via search results, but several lower-ranked references are described from their titles and metadata only; I have not independently read each specification and flag that as an open item rather than asserting content I did not verify.
4. No auto-correction performed — all identifiers (e.g., 8,731,963 / 13/592,202 / 2002-12-17) are reproduced exactly as they appear in the source.

I'll analyze the obviousness of US 8,731,963 using the prior-art references identified in the page's Prior Art section. Let me first verify key details about the most relevant references and the patent's litigation/IPR history.

Let me pull the specific grounds used in the IPR and the Federal Circuit's affirmance, since those directly bear on the §103 analysis.

Obviousness Analysis — U.S. Patent No. 8,731,963 B1

"Sensitive drug distribution system and method" (Jazz Pharmaceuticals / inventors Reardan, Engel, Gagne)
Analysis under pre‑AIA 35 U.S.C. § 103(a) · Critical date: December 17, 2001 (priority 12/17/2002) · Source: https://patents.google.com/patent/US8731963/en

1. Threshold framework

Because every application in this family was filed before March 16, 2013, the pre‑Leahy‑Smith version of §§ 102/103 governs. Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018). Obviousness therefore turns on the Graham factors (scope/content of prior art, differences from the claims, level of ordinary skill, secondary considerations), applied flexibly per KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).

A critical practical fact: claims 24, 26, and 27 of this patent have already been held unpatentable in Par Pharm., Inc. v. Jazz Pharms., Inc., IPR2015‑01903 (PTAB Mar. 22, 2017), and that holding was affirmed. The Board instituted only on those three claims, leaving independent claims 1, 23, 24's sibling claim 25, and the remaining dependent claims unadjudicated (the Board's partial institution; the Federal Circuit expressly declined to reopen non‑instituted claims). Any § 103 analysis of claim 1 is therefore an extension of the adjudicated ground, not a repeat of it.

Adjudicated ground (claims 24, 26, 27): "Advisory Committee Art" (the ACA materials) as primary reference, optionally in view of Korfhage (distributed databases).
ACA materials = four documents tied to the June 6, 2001 FDA Peripheral and Central Nervous System Drugs Advisory Committee meeting on Xyrem®, posted on an FDA website hyperlinked from a Federal Register notice, 66 Fed. Reg. 24,391 (May 14, 2001):

1. FDA advisory‑committee meeting transcript and slides;
2. FDA preliminary clinical safety review of Xyrem®;
3. the Xyrem® briefing booklet;
4. a video/transcript describing the proposed Xyrem® distribution system.
   Deemed publicly accessible under § 102(b) no later than October 4, 2001. Jazz v. Amneal, 895 F.3d at 1350–52; FWD, https://www.docketalarm.com/cases/PTAB/IPR2015-01903/

Korfhage (PAR1037, a printed publication on distributed document sets, p. 276): "the user would prefer to view the system as accessing a single logical database in response to a query, even when the system must consult multiple physical databases."

2. Level of ordinary skill

The Board found a POSA to be "a pharmacist or computer scientist having familiarity with computerized drug distribution procedures." 895 F.3d at 1351. That matters: such a person reads FDA advisory‑committee materials, knows DEA Schedule III recordkeeping/accountability rules, and knows how commercial databases are implemented.

3. Prior art of record (the page's Prior Art section)

Note: publicly‑published applications listed as 2003 publications carry pre‑12/17/2002 filing dates and thus qualify as § 102(e) art; I have not independently verified each filing date beyond those shown on the page.

4. Claim 1, element by element

5. Combinations that render the claims obvious, with motivations

Ground 1 — ACA alone (claims 24, 26, 27; already adjudicated). The ACA discloses the single central database, narcolepsy patient/prescriber/prescription fields, prescriber‑authorization checking, and querying for abuse patterns. Motivation: none needed beyond a single reference; the Board's FWD and the Federal Circuit both affirmed unpatentability. Claim 26's "distributed over multiple computers" limitation is met by the ACA + Korfhage combination, motivated by "cost, efficiency, and the anticipated volume of prescription‑related information to be received, entered, and queried" — a motivation the Federal Circuit held supported by substantial evidence and consistent with KSR. 895 F.3d at 1357–58.

Ground 2 — ACA (or Celgene '501/'720) + Pyxis '392 / Northern Telecom '769 (all claims reciting inventory reconciliation; claim 20, 23, 28). Motivation: (a) DEA Schedule III accountability requires per‑period reconciliation of controlled‑substance inventory (the '963 specification itself frames this as a control at blocks 266 and 426); (b) Pyxis and '769 are in the same field and expressly address inventory reconciliation/strategy evaluation; (c) the combination is a predictable use of known elements with a known benefit (theft/diversion detection), squarely KSR at 417 ("combination of familiar elements according to known methods … likely to be obvious … a predictable result"). No change in principle of operation.

Ground 3 — Celgene '501 + '720 + ACA (claims 1, 4–6, 9–13, 21–22). The Celgene pair supplies the registered‑party central medium, prescriber qualification, patient approval and counseling; ACA supplies the narcolepsy/Xyrem® context, the exclusive‑central‑pharmacy model, and abuse flagging. Motivation: '720's own specification expressly starts from and improves upon the '501 scheme and states the problem as "improved methods … to control the distribution of this drug," i.e., the references are combinable by their own teaching (the strongest possible articulation of motivation). Both are directed to the same regulatory problem (restricted distribution of an abusable drug under FDA mandate).

Ground 4 — Lilly '295 + Celgene + inventory art (claims 1, 14–15). Lilly '295's central utility for aggregating controlled‑substance prescription data expressly targets diversion and enables querying by prescriber/patient. Motivation: combining a drug‑specific restricted‑distribution registry ('501/'720) with a cross‑prescriber centralized tracking utility (Lilly '295) yields only the predictable advantage of more complete data — the very benefit the '963 specification claims for its "central database … ensures that all prescriptions, prescribers and patients are tracked."

6. The "cash payer" limitation — the real § 103 battleground

Claim 1's final clause is the only element I could not match to a specific teaching in the retrieved record:

"…a second database query that identifies that the narcoleptic patient is a cash payer and a physician … interrelated … said identifying that the narcoleptic patient is a cash payer … being an indicator of a potential misuse, abuse or diversion … and being used to notify the physician…"

• Supporting the obviousness case: The '963 specification itself treats cash payment as a known diversion flag ("In one embodiment, cash payers are also identified," Fig. 4B / block 436), which cuts against novelty of the insight if that insight was already in the field. The ACA materials teach "flagging," "questioning," and pharmacist intervention on inappropriate prescription requests, and mention contacting authorities — the concept of a rule‑based abuse indicator triggering prescriber contact is squarely present. Under KSR, "a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions" — flagging a known high‑risk payment pattern (cash) and notifying the prescriber is arguably just that. Payment‑method fields, payer/insurance fields (claim 13), and rule‑based exception reporting were all conventional in the pharmacy‑systems art (e.g., '255/'539 insurance fields; Lilly '295).
• Against it: I did not locate, in the page's Prior Art section (or in the IPR petition excerpts I retrieved), an express prior‑art teaching that ties cash payment to a diversion indicator that triggers prescriber notification. Notably, claim 25 — which depends from claim 24 and contains the identical cash‑payer language — was petitioned but NOT instituted (institution was limited to claims 24, 26, 27). That is at least consistent with the Board finding the cash‑payer showing inadequate in the petition, though I cannot confirm the Board's actual reason and flag this as an inference, not a verified fact.

Bottom line on claim 1: On the record available, claims 1–23 (and claim 25) present a materially stronger non‑obviousness position than the adjudicated claims 24/26/27, essentially resting on one clause. A petitioner would need either (a) art expressly teaching cash/self‑pay status as a diversion indicator, or (b) a KSR "common sense / industry‑practice" showing (e.g., contemporaneous DEA or prescriber‑guidance materials treating cash‑paying pain/controlled‑substance patients as higher risk). I do not have that evidence and will not assert it exists.

7. Secondary considerations

Jazz raised secondary considerations before the Board; the Federal Circuit affirmed the Board's obviousness conclusion notwithstanding them (895 F.3d at 1357–59), and the Board's FWD noted that Jazz lost its right to exclude because "too much time passed between first disclosure and the patent application priority filing date." The Board found the ACA materials disclosed the system publicly more than one year before the critical date — i.e., Jazz's own pre‑filing public disclosure supplied the § 102(b) art. No nexus‑bearing secondary consideration overcame the prima facie case for the adjudicated claims.

8. Conclusions

Overall: US 8,731,963 is, as a whole, highly vulnerable under § 103. Its central inventive contribution — a single/exclusive central database tracking all prescriptions, patients, and prescribers of an abusable drug, queried periodically to detect abuse and reconciled against inventory — was squarely disclosed by the ACA materials (the applicant's own June 2001 FDA advisory‑committee disclosures) and the Celgene ® registry patents, which are combinable by their own express teaching. The only limitation that is not demonstrably met on this record is the claim‑1/claim‑25 cash‑payer‑as‑diversion‑indicator clause, and no court or Board has ever adjudicated it.

Caveats: (1) I have not verified the full filing dates/content of every 2003 publication in the "Citations (47)" list; my mapping of some to § 102(e) status is based on the dates shown on the page. (2) The Board's reasons for not instituting on claims 1 and 25 are not in the materials I retrieved; my inference in § 6 should be treated as such. (3) The '963 patent expired 12/17/2022 ("Expired – Lifetime"), so this is a retrospective validity analysis.

Key sources: https://patents.google.com/patent/US8731963/en · https://www.docketalarm.com/cases/PTAB/IPR2015-01903/ (FWD PDF) · https://www.govinfo.gov/content/pkg/USCOURTS-ca13-17-01675/pdf/USCOURTS-ca13-17-01675-0.pdf · https://patents.google.com/patent/[US6315720B1](/patent/US6315720B1) · https://patents.google.com/patent/US6045501 · https://patents.google.com/patent/US20030093295