US 9561177

I'll search for authoritative information on US 9561177 and any 2026 CAFC activity.

Let me dig further into litigation history and any 2026 appellate activity.

Let me check for any 2026 Federal Circuit docket specifically naming this patent, and confirm the claim set.

US 9,561,177 — Analyst Summary

Scope note / confidence flag: I searched for the exact string "9561177" together with USPTO, PTAB and Federal Circuit sources. I found no 2026 Federal Circuit docket naming US 9,561,177. The only Federal Circuit appeal I can substantiate for this patent family is 20-2106, decided February 10, 2022. I state that explicitly rather than infer 2026 activity. I also note that the authoritative full text supplied to me (Google Patents fetch) contains the abstract, description and definitions but cuts off before the claims, so my per-claim overview is partly reconstructed from secondary sources and is flagged accordingly.

1. Bibliographic data

Caution: expiry, status and "current assignee" fields on patent aggregators are assumptions, not legal conclusions. The 2035-03-16 date is derived from the 2015-03-16 parent filing (14/659,472), not from the 2016-06-15 filing of 15/183,441.

2. Abstract (verbatim from the granted patent)

"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."

The commercial embodiment is NARCAN® (naloxone hydrochloride) Nasal Spray, 4 mg/spray, approved under NDA No. 208411 (FDA approval November 18, 2015).

3. Independent-claim overview (plain language)

The specification frames the invention in three ways: (a) an improvement to a single-use, pre-primed nasal device containing ≥ ~4% (w/v) naloxone hydrochloride, where the improvement is that the device sprays a round plume with an ovality ratio < ~2 (or < ~1.5); (b) an equivalent device improvement defined by the presence of an isotonicity agent at 0.2–1.2% (w/v); and (c) an equivalent device improvement defined by a preservative at 0.005–0.015% (w/v). Related method, kit, drug-product and intranasal-composition claims flow from these.

Reconstructed independent claims, by family:

• Method of treating opioid overdose (primary claim family). Administer a nasally delivered spray from a pre-primed (no priming actuation required) single-use or bi-dose device into a patient's nostril, where the device contains an aqueous naloxone hydrochloride solution at roughly 4 mg / ~100 µL, including benzalkonium chloride ~0.005–0.015% (w/v) as preservative/permeation enhancer/cationic surfactant, an isotonicity agent (e.g., NaCl), a stabilizer (e.g., disodium edetate), and acid to pH 3.5–5.5.
• Device claim family. A pre-primed, single-use or bi-dose nasal delivery device filled with the opioid-antagonist solution, with the therapeutically effective amount defined as equivalent to about 2 mg to 12 mg naloxone hydrochloride (expressly about 4 mg or about 4.4 mg naloxone hydrochloride dihydrate), optionally substantially free of antimicrobial preservatives.
• Drug-product / kit family. A combination of a therapeutically effective amount of an opioid agonist (e.g., oxycodone, morphine, fentanyl, methadone) and naloxone hydrochloride in the pre-primed nasal device — i.e., a take-home co-packaged co-prescription product to lower opioid overdose risk.
• Intranasal composition family. An aqueous solution of not more than about 140 µL (typically ~100 µL) containing the specified naloxone HCl amount plus excipients.
• Plume/droplet characteristics recited across these claims: Dv(50) ≈ 30–70 µm, Dv(90) ≤ 100 µm, < 10% (or <5%, <2%, <1%) of droplets under 10 µm, and ovality ratio < 2.0 (dependent values <1.5, <1.3, <1.2, <1.1, ~1.0), measured at 3 cm.
• Functional/PK limitations appearing in dependent claims and related family patents: t_max < 30 min (about 18.5–20 min), >90% opioid-receptor occupancy at the respiratory control center at t_max, freedom from respiratory depression for 1–6 hours, <10% (or <5%) nasal-cavity drainage, and ≥35–55% bioavailability.

Confidence caveat on claim text. A single source (a Korean court/agency case digest) reports the granted claim 1 of the '177 patent as: "A method of treating opioid overdose, the method comprising: delivering a 25-200 µL spray of a pharmaceutical solution from a pre-primed device into a nostril of a patient, wherein the device is adapted for nasal delivery, and wherein the pharmaceutical solution comprises about 4 mg naloxone hydrochloride or a hydrate thereof, between about 0.005% and about 0.015% (w/v) of benzalkonium chloride, and an isotonicity agent." I could not verify this against the granted claim set itself, and the pre-grant publication US 2016/0303041 A1 is reported with a materially different claim 1 (a ≥4% (w/v) naloxone solution delivered as a round plume with ovality ratio < 2.0 measured at 3 cm). Prosecution documents in the PTAB record (a 2016-08-22 non-final action, a 2016-10-21 response, and a 2016-12-21 Notice of Allowance for application 15/183,441) confirm that the claims were amended before grant, which would explain the difference between the published and granted claim 1. Treat the exact granted independent-claim wording as unverified pending direct review of the issued patent's claim sheet.

4. Litigation and post-grant history (as found)

District court (invalidity — this is the controlling outcome):

• D.N.J. 2:16-cv-07721-BRM-JAD, Adapt Pharma Operations Ltd. et al. v. Teva Pharmaceuticals USA, Inc. et al., filed October 21, 2016. Related/consolidated D.N.J. actions: 2:17-cv-00864, 2:17-cv-02877, 2:17-cv-05100, 2:18-cv-09880 (also 2:18-cv-15287 per Google Patents).
• Two-week bench trial Aug 26 – Sep 6, 2019; decision June 26/30, 2020 holding the asserted claims of the patents-in-suit — US 9,468,747, US 9,561,177, US 9,629,965 and US 9,775,838 — INVALID as obvious under 35 U.S.C. § 103. Infringement was not contested by Teva.

Federal Circuit:

• Appeal 20-2106, Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., decided February 10, 2022: AFFIRMED (majority: Judges Stoll and Prost; Judge Newman dissenting). The panel upheld the district court's motivation-to-combine findings (Davies + Kerr/Kerr Formulation + Bahal; and Strang + Kulkarni + Djupesland), found no teaching away from benzalkonium chloride beyond high concentrations, and found any error in the objective-indicia analysis harmless. Judge Newman's dissent argued hindsight bias and inadequate motivation to combine.
• No 2026 Federal Circuit docket naming US 9,561,177 was located. If a 2026 appeal exists, it did not surface in my searches and I am not asserting one.

PTAB:

• IPR2019-00691, IPR2019-00692, IPR2019-00693 — Nalox-1 Pharmaceuticals, LLC et al. v. Opiant Pharmaceuticals, Inc., all filed February 19, 2019, each listing Patent 9,561,177 as the challenged patent (app. 15/183,441). Unified Patents records all three as "Not Instituted – Merits." A separate aggregator (drugpatentwatch) lists a decision date of 2019-08-27, which is inconsistent with the "not instituted" status; I flag that discrepancy rather than resolve it. Patent Owner's Preliminary Response in IPR2019-00692 argued the petitions were redundant and should be denied under the Board's discretion (a parallel Teva district-court trial was imminent).
• Exhibit 1001 in IPR2019-00692 and -00693 is a copy of US 9,561,177 itself; exhibits included Wyse (US 9,192,570), Chinese Patent 1,575,795 (Wang), WO 00/62757 (Davies), Djupesland (2013), Grassin-Delyle (2012), Bahal (US 5,866,154), Wermeling (2013), and others.

5. Residual uncertainty

• The granted claim set of US 9,561,177 is not in the authoritative text I was given (it ends before the claims), and the two secondary sources I found describe different claim 1 wording. Verify against the USPTO PatentCenter claim sheet or the patent PDF before relying on exact language.
• Current assignee and legal status are aggregator assertions ("may be inaccurate"). The Nov 2015 – Sep 2016, and June 2023 reassignments are recorded; the Emergent Biosolutions Ireland Ltd listing is unverified.
• 2026 CAFC activity: none found; absence of search results is not proof of absence.

I'll research litigation involving US patent 9561177. Let me start with several targeted searches.

Let me dig deeper into the specific Teva and Perrigo cases and their outcomes.

Let me pin down the filing dates for the individual Teva complaints and confirm no other defendants.

Litigation Involving U.S. Patent No. 9,561,177 ("Nasal Drug Products and Methods of Their Use")

I identified litigation and PTAB proceedings involving the '177 patent. Note: the '177 patent was asserted alongside several sibling patents ('253 = 9,211,253; '747 = 9,468,747; '965 = 9,629,965; '838 = 9,775,838; and '937 = 10,085,937) all listed in the Orange Book for NARCAN® (naloxone HCl) Nasal Spray, NDA No. 208411. All are owned by Adapt Pharma/Opiant (later Emergent BioSolutions; the '177 patent is now shown as assigned to Indivior UK Limited for Opiant Pharmaceuticals, Inc.).

Below, I separate the district court actions, the PTAB proceedings, and the Federal Circuit appeal.

1. District Court — District of New Jersey

1a. Adapt Pharma Operations Ltd. et al. v. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries, Ltd.

• Plaintiffs: Adapt Pharma Operations Limited; Adapt Pharma Inc.; Adapt Pharma Limited; Opiant Pharmaceuticals, Inc.
• Defendants: Teva Pharmaceuticals USA, Inc.; Teva Pharmaceuticals Industries, Ltd.
• Jurisdiction/Court: U.S. District Court for the District of New Jersey
• Lead case number: 2:16-cv-07721 (BRM)(JAD) (consolidated)
• Consolidated member cases: 2:17-cv-00864-JLL-JAD, 2:17-cv-02877-JLL-JAD, 2:17-cv-05100-JLL-JAD, 2:18-cv-09880-JLL-JAD
• Filing date: The lead '253-patent action was filed in 2016; the related complaints (including the '177 patent complaint) were consolidated into it (2016–2018). (The exact 2016 filing date for 2:16-cv-07721 is not confirmed in my search results — treat with caution.)
• Asserted claim of the '177 patent: Claim 4
• Procedural posture: Teva stipulated to infringement; the case proceeded to a bench trial on validity (obviousness under 35 U.S.C. § 103). A two-week bench trial was held Aug. 26–Sept. 6, 2019 (with an additional Oct. 17, 2019 session); closing arguments Feb. 26, 2020.
• Outcome: The court found the asserted claims obvious. Per the June 26, 2020 Judgment/Order (ECF Nos. 341–342; J. Brian R. Martinotti): "the asserted claim of the '177 Patent (Claim 4) is declared to be invalid on the ground of obviousness, under 35 U.S.C. § 103," and judgment was entered in favor of Teva.
• Status: Concluded at district court; appealed and affirmed (see §3).
• Source: CourtListener D.N.J. judgment (gov.uscourts.njd.340302); Fed. Cir. opinion 20-2106.

1b. Adapt Pharma Operations Limited et al. v. Perrigo UK Finco Limited Partnership

• Plaintiffs: Adapt Pharma Inc.; Adapt Pharma Limited; Opiant Pharmaceuticals, Inc. (Adapt Pharma Operations Limited)
• Defendant: Perrigo UK Finco Limited Partnership
• Jurisdiction/Court: U.S. District Court for the District of New Jersey
• Case numbers: 2:18-cv-15287 (filed 2018-10-25); related/consolidated 2:18-cv-16987 (filed 2018-12-07)
• Patents-in-suit: 9,211,253; 9,468,747; 9,561,177; 9,629,965; 9,775,838; and 10,085,937
• Cause: ANDA patent infringement (triggered by Perrigo's Sept. 14, 2018 notice letter re: ANDA No. 211951)
• Outcome: The parties settled. A Consent Judgment was entered March 2, 2020 (J. Brian R. Martinotti), enjoining Perrigo from infringing the "Licensed Patents" (expressly including 9,561,177); all claims and counterclaims dismissed with prejudice. 2:18-cv-15287 terminated 2020-03-02; 2:18-cv-16987 terminated 2019-05-03.
• Status: Settled/closed.
• Source: CourtListener, Consent Judgment, Dkt. #73 in 2:18-cv-15287.

2. PTAB — Inter Partes Review (against the '177 patent)

Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Limited and Opiant Pharmaceuticals, Inc. (Nalox-1 is a non-practicing entity)

Nalox-1 filed 15 IPR petitions covering the '253, '747, '177, '965, and '838 patents. Three were directed at the '177 patent — all challenging claims 1–30:

• Panel (e.g., IPR2019-00691): Judges Erica A. Franklin, Zhenyu Yang, Jacqueline T. Harlow (Harlow authored the decision).
• Outcome: The Board denied institution under 35 U.S.C. § 314(a), agreeing with the patent owner that the prior art taught away from the claimed invention (specifically, Wyse teaches away from using benzalkonium chloride (BZK) with naloxone).
• Status: No institution; '177 patent claims survived these IPRs.
• Sources: PTAB Institution Decisions (Aug. 27, 2019); Unified Patents PTAB caselist.

(By contrast, the Board instituted review on the '253, '747, and '965 patents and ultimately, on Aug. 21, 2020, confirmed those claims were not unpatentable. It denied institution on the '177 and '838 patents.)

3. Court of Appeals for the Federal Circuit

Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc. (Consolidated appeals from §1a)

• Case No.: 2020-2106 (Fed. Cir.)
• Filed: Notice of appeal filed July 23, 2020
• Decision: February 10, 2022 — 25 F.4th 1354
• Panel: Circuit Judges Newman, Prost, and Stoll (Opinion by Stoll, J., joined by Prost, J.; dissent by Newman, J.)
• Outcome: AFFIRMED — the Federal Circuit upheld the district court's obviousness judgment invalidating the asserted claims of the '747, '177 (claim 4), '965, and '838 patents. The court found no error in motivation to combine, no teaching away, and no reversible error on objective indicia.
• Status: Final as to this appeal. Judge Newman dissented, characterizing the majority's analysis as impermissible hindsight.

Summary Table

Caveats / Confidence Notes

• Confirmed with high confidence: the three IPRs (00691, 00692, 00693), their filing/decision dates and denial; the Teva consolidated D.N.J. case and its June 26, 2020 invalidity judgment finding claim 4 of the '177 patent obvious; the Perrigo consent judgment (March 2, 2020); and the Fed. Cir. affirmance (2020-2106, Feb. 10, 2022).
• Lower confidence: the specific filing dates of the individual Teva member complaints (2:17-cv-00864, 2:17-cv-02877, 2:17-cv-05100, 2:18-cv-09880) and the precise 2016 filing date of the lead 2:16-cv-07721. My searches confirm the case numbers and consolidation but not each individual filing date.
• I did not find any litigation involving the '177 patent outside these New Jersey actions, the three IPRs, and the Federal Circuit appeal. A Canadian action against Teva (filed ~July 23, 2020) exists for the NARCAN portfolio, but that concerns a Canadian patent, not U.S. 9,561,177.
• The '177 patent's own Google Patents page lists family litigation for exactly these New Jersey dockets (2:16-cv-07721, 2:17-cv-02877, 2:18-cv-15287) and Fed. Cir. 20-2106, consistent with the above. Per the Google Patents record, the patent's legal status is "Expired - Fee Related" with anticipated expiration 2035-03-16.

I'll verify the PTAB record for this patent, since the structured block and my earlier sections conflict.

Let me check for any later-filed PTAB proceedings against this patent and confirm the denial details.

Let me pin down the basis for the -00692 and -00693 denials rather than assume.

PTAB / AIA Trial Analysis — U.S. Patent No. 9,561,177

⚠️ Source reconciliation (read first)

The structured "PTAB proceedings on file" block supplied in this prompt states: "The USPTO ODP API returns no AIA trial proceedings for this patent as of the most recent ingest… the default should be 'no PTAB activity on file.'"

That block is under-inclusive for this patent, and I am explicitly flagging the contradiction rather than silently resolving it. Primary PTAB documents retrieved by web search establish three inter partes reviews on claims 1–30 of U.S. 9,561,177 — IPR2019-00691, IPR2019-00692 and IPR2019-00693 — including the Board's own text: "Claims 1-30 of the '177 patent are also the subject of IPR2019-00692 and IPR2019-00693, initiated by Petitioner contemporaneously with the instant proceeding… We issue our decisions declining to institute inter partes review in IPR2019-00692 and IPR2019-00693 concurrently with this Decision." (IPR2019-00691, Paper 14, Decision Denying Institution, 2019-08-27.)

I reconcile this as an ODP indexing gap (all three were not instituted, so they never became "trials" with a trial number, and non-instituted IPRs are commonly missing from downstream case-ingest feeds). I proceed on the documented record. If your internal ODP ingest is the systems-of-record for your workflow, treat the third-party aggregator fields below as needing a PatentCenter/E2E confirm — but the existence and disposition of these three proceedings is not in doubt.

Two further reconciliations with the earlier-generated sections:

1. Resolved: the earlier section flagged a discrepancy in which drugpatentwatch listed a "decision date" of 2019-08-27 for the '177 IPR. That date is the institution-decision date (denial), not a Final Written Decision — there is no FWD in any of the three. The discrepancy is now explained.
2. Resolved: the earlier section flagged uncertainty over the granted claim 1 wording (the pre-grant publication US 2016/0303041 A1 vs. a secondary digest). The Board's IPR2019-00692 decision states, tracking the granted claim: "Each independent claim of the '177 patent requires a naloxone formulation that includes BAC. Specifically, claim 1 recites '[a] method of … naloxone hydrochloride or a hydrate thereof, between about 0.005% and about 0.015% (w/v) of benzalkonium chloride, and an isotonicity agent.'" The granted independent claims are BAC-limited — consistent with the "Korean digest" wording, not the ovality-ratio framing of the pre-grant publication.

Proceedings overview

Three AIA proceedings exist on US 9,561,177 — all three inter partes reviews, all filed by the same petitioner (Nalox-1 Pharmaceuticals, LLC) on 2019-02-19, all against claims 1–30, and all three denied institution on 2019-08-27; zero claims invalidated, zero claims sustained on the merits, zero FWDs, zero appeals — so the Board has never reached the patentability merits and has created no estoppel, leaving the real defensive value in this family in the Article III judgment, not the PTAB record.

Bottom line for a defendant today: the PTAB record is a nulla bona — three denials, no claim-level rulings. The genuine kill-shot is the D.N.J./Federal Circuit invalidity judgment, which is limited to claim 4 of the '177 patent. If a demand letter asserts claim 4, it is asserting a judicially dead claim; if it asserts any other '177 claim, that claim was never adjudicated by the Board and was never invalidated by the district court, and you should expect the patent owner to say so.

IPR2019-00691 — Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Limited and Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review (post-AIA, 35 U.S.C. § 311 et seq.)
• Filed: 2019-02-19 (filing date accorded 2019-03-21, Paper 7)
• Status: Not Instituted – Merits (Unified Patents field, verbatim). Plain English: the Board evaluated the petition on the merits and refused to open a trial.
• Judge panel: Administrative Patent Judges Erica A. Franklin, Zhenyu Yang, and Jacqueline T. Harlow — Harlow authored.
• Petition grounds: All 30 claims challenged (claims 1–30), solely under 35 U.S.C. § 103, led by U.S. Pat. No. 9,192,570 (Wyse) as the primary reference, combined with HPE for the benzalkonium chloride ("BAC"/"BZK") teaching, plus Djupesland (2013), Bahal (U.S. Pat. No. 5,866,154), Kushwaha, Wang (CN 1,575,795) and others. Supporting expert declarations: Dr. Maureen Donovan (Nalox1002) and Dr. Günther Hochhaus (Nalox1003). Exhibits Nalox1004–1006 were the '177 patent's own file history (the 2016-08-22 non-final rejection, the 2016-10-21 amendment, and the 2016-12-21 Notice of Allowance).
• Institution decision: Denied 2019-08-27 under 35 U.S.C. § 314(a). The panel's reasoning, verbatim: "Having considered the evidence and arguments of record, we agree with Patent Owner that the prior art teaches away from the claimed invention, and, therefore, decline to institute inter partes review." And on Wyse specifically: "U.S. Pat. No. 9,192,570 to Wyse reports naloxone formulations for intranasal administration. Wyse reports (column 27, lines 29-37) that benzalkonium chloride [("BAC") or ("BZE")] is not suitable in such formulations, because it facilitates unacceptable degradation of the naloxone. Wyse recommends (lines 41-43) benzyl alcohol and paraben preservatives in place of benzalkonium chloride."
• Final Written Decision: None. No trial was instituted, so no FWD, no claim cancellation, no patentability holding. Do not represent otherwise in any filing.
• Settlement / termination: No settlement. Termination was by denial of institution; the petitioner then sought a refund of the post-institution fees (request 2019-10-03; Notice of Refund 2019-10-21).
• Appeal: None. A denial of institution is not appealable — 35 U.S.C. § 314(d); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016). Nalox-1 could not and did not appeal it.
• Defensive value: Modest and non-estoppel. Because there is no FWD, § 315(e)(2) estoppel never attached — neither Nalox-1 nor its privies are barred, and no other defendant is barred at all. The heavy value to a defendant is that the Board's reasoning (Wyse disparages BAC for intranasal naloxone) is exactly the reasoning the examiner adopted in allowing the '177 claims (see the -00692 section below), which means a new Wyse-based § 103 challenge faces both a § 325(d) ("same art, same argument") headwind and a pre-existing adverse teaching-away finding on the same record.
• Links: PTAB E2E (https://ptacts.uspto.gov/) · institution decision PDF: https://www.docketalarm.com/cases/PTAB/IPR2019-00691/Inter_Partes_Review_of_U.S._Pat._9561177/docs/08-27-2019-Board/Institution_Decision-14-Decision_Denying_Institution_of_Inter_Partes_Review.pdf · https://portal.unifiedpatents.com/ptab/case/IPR2019-00691

IPR2019-00692 — Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Limited and Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review
• Filed: 2019-02-19 (accorded 2019-03-21)
• Status: Not Instituted – Merits (verbatim, Unified Patents)
• Judge panel: Same panel — Franklin, Yang, Harlow (Harlow authored).
• Petition grounds: Claims 1–30, all under § 103, led by Davies (WO 00/62757) — but, as the patent owner pointedly observed, "the Wang and Davies Petitions cite Wyse—not Wang or Davies—for the dose limitation of all claims." Expert declarations: Donovan (Nalox1002), Hochhaus (Nalox1003).
• Institution decision: Denied 2019-08-27. Two threads:
  1. Merits — teaching away. The decision contains a dedicated section, "D. The Examiner Found that Wyse Teaches Away from the Claimed Invention," reproducing the examiner's Reasons for Allowance: "Wyse is considered to expressly exclude the use of benzalkonium chloride stating that benzalkonium chloride, a common nasal product preservative, results in increased degradation of the naloxone active and teaches outright that apart from the preservative (i.e., benzalkonium chloride) the formulation of Example 7 is suitable for nasal administration… This is considered to be a direct departure from the instantly claimed composition." The Board agreed with the examiner and the patent owner on this record.
  2. Discretion — parallel petitions. Following the 2019-07-30 Order (Paper 11, Conduct of the Proceeding, 37 C.F.R. § 42.5), which invoked General Plastic and the July 2019 Trial Practice Guide Update on parallel petitions, the Board pressed the petitioner to justify three petitions against the same patent. The patent owner argued -00692 was a "secondary, redundant petition" with "large swaths of text word-for-word identical" to the Wyse petition, and that the Board should exercise § 314(a) discretion to deny even if the merits threshold were met.
  • Note on which rationale carried the day: the D.N.J. court later characterized the outcome as "the Board exercised its discretion to deny all the petitions except some of the ones based on Wyse" — i.e., the court attributed the -00692/-00693 denials to discretion/redundancy, whereas the decision text I retrieved contains a substantive teaching-away analysis. I flag this as an unresolved ambiguity; both rationales appear in the record and I cannot state with confidence which was dispositive in -00692. What is certain: institution was denied.
• Final Written Decision: None.
• Settlement / termination: No settlement. Denial of institution; refund proceedings (Paper 14 denial 2019-08-27; refund documentation entry dated 2019-10-18).
• Appeal: None (non-appealable under § 314(d)).
• Defensive value: The key evidentiary nugget for a defendant is the prosecution-history teaching-away finding (Ex. 1006, Reasons for Allowance) — the examiner expressly allowed over Wyse because Wyse discredited BAC in intranasal naloxone. That finding is cited verbatim in the -00692 decision and again by Judge Newman in dissent at the Federal Circuit. Any fresh IPR built on Wyse must now overcome an examiner finding, a Board finding, and a dissent all pointing the same way.
• Links: https://portal.unifiedpatents.com/ptab/case/IPR2019-00692 · decision text (Paper 14, 2019-08-27) via Docket Alarm: https://gaeflexstaging-dot-docketupdate.appspot.com/cases/PTAB/IPR2019-00692/Inter_Partes_Review_of_U.S._Pat._9561177/08-27-2019-Board/Institution_Decision-14-Decision_Denying_Institution_of_Inter_Partes_Review/

IPR2019-00693 — Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Limited and Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review
• Filed: 2019-02-19 (accorded 2019-03-21)
• Status: Not Instituted – Merits (verbatim, Unified Patents)
• Judge panel: Same panel — Franklin, Yang, Harlow.
• Petition grounds: Claims 1–30, § 103, led by Wang (Chinese Patent No. 1,575,795). Petitioner submitted a certified English translation of Wang, distinguishing it from the machine translation that had been before the examiner — an argument the patent owner dismissed as "a convoluted way of stating the truism that the three Petitions do not cite exactly the same references."
• Institution decision: Denied 2019-08-27, issued concurrently with the -00691 and -00692 denials. ⚠️ I was unable to retrieve the text of the -00693 decision itself (my search quota was exhausted before I could pull it), so I cannot quote its dispositive rationale. Given that (a) all three decisions issued the same day by the same panel, (b) Patent Owner's consolidated response treated all three as suffering "fatal deficiencies" on the same BAC/teaching-away axis, and (c) the Board in the lead decision stated "all three Petitions contain the same discussion about Wyse's teaching on BZK—or, more precisely, teaching away—verbatim," the -00693 denial almost certainly rests on the same teaching-away and/or parallel-petition redundancy grounds. Treat that as inference, not verified text.
• Final Written Decision: None.
• Settlement / termination: No settlement; non-institution. Docket entries include a Patent Owner Response to Petitioner's Notice (Paper 13, 2019-08-12) and the Board's institution decision (Paper 14, 2019-08-27).
• Appeal: None.
• Defensive value: Same as the other two, with one bonus: a certified-translation defect is not a ground you can rely on, but the record shows the petitioner never demonstrated that Wang added anything over Wyse — a caution for anyone thinking of building a petition on non-English art.
• Links: https://portal.unifiedpatents.com/ptab/case/IPR2019-00693 · consolidated patent-owner response: https://www.docketalarm.com/cases/PTAB/IPR2019-00693/Inter_Partes_Review_of_U.S._Pat._9561177/docs/08-12-2019-Patent_Owner/Response-13-PATENT_OWNERS_RESPONSE_TO_PETITIONERS_NOTICE.pdf

Context: the fifteen-petition campaign and why it matters

Nalox-1 Pharmaceuticals, LLC — not a party to any of the parallel district court actions — filed fifteen IPRs at once (IPR2019-00685 through IPR2019-00699), three against each of five Orange Book–listed NARCAN® patents: 9,211,253; 9,468,747; 9,561,177; 9,629,965; and 9,775,838. For each patent it filed one Wyse-led, one Davies-led and one Wang-led petition, all attacking every claim with substantially the same theory. The Board denied twelve of the fifteen (including all three '177 petitions), and instituted only on the Wyse petitions against the '253, '747 and '965 patents — and even there, per the district court, "the Board expressly recognized that Nalox-1 had not shown a reasonable likelihood of success as to any claims reciting BZK" and instituted on all claims only because SAS Institute v. Iancu compelled all-or-nothing institution. Those instituted trials ran to Final Written Decisions on 2020-08-21 sustaining the claims (per the '747 Wyse ID, 2020 WL 4920048, and the '838/'965 line of decisions) — a result that collapsed at the Federal Circuit the following year, as described below.

Counsel of record: Patent Owners' certificates of service identify Williams & Connolly LLP (Jessamyn S. Berniker, David M. Krinsky, Anthony H. Sheh et al.); Opiant's power of attorney additionally names Robert F. Green (Reg. No. 27,555), Green, Griffith & Borg-Breen LLP. Petitioner Nalox-1 appears to have been represented by a small PTAB-focused firm. Tech Center 1600 / Art Unit 1615.

Strategic summary

Claim status of 9,561,177.

• CANCELED by the PTAB: none. No petition was instituted, so no claim was ever canceled. There is no FWD to cite, quote, or link.
• INVALIDATED by an Article III court: claim 4 only. In Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 2:16-cv-07721-BRM-JAD (D.N.J.), the court held the asserted claims of the '747, '177, '965 and '838 patents invalid as obvious under § 103 (opinion filed 2020-06-22, judgment 2020-06-26; Docket Alarm/CourtListener entries show termination 2020-06-30), and the Federal Circuit affirmed on 2022-02-10 in Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., 25 F.4th 1354 (No. 2020-2106) (Stoll, J., joined by Prost, J.; Newman, J., dissenting). The Board's contrary teaching-away findings did not save the patent.
• SUSTAINED on the merits: none expressly as to the '177. The Board's 2020-08-21 FWDs sustaining claims were for the '747, '965 and '838 patents, not the '177.
• UNTESTED: claims 1–3 and 5–30 of the '177 patent — including the independent claims, which the Board's -00692 decision confirms are all BAC-limited (claim 1 recited "between about 0.005% and about 0.015% (w/v) of benzalkonium chloride, and an isotonicity agent"; the -00692 decision's account of prosecution refers to application independent claims 1 and 24 at 0.005–0.015% w/v and claim 14 at 0.005–1% w/v). Only claim 4 was litigated, held invalid, and affirmed. Anyone asserting claims 1, 14, 24 or the balance of the set is asserting claims that no tribunal has ever adjudicated — legally alive, but exposed to a collateral-estoppel/invalidity rerun on the same BAC/EDTA formulation record.

Estoppel landscape. The two estoppel regimes point in opposite directions, and this is the single most important point for a current defendant:

• IPR estoppel (§ 315(e)(2)): inapplicable. Estoppel attaches only after a final written decision. With institution denied, there is no estoppel running against Nalox-1, against its privies, or against anyone else. The Wyse / Davies / Wang / HPE / Djupesland / Bahal art is not off the table for a new petitioner.
• Collateral estoppel from the Teva judgment: powerful but bounded. Blonder-Tongue–style issue preclusion on claim 4 runs against Adapt/Opiant/Emergent and their privies. Care is required now that the '177 patent was assigned to Indivior UK Limited (recorded 2023-06-14, assignor Opiant Pharmaceuticals, Inc.) — if Indivior is the current owner of record and is asserting the patent, privity with the Teva judgment's patent-owner side must be traced through the assignment chain. (Per the aggregator list in the earlier sections, current assignees are shown as Indivior UK Ltd and Emergent Biosolutions Ireland Ltd; Google Patents expressly disclaims verification.)
• A fresh IPR is legally available but practically hard. A new § 103 petition on Wyse would run into § 325(d) (the examiner applied Wyse and the Board agreed it teaches away), the Board's own 2019 teaching-away finding, and General Plastic discretionary risk for repeat petitioners. Expect the panel to ask "what is different?" — and expect patent owner to quote the -00691 decision back at you.

Pattern signals.

• Same petitioner, serial density. Nalox-1 filed 15 petitions in one day across five patents — the paradigm "parallel petitions" fact pattern that produced the 2019-07-30 Order requiring the petitioner to justify the redundancy and that presaged the Board's tightening on parallel petitions.
• No defensive aggregator in the '177 chain. The three '177 petitions came from Nalox-1 Pharmaceuticals, LLC, an NPE-style petitioner (it was not a party to the district court actions). Unified Patents is present in the record only as the data source for the case list ("Unified Patents PTAB Data"), not as a petitioner.
• No PTAB appeals. Patent owner had nothing to appeal (no adverse FWD on the '177); petitioner could not appeal non-institution. The only appellate event in the '177's history is CaFC 20-2106 — a district-court appeal, not a PTAB appeal.
• 2026 activity: none found. A patent-litigation database refresh dated 2026-03-25 still shows only the 2016–2020 D.N.J. docket and the single 2019-02-19 Nalox-1 PTAB entry. I found no 2026 PTAB filing, no 2026 Federal Circuit docket, and no new petitioner. Absence of search results is not proof of absence — verify against PTAB E2E and PACER before relying on it.

Recommended next steps

If you are a defendant being asserted on this patent today:

1. Attack claim 4 by preclusion, and cite the disposition verbatim. Claim 4 of the '177 patent was "declared to be invalid on the ground of obviousness, under 35 U.S.C. § 103" by the D.N.J. judgment (2020-06-26) and the Federal Circuit AFFIRMED on 2022-02-10. Quote the affirmance: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 2020-2106, 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022). Opinion PDF: https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf. A demand letter citing claim 4 should be answered with that link and a preclusion argument, not with a § 103 brief.
2. For claims 1–3 and 5–30, do not assume the judgment saves you. They were never adjudicated. Your leverage there is (a) the affirmed obviousness reasoning on the same BAC/EDTA/pH formulation limitations — the independent claims are all BAC-limited per the Board's own -00692 decision — and (b) the possibility of a new IPR on art not before the Board. If you go the IPR route, lead with something the Board has not seen, and pre-empt § 325(d) and General Plastic in the petition itself.
3. Check the maintenance-fee status before you do anything expensive. Google Patents' legal-status field for this patent reads "Expired - Fee Related," while the Orange Book listing (NDA 208411, NARCAN®) shows an expiration of 2035-03-16. Those two facts are in tension and the aggregator field is expressly disclaimed as unverified. A fee-related lapse would moot the whole dispute. Confirm at USPTO PatentCenter and in the Orange Book before scoping a defense budget.
4. There are no PTAB trial milestones to diarize. No pending IPR exists on this patent, so there is no institution deadline, no oral hearing, and no statutory one-year FWD date to track. The only live clocks are in whatever litigation you face.

If you are looking for the absence signal: for a patent asserted against multiple ANDA filers across 2016–2019, only three IPRs were ever filed (all by one NPE, all denied) — and the patent was then invalidated by a district court on the same references the Board had refused to institute on. That pattern says the PTAB was the wrong forum for this fight and Article III was the right one.

Confidence and verification ledger

I'll research the assignment record for US 9,561,177. Let me run several targeted searches.

Let me look for the specific reel/frame records and the assignment-center entries.

I was unable to retrieve the reel/frame-level detail or correspondent-of-record from the USPTO Assignment Center in this session — my search tooling did not surface the Assignment Center detail pages for this patent, and the Google Patents "legal events" feed (which is derived from the USPTO assignment database) reports the parties and dates but not reel/frame or correspondent. That gap is flagged explicitly below rather than papered over. Everything else is grounded in the sources cited.

This section builds on the two prior sections (Patent summary; Litigation summary) and is consistent with them, with one refinement noted at the end.

Inventors

Pattern observed — the clean "2 + 2 split." The four inventors divide exactly along corporate lines: two Adaptive-side inventors assign to Adapt Pharma Limited, two Opiant-side inventors assign to Opiant. This is the signature of a genuinely jointly-developed invention between two collaborating operating companies, not of a captured/assigned-out inventor group. It is not the "inventors all departed and the portfolio was dumped" pattern the brief asks me to watch for; there is no evidence in the record of any inventor departure, and all four inventors executed assignments to their respective employers contemporaneously with the 2016-06-15 filing of application 15/183,441.

Caveat: whether any individual inventor left their employer within 12 months of filing is not determinable from the sources I could reach (no employment‑history data on Assignment Center, and no issuer filings disclose rank‑and‑file inventor movements).

Original assignee

Joint original assignees as issued: Adapt Pharma Limited and Opiant Pharmaceuticals, Inc.

• Adapt Pharma Limited — Irish specialty pharmaceutical company; primary business: opioid-overdose reversal. It (through wholly owned subsidiary Adapt Pharma Operations Limited) held NDA No. 208411 for NARCAN® (naloxone HCl) Nasal Spray, 4 mg/spray, FDA-approved November 18, 2015 — i.e., it shipped a commercial product embodying the claims. Source: RPX litigation document ("Adapt Limited holds an approved New Drug Application … NDA No. 208411 … NARCAN® Nasal Spray"); Fed. Cir. 20-2106.
• Opiant Pharmaceuticals, Inc. — publicly held (Nasdaq: OPNT) specialty pharma developing opioid-antagonist treatments; successor to Lightlake Therapeutics, Inc. It was the development originator of the intranasal naloxone program and co-owner here (it is sole assignee of siblings '253, '747, '965; joint assignee with Adapt of '177 and '838). Source: PTAB Mandatory Notices (IPR2019-00693, Mar. 12, 2019; IPR2019-00688, Dec. 17, 2019).
• The two are tied together by an Exclusive License Agreement dated December 14, 2014, as amended (Opiant licensed the '253/'747/'177/'965/'838 family to Adapt; Adapt Pharma Operations Limited is the recorded limited exclusive licensee). Source: Opiant 10-K narrative; PTAB Mandatory Notices. (A license is an encumbrance, not a chain-of-title transfer.)

Current status of the original assignees:

• Adapt Pharma Limited — acquired by the Emergent BioSolutions group. Per PTAB filings, "Adapt is a wholly owned subsidiary of Emergent Acquisitions Limited … a wholly owned subsidiary of Emergent International Inc. … a wholly owned subsidiary of Emergent BioSolutions Inc." The Emergent 10-K confirms the Adapt entities were renamed into Emergent's convention ("Emergent Devices Inc. (formerly Adapt Pharma Inc.)" and "Emergent Operations Ireland Limited (formerly Adapt Pharma Operations Limited)"). This is the origin of the "Emergent Biosolutions Ireland Ltd" co-assignee listing on Google Patents.
• Opiant Pharmaceuticals, Inc. — acquired by Indivior PLC. Indivior's Q1/FY 2023 results state the Opiant acquisition completed effective March 2, 2023 (~$124m net cash outflow, plus a CVR). Opiant is therefore no longer an independent company.

Net: both original co-assignees were absorbed by larger operating pharmaceutical companies (Emergent, Indivior); neither went bankrupt and neither sold out to an NPE.

Assignment timeline

⚠️ Reel/frame and correspondent data not verified. The three records below are corroborated as to parties, conveyance and date by the USPTO-derived Google Patents legal-events feed. I could not retrieve the reel/frame numbers or the correspondent of record for any of them. Those fields must be pulled from the Assignment Center detail view (see link at the end). I state this rather than invent identifiers.

There is no recorded assignment for this patent before June 2016, and no assignment recorded after June 14, 2023 on the aggregator feed. The Google Patents "reassignment" dates are, in practice, recordation dates derived from the USPTO assignment database; the underlying execution dates may precede them and I could not confirm the execution dates.

• 2016-06-15 (recorded) — Reel/Frame not verified
  • Conveyance: Assignment of Assignors' Interest (see document for details)
  • Assignors: CRYSTAL, Roger; WEISS, Michael Brenner
  • Assignee: Opiant Pharmaceuticals, Inc.
  • Correspondent: not retrieved
  • Context: Original employer assignment — Opiant-side inventors assigning to their employer; contemporaneous with the 2016-06-15 filing of application 15/183,441.
• 2016-06-15 (recorded) — Reel/Frame not verified
  • Conveyance: Assignment of Assignors' Interest (see document for details)
  • Assignors: BELL, Robert Gerard; KEEGAN, Fintan
  • Assignee: Adapt Pharma Limited
  • Correspondent: not retrieved
  • Context: Original employer assignment — Adapt-side inventors assigning to their employer; parallel to the record above, creating the joint ownership.
• 2023-06-14 (recorded) — Reel/Frame not verified
  • Conveyance: Assignment (see document for details)
  • Assignor: OPIANT PHARMACEUTICALS, INC.
  • Assignee: INDIVIOR UK LIMITED
  • Correspondent: not retrieved
  • Context: M&A / merger consideration transfer — the assignment of Opiant's entire interest (including its undivided co-ownership share of the '177) to Indivior UK Limited, effectuating Indivior's March 2, 2023 acquisition of Opiant. This is the last recorded link in the chain.

Important structural consequence: the 2023 Opiant→Indivior assignment transferred only Opiant's undivided interest. Adapt's (now Emergent's) co-ownership share did not move in that record. That is why Google Patents shows the two co-owners as Indivior UK Ltd and Emergent Biosolutions Ireland Ltd — they are the two ends of two separate chains that merged from the original joint ownership.

Possible records I could not confirm: a change-of-name record for Lightlake Therapeutics → Opiant Pharmaceuticals (a 2015 rename; a change-of-name conveyance would have been recorded against the then-pending parent, not necessarily against '177, which was filed in 2016 after the rename — so it may legitimately not appear on this patent). Also possible: a merger record absorbing Adapt Pharma Limited into the Emergent group. Neither appears on the '177 legal-events feed.

Timeline diagram

timeline
    title Ownership of US 9561177
    2014 : Earliest priority date claimed
         : Opiant licenses family to Adapt
    2015 : Parent application 14 659 472 filed
         : NARCAN nasal spray approved
    2016 : Application 15 183 441 filed
         : Opiant inventors assign to Opiant
         : Adapt inventors assign to Adapt Pharma
         : Teva infringement suit filed
    2019 : Nalox-1 IPR petitions denied
    2020 : Claim 4 held invalid as obvious
    2022 : Federal Circuit affirms invalidity
    2023 : Indivior acquires Opiant
         : Opiant interest assigned to Indivior UK

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. Every assignee in the chain is an operating pharmaceutical company: Opiant Pharmaceuticals, Inc. (Nasdaq: OPNT), Adapt Pharma Limited (NDA 208411; NARCAN® on market), Indivior UK Limited (part of Indivior PLC, which markets SUBLOCADE/SUBOXONE). No "IP / Holdings / Licensing / Ventures" suffix appears, and no single-purpose Delaware/Texas LLC takes title. (Recorded on the 2016-06-15 and 2023-06-14 events.)

2. Known asserter in the chain — NOT PRESENT. No assignee matches the NPE lists (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Round Rock, Spangenberg entities, etc.). Critical distinction: Nalox-1 Pharmaceuticals, LLC is a non-practicing entity — the Emergent 10-K calls it "Nalox-1 Pharmaceuticals, a non-practicing entity" — but it appears only as the IPR petitioner/challenger (IPR2019-00691/-00692/-00693, filed 2019-02-19), never as an assignee. It is therefore not in the chain of title and does not make this an NPE-owned patent.

3. Repeat correspondent across the chain — CANNOT ASSESS. The correspondent fields were not retrievable (see timeline caveat). Because this chain has only one post-issuance transfer and no LLCs, the recurrence signal is unlikely to be probative even once retrieved — but I will not score it either way without the data. (For contrast, the litigation-side repeat players here are outside counsel, not assignment correspondents: Williams & Connolly LLP (Jessamyn S. Berniker, Reg. No. 72,328) for Adapt; the Opiant IPR Power of Attorney covers IPR2019-00685 through -00699 — that is a 15-petition defensive-response cluster, again a litigation-counsel pattern, not a title-recording pattern.)

4. Cascading transfers — NOT PRESENT. Only one post-issuance assignment exists (2023-06-14), occurring ~7 years after the inventor assignments and ~6 years after issuance. There is no <24-month chain of back-to-back LLC hops.

5. Pre-litigation transfer — NOT PRESENT (timing coincidence only). The two inventor→employer assignments recorded 2016-06-15 fall within ~4 months of the first suit naming this patent (Adapt Pharma Operations Ltd. v. Teva, D.N.J. 2:16-cv-07721, filed October 21, 2016). But the signal's purpose is to catch chains "arranged to enable assertion" by a new owner. Here the assignments are the original inventor-to-employer conveyances to the very co-owners that asserted the patent — the normal, required perfection of title before filing. I therefore score this not present as a substantive NPE tell, while noting the date proximity.

6. Bankruptcy fire-sale — NOT PRESENT. Opiant exited via a solvent all-cash merger into Indivior (effective 2023-03-02; ~$124m plus contingent value rights), not a Chapter 7/11 sale. No bankruptcy sale of these assets appears in any proceeding.

7. Privateering — NOT PRESENT. The assertion was made directly by the operating co-owners (Adapt/Emergent + Opiant) against actual ANDA competitors (Teva; Perrigo) in Hatch-Waxman § 271(e)(2) actions (D.N.J. 2:16-cv-07721; 2:18-cv-15287). There is no transfer of title to an NPE asserting on the operating company's behalf.

8. Defensive aggregator — NOT PRESENT. The chain terminates at Indivior UK Limited (an operating company), not at RPX, AST, LOT Network, Unified Patents, or OIN. Unified Patents appears in this family only as a data source/database and IPR-tracker — it is not an assignee. The patent has, however, been functionally neutralized by invalidation (see Verdict).

Flagged anomaly (unknowns, not findings): Google Patents lists the legal status as "Expired – Fee Related" while simultaneously listing an anticipated expiration of 2035-03-16. Those two statements are hard to reconcile for a patent whose term runs to 2035; plausible explanations include lapse for non-payment of a maintenance fee after the claims were invalidated, or a status-feed artifact. I record the contradiction rather than resolve it.

Verdict

Operating-company assertion.

The chain of title is inventors → Adapt Pharma Limited + Opiant Pharmaceuticals, Inc. (joint owners) → Indivior UK Limited (recorded 2016-06-15 ×2 and 2023-06-14). Every party in that chain is an operating pharmaceutical company, the invention was jointly developed in-house by two collaborators (the clean 2-and-2 inventor split), and the patent was asserted by its owners directly against ANDA filers Teva and Perrigo — the textbook operating-company pattern. There is no shell LLC, no NPE assignee, no cascading transfer, and no bankruptcy sale; the only NPE in this story (Nalox-1 Pharmaceuticals, LLC) appears solely as an IPR challenger, which is the opposite of an ownership signal. The one genuine attenuation is that the patent is now invalid (D.N.J. June 26, 2020 obviousness judgment as to claim 4; affirmed by the Federal Circuit, Adapt Pharma Operations Ltd. v. Teva, No. 2020-2106, Feb. 10, 2022) and its stated status is "Expired – Fee Related."

Verification link (Assignment Center): https://assignmentcenter.uspto.gov/ — search 9561177 (or application 15/183,441) and open each of the three records to capture the reel/frame and the correspondent of record, which I was unable to retrieve. The mirrored public query page is https://assignment.uspto.gov/patent/index.html.

Cross-reference note: this section is consistent with the two prior sections, which already identified the joint Adapt/Opiant original ownership and the 2023 Indivior assignment. The only refinement is attribution of the "Emergent Biosolutions Ireland Ltd" co-assignee listing to the renamed Adapt/Emergent Irish entities (per the Emergent 10-K naming "Emergent Devices Inc. (formerly Adapt Pharma Inc.)" and "Emergent Operations Ireland Limited (formerly Adapt Pharma Operations Limited)"), i.e., the second, parallel chain — a point the earlier sections left as "unverified."

I'll research the prior art citations and cited references for US 9,561,177.

Let me get the full front-page "References Cited" list for US 9,561,177.

Prior Art Analysis — U.S. Patent No. 9,561,177 (US9561177B2)

Current date for this analysis: April 26, 2026. I queried for the literal string "9561177" / "9,561,177" and restricted results to that number. Everything below concerns US 9,561,177 B2 and no similar number.

0. USPTO record confirmation (the "digit-for-digit" check)

I found no second USPTO record for "9561177." No similar-numbered patent was substituted.

Update to the previously generated Patent summary (resolve the flagged uncertainty): the granted claim 1 wording is now independently corroborated by two sources — DrugPatentWatch's claim sheet and the Korean KOHES case digest — and both give the same text:

Claim 1. "A method of treating opioid overdose, the method comprising: delivering a 25–200 μL spray of a pharmaceutical solution from a pre-primed device into a nostril of a patient, wherein the device is adapted for nasal delivery, and wherein the pharmaceutical solution comprises about 4 mg naloxone hydrochloride or a hydrate thereof, between about 0.005% and about 0.015% (w/v) of benzalkonium chloride, and an isotonicity agent."
(https://www.drugpatentwatch.com/p/patent-claims/9561177)

Claim 4 — the claim actually litigated against Teva — is the sodium chloride / disodium edetate / hydrochloric acid species claim sitting at the bottom of the 1→2→3→4 dependency chain. This supersedes the "ovality ratio < 2.0" framing that appears in the pre-grant publication US 2016/0303041 A1 (that language ends up in the mist claim 12/15 line, not in granted claim 1).

1. Scope and method

"Patent citation" is read the way the USPTO uses it: the front-page "References Cited" (Box 56) of the printed patent — i.e., the U.S. patent documents, foreign patent documents and other publications listed on the face of US 9,561,177. I reproduced that list from the issued patent's own cover page (Exhibit Nalox1001 in the IPRs, archived at docketalarm), cross-checked against FreePatentsOnline.

Critical framing before the tables, stated plainly: no reference cited on the face of US 9,561,177 was ever held to anticipate any claim under § 102. The patent was invalidated in district court on § 103 obviousness (D.N.J. Judgment, June 26, 2020; aff'd Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022)), and the PTAB denied institution of all three IPRs. So the "§ 102 anticipation" column below is my own provisional, limitation-by-limitation assessment — not a holding. I flag where a reference supplies only some limitations (which is § 103 material, not § 102 material).

2. U.S. patent documents cited on the face of US 9,561,177

(As printed in Box 56; issue/publication dates as listed. Class/subclass shown in the patent is given where legible.)

3. Foreign patent documents cited on the face of US 9,561,177

Honest limitation: items 21 and 23–28 are transcribed from the cover-page OCR. My open-web searches did not surface their titles, so I am explicitly declining to characterize them rather than guess. Any complete prior-art study of the '177 should pull each of those seven documents directly.

4. Other publications cited on the face (Box 56, "Other Publications")

5. § 102 anticipation — consolidated view

Independent claims are 1, 12 and 22 (per Petitioner's Notice in the three IPRs: "Wyse and Davies each anticipates the 'pre-primed device' limitation of independent claims 1, 12, and 22"). Claim 1 (method) and claim 12 (mist) are reproduced above; claim 22 carries the plasma-concentration limitations (per the same Notice, at claims "10, 11, 16, 22, and 28").

Anticipation map (best-case for each reference):

Conclusion on § 102: no reference cited on the face of US 9,561,177 contains every limitation of granted claim 1 (or of claims 12 or 22). Accordingly, none anticipates those claims, and by dependency none anticipates claims 2–30 either. The references are collectively § 103 art, which is exactly how the case was decided.

6. Reference-to-claim overlay against the grant

7. Cross-reference corrections to the earlier generated sections

1. ⚠ IPR-to-reference mapping contradiction. The previously generated Patent summary and Litigation summary assign IPR2019-00692 → Davies and IPR2019-00693 → Wang. The authoritative Petitioner's Notice (Aug. 5, 2019, filed in all three proceedings) ranks them: IPR2019-00691 = Wyse; IPR2019-00693 = Davies; IPR2019-00692 = Wang. The prior sections should be corrected. (https://www.docketalarm.com/cases/PTAB/IPR2019-00693/.../Notice-12-Petitioners_Notice.pdf)
2. Claim-1 text: confidence flag resolved. Both the DrugPatentWatch claim sheet and the KOHES Korean case digest give identical granted claim 1 wording (25–200 μL, pre-primed device, ~4 mg, 0.005–0.015% BZK, isotonicity agent). The previously flagged "ovality ratio <2.0" claim-1 text belongs to the pre-grant publication US 2016/0303041 A1, not the grant.
3. The three IPR primary references are all face-page citations. Wyse '570 (#4), Wang CN 1575795 (#18) and Davies WO 00/62757 (#22) each appear in Box 56 — worth noting, because it means the examiner had them and still allowed; the Board nonetheless found Wyse taught away from BZK (Institution Decision, Aug. 27, 2019) and denied institution, while the district court and Federal Circuit found the same art obvious.

8. Bottom line

• The most relevant prior art to US 9,561,177 is Wyse (US 9,192,570 / US 2015/0174061), Davies (WO 00/62757) and Wang (CN 1575795) — all three cited on the patent's face and all three used as IPR primary references. Secondary § 103 material: Bahal (US 5,866,154) (EDTA/stabilizer), Djupesland 2013 (device), and the Wermeling IN-opioid publications.
• No cited reference anticipates under 35 U.S.C. § 102. Every independent claim requires the pre-primed device plus ~4 mg naloxone HCl plus a BZK concentration range; no single face-page reference discloses all three (Wang lacks the pre-primed device; Wyse lacks the 4 mg dose and the 0.005–0.015% BZK use and disparages BZK; Davies lacks the pH and PK limitations).
• The patent's fate was decided on § 103, not § 102: claim 4 held obvious (D.N.J. June 26, 2020), affirmed 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022).
• Open verification items I did not resolve and will not guess at: the titles/contents of WO 98/03011, WO 00/74652, WO 01/58447, WO 01/48291, WO 02/17178, WO 03/084520 and WO 2004/054511; and the Namburi publication number (2006/0120807 vs. 2006/0120967).

I'll research the specific prior-art references identified in the record so my obviousness analysis is grounded in verified reference content, dates, and the court's own combination findings.

Let me pin down the granted claim text of the '177 patent (the litigation record shows claim 4 was asserted) and the remaining prior-art references from the Strang combination.

Obviousness Analysis — U.S. Patent No. 9,561,177 B2 under 35 U.S.C. § 103

Scope and cross-reference. This section builds on the previously generated Patent Summary and Litigation Summary. It does not repeat the bibliographic, family, or docket tables. Where the earlier work flagged open questions, I resolve them below (§1.1). Two contradictions with the earlier sections are expressly flagged in §8.

1. Analytical frame and claim set

1.1 The governing claim set — earlier caveat resolved

The Patent Summary flagged that the granted claim 1 had not been verified because the authoritative Google Patents text cut off before the claims, and that a Korean case digest supplied a method claim while the pre-grant publication (US 2016/0303041 A1) supplied an ovality-ratio device claim. The claim sheet is now confirmed by three independent sources, and the discrepancy is resolved:

Claim 1 (granted): "A method of treating opioid overdose, the method comprising: delivering a 25-200 μL spray of a pharmaceutical solution from a pre-primed device into a nostril of a patient, wherein the device is adapted for nasal delivery, and wherein the pharmaceutical solution comprises about 4 mg naloxone hydrochloride or a hydrate thereof, between about 0.005% and about 0.015% (w/v) of benzalkonium chloride, and an isotonicity agent."

Sources: claim sheet reproduced in the infringement pleading at https://insight.rpxcorp.com/litigation_documents/13116749 ; Donovan Declaration, Ex. 1002 in IPR2019-00692, https://www.docketalarm.com/cases/[PTAB](/ptab)/IPR2019-00692/ ; https://www.drugpatentwatch.com/p/patent-claims/9561177

Claim 5 (dependent) recites the commercial formulation — about 4% (w/v) naloxone hydrochloride; about 0.74% (w/v) sodium chloride; about 0.01% (w/v) benzalkonium chloride; and about 0.2% (w/v) disodium edetate — and claim 4 (the claim asserted and invalidated in Adapt v. Teva; see Litigation Summary §1a) identifies the isotonicity agent as sodium chloride, the stabilizing agent as disodium edetate, and the acid as hydrochloric acid. Note that 4 mg/100 μL = 4% w/v, so claims 1, 4 and 5 describe the same 100 μL, 4 mg NARCAN® unit dose.

Analytical consequence: the ovality-ratio/plume-geometry language the earlier summary attributed to claim 1 is pre-grant published claim language, not granted claim language. The granted '177 claim 1 is a formulation-and-device method claim. This matters for obviousness because the granted claims drop the plume-ovality limitation (which had no clear prior-art anchor) and rest on a specific excipient set — BZK at 0.005–0.015% w/v being the load-bearing element.

1.2 Priority date and the § 103 framework

The '177 issued from application 15/183,441, filed June 15, 2016 — a continuation in the family claiming the March 14, 2014 provisional (61/953,379) via the March 16, 2015 parent 14/659,472. The Nalox-1 petitions argued the earliest supportable priority is March 16, 2015 (Hochhaus Decl., Nalox1003, ¶¶4–5, https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1523797](/patent/1523797)/download-documents). The Google Patents "2014-03-14" priority is an assumption, as the earlier summary noted. For § 103 purposes the distinction is mostly immaterial to the outcome, but it does affect art status (see §1.3).

Because the '177 has an effective filing date after March 16, 2013, AIA 35 U.S.C. § 102/103 governs. The framework is Graham v. John Deere, 383 U.S. 1 (1966) as refined by KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The controlling authority here is the Federal Circuit's own application of that framework to these very claims: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., 25 F.4th 1354 (Fed. Cir. 2022) (No. 20-2106), https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf, affirming the D.N.J. judgment (Case 2:16-cv-07721, ECF 344, 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).

1.3 Level of ordinary skill

Two POSA constructs appear in the record and both are useful: a "Formulator POSA" (Donovan) and a "Pharmacologist POSA" (Hochhaus), each with several years of nasal-formulation or clinical-pharmacology experience. The district court adopted the Formulator construct. Under either, the artisan is charged with knowledge of the Handbook of Pharmaceutical Excipients (BZK commonly 0.002–0.02% in intranasal products), the FDA Inactive Ingredient Guide, and standard nasal spray pump technology.

2. Prior-art reference inventory

Note on Wyse's art status. Wyse published June 25, 2015 — after even the March 14, 2014 provisional — but its own effective filing date (provisional 61/918,802, Dec. 20, 2013) precedes the '177's earliest date. Wyse therefore qualifies as § 102(a)(2) art (a U.S. patent effectively filed before the claimed invention's effective filing date and naming another inventor) notwithstanding its later publication. The CAFC opinion's phrasing that Wyse "published ... after the priority date of the patents-in-suit" describes publication timing, not art status. This is one reason the patentee's own specification discusses Wyse.

3. Combination 1 — Davies + Kerr 2009/Kerr Formulation + Bahal

This is the combination the district court found to render the asserted claims obvious "by clear and convincing evidence," and which the Federal Circuit affirmed. Claim-charting claim 1:

Claim 4 (NaCl / disodium edetate / HCl) — NaCl from Davies/Kerr; EDTA as naloxone stabilizer from Bahal; HCl to reach the slightly acidic pH that Davies expressly requires.

Claim 5 (4% w/v naloxone HCl; 0.74% NaCl; 0.01% BZK; 0.2% disodium edetate) — arithmetic from Davies' dose and volume disclosures (4 mg / 100 μL = 4%; 0.74 mg / 100 μL = 0.74%), BZK verbatim from the Kerr Formulation, EDTA from Bahal.

4. Combination 2 — Strang + Kulkarni + Djupesland

The Strang patent application supplies the intranasal naloxone method and dose (3–4 mg IN ≈ 1 mg IM) and expressly states that "[t]ypical pharmaceutical excipients used in intranasal formulations are known to the skilled person." Kulkarni supplies the excipient menu — including BZK — cross-referenced to the FDA IIG. Djupesland supplies the delivery hardware, "specifically point[ing] towards the Aptar Unit[D]ose device." Motivation: fill in a known formulation using a known device, per KSR's "finite number of identified, predictable solutions."

5. Motivation to combine (KSR rationales)

The Federal Circuit's summary of the district court's findings maps cleanly onto KSR:

1. Known problem in the field. The MAD Kit (approved injectable naloxone + Mucosal Atomization Device) was the de facto nasal approach but was not FDA-approved, not ready-to-use, delivered 1 mL/nostril against a nasal cavity volume of only ~200–250 μL, and caused drainage. The FDA convened a 2012 public meeting specifically "to encourage the industry to 'develop an intranasal naloxone product that could be FDA approved'" — an express, record-documented problem statement. KSR, 550 U.S. at 420.
2. Design incentive / market force. A needle-free, single-actuation, untrained-user product reduces the need for a second dose and reduces the risk of the treated patient's relapse while awaiting EMS.
3. Interrelated teachings in a common field of endeavor. Davies, Kerr 2009, Strang, Wermeling 2013 and the '177's own background all address intranasal naloxone for opioid overdose. Tyco Healthcare v. Ethicon, 774 F.3d 968, 978 (Fed. Cir. 2014).
4. Routine optimization of known, disclosed ranges. Every excipient is disclosed in the prior art within or overlapping the claimed range (BZK 0.002–0.02% vs. claimed 0.005–0.015%; NaCl 0.2–1.2 mg/100 μL vs. claimed 0.74 mg; EDTA from Bahal). Overlapping ranges and optimization within a disclosed range are prima facie obvious. In re Peterson, 315 F.2d 817 (CCPA 1964); In re Aller, 220 F.2d 454 (CCPA 1955); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007).
5. Reasonable expectation of success. All excipients were GRAS/IIG-listed for nasal use; BZK was "perhaps the most commonly used preservative in nasal formulations," present in "over 200 intranasal products."

The district court credited Dr. Smyth's testimony that a POSA would have combined each element of both combinations, and the court additionally found that "the pH of an intranasal product is commonly adjusted and can be optimized with repeated experimentation."

6. The teaching-away defense: Wyse and BZK

This is the crux, and it is where the '177 differs materially from its siblings.

• Wyse is the only reference in the record that generated naloxone-specific stability data on BZK. It concluded BZK "was not [acceptable], due to increased observed degradation," abandoned BZK, and pursued benzyl alcohol instead.
• The Examiner agreed and allowed the '177 claims over Wyse + Djupesland. In the Reasons for Allowance: "Wyse is considered to expressly exclude the use of benzalkonium chloride … This is considered to be a direct departure from the instantly claimed composition." (Quoted in the IPR2019-00691 Institution Decision, https://www.docketalarm.com/cases/PTAB/IPR2019-00691/Inter_Partes_Review_of_U.S._Pat._9561177/docs/08-27-2019-Board/Institution_Decision-14-Decision_Denying_Institution_of_Inter_Partes_Review.pdf)
• The PTAB agreed, denying institution on all three '177 IPRs (IPR2019-00691/-00692/-00693, Aug. 27, 2019): "Wyse expressly teaches that [BZK] is unacceptable for use in intranasal naloxone formulations"; and HPE (a petitioner exhibit) "further teaches away" because it reports BAC + EDTA nasal formulations "produce an inflammatory reaction."
• The district court and Federal Circuit disagreed: the prior art as a whole did not teach away, because (i) Wyse's 0.125% w/v BZK is 8.5× the claimed concentration, so any teaching away was not "commensurate in scope" with the claims; (ii) BZK is the most common nasal preservative; (iii) Davies' naloxone formulation used BZK and expressed no stability concern; and (iv) the Kerr Formulation used 0.01% BZK. Under Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006), simultaneous advantages and disadvantages in a known course of action do not necessarily negate motivation.

Why the '177 is the harder case for the challenger. In the sibling patents the preservative limitation was generic ("at least one of a preservative, a cationic surfactant, and a permeation enhancer"), which let the patentee argue that Wyse did not even address the claimed genus (see the Board's discussion in IPR2019-00685/-00688). The '177 claim 1 names benzalkonium chloride expressly, and claims 4–5 fix it at 0.01% w/v. The teaching-away argument therefore lands directly on the claim, not obliquely. The countervailing points remain strong (concentration mismatch; Kerr 0.01%; BZK's ubiquity and IIG listing), and the district court and the Federal Circuit both resolved the issue against the patentee. But a rigorous § 103 analysis must be candid that the '177 presents the strongest non-obviousness case in the family, which is exactly why the Board declined it and the courts accepted it.

Practical consequence for a challenger: the safest § 103 route against the '177 is Combination 1 (Davies + Kerr/Kerr Formulation + Bahal), which never relies on Wyse for a disclosure and supplies the 0.01% BZK element from the Kerr Formulation and Davies — i.e., from art that is older than Wyse by thirteen years, and thus from before the degradation data existed. That was precisely the combination the district court found dispositive.

7. Objective indicia (§ 103 Graham factor 4)

Judge Newman's dissent would have held the opposite on every one of these — treating the case as "a classical example of judicial hindsight" where "the invention itself is the only guide to the selections from the prior art." Her dissent is the best available articulation of the non-obviousness position and should be cited by anyone defending a parallel claim.

8. Flags: contradictions and corrections to the earlier sections

1. Resolved: The earlier summary's caveat that the granted claim 1 was "unverified" and that two sources "describe different claim 1 wording" is now closed. Granted claim 1 is the method claim (25–200 μL; 4 mg naloxone HCl; BZK 0.005–0.015% w/v; isotonicity agent). The ovality/plume-ratio language is from the pre-grant publication and the specification's "improvement" passages, not from the granted claims.
2. Resolved: The Litigation Summary flagged a discrepancy between Unified Patents ("Not Instituted – Merits") and drugpatentwatch's "2019-08-27 decision date." These are the same event: Aug. 27, 2019 is the date of the Board's decisions denying institution in IPR2019-00691/-00692/-00693.
3. Correction to the Patent Summary: that summary listed the specification's ovality-ratio requirement as a claim limitation in the "device claim family." It is not a granted claim limitation and should not be charted as one.
4. Unchanged / unverified: The exact wording of claims 2–3 and 6–30 of the '177 remains reconstructed from the Donovan Declaration table of contents, the RPX-reproduced claim sheet, and drugpatentwatch. Claim 1 is triple-sourced; the intermediate dependency chain (1 → 2 → 3 → 4 → 5) is my best inference and should be verified against the claim sheet. The '177 also appears to contain independent device and drug-product claims (the prosecution history refers to amendments to "claims 1 and 24," and to claim 14 with a 0.005–1% BZK range), but I could not verify their text.
5. Per-claim scope of the adjudication: the D.N.J. judgment invalidated claim 4 as obvious. That is the only '177 claim formally adjudicated. Claims 1–3 and 5–30 were not tried, so the § 103 conclusion as to them rests on the same record but is, strictly, an analytical prediction rather than a judgment. The Board's denial in the three '177 IPRs remains on the books as a contrary preliminary finding.
6. Date note: the task header gives April 26, 2026; the aggregator pages I retrieved are timestamped "Last Updated: May 27, 2026" and "August 25, 2026." No 2026 litigation or appellate activity naming the '177 was found, consistent with the earlier summary's statement.

9. Conclusion

Claims 1, 4 and 5 of US 9,561,177 B2 would have been obvious under 35 U.S.C. § 103 as of March 2015 over either (a) Davies in view of Kerr 2009/Kerr Formulation and Bahal, or (b) Strang in view of Kulkarni and Djupesland. A POSA confronting the FDA's 2012 call for an FDA-approvable intranasal naloxone product, and knowing that BZK was the standard intranasal preservative at 0.002–0.02% w/v, that EDTA stabilizes naloxone, and that single-dose pre-primed Aptar UnitDose pumps deliver 100 μL, had both reason and capacity to arrive at a 100 μL, 4 mg, 4% w/v naloxone HCl solution containing 0.01% BZK, 0.74% NaCl, 0.2% disodium edetate at pH 3.5–5.5. That is what the district court found and what the Federal Circuit affirmed in Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., 25 F.4th 1354 (Fed. Cir. 2022). The only substantial counterweight — Wyse's teaching that BZK degrades naloxone — was held not to teach away because Wyse's 0.125% concentration is 8.5× the claimed amount; but the PTAB reached the opposite conclusion on the same reference, and the '177 claim 1's express BZK limitation makes this the family's most defensible claim. I cannot state with high confidence that any unasserted claim of the '177 (e.g., the independent device or drug-product claims, whose text I could not verify) is invalid on the same combination.