US 10624911

I'll search for authoritative information on this patent number and related litigation.

Let me check for any CAFC 2026 appellate dockets and PTAB proceedings involving this patent.

Let me verify whether there's any Federal Circuit (CAFC) 2026 docket involving this patent specifically.

US Patent 10,624,911 — Summary

Important caveat up front: I did not find any Federal Circuit (CAFC) 2026 docket, or any CAFC appeal at all, involving US 10,624,911. Searches of PTAB/CAFC-related reporting returned only district-court and PTAB activity for related Helsinn patents. I also cannot directly query the USPTO PatentCenter or CAFC docket APIs, so my district-court and PTAB findings come from secondary aggregators (DrugPatentWatch, CourtListener RECAP, PTAB petitions hosted on ptacts.uspto.gov). Treat the litigation/PTAB items below as "reported," not as verified docket entries.

Bibliographic data (as reported)

Source: https://patents.google.com/patent/US10624911/en; https://www.drugpatentwatch.com/p/patent/10624911; https://pharsight.greyb.com/ingredient/fosnetupitant-chloride-hydrochloride;-palonosetron-hydrochloride-patent-expiration

Abstract (verbatim)

"Injectable dosages and formulations of fosnetupitant and pharmaceutically acceptable salts thereof are provided that are efficacious, chemically stable and physiologically balanced for safety and efficacy."

Claim-set note

A discrepancy worth flagging: independent claims 1 and 2 recite palonosetron hydrochloride as a required element ("from 5 to 50 μg/mL"), whereas the written description consistently describes palonosetron as optional. Claims 1 and 2 also contain no pH limitation (only claims 3 and 4, at pH 7.0–10.0, and dependent claims 14–17, at pH 7.5–10.0, do). Claim 3 has an apparent lettering gap — "e) NaOH; optionally HCl; and g) water q.s." (no element "f)"). I am quoting this literally and not correcting it.

Plain-language overview of each independent claim

• Claim 1 — Liquid formulation. A stable injectable liquid containing fosnetupitant chloride hydrochloride at 2.3–30 mg/mL, palonosetron HCl at 5–50 μg/mL (free-base basis), sodium hydroxide, disodium edetate, optionally hydrochloric acid, and mannitol. No pH limit and no water q.s. element.

• Claim 2 — Lyophilized formulation. Same ingredient list as claim 1, but the product is a lyophilized (freeze-dried) formulation. Again no pH limit.

• Claim 3 — Liquid solution at defined pH with quantitative excipient ranges. A liquid injectable at pH 7.0–10.0 with fosnetupitant chloride hydrochloride 2.3–30 mg/mL, palonosetron HCl 5–50 μg/mL, disodium edetate 0.05–0.9 mg/mL, mannitol 10–100 mg/mL, NaOH, optionally HCl, and water q.s.

• Claim 4 — Lyophilized powder at defined pH. A lyophilized powder injectable at pH 7.0–10.0 (concentrations expressed based on reconstitution in a suitable water volume) with fosnetupitant chloride hydrochloride 2.3–30 mg/mL, palonosetron HCl 5–50 μg/mL, disodium edetate 0.1–2.0 mg/mL (higher than claim 3's liquid range), mannitol 10–100 mg/mL, and NaOH and optionally HCl.

• Claim 7 — Manufacturing method. A method of making either a liquid injectable or lyophilized fosnetupitant formulation by (a) simultaneously admixing fosnetupitant chloride hydrochloride with sodium hydroxide in water at a basic pH of ~11–14 to dissolve it, (b) lowering the pH to a still-basic ~7–10 with one or more acidic pH adjusting agents, and (c) optionally adding pharmaceutically acceptable excipients. (The specification notes disodium edetate and/or HCl as preferred acidifying agents; claim 18 limits the agent to HCl.)

• Claim 8 — Reconstituted infusion formulation. An intravenous fosnetupitant formulation made by mixing the lyophilized formulation of claim 2 with 0.9% saline or 5% glucose (i.e., a product-by-process style claim directed at reconstitution/dilution practice).

• Claim 19 — Broad genus/formulation. The broadest independent claim: a stable injectable liquid fosnetupitant formulation comprising 2.3–30 mg/mL fosnetupitant chloride hydrochloride, 5–50 μg/mL palonosetron HCl, an alkalizing agent, and an alkaline pH — i.e., defined generically by class of base and by pH rather than by specific excipients. Claims 20–21 narrow it to NaOH at pH 7–10 and to about 13.0 mg/mL fosnetupitant / 14.04 μg/mL palonosetron HCl.

Related (dependent) claims of interest

• Claims 5–6, 12–13, 15–17: lyophilized variants, with claim 6 specifying ~13.0 mg/mL fosnetupitant chloride hydrochloride, ~14.04 μg/mL palonosetron HCl, ~0.32 mg/mL disodium edetate, ~38 mg/mL mannitol, pH 8.5–9.5, 20 mL reconstitution.
• Claims 9–11, 14: liquid variants (claim 11 mirrors claim 6's quantitative profile at pH 8.5–9.5).
• Claim 21 is notably broad (NaOH + pH 7–10 with the two actives).

Reported litigation / PTAB activity (not verified against primary dockets)

• District court: Helsinn Healthcare SA v. Gland Pharma (or Gland) — D.N.J. docket 2:22-cv-04635 (also indexed as 3:22-cv-04635), filed 2022-07-18, terminated 2022-12-23. The asserted patents reportedly include the '911 patent along with '450, '586, '357, '772, '907, '073, '721, '297 and '698, based on Gland's ANDA No. 217374 for EQ 11.75 mg/mL fosnetupitant chloride hydrochloride / 0.0125 mg/mL palonosetron HCl, 235 mg/0.25 mg per 20 mL vials. (Sources: CourtListener RECAP docs at https://storage.courtlistener.com/recap/gov.uscourts.njd.[499051](/patent/499051)/; Google Patents "Family has litigation" links; https://www.drugpatentwatch.com/p/alphasignals/litigation/drugname/index.php?query=fosnetupitant+chloride+hydrochloride%3B+palonosetron+hydrochloride)
• PTAB: The IPR activity I could identify for this drug family is not against the '911 patent. Azurity Pharmaceuticals filed IPRs against US 10,828,297 and US 9,186,357 (filed 2025-05-01; institution decision 2025-11-19), and related petitions IPR2025-00945 through -00949 concern US 8,623,826, 9,186,357, 9,943,515 and 10,828,297. I found no PTAB challenge to 10,624,911. (Sources: ptacts.uspto.gov petition documents; docketalarm IPR2025-00948 institution decision.)
• CAFC 2026: No appeal involving 10,624,911 was found. I checked Federal Circuit argument calendars/summaries circulating for 2026 (April and June 2026 panels) and found no Helsinn/Akynzeo entry. If an appeal exists, it is not surfacing in the sources I can reach — this is a genuine gap in my answer, not a confirmed negative.

Post-grant family activity (same priority, 2016-06-06)

Continuation/divisional filings from the same family include US 16/817,683 (US 11,529,362 B2), US 17/986,934 (US 12,208,109 B2), US 18/999,533 (US 2025/0235473 A1) and US 19/347,686 (US 2026/0027138 A1). Note that the '109 continuation appears to drop palonosetron from independent claim 1, claiming an "active ingredient component consisting essentially of" fosnetupitant chloride hydrochloride plus an alkalizing agent — a materially different claim scope from the '911 patent.

Uncertainties / things I could not confirm

1. No authoritative confirmation of a CAFC 2026 docket for this patent — searches returned nothing; I cannot rule out an appeal that simply isn't indexed in the sources reached.
2. The docket number discrepancy (2:22-cv-04635 vs. 3:22-cv-04635) appears in Google Patents and in the aggregator table; I could not verify which is the operative number (New Jersey has used both Camden 1:xx and Newark 2:xx/3:xx prefixes).
3. The 2022-12-23 termination date may reflect a dismissal/refiling event rather than final resolution of an infringement merits decision; I did not find a judgment or settlement document.
4. I could not retrieve the USPTO PatentCenter or Patent Assignment records directly; the maintenance-fee, terminal-disclaimer, and any reissue/re-examination status are therefore not confirmed beyond "Active" as reported by Google Patents.
5. Claim 7's preambles differ between the patent (as granted, "simultaneously admixing … at a basic pH of from approximately 11 to 14") and the as-published application/specification summary, which describes only "admixing" — I report the granted text as controlling.

I'll research the litigation history for US patent 10624911 (fosnetupitant formulations, Helsinn Healthcare SA).

Let me gather more detail on specific cases and related IPR proceedings.

Let me confirm whether the '911 patent was asserted in any other litigation and check the Slayback/Azurity matters.

Litigation Involving U.S. Patent No. 10,624,911

Interpretation note: I have treated the identifier "10624911" literally as U.S. Patent No. 10,624,911 ("Physiologically balanced injectable formulations of fosnetupitant," Helsinn Healthcare SA). No similar-but-different numbers are included.

Summary finding

Based on my searches, U.S. Patent No. 10,624,911 appears in exactly one known litigation: a single Hatch‑Waxman/ANDA Paragraph IV action brought by Helsinn Healthcare S.A. against Gland Pharma Limited in the District of New Jersey. It was resolved by a negotiated consent judgment. I found no other district court actions, no CAFC appeal of this patent, and no PTAB proceeding against this specific patent.

(Note: the Google Patents record for this patent flags two New Jersey District Court docket links — 3:22-cv-04635 and 2:22-cv-04635. These are the same case; the docket carries both a Newark ("2:") and Trenton ("3:") division designation. It should not be counted as two suits.)

Case 1 — Helsinn Healthcare S.A. v. Gland Pharma Limited

Supporting sources:

• Google Patents "Family has litigation" entries pointing to D.N.J. cases 3:22-cv-04635 and 2:22-cv-04635 (https://patents.google.com/patent/[US10624911](/patent/US10624911)/en).
• Consent Judgment and Dismissal Order text naming the '911 patent among the "Helsinn Patents": https://paragraphfour.com/wp-content/uploads/2022/07/njdc22cv4635CJ.pdf and https://www.courtlistener.com/docket/63601016/50/helsinn-healthcare-sa-v-gland-pharma-limited/
• Gland's counterclaims referencing the '911 patent (EX. H) and its Paragraph IV notice letters: https://storage.courtlistener.com/recap/gov.uscourts.njd.[499051](/patent/499051)/gov.uscourts.njd.499051.25.0.pdf
• Docket termination entry (Consent Judgment, all claims dismissed with prejudice; terminated 12/23/2022): https://www.courtlistener.com/docket/63601016/helsinn-healthcare-sa-v-gland-pharma-limited/
• Litigation listing for Helsinn showing 10,624,911 (filed 2022-07-18; terminated 2022-12-23; D.N.J.; 35:271): https://www.drugpatentwatch.com/p/alphasignals/litigation/party/index.php?query=Helsinn

Important distinction: The counterclaim docket text initially refers to the complaint as "Case No. 2:22-cv-04635," while the order header and CourtListener show "3:22-cv-04635-ZNQ-JBD." Same action — do not treat as distinct cases.

Related matters that do NOT involve U.S. 10,624,911 (for completeness)

To avoid over-attribution, note the following Helsinn proceedings that are sometimes confused with, but do not target, the '911 patent:

• Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A. — IPR2025-00945, -00946, -00947, -00948, -00949 (PTAB). These inter partes review petitions challenge U.S. 8,623,826; 9,186,357; 9,943,515; 10,828,297; and related patents — not the '911 patent. (Sources: docketalarm.com IPR2025-00948 docket; PTAB institution decision granting review, Nov. 19, 2025.)
• Pre-2017 Helsinn actions (e.g., the palonosetron "Aloxi" cases against Teva, Dr. Reddy's, Sandoz, Mylan, Hospira, Baxter) involve different patents (the '724, '725, '424, '219, '981, '826 patents) and predate issuance of the '911 patent.
• The Slayback Pharma Paragraph IV notice (Dec. 2023) surfaced in the search results relates to a different product line (CINVANTI®/aprepitant) and does not name the '911 patent.

Caveats

• My searches were based on public aggregators (Google Patents, DrugPatentWatch, CourtListener/RECAP, ParagraphFour, PTAB dockets). These are not guaranteed complete, so I cannot rule out a sealed or very recent filing involving the '911 patent that has not yet surfaced in these databases.
• I found no CAFC appeal concerning the '911 patent; the Gland action ended in a consent dismissal rather than a litigated judgment, so no appeal would ordinarily follow as to this patent.
• I did not locate any decision on the merits (validity or infringement findings) for the '911 patent itself — the consent judgment expressly states "No decision has been obtained by the parties from this Court regarding these charges of infringement or these defenses and counterclaims."

If you need me to pull the full docket entry list or the sealed/redacted consent judgment pages specific to the '911 patent, I can narrow further on the CourtListener docket 63601016.

I'll verify the ODP "no proceedings" default against public sources before writing this up.

Let me run additional targeted checks on the PTAB dockets and the related litigation.

Two more checks to confirm nothing was filed against the '911 patent specifically.

PTAB Proceedings — US Patent No. 10,624,911 ("Physiologically balanced injectable formulations of fosnetupitant", Helsinn Healthcare SA)

Proceedings overview

Total AIA trial proceedings on file against US 10,624,911 as of 2026-09-18: 0 (0 active, 0 with claims invalidated, 0 with claims sustained, 0 settled, 0 institution-denied) — the USPTO Open Data Portal returns no AIA proceedings, and my independent checks of PTAB dockets and third-party litigation trackers found none either, so the bottom line for a defendant is that this patent has never been tested at the PTAB: no claim has been canceled, no claim has been affirmed, and no § 315(e) estoppel exists against anyone — meaning the full § 102/§ 103 printed-publication toolkit remains available, but you get none of the shortcut benefit of a prior FWD knocking out claims. The one thing to watch is that Helsinn's Akynzeo IV patent family is under active IPR attack by Azurity Pharmaceuticals — just against sibling patents, not the '911 patent (details below, clearly flagged as not this patent).

Because there are no proceedings to render claim-by-claim, the per-proceeding template is replaced with an "adjacent proceedings" section, followed by the strategic read.

No proceedings on US 10,624,911

• Type: n/a
• Filed: n/a
• Status: No AIA trial proceeding on file (ODP canonical list is empty; corroborated by search)
• Judge panel / petition grounds / institution decision / FWD / settlement / appeal: none exist. I will not supply these, because inventing a docket number or a panel would be worse than an empty field.
• Corroboration: DrugPatentWatch's PTAB-case table for the fosnetupitant/palonosetron drug product lists only Azurity petitions against US 10,828,297 and US 9,186,357 (filed 2025-05-01, decision dates 2025-11-19) — not the '911 patent — and its per-patent page for 10,624,911 shows only district-court litigation, no PTAB row (DrugPatentWatch PTAB table; DrugPatentWatch patent page). Google Patents' "Family has litigation" flags on the '911 record are district-court entries in D.N.J., not PTAB (US10624911B2).

Adjacent proceedings — NOT on US 10,624,911 (context only)

These matter because they show the enforcement posture around Helsinn's injectable Akynzeo portfolio and because they will shape any future petition against the '911 patent. Do not cite these as proceedings on the '911 patent.

Caveat on docket-to-patent mapping: public snippets conflict on which docket number maps to which patent (e.g., IPR2025-00948 is described in one source as involving 9,943,515, while a party brief in the same docket number discusses the '297 patent, and the five-petition list is rendered inconsistently across text extractions). I am therefore giving you the cluster but not asserting a specific IPR number ↔ patent pairing. Verify each on PTAB E2E before relying on it. If you need exact pairings, that is a 10-minute E2E lookup per docket.

What is unambiguous: none of the Azurity petitions is directed at US 10,624,911, US 11,529,362, or US 12,208,109 — the three issued members of this patent's family.

Strategic summary

Claim status on the '911 patent. Zero claims are canceled; zero claims have been sustained through PTAB. That leaves all 21 issued claims UNTESTED: independent claims 1, 2, 3, 4, 7, 8, 19 and dependent claims 5, 6, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 21. The closest thing to a validity ruling on this patent is the Helsinn v. Gland Pharma consent judgment in D.N.J. — where Gland's §§ 101/102/103/112 counterclaims were dismissed without prejudice and no court decided them (the order expressly states "No decision has been obtained by the parties from this Court regarding these charges of infringement or these defenses and counterclaims," and Gland's admission on validity was expressly "without prejudice to Gland's defenses and counterclaims that the Helsinki Patents are invalid"). So the presumption of validity is intact and unrebutted, but nothing has been tested adversarially. Two practical wrinkles: the patent is part of a family of five US applications (11,529,362, 12,208,109, and two pending applications US 2025/0235473 and US 2026/0027138), all claiming the same 2016-06-06 priority and all expiring 2037-06-02 — invalidating the '911 patent alone would not clear the continuations; and this patent is Orange-Book listed against NDA 210493 (Akynzeo IV, 235 mg/0.25 mg per 20 mL), so it is a live blocking patent, not a paper tiger.

Estoppel landscape. Because there is no final written decision on any claim of the '911 patent, § 315(e)(1) and (e)(2) estoppel is zero for everyone. No petitioner, real party in interest, or privy is barred from raising any § 102/§ 103 printed-publication ground in district court, at the ITC, or back at the Office. Even the Azurity cluster generates no '911 estoppel, since estoppel is claim- and patent-specific. Conversely, there is no § 315(b) problem for the patent owner to exploit against a new petitioner unless that petitioner was itself served with an infringement complaint more than one year ago — check your own service date first, because that clock, not the merits, is the most common way defendants lose the IPR option. And with the patent having issued 2020-04-21, the § 311(c) nine-month post-issuance bar is long expired, so an IPR can be filed immediately. One thing you cannot raise in an IPR on this patent: the apparent claim-drafting defect in claim 3, which recites limitations "(e) NaOH; optionally HCl; and g) water q.s." while skipping "(f)" — that is a § 112 indefiniteness/enablement-flavored point that the Board has no jurisdiction to hear, so it belongs in district court or the ITC, not a petition.

Pattern signals. (1) No serial petitioner exists against the '911 patent — the patent has attracted zero petitions in six years of issuance and four years of active enforcement. That is itself a signal worth weighing: unlike its sibling claims, this formulation patent has survived the generic-landscape "attack window." (2) The patent owner is aggressive in district court but has never had to defend this patent at the Board: Helsinn sued Gland Pharma on 2022-07-18 (D.N.J. No. 2:22-cv-04635 / 3:22-cv-04635) asserting ten patents including the '911 patent, and obtained a consent judgment and dismissal on 2022-12-23 (entered 2023-01-19, Judge Zahid N. Quraishi), with Gland agreeing not to market its ANDA No. 217374 product before expiry (CourtListener Order #50). Notably, Gland raised full §§ 101/102/103/112 invalidity counterclaims but never filed an IPR — meaning the strongest invalidity contentions against this patent were pleaded and then abandoned via settlement, and remain untested public-adjacent material worth mining from Gland's Paragraph IV detailed statements if discoverable. (3) Azurity Pharmaceuticals is the emerging challenger to the family — five IPRs filed 2025-05-01 — which means the art and expert infrastructure for attacking fosnetupitant injectable formulations is now being built and paid for, and a § 315(e)-free aggressor could later reuse it against the '911 patent. (4) No defensive aggregator: Unified Patents appears in the record only as the source of the litigation-data link on the Google Patents page, not as a petitioner. (5) No Federal Circuit activity — there are no FWDs to appeal, so no CAFC docket exists for this patent.

Recommended next steps

1. Treat the absence as the headline, not as an afterthought. There is no FWD to link to and no disposition to quote. If a demand letter on US 10,624,911 cites claims 1–21 as adjudicated-valid, that is overstatement: the only validity "ruling" is the unrebutted statutory presumption from the 2023 Gland consent judgment. Conversely, if your opponent claims the patent is "hardened by IPR," that is also false — it has never been before the Board.
2. Run your own § 315(b) service-date audit today. If you were served with a complaint alleging infringement of the '911 patent more than one year ago, the IPR door is closed; if not, it is wide open and there is no estoppel encumbrance on the art you would raise.
3. Mine the Gland source material before you commission new art. Gland's Paragraph IV First Notice Letter (June 2, 2022) and Second Notice Letter (July 11, 2022) contained detailed §§ 101/102/103/112 bases against the '911 patent; Gland's counterclaims in D.N.J. No. 3:22-cv-04635 plead invalidity of the '911 patent alongside the ten-patent family. Those positions were abandoned by settlement, were never adjudicated, and therefore create no estoppel for anyone. That is the cheapest starting point for a § 103 obviousness theory against claims 1–21.
4. Consider the claim-drafting defect as a non-IPR lever. Claim 3's limitation lettering skips "(f)"; claims 20 and 21 also recite "a pH of from 7 to 10" in a limitation-format that is worth a § 112 look. These are outside IPR jurisdiction (§ 311(b)) and belong in the district court or ITC case theory.
5. Don't stop at the '911 patent. The commercial block is a family: 11,529,362 (issued 2022-12-13), 12,208,109 (issued 2025-01-28), plus pending US 2025/0235473 and US 2026/0027138, all expiring 2037-06-02, together with 10,828,297 and 9,186,357 (expiring 2030-12-17 and 2030-11-18). Clearing only the '911 patent leaves Akynzeo IV protected. Map the family before you commit to a single-patent strategy.
6. Monitor the Azurity cluster for art reuse and for objective-indicia evidence. Institution decision dated 2025-11-19 is on the record; PTAB's statutory deadline is one year from institution, so any FWD in the instituted Azurity cases lands on or about 2025-11-19 + 12 months. Watch (a) whether the panel reaches the merits and rejects Helsinn's § 325(d) position — a § 325(d) rejection of cumulative art is a warning about recycling the same references against the '911 patent — and (b) whether Helsinn's aggressive discretionary-denial posture holds, since the same playbook will be run against you. Track at PTAB E2E and Docket Alarm's IPR2025-00948 docket.

Confidence statement: I am highly confident there is no AIA proceeding on US 10,624,911 as of 2026-09-18 — the ODP canonical list is empty, and two independent search passes over PTAB dockets and third-party trackers produced none. I am not confident in the specific docket-number-to-patent mapping within the Azurity cluster, so I have declined to assign IPR numbers to specific Helsinn patents; verify those on PTAB E2E before citing them.

I'll research the assignment record, litigation, and corporate facts before drafting. Let me run several searches in parallel.

Let me dig for the reel/frame records, the correspondent attorney, and the identity of the secured party.

Assignment & Ownership Analysis — US 10,624,911 B2

Scope note / data limitation. Google Patents' legal-events mirror for this patent shows three recorded post-filing transactions (below), but I was unable to retrieve the underlying Assignment Center reel/frame numbers or the correspondent-of-record names in this session — the Assignment Center query did not return document-level data before my tool budget expired. I therefore report the event facts and dates that are mirrored from the USPTO record, and I explicitly mark reel/frame and correspondent as not retrieved rather than guessing. Anyone needing the reel/frame should re-run the patent-number search at https://assignmentcenter.uspto.gov/ (mirror: https://assignment.uspto.gov/patent/index.html).

Inventors

• Both inventors assigned within 3 days of the 2017-06-02 US filing date, which is the standard employee-invention assignment pattern for a corporate applicant — consistent with both being Helsinn R&D personnel. The specification is written from the first-person plural of the Helsinn development team.
• No unusual departure pattern is determinable from the assignment record. There is no recorded assignment by either inventor to any third party, and no evidence (in the record reviewed) of either inventor leaving Helsinn. The "all inventors exit within 12 months" fire-sale precursor is not present.
• Priority: provisional US 62/345,942 (2016-06-06); PCT/EP2017/063268 filed 2017-06-01 (published WO2017/211663 A1); US 15/611,785 filed 2017-06-02.

Original assignee

Helsinn Healthcare SA — Lugano/Pazzallo, Switzerland. Helsinn is a privately held, family-owned pharmaceutical group (founded 1976) whose stated business model is "licensing-in, develop, and licensing-out" of cancer-care / supportive-care products (per Helsinn CEO deposition testimony quoted in the Helsinn v. Teva cert. record).

• Primary line of business: specialty pharma — supportive care in oncology (CINV, chemotherapy-induced nausea and vomiting).
• Does it ship a product embodying the claims? Yes. US 10,624,911 is Orange-Book listed against AKYNZEO (fosnetupitant 235 mg / palonosetron 0.25 mg IV, 20 mL single-dose vial), approved by FDA 19 April 2018 (the oral AKYNZEO capsule launched 2014). The claims (e.g. claim 6: ~13.0 mg/mL fosnetupitant chloride hydrochloride + ~14.04 µg/mL palonosetron HCl + 0.32 mg/mL disodium edetate + 38 mg/mL mannitol, reconstituted in 20 mL) map directly onto the marketed IV product.
• Group entities relevant to the record: Helsinn Birex Pharmaceuticals Limited (Dublin, Ireland — drug-product manufacturing/supply subsidiary) and Helsinn Therapeutics (U.S.), Inc. (US commercial arm; UPC-marketed AKYNZEO). Both appear as co-grantors on the 2022 security-interest recording.
• Current status: Operating. No bankruptcy, no dissolution, no assignment of the patent out of the Helsinn group is on record.

Assignment timeline

Sources: Google Patents legal-events mirror for US 10,624,911 (fetched 2026-09-17). Reel/Frame and correspondent were not retrievable in this session and are marked accordingly.

• 2017-06-05 (recorded) — Reel/Frame not retrieved

  • Conveyance: Assignment of assignors' interest (inventor → company)
  • Assignor: CANNELLA, ROBERTA; VENTURINI, ALESSIO
  • Assignee: HELSINN HEALTHCARE SA
  • Correspondent: not retrieved — correspondent flag therefore cannot be run
  • Context: Routine employee-invention assignment; perfects Helsinn's title three days after the 2017-06-02 US filing.

• 2022-12-30 (recorded) — Reel/Frame not retrieved

  • Conveyance: Security Interest (lien — not a conveyance of title)
  • Assignor: HELSINN BIREX PHARMACEUTICALS LIMITED; HELSINN HEALTHCARE SA; HELSINN THERAPEUTICS (U.S.), INC.
  • Assignee: HAMILTON SA LLC (as secured party / collateral agent)
  • Correspondent: not retrieved
  • Context: Securitization / financing lien. The "…SA LLC" naming convention matches the structured-finance collateral-agent pattern (cf. "Eiger III SA LLC" acting as collateral agent in comparable life-sciences financings). This created a lien over the Helsinn patent estate; it did not transfer ownership.

• 2023-09-20 (recorded) — Reel/Frame not retrieved

  • Conveyance: Release by Secured Party (termination of the 2022 lien)
  • Assignor: HAMILTON SA LLC
  • Assignee/Releasor-to: HELSINN HEALTHCARE SA; HELSINN BIREX PHARMACEUTICALS LIMITED; HELSINN THERAPEUTICS (U.S.), INC.
  • Correspondent: not retrieved
  • Context: Lien release — the security interest recorded 2022-12-30 was extinguished ~9 months later, returning clean title to the Helsinn group.

Bottom line of the chain: there has been exactly one ownership assignment in the patent's life (inventors → Helsinn, 2017). Everything after that is a lien and its release, both inside the Helsinn group's own financing. No post-issuance sale, no assignment to a third-party owner, no change of name.

Timeline diagram

timeline
    title Ownership of US 10624911
    2016 : Priority date 2016-06-06
    2017 : PCT and US applications filed
         : Inventors assign rights to Helsinn Healthcare SA
    2020 : US 10624911 issued 2020-04-21
    2022 : Helsinn sues Gland Pharma in D NJ
         : Security interest recorded to Hamilton SA LLC
    2023 : Security interest released by secured party

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. No transfer to a licensing-only LLC on record. The only LLC appearing anywhere in the chain is HAMILTON SA LLC, and it took a security interest (lien), not title, on 2022-12-30; that lien was released 2023-09-20. A security-interest recordal is the opposite of a shell-entity divestiture.

2. Known asserter in the chain — NOT PRESENT. No assignee or assignor in the chain matches Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, or any Spangenberg entity. The owner throughout is Helsinn Healthcare SA, a named brand pharmaceutical manufacturer.

3. Repeat correspondent across the chain — UNVERIFIED / INSUFFICIENT DATA. Correspondent-of-record names were not retrieved for any of the three recordings, so the recurrence test cannot be run. (Note for completeness only: the only attorney/firm name that surfaced anywhere in related Helsinn prosecution papers was Arnall Golden Gregory LLP; Clark G. Sullivan, from an older palonosetron 724-family filing — this is not attributable to the '911 assignment records and must not be treated as the correspondent here.)

4. Cascading transfers — NOT PRESENT. One ownership assignment (2017) plus one lien and its release (2022–2023) is not a chain of chained LLCs. No shared correspondent address or common-principal pattern is evidenced.

5. Pre-litigation transfer — NOT PRESENT. The ownership assignment is from 2017-06; the first infringement suit asserting '911 (Helsinn v. Gland Pharma, D.N.J. 3:22-cv-04635, filed 2022-07-18) came roughly five years later. The 2022-12-30 security interest post-dates the suit and is not an ownership transfer in any event.

6. Bankruptcy fire-sale — NOT PRESENT. No Chapter 7/11 proceeding involving Helsinn appears in the record; Helsinn is an active, privately held operating group.

7. Privateering — NOT PRESENT. The patent is asserted directly by the operating-company owner itself (Helsinn Healthcare S.A. as plaintiff), not by a spun-out NPE asserting on Helsinn's behalf.

8. Defensive aggregator (anti-NPE) — NOT PRESENT. The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN.

Litigation context (why this matters to the ownership picture)

Helsinn's enforcement of '911 is classic Hatch-Waxman brand-vs-ANDA litigation, not NPE assertion:

• Helsinn Healthcare S.A. v. Gland Pharma Limited, D.N.J. No. 3:22-cv-04635 (also listed as 2:22-cv-04635), filed 2022-07-18, terminated 2022-12-23 by consent judgment. Asserted patents included 10,624,911 together with 8,426,450 / 8,895,586 / 9,186,357 / 9,403,772 / 9,908,907 / 10,208,073 / 10,717,721 / 10,828,297 / 11,312,698. The trigger was Gland's ANDA No. 217374 for generic EQ 11.75 mg/mL fosnetupitant chloride hydrochloride + 0.0125 mg/mL palonosetron HCl, 235 mg/0.25 mg per 20 mL vial — i.e., a direct generic copy of the claimed IV product.
• Separately, Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A., IPR2025-00949 challenges US 10,828,297 (not '911) — again a competitor-vs-brand posture, not an NPE attack.

Verdict

Operating-company assertion.

US 10,624,911 has been owned by Helsinn Healthcare SA since the 2017-06-05 inventor assignment and remains within the Helsinn group; the only subsequent records are a 2022-12-30 financing lien to Hamilton SA LLC and a 2023-09-20 release — neither is an ownership transfer, and no NPE, aggregator, or shell LLC ever took title (Google Patents legal-events mirror for US 10,624,911, fetched 2026-09-17). Helsinn ships AKYNZEO IV, which embodies the claims (FDA approval 2018-04-19), and it sued the ANDA filer Gland Pharma directly (D.N.J. 3:22-cv-04635, filed 2022-07-18), which is brand-vs-competitor enforcement rather than NPE assertion. The single caveat is evidentiary, not substantive: reel/frame numbers and correspondent names could not be pulled in this session, so signals 3 (repeat correspondent) remains unverified pending an Assignment Center lookup.

Verify at: https://assignmentcenter.uspto.gov/ (search patent number 10624911) — or the mirror https://assignment.uspto.gov/patent/index.html

I'll research the USPTO record for US 10,624,911 and analyze each of its cited prior-art references. Let me run several searches in parallel.

Let me gather details on the remaining Merck references and the non-patent literature.

Prior-Art Analysis for US 10,624,911 (fosnetupitant injectable formulations)

Scope and method note. I treated the identifier "10624911" literally as US 10,624,911 B2. The authoritative citation list below is taken from the face of the patent (the "Patent Citations (5)" and "Non-Patent Citations (4)" tables in the USPTO/Google Patents record at https://patents.google.com/patent/US10624911/en). I could not directly query the USPTO PatentCenter/PAIR API; the citation list is therefore the prosecution-era IDS art as printed on the granted patent, which is the correct universe for the "cited references" question. Per the strict rule, I have not renumbered or "corrected" any citation.

I do not repeat the bibliographic summary, claim map, or litigation findings generated earlier — those remain authoritative. One cross-check: the earlier sections already flagged the palonosetron "required vs. optional" discrepancy, which matters below because every claim except claim 7 affirmatively requires palonosetron, so no palonosetron-free reference can anticipate.

1. The cited references at a glance

§ 102 statutory frame. The '911 patent's effective filing date is 2016-06-06 (provisional 62/345,942), so the AIA § 102(a)(1)/(a)(2) regime applies. Every patent citation above published in 1995–2013 — i.e., more than one year before the effective filing date — so all are § 102(a)(1) "printed publication" art, and none qualifies for the § 102(b)(1) grace-period exception (P5, though it shares two named inventors with the '911 patent, published ~3 years before priority, more than the one-year window). They are therefore all legally available as anticipatory references if they disclose every claimed element.

2. Reference-by-reference § 102 assessment

P1 — WO 95/16679 A1 (Merck & Co.)

• Description: Discloses substituted heterocyclic (morpholine/thiomorpholine) compounds of formula (I) as tachykinin/NK-1 receptor antagonists said to be useful for inflammatory disease, pain/migraine, asthma, and emesis.
• § 102 analysis — anticipates: none. The reference is directed to a morpholine/thiomorpholine scaffold. Fosnetupitant is a 4-phenyl-pyridine piperazinium phosphate (see P5). P1 discloses neither the fosnetupitant structure, nor palonosetron, nor any injectable vehicle containing sodium hydroxide, disodium edetate, and mannitol at the claimed ranges/pH. It supports at most a generic "NK-1 antagonists treat emesis" motivation (obviousness), not anticipation. It does not touch claims 1–21.

P2 — WO 95/18124 A1 (Merck Sharp & Dohme)

• Description: Morpholine derivatives bearing an amine-substituted azo-heterocyclic moiety, as tachykinin antagonists for pain, inflammation, migraine, and emesis.
• § 102 analysis — anticipates: none. Same scaffold family as P1; no fosnetupitant, no palonosetron, no claimed excipient combination. Not anticipatory of any claim.

P3 — WO 95/23798 A1 (Merck & Co.)

• Description: Prodrugs of morpholine tachykinin antagonists, including phosphoryloxy/phosphonate prodrugs (e.g., –CH(R⁴)–PO(OH)O⁻ M⁺) explicitly described as improving aqueous solubility for parenteral administration. This is the conceptual ancestor of the phosphate-prodrug strategy (netupitant → fosnetupitant).
• § 102 analysis — anticipates: none directly. Although P3 teaches the phosphate-prodrug-for-injectable-solubility concept, the parent scaffold is morpholine-based, not the 4-phenyl-pyridine netupitant scaffold, and it discloses no fosnetupitant, no palonosetron, and none of the claimed excipients/pH. Because even claim 7 requires the chloride hydrochloride salt of fosnetupitant specifically, P3 does not anticipate any claim. It is a § 103 background reference (motivation to make a soluble phosphate prodrug), not § 102 art.

P4 — US 2010/0048607 A1 (Kocherlakota) — the examiner-cited palonosetron reference

• Description: Ready-to-use and lyophilized palonosetron formulations. Representative lyophilized unit: palonosetron (0.25 mg), mannitol 207.5 mg, edetate disodium dihydrate 2.5 mg, citrate buffer, NaOH and/or HCl q.s., water; pH adjusted ~5; also discloses a 0.05 mg/mL ready-to-use solution, mannitol ~10–80 mg/mL, EDTA ~0.3–0.7 mg/mL, pH ~4–6.
• § 102 analysis — anticipates: none. This is the closest reference to the palonosetron + mannitol + disodium edetate + NaOH/HCl + water vehicle of claims 1, 3, and 4, and it is why the examiner cited it. But it contains no fosnetupitant (the recited active of every claim) and its pH is acid (4–6), whereas the '911 claims require pH 7.0–10.0 (claims 3, 4, 14–17) or no pH limit but the fosnetupitant/mannitol/edetate combination (claims 1, 2). It cannot meet the "comprising fosnetupitant chloride hydrochloride at 2.3–30 mg/mL" element. Relevant to obviousness of the vehicle, not § 102 anticipation.

P5 — WO 2013/082102 A1 (Helsinn Healthcare SA) — the most relevant cited reference

• Description: Discloses 4-phenyl-pyridine compounds of formula (I) and, in claim 10, the specific species GA1 = 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tolyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium — i.e., fosnetupitant — and its pharmaceutically acceptable salts, together with pharmaceutical compositions and methods of treating NK-1-mediated disease. The '911 patent itself credits P5 as the source of the method of preparing fosnetupitant and notes P5's disclosure of IV dosing (~10 mg/mL, 10–200 mg).

• § 102 analysis — anticipates: potentially the fosnetupitant compound, but not the claimed formulations. P5 is the reference that could, in principle, be § 102(a)(1) anticipatory, because it is the only cited art that discloses fosnetupitant (and its chloride hydrochloride salt). However, anticipation requires a single reference disclosing all claimed elements arranged as claimed:

  • Claims 1–6, 12–13 (formulations with palonosetron): require fosnetupitant Cl·HCl plus palonosetron HCl at 5–50 μg/mL plus the specific vehicle (NaOH, disodium edetate, optional HCl, mannitol) within defined amounts/pH. A compound-focused application like P5 is unlikely to disclose that assembled formulation. I could not verify that P5 discloses a fosnetupitant/palonosetron injectable with mannitol + disodium edetate at pH 7–10. On the record available, P5 does not anticipate these claims.
  • Claims 19–21 (generic "alkalizing agent + alkaline pH"): the broadest genus claims. If P5 disclosed any alkaline injectable solution of fosnetupitant Cl·HCl with palonosetron, claim 19 could be at risk. I could not confirm such a disclosure; absent it, no anticipation.
  • Claim 7 (manufacturing method: simultaneously admixing fosnetupitant Cl·HCl with NaOH at pH ~11–14, then reducing to pH ~7–10):** this is the claim for which a Helsinn compound/process application is most plausibly relevant, but P5 is not shown to disclose the "dissolve in NaOH at pH 11–14 → back-titrate to pH 7–10" sequence. Likely not anticipated; relevant to obviousness.

  Bottom line for P5: it is the key art on the compound and on the general injectable-utility, and it establishes that fosnetupitant was known; but the novelty of the '911 claims resides in the physiologically balanced injectable formulation (vehicle, excipient concentrations, pH window), which P5 does not appear to disclose. P5 is thus best characterized as § 103 art / antecedent disclosure, not § 102 anticipation of the challenged claims — with the caveat that I could not retrieve P5's full formulation examples.

N1–N4 — Non-patent literature

• N1 (Maggi et al., 1993, J. Auton. Pharmacol. 13:23–93): review of tachykinin receptors and antagonists. Background pharmacology; no fosnetupitant, no formulation. Anticipates: none.
• N2 (Can. J. Physiol. Pharmacol. 1997;75:612–621): NK-1/substance-P in CNS/psychiatric indications. Background; none.
• N3 (Kramer et al., Science 1998;281:1640–1645): clinical evaluation of NK-1 (substance P) antagonists in anxiety/depression/emesis. Background efficacy rationale; none.
• N4 (N. Engl. J. Med. 1999;340(3):190–195): reduction of cisplatin-induced emesis by a selective NK-1 antagonist (aprepitant/MK-0869). Establishes NK-1 antagonism as an antiemetic mechanism, but concerns a different compound and no formulation. Anticipates: none.

None of N1–N4 discloses fosnetupitant or the claimed formulation, so none anticipates any of claims 1–21; they are mechanism/utility background.

3. Overall § 102 conclusion

• No cited reference anticipates any claim of US 10,624,911. The two claims-shaping elements — (i) fosnetupitant chloride hydrochloride as the active and (ii) the specified injectable vehicle/pH window (NaOH + disodium edetate + mannitol, optional HCl, pH 7–10 or an alkaline pH) — never appear together in a single cited reference:
  • P1, P2, P3 supply NK-1 antagonist/prodrug background but a different chemical scaffold.
  • P4 supplies the palonosetron/mannitol/edetate/NaOH vehicle but no fosnetupitant and an acid pH (4–6).
  • P5 supplies fosnetupitant (the compound) and its injectable utility but not the assembled balanced formulation as claimed.
  • N1–N4 are mechanism/utility background only.
• The cited art's real value is § 103 obviousness, not § 102: P5 (fosnetupitant known) + P4 (palonosetron/mannitol/EDTA/NaOH vehicle known) + P3 (phosphate-prodrug-for-solubility concept) is the combination one would expect a challenger to run — which is consistent with the earlier-noted fact that the asserted family patents, including related family members, have drawn IPR attacks (though, as previously flagged, not the '911 patent itself in the activity identified).

4. Caveats / limits of this analysis

1. Source of the citation list. I relied on the face-of-patent citation tables; I could not open the USPTO PatentCenter "References Cited" pane directly. If the granted patent's IDS contains additional art not surfaced on the retrieved page, that art is not covered here.
2. P5's disclosure depth is unverified. My "not anticipatory" conclusion for P5 (especially as to the broad claims 19–21 and method claim 7) could change if P5's full example section discloses a fosnetupitant/palonosetron alkaline injectable containing mannitol and disodium edetate. I flagged this explicitly rather than assuming.
3. No family/litigation art is included. The "Families Citing this family" and later Helsinn continuations (e.g., US 11,529,362; US 12,208,109; US 2025/0235473; US 2026/0027138) and the Slayback/Azurity references are not prior art to the '911 patent and are properly excluded from a § 102 analysis; they were addressed in the earlier sections.
4. Claim-lettering and other literal-text issues (e.g., claim 3's "e) NaOH; optionally HCl; and g) water q.s." gap) are quoted as-is and not corrected, per the strict rule.
5. § 102(b) timing note. P5 shares inventors Cannella and Venturini with the '911 patent, but because it published 2013-06-06 — more than one year before the 2016-06-06 effective filing date — the AIA grace-period exception does not remove it from the prior art; it is available under § 102(a)(1) as a printed publication.

I'll ground the prior-art disclosure analysis with targeted searches on the references cited on the patent face and in the family, then build the § 103 framework.

Let me pull the specifics of the WO 2013/082102 formulation teachings and any prosecution-history obviousness record.

Obviousness Analysis — U.S. Patent No. 10,624,911 under 35 U.S.C. § 103

Analyst's note on scope and evidence. This analysis builds on the previously generated bibliographic and litigation sections and does not repeat them. Two limits apply and are flagged throughout rather than papered over:

1. For the prior-art references on the patent face and in the family, I have the bibliographic record, abstracts, claims and cited portions of each, plus the '911 patent's own characterizations — I do not have full-text claim charts of each reference. Disclosure statements below are therefore "as reported / as cited," and where I am inferring disclosure from a title or abstract I say so.
2. "Obviousness" is a legal conclusion applied to facts. What follows is a technical analyst's prima facie case plus the counter-case, not a validity judgment.

Also relevant to framing: the '911 application has a 2016-06-06 priority and a 2017-06-02 filing, so AIA § 102/§ 103 governs. Several key references are commonly owned by Helsinn (WO 2013/082102; EP 2,744,497). That does not shield them here: they published before the priority date and therefore are § 102(a)(1) printed publications, to which the § 102(b)(2)(C) common-ownership exception does not apply. This is an important nuance a challenger would press and a patentee would have to concede.

1. The person of ordinary skill (POSITA)

A formulation scientist / parenteral pharmaceutics specialist (M.S./Ph.D. or Pharm.D.) with ~3–5 years developing injectable small-molecule antiemetics, familiar with: solubility/pH relationships for weakly basic and zwitterionic drugs; tonicity adjustment; chelating agents; lyophilization; and the CINV treatment landscape (5-HT3 RA + NK-1 RA + corticosteroid). This is the skill level the '911 specification itself presumes — e.g., the specification's own statement that the solution is made by "conventional" pH adjustment and its reliance on the Handbook of Pharmaceutical Excipients type of knowledge.

2. Prior-art inventory

Key structural fact for § 103: every claimed excipient is individually conventional and several are disclosed together in a palonosetron injectable vehicle (Kocherlakota) and in an injectable NK-1 antagonist (Pharmathen).

3. The gap the claims leave open (threshold observation)

The title and specification advertise a "physiologically balanced" formulation built on the netupitant∶fosnetupitant ratio. No independent claim recites netupitant at all (this is noted in the prior section and I confirm it against the granted text). The ratio, the anti-hydrolysis role of EDTA, and the "specificity" of the alkaline window — the narrative merits of the specification — are largely absent from claims 1, 2, 3, 4, and 19. Under § 103 this matters: a patentee cannot argue non-obviousness based on features it did not claim. The claims, as granted, read on a conventional injectable combination formulation, which is precisely the terrain the prior art occupies.

4. Prima facie obviousness — claim groups

Claim 1 (liquid: fosnetupitant salt 2.3–30 mg/mL; palo HCl 5–50 µg/mL; NaOH; EDTA; opt. HCl; mannitol)

Ground 1: WO 2013/082102 in view of EP 2,744,497 and US 2010/0048607.

• (a) 2.3–30 mg/mL fosnetupitant chloride hydrochloride — disclosed by WO 2013/082102's preferred IV formulation (~10 mg/mL on a netupitant-moiety basis ≈ 11–13 mg/mL of the salt), which falls squarely inside the range.
• (b) 5–50 µg/mL palonosetron HCl — the approved IV palonosetron dose (0.25 mg, Aloxi**)**, taught by EP 2,744,497 and rendered as a concentration by Kocherlakota (0.05 mg/mL = 50 µg/mL; 0.25 mg/20 mL = 12.5 µg/mL free base). Both ends of the claim 1 range (5–50 µg/mL) are hit.
• (c)–(f) NaOH, EDTA, HCl, mannitol — these are the routine parenteral vehicle: Kocherlakota discloses a palonosetron injectable containing mannitol + edetate disodium + "NaOH and/or HCl q.s."; Pharmathen teaches NaOH/HCl pH adjustment and mannitol tonicity for injectable NK-1 antagonists.

Motivation to combine (strong, multiple independent strands):

1. Common assignee / same program. WO 2013/082102 and EP 2,744,497 are both Helsinn; fosnetupitant is the prodrug of netupitant (the active moiety of the EP 2,744,497 combination). Combining the prodrug with the partner drug of its own active moiety is a natural, self-evident step.
2. Oral → IV line extension. EP 2,744,497 and the FDA record establish the netupitant-palonosetron oral FDC (Akynzeo) as standard of care; the well-recognized need to serve patients who cannot swallow (a classic motivation) drives development of an IV counterpart.
3. A ready-made vehicle. Kocherlakota supplies the palonosetron-compatible, EDTA/mannitol/NaOH vehicle, so the POSITA would simply co-dissolve the NK-1 component into a known palonosetron platform (or vice versa).
4. Predictable result. Two known antiemetics, each separately formulated as injectables, in a conventional vehicle — the combination is a "predictable variation" combining known elements for their known functions (KSR Int'l v. Teleflex).

Reasonable expectation of success: high. WO 2013/082102 already states an IV fosnetupitant formulation is feasible at ~10 mg/mL, and Kocherlakota/Pharmathen show the vehicle works for both drug classes.

Claim 2 (lyophilized version of claim 1)

Same Ground 1, further in view of US 2015/0165045 (Pharmathen) and Kocherlakota, both of which disclose lyophilized injectables in this exact space (Kocherlakota: lyophilized palonosetron, reconstituted with 5 mL; fosaprepitant is itself a lyophilized NK-1 powder). Lyophilizing a liquid injectable for stability/shelf life is routine and expressly motivated. No claim element differentiates the lyophilizate beyond the physical form.

Claim 3 (liquid, pH 7.0–10.0, EDTA 0.05–0.9 mg/mL, mannitol 10–100 mg/mL, water q.s.)

Ground 1 further in view of routine optimization (Gibson, Pharmaceutical Preformulation and Formulation; Handbook of Pharmaceutical Excipients, cited on the face of WO 2013/082102). pH 7–10 is described in the '911 specification itself as the balance of "solubility, stability and physiological acceptability" — i.e., an optimization a POSITA performs as a matter of course. Kocherlakota's EDTA (2.5 mg/vial → 0.5 mg/mL in 5 mL) and mannitol fall in the claimed ranges. The relevant pH was also already in the art: the '911 Example 1 uses pH 7.8, and WO 2013/082102's IV work is the source of that teaching.

Claim 4 & 5 (lyophilized at pH 7.0–10.0; EDTA 0.1–2.0 mg/mL; NaOH + HCl)

Same as claim 3 with lyophilization added (Pharmathen/Kocherlakota). Note the '911 specification's own admission that lyophilized formulations conventionally use ~double the EDTA of liquid ones — i.e., the higher EDTA range is the routine consequence of the dosage-form change, not an invention.

Claim 6 / 11 / 13 (the numeric profile: ~13.0 mg/mL fosnetupitant, ~14.04 µg/mL palo, ~0.32 mg/mL EDTA, ~38 mg/mL mannitol, pH 8.5–9.5, 20 mL)

The numbers are dose÷volume arithmetic on approved doses: 260 mg salt ÷ 20 mL = 13.0 mg/mL; 0.25 mg palonosetron ÷ 20 mL = 12.5 µg/mL free base = 14.04 µg/mL salt (the Aloxi**®** IV dose); 0.32 mg/mL EDTA and 38 mg/mL mannitol are within conventional tonicity/stabilizer ranges. A POSITA scaling an approved dose into a fixed-volume vial reaches these values without invention. pH 8.5–9.5 is a routine selection within the alkaline window.

Claim 7 / 18 (method: simultaneously admix fosnetupitant chloride hydrochloride with NaOH at pH ~11–14; acidify to ~7–10; optional excipients; HCl as acid)

Ground: WO 2013/082102 in view of routine pharmaceutical practice. The "dissolve the basic drug as a salt at high pH, then bring to target pH" sequence is a standard solubility-enhancement technique for poorly soluble weak bases; Pharmathen and Kocherlakota teach the NaOH/HCl pH-adjustment step. The '911 specification's own Summary describes a plain "admixing," and the granted claim's added "simultaneously" is, on the face of the record, an order-of-addition detail with no demonstrated criticality (no comparative data in the '911 tables isolating the simultaneous-addition step). A challenger would argue it is a result-effective variable optimized by routine experimentation; the '911 Examples describe the pH targets (≈13 then ≈9) as targets to "reach," not as a discovered critical sequence.

Claim 8 (product-by-process: claim-2 lyophilizate mixed with 0.9% saline or 5% glucose)

Reconstitution with normal saline or D5W is expressly disclosed as routine in the field and in the '911 specification itself (its own pre-administration instruction). Under In re Thorpe / Abbott v. Sandoz, process limitations in a product claim do not impart patentability unless they change the product's structure; the reconstituted solution does not differ structurally from the lyophilizate plus diluent.

Claim 19 / 20 / 21 (broad genus: fosnetupitant salt + palo HCl + an alkalizing agent + an alkaline pH)

Ground 1 alone largely disposes of these. Claim 19 is the broadest claim — any alkaline injectable combination of the two actives with any base. WO 2013/082102 supplies the fosnetupitant component; EP 2,744,497 supplies the palonosetron combination and dose; the "alkalizing agent"/"alkaline pH" is met by the routine NaOH/pH-7-plus teaching of Pharmathen and Kocherlakota. Claim 21 (NaOH + pH 7–10) adds nothing beyond routine selection.

5. The counter-case (why the patentee would argue non-obviousness)

A rigorous analysis must state the rebuttal and whether it holds:

1. Unexpected stability/solubility behavior of fosnetupitant. The specification asserts that fosnetupitant's solubility "varies irregularly and unpredictably," that it partially hydrolyzes to netupitant, and that EDTA surprisingly suppressed hydrolysis and opalescence. Strength: This is the patentee's best argument. Weakness: (i) the asserted benefit is not required by the independent claims, which recite EDTA generically at conventional concentrations; (ii) Kocherlakota had already disclosed EDTA in a palonosetron injectable, so using EDTA as a stabilizer in the same drug family is not novel; (iii) the '911 stability data (Tables 4a–4c) show increasing 14-Netu (e.g., 0.46% → 0.96% at 3M/40 °C → 1.32% at 6M/40 °C), i.e., a modest and arguably predictable improvement over Example 3's 1.0–2.9% range, not a dramatic, unexpected suppression.

2. Avoiding surfactants / injection-site reactions. The literature (and the '911 background) recount that earlier IV netupitant and IV aprepitant formulations required polysorbate 80 and caused thrombophlebitis/ISRs, and were discontinued. A surfactant-free fosnetupitant formulation could be argued non-obvious. Strength: moderate, if framed as "overcoming the failure of others." Weakness: the surfactant-free result flows directly from WO 2013/082102 itself, which taught that fosnetupitant (the phosphate prodrug) was developed to overcome netupitant's injection-site problems. The patentee's own primary reference supplies the solution, undercutting the "unexpected" framing.

3. Commercial success / long-felt need. Akynzeo (netupitant-palonosetron) and IV NEPA are commercially significant, and the need for an IV NK-1 option is real. Weakness: no nexus to the claimed excipient set — the success plausibly flows from the active combination (already protected by EP 2,744,497 / Akynzeo), not from NaOH/EDTA/mannitol or the specific pH. Commercial success without nexus carries little weight.

4. The "balanced ratio" teaching. The specification's framing suggests deliberate netupitant∶fosnetupitant control. Weakness: as noted, the granted independent claims do not recite netupitant, so this teaching cannot support the claims.

Net assessment: the prima facie § 103 case against independent claims 1 and 2 is strong; against claims 3–5, 9–17 it is moderately strong (routine optimization of a disclosed combination); against claims 7/18 and 8 it is strong-to-moderate (conventional processing and product-by-process). Claim 19 is the most exposed. The patentee's viable defenses are essentially (a) a properly evidenced unexpected-results argument tied to claims that actually recite the stabilizing/property-driving limitations, and (b) a nexus-bearing commercial-success argument. Both face the recurring problem that the claims are broader than the story.

6. Strongest single combination for a petition

WO 2013/082102 (primary) + EP 2,744,497 + US 2010/0048607, optionally + US 2015/0165045 and routine-optimization evidence (Gibson / Handbook of Pharmaceutical Excipients).

This combination maps every limitation of claims 1, 2, 9, 14–15 and 19–21, supplies an articulated motivation (same assignee; prodrug/active-moiety relationship; oral→IV line extension; ready-made vehicle), and rests on a predictable-result rationale under KSR. It is the combination a challenger would lead with and the one most likely to invalidate the broad independent claims.

7. Caveats and confidence

• Evidence depth. I analyzed disclosures from abstracts, claim sets, cited passages and the '911 patent's own characterizations. I did not obtain full-text claim charts for WO 2013/082102, EP 2,744,497, US 2010/0048607 or US 2015/0165045. Before any conclusion is relied upon, each reference must be read in full to confirm it teaches (or fairly suggests) the specific concentrations, the EDTA/mannitol vehicle, and the pH range — especially whether WO 2013/082102's IV formulation expressly discloses an excipient set or pH, which the '911 specification's paraphrase does not state.
• Common ownership nuance. I flagged that Helsinn's own § 102(a)(1) publications are usable as § 103 art; this should be confirmed against each reference's actual publication date.
• This is not a validity opinion. Obviousness depends on the full record (including any objective indicia properly linked to claims) and on claim construction. The claims' apparent defects noted here (palonosetron recited as mandatory in claims 1–2 though optional in the specification; the missing "f)" element in claim 3; the recited "simultaneously" in claim 7 absent from the specification) are primarily § 112 issues, but they also bear on § 103 because they confirm that the claims, not the specification's narrative, define the invention to be tested for obviousness.
• No admission. Nothing here should be treated as a legal conclusion that any claim is invalid; it is a technical, evidence-based prima facie analysis for a challenger's side of the ledger.