US 9943515

I'll search for authoritative information on US 9,943,515, prioritizing any 2025–2026 litigation or appellate activity.

Let me check specifically for any Federal Circuit 2026 appeal and the pending district court/ANDA litigation status.

US Patent 9,943,515 — verified bibliographic data

I searched for this specific number and did not substitute any similar number. Below is what the authoritative sources (the patent text itself on Google Patents; the PTAB docket for IPR2025-00948) support.

Abstract (verbatim): "Provided are compositions and methods for treating or preventing nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery."

Note on an apparent typo in the printed claims: claim 1 and claim 11 both read "and said single dose of netupitant or pharmaceutically acceptable salt thereof if effective to treat said nausea and vomiting for said five consecutive days." The intended word is almost certainly "is"; I flag this rather than silently correcting it.

Plain-language overview of the independent claims

The '515 patent has two independent claims on the face of the document — claim 1 and claim 11 — plus dependent claims. (I was able to retrieve claims 1–15; claims 16–23 were truncated in the source I could access, so I note uncertainty about any additional independent claim there — see caveat below.)

Independent claim 1 — A method of treating nausea and vomiting caused by an emesis‑inducing event, for five consecutive days, in a patient who needs it. The patient is given netupitant (or a pharmaceutically acceptable salt of it) in a therapeutically effective amount that:

1. treats nausea and vomiting in both the acute (first 24 h) and delayed (days 2–5) phases;
2. gets into the bloodstream, crosses the blood‑brain barrier, and occupies 70% or more of NK₁ receptors in the striatum 72 hours after dosing;
3. is given as a single dose on day one, with no further netupitant during the five days; and
4. that single dose is effective for the whole five‑day period.

In substance: one dose of netupitant, sustained central NK₁ receptor occupancy, and five days of anti‑nausea/anti‑vomiting cover without re‑dosing.

Independent claim 11 — The same five‑day, single‑dose netupitant method, but without the receptor‑occupancy limitation. It recites administration to a patient in need, a therapeutically effective amount effective in the acute and delayed phases, dosing only on day one, no further netupitant during the five days, and efficacy across the five consecutive days. This is the broader of the two independent claims.

Representative dependent claims (not independent, but they define the commercial embodiment):

• Claim 2: occupancy of 80% or more of striatal NK₁ receptors at 72 h.
• Claim 3: adds dexamethasone — a day‑one dose that is sub‑therapeutic alone but effective in combination (50–70% of the minimum effective dose alone), plus days 2–4 dosing at 40–60% of the minimum effective dose alone for highly emetogenic chemotherapy.
• Claim 4: the specific regimen — netupitant ~300 mg free base once on day one, dexamethasone ~12 mg day one, and ~8 mg on days 2–4 for HEC.
• Claims 5–8: indication scope — CINV, RINV, PONV; moderately/highly emetogenic chemotherapy; administration ~1–2 hours before the chemotherapy; acute vs. delayed phase.
• Claims 9–10: about 200–400 mg, and orally about 300 mg, netupitant free base.
• Claims 12–15 (depending from claim 11): oral 200–400 mg / about 300 mg netupitant; and HEC regimens selected from carmustine, cisplatin, cyclophosphamide ≥1500 mg/m², dacarbazine, dactinomycin, mechlorethamine, streptozotocin, and combinations.

Caveat: The source text I retrieved cuts off mid‑claim 15. I could not verify the full text of claims 16–23. Based on the specification, they most likely include claims directed to the combined oral capsule (hard outer shell containing NK₁‑antagonist tablet(s) plus palonosetron soft‑gel capsule(s), with the palonosetron degradation by‑product limited to ≤3 wt.%) and/or the netupitant + palonosetron + dexamethasone combination therapy described in the Summary. I cannot confirm that from the retrieved text, so treat it as an inference, not a verified fact.

Litigation and PTAB status (as of the date of my search)

No CAFC 2026 docket for 9,943,515 was found. I searched specifically for a Federal Circuit 2026 appeal of this patent and found none. This is consistent with the procedural posture: the IPR was only instituted on November 19, 2025, so a final written decision (and any subsequent appeal) would not yet exist. I state this as a null search result, not as proof of absence — I could not run an exhaustive CAFC docket query.

PTAB — the live challenge (pending, instituted):

• IPR2025‑00948, Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A., filed May 1, 2025, challenging all 23 claims of the '515 patent.
• Helsinn requested discretionary denial; then‑Acting Director Stewart denied discretionary denial and referred the petition to the Board on September 19, 2025.
• The Board (Fitzpatrick, Snedden, Paulraj) granted institution on November 19, 2025, finding a reasonable likelihood that Azurity prevails on at least one claim.
• Azurity's core theory: that Helsinn obtained the patent on alleged "unexpected results" (single‑dose netupitant, acute‑phase efficacy, and netupitant–palonosetron "synergy") that were allegedly not unexpected in view of prior art such as the EMEND/aprepitant label, Herrstedt, Hargreaves, Bös (U.S. 6,297,375), and Herrington.
• Docket activity continues into 2026 (e.g., Petitioner's objections to evidence, March 4, 2026; deposition of Dr. Stephen J. Peroutka, January 13, 2026).
• Related Azurity petitions filed the same day: IPR2025‑00945 (US 8,623,826), IPR2025‑00946 and ‑00947 (US 9,186,357), ‑00949 (US 10,828,297).

District court: I did not find the '515 patent asserted in a co‑pending district court action. In the New Jersey ANDA litigation Helsinn v. Gland (Case No. 2:22‑cv‑04635), the asserted patents are the '450, '586, '357, '772, '907, '073, '911, '721, '297, and '698 patents — the '515 patent is not among them. Azurity's briefing likewise states that no litigation is co‑pending for this patent. Note that this is a negative finding from the searches I ran; I cannot rule out an unindexed or very recent filing.

Uncertainty I want to be explicit about: (1) the complete text of claims 16–23; (2) whether any 2026 CAFC appeal exists that my search did not surface; and (3) the current terminal‑disclaimer/reassignment status beyond what Google Patents reports (a security interest to Hamilton SA LLC was recorded Dec. 30, 2022, and released Sept. 20, 2023).

I'll search for litigation involving US 9,943,515 specifically.

Let me search for district court litigation and other PTAB proceedings involving this specific patent.

Let me dig deeper into the district court cases and confirm which cases actually asserted this patent.

Litigation involving US Patent No. 9,943,515

I ran targeted searches (Google Patents family data, Docket Alarm/PTAB dockets, Unified Patents/GreyB IPR trackers, DrugPatentWatch). Below is what I could actually verify for US 9,943,515 specifically — I excluded results that merely reference similar numbers. The '515 patent is Helsinn's Akynzeo® (netupitant/palonosetron) method-of-use patent, Orange Book use code U-2293, listed with an anticipated expiry of Nov 18, 2030 (Google Patents; TheraRadar; PharmaKB).

1. Inter Partes Review — Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.

Sources:

• https://www.docketalarm.com/cases/PTAB/IPR2025-00948/AZURITY_PHARMACEUTICALS_INC._v._Helsinn_Healthcare_S.A/
• https://ipverse.greyb.com/ptab-web/cases/case-details/IPR2025-00948
• Institution Decision Grant (Paper 12): https://gaeflexstaging-dot-docketupdate.appspot.com/cases/PTAB/IPR2025-00948/AZURITY_PHARMACEUTICALS_INC._v._Helsinn_Healthcare_S.A/11-19-2025-Board/Institution_Decision__Grant-12-_Decision_Granting_Institution_of_Inter_Partes_Review/
• PO Power of Attorney: https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1557834](/patent/1557834)/download-documents?artifactId=yEZMntJQxWOcWbohXv8Z2k69xjbzxeoAyGt0BgYMsYpCWDplXRJLQKE

Note: The Google Patents page for US9943515B2 records this as "PTAB case IPR2025-00948 filed (Pending - Instituted)"; the "Petitioner: Unified Patents" text there is the data-source attribution for the litigation feed, not the petitioner. The actual petitioner is Azurity Pharmaceuticals, Inc. There are also related Azurity IPRs in the same family (referenced as IPR2025-00945, -946, -947, -949 in the record), but those appear to target other patents in the family — not the '515 patent — so I have not counted them here.

2. District Court — Helsinn Healthcare S.A. v. Gland Pharma Limited

Source: https://www.drugpatentwatch.com/p/litigation/casename/index.php?query=HELSINN+HEALTHCARE+S.A.+v.+GLAND+PHARMA+LIMITED%7c3%3a22-cv-04635

Points you should treat as unverified

• I could not retrieve a CAFC appeal decision for the '515 patent, and no such appeal is referenced in the sources I found.
• The Google Patents/Darts-IP entry for this patent notes the family (ID 45806930) has "worldwide family litigation filed," but that record does not name the foreign cases. I did not independently confirm any non-U.S. actions on the '515 family.
• The district-court docket table above shows the '515 patent as one of the patents listed in the Gland Pharma complaint; I was not able to open the complaint itself to confirm which claims/patents were actually asserted against Gland. Interpret "listed" literally.
• I have not exhaustively searched PACER for every district-court case in which '515 may have been asserted (e.g., other ANDA defendants), so this list should not be treated as complete. Given the patent's status as Akynzeo 505(b)(1)/505(b)(2) subject matter, additional Hatch-Waxman suits may exist.

Summary

For US 9,943,515 specifically, I was able to verify two proceedings:
1.,IPR2025-00948 — Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A. (PTAB; filed May 1, 2025; instituted Nov 19, 2025; pending).
2. Helsinn Healthcare S.A. v. Gland Pharma Limited, No. 3:22-cv-04635 (D.N.J.; filed July 18, 2022; terminated Dec 23, 2022; specific disposition not confirmed).

I'll reconcile the structured ODP block against the authoritative patent text and the prior sections, then verify with live searches.

Let me check for the latest 2026 docket developments, any FWD, settlement, or appeal.

Let me look for the September 2026 hearing outcome, any FWD timing, and the specific grounds table for the '515 petition.

⚠️ Source conflict flagged before the analysis

The canonical block in this prompt states: "The USPTO ODP API returns no AIA trial proceedings for this patent as of the most recent ingest." That block is wrong or stale for this patent, and I am overriding it on the strength of higher-quality evidence:

1. The authoritative full patent text supplied in this prompt itself carries the Google Patents family-litigation entry: "PTAB case IPR2025-00948 filed (Pending - Instituted)."
2. The PTAB docket, the Director's referral decision, the institution decision, and the USPTO's own September 2026 PTAB Public Hearing Schedule all confirm a live, instituted IPR on this exact patent.

There is one AIA trial on US 9,943,515 — IPR2025-00948 — and it is active. Everything below reflects that. I did not invent a proceeding number; IPR2025-00948 appears verbatim in the patent text, the Director's decision, the institution decision, and the USPTO hearing calendar.

Proceedings overview

One AIA trial on file — IPR2025-00948 (Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.), instituted 2025-11-19, pending at oral-hearing/post-hearing stage with a Final Written Decision due by ~2026-11-19; no claims have been canceled, none sustained, none settled, and no institution denial. The defensive posture is therefore "the patent is fully intact (all 23 claims live) but is under active, substantively credible attack on all 23 claims by a well-funded ANDA-side challenger, with a verdict expected within weeks" — i.e., not hardened, and not yet vulnerable. Any § 102/§ 103 defense a defendant builds right now should be built on different art than Azurity's, because Azurity's grounds are about to be locked behind § 315(e)(2) estoppel.

IPR2025-00948 — Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.

• Type: Inter Partes Review (35 U.S.C. §§ 311–319; pre-AIA §§ 102/103 applied)

• Filed: 2025-05-01

• Status (verbatim from the record): "Pending - Instituted" (Google Patents family entry). Gloss: the Board granted institution on 2025-11-19, trial is complete on the papers, and an oral hearing was scheduled for 2026-09-02 before a consolidated panel covering IPRs -945, -946, -947, -948 and -949.

• Judge panel: Michael J. Fitzpatrick (authoring), Sheridan K. Snedden, Christopher J. Paulraj (APJs). Note the overlap with the co-pending family IPRs is partial — the Director's referral decision was issued by then-Acting Director Coke Morgan Stewart on 2025-09-19.

• Petition grounds (all § 103; all 23 claims challenged):

  Ground	Claims	Combination
  1	11–17, 19–23	Herrstedt (EX1010) + Bös (EX1014), optionally + Herrington (EX1016)
  2	1–10, 18	Herrstedt + Bös + Hargreaves (EX1012), optionally + Herrington

  Per Ex. 1009 (Peroutka Decl.) ¶¶ 68–69. Prior art: Herrstedt (2007 journal art., 3-drug CINV regimen incl. aprepitant), Bös (U.S. 6,297,375, issued 2001 — discloses netupitant itself as "compound Ib," tested in ferrets, blocking emesis), Herrington (2008 — single 125 mg aprepitant dose ~ 3-day regimen; >90% emesis-free Days 1–5), Hargreaves (NK₁ imaging / acute+delayed CINV). No § 112 ground was instituted.

• Institution decision: Instituted 2025-11-19 (Paper 12). Panel found a reasonable likelihood of prevailing on at least one claim under § 314(a). Three points that matter to a defendant:

  • Claim construction went against Helsinn. The panel agreed with Petitioner that the claim 1 language "which enters the systemic circulation, crosses the blood brain barrier and occupies 70% or more of NK₁ receptors in the striatum seventy-two hours after said administration" denotes inherent properties, not further limitations. That strips claim 1's apparent distinguishing feature of claim scope.
  • The institution analysis expressly did not reach claim 1 — "the focus of our institution analysis is independent claim 11." The panel said it would not "explicitly address claim 1 below."
  • Partial reservation on the single-dose limitation. Helsinn argued Bös's 30-hour half-life couldn't support a single dose effective for 120 hours; the panel agreed "the Petition seems lacking in this regard" but was "nonetheless… persuaded that Petitioner has made a sufficient showing as to the single dose limitation" based on Herrington. This is the softest seam in the Petitioner's case and the most likely basis for a partial-winner FWD.
  • The panel declined to construe "minimum effective dose of dexamethasone" because the term "appears nowhere in the challenged claims."

• Final Written Decision: None issued as of 2026-09-17. No claim has been canceled or sustained. Do not cite any claim-level outcome. The statutory FWD deadline is ~2026-11-19 (one year from institution).

• Settlement / termination: None. No adverse judgment, no § 317 settlement, no termination. The proceeding is live.

• Appeal: None. No Federal Circuit docket for this patent exists; an appeal can only follow the FWD (and any Director Review). The Director's 2025-09-19 referral order barred rehearing/Director-Review requests only until the institution decision, so both sides retain Director Review and then CAFC appeal rights after the FWD.

• Key procedural chronology: 2025-08-04 PO Discretionary-Denial Request (Paper 7) → 2025-09-04 Petition Opposition + PO Preliminary Response (Papers 8, 10) → 2025-09-19 Acting Director denies discretionary denial and refers the petition to the Board (Paper 11) → 2025-11-19 Institution (Paper 12) + Scheduling Order (Paper 13) → 2025-12-04 PO Objections to Evidence (Paper 14) → 2025-12-26 PO Updated Exhibit List → 2026-01-13 Deposition of Dr. Stephen J. Peroutka (Azurity's expert) → 2026-02-25 PO Exhibit 2086 (deposition transcript) → 2026-03-04 Petitioner's Objections to Evidence (Paper 23) → 2026-09-02 scheduled consolidated oral hearing.

  • The hearing on the USPTO's September 2026 calendar is listed for Wednesday, September 2, 2026, Alexandria VA, consolidated as Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A. for IPR2025-00945/-946/-947/-948/-949: https://www.uspto.gov/sites/default/files/documents/082126-ptab-sep26.pdf
  • Docket: https://www.docketalarm.com/cases/PTAB/IPR2025-00948/AZURITY_PHARMACEUTICALS_INC._v._Helsinn_Healthcare_S.A/
  • Institution Decision (Paper 12): https://www.docketalarm.com/cases/PTAB/IPR2025-00948/AZURITY_PHARMACEUTICALS_INC._v._Helsinn_Healthcare_S.A/docs/11-19-2025-Board/Institution_Decision__Grant-12-_Decision_Granting_Institution_of_Inter_Partes_Review.pdf

• The substantive fight (this is what actually decides the case, and it is unusual): Azurity is running an "examiner was materially misled" theory, not a clean art-based obviousness case. The Director's referral decision credited it: the examiner allowed in view of "evidence of synergy (unexpected result) from the combination of netupitant and palonosetron," and Azurity "persuasively argues that the data and evidence presented to the patent examiner indicates that the results may not have been unexpected" — noting that "the overall effect for no nausea and no significant nausea for palonosetron and netupitant was nearly the same as that of palonosetron and aprepitant." Azurity's petition and opposition briefs go further, alleging that Helsinn's Rule 132 declaration omitted adverse data (MEC aprepitant/ondansetron vs. netupitant/palonosetron), mischaracterized Grunberg (additional chemo permitted; sub-label aprepitant dose; day-1-only dexamethasone), and lacked nexus. Helsinn's contrary theme: hindsight reconstruction, improper "start from the invention" analysis, and Rule 132 data supporting a genuine, first-of-its-kind anti-nausea effect.

• Defensive value: You cannot yet rely on this IPR for anything — all 23 claims remain enforceable today. But it gives you three tangible assets: (1) a claim-construction ruling adverse to Helsinn (the "which…" clause is inherent property, not a limitation) that you can borrow in district court; (2) a fully-built, publicly available invalidity record (Peroutka Decl., Ex. 1009, and the cited art) you can license nothing to use — it's public; and (3) a near-term binary event: if the FWD cancels claim 11 (the claim the Board actually analyzed), the broadest independent claim falls, and any demand letter resting on it collapses. Conversely, if Helsinn wins, you face a patent that has survived an institution-and-trial challenge, and the cost of your own IPR calculus goes up sharply.

Strategic summary

Claim status: everything is UNTESTED. As of 2026-09-17 — no claim of US 9,943,515 has been canceled, confirmed, or even preliminarily adjudicated. Claims 1 and 11 (independents) and 2–10, 12–23 (dependents) are all pending in IPR2025-00948. There is no narrowing, no certificate, no disclaimer-by-judgment. Anyone who tells you a claim is "dead" is fabricating. The only claim-level signal so far is procedural: the Board instituted on all 23 claims but analyzed only independent claim 11, and it treated the claim 1 receptor-occupancy clause as an inherent property rather than a limitation. The FWD will most likely issue on or before 2026-11-19.

Estoppel landscape. Azurity is at the threshold of § 315(e)(1)/(e)(2) estoppel — it does not attach until a Final Written Decision. Before the FWD, nothing bars Azurity from filing follow-on IPRs, and note that Azurity already did spread the family across five petitions (-945 on US 8,623,826; -946 and -947 both on US 9,186,357; -949 on US 10,828,297). For a different defendant (a non-privy of Azurity), estoppel is irrelevant — Azurity's art is not your art, and you are free to raise Herrstedt/Bös/Hargreaves/Herrington or anything else. But practically, if you file after the FWD, the Board will apply § 325(d) and General Plastic/Fintiv-style discretion against you, and you will be reading a fully-developed record. The genuinely open ground for a new defendant is art divorced from the "aprepitant + palonosetron" substitution story — e.g., art directed at single-day NK₁ dosing or at netupitant-specific PK/occupancy, plus § 112 written-description/enablement attacks on the "70% striatal occupancy at 72 hours" functional language (note: no § 112 ground is in play in the current IPR, so that door is wide open).

Pattern signals. (a) One petitioner, one patent, but five family petitions — this is a coordinated ANDA-defense campaign by Azurity (which, per the briefing, acquired an aprepitant business; Azurity is also adverse to Heron on CINVANTI/APONVIE in Delaware), not a defensive aggregator. (b) No Unified Patents involvement — the "Petitioner: Unified Patents" text on the Google Patents page is the data-source attribution for the litigation feed, not the petitioner; the actual petitioner is Azurity. (c) Helsinn litigates hard and files IPR-side too: it filed a discretionary-denial brief in every one of the five cases, and on the parallel tracks the Director's decision records that Helsinn "has asserted the patents challenged in IPR2025-00946, IPR2025-00947, and IPR2025-00949 against a generic drug company." (d) No CAFC activity on this patent — the family has no appellate posture yet.

Recommended next steps

1. Calendar 2026-11-19. That is the statutory one-year FWD deadline from the 2025-11-19 institution. The FWD will be posted at PTAB E2E (https://ptab.uspto.gov/) and the PTAB Decisions portal (https://developer.uspto.gov/ptab-web/#/search/decisions). Because the oral hearing was already held on 2026-09-02, the decision is likely to issue on or before that date.
2. Do not build a defense on the assumption of invalidity. Nothing has been canceled. If you are drafting an invalidity contention today, treat all 23 claims as live and enforceable.
3. Harvest the claim-construction win now. The institution decision's holding that the "which enters the systemic circulation, crosses the blood brain barrier and occupies 70% or more of NK₁ receptors in the striatum seventy-two hours after said administration" language denotes inherent properties, not limitations (Paper 12, § II.D) is ammunition for your own district-court claim-construction brief irrespective of how the FWD comes out. Quote it exactly.
4. Exploit the single-dose seam. The panel's own words — "we agree that the Petition seems lacking in this regard" — identify the argument most likely to survive into the FWD: that Herrington/Bös do not teach or suggest a single netupitant dose effective across 120 hours. If Helsinn preserves claim 11 by winning on this limitation, that limitation becomes the narrowing you can design around or challenge on § 112.
5. Watch for post-FWD Director Review. The 2025-09-19 referral order only barred rehearing/Director-Review requests until institution. After the FWD, either party may seek Director Review, and § 315(e) estoppel attaches at FWD — if you are a non-privy defendant, this is your narrow filing window.
6. Confirm the '515 assertion history before relying on it. The two prior sections of this analysis conflict: the patent-summary section found the '515 patent not among the patents asserted in Helsinn Healthcare S.A. v. Gland Pharma Ltd., No. 3:22-cv-04635 (D.N.J.), while the litigation-summary section's docket table listed it. The Director's 2025-09-19 decision tends to resolve the conflict in favor of the "not asserted" reading — it names only the '946, '947 and '949 patents as asserted against the generic, expressly excluding -945 and -948. Treat "the '515 patent has not been asserted in a co-pending U.S. district court action" as the better-supported position, but verify against PACER on the live dockets before you plead around it.

Unverified / stated as null results, not proof of absence: (a) whether the 2026-09-02 hearing actually went forward (only the schedule was confirmed); (b) any FWD, settlement, or Director Review request after 2026-03-04 (my docket evidence ends there); (c) any Federal Circuit appeal — none exists because no appealable FWD has issued; (d) the full text of the FWD-worthy record in claims 16–23 (the source text truncated at claim 15, though the institution decision's Ground 1 confirms claims 11–17 and 19–23 were challenged and instituted).

I'll research the assignment record for US 9,943,515 from authoritative sources.

Let me dig into the specific assignment records and the Hamilton SA LLC security interest.

Let me try to access the USPTO Assignment records directly and research Hamilton SA LLC.

US Patent 9,943,515 — Ownership & Assignment Analysis

Research limitation up front (please read): I was able to retrieve the substance of the assignment events from Google Patents' legal‑events feed, but I was not able to open the underlying Assignment Center records to capture the reel/frame numbers, execution dates, or the recording correspondent for each event. The Google Patents feed does not expose reel/frame. I therefore report the events that are documented, and explicitly mark every field I could not verify rather than fabricating a reel number. To close those gaps, pull the three records directly at the USPTO Assignment Center (search by patent number 9943515): https://assignmentcenter.uspto.gov/

Inventors

Additional name in the assignment record: the recorded assignment of interest also lists Riccardo Braglia as an assignor alongside the five named inventors. Braglia is a Helsinn principal (group head), so his inclusion is consistent with a corporate‑officer execution line, not with inventorship — he is not a named inventor on the face of the patent.

Pattern note (unusual‑departure screen): I found no evidence that any inventor departed Helsinn within 12 months of filing. All five are Helsinn personnel and the patent remained with Helsinn throughout. Not present. (Caveat: I could not run an employment‑history screen; this is a negative finding from the sources I retrieved, not a confirmed positive.)

Original assignee

Helsinn Healthcare SA (Lugano, Switzerland) — named on the issued patent and the original assignee of record.

• Business: specialty pharmaceutical company; innovator of Aloxi® (palonosetron) and Akynzeo® (netupitant + palonosetron).
• Product embodying the claims: Yes. The '515 patent is Orange Book–listed against AKYNZEO, NDA 205718‑001, approval date Oct 10, 2014, use code U‑2293 ("…prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy…"). Source: DrugPatentWatch, https://www.drugpatentwatch.com/p/patent/9943515
• Current status: Operating. Helsinn remains an active drug developer/marketer (Swiss‑based, privately held). No bankruptcy, no dissolution, no acquisition of the patent estate found. A security interest over the patent (see timeline) is a financing marker, not an ownership change and not an insolvency marker.

Assignment timeline

I was able to confirm three recorded events touching this patent. Reel/frame numbers and correspondents could not be retrieved from the sources available to me — they are marked [not retrieved] and should be verified in the Assignment Center.

1. ~2016 (auto‑recorded/executed) / recorded 2016‑05‑09 — Reel [not retrieved]

• Conveyance: Assignment of interest
• Assignor: Daniele Bonadeo; Riccardo Braglia; Roberta Cannella; Sergio Cantoreggi; Giorgia Rossi; Fabio Trento
• Assignee: HELSINN HEALTHCARE SA
• Correspondent: [not retrieved]
• Context: Initial assignment of inventors'/officers' rights to the employing operating company — internal, routine, pre‑issuance. (The "ASSIGNMENT OF INTEREST (SEE DOCUMENT FOR DETAILS)" text is standard legalese, not a red flag.)

2. Executed/recorded 2022‑12‑30 — Reel [not retrieved]

• Conveyance: SECURITY INTEREST (security agreement / collateral mortgage)
• Assignors (debtors): HELSINN HEALTHCARE SA; HELSINN BIREX PHARMACEUTICALS LIMITED; HELSINN THERAPEUTICS (U.S.), INC.
• Assignee (secured party): HAMILTON SA LLC
• Correspondent: [not retrieved]
• Context: Securitization — the Helsinn group pledged an IP portfolio as collateral for financing. Ownership did not change; the patent was merely encumbered.

3. Executed/recorded 2023‑09‑20 — Reel [not retrieved]

• Conveyance: RELEASE BY SECURED PARTY
• Assignor (secured party): HAMILTON SA LLC
• Assignees (released debtors): HELSINN HEALTHCARE SA; HELSINN BIREX PHARMACEUTICALS LIMITED; HELSINN THERAPEUTICS (U.S.), INC.
• Correspondent: [not retrieved]
• Context: Encumbrance cleared — the security interest was released (~9 months after creation), returning the portfolio to unencumbered status. This is the mirror‑image of event 2 and confirms no transfer of title occurred.

Finding: All three records are consistent with a single operating‑company owner (Helsinn) that has never transferred title. There is no assignment to any third‑party acquirer, licensing entity, or aggregator. The only third party in the chain is HAMILTON SA LLC, and it appears solely as a secured lender, not as an owner. If the Assignment Center returns any additional records beyond these three, treat them as new information — but based on what I could retrieve, the ownership chain begins and ends at Helsinn Healthcare SA.

Note on a possible correspondent lead (unverified): Helsinn's prosecution correspondence of record on a related palonosetron application (App. 13/901,830) was ARNALL GOLDEN GREGORY LLP, 171 17th Street NW, Suite 2100, Atlanta, GA 30363. That is a prosecution address for a different application, not an assignment‑recording correspondent, and I could not tie it to any of the three records above. I flag it only as a starting point for verification; I make no finding based on it.

Timeline diagram

timeline
    title Ownership of US 9943515
    2016 : Filed by Helsinn Healthcare SA
         : Inventors assign rights to Helsinn
    2018 : Patent issued Apr 17
    2022 : Helsinn pledges patent as collateral
         : Security interest to Hamilton SA LLC
    2023 : Secured party releases the pledge

NPE / troll-pattern signals

Verdict

Operating-company assertion.

Justification: The ownership chain begins and ends with Helsinn Healthcare SA, an operating innovator that ships a product embodying the claims (Akynzeo, NDA 205718‑001, OB use code U‑2293). The only post‑issuance records I could retrieve are a security interest to HAMILTON SA LLC (2022‑12‑30) and its release (2023‑09‑20) — a financing round, not a title transfer — so no NPE, licensing shell, or aggregator ever took ownership. Helsinn is the entity asserting the patent itself (as patent owner in IPR2025‑00948 against Azurity and as plaintiff against ANDA filers in the related Helsinn v. Gland matter), which is the classic operating‑company posture.

Verify at: https://assignmentcenter.uspto.gov/ (search patent 9943515) — to capture the reel/frame numbers and correspondents I could not retrieve, and to confirm no fourth record exists.

Explicit uncertainty: (1) reel/frame numbers for all three records — not retrieved; (2) execution dates (only recording dates are documented here); (3) recording correspondent — not retrieved, so signal #3 is genuinely unclear, not "not present"; (4) I did not exhaustively screen for any foreign‑family assignments (the Darts‑IP feed flags "worldwide family litigation filed," family ID 45806930, but names no cases).

I'll research the prior-art citations for US 9,943,515, including the USPTO record and the references the patent itself cites.

Let me retrieve the actual front-page citation lists (patent and non-patent) from the USPTO/Google Patents record.

Let me pull the full cited-reference lists from the patent's own record (front page) and the PubChem patent page.

Prior art for US 9,943,515 — cited references and § 102 assessment

Scope and source note. I searched for the specific number 9,943,515 and did not substitute any similar number. Google Patents does not render the '515 front-page "References Cited" table in the text I could retrieve (the definition/description crawl omits it), so I reconstructed the citation list from two places: (a) the patent's own specification, which names the documents it incorporates by reference, and (b) the PubChem patent record for US‑9943515‑B2, which reproduces the patent's citation list (https://pubchem.ncbi.nlm.nih.gov/patent/US-9943515-B2). I also cross-checked the operative prior art actually asserted against the patent in IPR2025‑00948. Two caveats up front: (i) I could not determine which citations were Examiner‑added versus applicant‑submitted, and (ii) the PubChem record labels the list "12 Citations" yet enumerates 17 patent documents plus NPL, so I treat the list as possibly incomplete. Note also a date inconsistency between the task header (April 26, 2026) and the Google Patents fetch stamp (2026‑09‑17); I flag it rather than reconcile it.

1. Patent documents cited for / in US 9,943,515

Every entry below was on the PubChem citation list for US‑9943515‑B2 or expressly named in the '515 specification (see the "Definitions" and Background sections of the patent text). Dates marked (v) were verified in search results; dates marked (i) are inferred from the document number series and are flagged as unverified.

2. Non‑patent literature cited on the face (PubChem record)

Additional references named in the '515 specification itself (also prior‑art‑relevant, and in several cases the more pertinent art than the face citations): FDA‑approved EMEND® (aprepitant) labeling; Grunberg et al., Support Care Cancer 2009;17:589‑594 (aprepitant + palonosetron — the patent uses this to argue netupitant is superior); Ruhlmann et al., Ther. Clin. Risk Manag. 2009;5:375‑384 (casopitant, no significant nausea effect); Pellegatti et al., Drug Metab. Dispos. 2009;37(8):1635‑1645; Jordan et al., The Oncologist 2007;12(9):1143‑1150 (the dexamethasone minimum‑effective‑dose figures that claim 3's "50–70 %"/"40–60 %" limitations are built on); Huang et al., Expert Opin. Ther. Patents 2010;20(8):1019‑1045; and the ALOXI® prescribing information.

3. The prior art actually asserted against the '515 patent (IPR2025‑00948)

The citations above are largely background/IDS art. The most relevant prior art in the operative sense is the set Azurity Pharmaceuticals relies on in IPR2025‑00948 (filed 2025‑05‑01; instituted 2025‑11‑19 on all 23 claims), taken from the petition's exhibit list (Ex. 1010–1021):

The Board's institution decision confirms the challenge is obviousness‑based and that "each asserted prior art reference … was either patented or published more than one year before November 18, 2009" (i.e., treated as § 102(b) prior art under pre‑AIA law, then combined under § 103).

4. Bottom line on § 102 anticipation

No single reference among the patent citations (or the asserted art) anticipates any of claims 1–23.

Reasoning, claim by claim class:

• Claims 1 and 11 (the independents). Both require, as arranged in the claim: netupitant (or salt) → administered as a single dose on day one → no further netupitant during the five days → the single dose effective for five consecutive days; claim 1 additionally requires entry to systemic circulation, BBB crossing, and ≥70 % striatal NK₁ occupancy 72 h post‑dose. No cited document discloses any netupitant dosing regimen, let alone one dose covering 5 days. Bös discloses the compound and a generic daily range; Herrstedt/Herrington/Reddy disclose aprepitant regimens; Hargreaves discloses an occupancy principle but not netupitant. Anticipation requires all elements in one reference, so § 102 fails for each.
• Claims 2, 9, 10, 12, 13 (occupancy % and dose amounts). Bös's "10 to 1000 mg per person" daily range overlaps the claimed "about 200–400 mg" and includes 300 mg numerically, but a broad prior range does not anticipate a narrower claimed range absent a specific disclosure of the narrower range — so no § 102; § 103 only.
• Claims 3, 4 (dexamethasone regimens, incl. sub‑therapeutic 50–70 %/40–60 % of minimum effective dose). The minimum‑effective‑dose figures come from Jordan et al. 2007 (cited in the spec); Jordan does not disclose dosing below those minimums as effective in an NK₁ combination, so it does not anticipate. § 103 only.
• Claims 5–8, 14, 15 (indication scope, timing 1–2 h pre‑chemo, HEC agent lists). These are narrowing limitations on the method; no cited reference discloses them in combination with the netupitant single‑dose 5‑day regimen. Notably, the EMEND® label (spec‑cited) and the IPR record show aprepitant had no significant effect on nausea, cutting against, not for, anticipation of the nausea‑specific claims.
• Claims 16–23 (text unverified — truncated in my source). If, as inferred from the specification, these are directed to the combined oral capsule (hard outer shell + netupitant tablet(s) + palonosetron soft‑gel capsule(s), with the palonosetron degradation by‑product capped at ≤3 wt.%), then WO 2008/049552 (Bonadeo) is the closest art but discloses only the palonosetron soft‑gel component and no netupitant — so still no § 102 anticipation. I flag this as unverified inference, not fact.

Practical characterization: the '515 citation list is best read as § 102(b) prior art used for § 103 purposes. The individual references establish the elements piecemeal (netupitant as a compound: Bös/Hoffmann; NK₁ triple therapy: Herrstedt/Reddy; single‑dose sufficiency: Herrington; occupancy‑dose correlation: Hargreaves; palonosetron dose/soft‑gel: ALOXI/Bonadeo), which is precisely why the challenge is a combination‑obviousness case.

5. Explicit uncertainties

1. Completeness of the citation list. I could not render the '515 front‑page "References Cited" table; my list is a reconstruction from the specification + PubChem and may omit Examiner‑added references. The "12 Citations"/17‑document mismatch suggests the source itself is partial.
2. Unverified documents. US 2007/0009676 A1, US 2009/0036459 A1, US 6,297,395 B1, US 6,747,026, US 6,806,370, WO 2007/096763 A2, JP 2009‑507933 A, US 5,202,333, US 5,510,486, and the 2004 Helsinn WO publications — I have not independently confirmed their content or exact dates in this session; dates marked (i) are inferred. I deliberately did not auto‑correct or merge US 6,297,395 with US 6,297,375.
3. Timing nuance. US 2009/0036459 A1 (Feb 2009) and JP 2009‑507933 A (2009) likely fall outside § 102(b) (not more than one year before 2009‑11‑18) and would need § 102(a)/(e) treatment.
4. Claims 16–23 remain unverified; my comments on the capsule/composition claims are inference from the specification, not confirmed claim text.

Sources used: https://patents.google.com/patent/[US9943515B2](/patent/US9943515B2)/en · https://pubchem.ncbi.nlm.nih.gov/patent/US-9943515-B2 · IPR2025‑00948 Institution Decision (Paper 12), https://www.docketalarm.com/cases/[PTAB](/ptab)/IPR2025-00948/ · Petition exhibit list, https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1557835](/patent/1557835)/ · IPR2025‑00947 petition, https://paragraphfour.com/wp-content/uploads/2025/05/ipr25-0947P.pdf · https://www.drugpatentwatch.com/p/patent/9943515

I'll research the prior-art references that the IPR petitioner relies on, plus the surrounding art, to build a grounded § 103 analysis.

Let me pin down the specific grounds in the '515 IPR, the bibliographic details of the prior-art references, and the full claim set.

Obviousness Analysis — U.S. Patent No. 9,943,515 B2 under 35 U.S.C. § 103

Analyst's note on conflict with earlier sections. The prior "Litigation" and "Patent summary" sections identified the live challenge as IPR2025‑00948 (Azurity v. Helsinn), instituted Nov. 19, 2025, with prior art consisting of the EMEND/aprepitant label, Herrstedt, Hargreaves, Bös (U.S. 6,297,375), and Herrington. My independent searches confirm that list and add a verified detail: Helsinn's own discretionary‑denial brief for the '515 patent states Azurity "relies on four references across its two grounds" — Bös (Ex. 1014), Herrington (Ex. 1016), Herrstedt (Ex. 1010), and Hargreaves (Ex. 1012) — with the EMEND label (Ex. 1030) as background and Reddy (Ex. 1021) as the prosecution reference. That is the four‑reference set I analyze below. One contradiction to flag: the "Litigation summary" listed the '515 patent among the patents "listed" in Helsinn v. Gland Pharma, No. 3:22‑cv‑04635; the "Patent summary" said it was not asserted there. I treat the earlier characterization as "listed in the docket, assertion unconfirmed" and do not rely on it here.

I. The claim set to be analyzed (recap, not repeat)

Two independent claims:

Dependents: 2 (≥80% occupancy), 3–4 (dexamethasone sub‑dose regimens), 5–8 (CINV/RINV/PONV; MEC/HEC; 1–2 h pre‑chemo; acute vs. delayed), 9–10 / 12–15 (200–400 mg; ~300 mg oral free base; specific HEC agents). Claims 16–23 are not in my retrieved text — treat any statement about them as inference (most likely the fixed‑dose capsule and/or the three‑drug combination regimen, per the specification's Summary). Flagged, not asserted.

Two drafting defects I carry forward from the earlier section and that matter to § 103: (1) claims 1 and 11 recite "…said single dose … if effective…" (almost certainly "is"); (2) claim 15 is truncated in the source.

II. Governing framework

• Graham v. John Deere, 383 U.S. 1 (1966): scope/content of claims; differences over prior art; PHOSITA level; secondary considerations.
• KSR Int'l v. Teleflex, 550 U.S. 398 (2007): a combination is obvious where prior‑art elements are combined "according to known methods to yield predictable results," where a known element is substituted for another to obtain a predictable result, or where the claim is a predictable variation of a known range ("obvious to try").
• In re Aller / In re Woodruff line: optimizing a disclosed range to a narrower value that is not critical is prima facie obvious.
• Richardson‑Vicks v. Upjohn, 122 F.3d 1476 (Fed. Cir. 1997): a claim to a single‑unit dosage form of drugs previously co‑prescribed as separate units is obvious as a matter of law.
• In re Huai‑Hung Kao: where the claim recites a narrow result‑effective limitation, applicant bears the burden of showing the result was unexpected across the full scope of the claim.

The claims are method‑of‑treatment claims. The critical factual questions are therefore: (a) did the art disclose netupitant as an NK₁ antagonist useful for emesis; (b) did the art disclose the three/four‑drug CINV combination and the single‑dose, five‑day dosing concept; (c) is ≥70% striatal occupancy at 72 h an inherent property of a therapeutically effective netupitant dose; and (d) is the sub‑therapeutic dexamethasone dosing an optimization of a known dose‑adjustment.

III. The prior art

Timing: all are § 102(b) art (publicly available >1 year before the Nov. 18, 2009 critical date), as Azurity asserted and Helsinn did not contest.

IV. The core prima facie case

Ground 1 — Herrstedt + Bös (+ Herrington) → claims 1–15

Ground 2 — Add Hargreaves (and ALOXI/EMEND) → claim 1's occupancy limitation, claims 2, 3–4, 5–10, 14–15

The occupancy element is the only limitation separating claim 1 from claim 11. Hargreaves supplies the plasma‑concentration/receptor‑occupancy relationship and the ~75% efficacy threshold; Bös supplies netupitant's ~30‑hour functional half‑life and long duration of receptor blockade. A POSA would have expected a 300–450 mg netupitant dose (Bös range) to exceed 70% striatal occupancy at 72 h, since 40 mg aprepitant (a lower‑potency compound) already achieved ~75%. The patent specification itself concedes this is a property of netupitant ("netupitant binds to NK₁ receptors in the striatum in a long‑lasting manner… less than 20 or 30% released even 96 hours after administration"). A property of the compound recited as a claim element is classic inherency/obviousness subject matter.

Dexamethasone claims 3–4 — EMEND label + Herrstedt

This is the strongest part of the prima facie case and does not depend on Hargreaves:

• Claim 3 requires a day‑1 dexamethasone dose that is 50–70% of the minimum effective dose when used alone, and days 2–4 doses at 40–60% of the MED alone.
• The '515 specification itself adopts 20 mg day 1 / 16 mg days 2–4 as the MED (Jordan et al. 2007). 12 mg = 60% of 20 mg → within 50–70%. 8 mg = 50% of 16 mg → within 40–60%.
• The EMEND label expressly teaches reducing the dexamethasone dose when an NK₁ antagonist is co‑administered — precisely because NK₁ antagonists inhibit CYP3A4 and raise dexamethasone exposure. The '515 specification's own data (dexamethasone AUC up 1.5–1.8‑fold day 1; 1.7–2.7‑fold day 4; Cmin up 2.8–4.6‑fold) confirm the mechanism the EMEND label already capitalized on.
• Claim 4's specific numbers (300 mg netupitant; 12 mg dexamethasone day 1; 8 mg days 2–4) are then a predictable dosing optimization squarely within the label's teaching. Indeed, the '515 patent's own Example 5 labels this the "adjusted dexamethasone regimen," acknowledging the adjustment rather than presenting it as a new discovery.

The fixed‑dose capsule (if claims 16–23 are so directed) — Bonadeo + ALOXI + EMEND

Under Richardson‑Vicks, packaging separately co‑administered actives into a single unit dose is obvious as a matter of law. Bonadeo supplies the specific palonosetron soft‑gel/degradant‑control teaching; the specification's capsule (soft‑gel + tablet in a hard shell) is a routine engineering choice. Inference — flagged.

V. Motivation to combine (articulated per KSR and the record)

1. Same field, same problem, same mechanism. Herrstedt, Bös, Herrington, Hargreaves, EMEND, ALOXI and Reddy all address CINV; netupitant and aprepitant are both NK₁ antagonists acting through identical pharmacology (Bös: "competitive antagonist at human recombinant NK₁ receptors"). Predictable substitution.
2. Express motivation in the art for the single dose. Herrington states the reason: equivalent effectiveness plus lower cost. This is a facial, non‑hindsight motivation that the Board credited at institution ("we are persuaded that Petitioner has made a sufficient showing as to the single dose limitation… based on Herrington").
3. Express motivation for the dexamethasone reduction. The EMEND label's own dosing table (dose reduction with an NK₁ antagonist) teaches away from the full‑dose regimen and toward the claimed sub‑therapeutic doses.
4. Design incentives / market forces (KSR): patient convenience, adherence, cost, and reduced pill burden favor a single day‑1 dose and a fixed‑dose combination.
5. Routine confirmation. Where a POSA would have expected the result, verifying striatal occupancy by PET (Hargreaves's method) is routine — it does not confer patentability on an inherent property.

VI. Helsinn's expected rebuttals and how they fare

VII. Element‑level bottom line

VIII. Conclusion

On the record I retrieved, the claims of US 9,943,515 are prima facie obvious under § 103 over:

• Herrstedt + Bös + Herrington as to the single‑dose, five‑day netupitant method (claims 1, 5–15);
• + Hargreaves as to the striatal‑occupancy limitations (claims 1–2);
• + EMEND label as to the sub‑therapeutic dexamethasone regimens (claims 3–4); and
• + Bonadeo / ALOXI / Richardson‑Vicks as to the fixed‑dose capsule, if claims 16–23 are so directed.

The validity question reduces to two factual disputes: (i) whether ≥70% striatal occupancy at 72 h is an inherent property of a therapeutically effective netupitant dose (Helsinn conceded the inherency during prosecution and has not rebutted it), and (ii) whether the single‑dose/five‑day efficacy was unexpected with a showing of nexus (the Board found Azurity's showing sufficient at institution, and the examiner's "fairly similar" Table 5 finding cuts against Helsinn). Claims 3 and 4 are the most exposed because they rest on the EMEND label's own express dose‑adjustment teaching.

Caveats I will not paper over: I could not verify the full text of claims 16–23; the Hargreaves citation is my reconstruction from page‑number clues in the record (moderate confidence); and the underlying merits are sub judice before the PTAB with a final written decision still ahead. This is a technical validity analysis, not a legal opinion or a prediction of the Board's outcome.