US 9211253

I'll search for the specific patent number and related 2026 docket information.

Let me search for the specific Federal Circuit appeal and any 2026 docket activity.

Let me do one more targeted search for any 2025–2026 litigation activity on this patent.

US Patent 9,211,253 — Analyst Summary

Scope note: I searched for the literal identifier 9211253 / US 9,211,253 B2 (and its family litigation dockets). I did not find any Court of Appeals for the Federal Circuit docket for this patent in 2026. The only Federal Circuit appeal in this patent family that I can verify is No. 20-2106, decided February 10, 2022. I explain that below and flag the residual uncertainty.

1. Bibliographic data (verified against the granted patent record)

Sources: https://patents.google.com/patent/US9211253/en ; https://patents.justia.com/patent/9211253

Assignment chain (from the Google Patents reassignment entries):

• 2015‑04‑03 — assigned to Lightlake Therapeutics, Inc. (inventors Crystal & Weiss)
• 2016‑04‑22 — change of name → Opiant Pharmaceuticals, Inc.
• 2023‑06‑14 — assigned to Indivior UK Limited (assignor: Opiant Pharmaceuticals, Inc.), following Indivior's March 2, 2023 acquisition of Opiant (https://ir.indivior.com/node/10521/pdf)

Note the apparent discrepancy with secondary sources: Justia still lists the assignee as "Lightlake Therapeutics Inc." because it reports the original assignee; Google Patents reports Indivior UK Ltd as current assignee. Both are consistent with the chain above.

2. Abstract (verbatim)

"Provided are 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."

(This is the abstract as reproduced in the patent text and in the PTAB exhibit copy of the printed patent.)

3. Plain-language overview of the claims

The patent has 29 claims (PTAB IPR2019‑00685 challenged "claims 1–29"). The PTAB's institution decision identifies claim 1 as the independent claim it reproduced for analysis.

Independent claim 1 — the core "product" claim (device + formulation)

In plain language, claim 1 covers a single-use nasal spray device that is "pre-primed" (ready to spray on the first press, with no priming step), containing in one reservoir about 100 µL of an aqueous solution comprising, as active:

• about 4 mg naloxone hydrochloride (or a hydrate);
• about 0.2 mg to about 1.2 mg of an isotonicity agent;
• about 0.005 mg to about 0.015 mg of a preservative;
• a stabilizing agent; and
• enough acid to reach pH 3.5–5.5.

Delivery is by one actuation into one nostril.

Important caveat on the exact wording: the PTAB decision reproduces the granted claim 1 as reciting "about 0.2 mg of a stabilizing agent," whereas the published application (US 2015/0258019 A1) recited a different range ("between about 0.01 mg and about 0.05 mg of a stabilizing agent"). I report both because the as-issued numeric range matters and I could not independently re-verify the printed claim 1 character-for-character from the sources retrieved. Verify against the granted claim listing.

Dependent claims (the great majority of the claim set, 2–29)

These add narrowing limitations, including (from the sources retrieved):

• claim 2 — species: isotonicity agent = NaCl; preservative = benzalkonium chloride; stabilizing agent = disodium edetate; acid = hydrochloric acid;
• specific excipient/water packages and "substantially free of antimicrobial preservatives" variants;
• reservoir volume ≤ about 140 µL; about 100 µL delivered per actuation; sterile filling; storage stability ~12 months at 25 °C/60% RH;
• patient status (opioid overdose or suspected opioid overdose), patient position (lying, supine, or recovery position), administration by an untrained individual;
• dose equivalents (about 2 mg, 4 mg, 8 mg naloxone HCl; and dihydrate equivalents);
• pharmacokinetic limitations: Tmax < 30 / < 25 / about 20 / about 18.5 minutes, and threshold plasma levels on single actuation (≥0.2 ng/mL within 2.5 min; ≥1 ng/mL within 5 min; ≥3 ng/mL within 10 min);
• receptor occupancy >90 / >95 / >99% at the respiratory control center at Tmax; freedom from respiratory depression for 1, 2, 4 or 6 hours;
• delivery time < 25 s (< 20 s); dose-delivered 90%/95% CI of ±2%/±2.5%; <20%/<10%/<5% nasal drainage.

Uncertainty about additional independent claims

The dependent claims cross-reference claim 7 (e.g., claims 15 and 25: "The device of claim 7…") and claim 3 (e.g., claims 28 and 29: "The device of claim 3…"). That pattern could indicate that claim 1 is the only independent claim with everything hanging off a single dependency tree, or it could mean claims 3, 7 and/or 9 are themselves independent. The PTAB decision reproduces only claim 1 as "the independent" claim, which supports the single-independent-claim reading — but I do not have authoritative confirmation of the complete independent-claim set and recommend checking the granted-claims listing in USPTO Patent Center / Patent Public Search before relying on it.

4. Litigation, PTAB and Federal Circuit status

District court (D.N.J.):

• 2:16‑cv‑07721 (Adapt Pharma Operations et al. v. Teva, consolidated) — listed on Google Patents as family litigation
• 2:18‑cv‑15287 (Adapt Pharma Operations et al. v. Perrigo UK FINCO) — listed on Google Patents
• Third-party records (DrugPatentWatch) show a D.N.J. infringement case involving the '253 filed 2018‑04‑09 and terminated 2022‑07‑27; I could not tie that entry to a single docket number with certainty.

PTAB — IPR2019‑00685 (the relevant one for the '253):

• Petitioner Nalox‑1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.; filed Feb. 19, 2019; instituted Aug. 27, 2019; Final Written Decision Aug. 21, 2020.
• Result: the PTAB did not hold the challenged claims unpatentable — i.e., the '253 survived. See https://www.ptablitigationblog.com/wp-content/uploads/2020/09/PTAB-IPR2019-00685-57.pdf and https://www.oindpnews.com/2019/09/us-patent-trial-and-appeal-board-grants-inter-partes-review-of-narcan-patent/
• IPR2019‑00699 against the '253 was not instituted (procedural), and IPR2019‑00686/00687 were also not instituted. Nalox‑1 filed ~15 petitions against five Orange Book NARCAN patents ('253, '747, '177, '965, '838); institution was granted only for '253, '747 and '965.

Federal Circuit:

• Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., No. 20‑2106 (Fed. Cir.), filed Aug. 3, 2020; opinion Feb. 10, 2022 — affirming the district court's finding that certain asserted claims were obvious (Prost & Stoll, JJ.; Newman, J., dissenting). https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf
• Caution: the 20‑2106 appeal concerned the NARCAN patent family, but the opinion states the district court treated claim 9 of the '747 patent as representative, and the appeal involved "four patents listed in the Orange Book." I could not confirm from the retrieved sources that the '253's own claims were among those held invalid on appeal — and PTAB expressly upheld the '253 in parallel. Treat any statement that the '253 was invalidated with skepticism unless independently verified.
• 2026 CAFC docket: I found none for US 9,211,253. My searches returned no 2026 Federal Circuit activity naming this patent. If such a docket exists, it was not surfaced by the searches run, and I will not speculate about it.

5. Explicit uncertainties

1. Exact granted wording of claim 1 (particularly the stabilizing-agent amount): PTAB-reproduced granted text ("about 0.2 mg") vs. published-application text ("about 0.01–0.05 mg") differ. Not resolved.
2. Complete set of independent claims in the granted '253: not authoritatively confirmed (see §3).
3. Whether the '253's claims were among those invalidated in the D.N.J. Teva judgment and carried into Fed. Cir. 20‑2106: not confirmed; the PTAB outcome for the '253 was favorable to the patent owner.
4. No 2026 CAFC docket for 9,211,253 was found; the parties/ownership changed in 2023 (Indivior UK Limited), so any post‑2023 appellate activity would likely be captioned under Indivior.

Key sources: https://patents.google.com/patent/US9211253/en ; https://patents.justia.com/patent/9211253 ; https://www.ptablitigationblog.com/wp-content/uploads/2020/09/PTAB-IPR2019-00685-57.pdf ; https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf ; https://dockets.justia.com/docket/circuit-courts/cafc/20-2106

I'll research litigation involving US patent 9211253 using multiple targeted searches.

Let me dig deeper into the specific district court cases and the Federal Circuit appeal.

Based on my searches, here is what I can confirm about litigation involving US Patent 9,211,253 ("Nasal drug products and methods of their use," assigned originally to Lightlake Therapeutics, later Opiant Pharmaceuticals, now Indivior UK Ltd.). I've confined results strictly to the '253 patent and its litigation family; I have flagged where search results were ambiguous.

1. District Court — Adapt Pharma Operations Ltd. et al. v. Teva Pharmaceuticals USA, Inc. et al.

Important caveat on the '253 patent's role in this case: The patents-in-suit in the district court action are described in the appellate opinion and summaries as four patents directed to methods of treating opioid overdose by intranasal naloxone. The published decisions consistently refer to the '747 patent (U.S. 9,468,747) and its representative claim 9, and to the '747 claims 1–2 for the formulation limitations. My sources do not explicitly state that the '253 patent was one of the four asserted patents-in-suit, nor state its outcome in that case. Both the '253 and '747 patents are listed in the Orange Book for NDA 208411 (NARCAN®) with a 3/16/2035 expiry, and both claim priority to application 14/659,472 (filed 3/16/2015) — so they are siblings in the same family. You should verify from the D.N.J. docket (2:18-cv-15287 / 2:16-cv-07721) whether the '253 patent was actually asserted, and if so, how it was adjudicated.

Source: https://www.docketalarm.com/FDA/Orange_Book/208411/NARCAN/ ; https://ir.opiant.com/static-files/28f9434e-4720-408c-b2bc-b307e722c56b

2. PTAB — Nalox-1 Pharmaceuticals, LLC et al. v. Opiant Pharmaceuticals, Inc.

This is the one proceeding in which I found direct, explicit confirmation that the '253 patent itself was at issue.

Sources: https://portal.unifiedpatents.com/ptab/caselist?judges.panel=Jacqueline+T.+Harlow ; https://services.patexia.com/lawsuits/Nalox-1-Pharmaceuticals-LLC-et-al-v-Opiant-Pharmaceuticals-Inc-id-[122597](/patent/122597) ; https://www.ptablitigationblog.com/wp-content/uploads/2020/09/PTAB-IPR2019-00685-57.pdf

Related PTAB challenges (same petitioner / same patent family)

The Google Patents litigation panel for US 9,211,253 also lists two companion petitions:

• IPR2019-00686 — "Not Instituted – Procedural"
• IPR2019-00687 — "Not Instituted – Procedural"
• Additionally, IPR2019-00698 (Nalox-1 Pharmaceuticals, LLC et al. v. Opiant Pharmaceuticals, Inc.) appears in results; its document record includes "AdaptOpiant2034 US9211253" as an exhibit, meaning the '253 patent was part of that record, though the '698 number may relate to a different patent in the family.

Sources: https://patents.google.com/patent/US9211253/en ; https://services.patexia.com/lawsuits/Nalox-1-Pharmaceuticals-LLC-et-al-v-Opiant-Pharmaceuticals-Inc-id-[122623](/patent/122623)

3. Not confirmed / things I could not verify

• A case styled "Opiant Pharmaceuticals, Inc. v. Teva": I found no such case. The NARCAN® Hatch-Waxman plaintiff was Adapt Pharma Operations Limited (with Opiant/Emergent as related plaintiffs); the defendant was Teva. If you have a reference to a case captioned "Opiant v. Teva," treat it with caution.
• Any litigation specifically enforcing the '253 patent in district court: I could not confirm one from available search results. The '253 patent appears in the record as an Orange Book reference and as a PTAB challenge target, but the district court/CAFC NARCAN litigation decisions I found discuss the '747 patent explicitly.
• Other alleged infringers/generics (e.g., Amphastar, Sandoz, Perrigo, or other ANDA filers with respect to the '253): no results surfaced. Note there may be additional ANDA litigations in the family not captured here; PACER/RPX/Unified Patents docket searches on the specific patent number would be needed.

Summary table

Bottom line: The only proceeding I can tie unambiguously to US 9,211,253 is IPR2019-00685 (with companion petitions IPR2019-00686/00687), filed by Nalox-1 Pharmaceuticals against Opiant Pharmaceuticals, decided by Final Written Decision on August 21, 2020. The well-documented NARCAN® Hatch-Waxman litigation (Adapt Pharma Operations Ltd. v. Teva, D.N.J. 2:18-cv-15287 / CAFC 20-2106) involves the same patent family and Orange Book listing, but my sources identify the '747 patent, not the '253, as the representative asserted patent—so please confirm the '253's precise role on the district court docket before relying on it.

I have deliberately not auto-corrected any numbers, and where I could not verify an outcome (notably the substantive result of IPR2019-00685), I've said so explicitly rather than guessing.

I'll research the PTAB proceedings, starting with the apparent contradiction between the structured ODP block (no proceedings) and the earlier litigation summary (IPR2019-00685 et al.).

Key finding already: the FWD is titled "Determining No Challenged Claims Unpatentable." Let me nail down the panel, the companion petitions, and any appeal.

⚠️ Threshold conflict to flag before anything else

The structured "PTAB proceedings on file" block in this prompt states that the USPTO ODP API returns no AIA trial proceedings for US 9,211,253. That is contradicted by every other source in this record — including the Google Patents litigation panel in the same prompt, which itself lists "PTAB case IPR2019-00685 filed (Final Written Decision)."

Document-backed reality: three AIA petitions were filed against the '253 patent, all on 2019-02-19, all by the same petitioner (Nalox-1 Pharmaceuticals, LLC) — one instituted and tried to a Final Written Decision, two denied institution. The ODP "on file" block appears stale/incomplete (these trials all terminated in 2020 and the patent has been reassigned twice since: Lightlake → Opiant → Indivior UK Ltd. on 2023-06-14). I am treating the ODP block as not canonical here and sourcing the list from the PTAB papers themselves. Anyone relying solely on the ODP feed would wrongly conclude this patent has never been challenged — a materially dangerous error for a defendant.

A second data artifact to flag: the Google Patents block labels the "Petitioner" on IPR2019-00685 as "Unified Patents PTAB Data." That is the data-source attribution, not a party. The actual petitioner of record is Nalox-1 Pharmaceuticals, LLC. There is no Unified Patents (defensive aggregator) involvement in this patent's PTAB history.

Proceedings overview

Total: 3 AIA trial proceedings on US 9,211,253 — 0 claims invalidated, 0 settled, 1 instituted and tried to FWD (all 29 claims sustained), 2 institution denied (procedural/discretionary). The bottom line for a defendant today: the patent has survived its only full IPR with every claim intact, and it was also dropped from the parallel district-court case before trial — so there is no existing invalidity judgment you can borrow. This is the opposite of a "troll with dead claims" posture; the '253 is, on the current public record, the hardened member of the NARCAN Orange Book family.

IPR2019-00685 — Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Operations Limited and Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review.
• Filed: 2019-02-19 (accorded filing date 2019-02-19).
• Status: "Final Written Decision" (structured). Plain English: instituted, fully tried, and the petitioner lost on every challenged claim. Paper 57, dated 2020-08-21, is captioned "Final Written Decision Determining No Challenged Claims Unpatentable — 35 U.S.C. § 318(a)."
• Judge panel: Erica A. Franklin, Zhenyu Yang, and Michael A. Valek, Administrative Patent Judges; Yang authored. (Source: FWD caption and the Board's 2019-11-25 Order Conduct of Proceeding, Paper 26.) ⚠️ Discrepancy flagged: Patexia's case summary lists the panel as "Zhenyu Yang, Jacqueline T. Harlow." That is wrong for '685 — Harlow sat on the '838 panel (see the 2019-10-16 denial in IPR2019-00699). I am preferring the primary PTAB documents over the third-party aggregator.
• Patent Owner: captioned as Adapt Pharma Operations Limited and Opiant Pharmaceuticals, Inc. The Joint Amended Mandatory Notices state "Adapt and Opiant are the assignees of U.S. Patent Nos. 9,211,253; 9,468,747; and 9,629,965." (Notice the assignment discrepancy with the Google Patents reassignment chain in this record, which shows the '253 going Lightlake → Opiant → Indivior without an Adapt link — I cannot reconcile that from the documents available and I flag it rather than paper over it.)
• Petition grounds: § 103 obviousness (and § 102 anticipation theories as to certain limitations), challenging claims 1–29 — i.e., all claims. Lead reference: Wyse (U.S. Patent No. 9,192,570), supported by the Donovan and Hochhaus declarations and, per the petitioner's own framing, secondary references including Davies (WO 00/62757), Wang, Djupesland, Kerr 2009, and Bahal. Petition 1 was unique among Nalox-1's three '253 petitions in that it also attacked the '253 patent's priority claim, arguing the patent was not entitled to a 2014-03-14 priority date — which was necessary to make Wyse § 102(a)(2) prior art. Source: Petitioner's Notice of Petitioner's Rankings, Paper 8 (2019-06-17).
• Institution decision: Instituted 2019-08-27 (Paper 11, § 314(a)). The Board found a presumption of obviousness from overlapping ranges — Wyse's "from about 5 mg/mL to about 50 mg/mL of naloxone" delivered in a 100 µL unit dose (0.5–5 mg) "fully encompasses the dosage of 'about 4 mg naloxone hydrochloride or a hydrate thereof' in challenged claim 1." It rejected Patent Owner's argument that 50 µL of a 50 mg/mL solution yields only 2.5 mg, noting the broader range still reaches 10 mg. It instituted on all claims 1–29 (SAS-driven) even though it did not find a reasonable likelihood as to the BZK-specific claims.
• Final Written Decision: 2020-08-21 (Paper 57; reported at Nalox-1 Pharms., LLC v. Adapt Pharma Operations Ltd., No. IPR2019-00685, 2020 WL 4920048 (P.T.A.B. Aug. 21, 2020)). Verdict: "we conclude Petitioner has not established by a preponderance of the evidence that claims 1–29 of the '253 patent are unpatentable." Zero claims canceled. Zero claims held unpatentable. All of claims 1–29 sustained. The Board's core reasoning was teach-away: "Wyse expressly teaches that [benzalkonium chloride] is unacceptable for use in intranasal naloxone formulations"; Wyse "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." Because the '253 claims require a preservative (0.005–0.015 mg per 100 µL, i.e., BAC at ~0.01%), the Board held the Wyse-based combinations would not have been arrived at by a POSA. The Board also credited Patent Owner's objective-indicia evidence. (FWD reproduced in relevant part at https://www.ptablitigationblog.com/wp-content/uploads/2020/09/PTAB-IPR2019-00685-57.pdf.)
• Settlement / termination: No settlement. The case terminated by adverse FWD on the merits. (Note: the paper is docketed as a "Termination Decision Document," which is the PTAB's E2E document-classification label for the FWD — it does not signify a settlement.)
• Appeal: Not verified. I searched for a Federal Circuit appeal from the '685 FWD and found none. The only CAFC activity I can tie to this family is No. 20-2106, Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc. — and that is Patent Owner's appeal of the district court's obviousness judgment, not an appeal of the '685 IPR. Do not cite 20-2106 as the appeal of this IPR. If a '685 appeal exists, it would be Nalox-1's; PACER/Docket Alarm for Nalox-1 as appellant is the place to confirm.
• Defensive value: A prior IPR loss is the single worst fact for a defendant hoping to kill this patent administratively. All 29 claims are confirmed patentable over the Wyse/BAC combination. Any new petition built on the same Wyse-teaches-BAC theory faces § 325(d) and General Plastic headwinds, and the FWD's teach-away finding is now adversarial precedent your own expert must confront. The commercially useful path is a design-around: claim 1 recites specific quantitative excipient windows — "about 4 mg naloxone hydrochloride," "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 preservative," "about 0.2 mg of a stabilizing agent," and pH "3.5–5.5" in ~100 µL. A formulation outside those windows (e.g., different preservative, different EDTA loading) is a more promising non-infringement theory than an invalidity theory.

IPR2019-00687 — Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review.
• Filed: 2019-02-19.
• Status: "Not Instituted – Procedural" (structured). Plain English: institution denied; never tried.
• Judge panel: Not confirmed for this petition number from a primary document; the '253 petitions were handled by the same three-judge configuration (Franklin, Yang, Valek), but I am not asserting panel identity without the paper.
• Petition grounds: § 103 obviousness with Davies (WO 00/62757) as the lead reference, a § 102(a)(1) prior art theory (so not dependent on knocking out the priority claim). Petitioner ranked this as its second-priority '253 petition.
• Institution decision: Denied 2019-08-27 — docketed as "Institution Decision — Denying Institution of Inter Partes Review, 35 U.S.C. § 314(a)," Paper 11. A Notice of Refund issued 2019-10-21 (Paper 13), which is the standard consequence of a denial. The denial was one of twelve Nalox-1 petitions the Board turned away in the same discretionary-denial sweep (see Joint Amended Mandatory Notices, listing denials in IPR2019-00686, -00687, -00689, -00690, -00691, -00692, -00693, -00695, -00696, -00697, -00698, and -00699). The practical basis was redundancy — Nalox-1 conceded the three '253 petitions were meant to be ranked (Wyse > Davies > Wang), and the Board instituted only the lead one.
• Final Written Decision: None — no FWD issued.
• Settlement / termination: N/A.
• Appeal: None (non-institution decisions are not appealable to the Federal Circuit as of right).
• Defensive value: Minimal for a defendant — a denial produces no claim-level estoppel and no invalidity holding. Its only value is evidentiary: the Board's 2019-08-27 denials on the sibling patents show the PTAB's skepticism of the Wyse/BAC theory months before the FWD, corroborating the teach-away finding.

IPR2019-00686 — Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review.
• Filed: 2019-02-19.
• Status: "Not Instituted – Procedural" (structured). Institution denied; never tried.
• Judge panel: Not confirmed (same grouping as above).
• Petition grounds: § 103 obviousness with Wang as the lead reference, ranked third by petitioner. Notably, petitioner used a certified human translation of Wang, whereas the '253 prosecution record contained only a machine translation — petitioner argued this made its petition non-redundant.
• Institution decision: Denied 2019-08-27 (same discretionary sweep as -00687).
• Final Written Decision: None.
• Settlement / termination: N/A.
• Appeal: None.
• Defensive value: Negligible; a denied petition.

Sibling-patent context (not '253, but the pattern matters)

Nalox-1 filed 15 petitions — three each against five Orange Book NARCAN patents. Per the D.N.J. court's own recitation (Case 2:16-cv-07721-BRM-JAD, Doc. 283, filed 2019-11-13), it filed three against each of the four then-asserted patents ('747, '177, '965, '838) "plus three against no-longer-asserted U.S. Patent No. 9,211,253." The Board instituted only the Wyse-based petitions on three patents and issued a trio of adverse FWDs on 2020-08-21 — IPR2019-00685 ('253), IPR2019-00688 ('747, claims 1–45), and IPR2019-00694 ('965) — each "Determining No Challenged Claims Unpatentable." Denials included IPR2019-00689 ('747, procedural), IPR2019-00693 ('177, "Not Instituted – Merits"), and IPR2019-00699 ('838, denied 2019-10-16). Law360 headlined the outcome "PTAB Upholds Entirety Of 3 Narcan Patents."

Strategic summary

Claim status on US 9,211,253. No claim has been canceled and no claim has been held unpatentable. The full set, claims 1–29, was challenged in the only instituted IPR and all 29 survived (IPR2019-00685, FWD 2020-08-21: "Petitioner has not established by a preponderance of the evidence that claims 1–29 of the '253 patent are unpatentable"). Claim 1 — the single-use, pre-primed 100 µL single-reservoir device claim reciting ~4 mg naloxone HCl, 0.2–1.2 mg isotonicity agent, 0.005–0.015 mg preservative, ~0.2 mg stabilizing agent, pH 3.5–5.5 — is sustained. Claims 2–29 (dependents/related embodiments) are sustained as well. Separately, the '253 was not part of the district court's 2020-06-26 final judgment of invalidity in Adapt v. Teva; that judgment covered claims 7 and 9 of the '747, claim 4 of the '177, claims 21/24/25 of the '965, and claims 2/24/33/38 of the '838 (affirmed, Fed. Cir. No. 20-2106, 2022-02-10). So there is no invalidity judgment against the '253 in either forum. "Untested" territory is thin — the '253 has been tested and passed. The one genuinely untested angle is the § 112 / written-description and utility axis: the District Court/Court of Appeal reasoning in the unrelated Canadian '687 proceeding (dividing claims by plasma-concentration and Tmax limitations) shows how a utility/enablement attack on the plasma-concentration limitations can be framed, and the PTAB FWD never reached those theories.

Estoppel landscape. Under 35 U.S.C. § 315(e)(2), IPR estoppel attaches only after a Final Written Decision — so it bites only on IPR2019-00685. Nalox-1 Pharmaceuticals, LLC and its real parties in interest/privies are barred from asserting, in any civil action or ITC proceeding, any ground they raised or reasonably could have raised in the '685 petition. That is a broad bar: the Wyse, Davies, Wang, Djupesland, Kerr 2009, and Bahal combinations, and the priority-date attack on the '253, are all off the table for Nalox-1 and its privies. The denials in IPR2019-00686 and -00687 generate no estoppel at all. Critically for a new defendant: § 315(e)(2) estoppel does not run against you merely because someone else IPR'd the patent. You could file your own petition — but you would face § 325(d) (same Wyse art already considered) and the General Plastic follow-on-petition factors, and the FWD's teach-away finding is now a public, adverse record. Realistic remaining grounds for a fresh challenger: (i) newly located art not in the '685 record, (ii) § 112 written description/enablement/utility theories never presented to the Board, and (iii) prior public use/on-sale evidence, if any predates 2014-03-14 and is documented.

Pattern signals. One petitioner, one campaign, no aggregator. Nalox-1 Pharmaceuticals, LLC — which described itself as a pharmaceutical company "currently developing, and plan[ning] to seek FDA approval to market ... a generic version of Narcan® naloxone nasal spray" — filed three petitions against the '253 plus three each against four sibling patents, expressly to "remove the barriers to an approved generic naloxone nasal spray." It lost every instituted trial on 2020-08-21. There is no Unified Patents, RPX, or other defensive-aggregator IPR on this patent (the "Unified Patents" text in the Google Patents block is a data-source credit, not a party). Patent Owner (Adapt/Opiant, now Indivior UK Limited per the 2023-06-14 reassignment) litigated the IPRs aggressively to judgment rather than settling, and appeared through Williams & Connolly (Adapt) and Green, Griffith & Borg-Breen (Opiant). I found no evidence the patent owner or Nalox-1 appealed any of the three '253 decisions; the well-known 20-2106 appeal is the district court case.

Recommended next steps

1. If you are a defendant today: assume the patent is live and validated. Cite the FWD directly — Nalox-1 Pharms., LLC v. Adapt Pharma Operations Ltd., No. IPR2019-00685, 2020 WL 4920048 (P.T.A.B. Aug. 21, 2020) — quoting the disposition: "we conclude Petitioner has not established by a preponderance of the evidence that claims 1–29 of the '253 patent are unpatentable." FWD PDF: https://www.ptablitigationblog.com/wp-content/uploads/2020/09/PTAB-IPR2019-00685-57.pdf. Do not represent that any '253 claim is canceled. If a demand letter says claims 1–5 are invalid, that is wrong on the published record.
2. Do not assume borrowed invalidity. The concurrent Lexology/PTAB Litigation Blog analysis (2020-09-18, https://www.lexology.com/library/detail.aspx?g=5b8cad19-9e66-49ee-a5e2-058b6acb892a) is explicit that the PTAB and the D.N.J. district court reached opposite conclusions on the same Wyse reference — and the district court's ruling covered the '747/'965, not the '253. You cannot import the district court's obviousness judgment onto the '253.
3. Verify the appeal question on PACER. Confirm whether Nalox-1 appealed the '685 FWD and, if so, the CAFC docket number and disposition. I could not confirm this and will not guess. Docket Alarm shows no notice of appeal among the '685 papers through 2020; check CAFC filings naming Nalox-1 Pharmaceuticals as appellant after 2020-08-21.
4. Confirm the current owner. Google Patents shows the '253 assigned to Indivior UK Limited as of 2023-06-14 (Indivior's acquisition of Opiant). Confirm standing and any exclusive-licensee arrangements (Adapt/Emergent was co-named as Patent Owner in the IPR despite the assignment chain not reflecting it) before evaluating who can sue you and who is bound by estoppel.
5. Build on non-infringement, not invalidity. The claim-window limitations (excipient mass ranges, 100 µL fill, 3.5–5.5 pH, single-reservoir, one-actuation) are the highest-value negotiating/design-around levers, given the patent has defeated the only serious invalidity challenge to reach judgment.
6. Fix the internal data feed. The ODP-derived "PTAB proceedings on file" block reporting zero proceedings for US 9,211,253 is wrong. If that feed drives your docket watch, it will miss this patent's entire PTAB history.

Assignment & Ownership Analysis — US 9,211,253 B2

Data-source caveat (read first). The authoritative text supplied for this patent includes the Google Patents "legal events / reassignment" block, which mirrors the underlying USPTO assignment records but does not expose reel/frame numbers, execution dates, or the correspondent of record. My search tooling could not reach the Assignment Center's interactive record view, and I found no third-party mirror of the '253 reel/frame entries. I have therefore reconstructed the chain from the recorded events and from SEC/IPR documents, and I am explicitly not inventing reel/frame values or correspondent names. Where a required field could not be verified, it is marked not retrievable rather than guessed. Verify at: https://assignmentcenter.uspto.gov/ (search "9211253") or https://assignment.uspto.gov/patent/index.html.

Note also the cross-reference contradiction flagged later: IPR mandatory notices describe Adapt Pharma Operations Limited inconsistently (co-assignee vs. limited exclusive licensee), yet no assignment to Adapt appears in the recorded chain.

Inventors

• Inventor addresses are taken from the front pages of the sibling patents in this family ('747 and '965, which share the same two inventors) and from the '253 record.
• No "inventor exodus" pattern. Roger Crystal did not leave the assignee — he became President/CEO of the renamed company (Opiant) and remained in that role through the March 2023 Indivior acquisition (he is quoted as "Opiant's President and Chief Executive Officer" in Indivior's 14 Nov 2022 announcement). This is the opposite of the "all inventors out within 12 months" fire-sale signal.
• Family grew via collaboration, not spin-out. Sibling patents '177 and '838 name four inventors — Fintan Keegan, Robert Gerard Bell, Roger Crystal and Michael Brenner Weiss — i.e., the Adapt-side collaborators were added to later filings. This is consistent with a genuine development collaboration (Lightlake/Opiant + Adapt), not a pure patent-procurement vehicle.

Original assignee

Lightlake Therapeutics Inc. — the entity named as original assignee, with a New York, NY address on the issued-family front pages.

• Business: specialty pharmaceutical company (incorporated in Nevada 21 Jun 2005 as Madrona Ventures, Inc.; renamed Lightlake Therapeutics Inc. on 16 Sep 2009; renamed Opiant Pharmaceuticals, Inc. on 28 Jan 2016; reincorporated into Delaware 2 Oct 2017).
• Did they ship a product embodying the claims? Yes — indirectly. The '253 covers the pre-primed intranasal naloxone drug product. Lightlake/Opiant developed the intranasal naloxone formulation, licensed it to Adapt Pharma Operations Limited (Dec 2014), and NARCAN® (naloxone HCl) Nasal Spray was FDA-approved 18 Nov 2015 and marketed by Adapt. Opiant was the patent owner; Adapt was the NDA holder/marketer. (Opiant later also developed OPVEE®/nalmefene nasal spray, approved May 2023.)
• Current status: No longer independent. Acquired by Indivior PLC for ~$145M upfront plus CVRs; deal closed 2 Mar 2023. Opiant was subsequently merged with and into Indivior (per the Nov 2024 Aegis↔Indivior assignment recital). Opiant's common stock ceased trading on Nasdaq at close.

Assignment timeline

Three recorded conveyance events are visible in the authoritative record. Execution dates and reel/frame numbers are not retrievable from the sources available to me.

1. ~2015-03 (executed, proximate to the 2015-03-16 filing) / recorded 2015-04-03 — Reel/frame not retrievable

   • Conveyance: Assignment of assignors' interest (inventor-to-company)
   • Assignor: Crystal, Roger; Weiss, Michael Brenner
   • Assignee: Lightlake Therapeutics, Inc.
   • Correspondent: not retrievable (no recurrence assessment possible)
   • Context: ordinary inventor assignment to the operating start-up at filing — establishes original ownership; not a shell transfer.

2. On/around 28 Jan 2016 (corporate name change) / recorded 2016-04-22 — Reel/frame not retrievable

   • Conveyance: Change of Name (see document for details)
   • Assignor: Lightlake Therapeutics, Inc.
   • Assignee: Opiant Pharmaceuticals, Inc.
   • Correspondent: not retrievable
   • Context: internal reorg only — same legal entity, new name. Not an acquisition and not an arm's-length transfer. (SEC filings confirm the name change to Opiant on 28 Jan 2016.)

3. 2023-03-02 (merger close) – 2023-06-14 (recorded) — Reel/frame not retrievable

   • Conveyance: Assignment of assignors' interest (M&A transfer / merger succession)
   • Assignor: Opiant Pharmaceuticals, Inc.
   • Assignee: Indivior UK Limited (The Chapleo Building, Henry Boot Way, Priory Park, Hull HU4 7DY, UK)
   • Correspondent: not retrievable. (Note: Indivior's transaction counsel was Covington & Burling LLP and Opiant's was Latham & Watkins LLP — but these are deal counsel, not confirmed as the USPTO recording correspondent.)
   • Context: strategic acquisition — Opiant merged into Indivior PLC's group; the '253 moved with the Opiant estate to the Indivior UK entity.

Related license/encumbrance records (not assignments; do not appear as recorded conveyances in the chain):

• Dec 2014: Opiant granted Adapt Pharma Operations Limited a global license to the intranasal naloxone program. IPR mandatory notices ('693) describe Adapt Pharma Operations Limited as a limited exclusive licensee of the '253.
• 13 Dec 2016: Opiant entered a Purchase and Sale / Note Purchase and Security Agreement with SWK Funding LLC that took "a lien covering all of our assets, with the exception of certain intellectual property including intellectual property related to our NARCAN® ... Nasal Spray." → the '253 family was carved out; it was not collateralized.

⚠ Contradiction to flag: IPR2019-00688's joint amended mandatory notices state "Adapt and Opiant are the assignees of U.S. Patent Nos. 9,211,253; 9,468,747; and 9,629,965," whereas IPR2019-00693's notice states "Opiant is the assignee, and Adapt Pharma Operations Limited is a limited exclusive licensee, of U.S. Patent No. 9,211,253." These two PTAB filings are inconsistent about Adapt's status. No assignment to Adapt appears in the recorded Google Patents/USPTO event chain, which favors the "exclusive licensee" characterization — but the docket and the Assignment Center should be checked to resolve it.

Timeline diagram

timeline
    title Ownership of US 9211253
    2014 : Priority filing 14 Mar
         : Opiant licenses program to Adapt Dec
    2015 : Inventors assign to Lightlake 3 Apr
         : Patent issued 15 Dec
    2016 : Lightlake renamed Opiant 22 Apr
         : Suit filed vs Teva and Perrigo Oct
    2020 : PTAB Final Written Decision Aug
    2023 : Opiant acquired by Indivior 2 Mar
         : Opiant assigns to Indivior UK 14 Jun

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The two post-filing events are (i) a pure Change of Name from Lightlake to Opiant (recorded 2016-04-22) and (ii) an M&A succession to Indivior UK Limited (recorded 2023-06-14). Neither assignee is a licensing-only LLC with an agent-service address; both are operating pharma entities. No "IP/Holdings/Ventures"-suffixed single-purpose vehicle appears in the chain.

2. Known asserter in the chain — NOT PRESENT. Lightlake/Opiant and Indivior match none of the enumerated NPE directories (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, etc.). To the contrary, Opiant was a publicly traded specialty pharma (Nasdaq: OPNT) and Indivior is a listed global pharma (LSE/Nasdaq: INDV).

3. Repeat correspondent across the chain — UNCLEAR. No correspondent-of-record data was retrievable for any of the three events, so recurrence cannot be assessed. This is a data gap, not a negative finding.

4. Cascading transfers — NOT PRESENT. Three events span 2015 → 2016 → 2023 (≈8 years). No chained LLC-to-LLC hops, and no shared correspondent address is observable. The 2016 event is a name change, not a transfer of interest.

5. Pre-litigation transfer — NOT PRESENT. The first suits naming the patent (Adapt Pharma Operations Ltd. v. Teva, 2:16-cv-07721-JLL-JAD (D.N.J.), filed 21 Oct 2016, consolidated; and Adapt v. Perrigo UK FINCO) were filed ~Oct 2016, close in time to the 2016-04-22 recording — but that recording was a Name Change, not an arm's-length transfer arranged to enable assertion or set venue. The suit was brought by the operating NDA holder (Adapt) together with the patent owner (Opiant), not by an assignee shell.

6. Bankruptcy fire-sale — NOT PRESENT. The only distress-adjacent event is the 13 Dec 2016 SWK Funding secured financing, under which the NARCAN-related IP (including the '253 family) was expressly excluded from the lien. The 2023 exit was a solvent, all-cash acquisition (~$145M upfront + CVRs), not a Chapter 7/11 sale.

7. Privateering — NOT PRESENT (with a nuance). The '253 was asserted by Opiant together with its licensee Adapt Pharma Operations Ltd. against generic competitors (Teva, Perrigo) in Hatch-Waxman litigation. That is a pharma licensor/licensee co-plaintiff arrangement, not a transfer to an unrelated assertion vehicle asserting on the operating company's behalf. Not classic privateering.

8. Defensive aggregator — NOT PRESENT. The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. It terminates at Indivior UK Limited, an operating pharma affiliate. (For completeness: the post-litigation Federal Circuit decision in Adapt v. Teva, No. 20-2106 (Fed. Cir. 10 Feb 2022), affirmed invalidity/obviousness of the asserted claims — but "claims held obvious" is a validity outcome, not a defensive-aggregation ownership outcome.)

Verdict

Operating-company assertion.

The chain runs RightLightlake inventors → Lightlake Therapeutics (2015) → Opiant Pharmaceuticals, change of name only (2016) → Indivior UK Limited (2023) — all operating pharmaceutical entities, with the only "transfer" before the 2016 suits being an internal Change of Name recorded 2016-04-22, not an assertion-enabling assignment. The patent was enforced by the operating NDA holder and patent owner together against actual generic competitors (Adapt/Opiant v. Teva, 2:16-cv-07721-JLL-JAD, filed 21 Oct 2016; and Adapt v. Perrigo), and the current assignee Indivior UK Limited is an affiliate of a listed pharma that ships overdose-reversal products. No shell entity, no NPE-list assignee, no cascading LLC transfers, and no bankruptcy sale appear on the record — so the NPE/troll signals come back not present across the board, with the sole "unclear" being the correspondent-recurrence test (a data gap).

Verification links: https://assignmentcenter.uspto.gov/ · https://assignment.uspto.gov/patent/index.html/ · Google Patents legal events: https://patents.google.com/patent/US9211253/en

Items to confirm on the primary source (not fabricable from here): (a) the reel/frame numbers and correspondents of record for all three recorded events; (b) the execution dates behind the 2015-04-03 and 2023-06-14 recordings; and (c) whether any separate assignment to Adapt Pharma Operations Limited was ever recorded (the PTAB notices conflict on this point).

I'll research the prior art cited against and within US 9,211,253, including the PTAB challenge record.

Let me pull the specific "References Cited" on the '253 front page and the IPR grounds references.

Prior Art Analysis — US Patent 9,211,253

Patent: US 9,211,253 B2, "Nasal drug products and methods of their use"
App. No.: 14/659,472 · Filed: 2015-03-16 · Granted: 2015-12-15
Priority: 2014-03-14 (provisional 61/953,379)
Inventor: Roger Crystal; Michael Brenner Weiss · Assignee history: Lightlake Therapeutics → Opiant → Indivior UK
Claims: 1–29 (device claims, method claims, and kit claims)
Certificate of Correction: Review Certificate mailed 2021-08-23 (flagged as a caveat below)

Methodological caveat (read first)

I was able to retrieve the background-art discussion printed in the '253 specification itself (authoritative, from the full patent text supplied) and the prior-art references relied on in the PTAB challenge to the '253 (IPR2019-00685). I was not able to pull a clean, complete copy of the '253's own front-page "References Cited" (U.S. Patent Documents / Foreign Documents / Other Publications) block from USPTO PatentCenter within this session. Where a reference is reported below as appearing on the front page of a sibling patent (the '177 patent, U.S. 9,561,177 — same specification, same family), I have labelled it as such. Do not treat the sibling-derived list as the '253's certified citation list; verify against the '253 front page directly.

A second caution: search results returned a US 9,211,253 that is an unrelated PCT international application number (US9211253 W 19921217) cited in EP 0619061 (a data-comm receiver/decoder). That is a different identifier in a different numbering system and is not the patent at issue. I flag it because it pollutes naive searching for "9211253."

Part 1 — Prior art discussed on the face of the '253 specification

These references are recited in the '253 background/definitions (authoritative text supplied). Under 35 U.S.C. § 102, these are the references most likely to be cited by an examiner or challenger as anticipating.

Part 2 — Patent-family citation list (reported on the sibling '177 patent front page; verify against '253)

The U.S. 9,561,177 front-page "U.S. Patent References" list (same specification family) names the following. Treat these as candidate front-page citations for the '253 pending verification:

Part 3 — Prior art actually relied on in the PTAB challenge (IPR2019-00685)

This is the adjudicated prior-art record for the '253 and is the most probative "most relevant prior art" answer.

• Proceeding: Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc., IPR2019-00685 (Patent 9,211,253 B2)
• Filed: 2019-02-19 · Instituted: 2019-08-27 · Final Written Decision: 2020-08-21
• Petitioner's theory: obviousness — the '253 claims were obvious from Wyse as the lead reference, combined with secondary references, on the rationale that a POSA would have been motivated to (i) develop an improved IN naloxone formulation, (ii) use a 4–6 mg dose, (iii) select commonplace excipients (BZK, EDTA), and (iv) load it into an easy-to-use single-dose, pre-primed nasal sprayer.

Companion petitions against the '253: IPR2019-00686 and IPR2019-00687 (not instituted — the Board exercised discretion under § 314(a)/§ 325(d), denying all petitions except the Wyse-based ones). Across all four NARCAN patents, Nalox-1 filed fifteen petitions (three per patent, each using one of Wyse / Davies / Wang as the lead).

Outcome note (reconciling with the earlier section): The earlier litigation write-up correctly flagged the IPR2019-00685 substantive outcome as unverified. Two independent sources now report the event as a "Termination or Final Written Decision" dated 2020-08-21, and the litigation summary further notes the Board declined to institute on claims reciting BZK specifically (instituting on all claims only because SAS required it). A Review Certificate (Certificate of Correction) for the '253 was issued 2021-08-05 / mailed 2021-08-23, consistent with the patent being upheld and corrected rather than cancelled. I still have not read the FWD's ultimate claim-by-claim disposition, so this remains a partial confirmation.

Also relevant — a correction to the earlier litigation section: The D.N.J. summary-judgment record (2:16-cv-07721, Doc. 283, filed 2019-11-13) states the '253 was "no-longer-asserted" in that district court case. That resolves the open question flagged earlier: the '253 was listed among the patents originally in suit (Exhibit A of the complaint shows "U.S. Pat. No. 9,211,253") but was dropped before trial; the patents litigated to judgment were the '747, '177, '965, and '838.

Part 4 — Claim-by-claim § 102 screen (summary)

Part 5 — Bottom line

1. Most relevant prior art for the '253: Wyse, U.S. 9,192,570 (granted 2015-11-24, publication US 2015/0174061). It is the reference the PTAB actually instituted on and the only reference that, combined with a 100 µL dose volume, the Board held created a presumption of obviousness over the claimed "about 4 mg" dose. Wyse simultaneously supplies a teaching away (from BZK) that is the patent owner's principal nonobviousness argument.
2. Strongest single-reference § 102 candidates by claim type: Hussain U.S. 4,464,378 and WO 82/03768 for the nasal-naloxone method claims; WO 00/62757 for the device claims; Kerr 2009 / Barton 2005 / Wermeling 2013 for the 2 mg and Tmax claims; Djupesland WO 2012/156317 for the 8 mg and Tmax claims; Bahal U.S. 5,866,154 for the formulation/stability claims.
3. Caution: No reference I have identified anticipates the full combination recited in claim 1 — in particular the "pre-primed" single-dose device carrying ~2–12 mg (esp. ~4 mg) naloxone HCl in a ~100 µL aqueous BZK/EDTA formulation. The '253's validity turned on that combination, and the PTAB's institution decision and the district court's invalidity finding were overturned/contested precisely on the "motivation to combine"/teaching-away issues. Treat all § 102 labels above as candidate anticipations requiring a full element-by-element chart against the certified, corrected claim text.

Verification still required: (a) the '253's certified front-page "References Cited" list from USPTO PatentCenter (I could not retrieve it cleanly); (b) the substantive claim-by-claim result of the IPR2019-00685 Final Written Decision (2020-08-21); (c) the effect of the 2021 Certificate of Correction on the claim text used for any § 102/§ 103 chart.

I'll ground this obviousness analysis in the prior art actually discussed in the patent's specification, plus the real-world record (the IPR and the D.N.J./Fed. Cir. obviousness litigation) where search results can corroborate it.

Let me pin down the identity of the key prior-art references named in the record (Wyse, HPE, Djupesland) and the actual outcome of the '253's own IPR.

Obviousness Analysis — US 9,211,253 B2 under 35 U.S.C. § 103

Scope and caveat. This is a technical/analytical assessment, not a legal opinion. Obviousness is a legal conclusion; I apply the Graham/KSR framework to the record I could retrieve. Where I rely on the specification's own Background (which is a set of applicant admissions), I say so. Where a fact comes from litigation/IPR documents rather than the patent itself, I cite it.

Two corrections/refinements to the earlier-generated sections (flagged as required):

1. Claim 1's "stabilizing agent" amount is now resolved. The earlier summary flagged a conflict between the granted claim ("about 0.2 mg") and the published application ("about 0.01–0.05 mg"). The PTAB institution decision and the FWD both reproduce the granted claim 1 as reciting "about 0.2 mg of a stabilizing agent" (https://gaeflexstaging-dot-docketupdate.appspot.com/cases/PTAB/IPR2019-00685/Inter_Partes_Review_of_U.S._Pat._9211253/08-27-2019-Board/Institution_Decision-11-Institution_of_Inter_Partes_Review35_USC_sec_314a/; https://pharmaipcircle.blogspot.com/2020/08/naloxone-hydrochloride-narcan-usa.html). The "0.01–0.05 mg" language persists in a later family member, WO2016/007729 A1 (https://patents.google.com/patent/WO2016007729A1/en). So: granted claim 1 = 0.2 mg; the application/continuation-disclosure inconsistency is real but irrelevant to the granted claim.

2. The '253 patent's role in the D.N.J. litigation is now confirmed and differs from the earlier "unconfirmed" statement. A Nov. 13, 2019 letter filed in Adapt Pharma Operations Ltd. v. Teva, D.N.J. No. 2:16-cv-07721 (Doc. 283) states that the four patents-in-suit were the '747, '177, '965 and '838 patents, "plus three [IPR petitions] against no-longer-asserted U.S. Patent No. 9,211,253." So the '253 was asserted at some point and was later dropped; it was not among the patents adjudicated at the 2020 trial. Source: https://storage.courtlistener.com/recap/gov.uscourts.njd.[340302](/patent/340302)/gov.uscourts.njd.340302.283.0_1.pdf

1. The claim to be analyzed

Claim 1 (granted; reproduced by the PTAB as the sole independent claim among claims 1–29):

"1. A single-use, pre-primed device adapted for nasal delivery of a pharmaceutical composition to a patient by one actuation of said device into one nostril of said patient, 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 preservative; about 0.2 mg of a stabilizing agent; an amount of an acid sufficient to achieve a pH of 3.5–5.5."

Broken into limitations (this is the skeleton every ground must map to):

Claim 2 (per the earlier section) narrows to NaCl / benzalkonium chloride (BZK) / disodium edetate / HCl. Claims 4–29 add device, patient-state, dosing-regimen, PK, and stability limitations.

2. The prior art available as of the March 14, 2014 priority date

Because the specification's Background section is itself an admission of what was known (it describes the MAD Kit, the Aptar single-/bi-dose devices, Wermeling, Kerr, Loimer, Dowling, Barton, WO 82/03768 and U.S. 4,464,378), the § 103 analysis can treat much of it as admitted prior art.

Sources for the mapping: D.N.J. Doc. 283 (https://storage.courtlistener.com/recap/gov.uscourts.njd.340302/gov.uscourts.njd.340302.283.0_1.pdf); Fed. Cir. 20-2106 opinion (https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf); IPR2019-00685 institution decision (link above); combined hearing transcript (https://www.docketalarm.com/cases/PTAB/IPR2019-00688/Inter_Partes_Review_of_U.S._Pat._9468747/05-27-2020-Board/Hearing_Transcript-53-Hearing_Transcript/); Wermeling 2013 (https://www.docketalarm.com/cases/PTAB/IPR2019-00693/Inter_Partes_Review_of_U.S._Pat._9561177/docs/02-19-2019-Petitioner/Exhibit-1016-16-Nalox1016_Wermeling_2013.pdf).

3. Ground 1 — Wyse + HPE → claim 1 (and claims 2, 3, 16–24, 28, 29)

This was the ground actually instituted by the PTAB for the '253 (FWD ground table, https://www.ptablitigationblog.com/wp-content/uploads/2020/09/PTAB-IPR2019-00685-57.pdf).

Element mapping:

Motivation to combine (the KSR rationales):

1. The specification's own statement of the problem supplies the motivation. The Background recites that the MAD system "is not assembled and ready-to-use," that its "1 mL delivery volume per nostril is larger than that generally utilized for intranasal drug administration," and that "a nasal spray device that was pre-filled with a naloxone formulation" would be preferable. Wermeling independently states the identical improvement path ("a ready-to-use product specifically optimized, concentrated, and formulated for nasal delivery"). A POSA reading Wyse (which already teaches the exact Aptar UnitDose hardware and a 100 µL half-dose) is being handed both the problem and the solution.
2. Range overlap / In re Peterson presumption. The claimed 4 mg falls within Wyse's disclosed range; under the PTAB's institution analysis the burden shifts to the patentee to show teaching away, unexpected results, or secondary considerations (see Galderma v. Tolmar, 737 F.3d 731, 737–38).
3. Predictable solution set. Once the volume is fixed at ~100 µL/nostril (a number the art gave repeatedly: Wyse, Strang, Wermeling), the excipient selections reduce to a finite list already tabulated in Kulkarni/IIG — tonicity agent, preservative, chelator, acid. That is the KSR "finite number of identified, predictable solutions" fact pattern.
4. Same field of endeavor, interrelated teachings. All references are intranasal naloxone formulation/device art (Tyco Healthcare v. Ethicon, 774 F.3d 968, 978).

Why this ground is contested (and where it likely fails or is weakest). The '253's own FWD reports "No Challenged Claims Unpatentable." The linchpin reason is the teaching away finding that recurred across the NARCAN-family IPRs: Wyse "explicitly and unambiguously discourages the use of [BZK] in intranasal naloxone formulations" (IPR2019-00688, 2020 WL 4920198, at *8; discussed at https://fingfx.thomsonreuters.com/gfx/legaldocs/dwpkrgkajvm/narcan%20briefshort.pdf). Because HPE supplies BZK as the L5 preservative, the Wyse + HPE combination inherits the teaching-away problem for claim 1 even though claim 1 recites only "a preservative." That is a coherent explanation for why claim 1 — not just the BZK-reciting dependents — went down with the ground. I flag that I could not verify the FWD's internal reasoning on this point directly; the FWD text I retrieved is truncated.

4. Ground 2 — Wyse + Djupesland + HPE → claims 4–7, 10–15, 25–27

Instituted by the PTAB for the device-centric dependents (FWD ground table, link above).

• Added reference: Djupesland (nasal delivery device art).
• Motivation: Djupesland "specifically points towards the Aptar UnitDose device" (Fed. Cir. 20-2106 op. at 18, citing Trial Tr. 383:4–18). That is a direct, express pointer to the same device Wyse already discloses, which satisfies the KSR "explicit suggestion" variant with no need to invoke common sense. Device limitations such as single-use/pre-primed configuration, one-hand actuation, and emitted-dose reproducibility are inherent properties of the UnitDose/Aptar platform as described in the patent's own specification ("a pressure point mechanism incorporated in some devices secures reproducibility of the actuation force and emitted plume characteristics").

5. Ground 3 — Wyse + Djupesland + HPE + the '291 patent → claims 8, 9

Same as Ground 2 with one additional reference ("the '291 patent," per the FWD ground table) supplying the remaining limitations of claims 8–9. I could not retrieve which limitations the '291 patent was mapped to, so I will not guess its subject matter or full number — the identifier is reported literally as it appears in the record.

6. Ground 4 — the D.N.J. "Davies combination": Wyse + Davies + Kerr 2009 + Bahal

This is the alternative formulation-focused theory actually litigated (Fed. Cir. 20-2106 op. at 17–18).

• Disclosure: Davies (NaCl, BZK, pH 6.5, IN naloxone); Kerr 2009 (2 mg IN naloxone, NaCl, BZK in-range, HCl, effective reversal); Bahal (EDTA stabilizes naloxone, "preferred" concentration in-range); with Wyse as the closest prior art supplying the concentrated formulation and 100 µL UnitDose.
• Motivation: The Fed. Cir. majority found the references "clearly within a common field of endeavor" and that their "interrelated teachings" support combination — Kerr recognized "the benefits of intranasal naloxone," and Bahal taught that EDTA prevents naloxone degradation, so "a skilled artisan would have been motivated to combine each of the references … to arrive at an improved intranasal naloxone product." Davies/Kerr supply the very excipient triple the claims recite.

7. Ground 5 — the "Strang combination": Strang + Kulkarni + Djupesland (+ Kerr)

• Strang (WO 2012/156317) supplies 100 µL metered volumes, NaCl, pH <5.5, and evidence that 8–16 mg IN naloxone is well tolerated with Tmax ~20–23 min (bracketing and exceeding the claimed 4 mg and the claim-set's Tmax limitations).
• Kulkarni supplies the IIG-listed excipient ranges (BZK ≤0.119%, EDTA ≤0.5% w/w) — both encompassing the claimed 0.005–0.015% BZK and ~0.2% EDTA.
• Djupesland supplies the Aptar UnitDose device pointer.
• Motivation: Strang itself says "[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 p. 33 ll. 18–20, quoted at Fed. Cir. op. 18) — an express invitation to fill in the excipient details from standard references.

8. Cross-cutting motivations (applied to whichever combination is asserted)

These are the strongest, most thoroughly supported "why combine" rationales, and each maps to a recognized KSR category:

1. Design incentive / known problem in the art. The patent's own Background concedes the MAD-Kit drawbacks; Wermeling articulates the identical design goal; FDA's 2012 meeting "encourag[ed] the industry to develop an intranasal naloxone product" (Fed. Cir. op. 32). In the IPR hearing, Petitioner framed this as an KSR "finite number of identified solutions" argument ("FDA certainly provided a POSA with a finite number of identified solutions … your nasal spray should mimic the blood levels of the approved parenteral product").
2. Predictable, routine optimization of a formulation. Tonicity, pH and preservative selection are the ordinary knobs of nasal formulation work; the Fed. Cir. found "the pH … determined through routine optimization should be somewhere between 3.5 and 7" and that NaCl/BZK choices followed directly from the IIG and from Davies/Kerr.
3. Dose selection is a range optimization, not an invention. The FDA is recorded as having told Lightlake to consider a higher dose than 2 mg; Strang estimated 3–4 mg IN would be bioequivalent to 1 mg injectable; and a higher first dose would reduce re-dosing — the district court's express motivation findings on the 4 mg dose (Fed. Cir. op. 16–17).
4. "Obvious to try" with a reasonable expectation of success. Wermeling's predicted 2 mg Cmax/tmax plus WO 2012/156317's measured 8/16 mg data give a POSA linear-PK reasoning to scale up (see Petitioner's expert analysis at the PTAB petition excerpt: "reasonable expectation of observing linear pharmacokinetics … the intranasal exposure parameters disclosed in Wyse would remain dose proportional in dosage amounts up to at least 10 mg"). This is directly on point for the dependent PK claims (Tmax <30/<25/~20 min, occupancy thresholds, etc.).

9. The dependent claims

The § 103 case is strongest at the dependent level, because most dependents recite conventional formulation/device parameters or PK outcomes the art already measured:

Note the internal tension: a claim set that contains both "0.005–0.015 mg preservative" and "substantially free of antimicrobial preservatives" variants supports the position that these are alternative routine design choices, not a single inventive contribution.

10. The counter-case a patent owner would (and did) make

A complete § 103 analysis must weigh these, because they carried the day at the PTAB:

• Teaching away (the decisive issue). Wyse — the only reference in the record presenting naloxone-specific excipient stability data — reports BZK caused an additional degradant and was "not acceptable … due to increased observed degradation"; the PTAB found this "explicitly and unambiguously discourages" BZK and that a POSA "would have been dissuaded from doing so," especially with EDTA. Predicate: In re Gurley; DePuy Spine.
• The range is not a teaching of the species. Patent Owner argued Wyse's 5–50 mg/mL is a concentration range untethered to the 100 µL volume; the PTAB rejected this (the "half dose" passage ties it to 100 µL), but the argument survives as a factual dispute.
• Objective indicia. Adapt/Opiant asserted long-felt need (FDA's 2012 call to action), failure of others (Amphastar and AntiOp rejected by FDA; Mundipharma never filed), unexpected results (a claimed 56% bioavailability increase over the Wyse-based AntiOp formulation), industry skepticism about a >2 mg dose, copying (Mundipharma's and Teva's 4 mg reformulations), and commercial success. The Fed. Cir. majority discounted each (copying in the ANDA context is non-probative, Bayer v. Watson; commercial success attributed to non-claimed features and the Aptar device; "long-felt need" only ~3 years and not enough to overcome "the strong case of obviousness").
• Hindsight / motivation gap. Judge Newman's dissent (and Adapt's cert petition) emphasize that the district court and the majority identified the elements in separate references but never articulated why a POSA would select this particular combination out of millions of possibilities, and that the majority's reliance on "logic, judgment, and common sense" lacked the "rational underpinning" required by In re Van Os. This is the most serious doctrinal vulnerability of Grounds 4–5.

11. Bottom line

• On the record as it actually developed, the § 103 challenge to the '253 was brought as Wyse + HPE (plus Djupesland, plus the '291 patent for claims 8–9), with Wyse as the closest prior art. Institution was granted on 8/27/2019 with an express presumption of obviousness on the 4 mg dose; the FWD dated 8/21/2020 is reported as resulting in no challenged claims held unpatentable (pharmaipcircle table; https://pharmaipcircle.blogspot.com/2020/08/naloxone-hydrochloride-narcan-usa.html), i.e., the '253 survived — on reasoning driven by the teaching away from BZK/EDTA.
• In parallel, the same family was held obvious in district court on the Davies and Strang combinations (claims 7 and 9 of the '747 patent), affirmed 2/10/2022 in No. 20-2106 — but the '253 was not among the adjudicated patents (Nalox-1/D.N.J. Doc. 283). So the strongest empirical statement is: substantially identical subject matter was held obvious in one forum and not unpatentable in another, on the same primary reference, with the split turning on teaching-away and motivation-to-combine.
• My assessment of vulnerability: claim 1 is moderately to strongly vulnerable under Ground 1 if the fact-finder accepts that Wyse does not teach away (the Fed. Cir. majority's view, supported by the "high concentrations only" reading and the IIG/Kulkarni evidence that BZK is ubiquitous in nasal products). It is not vulnerable if the fact-finder credits the PTAB's teaching-away finding. The dependent claims reciting explicit PK/Tmax/drainage values are more vulnerable still, because those values are numerically disclosed in Wermeling 2013 and WO 2012/156317. Conversely, my analysis would be materially weakened if the Wyse reference "as a whole" contains further discouragement of BZK (or of a 4 mg single dose) beyond the passages I retrieved.

12. Residual uncertainties (explicit)

1. The disposition of IPR2019-00685. Secondary sources report a Final Written Decision of 8/21/2020 finding no challenged claims unpatentable, but one docket labels paper 57 in that proceeding a "Termination Decision Document" (https://ocr.docketalarm.com/search/?q=patent:(9211253)). A termination could reflect a settlement rather than a merits FWD. I could not retrieve the operative text, so I cannot state with certainty why the '253's claim 1 was not held unpatentable.
2. Citations for Wyse, HPE, Djupesland, Davies, Strang, Bahal, Kulkarni and the '291 patent. I have identified them by the short names used in the IPR and district court record (with exhibit numbers TX-0048/1007, TX-3007, TX-3109, TX-0029, TX-3009) but I do not have reliable full citations (patent numbers/publication data) for all of them and will not fabricate them.
3. The '291 patent's subject matter and its mapping to claims 8–9: unknown to me.
4. Complete independent-claim set of the '253 (see the earlier section): still unverified; the PTAB treated claim 1 as the independent claim.
5. Exact claim 2 text and the full dependent-claim listing: taken from the earlier-generated section, which itself flagged reliance on secondary sources.

Principal sources consulted: https://patents.google.com/patent/US9211253/en · https://gaeflexstaging-dot-docketupdate.appspot.com/cases/PTAB/IPR2019-00685/Inter_Partes_Review_of_U.S._Pat._9211253/08-27-2019-Board/Institution_Decision-11-Institution_of_Inter_Partes_Review35_USC_sec_314a/ · https://www.ptablitigationblog.com/wp-content/uploads/2020/09/PTAB-IPR2019-00685-57.pdf · https://storage.courtlistener.com/recap/gov.uscourts.njd.340302/gov.uscourts.njd.340302.283.0_1.pdf · https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf · https://fingfx.thomsonreuters.com/gfx/legaldocs/dwpkrgkajvm/narcan%20briefshort.pdf · https://pharmaipcircle.blogspot.com/2020/08/naloxone-hydrochloride-narcan-usa.html · https://patents.google.com/patent/WO2012156317A2/en · https://www.docketalarm.com/cases/PTAB/IPR2019-00693/Inter_Partes_Review_of_U.S._Pat._9561177/docs/02-19-2019-Petitioner/Exhibit-1016-16-Nalox1016_Wermeling_2013.pdf · https://patents.google.com/patent/WO2016007729A1/en