US 10085937

I'll search for litigation and docket information to supplement the authoritative patent text provided.

US 10,085,937 — Bibliographic Summary

All identifiers below are reported literally as they appear in the sources; I have not normalized or corrected anything.

Sources: https://patents.google.com/patent/US10085937/en ; https://www.docketalarm.com/patentapps/US/15-268,066/ ; https://www.docketalarm.com/FDA/Orange_Book/[208411](/patent/208411)/NARCAN/

Abstract (verbatim)

"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."

Independent Claim — Plain-Language Overview

⚠️ Important caveat: the authoritative full text you supplied was truncated in the "Definitions" section and does not include the claims. I could not retrieve the official claim set from an authoritative source in this session. The following is drawn from a third-party patent database (DrugPatentWatch) and should be treated as unverified against the USPTO face of the patent.

Claim 1 (the only claim the sources indicate is independent; claims 2–18 appear dependent on it):
A method of treating opioid overdose in a patient whose bloodstream contains an opioid of Formula (I) — the formula class that, in this patent's specification and Table A, corresponds to fentanyl and fentanyl derivatives — by:

1. delivering a spray from a pre-primed device into a nostril of the patient (the device being adapted for nasal delivery);
2. the spray delivering a 25–200 µL volume of a pharmaceutical solution containing:
   • between about 4 mg and about 10 mg naloxone hydrochloride (or a hydrate);
   • an isotonicity agent; and
   • between about 0.005% and about 0.015% (w/v) benzalkonium chloride.

Plain-language gist: "Give a single, already-primed nasal spray of a concentrated naloxone solution — 4–10 mg in one 25–200 µL shot, with a small amount of benzalkonium chloride and a salt — to someone overdosing specifically on fentanyl-type opioids."

Dependent claims add limitations such as: specific fentanyl derivatives (a long list incl. fentanyl, carfentanyl, sufentanyl, furanylfentanyl, etc.); a round plume with ovality ratio < ~1.5 at 3 cm; NaCl / disodium edetate / HCl as the isotonicity agent, stabilizer, and acid; pH 3.5–5.5; a geometric mean naloxone Cmax ≥ ~3 ng/mL after a single spray; < ~10% nasal drainage; and transdermal fentanyl exposure ("touching the fentanyl with an unprotected area of the patient's skin"). Again — dependent-claim detail is from a secondary source.

Source (secondary/unverified): https://www.drugpatentwatch.com/p/patent-claims/[10085937](/patent/10085937)

Docket / Litigation Search Results (USPTO & CAFC)

District court (D.N.J., patent infringement under 15:1126):

• Adapt Pharma Operations Limited v. Perrigo UK Finco Limited Partnership, Docket 2:18-cv-16987 (D.N.J.), filed 2018-12-07, terminated 2019-05-03, assigned to Judge Jose L. Linares. Patents listed in that case: 10,085,937; 9,211,253; 9,468,747; 9,480,644; 9,561,177. The complaint sought relief until "expiration of the '937 patent" (CourtListener, Docket No. 1).
• A related docket, 2:18-cv-15287 (D.N.J.), filed 2018-10-25, terminated 2020-03.
• Google Patents flags "Family has litigation" for this patent and links a New Jersey case (2:18-cv-16987).

CAFC:

• I found no 2026 Federal Circuit docket activity for patent 10,085,937 specifically. The well-known CAFC naloxone decision — Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., No. 20-2106 (Fed. Cir. Feb. 10, 2022) — involved patents 9,468,747; 9,561,177; 9,629,965; and 9,775,838, i.e., not the '937 patent. I want to be explicit on this: the widely reported affirmance of invalidity-for-obviousness in that appeal does not by its terms cover US 10,085,937.
• Likewise, the 2019 Nalox-1 Pharmaceuticals IPRs (IPR2019-00685, -00688, -00694) concerned the '253, '747, '177, '965, and '838 patents, not the '937 patent.
• A general naloxone-hydrochloride litigation listing does show 10,085,937 in the Perrigo/Adapt D.N.J. cases only, with no CAFC appeal entry tied to that patent number.

Sources: https://www.drugpatentwatch.com/p/alphasignals/litigation/casename/index.php?query=ADAPT+PHARMA+OPERATIONS+LIMITED+v.+PERRIGO+UK+FINCO+LIMITED+PARTNERSHIP%7C2%3A18-cv-16987 ; https://www.courtlistener.com/docket/[8436177](/patent/8436177)/1/adapt-pharma-operations-limited-v-perrigo-uk-finco-limited-partnership/ ; https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf

Orange Book / Product Link

The '937 patent is listed in the Orange Book for NARCAN (NDA 208411), naloxone hydrochloride, "SPRAY, METERED, NASAL," first approved 11/18/2015 (4 mg/spray), with a 2 mg/spray approval 1/24/2017. Orange Book-tracked expiration for 10,085,937: 3/16/2035.

Explicit Uncertainty Flags

1. Claims not in the authoritative text. The supplied full text stops mid-specification; I could not verify the exact number, wording, or independence/dependency structure of the claims from an authoritative source. Claim 1's text above is from a secondary database — verify against USPTO PatentCenter / the printed patent before relying on it.
2. Priority date discrepancy. Google Patents lists a priority/prior-art date of 2014-03-14, while the earliest external priority document it lists is US 14/659,472 filed 2015-03-16, and the Fed. Cir. opinion in the related appeal states Adapt filed 14/659,472 on March 16, 2015. A 2014-03-14 provisional may be the explanation, but I did not confirm that.
3. Assignee chain. Google Patents' "current assignee" listing (Indivior UK Ltd / Emergent Biosolutions Ireland Ltd) reflects recorded assignments (Opiant → Indivior in 2023; Adapt → Emergent legacies) but Google itself disclaims accuracy of assignee lists.
4. No 2026 CAFC activity located for this patent number; absence of results in my searches is not proof that none exists.

I'll search for litigation involving US patent 10085937. Let me run several targeted searches.

Let me dig deeper into the specific cases and check for any others.

Litigation Involving U.S. Patent No. 10,085,937 ("the '937 patent")

Important caveats up front. The findings below are drawn from public patent-litigation databases (Docket Navigator/DrugPatentWatch, CourtListener/RECAP, Unified Patents, Stanford NPE database) and from SEC filings by Opiant Pharmaceuticals and Emergent BioSolutions, as surfaced by search on 2026‑04‑26. Docket data in these aggregators is not authoritative; PACER and the court's own docket control. I also note that I was cut off before exhausting all searches, so I cannot rule out additional cases (particularly any post‑2020 Hatch‑Waxman or post-approval suits I did not surface). Where a fact is uncertain I say so explicitly. All patent numbers are reproduced literally as found.

Identifier hygiene note (per your instruction): One search returned Unified Patents record US‑20020193102‑A1 ("Electronic Transactions," Nokia), which carries application number 10085937. That is not U.S. Patent No. 10,085,937 and is excluded as a false positive. Similarly, results for the NuVasive/Alphatec dispute and various Texas docket excerpts are unrelated and excluded.

Case 1 — Adapt Pharma Operations Ltd. et al. v. Perrigo UK Finco Limited Partnership (lead consolidated case)

Case 2 — Adapt Pharma Operations Ltd. et al. v. Perrigo UK Finco Limited Partnership (companion case; the one expressly asserting the '937 patent)

Cross-references: Google Patents' litigation field for US10085937 links to the New Jersey case 2:18‑cv‑16987, consistent with Case 2 above. The PTAB termination decision in IPR2019‑00688 (regarding U.S. 9,468,747) independently recounts that Plaintiffs asserted the five Orange‑Book‑listed patents in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., No. 2:16‑cv‑07721 (D.N.J.), and in Adapt Pharma Operations Ltd. v. Perrigo UK FINCO Limited Partnership, No. 2:18‑cv‑15287 (D.N.J.), and that the Perrigo case was dismissed with prejudice by consent judgment on March 2, 2020.

Matters where the '937 patent was raised in notices but NOT asserted

• Adapt Pharma Operations Ltd. et al. v. Teva Pharmaceuticals USA, Inc., No. 2:16‑cv‑07721 (D.N.J.) (consolidated). Per SEC filings by Emergent BioSolutions and Opiant, Teva's 2016 ANDA notice letters (received on or about September 13, 2016, with additional notices) asserted non‑infringement/invalidity as to the '253, '747, '177, '965, '838 and '937 patents — but Plaintiffs filed suit only on the '253, '747, '177, '965 and '838 patents. The same filings state expressly: "As of the date of this filing, Adapt Pharma Inc., Adapt Pharma Operations Limited, and Opiant have not filed a complaint related to the '937 Patent." The consolidated Teva case went to judgment in favor of Teva on June 5, 2020, and the Federal Circuit affirmed obviousness in Adapt Pharma Operations v. Teva Pharmaceuticals USA, Inc., No. 20‑2106 (Fed. Cir. Feb. 10, 2022). The '937 patent was not among the patents adjudicated there.
• PTAB / inter partes review: Nalox‑1 Pharmaceuticals LLC filed fifteen IPR petitions (notices received on or about February 19, 2019) against the '253, '747, '177, '965 and '838 patents. Per the same SEC filing, "Nalox‑1 did not request review of the '937 Patent." I found no IPR, PGR, or other PTAB proceeding directed to the '937 patent in these sources.

Bottom line

1. The only litigation I could identify that actually asserted U.S. 10,085,937 is the Perrigo action in the District of New Jersey — Adapt Pharma Operations Ltd., Adapt Pharma Inc., Adapt Pharma Ltd. and Opiant Pharmaceuticals, Inc. v. Perrigo UK Finco Limited Partnership, 2:18‑cv‑16987 (filed Dec. 7, 2018), consolidated into 2:18‑cv‑15287 (filed Oct. 25, 2018). It ended in a consent judgment entered March 2, 2020, dismissing all claims with prejudice and enjoining Perrigo as to the Perrigo Product (ANDA No. 211951) under the Licensed Patents, which included the '937 patent.
2. No other U.S. litigation asserting the '937 patent was found in the sources searched, and no PTAB challenge to the '937 patent was found. The '937 patent appeared in Teva's Paragraph IV notice letters but was never asserted against Teva.
3. No Federal Circuit appeal specific to the '937 patent was located; the relevant CAFC decision (20‑2106) concerns the asserted '747/'253-family claims, not the '937 patent.
4. Status of the patent itself: per Google Patents, US10085937B2 is Active, with an adjusted expiration of 2035‑11‑18, current assignees listed as Indivior UK Ltd and Emergent Biosolutions Ireland Ltd (originally Adapt Pharma Ltd / Opiant Pharmaceuticals Inc.), following a 2023 assignment from Opiant to Indivior UK Limited.

Recommended verification: Pull the PACER dockets for 2:18‑cv‑15287 and 2:18‑cv‑16987 (D.N.J.) and run a fresh Docket Navigator / Unified Patents / CourtListener search for "10,085,937" to confirm no suits have been filed since 2020 and to capture any counterclaim or appeal-level activity I was unable to reach.

I'll verify the structured block against live sources before drafting.

The critical corroboration appeared: Emergent's 10-K says "Nalox-1 did not request review of the '937 Patent." Let me stress-test that against later filings before concluding.

Corroborated on three independent fronts. Two more checks: later-filed IPRs (2020–2026) and any PGR/CBM.

PTAB / AIA Trial Proceedings — US 10,085,937

Proceedings overview

There are zero AIA trial proceedings on file against US 10,085,937 — no IPR, no PGR, no CBM. This is the structured USPTO ODP answer in the prompt block, and I independently corroborated it on three fronts rather than accepting it on faith. The bottom-line defensive posture for a defendant is unusual and worth understanding precisely: the patent is not "hardened by surviving IPRs," and it is not "weakened by canceled claims." It is an untested patent sitting inside a heavily-litigated family — its five closest siblings (the '253, '747, '177, '965, and '838 patents) absorbed a fifteen-petition IPR barrage from Nalox‑1 Pharmaceuticals, LLC, while the '937 was expressly left alone. Emergent BioSolutions represented to the SEC: "Nalox-1 did not request review of the '937 Patent." That means claims 1–18 of the '937 have never been construed by the Board, never been the subject of an institution decision, and carry no § 315(e) estoppel against anyone. Every prior-art ground a new petitioner can find is presumptively still on the table.

No proceedings exist — so here is the near-miss docket instead

Because there is nothing to chart proceeding-by-proceeding, the substantively useful artifact is the campaign that skipped this patent. The following IPR numbers are real and are quoted from the patent owner's own SEC disclosures; none of them is a proceeding against the '937 patent, and I want that stated flatly so the table is not misread.

Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Ltd / Opiant Pharmaceuticals, Inc. — fifteen petitions, 2019-02-19

The three instituted trials were heard at oral argument on 2020-05-19, and on 2020-08-21 the Board issued final written decisions holding the challenged claims not unpatentable as obvious — i.e., the patent owner prevailed. Petitions in that campaign also attacked the family's priority to provisional 61/953,379 (the '838 and '177 petitions each carried a section titled "The '___ Patent Lacks Priority to the Filing Date of the '379 Provisional"). That priority attack was a known theme in this family; it was simply never aimed at the '937.

Disposition: no settlement-driven terminations, no claims canceled, no claims sustained as to this patent — because no trial was ever instituted against it.

Federal Circuit appeal: none exists for the '937. The Nalox‑1 decisions were not appealed by Nalox‑1 to the extent I can locate. The prominent CAFC naloxone decision — Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., No. 20-2106 (Fed. Cir. 2022-02-10) — arose from the district court bench trial, not from any PTAB trial, and covered the '747, '177, '965, and '838 patents. It says nothing about the '937.

Sources: Emergent BioSolutions 10-K disclosure · Emergent BioSolutions 10-K (IPR narrative) · Opiant Form 10-K (IPR numbers enumerated) · IPR2019-00698 petition, '838 patent

Strategic summary

Claim status: all of claims 1–18 are UNTESTED. Nothing is canceled, nothing is confirmed by the Board. Claim 1 (as retrieved from the secondary database and set out in the earlier section) is a fentanyl-specific method claim — a pre-primed nasal spray delivering 25–200 µL containing about 4–10 mg naloxone hydrochloride, an isotonicity agent, and 0.005–0.015% (w/v) benzalkonium chloride, into a patient whose bloodstream contains an opioid of Formula (I), the formula class mapping to fentanyl and its analogs. Claim 2 recites a 31-member fentanyl analog list. This is a narrow, but currently very commercially relevant, claim — and because no tribunal has ever construed "Formula (I)," "pre-primed," or the 4–10 mg range as applied to this claim set, its scope in litigation is genuinely open rather than foreclosed. Compare this to the sibling patents: the '747, '177, '965, and '838 were held invalid for obviousness by D.N.J. on 2020-06-05, and that judgment was affirmed on 2022-02-10. The '937 was deliberately excluded from that fight. A defendant today faces the least-tested patent in the NARCAN® portfolio, which cuts both ways: its validity is unproven and its claim boundaries are unlitigated.

Estoppel landscape: nothing is blocked. Because the '937 was never the subject of an instituted trial, no § 315(e)(2) estoppel attaches to any ground — not against Nalox‑1, not against Teva, not against Perrigo, not against anyone. A new petitioner can run any § 102 or § 103 combination it can support, including art that was (or could have been) used against the sibling patents. Two procedural traps nonetheless deserve immediate attention: (1) § 315(b) — the one-year bar. Adapt/Opiant asserted the '937 against Perrigo in D.N.J. actions 2:18-cv-15287 (filed 2018-10-25) and 2:18-cv-16987 (filed 2018-12-07, terminated 2019-05-03). Any party previously served with a complaint alleging infringement of the '937 and its privies is now time-barred from filing an IPR, so a client in that position cannot be told an IPR is available. (2) § 315(a)(1) bars an IPR by anyone who first filed a civil action challenging validity. Also expect the Board to weigh § 325(d) and the General Plastic factors, given the fifteen-petition history on the siblings — a new petition should be drafted to distinguish itself from that prior campaign rather than resemble it. Sibling-patent estoppel does not travel: Nalox‑1's participation in the '253/'747/'965 trials does not estop it, or anyone else, as to the '937, since estoppel is patent-specific.

Pattern signals. The same petitioner (Nalox‑1, a non-practicing entity) filed fifteen petitions at once — a coordinated validity attack, not a one-off — and pointedly omitted the '937, the only Orange Book patent in the portfolio with a fentanyl-specific claim. The patent owner (via Emergent/Adapt/Opiant, now Indivior UK Limited per the 2023 recorded assignment) litigated hard in district court and appealed the adverse obviousness judgment to the Federal Circuit, but has had no PTAB appeal practice on this family, because it never lost a PTAB trial on these patents. I found no defensive aggregator such as Unified Patents in the chain — the only petitioner of record in this family is Nalox‑1. Note also that the '937 front page carries "This patent is subject to a terminal disclaimer" and a 247-day PTA; the terminal disclaimer is a useful lever for obviousness-type double patenting arguments against the claim set, and it is a ground Nalox‑1 never had to test.

Contradiction to flag against the earlier section. The earlier section listed a current-assignee chain and an unresolved priority-date discrepancy. The priority discrepancy is now resolved: the '937 is a continuation-in-part whose benefit chain runs to provisional 61/953,379, filed 2014-03-14 — which is exactly why Google Patents reports a 2014-03-14 priority date while the earliest non-provisional in the chain (14/659,472) was filed 2015-03-16. Separately, the earlier section quoted Emergent's statement that Adapt/Opiant "have not filed a complaint related to the '937 Patent," while DrugPatentWatch lists the '937 in the Perrigo D.N.J. cases. These are reconcilable — the 10-K language appears directed at the Teva complaints — but a practitioner should not rely on the SEC language to conclude the '937 has never been asserted. The CourtListener copy of the 2:18-cv-16987 complaint does plead the '937 and Perrigo's Paragraph IV certification against it. Treat the '937 as asserted, at least historically, against Perrigo.

Recommended next steps

1. State the negative plainly to the client: no IPR, PGR, or CBM has ever been filed against US 10,085,937. Do not let anyone prepare an IPR defense narrative around an FWD that does not exist. There is no Board disposition to quote because there is no Board disposition.
2. Screen § 315(b) before anything else. If your client (or a privy) was served with a complaint pleading the '937 — the Perrigo D.N.J. actions are the candidates — an IPR is likely foreclosed. Ex parte reexamination and district-court invalidity defenses remain available, and neither is barred by § 315(b).
3. Mine the Nalox‑1 record as a free work product. The '838 petition's priority challenge to provisional 61/953,379 and its prior-art framing (Wang, Davies, HPE, Djupesland, the 2012 FDA materials, the Zomig Review) are public and map onto the same specification lineage. The '937 shares that specification and that provisional. IPR2019-00698 petition is the most directly reusable starting point, but note that its contents are prior art the Board has already seen and rejected in a sibling context — § 325(d) discretion is a real risk, so any new petition should lead with art Nalox‑1 never used.
4. Attack the '937's own claim 1 specifically, where no one has. The Formula (I) limitation, the fentanyl-in-the-bloodstream limitation, and the 4–10 mg / 0.005–0.015% BAK range have never been construed. The written-description question of whether the 2014-03-14 provisional (61/953,379) supports a fentanyl-specific method claim is an unexplored § 112/priority line with no adverse Board precedent attached to it.
5. Verify the claim set against the face of the patent before relying on it. The authoritative full text supplied for this analysis is truncated mid-"Definitions" and does not contain the claims. Claim 1's wording above is from a secondary database. Pull the issued patent and file history from USPTO PatentCenter and confirm claim numbering, dependency, and the exact preambles before drafting anything dispositive.
6. Watch the live district-court layer, not the PTAB layer. The active risk on this family is currently in D.N.J. — including a complaint directed at the NARCAN® Nasal Spray 2 mg product referencing the '226 and '644 patents (CourtListener). Check USPTO PTAB E2E and CourtListener periodically; given the '937's fentanyl claim scope and 2035 expiry, a first-ever IPR against it would not be surprising.

Confidence note: I am highly confident in the absence of PTAB proceedings — it is confirmed by the structured USPTO ODP data in the prompt and independently by patent-owner SEC filings. I could not, however, retrieve a raw PTAB E2E search result page in this session, and absence of results is never absolute proof. Everything I have not personally verified (judge panels, institution reasoning for the sibling IPRs beyond institution dates, and the claim text) is flagged as such above, and no proceeding number has been inferred or invented.

I'll research the assignment record for this patent, starting with targeted searches of the USPTO assignment data and the corporate history of the named entities.

Good — I now have the patent face data and corporate history. Let me dig for the actual assignment records and reel/frame data.

Assignment Reconstruction — US 10,085,937 B2

"Nasal drug products and methods of their use" · App. 15/268,066 · Assignee of record on the face: Adapt Pharma Limited + Opiant Pharmaceuticals

⚠️ Data-limitation banner (read before the timeline)

I was unable to open USPTO Assignment Center / assignment.uspto.gov in this session — those portals are query-driven (POST/search-form) and my available tooling could not submit a patent-number query. I therefore have no reel/frame numbers and no correspondent-of-record names for any link in this chain, and I will not invent them.

What I do have, and what grounds every statement below:

Every reel/frame slot below is marked [NOT RETRIEVED]. Treat this document as a named-entity chain reconstruction, not a record-level one. Re-run the search at https://assignmentcenter.uspto.gov/ and https://assignment.uspto.gov/patent/index.html using Patent No. 10085937 or Application No. 15/268,066 to fill them.

Inventors

Four inventors are named on the face (App. 15/268,066, filed 2016-09-16). Their residences and — decisively — which co-assignee each assigned to on 2016-11-09 split them into two clean groups:

Pattern assessment — the "inventor exodus" tell is ABSENT. The conventional fire-sale precursor (all inventors gone within 12 months of filing, leaving only a monetization shell) does not appear:

• The two Opiant-side inventors signed their confirmatory assignments to their own employer, not to a third party.
• Crystal stayed at Opiant from filing (2016) through the Indivior merger (2023-03) — roughly 6.5 years of continued employment at the co-owner, and he is quoted in the acquirer's press materials as Opiant's CEO.
• Keegan and Bell are the Adapt-side inventive contribution; Adapt continued to hold NDA 208411 and commercialize the covered product.

The two-inventors-per-co-owner split is best read as a co-development / license architecture (Opiant/Lightlake contributing the nasal naloxone formulation IP, largely NIDA-funded; Adapt contributing the device, NDA, and commercialization), with each co-owner taking home its own employees' rights. That shape — not an inventor walk-out — is what the assignment record shows.

Original assignee

Named on the issued patent (73): ADAPT PHARMA LIMITED, Dublin (IE); OPIANT PHARMACEUTICALS, Santa Monica, CA (US) — co-owned from issuance. Applicants (71) are identical. The patent is also subject to a terminal disclaimer (PTA credited 247 days; Google lists adjusted expiration 2035-11-18 while the Orange Book reflects 3/16/2035 — the terminal disclaimer ties expiry to the '253 family).

Adapt Pharma Limited (Dublin, Ireland)

• Line of business: Specialty pharma focused solely on opioid overdose; holder through subsidiary Adapt Pharma Operations Limited of NDA 208411 for NARCAN® (naloxone HCl) Nasal Spray, 4 mg/spray (FDA approval 2015-11-18) and 2 mg/spray.
• Product embodying the claims: YES — it shipped one. NARCAN Nasal Spray is the first FDA-approved needle-free naloxone nasal spray. The D.N.J. opinion (Doc. 344) describes the covered product as ~4.4 mg naloxone HCl dihydrate, 0.005–0.015 mg benzalkonium chloride, 0.1–0.5 mg disodium edetate, 0.2–1.2 mg NaCl, acid to pH 3.5–5.5, in ~100 µL delivered by the Aptar UnitDose device. Note this corroborates the DrugPatentWatch claim-1 formulation parameters in the earlier section (4–10 mg naloxone HCl; 0.005–0.015% w/v BKC) — those secondary-source numbers are at least internally consistent with the commercial product.
• Status: acquired, entity retained. Emergent BioSolutions agreed 2018-08-28 and closed the acquisition in October 2018 for $635M upfront + up to $100M sales milestones (up to $735M total). Per the IPR mandatory notices, Adapt Pharma Operations Limited is a wholly owned subsidiary of Adapt Pharma Limited, which is a wholly owned subsidiary of Emergent Acquisition Limited → Emergent International Inc. → Emergent BioSolutions Inc. (NYSE: EBS, publicly held).
• Critical structural point: this was a share purchase, not an asset purchase — which is why no adapter→Emergent patent assignment appears in the Google Patents legal events. The Irish entities survived inside Emergent and were renamed (Adapt Pharma Inc. → Emergent Devices Inc.; Adapt Pharma Operations Limited → Emergent Operations Ireland Limited). Google's "current assignee: Emergent Biosolutions Ireland Ltd" likely reflects this family, but I could not verify a recorded change-of-name for Adapt Pharma Limited. [UNVERIFIED]

Opiant Pharmaceuticals, Inc. (Santa Monica, CA)

• Line of business: Clinical-stage specialty pharma for addiction/overdose; formerly Lightlake Therapeutics (renamed 2016-01-28); publicly held on Nasdaq (OPNT). Received royalties from Emergent on NARCAN sales and developed OPNT003 (intranasal nalmefene, later approved as OPVEE).
• Product embodying the claims: not directly — Opiant was the IP/royalty side of NARCAN and did not itself commercialize a naloxone nasal spray. Its own commercial product (OPVEE, nalmefene) is a different molecule.
• Status: acquired (merged out of existence). Indivior PLC agreed 2022-11-13 and completed the acquisition 2023-03-02 for ~$145M upfront ($20.00/share) plus up to $8.00/share in CVRs. Opiant's stock ceased trading on Nasdaq.

Neither original assignee is a shell, a licensing-only LLC, or an aggregator. Both had (or were acquired by parents with) real products, real regulatory filings, and real employees.

Assignment timeline

Chronological, per the Google Patents legal events in the authoritative text. Reel/frame and correspondent fields were not retrievable in this session — marked explicitly.

2015-03-16 / 2015-11-16 / 2016-06-15 — Family-only events, not assignments. Priority claims to US 14/659,472, US 14/942,344, US 15/183,441 respectively. Included only because they explain the "priority date" discrepancy flagged in the earlier section: the earliest external priority document is 14/659,472 (filed 2015-03-16, per the Fed. Cir. opinion in the related appeal), while Google lists a 2014-03-14 priority/prior-art date, consistent with an earlier provisional not separately surfaced here.

• [NOT RETRIEVED / likely no recorded assignment — these are sibling filings by the same two co-applicants]

2016-11-09 / recorded 2016-11-09 — Reel [NOT RETRIEVED] / Frame [NOT RETRIEVED]

• Conveyance: Assignment (confirmatory inventor→employer; conveyance type not retrievable)
• Assignor: BRENNER WEISS, MICHAEL; CRYSTAL, Roger (appears literally in the Google Patents event as "assignors")
• Assignee: Opiant Pharmaceuticals (recorded as "Opiant Pharmaceuticals")
• Correspondent: [NOT RETRIEVED]
• Context: Original-hire / confirmatory assignment vesting each inventor's rights in his own employer — not an acquisition, fire-sale, or reorg.

2016-11-09 / recorded 2016-11-09 — Reel [NOT RETRIEVED] / Frame [NOT RETRIEVED]

• Conveyance: Assignment (confirmatory inventor→employer)
• Assignor: BELL, ROBERT GERARD; KEEGAN, FINTAN
• Assignee: Adapt Pharma Limited
• Correspondent: [NOT RETRIEVED]
• Context: Same date, mirror-image confirmatory assignment to the other co-owner — establishes the co-ownership on the face of the patent. Consistent with two separate law firms/in-house channels filing the same day; I cannot confirm whether the same correspondent handled both, which is the field that would matter here.

Both 2016-11-09 events pre-date issuance (2018-10-02) by ~23 months. They are application-stage, not post-issuance, transfers.

2018-09-14 — Priority claimed to US 16/131,641 (published as US 2019/0015323 A1). Not an assignment — a continuation/divisional filed while Adapt+Opiant still co-owned. Signals the portfolio was still being actively prosecuted by the co-owners.

2018-10-02 — Patent granted. No assignment recorded on the grant date.
2018-10 — Emergent BioSolutions closes the Adapt Pharma share acquisition. No patent assignment recorded (share purchase; entities survived). [This absence is itself the finding — see structural note above.]

2019-10-08 / 2020-05-07 / 2021-11-17 — Priority claims to US 16/595,631, US 16/868,816, US 17/528,877 (published as US 2020/0030229 A1, US 2021/0093557 A1, US 2022/0071896 A1). Not assignments — further continuations filed under the same co-ownership.

2023-06-14 / recorded 2023-06-14 — Reel [NOT RETRIEVED] / Frame [NOT RETRIEVED]

• Conveyance: Assignment
• Assignor: OPIANT PHARMACEUTICALS, INC.
• Assignee: INDIVIOR UK LIMITED
• Correspondent: [NOT RETRIEVED]
• Context: Merger-cleanup transfer. Executed ~3.5 months after the Indivior/Opiant merger closed (2023-03-02) — the standard post-closing recordation of target IP into the acquirer's designated holding subsidiary. Not a fire-sale; a solvent, publicly announced $145M cash acquisition.

Records that do NOT exist (and why that matters)

• No Adapt Pharma → Emergent assignment. Correct and expected for a stock acquisition. Do not read this as an unrecorded gap.
• No Emerald/aggregator transfer, no security interest, no license, no release, no correction appears anywhere in the Google Patents legal-event list for this patent.
• No bankruptcy sale. Nothing in the chain (Adapt Pharma Limited, Opiant, Emergent, Indivior) went through Chapter 7/11 in connection with this patent on the record reviewed.

Timeline diagram

timeline
    title Ownership of US 10085937
    2014 : Priority date listed by Google Patents
    2015 : Earliest external priority filing
    2016 : App 15268066 filed Sep 16
         : Inventor assignments recorded Nov 9
    2018 : Patent issued Oct 2
         : Emergent acquires Adapt Pharma
         : Perrigo suits filed in D N J
    2023 : Indivior completes Opiant merger Mar 2
         : Assignment to Indivior UK Ltd recorded Jun 14

(Note: the 2018 "Adapt Pharma to Emergent" arrow is shown for corporate-reality completeness; it is not a recorded patent assignment, because the acquisition was a share purchase.)

NPE / troll-pattern signals

Verdict

Operating-company assertion

Basis: Both co-owners named on the face of US 10,085,937 — Adapt Pharma Limited (Dublin, IE) and Opiant Pharmaceuticals (Santa Monica, CA) — are/were operating pharmaceutical companies, not monetization vehicles. Adapt, through subsidiary Adapt Pharma Operations Limited, held NDA 208411 and commercialized NARCAN® Nasal Spray, the product the D.N.J. court found embodies the asserted claims; Opiant was a Nasdaq-listed drug developer that received NARCAN royalties. They sued as co-plaintiffs in their own names against ANDA filers Teva (2:16-cv-07721) and Perrigo (2:18-cv-15287 / 2:18-cv-16987) — a textbook brand-vs-generic posture.

The chain of title is short, benign, and fully explicable: two same-day confirmatory inventor→employer assignments on 2016-11-09 establishing co-ownership, an unrecorded-but-correct share purchase of Adapt by Emergent (Oct 2018), and one merger-cleanup assignment of Opiant's interest to Indivior UK Limited recorded 2023-06-14 — 3.5 months after the publicly announced, all-cash Indivior/Opiant merger closed (2023-03-02). Zero of the eight NPE indicators is present; signals 3 (correspondent recurrence) and the address dimension of signal 1 are unassessable because Assignment Center was not reachable in this session, but nothing in the retrievable record suggests a shell-entity or asserter pattern.

Contradictions and gaps to flag against the earlier sections

1. ⚠️ Direct contradiction on '937 assertion status. Emergent BioSolutions' SEC filing language states: "As of the date of this filing, Adapt Pharma Inc., Adapt Pharma Operations Limited, and Opiant, have not filed a complaint related to the '937 Patent." DrugPatentWatch nonetheless lists 10,085,937 in both Perrigo D.N.J. dockets (2:18-cv-15287 and 2:18-cv-16987), and the earlier generated section lists '937 as a patent-in-suit in 2:18-cv-16987. Meanwhile the consolidated Teva case conspicuously did not include '937. Unresolved — likely explanation is that '937 was added by later amendment or listed in the Orange Book paragraph-IV notice rather than a filed count, but I could not confirm. Do not treat '937 as adjudicated: it was not among the patents invalidated in the D.N.J. opinion, nor among those affirmed in Adapt Pharma v. Teva, No. 20-2106 (Fed. Cir. Feb. 10, 2022).
2. Claim set. The earlier section flagged that claims were unavailable and reproduced claim 1 from DrugPatentWatch (fentanyl-method, 4–10 mg naloxone HCl, 0.005–0.015% w/v BKC). Newly confirmed from the printed front page: 34 claims and a terminal disclaimer. The DrugPatentWatch BKC range now has independent corroboration from the D.N.J. formulation findings. Still not verified against USPTO PatentCenter.
3. Assignee identity for the Adapt leg. Google's "Emergent Biosolutions Ireland Ltd" is Google's own inference (Google explicitly disclaims assignee accuracy). The IPR mandatory notices instead identify the Adapt-side operating entities as Emergent Devices Inc. (ex-Adapt Pharma Inc.) and Emergent Operations Ireland Limited (ex-Adapt Pharma Operations Limited). Which entity actually holds legal title to the '937 is [UNVERIFIED] without the Assignment Center record.
4. Priority date. Still unexplained by any document I retrieved — 2014-03-14 (Google) vs. 2015-03-16 (earliest external priority, US 14/659,472). A 2014 provisional remains the likely but unconfirmed explanation.

Verify at: https://assignmentcenter.uspto.gov/ · https://assignment.uspto.gov/patent/index.html — search Patent 10085937 or Application 15/268,066. Priority fields to capture on the re-run: reel/frame for all three 2016-11-09 / 2023-06-14 events, and the corresponding correspondent of record for each (the signal-3 field).

I'll research the prior-art citations for US 10,085,937. Let me start with several targeted searches.

Let me pull the actual "References Cited" sections from authoritative/primary listings for this exact patent number.

Prior-Art Analysis — US 10,085,937 B2 ("Nasal drug products and methods of their use")

Analyst note on method and a hard limitation, stated up front: I searched for the citation block on the face of US 10,085,937 specifically (Google Patents front page, Justia, PTAB/PTACTS, and the D.N.J. litigation reproductions). I was not able to retrieve a complete, authoritative "References Cited" (U.S. Patent Documents / Foreign Patent Documents) box for US 10,085,937 itself in this session. The Google Patents render I fetched for US10085937/en returns the bibliographic data, the classification tree, the compound ("chemical compound") listing, and the specification — but no citations table. Everything below is therefore reported with explicit provenance labels so you can tell verified from unverified. I did not substitute citations belonging to other patents (e.g., US 12,458,591 or US 12,017,026) — those lists appeared in my searches but are patents that cite the '937 family, not citations made by the '937 patent, and I flag that distinction explicitly below.

1. First, a contradiction I must flag

The previously-generated section of this analysis attributes to claim 1 of US 10,085,937 (sourced from DrugPatentWatch) the following gist: a pre-primed nasal spray delivering 25–200 µL of solution containing about 4–10 mg naloxone HCl, an isotonicity agent, 0.005–0.015 % (w/v) benzalkonium chloride, to a patient whose bloodstream contains an opioid of Formula (I) (fentanyl/fentanyl derivatives).

However, the D.N.J. opinion in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc. quotes claim 1 of US 9,775,838 (the '838 patent) as:

"[D]elivering 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, wherein the spray delivers between about 4 mg and about 10 mg naloxone, an isotonicity agent, and between about 0.005% and about 0.015% (w/v) of benzalkonium chloride."

(Source: 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)

These are near-identical claim texts across two same-family continuations. That is not an error per se — '937 and '838 are siblings in the same Adapt/Opiant family — but it means I cannot confirm from an authoritative source which claim language belongs to '937 versus '838, and the fentanyl limitation appears in the DrugPatentWatch version of '937 but not in the court-quoted '838 claim 1. The § 102 mapping below is therefore done at two levels of granularity: (a) the elements common to both, and (b) the fentanyl-patient element that (per the secondary source) is specific to '937. Verify the claim text against USPTO PatentCenter before relying on any anticipation conclusion.

2. The citation landscape, tiered by relevance

Tier 1 — Prior art identified as the closest art in the '937 family's own litigation record

Grounding: the specification text reproduced in the litigation record states verbatim — "No. 9,192,570 to Wyse reports naloxone formulations for intranasal administration. Wyse reports (column 27, lines 29-37) that benzalkonium chloride 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." (Reproduced at https://insight.rpxcorp.com/litigation_documents/13116749). The Federal Circuit dissent likewise records: "Wyse, U.S. Patent No. 9,192,570, col. 27" and "Wyse taught away from using BZK." (https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf)

Tier 2 — References cited/discussed in the specification's own Background section

These are references the applicant itself characterized as the state of the art (verified in the authoritative text you supplied and in the litigation reproduction of the same specification):

Tier 3 — Patent documents appearing in the family's front-page citation list

A D.N.J. complaint reproduces a front-page citation list containing US 2016/0008277 A1 (Crystal et al., 1/2016) plus the following Foreign Patent Documents (as rendered, OCR-noisy): WO 98/30211 (7/1998); WO 00/62757 (10/2000); WO 00/76474 and WO 00/74652 (12/2000); WO 01/58447 (8/2001); WO 01/82931 (11/2001); WO 02/11778 (2/2002); WO 03/084520 (10/2003); WO 2004/054511 (7/2004); WO 2005/020906 (3/2005); WO 2006/058022 (6/2006); WO 2006/089973 (8/2006); WO 2007/083073 (7/2007); WO 2009/040595 (2/2009); WO 2012/026963 (3/2012); WO 2012/094283 (7/2012); WO 2012/156317 (11/2012, Euro-Celtique S.A.); WO 2014/016653 (1/2014, A61K 31/485); WO 2015/095644 (6/2015); WO 2015/136373 (9/2015); WO 2016/007729 (1/2016).
Source: https://storage.courtlistener.com/recap/gov.uscourts.njd.[371452](/patent/371452)/gov.uscourts.njd.371452.1.0.pdf

⚠️ Provenance warning: this fragment is embedded in a complaint that asserts US 9,211,253 as Exhibit A. I cannot confirm that this citation list is the face of US 10,085,937 rather than of another family member. Treat Tier 3 as indicative only.

Two of those are independently corroborated as family-relevant: the JP sibling JP2017508800A lists exactly two citations — JP 2002541921 A (Britannia Pharmaceuticals, "spray dispenser for opioid antagonists," 2002-12-10) and WO 2012/156317 A2 (Euro-Celtique S.A.) (https://patents.google.com/patent/JP2017508800A/en). Note that WO 2015/095644 is AntiOp/Wyse (Tier 1) and WO 2015/136373 is LightLake Therapeutics, the applicants' own predecessor — i.e., a family document, not third-party art.

Tier 4 — Prior art tested in the parallel PTAB/IPR proceedings

The Nalox-1 Pharmaceuticals IPRs (IPR2019-00685, -00688, -00694, -00699) were directed at the '253, '747, '177, '965 and '838 patents rather than at '937, but they establish the art set for this family. The petition record identifies Davies, Kerr, Bahal (EDTA for stability), Strang (intranasal naloxone 4 mg), and Kulkarni/Djupesland (formulation components) as the asserted art. Source: https://fedcircuitblog.com/wp-content/uploads/2022/03/Petition-20-2106.pdf

3. Reference-by-reference § 102 analysis

Threshold § 102 framing. The '937 patent's earliest listed priority is 2014-03-14, with intervening priority documents 14/659,472 (2015-03-16), 14/942,344 (2015-11-16) and 15/183,441 (2016-06-15), and the application itself filed 2016-09-16 as a CIP. A reference is § 102(a)/(b) art only if it predates the priority date of the specific claim; a CIP claim containing the fentanyl limitation added in 2016 may be entitled only to the 2016 date, which would make otherwise-2004–2015 art available. This date-by-claim analysis is the single most important determinant of anticipation and cannot be resolved without the issued claim set.

4. Bottom line

1. No single located reference appears to anticipate claim 1 of US 10,085,937 as its language was reported to me. The discriminating elements are (i) the 0.005–0.015 % (w/v) BZK range — which the closest art (Wyse/'570, and WO 2015/095644) teaches away from as degrading naloxone; and (ii) 4–10 mg naloxone delivered in a single 25–200 µL spray from a pre-primed device. Davies caps at 5 mg via a non-pre-primed spray applicator; Hussain '378 and WO 82/03768 disclose IN naloxone but not the concentrated, pre-primed, BZK-containing product.
2. Wyse US 9,192,570 is the reference to brief first. It is the closest art by the parties' own stipulation, it is the pivot of the Adapt v. Teva obviousness holding, and its BZK teaching cuts both ways (§ 102 disclosure of nasal naloxone and a teaching-away on the one element that differentiates the claim).
3. The realistic invalidity theory is § 103, not § 102, and in this family that theory succeeded — but at the district court and in a 2-1 Federal Circuit panel, and on the '747/'177/'965/'838 patents, not on '937. As previously flagged, the Fed. Cir. Adapt v. Teva decision (No. 20-2106, Feb. 10, 2022) does not by its terms reach US 10,085,937, and the Nalox-1 IPRs likewise did not target it.
4. Beware the CIP date trap. Because '937 is a continuation-in-part of 15/183,441, any claim element first added in the 2016-09-16 filing gets a 2016 priority date — which would make WO 2015/095644 (Wyse/AntiOp, published 2015-06-25) and WO 2015/136373 (LightLake, 2015-09-17) potentially available art against those claims. That is the highest-leverage § 102 argument available and it depends entirely on a claim-chart review of the issued claims.

5. Explicit uncertainty flags

1. The '937 citation box was not recovered. I found no authoritative source listing the complete "References Cited" of US 10,085,937 in this session. Google Patents' page for the patent renders no citations block. Do not treat Tiers 2–4 as the patent's official citation list.
2. Front-page provenance unresolved. The Tier 3 WO list is reproduced inside a D.N.J. complaint that asserts US 9,211,253; I could not confirm it belongs to the '937 face rather than to another family member, and the OCR rendering ("WO 908/30211," doubled "WO WO" prefixes, and an out-of-sequence "WO 00/76474") is unreliable.
3. Claim text conflict. As set out in §1, the claim-1 text attributed to '937 by DrugPatentWatch is substantially identical to court-quoted claim 1 of the '838 patent. One of the two attributions is likely imprecise. Claims should be taken from PatentCenter.
4. Dates I have not independently verified at the primary source are marked as such: WO 82/03768 publication year (1982); WO 00/62757 (Oct. 2000); US 4,988,136 (1991); US 2016/0008277 A1 (Jan. 2016). The Hussain '378 date (1984-08-07) and the Wyse '570 date (2015-11-24) are corroborated by an independent database listing.
5. I did not retrieve WO 2012/156317, WO 2014/016653, WO 2009/040595, WO 2007/083073 or the remaining Tier 3 documents' contents, so the § 102 column for those entries is a relevance assessment based on title/classification, not on a reading of the reference.
6. No post-2022 activity located for '937. Absence of results is not proof of absence.

I'll ground the prior-art analysis in actual search results before building the § 103 case, since the authoritative text supplied was truncated before the citations/claims sections.

Good — that gives me the litigation record and the prior-art universe. Now let me pin down the actual '937 claim text and its own citation list.

Obviousness Analysis — US 10,085,937 B2 under 35 U.S.C. § 103

Analyst note on the "Prior Art section." The copy of the Google Patents page supplied to me for this patent is truncated: it contains the bibliographic data, classifications, the abstract, and the "Definitions"/description text, but no "Citations"/"Cited By" table and no claims. I therefore rebuilt the prior-art record from three traceable sources, and I flag which is which:

1. The patent's own Background/Definitions text (authoritative — quoted in the full text I was given and corroborated by a litigation copy of the same specification). This is the closest thing to a "Prior Art section" that actually exists on the patent.
2. The family citation list visible on the corresponding Japanese family member JP 2017-508800 A (Google Patents), which reproduces the citations that run with this family.
3. The prior-art record of the related litigations (D.N.J. 2:16-cv-07721; Fed. Cir. 20-2106; PTAB IPR2019-00685/-00688/-00694/-00697/-00698/-00699), which is the only body of evidence in which these very formulations were actually tested for § 103.

Everything below is drawn from those sources or is expressly labelled as my inference.

1. The claim to be tested

Claim 1 as reported by a secondary database (DrugPatentWatch, retrieved for this analysis; not verified against the USPTO face of the patent, consistent with the caveat in the previously generated section):

A method of treating opioid overdose in a subject in need thereof, the method comprising: delivering a spray from a pre-primed device into a nostril of a patient whose bloodstream contains an opioid of Formula (I) … wherein the device is adapted for nasal delivery, and wherein the spray delivers a 25–200 μL spray of a pharmaceutical solution comprising between about 4 mg and about 10 mg naloxone hydrochloride or a hydrate thereof, an isotonicity agent, and between about 0.005% and about 0.015% (w/v) of benzalkonium chloride.

Dependent claim 3 (per the same source) adds: "wherein the spray is delivered as a round plume with an ovality ratio less than about 1.5 when measured at 3 cm."

The single most important structural observation for the § 103 analysis: stripping the Formula (I) preamble, this claim is materially co-extensive with claim 1 of US 9,775,838 ("delivering a 25-200 μL spray of a pharmaceutical solution from a pre-primed device into a nostril of a patient… wherein the spray delivers between about 4 mg and about 10 mg naloxone, an isotonicity agent, and between about 0.005% and about 0.015% (w/v) of benzalkonium chloride"). The '838 patent is one of the four patents **held invalid for obviousness by the District of New Jersey and affirmed by the Federal Circuit in Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 20-2106 (Fed. Cir. Feb. 10, 2022)**. The '937 claim adds only a patient-population limitation. That is the analytical fulcrum of this memo.

Two further structural points:

• Relative to the narrow sibling claim that was tried (claim 9 of the '747 patent: "about 4 mg," "about 100 μL," isotonicity agent + preservative/cationic surfactant/permeation enhancer + stabilizing agent, pH 3.5–5.5), the '937 claim is broader (4–10 mg; 25–200 μL) and drops the stabilizing agent (EDTA). Broader claims are ordinarily more exposed to § 103, not less.
• The '937 was, on the record I found, never adjudicated: Nalox-1 did not petition for IPR of the '937 (Emergent Biosolutions filing: "Nalox-1 did not request review of the '937 Patent"), and the Teva bench trial was limited to claims 7 and 9 of the '747, claim 4 of the '177, claims 21, 24 and 25 of the '965, and claims 2, 24, 33 and 38 of the '838. The Google Patents litigation flag points to Adapt Pharma Operations Ltd. v. Perrigo UK Finco LP, 2:18-cv-16987 (D.N.J.), filed 2018-12-07 and terminated 2019-05-03.

2. The prior art (each reference, rendered literally)

3. Element-by-element mapping (Ground 1: Davies in view of Kerr 2009, Bahal, HPE/Djupesland)

Ground 2 (alternative): Strang (WO 2012/156317) in view of Kulkarni and Djupesland — Strang supplies the concentration (4 mg/mL), the saline vehicle, the small unit volume (100 μL) and the ≤5.5 pH, but not the pre-primed device or the preservative; Kulkarni supplies BZK/EDTA/pH ranges; Djupesland supplies the single-/bi-dose, pre-primed device. This was the combination that carried the day at the district court in the Teva case, and the Fed. Cir. affirmed on substantial evidence.

Ground 3: Wyse in view of HPE and Djupesland — Wyse supplies the IN naloxone formulation framework and the 0.1–2% w/w antimicrobial range (assuming it is available as prior art; see § 6 below on the priority/filing-date question).

Ground 4 (fentanyl limitation): The Formula (I) preamble adds nothing beyond the disclosures listed in the "Prior Art" row above for the '937 specifically — the specification itself concedes that fentanyl overdose is a known indication for naloxone.

4. Why a POSA would have combined these teachings

The Fed. Cir. in Adapt v. Teva endorsed a four-step motivation: (1) formulate an IN naloxone product improving on the MAD Kit; (2) select the excipients and a device; (3) select the dose; (4) combine. Re-stated generally (per Plantronics, Tyco, KSR):

1. A problem known in the field, with the FDA as an express source of demand. The 2012 FDA public meeting and the FDA's direct suggestion that a higher dose was needed to reach IM-like exposure is about as explicit a "problem known in the field of endeavor at the time of invention" as KSR contemplates. Market forces (the opioid epidemic) supply an independent motivation.
2. The shortcomings of the closest working solution (the MAD Kit) were well known — assembly required at the moment of an emergency, 1 mL per nostril (far exceeding the ~200–250 μL nasal cavity), unreliable atomization, needlestick risk, and ~50% re-dosing (Walley 2013). Each drawback points toward a small-volume, ready-to-use, pre-primed device.
3. Dowling 2008 quantified the problem numerically. If IN delivery yields only ≈4% relative bioavailability, then achieving an IM-equivalent exposure requires raising the IN dose. A POSA would not need hindsight to reach a 4–10 mg IN dose; the arithmetic and the FDA's own 2012 statements do it.
4. Anatomical constraint drives the claimed volume range. With a nasal cavity of ~200–250 μL and a target of one-bolus dosing, a 25–200 μL (≈100 μL) unit volume is the predicted answer, not a discovery.
5. Excipient selection is routine optimization. NaCl (tonicity, to avoid irritation), HCl (pH 3.5–5.5, to avoid irritation and stabilize), and BZK (preservative, plus known permeation enhancement) are each individually taught for nasal products and, critically, each appears in a naloxone nasal formulation in the prior art (Davies, Kerr, Strang) or in the standard excipient literature (HPE, Kulkarni) — within the claimed ranges. Under In re Aller / In re Boesch, arriving at a narrower sub-range of a disclosed range by routine experimentation, for the recognized purpose of the ingredient, is obvious; and KSR's "finite number of identified, predictable solutions" applies squarely to a preservative selected from a shortlist of nasal-approved preservatives at a handbook-listed concentration.
6. The device was an off-the-shelf article of commerce. The Aptar UDS single-dose device was a known commercial unit (used for Zomig/Imitrex nasal sprays); Djupesland expressly recommended single-/bi-dose devices for drugs like naloxone; and Britannia's JP 2002541921 is a spray dispenser for opioid antagonists per se. Selecting the Aptar UDS was, in the D.N.J.'s words, the selection of a "well-known off-the-shelf device."
7. Fentanyl adds no independent act. Naloxone is a pure μ-opioid antagonist whose mechanism is opioid-agnostic; fentanyl is a μ-agonist; Boyer 2012 and the patent's own Definitions section treat fentanyl overdose as an ordinary instance of opioid overdose. The claim does not change any treatment step based on the identity of the opioid — a point that matters because Federal Circuit doctrine generally does not accord patentable weight to a newly identified patient population where the method steps are unchanged (cf. Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967 (Fed. Cir. 2014) — cited with the caveat that I am summarizing its theme, not its verbatim holding). Notably, the trial record shows Teva itself argued the "fentanyl crisis" would have motivated higher-dose IN naloxone development, so this is a proposition the litigants treated as common ground.

5. Reasonable expectation of success

Every element was known to work: naloxone was known to be IN-absorbed (Hussain; WO 82/03768; Davies); NaCl/HCl/BZK were known to be compatible with nasal administration; the swirl-chamber single-dose device was on the market. Nothing in the combination required a new mechanism, an unpredictable biological pathway, or a device that did not exist. The predictable consequence of adding BZK (a known permeation enhancer) to an IN naloxone formulation is increased bioavailability — which is precisely why the Fed. Cir. majority held the claimed 56% bioavailability gain was not an unexpected result.

6. Threshold issues that change which art is available

These are worth flagging because they cut in favour of the challenger:

• Effective filing date / new matter. Google Patents lists a "priority date"/"prior art date" of 2014-03-14, but the earliest external priority document it lists is US 14/659,472 filed 2015-03-16, and the '937 was filed 2016-09-16 as a continuation-in-part of, inter alia, US 15/183,441 (2015-06-15). In the IPR proceedings, Nalox-1 argued the sibling '838 patent "lacks priority to the filing date of the '379 provisional" — i.e., the priority question was contested and was decisive for whether Wyse qualified as § 102(a)(2) art. The same attack is available against the '937. The Formula (I) subject matter may or may not be supported by the earlier disclosures. If any claim element is new matter, the effective date becomes 2016-09-16, which enlarges the prior-art field (including the Lightlake/Euro-Celtique publications from 2014–2015). Flagged as an unresolved question, not a conclusion.
• The FDA-2012-to-priority interval. If the operative date is 2015-03-16, the "long-felt need" window is ~3 years (the Fed. Cir.'s finding); if it is 2016-09-16, ~4.5 years. Either way, the Fed. Cir. held that a need that began only in 2012 was not "so long felt" as to overcome the prior art.
• The '937 is not the claim set that survived the PTAB. The PTAB's final written decisions of August 21, 2020 held the challenged claims (of the '253, '747 and '965 patents) not unpatentable, on the ground that Wyse and HPE "taught away from using BAC as a preservative, especially in combination with the stabilizing agent EDTA." That qualifier is important: the '937's claim 1 does not require EDTA. The teaching-away finding, as the PTAB framed it in the decision text I retrieved, was bound up with the BZK+EDTA pairing. A challenger attacking the '937 can therefore argue that the very rationale that saved the IPR claims is inapplicable, and that the Article III record (D.N.J. + Fed. Cir.) already rejected the teaching-away defence on the same underlying facts.

7. Secondary considerations — what the record actually shows

8. The patent owner's best counter-case (and where it is weakest)

1. Hindsight reconstruction (the Newman dissent). "The invention itself is the only guide to the selections from the prior art"; the sheer number of interdependent choices (route, device, dose, concentration, excipients) meant "millions of possible combinations." This argument is potent in the abstract and won at the PTAB. Its weakness for the '937 specifically is that the claim is broader than the claims that were defended, and that the specific numbers it recites (0.005–0.015% BZK; ~100 μL; 4 mg) are the ones the Fed. Cir. majority said were suggested within prior-art ranges.
2. Teaching away (Wyse/BZK). Strongest on the merits; but the '937 claim omits EDTA, which is the very ingredient the PTAB tied its teaching-away conclusion to.
3. New patient population (fentanyl). Weak, for the reasons in § 4(7) — and weakened further by the specification's own admission that fentanyl is one of the opioids that induce overdose.
4. Unpredictability of the 4 mg dose. The patent owner's trial expert argued the art taught "low and slow" dosing and that 2 mg IN ≈ 0.4 mg IM. But on cross-examination the same expert conceded that Strang disclosed clinical IN doses of 8 mg and 16 mg — which directly undercuts the "art taught away from high IN doses" theory.
5. Litigation posture. The Perrigo action (2:18-cv-16987) terminated 2019-05-03, roughly five months after filing. Its disposition (settlement, licence, dismissal) is not established in the material I retrieved, and I decline to infer it. If it were a licence-on-the-'937, the patent owner could point to a competitor's willingness to take a licence — but under Iron Gorgon/Deere-type reasoning a settlement licence is generally weak evidence of nonobviousness, since it may reflect commercial risk-aversion rather than merit.

9. Conclusion

A prima facie case of obviousness under § 103 against claim 1 of US 10,085,937 is strong, and it is strong for a reason that does not require new fact-finding: a coordinate claim in the same family (claim 1 of the '838 patent) recites essentially the same elements, was held invalid for obviousness after a two-week bench trial, and that judgment was affirmed by the Federal Circuit on February 10, 2022. The '937 differs by (a) adding a fentanyl-population preamble, and (b) broadening the dose (4–10 mg) and volume (25–200 μL) ranges while deleting the stabilizing agent (EDTA). Each of those differences either adds nothing patentable (the population preamble, on the patent's own admissions) or makes the claim more vulnerable (broader ranges; omission of the ingredient that anchored the only successful non-obviousness argument in the parallel PTAB proceedings).

The best combinations to plead are:

• Ground 1: Davies (WO 00/62757) + Kerr 2009 + Bahal (US 5,866,154) + Handbook of Pharmaceutical Excipients (6th ed. 2009), optionally + Djupesland 2013.
• Ground 2: Strang (WO 2012/156317, rendered "WO 2012/15317" in the Fed. Cir. summary) + Kulkarni + Djupesland 2013.
• Ground 3: Wyse (US 9,192,570) + HPE + Djupesland 2013 — available only if the '937 is not entitled to its earliest claimed priority; that priority question should be pleaded and supported, because Wyse is otherwise § 102(b)(2) art of contested status.
• Ground 4 (fentanyl preamble): Boyer 2012 + the 2012 FDA Meeting materials + the patent's own specification admissions.

The principal risk to the challenge is the teaching-away question the PTAB resolved in the patent owner's favour on the BZK/EDTA pairing. That risk is materially reduced for the '937 because its claim 1 does not require EDTA, but it is not eliminated, and the Board's 2020 decisions are on the record and will be cited against any challenger.

10. Explicit uncertainty flags

1. Claim text is from a secondary source. The full text supplied to me is truncated before the claims; claim 1 and claim 3 above are from DrugPatentWatch, not from the USPTO face of the patent. They are consistent with the previously generated section — no contradiction found — but must be verified before reliance.
2. No "Prior Art section" existed in the material supplied. I reconstructed the art from the patent's own Background, the family citation list on JP 2017-508800 A, and the litigation/PTAB record. If the page's citation table contains references I did not surface, my list is incomplete.
3. Identifier discrepancy, not corrected: "WO 2012/15317" (Fed. Cir./patentdocs summary of the trial record) vs. "WO 2012/156317 A2" (Google Patents family citation list, Euro-Celtique, "Intranasal pharmaceutical dosage forms comprising naloxone"). I have rendered both literally.
4. Priority date remains unresolved. Google Patents' 2014-03-14 listing is not corroborated by any external priority document in the family listing; the earliest external document is US 14/659,472 (2015-03-16). This directly controls whether Wyse is available art and how long the "long-felt need" window is.
5. The '937 has not been adjudicated. Its invalidity is my prediction, not a holding. The Perrigo case (2:18-cv-16987) terminated on 2019-05-03 by a means I could not establish.
6. Prior-section discrepancy, minor: the previously generated section lists "9,480,644" among the patents in the Perrigo case, whereas the Emergent Biosolutions filings speak of the '965 ('9,629,965). I did not resolve whether both appear in that docket.
7. Legal-authority citations. My references to Bristol-Myers Squibb v. Teva, In re Aller and In re Boesch are by way of doctrinal illustration from memory; the case citations themselves were not retrieved in this session and should be verified before use in a filing.