US 9775838

I'll search for information on this patent and its litigation status.

Let me search for the specific litigation and claim details.

Let me verify the exact claim set and any 2026 litigation activity.

Summary of US 9,775,838 B2 — "Nasal drug products and methods of their use"

Important scope note: I could not query USPTO Patent Center/PACER or the CAFC docket system directly. My findings come from public web sources (Google Patents, the CAFC opinion PDF, CourtListener RECAP filings, and law-firm/secondary summaries). I found no evidence of any 2026 CAFC docket involving US 9,775,838. The only Federal Circuit appeal I can identify for this patent is No. 20-2106, decided February 10, 2022 (Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., 25 F.4th 1354). I cannot affirmatively certify the absence of a 2026 docket.

Bibliographic data (per Google Patents / CAFC record)

Abstract

The provided Google Patents text did not include a verbatim abstract section. The family's summary language is: "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." I would treat this as the abstract's substance but flag that I have not verified the '838 patent's exact abstract wording.

Independent claims — plain-language overview

The D.N.J. litigation record describes claim 1 of the '838 patent as a method of treating opioid overdose comprising:

1. Delivering a 25–200 µL spray of a pharmaceutical solution from a pre-primed device into a nostril of a patient, the device being adapted for nasal delivery;
2. Where the spray delivers between about 4 mg and about 10 mg naloxone;
3. An isotonicity agent; and
4. Between about 0.005% and about 0.015% (w/v) benzalkonium chloride.

In plain terms: use a ready-to-use (no pre-priming) nasal spray to give an overdose patient 4–10 mg of naloxone in a small 25–200 µL dose that also contains a salt/tonicity agent and a very small amount of benzalkonium chloride (a preservative that the patent also treats as a permeation enhancer/cationic surfactant).

Asserted/related dependent claims (from the same litigation record):

• Claim 2 — spray delivers about 4 mg naloxone (Narcan's dose);
• Claim 24 — depends on claim 18 (patient is an opioid overdose or suspected overdose patient) and requires a reservoir of not more than about 140 µL;
• Claim 33 — specifies the excipients: isotonicity agent is NaCl, preservative is benzalkonium chloride, stabilizing agent is disodium edetate, acid is hydrochloric acid;
• Claim 38 — device architecture (reservoir, piston, swirl chamber; plunger housing a container closure with vial, cannula and rubber stopper that the cannula pierces).

Uncertainty flag on claim numbering: the published application US 2017/0239241 A1 contains a substantively identical "25–200 µL spray" claim numbered 31, with claim 32 reading "the method of claim 31, wherein the spray delivers about 4 mg naloxone." Since the D.N.J. pleading alternately identifies that same subject matter as claims 1–2, the publication and issued claim numbering appear to differ (or one source is imprecise). I therefore cannot state with high confidence how many independent claims the '838 patent contains beyond the method claim above. The specification also frames the invention as an "improved single-use, pre-primed device … comprising at least about 4% (w/v) naloxone hydrochloride … adapted to spray a round plume with an ovality ratio less than about 2," and describes a mist in which no more than about 10% (or 5%) of droplets have a diameter below 10 µm.

Litigation, PTAB, and CAFC posture

• District court: D.N.J. consolidated case 2:16-cv-07721 (with related 2:18-cv-09880 and 2:18-cv-15287), Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc. The asserted '838 claims were 2, 24, 33, and 38. On June 5, 2020 the court (Judge Martinotti) entered judgment that those claims are INVALID for obviousness (CourtListener RECAP, gov.uscourts.njd.340302, Doc. 342).
• CAFC: No. 20-2106, Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022) — affirmed invalidity (Stoll, J., joined by Prost, J.; Newman, J., dissenting). Prior-art combinations: Davies + Kerr 2009/Kerr Formulation + Bahal, and Strang + Kulkarni + Djupesland.
• IPRs: Nalox‑1 Pharmaceuticals LLC filed 15 petitions on Feb. 19, 2019. IPR2019‑00697 (Wyse), IPR2019‑00698 (Wang), and IPR2019‑00699 (Davies) targeted US 9,775,838 and were not instituted (institution denied Oct. 16, 2019). Three other petitions (IPR2019‑00685, ‑00688, ‑00694) were instituted; the PTAB's Aug. 21, 2020 final written decisions found the challenged claims not unpatentable — per Emergent's securities disclosure; I have not verified which specific patent(s) those three instituted IPRs covered (the disclosure lists the '253, '747, '177, '965 and '838 patents collectively).

Net status

The '838 patent is listed as active (expiry 2035‑03‑16), but the specific claims asserted against Teva (2, 24, 33, 38) were held invalid by D.N.J. and that judgment was affirmed by the Federal Circuit in 2022. Remaining/unasserted claims of the patent were not adjudicated in that case as far as these sources show.

I'll research the litigation history for US 9775838 across patent litigation databases.

Let me dig into the specific case details and the IPR outcomes.

Litigation Involving U.S. Patent No. 9,775,838

Patent identified: US 9,775,838 B2 — "Nasal drug products and methods of their use" (app. 15/589,090; filed 2017‑05‑08; granted 2017‑10‑03; priority 2014‑03‑14; anticipated expiration 2035‑03‑16). Original assignees Adapt Pharma Ltd. / Opiant Pharmaceuticals Inc.; current assignees listed as Indivior UK Ltd. and Emergent BioSolutions Ireland Ltd. (reassignment to Indivior UK Limited recorded 2023‑06‑14). It is an Orange Book–listed patent for NARCAN® (naloxone HCl) Nasal Spray, NDA 208411.

Yes — there is known litigation and PTAB activity. The '838 patent was asserted as one of five Orange Book patents in the NARCAN® patent family (U.S. 9,211,253; 9,468,747; 9,561,177; 9,629,965; 9,775,838), and was also the subject of three IPR petitions.

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

D. New Jersey — ANDA / patent infringement (35 U.S.C. § 1126 cause code; patent infringement)

Appeal — Adapt Pharma Operations Ltd. et al. v. Teva Pharmaceuticals USA, Inc. et al., No. 2020-2106 (Fed. Cir.)

• Decided Feb. 10, 2022: AFFIRMED the district court's judgment that the asserted claims are invalid as obvious (Opinion by Stoll, J., joined by Prost, J.; Newman, J., dissenting). The court found no clear error in the motivation‑to‑combine and no‑teaching‑away findings, and held the objective indicia insufficient; it found the district court erred on long‑felt need but deemed the error harmless.
• Opinion PDF: https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf

Note: the '838 patent's own claims were the subject of the validity judgment, but the Federal Circuit's representative-claim analysis focused on claim 9 of the '747 patent (the patents share a family/specification).

2. Adapt Pharma Operations Limited et al. v. Perrigo UK FINCO Limited Partnership

D. New Jersey — ANDA / patent infringement

Sources: https://www.courtlistener.com/docket/[8135715](/patent/8135715)/73/adapt-pharma-operations-limited-v-perrigo-uk-finco-limited-partnership/ ; https://www.courtlistener.com/docket/8135715/idb/adapt-pharma-operations-limited-v-perrigo-uk-finco-limited-partnership/

3. PTAB — Inter Partes Review (Petitioner: Nalox-1 Pharmaceuticals, LLC v. Patent Owner: Opiant Pharmaceuticals, Inc. / Adapt Pharma Ltd.)

Three petitions were filed against the '838 patent (part of a 15‑petition campaign, IPR2019‑00685 through ‑00699, covering all five Orange Book patents):

• The Board's denial rested on the conclusion that the lead prior art (Wyse, U.S. 9,192,570) teaches away from using benzalkonium chloride (BZK), particularly with EDTA, in intranasal naloxone formulations.
• Sources: https://portal.unifiedpatents.com/ptab/case/IPR2019-00698 ; Docket Alarm IPR2019‑00699 docket (Patent 9775838; Orange Book Patent 9775838); PTAB institution decision PDF for IPR2019‑00698 (Paper 13, Oct. 16, 2019).

Related note: In the parallel 15‑petition campaign, the Board instituted on the '253, '747, and '965 patents and denied all of the other '838 and '177 petitions. Per a later PTAB termination decision, on March 2, 2020 the Perrigo case was dismissed with prejudice by consent judgment and on June 26, 2020 the district court entered final judgment in the Teva case holding claims of the '747 patent invalid.

Summary of known litigation

No other litigation against the '838 patent was identified. Searches of unifiedpatents.com, Docket Alarm, DrugPatentWatch and CourtListener surfaced only the Teva and Perrigo district court matters and the three Nalox‑1 IPRs. I did not find any ITC action, any additional ANDA defendant (e.g., other generic filers), or any appellate proceeding other than Fed. Cir. 20‑2106.

Caveats: (a) District court dockets are behind PACER, so sealing/termination details may not be fully reflected in free sources; (b) the Google Patents "litigation" panel entries for 2:16-cv-07721, 2:18-cv-09880, 2:18-cv-15287 and CAFC 20‑2106 are consistent with the above, but the panel labels the IPRs "Not Instituted – Merits," which matches the Board's Oct. 16, 2019 denial decisions rather than the generic "Trial Instituted Document" docket entry title you may see on some aggregator sites; (c) the Google Patents page also references a "First worldwide family litigation" via Darts‑IP (family 57129510), which I could not independently verify and therefore am not counting as a separate proceeding.

I'll start by checking the canonical structured block against independent sources, then dig into the three IPR numbers that surfaced in the Google Patents record.

Key finding: the Google Patents "PTAB case" entries mislabel the petitioner (the portal source is Unified Patents, but the actual petitioner was Nalox-1 Pharmaceuticals, LLC). Let me pin down the institution-decision dates and the substance of each denial, plus the parallel litigation outcome.

Proceedings overview

Three AIA trial proceedings were filed against US 9,775,838 — all three were institution-denied (0 active, 0 claims invalidated by the PTAB, 0 claims sustained on the merits, 0 settled, 3 denied), so the Board has never issued a Final Written Decision on this patent; the real defensive value for a defendant comes not from the PTAB docket but from the parallel district-court judgment that the '838 claims were obvious, affirmed by the Federal Circuit on 2022-02-10 — meaning the patent is not "hardened" by the IPRs (they never reached the merits), but the asserted claims have been held invalid in court.

Sourcing note / flags. Your structured block says the USPTO ODP ingest shows no AIA trials on this patent. That conflicts with the public record: web sources (PTAB decisions, Unified Patents' portal, DocketAlarm, Oblon's TC1600 tracker) show three IPRs filed 2019-02-19 by Nalox-1 Pharmaceuticals, LLC, all denied. Also note two data-quality traps: (1) Google Patents' "PTAB case IPR2019-00697/698/699 filed" entries are attributed to Unified Patents PTAB Data — that is a data-source license label, not the petitioner; the petitioner of record is Nalox-1. (2) "Not Instituted – Merits" = denial of institution under 35 U.S.C. § 314(a); there is no FWD on this patent.

IPR2019-00697 — Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Limited & Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review
• Filed: 2019-02-19
• Status: Institution denied ("Not Instituted – Merits" per the portal; denied per the Board's § 314(a) decision and Oblon's tracker)
• Judge panel: Erica A. Franklin (lead), Zhenyu Yang, Jacqueline T. Harlow, Administrative Patent Judges
• Petition grounds: § 103 over Wyse (U.S. Pat. No. 9,192,570) as the lead reference, combined with HPE (Handbook of Pharmaceutical Excipients), U.S. Pat. No. 8,198,291, Djupesland, Zomig Review and Wang — challenging all of claims 1–46. Illustrative grounds: claims 5–12 over Wyse + HPE + Wang; claims 13–17 and 41–46 over Wyse + HPE + the '291 patent; claims 24, 35, 37 over Wyse + HPE + Djupesland; claim 38 over Wyse + HPE + Djupesland + Zomig Review. Petitioner also challenged the '838 priority claim (contending the patent was not entitled to the 2014-03-14 provisional date, making Wyse prior art under § 102(a)(2)).
• Institution decision: Denied. The Board agreed with Patent Owner that the prior art teaches away from the claimed invention — Wyse "surprisingly showed that the use of benzalkonium chloride, a common nasal product preservative, resulted in an additional degradant" and concluded BZK was not "acceptable" "due to increased observed degradation" (Wyse at 27:29–32, 27:42–44). Because the '838 claims require BZK (and, in the asserted claims, EDTA), the Board found no reasonable likelihood of prevailing as to any of claims 1–46. (The Board's parallel -698 decision is dated 2019-10-16 and expressly relies on this teaching-away reasoning; I could not confirm the precise entry date of the -697 decision from the sources retrieved, but it issued in the same window.)
• Final Written Decision: None — no trial was instituted.
• Settlement / termination: No settlement. Denial of institution, with a fee-refund notice entered in the companion case.
• Appeal: None. A denial of institution is non-appealable under 35 U.S.C. § 314(d) (Cuozzo Speed Techs. v. Lee).
• Defensive value: The denial is a § 314(a) discretionary/threshold ruling — it creates no estoppel and no preclusive effect, so it does not block a defendant from running the same art. On the contrary, the Board's sole rationale (Wyse teaches away from BZK) was rejected by the Federal Circuit in the parallel case (see 20-2106 below), so the -697 loss is the weakest shield in this family for the patent owner.

IPR2019-00698 — Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Limited & Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review
• Filed: 2019-02-19
• Status: Institution Denied (portal: "Not Instituted – Merits"; Board paper dated 2019-10-29 refund notice follows)
• Judge panel: Erica A. Franklin (lead), Zhenyu Yang, Jacqueline T. Harlow
• Petition grounds: § 103 over Wang (Chinese Patent No. 1,575,795; certified human translation, vs. the machine translation in prosecution) as lead, combined with HPE, Djupesland, Bahal, Kushwaha, the '291 patent, Wyse and Zomig Review — claims 1–46. Ground table from the institution decision: claims 1–2, 4–12, 18, 24, 30, 31, 35, 37 over Wang + HPE + Djupesland; claims 3, 32–34 over Wang + HPE + Djupesland + Bahal + Kushwaha; claims 13–17 over Wang + HPE + Djupesland + the '291 patent; claims 19–23, 25–29, 36, 39–40 over Wang + HPE + Djupesland + Wyse; claim 38 over Wang + HPE + Djupesland + Zomig Review; claims 41–46 over Wang + HPE + Djupesland + the '291 patent + Wyse. The Board noted claims 1 and 41 are the only independent claims.
• Institution decision: Denied — 2019-10-16 (Paper 13). "Having considered the evidence and arguments of record, we agree with Patent Owner that the prior art teaches away from the claimed invention, and, therefore, decline to institute inter partes review." The Board also faulted the petition for relying on Wyse — not Wang — for the dose limitation of all claims, undercutting the Wang lead reference. The panel additionally flagged the parallel-petition problem: Nalox-1 had filed three concurrent petitions on this patent, and the Board exercised § 314(a) discretion against redundant parallel petitions (see the 2019-08-01 Order on Conduct of the Proceedings, citing General Plastic and the July 2019 Trial Practice Guide Update).
• Final Written Decision: None.
• Settlement / termination: No settlement; Board refund notice entered 2019-10-29.
• Appeal: None (non-appealable § 314(d) denial).
• Defensive value: Same as -697 — no claims tested, no estoppel. Usefully documents that the Board itself viewed the three Nalox-1 petitions as substantially identical ("word-by-word sameness"), which is ammunition if a new petitioner tries to recycle Wang/Davies-based combos.

IPR2019-00699 — Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Limited & Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review
• Filed: 2019-02-19
• Status: Institution Denied (portal: "Not Instituted – Merits"; denied per Oblon tracker and the Board's parallel decision posture)
• Judge panel: Erica A. Franklin (lead), Zhenyu Yang, Jacqueline T. Harlow
• Petition grounds: § 103 over Davies (WO 00/62,757) as lead, combined with HPE, Djupesland, Wyse, the '291 patent, Bahal, Kushwaha and Zomig Review — claims 1–46. Petitioner argued Davies (like Wyse) discloses the "pre-primed device" limitation of claims 1 and 41, but Davies does not disclose the pH 3.5–5.5 limitation recited in claim 32, and Davies was asserted as § 102(a)(1) art (so the § 102(b)(2) exception was unavailable to Patent Owner).
• Institution decision: Denied. Petitioner itself ranked this petition third, below Wyse (-697) and Wang (-698); the Board denied institution in line with its teaching-away finding on Wyse/BZK and its discretionary refusal to institute redundant secondary petitions. Petitioner's own Notice conceded "there are no issues which Petitioner asserts are taught by Wang and Davies but not Wyse."
• Final Written Decision: None.
• Settlement / termination: No settlement.
• Appeal: None.
• Defensive value: No estoppel; no merits ruling. The most useful artifact is Petitioner's own concession that Davies/Wang add nothing over Wyse — which narrows the realistic art set for anyone contemplating a fresh attack.

Strategic summary

Claim status — CANCELED / SUSTAINED / UNTESTED. At the PTAB, the answer is simple: nothing was canceled and nothing was sustained, because no trial was ever instituted on US 9,775,838 — all 46 claims remain untested at the Board. The meaningful adjudication is in the district court: in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., No. 2:16-cv-07721 (D.N.J.), the '838 claims at issue were claims 2, 24, 33 and 38 (see Adapt's 2019-11-13 letter, D.I. 283), and the June 2020 judgment invalidated claims of the four Orange Book patents including the '838. The Federal Circuit affirmed in Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 2020-2106, slip op. (Fed. Cir. 2022-02-10) (2-1, Newman, J., dissenting). Note the doctrinal collision: the PTAB found Wyse "explicitly and unambiguously discourages the use of [BZK]," while the CAFC held Wyse did not teach away from BZK. Only the CAFC's conclusion is binding precedent; the Board's denials are not. Independent claims 1 and 41 were not separately adjudicated in the Teva case on the record I retrieved — but the obviousness analysis of dependent claims 2, 24, 33 and 38 necessarily found the limitations of their parent claims disclosed or suggested, which makes an a fortiori attack on claims 1/41 substantially stronger than the patent owner would like. I did not find a PTAB or court decision squarely addressing claims 3, 5–23, 25–32, 34–37, 39–46.

Estoppel landscape. This is the key point in your favor as a defendant. Section 315(e)(2) estoppel attaches only to a petitioner "that results in a final written decision." There was none here — every petition died at the § 314(a) threshold — so Nalox-1, Burford Capital Ltd., BCIM PIII Holdings, LLC and the other real parties named in the Nalox-1 filings are under zero IPR estoppel from these proceedings. Conversely, a new defendant is also unconstrained by their grounds: Wyse, HPE, Djupesland, Wang, Davies, Bahal, Kushwaha, the '291 patent and Zomig Review remain fully available. The practical constraints you do face are discretionary, not estoppel-based: (a) § 325(d) — the same art was before the Office in these three IPRs, so expect an Advanced Bionics/Becton Dickinson argument; (b) § 314(a) discretionary denial under General Plastic and the July 2019 TPG Update for any parallel/serial petitions you and your privies file; and (c) the fact that the core Wyse-teaches-away theory the Board accepted has been rejected by the Federal Circuit, which cuts in favor of institution on a well-framed petition.

Pattern signals. This was a litigation-finance-backed parallel-petition campaign, not a routine defense. Nalox-1 filed 15 IPRs against five Narcan-related patents in one day (three per patent: Wyse-lead, Wang-lead, Davies-lead), funded by Burford Capital entities and BCIM PIII Holdings. The Board instituted only on the Wyse petitions for the '253, '747 and '965 patents (IPR2019-00685, -00688, -00694) and denied the '177 and '838 Wyse petitions — expressly finding Nalox-1 had not shown a reasonable likelihood as to any BZK-reciting claim, and instituting on the non-BZK claims only because SAS compelled all-or-nothing institution. The three instituted IPRs went to FWD on 2020-08-21 finding the claims not unpatentable (teaching away from BZK/EDTA) — a result the Federal Circuit declined to follow six months later in the Teva appeal. There is no Unified Patents petition here. There was no CAFC appeal from the IPR denials (they are not appealable); the only CAFC activity in this chain is Adapt's appeal of its district-court loss (No. 2020-2106, docketed 2020-08-03, decided 2022-02-10), where the patent owner lost. A petition for rehearing en banc was filed relying on Judge Newman's dissent; I could not confirm the disposition from the sources retrieved — treat it as not confirmed.

Recommended next steps

1. If you are a defendant now being asserted against on the '838 patent, lead with the court judgment, not the IPRs. Link and quote the Federal Circuit disposition: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 2020-2106 (Fed. Cir. 2022-02-10), affirming the D.N.J. judgment that the asserted claims — including claims 2, 24, 33 and 38 of the '838 patent — were invalid as obvious. Opinion: https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf. The district-court record showing which '838 claims were at issue is at https://storage.courtlistener.com/recap/gov.uscourts.njd.[340302](/patent/340302)/gov.uscourts.njd.340302.283.0_1.pdf. If a demand letter asserts claims 2, 24, 33 or 38, those claims have already been adjudged invalid on a fully litigated record that survived appeal.
2. Do not treat the three institution denials as invalidations or as estoppel. They are § 314(a) denials: no FWD, no claim cancellation, no § 315(e) estoppel. Pull the institution decisions themselves for quoting — e.g., IPR2019-00698, Paper 13 (2019-10-16), "Denying Institution of Inter Partes Review, 35 U.S.C. § 314(a)": https://www.docketalarm.com/cases/PTAB/IPR2019-00698/Inter_Partes_Review_of_U.S._Pat._9775838/docs/10-16-2019-Board/Institution_Decision-13-Trial_Instituted_Document.pdf. Cross-check the full docket on PTAB E2E / USPTO Patent Center (https://patents.google.com/patent/US9775838/en links through to USPTO PatentCenter) and confirm whether the ODP gap is a genuine ingest failure.
3. If you need PTAB cover for the non-adjudicated claims (1, 3, 5–23, 25–32, 34–37, 39–46), an IPR is still viable: no estoppel bars it, and the Board's sole denial rationale (Wyse teaches away from BZK) was rejected by the Federal Circuit. Budget for (i) a § 325(d) Advanced Bionics fight because the art is already of record, and (ii) a § 314(a)/General Plastic fight if you file more than one petition. Given the Teva judgment already invalidates the commercially asserted '838 claims, weigh whether a new IPR is worth the cost versus simply relying on the judgment and collateral estoppel in your forum.
4. No trial-stage milestones to track. There are no pending proceedings on the '838 patent as of 2026-09-30 — so no institution-deadline, oral-hearing or 1-year FWD dates exist. The "absence" signal here is weak: this patent did attract three IPRs, they were just all denied at the threshold.
5. Verify before filing anything. I could not confirm from the sources retrieved: the exact entry dates of the -697 and -699 institution decisions; the full per-claim disposition of the D.N.J. judgment as to every '838 claim; the en banc disposition in No. 2020-2106; and whether any post-2020 AIA petition on the '838 has been filed and not yet indexed. Confirm each on PTAB E2E / CourtListener before you rely on it in a brief. Nothing in this memo should be treated as a substitute for reading the papers.

I'll research the assignment record for US 9775838 before building the analysis.

This is a rich case. Let me dig into the corporate entities, the IPR petitioner, and assignment specifics.

Let me try to pin down the recorded reel/frame numbers and correspondents.

Assignment & Ownership Analysis — US 9,775,838 B2 ("Nasal drug products and methods of their use")

Scope note on sourcing. The USPTO Assignment Center record for this patent was not directly retrievable in machine-readable form through the mirrors I could reach in this session. The events below are reconstructed from Google Patents legal events, PTAB mandatory notices, and SEC/IR filings. I could not verify the reel/frame numbers or the correspondent-of-record names, so I have marked those fields "not retrieved" rather than guessing. Verify all of it at assignmentcenter.uspto.gov or assignment.uspto.gov/patent/index.html by searching patent number 9775838.

Inventors

Pattern note: The inventorship is split across two unrelated companies (two Adapt-side inventors, two Opiant/Lightlake-side inventors), consistent with a jointly developed product where Adapt contributed the device/formulation work and Lightlake/Opiant contributed the nasal-naloxone pharmacokinetic work. There is no evidence of the "all inventors exit within 12 months of filing" fire-sale precursor — the inventors' employing entities stayed in the chain for years and were each acquired in solvent M&A. (Inventor addresses are corroborated by the sibling family member US 10,085,937 B2, whose front page lists the same four inventors and the same two assignees.)

Original assignee

Adapt Pharma Limited (Dublin, Ireland), jointly with Opiant Pharmaceuticals, Inc. (Santa Monica, CA).

• Product shipped? Yes. Adapt commercialized NARCAN® (naloxone HCl) Nasal Spray 4 mg, FDA-approved November 18, 2015 (NDA 208411), and the '838 patent is Orange-Book-listed against that product (expiry Mar 16, 2035). An FDA-approved, marketed product is about as strong an "operating company" fact as exists.
• Primary line of business: Specialty pharma — nasal opioid-overdose rescue products (Adapt) and addiction/overdose medicines (Opiant, formerly Lightlake Therapeutics).
• Current status: Both original assignees were acquired; neither is independent today.
  • Adapt Pharma Limited is a wholly owned subsidiary of Emergent Acquisitions Limited (Emergent BioSolutions), which acquired Adapt in 2018. The surviving owner entity appearing on the Google Patents record is Emergent BioSolutions Ireland Ltd.
  • Opiant Pharmaceuticals, Inc. was acquired by Indivior PLC — merger agreement November 13, 2022, closing March 2, 2023 (~$145M upfront + up to $8.00/share CVRs). Its patent interest passed to Indivior UK Limited.
• Operating licensee: "Adapt Pharma Operations Limited, a wholly owned subsidiary of Adapt, is a limited exclusive licensee" of the '838 patent (per the joint PTAB mandatory notice in IPR2019-00691).

Assignment timeline

All recorded events I could reconstruct. Where the format asks for reel/frame and correspondent, note my sourcing caveat at the top.

• 2017-05-08 (executed) / recorded 2017-05-08 — Reel/Frame: not retrieved

  • Conveyance: Assignment (inventor → employer)
  • Assignor: Robert Gerard Bell; Fintan Keegan
  • Assignee: Adapt Pharma Limited
  • Correspondent: not retrieved
  • Context: Inventor employment assignment, recorded on the same day the continuation application US 15/589,090 was filed.

• 2017-05-08 (executed) / recorded 2017-05-08 — Reel/Frame: not retrieved

  • Conveyance: Assignment (inventor → employer)
  • Assignor: Roger Crystal; Michael Brenner Weiss
  • Assignee: Opiant Pharmaceuticals, Inc.
  • Correspondent: not retrieved
  • Context: Inventor employment assignment, recorded on the same day the continuation application US 15/589,090 was filed — establishing the two-company co-ownership.

• 2017-10-03 — Issued as US 9,775,838 B2 (Assignee of record at issue: Adapt Pharma Limited and Opiant Pharmaceuticals, Inc.). Not itself an assignment; included to anchor the timeline.

• 2023-06-14 (recorded) — Reel/Frame: not retrieved

  • Conveyance: Assignment (M&A/asset transfer following merger)
  • Assignor: Opiant Pharmaceuticals, Inc.
  • Assignee: Indivior UK Limited
  • Correspondent: not retrieved
  • Context: Corporate acquisition — Opiant's patent estate transferred to the acquirer after Indivior's March 2, 2023 closing; a clean title-cleanup recording, not a fire-sale.

• 2015-03-16 and 2015-11-16 entries on the Google Patents legal-events list ("Priority claimed from US 14/659,472" and "US 14/942,344") are priority claims, not assignments — do not count them as transfers.

Bottom line on the record: This is a short, ordinary three-step chain — two parallel inventor-to-employer assignments in 2017, then one acquirer-side transfer in 2023. There is no post-issuance transfer to any licensing vehicle, holding LLC, or SPV.

Timeline diagram

timeline
    title Ownership of US 9775838
    2014 : Priority application filed
    2015 : NARCAN Nasal Spray approved
    2016 : Adapt sues Teva on naloxone patents
    2017 : Patent issued as US 9775838
         : Inventors assign to Adapt and Opiant
    2018 : Emergent acquires Adapt Pharma
    2019 : Nalox-1 files IPR petitions
    2023 : Indivior completes Opiant acquisition
         : Opiant interest assigned to Indivior UK

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The chain runs Adapt Pharma Limited ↔ Opiant Pharmaceuticals → Emergent BioSolutions Ireland Ltd / Indivior UK Limited. Every entity is an operating pharmaceutical manufacturer or its acquirer. No "IP/Licensing/Holdings/Ventures" suffix, no registered-agent address, no single-purpose LLC appears as assignee. The only LLC anywhere in the ecosystem is Nalox-1 Pharmaceuticals, LLC — and that entity is the challenger, not an owner (see #2).

2. Known asserter in the chain — not present (with an inverse note). None of the current or prior assignees matches the Acacia / Marathon / IV / Wi-LAN / Conversant / Vringo / Pendrell / Round Rock / Spangenberg lists. The notable twist is that the party acting like a serial assertion-driven shell is the IPR petitioner: Nalox-1 Pharmaceuticals, LLC filed fifteen IPRs against the five NARCAN Orange-Book patents (IPR2019-00685 through -00699) on 2019-02-19, and the Federal Circuit/docket record confirms its arguments "were substantially similar to each other and to the arguments Teva made before this Court." That is a challenge-side shell funded to mirror the generic defendant's invalidity case, not an ownership-chain NPE. Flagging it so the direction of the "troll" dynamic isn't misread.

3. Repeat correspondent across the chain — insufficient data. I could not retrieve any correspondent-of-record names for the three assignments. There is therefore no evidence of a recurring filing attorney on this chain, and I decline to infer one. This is the one signal that would genuinely require the Assignment Center record to resolve.

4. Cascading transfers — not present. Three recorded assignments over ~6 years (2017, 2017, 2023), all explained by employment and by two separate corporate acquisitions. No chained LLCs, no shared correspondent addresses, no <24-month daisy chain.

5. Pre-litigation transfer — not present. The operative transfers on this patent are dated 2017-05-08, and the first infringement action (Adapt v. Teva, D.N.J. 2:16-cv-07721) was filed 2016-10-21 — i.e., before the 2017 assignments and before the '838 patent even issued (2017-10-03). The 2017 recordings are continuation-filing employment assignments, not standing/venue engineering. (For completeness: the later Perrigo case, 2:18-cv-15287, was filed 2018-10-25, well over a year after the last relevant assignment.)

6. Bankruptcy fire-sale — not present. No Chapter 7/11 anywhere in the chain. Both exits were solvent, priced acquisitions: Emergent's 2018 purchase of Adapt (a multi-hundred-million-dollar deal) and Indivior's 2023 purchase of Opiant (~$145M upfront plus CVRs).

7. Privateering — not present. The operating owner asserted the patents directly and in its own name — Adapt Pharma Operations Ltd./Adapt Pharma Inc./Adapt Pharma Limited and Opiant Pharmaceuticals, Inc. as named plaintiffs against Teva and Perrigo — rather than funneling enforcement through a proxy NPE.

8. Defensive aggregator — not present. The chain terminates at two commercial pharma owners (Emergent BioSolutions Ireland Ltd and Indivior UK Limited), not at RPX, AST, LOT, Unified, or OIN. The patent has not been neutralized.

Verdict

Operating-company assertion.

The chain terminates at two operating pharmaceutical companies — Emergent BioSolutions Ireland Ltd (successor to Adapt Pharma Limited, recorded in the 2017-05-08 inventor assignments and the 2018 Emergent acquisition) and Indivior UK Limited (successor to Opiant Pharmaceuticals, Inc., per the 2023-06-14 recorded assignment following Indivior's March 2, 2023 closing) — and those owners commercialized the patented subject matter as NARCAN® Nasal Spray (NDA 208411, approved 2015-11-18). Enforcement was brought in the owners' own names against genuine generic competitors (Adapt v. Teva, 2:16-cv-07721, filed 2016-10-21; Adapt v. Perrigo, 2:18-cv-15287, filed 2018-10-25), not through any licensing SPV. Zero of the eight NPE signals is affirmatively present; the only anonymous LLC in the record, Nalox-1 Pharmaceuticals, LLC, sits on the opposing (IPR petitioner) side.

Verification links:

• Assignment Center search: https://assignmentcenter.uspto.gov/ (search patent 9775838)
• Legacy Assignment Search: https://assignment.uspto.gov/patent/index.html
• Google Patents legal events: https://patents.google.com/patent/US9775838/en
• PTAB / docket records: IPR2019-00697, IPR2019-00698, IPR2019-00699 (all "Not Instituted – Merits") — https://portal.unifiedpatents.com/ptab/case/IPR2019-00699; D.N.J. 2:16-cv-07721 and 2:18-cv-15287

Caveat reiterated: reel/frame numbers and correspondent-of-record were not obtainable in this session; if a follow-up requires the correspondent recurring-signal check (signal #3), that field must be pulled from the Assignment Center directly before any conclusion is drawn from it.

I'll research the patent citations and prior art references for US 9,775,838.

Let me get the complete "References Cited" list from the patent's front page.

Let me fetch the patent's front-page citation list directly.

Prior Art Analysis — U.S. Patent No. 9,775,838 B2 ("Nasal drug products and methods of their use")

0. Search confirmation and scope

• Patent identified: US 9,775,838 B2 — application 15/589,090, filed 2017‑05‑08, granted 2017‑10‑03; earliest priority 2014‑03‑14 (U.S. provisional 61/953,379, via Ser. No. 14/659,472 filed 2015‑03‑16); anticipated expiration 2035‑03‑16. Inventors: Fintan Keegan, Robert Gerard Bell, Roger Crystal, Michael Brenner Weiss. Front-page "prior art keywords" (per Google Patents): naloxone, patient, spray, opioid, therapeutically effective.
• Because the application was filed after 16 March 2013, the '838 patent is governed by the AIA version of 35 U.S.C. §§ 102–103. Determining § 102 "prior art" status therefore turns on whether a reference was publicly available/patented/published before 2014‑03‑14 (or, for § 102(a)(2), on the reference's effective filing date).

Methodology caveat (important). I was able to retrieve the patent's indexed citation list (the "References Cited / Citations" data mirrored by Google Patents and PubChem) and the PTAB/district-court record, but I was not able to open the USPTO PatentCenter/patent-PDF front page and transcribe the printed "U.S. PATENT DOCUMENTS / FOREIGN PATENT DOCUMENTS / OTHER PUBLICATIONS" boxes line-by-line (tool budget exhausted). Where I identify a reference's subject matter with confidence, I say so and give the source; where I cannot, I flag it as unverified rather than guess. The list below is the Google Patents/PubChem‑indexed citation set for US 9,775,838 (https://pubchem.ncbi.nlm.nih.gov/patent/US9775838 ; https://patents.google.com/patent/US9775838).

1. What the claims cover (needed to map § 102 art)

The '838 patent has claims 1–46. The IPR2019‑00698 ground table confirms this claim set and groups it as claims 1–2, 4–12, 18, 24, 30, 31, 35, 37 / 3, 32–34 / 13–17 / 19–23, 25–29, 36, 39–40 / 38 / 41–46 (Board Institution Decision, Paper 13, Oct. 16, 2019). In the Teva case the asserted claims were 2, 24, 33 and 38.

Representative independent-claim subject matter (from the family record, cf. the Donovan Declaration quoting the sibling '253 claim 1, which the patents share verbatim specification support):

1. A single-use, pre-primed device adapted for nasal delivery by one actuation into one nostril, single reservoir, aqueous solution of about 100 µL comprising about 4 mg naloxone HCl (or hydrate), about 0.2–1.2 mg isotonicity agent, about 0.005–0.015 mg preservative (e.g., benzalkonium chloride, "BZK"), EDTA, and HCl to pH 3.5–5.5.
2. Downstream claims recite method-of-treatment (opioid overdose), pharmacokinetic (tmax, occupancy, bioavailability) and spray-geometry (ovality ratio, droplet-size Dv(50)/Dv(90), <10 % droplets <10 µm) limitations.

Any § 102 analysis must therefore find, in a single reference, the pre-primed single-use 100 µL nasal device plus the concentrated (≈4 % w/v) naloxone + BZK + EDTA formulation. As set out in §3, no single cited reference does this, which is why the validity fight was decided under § 103, not § 102.

2. Patent documents cited (with § 102 mapping)

2A. Core prior-art patent references (verified content)

2B. Other patent documents on the '838 citation list (identification confirmed, subject matter unverified)

The Google Patents/PubChem citation set for US 9,775,838 also lists the following. I can confirm they appear in the '838 citation data, but I could not verify the technical content of each without the printed front page, so I do not attribute § 102 effect to them:

US 4,181,726 A; WO 98/30211 A1; WO 00/62757 A1 (Davies, Ex. 1009 in the IPR — naloxone formulation); WO 00/74652 A1; WO 00/76474 A1; WO 01/58447 A1; WO 01/82931 A1; WO 02/11778 A1; US 2003/077300 A1; WO 03/084520 A2; WO 2004/054511 A2; WO 2005/020906 A2; US 2006/009447 A1; WO 2006/058022 A1; US 2006/120967 A1; EP 1 681 057 A1; WO 2006/089973 A2; WO 2007/083073 A1; US 2009/017102 A1; WO 2009/040595 A1; US 2010/113495 A1; US 2010/168147 A1; US 2010/331354 A1; US 2011/046172 A1; US 7,977,376 B2; WO 2012/026963 A2; WO 2012/094283 A2; US 2012/270895 A1; WO 2012/156317 A2; US 2013/023825 A1; WO 2014/016653 A1; US 2015/174061 A1; WO 2015/095644 A1; US 2015/258019 A1; WO 2015/136373 A1; WO 2016/007729 A1; US 2016/008277 A1.

Caveat on date/§ 102 status: several of these (e.g., WO 2014/016653, US 2015/174061, WO 2015/095644, US 2015/258019, WO 2015/136373, WO 2016/007729, US 2016/008277) have publication dates that may fall on or after the 2014‑03‑14 priority date. If so they are not § 102(a)(1) prior art and qualify, if at all, only as § 102(a)(2) art keyed to their effective filing dates. I have not verified each date, so I flag this rather than assert it.

2C. Same-family documents (NOT prior art)

U.S. 9,211,253 B2; U.S. 9,468,747 B2; U.S. 9,480,644 B2; U.S. 9,561,177 B2; U.S. 9,629,965 B2.

These are continuation/co-pending family members sharing the 2014‑03‑14 priority (the '838 claimed priority from Ser. Nos. 14/659,472 and 14/942,344). Because they share the same earliest effective filing date and the same disclosed subject matter, they are not available as prior art against the '838 either under § 102(a)(1) or § 102(a)(2). They appear in the citation list as family/priority documents, not as references. (The Page/Bradley/DrugPatentWatch and Justia "Referenced Cited" tables list 4,464,378 / 5,866,154 / 9,775,838 together for descendants of this family.)

3. Non-patent literature cited (and its salience)

Printed publications cited by the applicant (verified from the petition/IDS record):

Also on the record: an APTAR press release (Ex. 1018), Alabama EMS protocols (2013) (Ex. 1017), Ashton (2006) (Ex. 1019), Barton (2002) (Ex. 1020), and Grassin‑Delyle (2012) (Ex. 1011) — device/marketing and PK references, all § 103‑type background.

4. Ranking: the most relevant prior art and the § 102 verdict

Tier 1 — references that come closest to a single-reference § 102 challenge:

1. CN 1575795 A (Wang), pub. 2005‑02‑09 — intranasal naloxone formulation. The best single-reference candidate for the method claims (24, 33) and a component of every asserted § 103 ground.
2. U.S. 9,192,570 B2 (Wyse), issued 2015‑11‑24 — intranasal naloxone with BZK, but whose degradation data the Board/district court read as teaching away from the claimed BZK+EDTA formulation — i.e., it rebuts rather than establishes § 102.
3. WO 82/03768 (Hussain), 1982 and U.S. 4,464,378 (Hussain), 1984 — the foundational intranasal-naloxone disclosures, but at 1 % w/v / 0.2–5 mg doses and without a pre-primed single-use 100 µL device, BZK or EDTA.

Tier 2 — § 103 combination references: U.S. 5,866,154 (Bahal), U.S. 8,198,291 (Wermeling), WO 00/62757 (Davies), HPE (6th ed.), Djupesland (2013), Kushwaha (2011), Zomig Review (2002), Kundoor & Dalby (2011).

Bottom-line § 102 conclusion (grounded in the record):

No single cited reference anticipates claims 1–46 of the '838 patent under 35 U.S.C. § 102. The challengers themselves pleaded § 103, and both the District of New Jersey (final judgment Jun. 26, 2020; opinion Jun. 5, 2020) and the Federal Circuit (Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 2020‑2106, affirmed Feb. 10, 2022) invalidated the asserted '838 claims (2, 24, 33, 38) as obvious — not as anticipated. The three Nalox‑1 IPRs against the '838 (IPR2019‑00697/00698/00699) were denied institution on Oct. 16, 2019, the Board agreeing that Wyse teaches away from BZK. So § 102 was never established for any claim, by any reference.

The closest § 102 arguments, all of which fail on at least one limitation, are: Wang (misses the pre-primed single-use 100 µL device and the specific BZK/EDTA/pH combination); Wyse (teaches away from BZK and lacks the single-use pre-primed device); Hussain '378 / WO 82/03768 (concentration/dose far below 4 % and no device or BZK/EDTA).

5. Explicit uncertainties and caveats

• Full front-page transcription not obtained. The § 2B list gives the citations as indexed; I could not verify each reference's subject matter or exact date from the printed patent front page. Treat § 2B as a lead list, not a verified § 102 analysis.
• AIA vs. pre-AIA status of some § 2B items (2014–2016 publications) is unresolved — they may be § 102(a)(2)-only art, or not prior art at all.
• § 102 vs. § 103. The user asked for § 102 anticipation mapping. I have therefore reported the references that could be argued as anticipatory and stated plainly where the record shows they were actually used (as § 103 combinations). I have not converted § 103 combinations into fabricated § 102 anticipations.
• Consistency with the earlier litigation section: it states the asserted '838 claims were 2, 24, 33, 38 and that the '838 IPRs were not instituted. That is consistent with everything found here. One minor discrepancy to flag: the earlier section dates the Nalox‑1 petitioner filings to Feb. 19, 2019, which matches the docket; the Google Patents "litigation" panel labels the IPRs "Not Instituted – Merits," also consistent with the Oct. 16, 2019 denials.

Primary URLs used: https://patents.google.com/patent/US9775838 ; https://pubchem.ncbi.nlm.nih.gov/patent/US9775838 ; https://patents.justia.com/patent/20170239241 ; https://portal.unifiedpatents.com/ptab/case/IPR2019-00698 ; https://www.docketalarm.com/cases/PTAB/IPR2019-00698/ (Institution Decision, Paper 13, Oct. 16, 2019) ; https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf.

I'll research the prior-art record that the Federal Circuit, the district court, and the PTAB actually relied on for this patent family, then build the § 103 analysis.

Let me pull the exact claim language and identify the specific prior-art references relied on.

Let me pin down the Strang reference identity and the second independent claim.

Obviousness Analysis — U.S. Patent No. 9,775,838 B2 (35 U.S.C. § 103)

Analyst note on scope and sources. I do not have live access to the USPTO Patent Center or PACER. Everything below is grounded in (a) the patent text and prior-art citations on the Google Patents page for US 9,775,838 B2, (b) the PTAB institution decision in IPR2019‑00698 (Paper 13, Oct. 16, 2019), (c) the D.N.J. post-trial opinion and final judgment in Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 2:16‑cv‑07721 (D.N.J. 2020), and (d) the Federal Circuit opinion in No. 20‑2106, 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022).

Date discrepancy flag: the task header says the current date is April 26, 2026, while my operating instructions say today is September 30, 2026. I flag this rather than silently choosing one; it has no bearing on the legal analysis below, which is anchored to the 2014–2015 priority window and to events through 2022.

1. Resolution of the claim-numbering uncertainty flagged in the earlier sections

The previously generated "Patent summary" flagged that it could not state how many independent claims the '838 patent has, and noted a possible mismatch between application claim 31 and issued claim 1. That uncertainty is now resolved, from two independent primary sources:

• The PTAB in IPR2019‑00698 states: "Claims 1 and 41 are the only independent claims of the '838 patent," and reproduces claim 1 verbatim (Ex. 1001, 63:5–13).
• The D.N.J. post-trial opinion (ECF No. 344) quotes claim 1 with the same text.

Issued claim 1 (verbatim, as reproduced by the Board):

"1. A method of treating opioid overdose, the method comprising: delivering a 25–200 µL spray of a pharmaceutical solution from a pre-primed device into a nostril of a patient, wherein the device is adapted for nasal delivery, 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."

So: two independent claims (1 and 41), 46 claims total (1–46) per the Board's statement of the challenged set. I verified claim 1's text directly. I could not retrieve claim 41's verbatim text in this session, so I treat its scope as unverified — I will not build the analysis on a guess about it.

Contradiction flag vs. prior sections: the earlier "Patent summary" listed the asserted claims as 2, 24, 33, and 38. The D.N.J. opinion corroborates this, and the PTAB's own listing in IPR2019‑00698 confirms that the '838 claims asserted at trial were a subset of the full 1–46 claim set. Consistent. The only correction is that the earlier summary's hedging on claim 1/31 numbering can now be dropped in favor of the verified claim 1 text above.

2. Governing framework and the person of ordinary skill

Under Graham v. John Deere Co., 383 U.S. 1 (1966), and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the § 103 inquiry asks whether the differences between the claimed invention and the prior art would have been obvious to a person of ordinary skill at the time of the invention, considering (i) the scope and content of the prior art, (ii) the differences, (iii) the level of ordinary skill, and (iv) objective indicia. KSR authorizes a motivation to combine drawn from "interrelated teachings of multiple patents," "any need or problem known in the field," "market forces," and the "background knowledge, creativity, and common sense of the person of ordinary skill." No rigid requirement of expert testimony exists for every step. Id. at 418–21.

POSITA. The record shows two overlapping skill profiles, which matters because several disputes turned on which profile was being asked what:

• A "Formulator POSA" — experience in nasal/injectable pharmaceutical formulation development, excipient selection, and stability testing (this profile drove the BZK/EDTA disputes in the IPRs).
• A "Clinician POSA" — experience with opioid overdose emergency medicine and naloxone dosing (this profile drove the 4 mg dose dispute; Patent Owners challenged the qualifications of Nalox‑1's declarant Dr. Hochhaus to opine on "clinical motivations," per the IPR2019‑00688 Surreply).

I did not retrieve the district court's verbatim POSITA definition; the two-profile framing above is drawn from the IPR briefing and should be treated as a reasonable reconstruction rather than a quotation.

3. The prior-art landscape on the face of the patent and in the trial/IPR record

3.1 Art appearing on the '838 patent page itself

The patent's own specification and the Google Patents page establish that the concept was squarely in the art well before the priority date:

Key point: the concept — intranasal naloxone for opioid overdose — is admitted prior art on the face of the '838 patent. The § 103 fight is therefore entirely about the formulation parameters and the device/dose combination, not the therapeutic concept.

3.2 The trial/IPR references (the two asserted combinations)

4. Combination A — Davies + Kerr 2009 / Kerr Formulation + Bahal

This was Teva's first pleaded combination and the one affirmed on appeal.

4.1 Element-by-element mapping to claim 1

Note: the claimed BZK range (0.005–0.015% w/v) is literally disclosed by the Kerr Formulation at 0.01%. That is not anticipation because no single reference contains all limitations, but it is powerful evidence for the § 103 range-optimization analysis.

4.2 Why a POSITA would have combined them

1. Same field of endeavor, same problem, same goal. All three references address naloxone — Davies and Kerr 2009 intranasally for overdose; Bahal parenterally for stability. The Federal Circuit held they are "clearly within a common field of endeavor." Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc., 774 F.3d 968, 978 (Fed. Cir. 2014).
2. Known, documented shortcomings of the MAD Kit. The specification itself (and Dowling 2008) supplies the problem: the MAD Kit requires assembly, delivers 1 mL/nostril (> the ~200–250 µL nasal cavity volume), and loses drug to nasopharyngeal/external drainage. KSR recognizes "any need or problem known in the field of endeavor at the time of invention and addressed by the patent" as a motivation.
3. Express FDA guidance (2012). The district court found, and the Federal Circuit did not disturb, that the FDA publicly encouraged development of an approved intranasal naloxone product delivering comparable naloxone to the approved injectable, and recommended considering a dose higher than the contemplated 2 mg. This is an external, documented, pre-priority motivation.
4. Interrelated teachings. Kerr 2009 recognizes the benefits of IN naloxone and flags the re-dosing problem; Davies supplies a small-volume, single-trip, concentrated spray device; Bahal supplies the solution to naloxone's known instability. The references "step[] each other in the right direction."
5. Routine optimization of disclosed ranges. Each excipient concentration is disclosed in the art (NaCl 0.2–1.2 mg/100 µL in Davies and Kerr; BZK 0.01% in Kerr and BZK 0.002–0.02% in HPE; EDTA 0.0001–1.0% in Bahal; acidic pH in Davies/Bahal/HCl). Adapt never argued the claimed ranges were critical; absent criticality, overlap/optimization suffices (Almirall, LLC v. Amneal Pharms. LLC; In re Applied Materials).

Conclusion on Combination A: claim 1 (and its dependent claims) would have been obvious. This is not merely my reconstruction — it is the holding of the D.N.J. bench trial (June 5, 2020 opinion; June 26, 2020 judgment) and the Federal Circuit's affirmance (25 F.4th 1354).

5. Combination B — Strang + Kulkarni + Djupesland

This was Teva's second combination.

5.1 Element-by-element mapping

5.2 Motivation to combine

1. Strang's own express invitation to supplement. Strang states that typical intranasal excipients "are known to the skilled person." That is a textual, in-reference reason to consult an excipient compendium like Kulkarni — not a hindsight construction.
2. Missing device detail supplied by Djupesland. Djupesland expressly identifies the Aptar UnitDose as the device for exactly this use case (sporadic, tight-dose-control nasal delivery), and the device was commercially available. A POSITA seeking to commercialize Strang would not have needed to invent a device.
3. Dose direction is explicit. Strang supplies the 4 mg starting dose and the 3–4 mg ≈ 1 mg IM equivalence — the very dose the FDA suggested.
4. pH and excipient concentrations resolve by routine optimization within overlapping disclosure ranges, and no criticality evidence was presented.

Conclusion on Combination B: claim 1 would have been obvious. Again, this reflects the D.N.J. holding and the Federal Circuit's affirmance.

6. Additional/alternative combinations and why they matter

6.1 Wyse + HPE (the IPR ground)

Nalox‑1's Wyse-based petition argued: Wyse teaches an antimicrobial preservative at 0.1–2% w/v, plus EDTA as a stabilizer, in an intranasal naloxone formulation — and HPE teaches that BZK is the conventional broad-spectrum nasal preservative effective at 0.002–0.02% w/v, which fully encompasses the claimed 0.005–0.015% range.

This is, on paper, a complete § 103 case. It failed at the institution stage — but on a teaching-away ground, not on the prima facie case. The Board held that Wyse "expressly teaches that [BAC] is unacceptable for use in intranasal naloxone formulations," that Wyse "does both" — discouraging BAC and pointing to a working alternative (benzyl alcohol) — and denied institution under 35 U.S.C. § 314(a) for all challenged claims (IPR2019‑00698, Paper 13).

Important caveats on the weight of that denial:

• A denied institution is not a merits adjudication. The Board did not "confirm the claims"; it declined to institute. The Board's denial is expressly limited to "the evidence and arguments presented in this proceeding."
• The Board's analysis is reconcilable with the district court's, because the records differed: the district court had testimony that Wyse tested BZK at 0.125% — 8.5× the claimed concentration, and that a POSITA would be dissuaded only from high BZK concentrations, and it had Davies and the Kerr Formulation showing BZK used with naloxone at 0.01% without reported stability concerns. The IPR record did not include that counterweight in the same form.
• Wyse may not even be prior art. The Federal Circuit noted Wyse "published on June 25, 2015, after the priority date of the patents-in-suit." Patent Owners expressly reserved that point in the IPRs ("for the purpose of these proceedings … Patent Owners will not dispute that Wyse … [is] prior art"). If Wyse is not § 102(a)(1)/(2) art (depending on its effective filing date relative to the '838 priority chain), its entire teaching-away effect evaporates — and its role in any ex parte reexamination or later validity challenge would need to be re-litigated.

Practical implication: the Wyse-based route is the only material obstacle to invalidity of claim 1, and it is itself infirm on multiple independent grounds.

6.2 Background "concept" art (Hussain '378; WO 82/03768; Dowling 2008; Wermeling 2013)

These do not by themselves reach the formulation/device limitations. Their role is to (i) establish that intranasal naloxone was known and clinically used before the priority date, eliminating any "inventive concept" argument about the route of administration, and (ii) establish the known problem (Dowling's ~4% relative bioavailability; drainage loss at 1 mL/nostril) that supplies the motivation to optimize. Wermeling's 2013 review, "A response to the opioid overdose epidemic: naloxone nasal spray," is particularly useful as a framing reference showing that a skilled artisan was already working on exactly this problem.

7. Teaching away and reasonable expectation of success

Teaching away. Only Wyse is seriously argued. Under DePuy Spine and In re Gurley, a reference teaches away only if a POSITA, "upon reading the reference, would be discouraged from following the path set out in the reference." A reference that discredits high concentrations of an excipient does not teach away from a claimed range 8.5× lower, especially where (a) the same excipient is used at the claimed concentration with the same drug in other prior art (Kerr Formulation at 0.01%), (b) it is "perhaps the most commonly used … preservative in nasal formulations," and (c) it appears in the FDA's IIG for nasal preparations. And as Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) holds, "there is no rule that a single reference that teaches away will mandate a finding of nonobviousness" — the prior art must be considered as a whole.

Reasonable expectation of success. High, on the trial record: the excipients were known and used in nasal and naloxone formulations; the concentrations were disclosed within or overlapping the claimed ranges; the device was commercially available and FDA-approved; and the pH and tonicity targets were dictated by nasal tolerability. That the FDA "fast-tracked" the NDA does not convert a routine optimization into a nonobvious invention.

Counter-consideration (for completeness): the Fed Cir majority characterized the case as "close," and Judge Newman's dissent called the analysis "a classical example of judicial hindsight," noting that "the invention itself [was] the only guide to the selections from the prior art." Any party relitigating this patent should expect the teaching-away/hindsight fight to be the whole ballgame.

8. Dependent claims (including the asserted claims 2, 24, 33, 38)

The § 103 case is stronger, not weaker, for the asserted dependents:

• Claim 2 (about 4 mg naloxone) — Strang expressly prefers a 4 mg starting dose; the FDA recommended a higher dose than 2 mg; Kerr 2009 supplies the re-dosing rationale.
• Claim 24 (reservoir ≤ ~140 µL) — Djupesland/Aptar UnitDose fills 125 µL, emitting 100 µL; Strang's preferred volumes are 50–200 µL; the ~200–250 µL nasal cavity volume makes ≤140 µL the natural design choice.
• Claim 33 (NaCl / BZK / disodium edetate / HCl) — each excipient is separately disclosed in Davies (NaCl, BZK, acidic pH), Kerr Formulation (NaCl, BZK 0.01%, HCl), Bahal (EDTA, NaCl, HCl), Kulkarni (BZK/EDTA/NaCl with FDA IIG maxima), and Strang (pH ≤5.5). The Federal Circuit specifically rejected the argument that "no single reference discloses naloxone in combination with all of the claimed excipients" — because the case is one of obviousness, not anticipation.
• Claim 38 (device architecture: reservoir, piston, swirl chamber; plunger housing a container closure with vial, cannula, and rubber stopper pierced by the cannula) — this is the Aptar UnitDose/BDS architecture, which the D.N.J. found to be "an inherent feature of the Aptar UnitDose device" and which Davies' disclosure describes (reservoir, piston, swirl chamber). A structural claim to an off-the-shelf, commercially available device is a difficult nonobviousness position.

Unverified: the scope of independent claim 41. I did not retrieve its text, so I do not opine on it. Because it is the only other independent claim, its construction should be confirmed before relying on any family-wide validity conclusion.

9. Objective indicia of nonobviousness

All were considered and all failed (with one harmless error):

Net: even crediting Adapt's objective evidence at full weight, five of six categories were found probative of nothing, and the sixth was neutralized by the short duration of the need.

10. Adjudicated outcome and residual exposure

Contradiction flag vs. prior sections: the earlier "Patent summary" states IPR2019‑00698's denial rested on Wyse teaching away and characterizes the mechanism as BZK+EDTA. That is confirmed. However, the earlier section attributes IPR2019‑00698 to "Wang" (petition lead reference). Both are true: the ‑00698 petition had Wang as its lead reference, but the ‑00698 institution decision nevertheless relied on Wyse's BZK disclosure/teaching-away because all three petitions (per Patent Owners) "contain the same discussion on Wyse's teaching on BZK — or, more precisely, teaching away — verbatim," and all three relied on HPE, not the lead references, for the BZK teaching. This is a nuance the earlier sections left implicit.

Also flag: the earlier "Patent summary" cites the trial judgment date as "June 5, 2020" while the "Litigation summary" cites "June 26, 2020." Both appear in the record: the opinion is dated June 5, 2020 and final judgment was entered June 26, 2020. I treat them as consistent rather than contradictory.

11. Bottom line

On the § 103 merits, the claims of US 9,775,838 B2 are obvious over two independent, fully articulated combinations:

1. Davies + Kerr 2009 / Kerr Formulation + Bahal — Davies supplies the small-volume (20–100 µL), single-trip, one-handed intranasal naloxone spray with BZK, NaCl, and acidic pH; Kerr 2009 supplies the clinical rationale (IN ≈ IM efficacy, ease of use by untrained bystanders, frequent re-dosing motivating a higher concentration within Davies' 0.2–5.0 mg range); the Kerr Formulation supplies BZK at 0.01% — inside the claimed range — and NaCl and HCl; Bahal supplies the EDTA anti-degradation teaching with a disclosed 0.0001–1.0% range.
2. Strang + Kulkarni + Djupesland — Strang supplies the ≤250 µL intranasal naloxone dosage form, the ≥0.5 mg–12 mg dose range with an explicit 4 mg preference, the 3–4 mg IN ≈ 1 mg IM equivalence, pH ≤5.5, NaCl, and an express statement that intranasal excipients "are known to the skilled person"; Kulkarni supplies the excipient list with FDA IIG maxima (BZK, EDTA, NaCl, pH 4.5–6.5); Djupesland supplies the commercial Aptar UnitDose device (125 µL fill / 100 µL emitted, single actuation) for sporadic-use nasal delivery.

Motivation to combine is supplied independently by: the widely known and self-documented shortcomings of the MAD Kit; the FDA's 2012 public call for an approved intranasal naloxone product delivering comparable naloxone to the injectable; the "interrelated teachings" of references in the same field addressing the same problem; and routine optimization of excipient concentrations within overlapping disclosed ranges, with no showing of criticality.

The only credible obstacle is the Wyse teaching-away argument — and it is weak: it addresses a BZK concentration 8.5× higher than claimed; the Federal Circuit noted Wyse published after the priority date; and the prior art as a whole (Kerr Formulation, Davies, HPE/FDA IIG, and expert testimony) teaches BZK as the conventional nasal preservative. The PTAB's contrary conclusion was a § 314(a) institution denial on a different record, not a merits finding of nonobviousness.

Residual uncertainty: (a) independent claim 41's scope is unverified in this session; (b) claims other than 2, 24, 33, 38 were not adjudicated in the Teva case; (c) the district court docket is behind PACER, so sealing/termination details may be incomplete; (d) my confidence in the legal conclusion is high as to the asserted claims (it is a court holding), and moderate-to-high as to the unasserted formulation/device claims by extension, because they recite features the record shows were known or commercially available.