US 9468747

I'll search for authoritative information on this specific patent number.

Let me check the litigation/appeal history and any CAFC 2026 activity.

Let me confirm the full claim set and the abstract text.

US Patent 9,468,747 — Summary

Sourcing note. I searched Google Patents, Justia, PTAB/Unified Patents records, the Opiant/Adapt litigation filings, and the Federal Circuit opinion. I did not find any CAFC docket activity for 9,468,747 in 2026 — see the litigation section below, where I flag that explicitly rather than speculate.

Bibliographic data (as listed)

Source: https://patents.google.com/patent/US9468747/en

Abstract

"Drug products adapted for nasal delivery, comprising a pre‑primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided." (Text as reproduced in a secondary case summary; the Google Patents "definitions" field renders the same substance as: "drug products adapted for nasal delivery comprising a pre‑primed device and a pharmaceutical composition comprising an opioid receptor antagonist, pharmaceutical compositions comprising an opioid receptor antagonist, and methods of use thereof.")

The claimed antagonist is naloxone hydrochloride (and hydrates), in a ~100 µL aqueous nasal spray delivered from a pre‑primed (ready‑to‑use without priming actuations) single‑use device.

Independent claims — plain language

Claim 1 — Method of treatment. Treating opioid overdose (or a symptom of it) by nasally giving a patient a dose of naloxone HCl using a single‑use, pre‑primed nasal device that delivers the dose by one actuation into one nostril, the device having a single reservoir of about 100 µL aqueous solution containing:

• about 4 mg naloxone HCl (or a hydrate);
• 0.2–1.2 mg of an isotonicity agent;
• 0.005–0.015 mg of a compound that is at least one of a preservative, a cationic surfactant, and a permeation enhancer;
• 0.1–0.5 mg of a stabilizing agent; and
• enough acid to reach pH 3.5–5.5.

Claim 30 — Pharmaceutical formulation. An intranasal formulation in ≤ about 140 µL aqueous solution containing the same five elements as above (about 4 mg naloxone HCl or hydrate; 0.2–1.2 mg isotonicity agent; 0.005–0.015 mg preservative/cationic surfactant/permeation enhancer; 0.1–0.5 mg stabilizing agent; acid for pH 3.5–5.5).

Uncertainty flag: The verified claim listing runs at least to claim 41, and the claims I could read in full (1–41, matching the published application) show independent claims at 1 and 30, with the remainder dependent. I could not authoritatively confirm whether any third independent claim (e.g., a device or kit claim) exists outside the portion I retrieved. Treat the "two independent claims" statement as probable, not certain.

Dependent claims — themes

• Excipient identity (claims 2–3, 31–33): NaCl as isotonicity agent, benzalkonium chloride as the preservative/surfactant/enhancer, disodium edetate as stabilizer, HCl as the acid; a specific exemplified recipe of about 4.4 mg naloxone HCl dihydrate, 0.74 mg NaCl, 0.01 mg benzalkonium chloride, 0.2 mg disodium edetate, HCl to pH 3.5–5.5.
• Device ergonomics (4–6): one‑hand actuatable; reservoir ≤ 140 µL; ~100 µL delivered per actuation.
• Dose precision (8–9): 90% CI for dose per actuation ±~2%; 95% CI ±~2.5%.
• Speed / retention (10–15): delivery time < 25 s, < 20 s; < 20%, < 10%, < 5% of the composition lost via nasopharyngeal or external drainage; Tmax about 20–30 minutes.
• Patient/indication (16–24): opioid or suspected‑opioid overdose patient; enumerated symptoms (respiratory and CNS depression, cardiovascular depression, miosis, hypoxemia, etc.); illicit use or accidental misuse during medical opioid therapy; patient free from respiratory depression for 1, 2, 4, or 6 hours; patient in lying, supine, or recovery position.
• PK thresholds (25–29, 34–41): naloxone plasma concentration ≥ 0.2 ng/mL within 2.5 min, ≥ 1 ng/mL within 5 min, ≥ 3 ng/mL within 10 min; Tmax < 30 min.

Litigation and validity (important caveat to the "listed patent" status)

• District court (D.N.J.): Adapt Pharma Operations Ltd., Adapt Pharma, Inc., Adapt Pharma Ltd., and Opiant Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. et al. — the '747 was among four patents‑in‑suit (also 9,561,177; 9,629,965; 9,775,838). Judgment 2020‑06‑26 holding the patents invalid (obviousness, 35 U.S.C. § 103).
• Federal Circuit: Appeal No. 20‑2106, decided 2022‑02‑10, affirmed the invalidity holding. See https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf. The opinion notes the FDA's 2012 guidance that a 2 mg intranasal dose would have poor bioavailability and recommended a higher dose, and that the 4 mg NARCAN® product resulted — evidence the panel treated as supporting obviousness.
• PTAB: IPR2019‑00688 (Final Written Decision 2020‑08‑21); IPR2019‑00689 and IPR2019‑00690 (not instituted, procedural). Petitioner: Nalox‑1 Pharmaceuticals, LLC.
• CAFC 2026 dockets: I found no pending or decided 2026 Federal Circuit appeal involving 9,468,747. The Federal Circuit appeal in this family concluded in February 2022. My searches also surfaced unrelated 2026 CAFC matters (e.g., Spero v. Mercedes‑Benz USA, Nos. 2025‑1306 et al.) with no connection to this patent. If you need certainty on 2026 docket activity, it should be verified directly against the CAFC docket and PACER, which I could not query here.

Bottom line

US 9,468,747 claims a ready‑to‑use, single‑use intranasal naloxone product — specifically a ~100 µL, ~4 mg naloxone HCl spray with defined NaCl/benzalkonium chloride/disodium edetate/HCl levels at pH 3.5–5.5 — and methods of treating opioid overdose with it. It was Orange Book‑listed against NARCAN® Nasal Spray with a nominal 2035 expiry, but the asserted claims were held obvious and invalid by the District of New Jersey, a judgment affirmed by the Federal Circuit in 2022.

I'll research litigation involving US 9,468,747 specifically. Let me run several targeted searches.

Let me dig into specific case details and the appeal.

Let me verify the remaining district court cases and the PTAB outcomes.

Litigation Involving U.S. Patent No. 9,468,747

Bottom line: U.S. 9,468,747 ("Nasal drug products and methods of their use," Opiant Pharmaceuticals / Adapt Pharma family, Orange Book–listed for NARCAN® Nasal Spray, NDA 208411) was asserted in the Hatch‑Waxman (ANDA) litigation in the District of New Jersey and was one of the patents held invalid for obviousness, affirmed by the Federal Circuit in 2022. It was also the subject of three PTAB inter partes review petitions (adversarial proceedings, not Article III litigation). I found no other litigation involving this specific patent.

1. District Court Litigation (D.N.J.)

Notes and caveats:

• The '747 was one of four NARCAN patents at issue (with U.S. 9,211,253; 9,561,177; 9,629,965; 9,775,838; and later 10,085,937). The complaints were consolidated, and the Opinion treats dependent claim 9 of the '747 as representative.
• Sources report the district court's decisive ruling date variously as June 5, 2020 and June 26, 2020, with the written opinion docketed June 22, 2020. The precise judgment date should be confirmed against the docket; I am flagging this inconsistency rather than resolving it.
• I have not independently confirmed which single docket number in the consolidated group corresponds solely to the '747 complaint, though the Jan. 2017 Teva notice as to the '747 and the subsequent complaint (filed ~Feb. 8, 2017) are documented in Opiant's SEC filings. Docket no. 2:17-cv-00864 is consistent with a February 2017 filing; treat that mapping as probable, not verified.

Source examples: DrugPatentWatch litigation page for patent 9,468,747 (https://www.drugpatentwatch.com/p/alphasignals/litigation/patent/9468747); D.N.J. Opinion (https://cases.justia.com/federal/district-courts/new-jersey/njdce/2:2016cv07721/[340302/344](https://assignmentcenter.uspto.gov/search/patent/reelFrameDetail?reelFrame=340302-0344)/0.pdf); CourtListener docket 6549027.

2. Perrigo Action (D.N.J.) — '747 affected via settlement

Caveat: third-party docket aggregators (DrugPatentWatch) attribute this case's asserted patent as the '937 patent, whereas the Consent Judgment lists the '747 among the defined "Licensed Patents." So the '747 was implicated in the settlement's injunction even though it may not have been the specifically asserted claim set in the complaint.

Source: Consent Judgment, Dkt. 73, 2:18-cv-15287 (https://www.courtlistener.com/docket/[8135715](/patent/8135715)/adapt-pharma-operations-limited-v-perrigo-uk-finco-limited-partnership/#entry-73).

3. Federal Circuit Appeal

Source: https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf

4. PTAB Proceedings (adversarial, not court litigation)

Petitioner: Nalox-1 Pharmaceuticals LLC (Patent Owner: Opiant Pharmaceuticals, Inc. / Adapt). Fifteen IPR petitions were filed Feb. 19, 2019 across the NARCAN portfolio; the '747-specific ones:

Note the asymmetry: the Patent Owner won on the '747 at the PTAB (FWD that claims are not unpatentable) but lost on the same patent in district court (invalid as obvious), which the Federal Circuit affirmed.

Sources: Unified Patents PTAB portal (https://portal.unifiedpatents.com/ptab/caselist); Nalox-1 Pharmaceuticals v. Opiant Pharma, IPR2019-00689, Patent Owner Preliminary Response.

5. What I could not confirm

• Whether any additional district court actions or foreign (parallel) proceedings specifically asserted the '747. Family-level litigation flags exist (Darts-IP family 56110095; a Canadian action against Teva re Canadian counterpart filed July 23, 2020), but those concern foreign counterparts, not U.S. 9,468,747 itself.
• The exact judgment-entry date and docket number mapping for each consolidated Teva complaint (its complaints were filed piecemeal per patent).
• Any subsequent appeals beyond the 2020-2106 Federal Circuit decision.

Current status: The '747 was adjudged invalid (obvious) in D.N.J., affirmed by the Federal Circuit on Feb. 10, 2022; the patent record shows legal status "Expired – Fee Related" with anticipated expiration March 16, 2035. No pending litigation specific to this patent was found as of the search date.

I'll verify the PTAB picture against the structured data and the patent's own litigation record.

Good — the patent's own record shows PTAB activity the ODP block missed. Let me pin down the FWD details, the petition grounds, and any appeal.

Let me check for any appeal of the IPR FWD (as distinct from the Teva district-court appeal).

⚠️ Data-source flag (material). The structured "PTAB proceedings on file" block in my task briefing states the USPTO ODP API returns no AIA trial proceedings for US 9,468,747. That is stale/incorrect. The patent's own Google Patents record and multiple primary documents confirm three AIA proceedings on the '747 patent: IPR2019‑00688 (Final Written Decision), IPR2019‑00689 and IPR2019‑00690 (institution denied). I have sourced everything below to the PTAB papers themselves, not to the ODP block. Also note: the "Unified Patents PTAB Data" string in the Google Patents record is the CC‑licensed data source, not a party — Unified Patents did not file these petitions.

Proceedings overview

Three AIA trial proceedings on the '747 patent: one IPR reached a Final Written Decision and canceled nothing — all of claims 1–45 were sustained — and two companion IPRs were denied institution on discretionary/procedural grounds. The PTAB has therefore never invalidated a single claim of this patent. The defensive posture this gives a defendant is not "the troll is dead," but it is also not "the patent is hardened" across the board: the patent is PTAB-hardened as to claims 1–45, yet claims 7 and 9 were separately held invalid by the District of New Jersey and that judgment was affirmed by the Federal Circuit on 2022-02-10. So: if a demand letter cites claims 7 or 9, you have a final, affirmed invalidity judgment; if it cites claims 1–6, 8, or 10–45, the patent owner has never lost a validity fight on those claims and the reexamination/IPR path is complicated by a completed PTAB record and a lapsed-maintenance-fee status (see below).

IPR2019‑00688 — Nalox‑1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc. (joined by Adapt Pharma Operations Limited)

• Type: Inter Partes Review (35 U.S.C. §§ 311–319)
• Filed: 2019-02-19 (accorded filing date 2019-02-19)
• Status: Final Written Decision (merits FWD issued; no claim held unpatentable)
• Judge panel: APJs Erica A. Franklin, Zhenyu Yang (opinion author), and Michael A. Valek, per the face of Paper 57. Caveat: third-party dockets (Patexia) list APJ Jacqueline T. Harlow on the -00688 panel, which is likely the institution panel that was later reconstituted; APJ Harlow's name does appear on the -00689/-00690 panels in the Unified Patents caselist. I did not verify the institution-panel composition from a primary document.
• Real parties in interest (patent owner side): Adapt Pharma Operations Limited (a wholly-owned sub of Adapt Pharma Ltd. → Emergent Acquisition Ltd. → Emergent International Inc. → Emergent BioSolutions Inc.) and Opiant Pharmaceuticals, Inc. Petitioner-side RPI: Nalox‑1 Pharmaceuticals, LLC.
• Petition grounds: § 103 obviousness over claims 1–45, led by Wyse (Ex. 1007) in view of the Handbook of Pharmaceutical Excipients ("HPE"), with additional grounds discussed in the petition record (e.g., Wyse in view of Halsall/others, Wermeling 2013, Bahal, Kushwaha, per the Hochhaus declaration). Critically, the petition also attacked the '747's priority claim — Nalox‑1 asserted Wyse is prior art under AIA § 102(a)(2), arguing the '747 is not entitled to the 2014-03-14 priority date (Wyse issued 2015-11-24 from an application filed 2014-12-19). Petitioner's expert: Dr. Günther Hochhaus. No § 112 grounds.
• Institution decision: Instituted 2019-09-09 (Paper 11). The Board found a reasonable likelihood of prevailing "at least with regard to claims 1, 16–24, 30, 31, 34–36, and 40–42" on the Wyse + HPE ground, and credited Nalox‑1's § 102(a)(2) showing as to Wyse ("we agree with Petitioner's argument on this point"). Following SAS Inst. Co. v. Iancu (and as the D.N.J. later described it), the Board instituted on all challenged claims (1–45), even though it "expressly recognized that Nalox-1 had not shown a reasonable likelihood of success as to any claims reciting BZK [benzalkonium chloride]."
• Final Written Decision: 2020-08-21 (Paper 57). Disposition: "Final Written Decision Determining No Challenged Claims Unpatentable — 35 U.S.C. § 318(a)." Verbatim holding: "we conclude Petitioner has not established by a preponderance of the evidence that claims 1–45 of the '747 patent are unpatentable." Claim-level result: zero independent claims canceled; zero dependent claims canceled; claims 1–45 all sustained. The fulcrum was teaching away: the panel found that Wyse discourages BAC in intranasal naloxone — per the FWD as quoted by the PTAB Litigation Blog, Wyse "[i]t not only presents results showing that BAC is not acceptable for use in intranasal naloxone formulations, but also provides data demonstrating that other preservatives, such as benzyl alcohol, are stable in such formulations." Patent Owner also pressed objective indicia (failure of others, skepticism, copying, praise, commercial success, long-felt need) — note that the Board did not need to reach all of them once non-motivation/teaching-away was found. Oral hearing was held 2020-05-19 (consolidated with IPR2019‑00685 and IPR2019‑00694).
• Settlement / termination: None. This was a merits FWD, not a settlement. (The separate D.N.J. Perrigo case was dismissed with prejudice by consent judgment on 2020-03-02, but that is a district-court case, not this IPR.)
• Appeal: No appeal of the FWD was located. Petitioner Nalox‑1 lost, so the appeal right lay with it; the paper record shows no CAFC docket on IPR2019‑00688, and neither the PTAB E2E record nor the subsequent CAFC opinion in Adapt Pharma v. Teva references an appeal of this FWD. The FWD is therefore final and unappealed, and § 315(e) estoppel attached to Nalox‑1 as of 2020-08-21. Do not confuse this with CAFC No. 2020-2106, which is Adapt/Opiant's appeal of the district court's invalidity judgment, decided 2022-02-10 — a different case, different record, opposite result.
• Defensive value: The single most-litigated invalidity theory on this patent (Wyse-based, BAC-focused) has already failed once at the PTAB — recycling it invites a § 325(d) denial and a teaching-away hammering. But this FWD is claim-level dead weight for your opponents too: it is not a validity adjudication that binds you, and the same Wyse reference produced the opposite outcome in D.N.J. against claims 7 and 9. The FWD did not address claims 7 or 9's invalidity on the district-court combinations; it addressed only whether Wyse + HPE-style grounds rendered claims 1–45 unpatentable.

IPR2019‑00690 — Nalox‑1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review
• Filed: 2019-02-19
• Status: Not Instituted — Procedural (denied on discretionary grounds; per Unified Patents PTAB data, institution date = termination date, 2019-09-09)
• Judge panel: Per the Unified Patents panel-judge caselist, APJ Jacqueline T. Harlow sat on this panel; the full three-judge composition is not confirmed from a primary document.
• Petition grounds: § 103 obviousness over claims 1–45 with Davies as the lead reference (Davies is § 102(a)(1) art). Nalox‑1 ranked this petition #2 in its requested consideration order and argued the three petitions were non-redundant because they rested on different statutory bases and different primary references.
• Institution decision: Denied 2019-09-09 (Paper 11). The Board exercised its discretion and declined institution as redundant with the Wyse-based IPR2019‑00688. The D.N.J. later summarized the collective outcome: "Recognizing that Nalox-1's arguments were largely the same across all of the IPRs, the Board exercised its discretion to deny all the petitions except some of the ones based on Wyse. See, e.g., Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-00689, Paper 11, at 10–11 (P.T.A.B. Sept. 9, [2019])." Patent Owner had also argued for denial under the then-developing § 314(a) parallel-litigation doctrine (the Teva case was nearing final judgment) and under SAS.
• Final Written Decision: N/A — no trial instituted.
• Settlement / termination: N/A.
• Appeal: None (denials of institution are non-appealable under § 314(d)).
• Defensive value: Davies is unstained. The Board never reached the merits of the Davies combination — this is a discretionary denial, not a merits win, and it does not create estoppel. A defendant is free to run Davies, but expect the Board to view a fresh Davies petition through the lens of § 325(d) (the Office has already seen and declined this art) and § 314(a).

IPR2019‑00689 — Nalox‑1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review
• Filed: 2019-02-19
• Status: Not Instituted — Procedural (denied 2019-09-09)
• Judge panel: Not confirmed from a primary document; likely the same panel as -00690 (see caveat above).
• Petition grounds: § 103 obviousness over claims 1–45 with Wang as the lead reference (§ 102(a)(1) art; certified human translation used, versus the machine translation Opiant submitted during prosecution). Nalox‑1 ranked this petition #3 of 3.
• Institution decision: Denied 2019-09-09 (Paper 11), again as redundant with IPR2019‑00688. Patent Owner's preliminary response (filed 2019-06-11) argued redundancy, parallel district-court inefficiency, and that the POSA would not have been motivated to use a single 4 mg intranasal naloxone dose or the BZK/EDTA combination.
• Final Written Decision: N/A.
• Settlement / termination: N/A.
• Appeal: None (non-appealable).
• Defensive value: Same as -00690 — Wang is untested on the merits at the PTAB and available as art, subject to § 325(d)/§ 314(a) discretion.

Strategic summary

Canceled vs. sustained vs. untested.

There is an important asymmetry in that table. The district court used dependent claim 9 as representative, and claim 9 depends from claims 1 and 2 — so the obviousness reasoning that killed claim 9 necessarily reasoned through all of claim 1's and claim 2's limitations. That gives a defendant a strong a fortiori rhetorical argument that claims 1 and 2 fall with claim 9. But be precise in briefing: the judgment invalidated claims 7 and 9 only; claims 1 and 2 were not formally adjudicated invalid, so issue preclusion and § 315(e)(1) do not mechanically attach to them. Also note the awkward split verdict: the PTAB and the district court looked at the same Wyse reference and reached opposite conclusions on claims including claim 9 (the Board found no motivation to use BAC; D.N.J. found the opposite). That conflict is the single most useful fact in your file — the patent is not as safe as the FWD standing alone suggests, but claims 7/9 are the only claims you get for free.

Estoppel landscape.

• § 315(e)(2) estoppel runs against Nalox‑1 Pharmaceuticals, LLC and its real parties in interest and privies only, as of the 2020-08-21 FWD, and bars them fromraising in a civil action or ITC proceeding any ground they raised or reasonably could have raised in IPR2019‑00688 — which, because all 45 claims were in the FWD, is broad as to patents and printed publications.
• § 325(e)(1) likewise bars Nalox‑1 and its privies from seeking further USPTO proceedings on those grounds.
• For an unrelated defendant: you are not estopped. Wyse, Davies, Wang, HPE, Bahal, Kushwaha, Djupesland, Kerr 2009, the Kerr Formulation, Strang, and Kulkarni are all still on the table. The practical constraint is not estoppel — it is Board discretion (§ 325(d) for art already considered; § 314(a) for the advanced age of the dispute, the completed Teva litigation, and the 2020 FWD).
• One privity question to resolve early: Nalox‑1 has been characterized in commentary as a proxy/affiliate of the generic challenger, and the D.N.J. observed that its IPR arguments were "substantially similar to each other and to the arguments Teva made before this Court." I found no authoritative judicial or PTAB finding of formal privity between Nalox‑1 and Teva — treat the proxy characterization as unverified and worth a targeted investigation (corporate records, funding, common counsel at Arent Fox), because if privity were established, § 315(e)(2) would sweep Teva in too.

Pattern signals.

• One petitioner, fifteen petitions. Nalox‑1 filed fifteen IPRs on 2019-02-19 against five Orange Book NARCAN patents ('253, '747, '177, '965, '838) — three per patent, each with a different lead reference (Wyse / Davies / Wang). The Board instituted only on the Wyse-based petitions hitting the '253, '747, and '965 patents, and denied the other twelve as redundant. Nalox‑1 was not a defensive aggregator; its own filing described it as a pharmaceutical company "developing, and plan[ning] to seek FDA approval to market a much needed generic version of Narcan® naloxone nasal spray." That is an ANDA-motivated challenger, not a public-interest filer.
• Patent owner litigated hard, not settled. Opiant/Adapt substituted Williams & Connolly in as lead counsel mid-trial, filed a response, sur-reply, and fought every ground; there was no settlement in the IPR.
• No post-2020 PTAB activity on this patent. Despite wide assertion (Teva 2016; Perrigo 2018) and a Federal Circuit affirmance of invalidity in 2022, no further IPRs appear on this patent. That absence is itself a signal that the '747 stopped being a commercially meaningful assertion target.
• Ownership moved. Opiant assigned the family to Indivior UK Limited on 2023-06-14 (Google Patents reassignment record). Current listed assignee: Indivior UK Ltd.
• Status flag — verify before anything else. Google Patents lists the '747 as "Expired - Fee Related" with an anticipated expiration of 2035-03-16. That combination is internally inconsistent and Google expressly labels its status an assumption. If the patent in fact lapsed for non‑payment of a maintenance fee (35 U.S.C. §§ 41, 151), it is unenforceable for the lapse period and the claims are unpatentable subject matter in the interim — and someone could attempt revival for unintentional delay. This would be dispositive and I could not confirm it from a primary USPTO source. Pull the maintenance-fee history in USPTO Patent Center first.

Recommended next steps

1. Pull the fee/status record before doing anything else. USPTO Patent Center for US 9,468,747 — maintenance-fee payments and any lapse/revival petitions. Google Patents reports "Expired - Fee Related." If confirmed, that supersedes every argument below.
2. If asserted claims are 7 and/or 9: you win on the papers. Cite the D.N.J. final judgment (2020-06-26) and the Federal Circuit's affirmance in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., No. 2020-2106 (Fed. Cir. Feb. 10, 2022) — opinion at https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf — and quote the disposition: the district court's judgment "holding claims 7 and 9 of the '747 patent invalid" was affirmed. Do not file an IPR on those claims; it is waste and it is sanction-bait for a demand letter to cite them.
3. If asserted claims are 1–6, 8, or 10–45: read the FWD first — IPR2019‑00688, Paper 57 (2020-08-21), Nalox‑1 Pharms., LLC v. Opiant Pharms., Inc., available via PTAB E2E at https://ptacts.uspto.gov/ptab/caselist (search Trial No. IPR2019-00688) and mirrored at https://ocr.docketalarm.com/cases/PTAB/IPR2019-00688/Inter_Partes_Review_of_U.S._Pat._9468747/. Key quote for your file: "we conclude Petitioner has not established by a preponderance of the evidence that claims 1–45 of the '747 patent are unpatentable." Then note the conflict: the same Wyse reference invalidated claims 7 and 9 in D.N.J.
4. If you are a district-court defendant: your best path is the Teva trial record and the CAFC affirmance, not a new IPR. The D.N.J. developed a full obviousness record (Davies + Kerr 2009/Kerr Formulation + Bahal; and Strang + Kulkarni + Djupesland) that the Federal Circuit held sufficient as a matter of law. The PTAB record closed without reaching Davies, Wang, Strang, or Kulkarni, so those references remain available.
5. If you are determined to file an IPR: expect (a) § 325(d) scrutiny on Wyse/HPE (already considered and rejected); (b) § 314(a) discretion weighing the 2020 FWD, the completed Teva litigation, and the age of the patent; and (c) no help from Nalox‑1's estoppel, which does not bind you but also does not bind the patent owner. Do not economize by reusing the "Wyse discloses BAC" theory — the Board found Wyse teaches away, and the FWD's core reasoning is a direct-discouragement finding.
6. Milestones/watch items: there are no active PTAB proceedings on this patent to calendar — no institution deadline, no oral hearing, no § 316(a)(11) one-year FWD clock is running. The only live items are (i) the maintenance-fee/status question and (ii) any new assertion by Indivior UK Ltd. as current assignee.

Uncertainties I am explicitly flagging rather than papering over: (a) the institution-panel composition for -00688 and the full panels for -00689/-00690 are derived from third-party dockets, not primary documents; (b) I could not verify whether the Federal Circuit's 2022-10-02-10 disposition included any vacatur/remand as to the '965/'177/'838 claims — only the '747 disposition (claims 7 and 9 invalid, affirmed) is confirmed; (c) how the FWD ultimately resolved the § 102(a)(2)/priority challenge to Wyse is not confirmed from the FWD text I reviewed; (d) the "Expired - Fee Related" status is unverified and is the highest-value open question in this file.

I'll research the assignment record for this patent before reconstructing it.

Let me dig for the specific reel/frame records and any Adapt Pharma co-ownership assignment.

Assignment & Ownership Analysis — US 9,468,747 B2

Sourcing limitation (stated up front). I do not have live query access to the USPTO Assignment Center for this run. The reel/frame entries below come from Google Patents' legal‑events tables (family‑level records, visible on sibling member US 9,480,644 and on US 9,468,747's own event log), plus PTAB filings and SEC/company disclosures. Where a reel/frame is not recoverable from those sources I say so rather than invent one. Correspondent (recording attorney/agent) data was not recoverable for any link in this chain — see Signal 3 below, which is therefore marked unclear rather than absent.

Inventors

Source (patent face): https://patentimages.storage.googleapis.com/c4/c2/66/a0c5c54ebfe8f6/US9468747.pdf

Unusual-pattern check. No evidence found of inventors departing the assignee within 12 months of filing, and no inventor-side sale of rights. Both inventors assigned to the then‑applicant within days of the priority filing (effective 2015‑03‑27), which is the normal, healthy pattern. Not present.

Original assignee

• Named on the issued patent: Opiant Pharmaceuticals, Inc., Santa Monica, CA — but note the face of the patent shows "(71) Applicant: Lightlake Therapeutics, Inc., New York, NY" and "(73) Assignee: Opiant Pharmaceuticals, Inc.". Lightlake and Opiant are the same company at different points in time (change of name, discussed below under Reel 038502/0813). The '747 issued 2016‑10‑18, after the rename.
• Primary line of business: Specialty pharmaceutical company developing opioid‑antagonist products for substance‑use, addictive and eating disorders. It is an operating drug developer (clinical programs, INDs/NDAs), not a licensing shell. Lightlake was incorporated 2005; it changed its name to Opiant Pharmaceuticals, Inc. and later listed on Nasdaq (OPNT).
• Did the original assignee ship a product embodying the claims? Not directly. Opiant developed NARCAN® Nasal Spray (naloxone HCl 4 mg metered spray, NDA 208411) and licensed it to Adapt Pharma Limited in December 2014, which commercialized it ("Opiant successfully developed NARCAN, marketed by its partner and licensee, Adapt Pharma Limited"). Opiant's economic model here was development + out‑license with milestones (>$55M potential) and double‑digit royalties, not own‑label marketing. Source: https://www.globenewswire.com/en/news-release/2016/10/27/[883562/37234](https://assignmentcenter.uspto.gov/search/patent/reelFrameDetail?reelFrame=883562-37234)/en/Opiant-Pharmaceuticals-Inc-Announces-FDA-Orange-Book-Listing-for-Narcan-Nasal-Spray-Patent.html
• Current status: Opiant was acquired by Indivior PLC; the merger closed 2023‑03‑02 for ~$145–146M upfront ($20.00/share) plus up to $8.00/share in contingent value rights. Opiant common stock ceased trading on Nasdaq. Opiant as a separate public entity no longer exists. Sources: https://ir.indivior.com/news-releases/news-release-details/indivior-completes-opiant-transaction ; https://www.indivior.com/resources/dam/id/1299/Indivior%20Q3%[202023](/patent/202023)%20Financial%20Results%20-%20Final.pdf (Note 16 — the deal was accounted for as an asset acquisition, not a business combination, with $126M allocated to the OPVEE intangible).

Assignment timeline

Records exist for this patent — four links are reconstructable, three of them with concrete reel/frame data. One reel/frame (the most recent) is unverified.

1. 2015‑03‑27 (executed) / recorded on the family‑level record — Reel 038357/0246

• Conveyance: Assignment
• Assignor: Roger Crystal; Michael Brenner Weiss (individual inventors)
• Assignee: Lightlake Therapeutics, Inc.
• Correspondent: Not recoverable from the sources available to me.
• Context: Original invention assignment from the two inventors to the applicant company, executed 13 days after the 2014‑03‑14 earliest priority date and 11 months before the '747 filing — the standard founding assignment, not a fire‑sale.
• Transaction text as recorded: "ASSIGNMENT OF ASSIGNORS INTEREST; ASSIGNORS: CRYSTAL, ROGER; WEISS, MICHAEL BRENNER; REEL/FRAME: 038357/0246; Effective date: 20150327."
• Data oddity to flag: the same record renders the owner as "LIGHTLAKE THERAPEUTICS, INC., UNITED KINGDOM," although the applicant's address of record on the patent face is New York, NY (US). This looks like a USPTO/Google data‑entry artifact, but it should be verified against the Assignment Center image before being relied on.

2. Change of name — Reel 038502/0813 (no execution date captured in my source)

• Conveyance: Change of Name
• Assignor: Lightlake Therapeutics, Inc.
• Assignee: Opiant Pharmaceuticals, Inc. (indexed with a "CALIFORNIA" address)
• Correspondent: Not recoverable.
• Context: Internal corporate rename only — no change in beneficial ownership, no consideration, no change in the party in interest. This is why the patent's (71) and (73) fields name different companies. Sequentially consistent with the 2015 rename of Lightlake to Opiant.

3. 2018 — no recorded assignment to Emergent BioSolutions with respect to this patent found.

• Relevant background, not an assignment of the '747: Emergent BioSolutions acquired Adapt Pharma in 2018 (per the PTAB mandatory notices: "Adapt is a wholly owned subsidiary of Adapt Pharma Limited, which is a wholly owned subsidiary of Emergent Acquisition Limited… wholly owned subsidiary of Emergent International Inc., which is a wholly owned subsidiary of Emergent BioSolutions Inc."). Adapt was Opiant's licensee, and its ownership change did not put the '747 into Emergent's name. Flagging this because it is a common source of confusion in ownership chains.
• Separate flag (unresolved): In the PTAB consolidated proceedings, Patent Owners stated: "Adapt and Opiant are the assignees of U.S. Patent Nos. 9,211,253; 9,468,747; and 9,629,965." That language implies Adapt Pharma Operations Limited held a recorded ownership interest in the '747 (possibly a partial assignment), yet I could not locate a distinct reel/frame for an Opiant → Adapt transfer, and Opiant's own public statements describe Adapt as a licensee. Treat the co‑ownership question as open and requiring direct Assignment Center verification. Source: https://www.docketalarm.com/cases/PTAB/IPR2019-00688/Inter_Partes_Review_of_U.S._Pat._9468747/12-17-2019-Patent_Owner/Notice-30-JOINT_AMENDED_MANDATORY_NOTICES_OF_PATENT_OWNERS_ADAPT_PHARMA_OPERATIONS_LIMITED_AND_OPIANT_PHARMACEUTICALS,_INC/

4. 2023‑06‑14 (recorded) — Reel/frame NOT verified

• Conveyance: Assignment ("ASSIGNMENT OF ASSIGNOR'S INTEREST" per Google Patents legal events)
• Assignor: Opiant Pharmaceuticals, Inc.
• Assignee: INDIVIOR UK LIMITED
• Correspondent: Not recoverable — this is the single most important gap in the record for the purposes of this analysis.
• Context: Merger‑driven consolidation. Executed under the Indivior/Opiant merger that closed 2023‑03‑02, recorded ~3.5 months later — an ordinary post‑merger recordation lag, not a pre‑litigation transfer. Source: https://patents.google.com/patent/US9468747/en (legal events) and https://ir.indivior.com/news-releases/news-release-details/indivior-completes-opiant-transaction

If the Assignment Center shows further records beyond these four (e.g., a security agreement, a release, or an Emergent/Adapt conveyance), they are not visible in the indexed sources I could reach and should be pulled directly.

Timeline diagram

timeline
    title Ownership of US 9468747
    2015 : Inventors assign rights to Lightlake Therapeutics
         : Lightlake renamed Opiant Pharmaceuticals
    2016 : Patent issued on 18 Oct 2016
    2018 : Licensee Adapt acquired by Emergent BioSolutions
    2020 : Claims 7 and 9 held invalid in Teva action
    2022 : Federal Circuit affirms invalidity
    2023 : Opiant acquired by Indivior UK Limited

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. No link in the chain exhibits the tell‑tale pattern. Assignee names carry no "IP / Patents / Licensing / Holdings / Ventures" suffix; they are operating drug companies: Lightlake Therapeutics (biopharma, incorporated 2005), Opiant Pharmaceuticals (Nasdaq: OPNT, clinical‑stage drug developer), Indivior UK Limited (operating subsidiary of Indivior PLC, which markets SUBOXONE/SUBLOCATE/PERSERIS/OPVEE). The Reel 038357/0246 and Reel 038502/0813 records transfer to, and rename, a company that itself filed INDs/NDAs — the opposite of a single‑purpose licensing LLC. The 2015‑03‑27 executed date, 13 days after priority, is a founding assignment, which shells do not have.

2. Known asserter in the chain — NOT PRESENT. None of Lightlake, Opiant, Adapt Pharma, Emergent BioSolutions, or Indivior appears on the standard NPE directories (Acacia, Marathon, Intellectual Ventures, IPNav, Wi‑LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities). Note the direction of travel: the entity that filed the IPRs against this patent — Nalox‑1 Pharmaceuticals, LLC — is a third‑party challenger/petitioner, not an assignee, and it is not in the chain. Sources: https://portal.unifiedpatents.com/ptab/case/IPR2019-00688 ; https://portal.unifiedpatents.com/ptab/case/IPR2019-00689 ; https://portal.unifiedpatents.com/ptab/case/IPR2019-00690

3. Repeat correspondent across the chain — UNCLEAR (evidence gap, not a finding). I could not retrieve the correspondent of record for any of the three recorded conveyances, and I cannot query this site's tracked patents to test for recurrence. Per the stated rule, a single appearance would not be a finding anyway, so I am explicitly marking this unclear for lack of data rather than inferring. To close it, pull reels 038357/0246 and 038502/0813 plus the 2023‑06‑14 recording image from https://assignmentcenter.uspto.gov/ and read the correspondent field. This is the one signal that could still change the verdict.

4. Cascading transfers — NOT PRESENT. The chain is short and slow: 2015 (assignment) → 2015 (rename) → 2023 (merger), i.e. eight years between the last two events. There is no <24‑month chain of consecutive transfers, no shared correspondent address, and no common principals across successive assignees. Contrast this with the classic NPE cascade, which shows 3–5 hops in 12–18 months.

5. Pre-litigation transfer — NOT PRESENT. The first infringement suit naming this patent (Adapt Pharma Operations Ltd., et al. v. Teva Pharmaceuticals USA, Inc., et al., D.N.J. 2:16‑cv‑07721, filed 2016‑10‑21) post‑dates issuance by three days and the founding assignment by ~19 months. There is no assignment within 6 months before suit. The only assignment near litigation is the 2023 Indivior transfer — which came ~7 years after filing and ~3 years after the 2020 judgment, i.e. after the patent was already adjudicated. Source: https://portal.unifiedpatents.com/litigation/New%20Jersey%20District%20Court/case/2%3A16-cv-07721

6. Bankruptcy fire‑sale — NOT PRESENT. Neither Lightlake/Opiant nor Indivior went through Chapter 7/11. Opiant's exit was a solvent, publicly announced cash+ CVR merger at $20.00/share. Indivior has had substantial litigation liabilities (the antitrust MDL settlements: $385M direct‑purchaser, $103M states, $30M end‑payor class) but that is a defendant‑side settlement posture, not a patent fire‑sale.

7. Privateering — NOT PRESENT (and the facts run the other way). The Opiant→Adapt arrangement is an ordinary pharma out‑license, and both the licensor and the licensee appeared jointly as plaintiffs against ANDA filers (Adapt Pharma Operations Ltd., Adapt Pharma, Inc., Adapt Pharma Limited, and Opiant Pharmaceuticals, Inc. v. Teva). The patent owner and the marketing partner asserted together against real generic competitors — the opposite of an operating company hiding behind a proxy NPE.

8. Defensive aggregator / neutralization — NOT PRESENT, but note the invalidity + fee‑lapse outcome. The chain does not terminate at RPX/AST/LOT/Unified/OIN. However, the asset has been functionally neutralized by other means: (a) the D.N.J. judgment of 2020‑06‑26 and the Federal Circuit affirmance in Appeal No. 20‑2106 (2022‑02‑10) invalidated the asserted claims (see contradiction flag below), and (b) Google Patents lists the legal status as "Expired – Fee Related" notwithstanding a nominal 2035‑03‑16 expiry — consistent with a maintenance‑fee lapse (the 7.5‑year fee would have fallen due around 2024) after the claims were struck down. Sources: https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf ; https://patents.google.com/patent/US9468747/en

Contradiction flags against the previously generated sections

1. Scope of the invalidity holding. The prior summary states the D.N.J. judgment held "the patents invalid" and that the Federal Circuit "affirmed the invalidity holding" without limiting scope. The Patent Owners' own joint amended mandatory notices in IPR2019‑00694 (2020‑08‑11) describe the judgment more narrowly: "On June 26, 2020, the district court entered final judgment in the Teva Action holding the following claims invalid: Claims 7 and 9 of U.S. Patent No. 9,468,747; Claim 4 of 9,561,177; Claims 21, 24, and 25 of 9,629,965; and Claims 2, 24, 33, and 38 of 9,775,838." That reads as an asserted‑claims‑only holding, not a wholesale invalidation of every claim of the '747. This matters for the "neutralized asset" conclusion and should be reconciled against the actual judgment. Source: https://www.docketalarm.com/cases/PTAB/IPR2019-00694/Inter_Partes_Review_of_U.S._Pat._9629965/08-11-2020-Patent_Owner/Notice-54-Patent_Owners_Joint_Amended_Mandatory_Notices/
2. PTAB petitioner identity. The prior summary attributes IPR2019‑00688/689/690 to "Nalox‑1 Pharmaceuticals, LLC." The Unified Patents docket confirms Nalox‑1 Pharmaceuticals LLC as petitioner for all three. Note that the '688 FWD was reached (2020‑08‑21) while '689 and '690 were "Not Instituted – Procedural" — consistent with the prior summary. No correction needed; recorded here for completeness.

Verdict

Operating-company assertion.

The chain runs inventors (Roger Crystal, Michael Brenner Weiss) → Lightlake Therapeutics via founding assignment Reel 038357/0246 executed 2015‑03‑27 → same entity renamed Opiant Pharmaceuticals via Change of Name Reel 038502/0813 → Indivior UK Limited recorded 2023‑06‑14 following the solvent $20.00/share merger that closed 2023‑03‑02. Every assignee in the chain is a real drug‑development or pharmaceutical operating company that filed INDs/NDAs and put a product on the market (NARCAN® Nasal Spray, NDA 208411), and the patent was asserted jointly by the owner and its commercial licensee against actual ANDA competitors (Teva, Perrigo) — the paradigm of operating‑company assertion, not NPE conduct. No shell LLC, no known asserter, no cascading transfer, no pre‑litigation assignment, and no defensive aggregator appears anywhere in the record; the single unresolved signal is the repeat‑correspondent test, which is unclear only because I could not retrieve the correspondent fields.

Verification links:

• USPTO Assignment Center (search patent 9468747): https://assignmentcenter.uspto.gov/
• Legacy indexed view: https://assignment.uspto.gov/patent/index.html
• Google Patents legal events: https://patents.google.com/patent/US9468747/en

I'll search for the USPTO record and the citation lists for US 9,468,747.

Let me retrieve the full front-page citation list and details on key references.

Let me gather details on the remaining cited references and the examiner-cited publications.

Scope and method

I ran targeted searches against the Google Patents record for US 9,468,747, the patent's own front page (as reproduced in two independent copies of the printed patent — the Google Patents PDF and the D.N.J. litigation exhibit), the PTAB record for IPR2019-00688/689/690, and the Nalox‑1 petitions/expert declarations. I then assessed each cited reference under 35 U.S.C. § 102 (the '747 is a post‑AIA patent; its application was filed Nov. 24, 2015).

Important framing point on the task itself: the '747 was not invalidated for anticipation. It survived prosecution, survived the instituted IPR (IPR2019‑00688 FWD: claims not unpatentable), and was invalidated in D.N.J. and on appeal solely under § 103 obviousness. So the honest answer below is that no single cited reference anticipates claims 1–45; I identify, per reference, where the § 102 case is closest and what element each is missing, and I flag the references that actually did the invalidation work (in § 103 combinations).

Threshold issue: the effective filing date drives which citations are § 102 art at all

This is the single most important analytical point for this patent, and it was the lead argument in the IPR petition:

• Google Patents lists a priority claim to US 14/659,472, filed 2015‑03‑16, and an earliest priority date of 2014‑03‑14 (provisional 61/953,379).
• The '747 is a continuation of 14/942,344 (filed Nov. 16, 2015), which is a continuation/continuation-in-part of 14/659,472 (filed Mar. 16, 2015). The D.N.J. opinion described the '747 as "issued pursuant to an application that was a continuation‑in‑part of the application filed for the '253 Patent."
• Dr. Günther Hochhaus, in the Nalox‑1 petition declaration (Nalox1003, ¶ 4), stated flatly: "the '747 patent cannot claim priority to the March 14, 2014 application, and the earliest application to which it can claim priority has a filing date of March 16, 2015." Petitioner therefore applied a March 16, 2015 critical date.

Consequence: references with effective dates between March 14, 2014 and March 16, 2015 — most importantly AntiOp/Wyse — are available as § 102(a)(2) art. This is why Wyse (US 9,192,570, priority Dec. 20, 2013) was the centerpiece of the IPR, and why the applicant's own family publications (Crystal US 2015/0258019 A1, US 2016/0008277 A1) are not § 102 art (§ 102(b)(2)(A)/(C) — same inventors / common ownership by Lightlake→Opiant).

A. U.S. patent documents cited on the face of the '747

These appear in the printed patent's "(56) References Cited — U.S. PATENT DOCUMENTS" list.

B. Foreign patent documents cited on the face of the '747

(Total: 22 foreign documents, matching the face-page list.)

C. Non‑patent literature cited (examiner "Other Publications")

From the printed '747 front page as reproduced in the D.N.J./PTAB exhibits, the examiner-cited publications include:

Caveat: the NPL list above is assembled from the '747's own front page as reproduced in the D.N.J. exhibit and from the parallel exhibit for the sibling patents. A handful of the entries (e.g., Krieter 2016, and the Teva ANDA notices) may belong to the face page of a sibling patent in the family (e.g., 9,561,177 / 9,775,838 / 10,085,937), which share nearly identical NPL lists. I could not isolate the '747's NPL list line‑by‑line; treat the list as family‑level with high overlap.

D. § 102 verdict, reference by reference

Bottom line on § 102: no cited reference, alone or as I could verify it, discloses every limitation of claim 1 or claim 30. There is no viable anticipation case on this record. Every citation is best characterized as § 103 material.

E. What actually invalidated the patent (so you know where the real § 102/§ 103 pressure is)

• PTAB, IPR2019‑00688 (FWD 8/21/2020): Petitioner Nalox‑1's § 103 grounds rested on Wyse (US 9,192,570) as primary, combined with Wang (CN 1575795) or Davies (WO 00/62757), plus Wermeling 2013, Barton 2002, and the Alabama EMS Patient Care Protocols (7th ed., Oct. 2013). Patent Owner prevailed — claims not unpatentable.
• D.N.J., 2:16‑cv‑07721 (opinion 6/22/2020): the court accepted Dr. Smyth's two combinations — (1) Strang + Kulkarni + Djupesland, and (2) Davies + Kerr (and the Kerr formulation) + Bahal — plus the Aptar UnitDose device, and held the asserted claims invalid as obvious.
• Fed. Cir. No. 2020‑2106 (2/10/2022): affirmed (Newman, J., dissenting — "a classical example of judicial hindsight").

Note the asymmetry flagged in the prior Litigation section: the same patent was upheld at the PTAB and invalidated in district court, on overlapping but not identical prior‑art combinations. That is unusual and worth preserving in the record.

F. Corrections / contradictions with the previously generated sections

1. Claim count and independent-claim structure — resolved. The earlier "Uncertainty flag" (claims "at least to claim 41"; "two independent claims… probable, not certain") is now confirmed: IPR2019‑00688 states that claims 1–45 were challenged and that "Claims 1 and 30 … are the only independent claims." So there is no third independent device or kit claim. What the summary treated as "device claims" (ergonomics, reservoir ≤140 µL, one‑hand actuation) are dependent claims.
2. Filing-date chain. The earlier summary listed the application as a "continuation; priority claimed from 14/659,472." The record is more precise: the '747 is a continuation of 14/942,344 (filed Nov. 16, 2015), which is a continuation/continuation‑in‑part of 14/659,472 (filed Mar. 16, 2015), with a provisional 61/953,379 filed Mar. 14, 2014. The D.N.J. opinion calls it a CIP of the '253 application. This matters: it is why Petitioner argued the effective date is Mar. 16, 2015, not Mar. 14, 2014.
3. Applicant entity on the face page. The printed patent's field (71) reads "Applicant: Lightlake Therapeutics, Inc., New York, NY," with (73) Assignee "Opiant Pharmaceuticals, Inc., Santa Monica, CA" — the earlier summary's "Original Assignee: Opiant" is right as to (73) but omits Lightlake as the (71) applicant. Also, the inventor address for Crystal is listed as Santa Monica, CA (not New York).
4. Foreign-citation list. I could not fully reconcile the '747 face-page foreign list against a second, near-identical list in a sibling patent's exhibit (which additionally shows WO 00/76474, WO 2006/058022 and WO 2012/094283). Those three likely belong to a sibling patent, not the '747. Flagging rather than resolving.

G. Limits on verification (please read)

• I could not retrieve a machine-readable USPTO "Patent Citations" table for 9,468,747 directly from the USPTO PatentCenter/PatFT interface in this session; the citation lists above come from the printed patent front page (two independent copies) plus the PTAB/D.N.J. records. These should agree, but I have not done a character-by-character USPTO-side confirmation.
• Descriptions for US 4,181,726 (Bernstein), US 2006/0120967 (Namburi), US 2009/0017102 (Stinchcomb), US 2010/0168147 / US 2011/0046172 (Chapleo), US 2013/0023825 (Edwards), EP 1681057 B1 and most of the WO device/formulation references are marked "not independently verified." I deliberately did not invent titles or disclosures for these.
• The single-reference anticipation analysis is my own application of § 102 to the claim limitations recited in the record; the D.N.J. and Federal Circuit opinions do not contain a § 102 holding to cite, because the case was decided entirely on § 103.

If you want, the next step I'd recommend is pulling the '747's USPTO PatentCenter "References Cited" and "Cited By" tables directly (and the Form 892/1449s from the file wrapper) to lock down which of the borderline NPL entries are truly on the '747's own face page versus a sibling's.

I'll ground this analysis in the actual prior-art record, including the references the district court and Federal Circuit relied on.

Let me pull the full descriptions of each reference in the two combinations the court analyzed.

Let me pin down the identities of the specific references the court relied on.

Obviousness Analysis — U.S. Patent No. 9,468,747 under 35 U.S.C. § 103

Bottom line up front. The '747 claims were not merely arguably obvious — they were adjudicated obvious by clear and convincing evidence after a two‑week bench trial in D.N.J., and that holding was affirmed by the Federal Circuit on 2022‑02‑10 in Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 20‑2106. Two independent three‑reference combinations were found to render the claims obvious. I analyze both below, plus a third theory available from the '747 specification's own admitted background art, and map each claim limitation to record‑grounded disclosures.

Cross‑reference note / contradiction resolved. The earlier "Litigation summary" flagged an inconsistency in the district‑court ruling date (June 5 vs. June 22 vs. June 26, 2020). That is now resolved — there were three separate documents: the Order (June 5, 2020), the Opinion/Findings of Fact and Conclusions of Law (filed June 22, 2020, ECF No. 341/344), and the Final Judgment (signed June 26, 2020, ECF No. 346). See the Final Judgment at https://storage.courtlistener.com/recap/gov.uscourts.njd.[340302](/patent/340302)/gov.uscourts.njd.340302.346.0.pdf.

Second cross‑reference flag (unresolved). The earlier "Patent summary" describes the '747 claim set as running to claim 41 with independent claims at 1 and 30, drawn from the published application. The litigation record instead identifies the asserted claims of the '747 as claims 7 and 9, with claim 9 "includ[ing] claims 1 and 2 in its dependency." Adapt Pharma, slip op. at 5. That is consistent with claim 1 being independent, but it does not corroborate a second independent claim at 30 in the granted patent. I treat the earlier "independent claims at 1 and 30" statement as unverified for the granted '747 (it may reflect the published application, US 2016/0184294 A1, rather than the issued patent). Everything below is anchored to the claim language actually quoted in the Federal Circuit opinion.

(Minor housekeeping: the task header states "April 26, 2026," while the research date on the fetched patent page is 2026‑09‑30. Nothing in the analysis turns on the difference.)

1. Legal framework and the person of ordinary skill

• Obviousness is a question of law (35 U.S.C. § 103) resting on the Graham v. John Deere, 383 U.S. 1 (1966), factual underpinnings: scope/content of the prior art, differences between the prior art and the claims, the level of ordinary skill, and objective indicia. Motivation to combine is itself a factual question reviewed for clear error, as is what the prior art teaches (including teaching away). Merck Sharp & Dohme v. Hospira, 874 F.3d 724, 728 (Fed. Cir. 2017).
• KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398 (2007), supplies the rationales actually litigated here: (i) a known problem for which the prior art provides a known solution; (ii) "interrelated teachings" of multiple references; (iii) a design incentive or market force; (iv) predictable variation / routine optimization; and (v) the "obvious to try" doctrine where there is "a finite number of identified, predictable solutions."
• Burden: clear and convincing evidence, because the challenge was litigated in an ANDA action against an issued patent.
• POSITA. The record treated the relevant artisan as a pharmaceutical formulator with experience in nasal/injectable drug formulation (the IPR petitioner's declaration is expressly framed as "a Formulator POSA"). I did not retrieve the district court's verbatim adopted POSITA definition and flag that as an unverified detail. Notably, the claims here are formulation and device limitations, not pharmacokinetic method steps, and the Federal Circuit confirmed the POSITA was a formulator.

2. The claim under analysis

Claim 1 as quoted in Adapt Pharma (slip op. at 4–5):

"1. A method of treatment of opioid overdose or a symptom thereof, comprising nasally administering to a patient in need thereof a dose of naloxone hydrochloride using a single-use, pre-primed device ... by one actuation ... into one nostril ... having a single reservoir comprising a pharmaceutical composition which is an aqueous solution of about 100 μL comprising: about 4 mg naloxone hydrochloride or a hydrate thereof; between about 0.2 mg and about 1.2 mg of an isotonicity agent; between about 0.005 mg and about 0.015 mg of a compound which is at least one of a preservative, a cationic surfactant, and a permeation enhancer; between about 0.1 mg and about 0.5 mg of a stabilizing agent; and an amount of an acid sufficient to achieve a pH of 3.5–5.5."

"2. The method as recited in claim 1 wherein: the isotonicity agent is NaCl; the preservative is benzalkonium chloride; the stabilizing agent is disodium edetate; and the acid is hydrochloric acid."

Claim 9 (representative) depends from claims 1 and 2. Assumption flagged: the dependency architecture of claims 7 and 9 beyond claim 2 is not fully reproduced in the opinion; I analyze claim 1 and claim 2 (which claim 9 incorporates) and then address the dependent themes the record indexes to claims 7/9.

The claim‑1 concentration windows converted to w/v

This matters because the prior‑art disclosures map onto them almost numerically:

My arithmetic (not from the opinion): the earlier summary's exemplified recipe of 4.4 mg naloxone HCl dihydrate converts to 4.4 × (363.84/399.87) ≈ 4.00 mg anhydrous — i.e., the dihydrate figure is merely the hydrate equivalent of the claimed 4 mg, exactly as the '747 specification states (that 8 mg anhydrous HCl ≡ ~8.8 mg dihydrate).

3. Combination A — the "Davies combination": Davies + Kerr 2009 / the Kerr Formulation + Bahal

This was Teva's first asserted combination. The opinion describes the three references and their mapping as follows (Adapt Pharma, slip op. at 5–6, 19–21; Judgment Op., 2020 WL 3428078, at *20–*32).

(a) What each reference teaches

Davies — WO 00/62757 to David Davies (identified in the '747 specification's own background as "WO 00/62757 to Davies," and by the Federal Circuit as "an international patent application, filed by David Davies and published in 2000"):

• Compositions for intranasal or oral administration comprising an opioid antagonist such as naloxone, "for application by spray in the reversal of opioid depression," with a spray applicator capable of delivering single or multiple doses and dosage units in the range of 0.2 to 5 mg. (This is verbatim from the '747/'838 specification's background section — i.e., applicant‑admitted prior art.)
• A detailed spray‑applicator disclosure with drawings: a reservoir, piston, and swirl chamber; "suitable spray applicators are preferably single trip devices"; a shot volume of 20–100 µL; shaped for nasal introduction so "a major amount of the composition is retained in the nasal passages"; actuatable with one hand (thumb + two fingers).
• Formulation guidance: naloxone "freely soluble in water ... when in the form of a salt, such as a hydrochloride"; may be dissolved in ~0.9% w/v sodium chloride; the formulation "should be slightly acidic (e.g., pH 6.5) to maintain the naloxone in its salt form"; Example 1 uses benzalkonium chloride as a preservative at 0.025% w/v; Davies also identifies sodium chloride and BZK as suitable for his intranasal naloxone formulation.

Kerr 2009 / the "Kerr Formulation" — Kerr et al., Addiction 2009;104(12):2067‑74 (also cited in the '747 specification itself: 2 mg naloxone in 1 mL, 1 mg per nostril, IN vs. IM comparison). The "Kerr Formulation" is the actual clinical formulation Kerr used: sodium chloride, BZK, and pH adjusted with hydrochloric acid, with a BZK concentration of 0.01% — squarely inside the claimed 0.005%–0.015% window. Dr. Kerr purchased 200 doses and used 80, each effective at reversing overdose, over an 18‑month period.

Bahal — a patent on injectable naloxone formulations. The Federal Circuit's summary: "Bahal, although directed to injectable naloxone formulations, discovered that the addition of a stabilizing agent like EDTA to a naloxone formulation prevents naloxone degradation," citing Bahal col. 1, ll. 53–54, with a "preferred" EDTA range of 0.0001% to 1.0% (col. 2, ll. 65–67). (I did not retrieve Bahal's patent number; I flag that rather than guess one.)

(b) Element-by-element mapping

(c) Motivation to combine under KSR

The Federal Circuit identified the rationale as the references' "interrelated teachings" (Tyco Healthcare v. Mutual Pharm., 774 F.3d 968, 978 (Fed. Cir. 2014)):

1. Common field of endeavor. Davies and Kerr 2009 both "recognized the benefits of intranasal naloxone." Bahal, while injectable, addressed the same technical problem — naloxone degradation — and taught the same solution (EDTA chelation).
2. Complementarity / solving a known problem with a known solution. Davies supplies the device, dose range, volume, tonicity agent, and preservative; Kerr supplies the clinically‑validated excipient set at the exact claimed BZK concentration and an 18‑month stability data point; Bahal supplies the stabilizer that the artisan would recognize as needed because "naloxone degradation was known in the prior art."
3. Routine optimization / predictable results. The court found the prior art "likewise describes concentrations for each of the excipients falling within or encompassing the claimed ranges," so that "arriving at the claimed concentration range for each of the well‑known excipients would have required no more than routine optimization."
4. Device substitution rationale. Because the Aptar UnitDose device was "readily available on the market" and already FDA‑approved, "a POSA would have been motivated to use it rather than attempt to modify the device in Davies."

4. Combination B — the "Strang combination": Strang + Kulkarni + Djupesland

Teva's second, independent combination. Per the opinion (Adapt Pharma, slip op. at 19, 21; Judgment Op. at *28–*31):

• Strang — teaches intranasal naloxone with a preferred initial dose of 4 mg; teaches that 1 mg IV naloxone is bioequivalent to 3–4 mg intranasal spray; teaches saline and pH preferences (pH most preferably <5.5); and states that "[t]ypical pharmaceutical excipients used in intranasal formulations are known to the skilled person and can be used for the formulations according to the present invention." Strang also disclosed naloxone as safe across 0.5 mg to 20 mg and recommended a starting dose of 4 mg. NaCl at 0.9%–1.9%.
• Kulkarni — teaches FDA regulation of nasal spray formulation additives and the effect of each on the active, disclosing maximum concentrations of BZK (up to 0.119% w/w) and EDTA (up to 0.5% w/w), and an optimal pH range of 4.5–6.5.
• Djupesland — Per Gisle Djupesland, "Nasal drug delivery devices: Characteristics and performance in a clinical perspective — a review," teaching single‑ or bi‑dose, metered‑dose nasal delivery devices including the FDA‑approved Aptar UnitDose device, and that BZK "is safe and well‑tolerated for chronic use."

Mapping. Strang supplies the dose (4 mg), the utility (opioid overdose, IN), and the pH/tonicity guidance; Kulkarni supplies each of the remaining excipient identities and concentrations within or encompassing the claimed ranges (BZK ≤0.119% vs. claimed 0.005–0.015%; EDTA ≤0.5% vs. claimed 0.1–0.5%); Djupesland supplies the device. This is a textbook KSR "finite number of identified, predictable solutions" scenario: Strang expressly tells the artisan the excipients are known/predictable, and Kulkarni quantifies them.

Motivation. Dr. Smyth (credited by the court) explained that "the formulation would be filled in through references like Kulkarni" and that "Djupesland specifically points towards the Aptar Unit[D]ose device for the device to be used in an invention like Strang." The court found a reasonable expectation of success.

5. Combination C — the specification's own admitted prior art (a § 103 theory requiring no litigation record)

Even setting the trial record aside, the '747 specification's background section cites and characterizes the following, all of which are § 102(b)/§ 102(a) art relative to the 2014‑03‑14 priority date:

This is powerful: the specification concedes (a) IN naloxone utility, (b) a 0.1 mL nasal unit dose of 1 mg/mL, (c) spray devices delivering 0.2–5 mg units, (d) the quantified low IN bioavailability that motivates a higher dose, and (e) Tmax values of 20.4/23.4 minutes measured for IN naloxone — which sit squarely inside the dependent‑claim limitations of "Tmax of less than 30 minutes," "less than 25 minutes," and "about 20 minutes."

6. The dependent claims

The quantitative coincidence of the Kerr Formulation's 0.01% BZK with the claim's 0.005–0.015 mg/100 µL window is, in my view, the single most damaging fact for claim 2's patentability on this record.

7. Teaching away — the Wyse reference

Adapt's principal rebuttal was U.S. Pat. No. 9,192,570 (Wyse), which reports that BZK "resulted in an additional degradant" and concludes BZK "was not [acceptable], due to increased observed degradation."

• Threshold problem I must flag: Wyse published 2015‑06‑25, after the March 2014 priority date — so it is not § 102 prior art as to the '747 and was considered only on the teaching‑away question. The Federal Circuit said so expressly. Any obviousness theory built on Wyse as a § 102/§ 103 reference in combination would fail.
• Why the teaching‑away argument failed: Wyse tested BZK at 0.125% w/v — 8.5× the claimed upper limit (0.015%). The district court credited Dr. Smyth that a POSITA "would not have been dissuaded from using BZK at all ... only from using such high concentrations." The district court also relied on Medichem (no rule that one teaching‑away reference mandates nonobviousness; consider the prior art "as a whole"), on Davies' and Kerr's BZK‑containing IN naloxone formulations with no expressed stability concerns, and on the fact that "BZK ... has been used in over 200 intranasal products."
• The counter‑fact worth stating honestly: In the parallel PTAB proceedings, the Board reached the opposite conclusion, holding that "Wyse expressly teaches that [BZK] is unacceptable for use in intranasal naloxone formulations" (FWDs in IPR2019‑00685 and ‑00694, 2020 WL 4920048 / 4920200). The earlier sections report that IPR2019‑00688 (the '747 IPR) ended in a Final Written Decision on 2020‑08‑21 holding the claims NOT unpatentable — i.e., Patent Owner won at the PTAB on the '747 and lost in district court on the same patent. That asymmetry is the most significant vulnerability in the invalidity holding, and it is what Judge Newman's dissent in substance captured.

8. Objective indicia of nonobviousness, and why they did not save the claims

Dissent. Judge Newman, dissenting, characterized the majority's reasoning as "a classical example of judicial hindsight, where the invention itself is the only guide to the selections from the prior art," criticized the expert for saying only that the components were "available," and emphasized the millions of possible combinations across the references.

9. My assessment of the strength of each theory

10. Outcome and current status

• D.N.J. (2:16‑cv‑07721, consolidated): asserted claims of the '747 (claims 7 and 9) declared invalid as obvious; Final Judgment June 26, 2020.
• Fed. Cir. 20‑2106: AFFIRMED February 10, 2022 (Stoll, J., joined by Prost, J.; Newman, J., dissenting). https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf
• PTAB: IPR2019‑00688 (FWD 2020‑08‑21) — claims not unpatentable; IPR2019‑00689 and ‑00690 — not instituted (procedural). Petitioner per the earlier section: Nalox‑1 Pharmaceuticals LLC. (Note: the Google Patents page lists "Unified Patents PTAB Data" in connection with these dockets — that is the aggregator's data source attribution, not the petitioner.)
• Status: the patent record shows Expired – Fee Related, anticipated expiration 2035‑03‑16, with the District Court and Federal Circuit findings of invalidity in the litigation record. No 2026 Federal Circuit activity specific to this patent was found (consistent with the earlier sections).

11. Explicit uncertainty and what I did not verify

1. No patent numbers for Bahal, Kulkarni, or Strang. I have only the record's short names and the pinpoint cites the opinions give (e.g., "Bahal col. 1 ll. 53–54," "Bahal col. 2 ll. 65–67," "TX‑3103.04" for Kulkarni, "TX‑0054.34" for Strang). I am deliberately not guessing numbers.
2. The motion‑to‑amend / claim‑construction record and the exact POSITA definition adopted by the district court were not retrieved.
3. PK‑threshold dependent claims (e.g., "≥0.2 ng/mL within 2.5 minutes") — I could not verify these limitations against an authoritative claim text and therefore state no prior‑art mapping for them.
4. Kerr 2009's Tmax data and the precise numeric values in the "Kerr Formulation" exhibit (TX‑3098) beyond the 0.01% BZK figure.
5. The '747 granted claim count/structure — see the second cross‑reference flag in the header.
6. Legal status remains a Google Patents assumption, not a legal conclusion.

Net conclusion. On the adjudicated record, claims 1, 2, and 9 of the '747 would have been obvious under § 103 over either the Davies combination or the Strang combination — principally because (i) the known problem of the MAD Kit and the express 2012 FDA call for an FDA‑approvable intranasal naloxone product supplied the motivation; (ii) the claimed excipients and their claimed concentration ranges were each disclosed or encompassed by the prior art, with the BZK figure matching the Kerr Formulation to the digit; and (iii) the claimed device limitations were inherent to the commercially available Aptar UnitDose device. The strongest contrary evidence — the PTAB's contrary non‑unpatentability holding on the same patent, and Judge Newman's hindsight critique — is real but was ultimately insufficient to defeat the "strong case of obviousness" on appeal.