Invalidity dossier

US 7947724

Liquid pharmaceutical formulations of palonosetron

Current assignee: Helsinn Healthcare S.A., Roche Palo Alto LLC

Added 9/27/2026, 12:48:59 AM

IndustryMedical (M)
At a glanceNo PTAB challenges15 lawsuits on fileasserted by Helsinn Healthcare S.A. +1Medical (M)

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Patent summary

Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.

✓ Generated

I'll search for authoritative information on US patent 7947724, including any recent CAFC docket activity.

Let me check specifically for any 2026 CAFC docket activity involving this patent.

US Patent 7,947,724 — Verified Summary

I searched for this specific number (interpreting it literally as 7,947,724 / US7947724B2) and found no results pointing to any other patent. Below is what I can confirm from the authoritative patent text and corroborating sources.

Bibliographic Data

Field Value
Patent number US 7,947,724 B2
Title Liquid pharmaceutical formulations of palonosetron
Application no. 11/186,311
Filing date July 21, 2005
Priority date January 30, 2003 (U.S. Provisional 60/444,351)
Issue/grant date May 24, 2011
Pre-grant publication US 2006/0069114 A1 (March 30, 2006)
Inventors Giorgio Calderari; Daniele Bonadeo; Roberta Cannella; Enrico Braglia; Riccardo Braglia; Andrew Miksztal; Thomas Malefyt; Kathleen M. Lee
Original assignees Helsinn Healthcare SA; Roche Palo Alto LLC
Current assignees Helsinn Advanced Synthesis SA; Helsinn Birex Pharmaceuticals Ltd; Helsinn Therapeutics US, Inc.
Status Expired – Lifetime (anticipated expiration Jan 30, 2024)

The application is a continuation of PCT/EP2004/000888 (published as WO 2004/067005 A1), filed Jan 30, 2004, which claims priority to the 2003 provisional. The ’724 patent sits at the head of a large continuation family (’725, ’424, ’981, ’218, ’219, ’094, etc.).

Abstract (verbatim)

"The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments."

Plain-Language Overview of the Independent Claims

The patent has two independent claims — claim 1 and claim 8; claims 2–7 depend from claim 1 and claims 9–14 depend from claim 8.

Claim 1 — A pharmaceutically stable intravenous solution to reduce emesis (or the likelihood of emesis), containing:

  • (a) palonosetron (or a pharmaceutically acceptable salt) at 0.03–0.2 mg/mL, buffered to a pH of 4.0–6.0; and
  • (b) a sterile aqueous carrier that includes mannitol in a tonicifying effective amount plus EDTA at 0.005–1.0 mg/mL.

In plain terms: a low-concentration, buffered palonosetron IV solution stabilized by the specific combination of mannitol (as a tonicity agent) and EDTA.

  • Dependent claims narrow this to: ~0.05 mg/mL palonosetron (claim 2); palonosetron hydrochloride (3); pH 4.5–5.5 (4); 10–100 mM citrate buffer (5); 0.3–0.7 mg/mL EDTA + 10–40 mM citrate (6); and 0.3–0.7 mg/mL EDTA + 10–80 mg/mL mannitol + 10–40 mM citrate (7).

Claim 8 — A pharmaceutically stable isotonic intravenous solution to reduce emesis (or likelihood of emesis), containing:

  • (a) palonosetron (or salt) at the broader 0.01–5 mg/mL, at pH 4.0–6.0; and
  • (b) an aqueous pharmaceutically acceptable carrier including a chelating agent.

In plain terms: the broader genus — a buffered isotonic palonosetron IV solution with any chelating agent, not limited to the mannitol/EDTA combination or the narrow concentration of claim 1.

  • Dependent claims narrow this to ~0.05 mg/mL palonosetron (9); palonosetron hydrochloride (10); pH 4.5–5.5 (11); EDTA at 0.005–1.0 mg/mL as the chelating agent (12); mannitol in the carrier (13); and adaptation for IV administration (14).

Litigation / Docket Note (important caveat)

I found no 2026 CAFC docket activity for US 7,947,724. Any appellate activity involving this patent appears to be historical:

  • The ’724 patent was one of four patents-in-suit in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. — Federal Circuit Nos. 16-1284 and 16-1787; the Federal Circuit held the pre-AIA claims invalid under the on-sale bar (855 F.3d 1356 (2017)).
  • The related AIA patent appeal went to the Supreme Court as No. 17-1229, decided Jan 22, 2019 (Helsinn v. Teva).
  • Additional reported appeals: 17-1746 (Fed. Cir.).
  • The Google Patents litigation links list numerous district-court cases (D.N.J., D. Del., E.D. Pa.) but no 2026 Federal Circuit filing.

Because the patent reached its anticipated expiration on January 30, 2024 (with pediatric exclusivity listed as extending to July 30, 2024 by third-party databases), a fresh 2026 CAFC appeal is unlikely and I found none.

Uncertainty Flags

  • Filing date: The patent dates itself "Filed: Jul. 21, 2005" for application 11/186,311. If you were expecting a 2004 filing date, that is the parent PCT application (PCT/EP2004/000888), not this U.S. national-stage continuation.
  • Inventor name spelling: PubChem renders one inventor as "Miksztal Andrew"; a later-family PDF renders it "Andrew Mikszta." I am reporting the ’724 front-page spelling; the discrepancy appears in derivatives of this family.
  • No USPTO/CAFC live query performed: My results come from indexed web sources (Google Patents, PubChem, FDA documents, court filings). I did not query the USPTO PatentCenter or the CAFC docket system directly, so I cannot rule out an unindexed filing. If you need definitive 2026 docket confirmation, that would require a direct PACER/CAFC CM/ECF lookup.

Sources: Google Patents US7947724B2; PubChem patent record US-7947724-B2; FDA NDA 203050 review documents (referencing the May 11, 2012 suit on patent 7947724); Helsinn v. Teva materials; patentdocs.org analysis of the Supreme Court decision.

Generated 9/27/2026, 6:12:41 PM

Cases on file (15)

Group view →

Specific litigation cases in our database that name US patent 7947724. The free-form analysis below may also discuss cases beyond this list.

Lawsuits filed per year

2011: 1 case'112012: 1 case'12'13'142015: 4 cases4'152016: 2 cases'16
Cases asserting US 7947724, by filing year.

Litigation summary

Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.

✓ Generated

I'll search for litigation involving US 7,947,724 across patent litigation databases.

Let me gather more detail on specific cases and the appellate outcomes.

Known Litigation Involving U.S. Patent No. 7,947,724 ("the '724 patent")

Interpretation note: I searched literally for "7947724" / "7,947,724" and excluded similar numbers (e.g., the sibling patents 7,947,725, 7,960,424, 8,598,218/219, 8,729,094). Where the sources below list the '724 patent alongside sibling patents, I flag that the docket may involve the whole family and not necessarily assert the '724 claims.

Bottom line: The '724 patent was heavily litigated in ANDA/505(b)(2) Hatch-Waxman actions between roughly 2011 and 2016, went up to the Federal Circuit and the Supreme Court (invalidated on the on-sale bar), and I found no litigation activity in 2026 — the patent's anticipated expiration was January 30, 2024.


1. Federal Circuit & Supreme Court (the dispositive appeals)

Court Case No. Parties Filed Outcome
U.S. Court of Appeals for the Federal Circuit 16-1284 Helsinn Healthcare S.A. (plaintiff-appellee) v. Teva Pharmaceuticals USA, Inc. & Teva Pharmaceutical Industries, Ltd. (defendants-appellants) appeal filed 2016 Reversed on May 1, 2017 — Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 855 F.3d 1356. Court held asserted claims of the '724, '725 and '424 patents invalid under the pre-AIA on-sale bar, and the '219 patent invalid under the post-AIA § 102(a)(1) on-sale bar.
U.S. Court of Appeals for the Federal Circuit 16-1787 Helsinn v. Teva (companion appeal) 2016 Consolidated/related Federal Circuit appeal in the same family; same on-sale-bar outcome.
U.S. Court of Appeals for the Federal Circuit 17-1746 Helsinn-related family appeal 2017 Listed in the Google Patents litigation data as a Federal Circuit case in this family.
U.S. Supreme Court 17-1229 Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. cert. granted June 25, 2018; argued Dec. 4, 2018 Affirmed Jan. 22, 2019 — Helsinn, 139 S. Ct. 628 (2019). Court held that a sale to a third party obligated to keep the invention confidential can trigger the on-sale bar; Congress did not alter the meaning of "on sale" when it enacted the AIA.

Effect: The Federal Circuit/ Supreme Court ruling invalidated the '724 (and '725, '424) claims, so the district-court judgments of validity and infringement in the lead D.N.J. case did not stand.


2. District of New Jersey (Judge Cooper) — the primary Hatch-Waxman actions

Case No. (D.N.J.) Plaintiffs Defendants Filed Grant/Status
11-3962 (MLC)(DEA) (consolidated) Helsinn Healthcare S.A. & Roche Palo Alto LLC [Dr. Reddy's Laboratories, Ltd.](/litigations/by-defendant/Dr.%20Reddy's%20Laboratories%2C%20Ltd.); Sandoz, Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd. 2011 Bench trial; Nov. 13, 2015 opinion held the asserted claims of the '724, '725 & '424 valid and infringed by Teva's 0.25 mg/5 mL and 0.075 mg/1.5 mL products; appealed (16-1284).
12-2867 (MLC)(DEA) Helsinn Healthcare S.A. & Roche Palo Alto LLC Dr. Reddy's Laboratories May 11, 2012 (per FDA NDA 203050 review record: "Lawsuit filed on May 11, 2012 for patent 7947724") 505(b)(2) case; April 2, 2015 claim-construction order construing the '724 term "a chelating agent."
14-4274 (MLC)(DEA) Helsinn / Roche Palo Alto Dr. Reddy's Laboratories 2014 Listed as related family case.
14-6341 (MLC)(DEA) Helsinn / Roche Palo Alto Teva Pharmaceuticals USA, Inc., et al. 2014 Related consolidated action.
15-1228 (MLC)(DEA) Helsinn / Roche Palo Alto GAVIS Pharma LLC 2015 Related family case.
15-2077 (MLC) Helsinn / Roche Palo Alto Hospira, Inc. 2015 April 5, 2016 opinion (2016 U.S. Dist. LEXIS 45826) denying Hospira's motion to dismiss (jurisdiction); patents-in-suit included the '724.

Additional D.N.J. dockets listed in Google Patents' litigation data for this family: 3:11-cv-05579; 3:12-cv-02867; 3:13-cv-05815; 3:15-cv-01228; 3:15-cv-02077; 3:15-cv-02078; 3:15-cv-07015; 3:15-cv-07378; 3:15-cv-08132; 3:16-cv-00173; 3:16-cv-00681; 2:16-cv-01683; 2:16-cv-04239; 3:17-cv-03216; 2:17-cv-03216; 1:16-cv-01394; 2:16-cv-00173; 2:15-cv-02077. Caveat: I could not individually verify that each of these dockets asserted the '724 patent specifically rather than sibling family members.


3. District of Delaware (Judge Sleet) — "Helsinn v. Cipla" cluster

DrugPatentWatch lists the following dockets as citing 7,947,724:

Case Name Docket (D. Del.) Filed Terminated Patents cited
Helsinn Healthcare SA v. Cipla Ltd. 1:13-cv-00688 2013-04-16 2015-10-26 7,947,724; 7,947,725; 7,960,424; 8,518,981; 8,598,218; 8,598,219; 8,729,094
(Helsinn family) 1:13-cv-01612 2013-09-25 2015-10-27 7,947,724 (family)
Helsinn Healthcare S.A. v. Cipla Ltd. 1:14-cv-00427 2014-04-07 2015-10-27 7,947,724; 7,947,725; 7,960,424; 8,518,981; 8,598,218; 8,598,219
(Helsinn family) 1:14-cv-00709 2014-06-04 2015-10-05 7,947,724 (family)
Helsinn Healthcare S.A. v. Hospira Inc. 1:15-cv-00264 2015-03-25 2018-09-11 7,947,724 (family)
(Helsinn family) 1:15-cv-00265 2015-03-25 2015-12-03 7,947,724 (family)

The 1:13-cv-00688 docket (CourtListener, case 1:13-cv-00688-GMS) shows the original April 16, 2013 complaint asserted 7,947,724; 7,947,725; 7,960,424 against Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc. (ANDA No. 204702), with later amended complaints adding Cipla Ltd./Cipla USA Inc., Accord Healthcare Inc., AuroMedics Pharma LLC, and Ben Venue Laboratories. Additional D. Del. dockets in Google Patents' data: 1:13-cv-02101, 1:15-cv-00865, 1:15-cv-00918.


4. Eastern District of Pennsylvania

  • 2:15-cv-06392 (E.D. Pa.) — listed in the Google Patents "family has litigation" data (filed 2015). Defendant name not confirmed from the sources retrieved; it appears in the same 2015 Helsinn enforcement wave.

5. Outcome / current status summary

  • The '724 patent (and '725 and '424) were held invalid under the pre-AIA on-sale bar by the Federal Circuit in Helsinn v. Teva, 855 F.3d 1356 (Fed. Cir. 2017), affirmed by the Supreme Court, 139 S. Ct. 628 (2019).
  • Based on the district-court settlements/public statements, Dr. Reddy's and Sandoz were permitted to launch generic palonosetron no earlier than ~Sept. 30, 2018 (with certain earlier-entry triggers).
  • The '724 patent's Orange Book expiration was Jan. 30, 2024 (with pediatric exclusivity to July 30, 2024); Google Patents lists legal status as Expired – Lifetime (anticipated expiration Jan. 30, 2024).

6. 2026 activity

I found no litigation filed in 2026 involving US 7,947,724. Given the patent has expired and was invalidated, a new 2026 suit or appeal on this patent is unlikely, and none appears in the litigation databases searched (Google Patents litigation links, DrugPatentWatch "PALONOSETRON HYDROCHLORIDE" litigation table, CourtListener).


Uncertainty flags (per your strict rules)

  1. Sources are index-based, not primary dockets. Google Patents' "family has litigation" list and DrugPatentWatch tables are aggregators. I did not complete a direct PACER/CM‑ECF or CAFC CM/ECF pull, so an unindexed filing cannot be categorically excluded.
  2. Family vs. '724-specific. Several aggregated dockets may involve the sibling patents (e.g., '725, '424, '219, '981) rather than the '724 claims specifically. Only the lead D.N.J. 11-3962/12-2867 and the Cipla/Hospira D. Del. dockets were affirmatively linked to the '724 patent in the retrieved text (asserted '724 claims 2 and 9 in the Teva appeal; "a chelating agent" construction for the '724 in 12-2867).
  3. Filing-date precision for several D.N.J. dockets (e.g., 11-3962) is approximate; only 12-2867 is pinned to a specific date (May 11, 2012) by the FDA record.
  4. Date discrepancy: the previously generated summary dated itself Sept. 27, 2026, while this task states April 26, 2026. Neither changes the substantive litigation list; I used the task date.

Key sources: Google Patents US7947724B2 (litigation links); DrugPatentWatch "Litigation for PALONOSETRON HYDROCHLORIDE" and "Helsinn Healthcare SA v. Cipla Ltd." pages; Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 855 F.3d 1356 (Fed. Cir. 2017) and 139 S. Ct. 628 (2019); FDA NDA 203050 review documents ("Lawsuit filed on May 11, 2012 for patent 7947724"); Robinson & Kaplan Hatch-Waxman bulletins (Helsinn v. Dr. Reddy's; Helsinn v. Hospira); CourtListener docket 4220119 (D. Del. 1:13-cv-00688).

Generated 9/27/2026, 6:13:07 PM

Proceedings on file (0)

All PTAB activity →

AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.

Current assignee: Helsinn Healthcare S.A., Roche Palo Alto LLC

No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.

PTAB challenges

AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.

✓ Generated

I'll verify the structured data against live sources before writing anything, since the "no PTAB activity on file" default should be tested against web search.

The structured block says "no PTAB activity on file." My first search surfaced PTAB cases on sibling patents (8,598,219; 8,729,094; 9,173,942) but nothing on 7,947,724 itself. Let me run targeted confirmations before I write.

Confirmed pattern: all PTAB activity in the palonosetron family targeted sibling patents — nothing on 7,947,724 itself. Let me pin down the sibling outcomes for family-level context and confirm the '724 was never subject to an AIA trial.

PTAB / AIA Trial Analysis — US 7,947,724 B2 ("Liquid pharmaceutical formulations of palonosetron")

Bottom line up front: I found zero AIA trial proceedings against US 7,947,724. The structured "PTAB proceedings on file" block (canonical per the task) returns none, and my independent web searches corroborate that: every palonosetron-family PTAB filing I could locate was directed at sibling patents (’219, ’094, ’942), never at the ’724. This is a case where the honest answer is "no PTAB activity," and that absence — not any IPR outcome — is the strategically decisive fact.


Proceedings overview

Total AIA trial proceedings on US 7,947,724: 0. Breakdown: 0 active, 0 with claims invalidated, 0 with claims sustained, 0 settled, 0 with institution denied. Nothing was ever petitioned, so no panel, no FWD, no estoppel, and no PTAB appeal exists for this patent.

Defensive posture this gives a defendant: the patent's problem is not a PTAB cancellation — it is that the asserted claims were held invalid by the Federal Circuit under the on-sale bar of 35 U.S.C. § 102 in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 855 F.3d 1356 (Fed. Cir. 2017-05-01), affirmed by the Supreme Court at No. 17-1229 (2019-01-22). Claims 2 and 9 of the ’724 patent — the only claims ever asserted in that litigation — are dead. Combined with the patent's expiry (anticipated 2024-01-30; pediatric exclusivity to 2024-07-30 per third-party listings), a demand letter built on the ’724 patent today has essentially no forward-looking enforcement value. Details and caveats below.

⚠️ Contradiction flag vs. the task's framing. The prompt anticipates "the patent has survived two IPRs and is hardened" or "claims 1-5 have been canceled." Neither is true here. US 7,947,724 had no IPRs or PGRs. If a prior working note in this project implied otherwise, it conflated the ’724 with its sibling patents. Do not attribute any IPR FWD to this patent number.


No proceedings to itemize (and why that's not an oversight)

Because the proceeding count is zero, the per-proceeding template is inapplicable. Instead I verified the negative and mapped the adjacent family activity, which is what a defendant actually needs.

Negative verification performed (2026-09-27):

  • Structured "PTAB proceedings on file" block → none for 7,947,724.
  • DrugPatentWatch PTAB listings for "palonosetron hydrochloride" and for patent owner "Helsinn" → list only 8,598,219, 8,729,094, and 9,173,942; the ’724 does not appear.
  • Google Patents litigation/PTAB links on the ’724 record → district-court and CAFC cases only; no PTAB trial numbers.

Family PTAB activity (NOT on the ’724 — context only)

These proceedings challenged other Helsinn patents that share the ’724 specification/priority family. They are relevant because they show what challengers did instead of attacking the ’724, and because estoppel and preclusion nuances differ across the family.

PGR2014-00009 — Accord Healthcare, Inc. v. Helsinn Healthcare S.A. (US 8,598,219)

  • Type: Post-Grant Review
  • Filed: 2014-09-02 (accorded 2014-09-02)
  • Status / decision date: 2014-11-24
  • Petition grounds: PGR-style challenge to the ’219 claims (included § 112 and on-sale-type grounds available in PGR).
  • Disposition: I could not verify the claim-level disposition with high confidence (search budget exhausted); third-party trackers show only the filing and decision date. Flag as unverified — do not represent whether institution was granted or denied without pulling the decision from PTAB E2E.
  • Appeal: None confirmed.

IPR2015-01550 / -01551 / -01553 / -01554 — [Dr. Reddy's Laboratories, Ltd.](/litigations/by-defendant/Dr.%20Reddy's%20Laboratories%2C%20Ltd.) et al. v. Helsinn Healthcare S.A. (US 8,729,094)

  • Type: Inter Partes Review (four parallel petitions)
  • Filed: 2015-07-03 (accorded 2015-07-03)
  • Status / decision date: 2015-10-14
  • Petition grounds: § 102/§ 103 challenges to the ’094 claims, relying on prior art including the Gibson/Broadhead formulation text, the PDR entries for ondansetron/granisetron/dolasetron, and Tang/Chelly/Eglen — as recited in DRL's petition (CourtListener exhibits).
  • Disposition: Institu­tion outcome not independently verified here. These petitions are documented as filed and were accompanied by expert declarations (Frame, DeCormier/McGurny, DeLuca). Treat the ultimate disposition as open pending an E2E check.
  • Appeal: None confirmed.

PGR2016-00007 — Dr. Reddy's Laboratories, Ltd. et al. v. Helsinn Healthcare S.A. (US 9,173,942)

  • Type: Post-Grant Review
  • Filed: 2016-02-05
  • Status: Institution Denied (Board decision 2016-08-17: "Decision – Denying Institution of Post-Grant Review")
  • Challenged claims: 1–19 of the ’942 patent
  • Panel: Not captured in the sources I retrieved; obtain from the E2E decision paper.
  • Defensive value: Confirms Helsinn successfully defeated at least one family PGR at the institution stage — i.e., the family is not uniformly vulnerable at the PTAB. But this says nothing about the ’724, which was never petitioned.

Docket source: Dr. Reddy's Laboratories, Ltd v. Helsinn Healthcare S.A., PGR2016-00007 (P.T.A.B.), https://sandbox.docketalarm.com/cases/PTAB/PGR2016-00007/Dr._Reddy%27s_Laboratories_Ltd_v._Helsinn_Healthcare_S.A/


The real "invalidation" event for the ’724 patent — and it wasn't the PTAB

Because a defendant facing the ’724 should lead with the on-sale bar, not with IPR:

  • District court (D.N.J. 11-3962, consolidated): After an 11-day bench trial, Judge Cooper's 2015-11-13 memorandum opinion held the four patents-in-suit (’724, ’725, ’424, ’219) valid and infringed (the ’219 not infringed as to Teva's 0.075 mg product). Asserted claims were claims 2 and 9 of the ’724 patent.
  • Federal Circuit (2017-05-01), 855 F.3d 1356: Reversed, holding the asserted claims — "claims 2 and 9 of the ’724 patent, claim 2 of the ’725 patent, claim 6 of the ’424 patent, and claims 1, 2, and 6 of the ’219 patent" — invalid under the on-sale bar because the invention was ready for patenting before the 2002-01-30 critical date and was subject to a pre-critical-date supply/license agreement.
  • Supreme Court, No. 17-1229 (2019-01-22): Affirmed — the AIA did not change the scope of the on-sale bar.

Claim-level status of the ’724 patent after that judgment:

Claims Status
2, 9 (asserted) Held invalid (on-sale bar) — final judgment, affirmed through SCOTUS
1, 3–8, 10–14 Never adjudicated — not asserted in the Teva/DRL case. No PTAB proceeding touched them. They are "untested," not "sustained."

Note the structural oddity worth flagging to a client: the independent claims (1 and 8) were never invalidated, while the narrower dependent claims (2 and 9, which add the ~0.05 mg/mL limitation) were. So an assertion could theoretically be repackaged onto claims 1/8 — but those claims never carried a damages case, and the patent expired in 2024.


Strategic summary

Canceled vs. sustained vs. untested. On the ’724 patent, claims 2 and 9 are invalid by unappealed final judgment (subsequently affirmed), and claims 1, 3–8, 10–14 were never tested in any forum. There is no PTAB cancellation, and equally no PTAB vindication — the patent is simply a stranger to the IPR/PGR system. Any assertion today would rest on the untested independent claims, against an expired patent.

Estoppel landscape. Because no IPR or PGR was ever instituted on the ’724, § 315(e)(2) / § 325(e)(2) estoppel does not attach to this patent at all. There is no petitioner-side bar. The operative preclusion is instead issue preclusion/collateral estoppel flowing from the Teva judgment as to claims 2 and 9 — and that binds only Teva and its privies. A new defendant who was not a party or privy can still contest the untested claims, though it would face the ’724's § 102 record. The practical prior-art toolbox remains wide open: no IPR estoppel, and the on-sale-bar rationale itself is a court-facing (and, for an AIA patent, PGR-facing) ground that an IPR cannot reach for the pre-AIA ’724.

Pattern signals. The family's challenge history is court-centric, not PTAB-centric: Teva, Sandoz, and Dr. Reddy's litigated the validity of the ’724/’725/’424/’219 in D.N.J. rather than petitioning IPRs against them. The PTAB filings that do exist targeted later-issued family members (’219, ’094, ’942) — plausibly because those AIA-era patents were PGR-eligible and were not subsumed by the district-court on-sale-bar fight. No defensive aggregator (e.g., Unified Patents) appears in the ’724 chain; the recurring petitioners are generic ANDA filers.


Recommended next steps

  1. If you are a defendant and the demand letter cites US 7,947,724: lead with the final judgment. The asserted claims (2 and 9) were held invalid under the on-sale bar, 855 F.3d 1356 (Fed. Cir. 2017-05-01), aff'd, No. 17-1229 (2019-01-22). Quote the operative sentence: "We hold that the asserted claims, claims 2 and 9 of the ’724 patent, claim 2 of the ’725 patent, claim 6 of the ’424 patent, and claims 1, 2, and 6 of the ’219 patent, are invalid under the on-sale bar." An infringement theory on claims 2 or 9 is untenable.
  2. Check expiry before anything else. Anticipated expiration 2024-01-30 (pediatric exclusivity to 2024-07-30 per Orange Book listings). As of 2026-09-27 the patent is expired; exposure is limited to past damages, not injunctive relief.
  3. No PTAB estoppel to worry about — but if you do contemplate an AIA challenge, note that an IPR cannot raise the on-sale bar, and the patent is expired, so any new petition faces the same venue/eligibility headwinds described in the 2025–2026 USPTO policy changes. In practice a PGR is unavailable (9-month window long passed) and an IPR would be an odd use of resources against an expired patent.
  4. Verify the sibling dispositions before relying on them: pull PGR2014-00009 (’219) and IPR2015-01550/-01551/-01553/-01554 (’094) from USPTO PTAB E2E (https://ptacts.uspto.gov/) to confirm institution/disposition. I flagged these as unverified above; only PGR2016-00007 (’942) is confirmed as institution denied (2016-08-17).

Uncertainty flags: (a) I confirmed the absence of proceedings on the ’724 through the structured data plus indexed trackers; I did not run a live PTAB E2E docket query, so a very recently filed — and unlikely — petition cannot be categorically excluded. (b) The dispositions of the ’219 PGR and the four ’094 IPRs are not independently verified in this analysis; do not quote a claim-level outcome for them without the E2E papers. I have not fabricated any trial number or verdict.

Generated 9/27/2026, 6:13:15 PM

Ownership chain (7)

Asserters network →

Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.

  1. ? · recorded 2006-06-21 · Assignment

    Daniele Bonadeo; Enrico Braglia; Riccardo Braglia; Giorgio Calderari; Roberta CannellaHelsinn Healthcare SA

    initial employer assignment

  2. ? · recorded 2010-12-06 · Assignment

    Kathleen M. Lee; Andrew Miksztal; Thomas MalefytRoche Palo Alto LLC

    initial employer assignment

  3. ? · recorded 2016-05-11 · Assignment

    Roche Palo Alto LLCHelsinn Healthcare SA

    settlement consolidation

  4. ? · recorded 2018-11-14 · reel 047534/0024 · Patent Co-Ownership Agreement

    Helsinn Healthcare SAHelsinn Advanced Synthesis SA; Helsinn Therapeutics (U.S.), Inc.; Helsinn Birex Pharmaceuticals Ltd.

    internal reorg

  5. ? · recorded 2018-11-21 · Correction

    Helsinn Healthcare SAHelsinn Birex Pharmaceuticals, Ltd.; Helsinn Therapeutics (U.S.), Inc.; Helsinn Advanced Synthesis SA

    change of name only

  6. ? · recorded 2022-12-30 · Security Agreement

    HELSINN BIREX PHARMACEUTICALS LIMITED; HELSINN HEALTHCARE SA; HELSINN THERAPEUTICS (U.S.), INC.Hamilton SA LLC

    securitization

  7. ? · recorded 2023-09-20 · Release

    Hamilton SA LLCHelsinn Healthcare SA; Helsinn Birex Pharmaceuticals Limited; Helsinn Therapeutics (U.S.), Inc.

    lien release

Assignment history

Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.

✓ Generated

I'll attempt to retrieve the recorded assignment details (reel/frame and correspondent) before writing, since the Google Patents mirror in the patent text does not expose those fields.

Let me try to pin down the reel/frame and correspondent data and the identity of the secured party "Hamilton SA LLC."

Ownership chain — US 7,947,724 B2 ("Liquid pharmaceutical formulations of palonosetron")

Data-source disclosure (read first). The Google Patents legal-events mirror embedded in the authoritative patent text reflects the same underlying USPTO assignment records that Assignment Center surfaces, and it is the basis for the chain below. However, that mirror exposes only the recordation date, conveyance type, assignor and assignee. It does not render the reel/frame number, the execution date, or the correspondent of record for most entries. I was unable to open Assignment Center directly within this session, and targeted searches did not surface the ’724 recordation pages. Accordingly: reel/frame is reported only where the record itself states it (one entry); execution dates and correspondents are reported as "not available — requires direct Assignment Center lookup." I have not fabricated any of these fields. Verify at the USPTO Assignment Center: https://assignmentcenter.uspto.gov/ (search by patent number 7947724) and https://assignment.uspto.gov/patent/index.html.


Inventors

Inventor Nationality (per PubChem) Employer at time of filing (as determinable)
Giorgio Calderari CH Helsinn — CMC/"chemistry manufacturing and control" lead on the palonosetron project per the Helsinn v. Teva trial record (D.N.J. 3:11-cv-03962, Dkt. 381)
Daniele Bonadeo IT Helsinn — chemist/pharmacist assisting Calderari's CMC group (same trial record)
Roberta Cannella IT Helsinn (inferred from co-assignment with the other Helsinn inventors; no independent confirmation)
Enrico Braglia CH Helsinn (inferred; co-assigned with Helsinn inventors)
Riccardo Braglia CH Helsinn (inferred; long-time Helsinn group principal)
Andrew Miksztal US Roche Palo Alto LLC (f/k/a Syntex / Roche Syntex)
Thomas Malefyt US Roche Palo Alto LLC — confirmed in the trial record as the former Syntex scientist who led the Roche Syntex palonosetron CMC team, later a Helsinn consultant
Kathleen M. Lee US Roche Palo Alto LLC (assigned with the Roche group in 2010)

Pattern note — NOT a fire-sale marker. The inventors split cleanly along corporate lines (five Helsinn, three Roche), and each group assigned to its own employer on different dates (Helsinn group in 2006, Roche group in 2010). There is no evidence that all inventors departed the original assignee within 12 months of filing. This is a classic co-development / in-licensing posture: Helsinn in-licensed palonosetron from Roche/Syntex in 1998 and took the compound through Phase III and FDA approval, so both organizations' scientists appear as co-inventors.


Original assignee

Two joint original assignees are named on the issued patent:

  • Helsinn Healthcare SA (Lugano/Pazzallo, Switzerland) — a privately held specialty pharma company. It ships a product embodying the claims: Aloxi® (palonosetron HCl injection, NDA 021372, approved July 25, 2003; U.S. launch 2008), distributed in the U.S./Canada by Eisai. Helsinn is an operating company, not a licensing vehicle, and it is the direct plaintiff in the palonosetron infringement campaigns (see below). Status: operating.
  • Roche Palo Alto LLC (Delaware; principal place of business California) — the former Syntex / Roche Syntex research organization; per its Rule 7.1 disclosure in Helsinn v. Fresenius Kabi (D. Del. 1:15-cv-00865), its corporate parent is Roche Holdings, Inc. Roche developed the palonosetron compound, discontinued the project, and licensed it to Helsinn in 1998. Status: operating as a Roche affiliate; it remained a named co-plaintiff/co-assignee in the Aloxi litigation through at least 2016, then conveyed its interest to Helsinn.

Google Patents currently lists the assignees as Helsinn Advanced Synthesis SA; Helsinn Birex Pharmaceuticals Ltd; Helsinn Therapeutics (U.S.), Inc., reflecting the 2018 group co-ownership agreement described below.


Assignment timeline

Recorded dates are as shown in the legal-events record; execution dates and correspondent names are not exposed in this source and are flagged accordingly. Reel/frame is available for one entry only.

  • recorded 2006-06-21 — Reel/frame: not available

    • Conveyance: Assignment of interest ("ASSIGNMENT OF INTEREST")
    • Assignor: Daniele Bonadeo; Enrico Braglia; Riccardo Braglia; Giorgio Calderari; Roberta Cannella
    • Assignee: Helsinn Healthcare SA
    • Correspondent: not available — requires direct Assignment Center lookup. No recurrence can be established on this record.
    • Context: Initial employer assignment — the five Helsinn inventors vesting title in their employer.
  • recorded 2010-12-06 — Reel/frame: not available

    • Conveyance: Assignment of interest
    • Assignor: Kathleen M. Lee; Andrew Miksztal; Thomas Malefyt
    • Assignee: Roche Palo Alto LLC
    • Correspondent: not available. No recurrence can be established on this record.
    • Context: Initial employer assignment — the three Roche/Syntex inventors vesting title in their employer.
  • recorded 2016-05-11 — Reel/frame: not available

    • Conveyance: Assignment
    • Assignor: Roche Palo Alto LLC
    • Assignee: Helsinn Healthcare SA
    • Correspondent: not available. No recurrence can be established on this record.
    • Context: Internal/settlement consolidation — Roche conveying its co-owner interest to its collaboration partner Helsinn, unifying title in one operating entity.
  • recorded 2018-11-14 — Reel/frame: 047534/0024 (this number is stated in the text of the subsequent corrective assignment; it has not been independently confirmed against Assignment Center)

  • recorded 2018-11-21 — Reel/frame: not available (this is the corrective record whose text corrects Reel 047534/0024)

  • recorded 2022-12-30 — Reel/frame: not available

    • Conveyance: Security Interest ("SECURITY INTEREST (SEE DOCUMENT FOR DETAILS)")
    • Assignor (grantors): Helsinn Birex Pharmaceuticals Limited; Helsinn Healthcare SA; Helsinn Therapeutics (U.S.), Inc.
    • Assignee: Hamilton SA LLC (as secured party)
    • Correspondent: not available.
    • Context: Securitization / collateral grant — a security interest, not an ownership transfer. A secured party does not take title. (I could not independently identify Hamilton SA LLC's principals via this session's sources; its role on the face of the record is collateral/lender, not acquirer.)
  • recorded 2023-09-20 — Reel/frame: not available

Bottom line on the chain: eight recorded events, all between operating organizations (with one collateral-agent security interest that was released within ~9 months). No transfer to a licensing-only or non-practicing entity appears anywhere on the record.


Timeline diagram

timeline
    title Ownership of US 7947724
    2003 : Priority application filed
    2005 : US continuation application filed
    2006 : Helsinn inventors assign to Helsinn
    2010 : Roche inventors assign to Roche Palo Alto
    2011 : Patent issued to Helsinn and Roche
    2016 : Roche Palo Alto conveys to Helsinn
    2018 : Helsinn group co-ownership agreement
    2018 : Corrective assignment filed
    2022 : Security interest to Hamilton SA
    2023 : Security interest released
    2024 : Patent expired

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. Every assignee in the chain is an operating or group entity: Helsinn Healthcare SA, Roche Palo Alto LLC, and the 2018 co-ownership recipients (Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals Ltd, Helsinn Therapeutics (U.S.), Inc.). No "IP / Patents / Licensing / Holdings / Ventures" suffix appears; the only LLC-style name, Hamilton SA LLC, took a security interest (recorded 2022-12-30) and released it (recorded 2023-09-20) — it never acquired title. Cited record: Reel 047534/0024 (2018 co-ownership agreement) and the 2022/2023 secured-party entries.

2. Known asserter in the chain — NOT PRESENT. No Acacia, Marathon, Intellectual Ventures, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Round Rock, or other listed high-frequency plaintiff appears as assignor or assignee. (Contrast: an unrelated Acacia/Monarch Networking Solutions patent record surfaced in searching, but it is a different patent family and is not part of this chain.)

3. Repeat correspondent across the chain — UNCLEAR / NOT DETERMINABLE. The record reviewed does not expose correspondent-of-record names for any of the eight entries, so recurrence cannot be tested. This is a data gap, not a finding. A direct Assignment Center pull is required to assess this signal.

4. Cascading transfers — NOT PRESENT. Transfers are spaced over a decade+ (2006, 2010, 2016, 2018, 2022) and are employer-vesting, partner-consolidation, internal-reorg, or collateral events. The two 2018 entries are a co-ownership agreement plus a same-month corrective filing, i.e., one substantive event, not a chain of distinct LLCs.

5. Pre-litigation transfer — NOT PRESENT. The first infringement suits predate every post-issuance assignment: complaints were filed in 2011 (D.N.J. 3:11-cv-03962, 7/8/2011; 3:11-cv-05579, 9/23/2011), 2012 (3:12-cv-02867, 5/11/2012 — the suit referenced in NDA 203050 regarding patent 7947724), and 2013. The 2016 Roche→Helsinn recordation occurred after trial and concurrent with the Federal Circuit appeals (Nos. 16-1284 / 16-1787), consistent with a co-owner title cleanup, not a transfer staged to enable assertion. Helsinn and Roche were co-plaintiffs throughout, so no venue/standing engineering is evident.

6. Bankruptcy fire-sale — NOT PRESENT. No Chapter 7/11 assignor appears; all Helsinn and Roche entities remained operating.

7. Privateering — NOT PRESENT. The inverse is true: the operating innovator (Helsinn) asserted its own patents directly against generic competitors, retaining Roche as co-plaintiff rather than transferring to an enforcement vehicle.

8. Defensive aggregator (anti-NPE) — NOT PRESENT. The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. It terminates with the Helsinn operating group (subject to a released security interest).


Verdict

Operating-company assertion.

The record shows a single, unbroken chain of operating entities: Helsinn inventors → Helsinn Healthcare SA (recorded 2006-06-21); Roche inventors → Roche Palo Alto LLC (recorded 2010-12-06); Roche Palo Alto → Helsinn Healthcare SA (recorded 2016-05-11); and an internal Helsinn group co-ownership agreement (recorded 2018-11-14, Reel 047534/0024, corrected 2018-11-21). The only non-operating-looking name, Hamilton SA LLC, functioned purely as a secured party (recorded 2022-12-30) and released its interest (recorded 2023-09-20) — a normal corporate financing lien, not a patent acquisition. Helsinn is the maker of Aloxi®, a commercial product embodying the claims, and it (with Roche) directly sued Teva, Sandoz, Dr. Reddy's, Fresenius Kabi, and Hospira — the hallmarks of an operating-company assertion rather than an NPE campaign.

Confidence caveat: this verdict rests on assignee/conveyance data only. Because the correspondent-of-record field was not retrievable, signal 3 cannot be scored, and no reel/frame could be confirmed except 047534/0024. Verify at https://assignmentcenter.uspto.gov/ (patent 7947724) to close that gap.

Generated 9/27/2026, 6:13:31 PM

Prior art

Earlier patents, publications, and products that may anticipate or render the claims unpatentable.

✓ Generated

I'll search for the specific patent and its cited prior art. Let me run several targeted queries.

I have the full citation lists. Let me verify details on the key references and confirm dates.

A. Confirmation of the target patent (ID read literally)

I searched for the exact string 7947724 and did not substitute any similar number. The record retrieved is:

Field Value (as indexed)
Patent US 7,947,724 B2
Application 11/186,311
Title Liquid pharmaceutical formulations of palonosetron
Filed Jul. 21, 2005
Priority Jan. 30, 2003 (US provisional 60/444,351)
Granted May 24, 2011
Assignees of record Helsinn Healthcare SA / Roche Palo Alto LLC (later co-owned by Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals Ltd, Helsinn Therapeutics US Inc.)

Source: Google Patents record for US7947724B2 (https://patents.google.com/patent/US7947724B2/en) and the PubChem mirror (https://pubchem.ncbi.nlm.nih.gov/patent/US7947724).

Database caveat (stated, not glossed): I could not run a native USPTO PatentCenter / Patent Public Search query in this environment. The results above come from the Google Patents and PubChem records, which reproduce the USPTO front-page "References Cited" data. I am treating the patent text you supplied as authoritative for the citation list.

Two flags before the analysis:

  1. Date contradiction. The session header says today is 2026-09-27; the task statement says April 26, 2026; the earlier generated summary also referenced 2026. These do not agree. Nothing in this prior-art analysis turns on the difference, but it is a real inconsistency and I am not silently reconciling it.
  2. Terminology. The task asks which cited references "potentially anticipate." I apply the strict §102 test (a single reference disclosing every element of a claim, arranged as claimed), not the looser colloquial use of "prior art." Under that test the answer is largely negative, and I say so explicitly rather than manufacture anticipation.

B. The §102 framework actually applicable here

  • Effective filing/priority date: Jan. 30, 2003 → pre-AIA §102(b) one-year critical date is Jan. 30, 2002.
  • Issued U.S. patents and printed publications before that date are §102(b) art against the subject matter claimed, regardless of inventor.
  • The '724 has two independent claims: claim 1 (0.03–0.2 mg/mL palonosetron, pH 4.0–6.0, sterile aqueous carrier with mannitol + EDTA 0.005–1.0 mg/mL) and claim 8 (0.01–5 mg/mL palonosetron, pH 4.0–6.0, aqueous carrier with a chelating agent; isotonic, IV).
  • Element that gates everything: palonosetron. A reference that does not disclose palonosetron (or a salt) cannot anticipate any claim of the '724.

Real-world context (already established in the prior section, not repeated): these claims were held invalid under the pre-AIA on-sale bar in Helsinn v. Teva, 855 F.3d 1356 (Fed. Cir. 2017), aff'd sub nom. Helsinn v. Teva, 586 U.S. 731 (2019). The printed references below were not the art that defeated the claims — a commercial offer for sale was.


C. Cited patent references, one by one

The '724 front page lists 28 patent citations. I group them by whether they can even reach the claimed subject matter.

Group 1 — Discloses palonosetron: the only genuine §102 candidate

# Reference Earliest date Publication Description §102 relevance to '724 claims
1 US 5,202,333 A (Syntex (U.S.A.) Inc.) "Tricyclic 5-HT3 receptor antagonists" (https://patents.google.com/patent/US5202333) priority 1989‑11‑28; granted 1993‑04‑13 1993‑04‑13 Genus of tricyclic 5‑HT₃ antagonists; expressly names palonosetron (RS‑25259‑197) and discloses an IV formulation in Example 13: palonosetron HCl 10–100 mg, dextrose monohydrate q.s. isotonic, citric acid monohydrate 1.05 mg, NaOH 0.18 mg, water to 1.0 mL, pH 3.7. The only cited reference that could be argued as §102 art against claims 1–14. Under strict anticipation it fails every independent claim: (a) claim 1 requires 0.03–0.2 mg/mL — Ex. 13 is ~10–100 mg/mL; (b) claim 1 requires mannitol — Ex. 13 uses dextrose; (c) claim 1 requires EDTA 0.005–1.0 mg/mL — absent; (d) both claims require pH 4.0–6.0 — Ex. 13 is pH 3.7; (e) claim 8 requires a chelating agent — absent. Net: no anticipation of any claim; it is the primary §103 reference (and it was the "D1" reference in the parallel EP/foreign oppositions, where it was used in an obviousness, not anticipation, attack — see the Colombian office action quoting D1 at https://veraabogados.com/wp-content/uploads/2025/08/08134323.pdf).

Group 2 — Different 5‑HT₃ antagonists; cannot anticipate (no palonosetron)

None of these disclose palonosetron or any palonosetron formulation, so none can anticipate claims 1–14. They are, at most, remote §103 art on generic formulation technique.

# Reference Earliest date Publication Description
2 US 4,695,578 A (Glaxo Group) 1984‑01‑25 1987‑09‑22 Carbazolone 5‑HT₃ antagonists (ondansetron class)
3 US 4,753,789 A (Glaxo Group) 1985‑06‑25 1988‑06‑28 Method of treating nausea/vomiting (ondansetron)
4 US 4,929,632 A (Glaxo Group) 1985‑06‑25 1990‑05‑29 Medicaments (ondansetron)
5 US 5,240,954 A (Glaxo Group) 1985‑06‑25 1993‑08‑31 Medicaments
6 US 5,578,628 A (Glaxo Group) 1985‑06‑25 1996‑11‑26 Medicaments for nausea/vomiting
7 US 5,578,632 A (Glaxo Group) 1985‑06‑25 1996‑11‑26 Medicaments for GI dysfunction
8 US 5,922,749 A (Glaxo Group) 1985‑06‑25 1999‑07‑13 Medicaments for nausea/vomiting
9 US 4,886,808 A (Beecham Group) 1985‑04‑27 1989‑12‑12 Indazolyl carboxamides (granisetron class)
10 US 4,937,247 A (Beecham Group) 1985‑04‑27 1990‑06‑26 1‑Acyl indazoles
11 US 5,034,398 A (Beecham Group) 1985‑04‑27 1991‑07‑23 1H‑indazole‑3‑carboxamide azabicyclooctanes
12 US 4,906,755 A (Merrell Dow) 1986‑11‑03 1990‑03‑06 Quinolizinone esters (dolasetron class)
13 US 5,011,846 A (Merrell Dow) 1988‑02‑23 1991‑04‑30 Quinolizine/quinolizinone medicaments
14 US 5,344,658 A (Glaxo Group) 1989‑06‑28 1994‑09‑06 Process/composition using ondansetron
15 US 5,622,720 A (Glaxo Group) 1989‑06‑28 1997‑04‑22 Reducing crystal size of ondansetron HCl dihydrate
16 US 5,854,270 A (Glaxo Wellcome) 1994‑11‑22 1998‑12‑29 Oral ondansetron compositions
17 US 5,955,488 A (Glaxo Wellcome) 1994‑11‑22 1999‑09‑21 Freeze‑dried ondansetron compositions
18 US 6,063,802 A (Glaxo Wellcome) 1994‑11‑22 2000‑05‑16 Ondansetron freeze‑dried oral dosage form
19 US 6,294,548 B1 (Hoffmann‑La Roche) "Multidose vial formulations…indazole‑3‑carboxamide hydrochloride" 1998‑05‑04 2001‑09‑25 Granisetron multidose vial; aqueous solution, citrate buffer, target pH 6 (range 5–7), terminal autoclave sterilization (https://patents.google.com/patent/[US6294548B1](/patent/US6294548B1)/en)
20 US 2001/0020029 A1 (SmithKline Beecham) 1998‑05‑04 2001‑09‑06 Same granisetron multidose‑vial family as #19
21 US 6,282,770 B1 / US 5,360,800 A (Glaxo) — listed in the specification's background for alosetron 1987‑09‑03 1994‑11‑01 Alosetron tetrahydro‑pyridoindolones (background, not front-page citation)

Note on #19/#20: these are the closest thing in the cited set to the '724's buffer/pH/vial concept, but the active is granisetron, not palonosetron, and there is no mannitol+EDTA combination as claimed. They cannot anticipate; they are §103 technique art at best, and they were cited by the applicant as background on citrate buffering.

Group 3 — Generic formulation / drug-delivery art; cannot anticipate

# Reference Earliest date Publication Description Note
22 US 5,272,137 A (McNeil‑PPC) 1992‑02‑14 1993‑12‑21 Aqueous pharmaceutical suspension vehicle No palonosetron; general excipient art
23 US 6,287,592 B1 (Boots Co.) 1996‑12‑10 2001‑09‑11 Aqueous drink composition with ibuprofen Oral-liquid technique only
24 US 6,284,749 B1 (Alcon) 1998‑10‑27 2001‑09‑04 Preservative system for topical compositions No antiemetic, no palonosetron
25 US 2003/0095926 A1 (Dugger) 1997‑10‑01 2003‑05‑22 Buccal/polar and non‑polar spray or capsule delivery Published after the 2003‑01‑30 priority date; §102(e)-type only, and irrelevant on the merits

Group 4 — Foreign/WO citations

# Reference Earliest date Publication Description §102 relevance
26 WO 03/100091 A1 (Epidauros Biotechnologie) 2002‑05‑24 2003‑12‑04 Pharmacogenomic "means and methods…using setrones" Not a palonosetron formulation; published after priority
27 WO 2004/045615 A1 (Helsinn Healthcare) 2002‑11‑15 2004‑06‑03 "Palonosetron for the treatment of chemotherapy‑induced emesis" — 0.25 mg dosing, method‑of‑use (https://patents.google.com/patent/WO2004045615A1) Same applicant; published after the 2003‑01‑30 priority date and before the 2005‑07‑21 U.S. filing. Not §102 art against claims entitled to the 2003 priority. It states palonosetron is "most stable at lower concentrations," so it is at most §103 art on the concentration point in a hypothetical where priority is broken
28 WO 2004/067005 A1 (Helsinn Healthcare) 2003‑01‑30 2004‑08‑12 The PCT parent of the '724 itself (Liquid pharmaceutical formulations of palonosetron) (https://patents.google.com/patent/WO2004067005A1) Same invention, same priority, same family — not prior art. Listed only because it is the parent application
29 WO 2004/073714 A1 (Helsinn Healthcare) 2003‑02‑18 2004‑09‑02 Palonosetron for post‑operative nausea and vomiting (PONV) Same applicant; post‑priority; method‑of‑use art, not a formulation reference

Cross-check (PubChem): the PubChem citation list for US‑7947724‑B2 reproduces essentially the same set and tags some as applicant‑cited (APP) vs. search‑report (SEA), including US‑6,294,548‑B1 and US‑2001/0020029‑A1 as SEA — consistent with the groupings above.


D. Direct answer to "which claims does each reference anticipate"

Applying §102 strictly:

  • US 5,202,333 (Syntex) — the only candidate; anticipates none of claims 1–14. It lacks, relative to claim 1: the 0.03–0.2 mg/mL range, mannitol, and EDTA; and relative to claim 8: the chelating agent and the pH 4.0–6.0 range (Ex. 13 is pH 3.7). It is the lead §103 reference.
  • All Group 2 references (ondansetron, granisetron, alosetron, dolasetron patents) — anticipate no claim, because they do not disclose palonosetron. Their only possible role is §103 technique art (buffering, tonicity, chelating agents, terminal sterilization, oral/injectable liquids).
  • Group 3 references — anticipate no claim; generic formulation art with no antiemetic and no palonosetron.
  • WO 2004/045615, WO 2004/073714 — anticipate no claim; post‑priority and same‑applicant.
  • WO 2004/067005 — anticipate no claim; it is the parent of the '724 and discloses the same invention (not "prior art" at all).

Bottom line: The examiner‑cited printed art does not disclose every element of any independent claim of the '724. There is therefore no true §102 anticipation in the cited set; the real novelty/invalidity battleground for claims 1–14 was (i) §103 over US 5,202,333 plus formulation technique, and (ii) the pre‑AIA on‑sale bar that ultimately prevailed in Helsinn v. Teva.


E. Non‑patent citations worth naming (secondary, but the closest timing art)

The '724 record also lists 40 non‑patent citations. The ones with any §102(b) bite — all pre‑2002 — describe palonosetron chemistry/pharmacology but not the claimed liquid formulation (no mannitol/EDTA/pH‑buffered carrier), so they likewise anticipate no claim:

  • Adis R&D Profile, Palonosetron RS 25259 (Drugs in R&D, Oct. 1999).
  • Eglen et al., Pharmacological Characterization of RS 25259‑197, Br. J. Pharmacol. 114:860‑866 (1995) — corresponds to the "Wong et al. (1995), Br. J. Pharmacol. 114:851‑859" citation.
  • Chelly et al., Oral RS‑25259 Prevents PONV…, Anesthesiology 85(3A):A21 (1996).
  • Tang et al., Anesth. Analg. 87:462‑467 (1998).
  • Stacher, Palonosetron Helsinn, Curr. Opin. Investig. Drugs 3(10):1502‑1507 (Oct. 2002).

These support the compound's known activity and half‑life, not the formulation elements, so they are §103‑type context, not §102 art.


F. Uncertainty / honesty flags

  • I did not run a live USPTO PatentCenter or PACER/CAFC query; the citation list is from the patent text you supplied plus Google Patents/PubChem mirrors of the USPTO record. An unindexed USPTO or IDS‑only reference cannot be ruled out from these sources.
  • Dates above are earliest/priority and publication dates as indexed; where a document's actual PCT filing date differs from the priority date shown, I have labeled them as such rather than asserting a filing date I could not verify.
  • The characterization of US 5,202,333 as "anticipates none / §103 lead" reflects the PTAB and opposition record for this family (e.g., the DRS/Teva IPR papers and the EP/Colombian opposition files), where Example 13 was treated as the primary reference for obviousness, not as an anticipatory disclosure.

Key sources: https://patents.google.com/patent/US7947724B2/en ; https://pubchem.ncbi.nlm.nih.gov/patent/US7947724 ; https://patents.google.com/patent/US5202333 ; https://patents.google.com/patent/US6294548B1/en ; https://patents.google.com/patent/WO2004045615A1 ; https://patents.google.com/patent/WO2004067005A1

Generated 9/27/2026, 6:13:50 PM

Obviousness

Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.

✓ Generated

I'll ground this obviousness analysis in the references actually listed in the Prior Art section of US 7,947,724, then verify key reference contents.

Obviousness Analysis — US 7,947,724 B2 under 35 U.S.C. § 103

Note on scope: This builds on the previously generated summary (claims 1–14; two independent claims — claim 1 narrow, claim 8 broad). I do not repeat claim text. All references below are drawn from the Prior Art section of the US 7,947,724 Google Patents page (Citations, Cited By, Families Citing, Non-Patent Citations), as instructed. Where I supplement with verification searches, I say so.


1. The governing framework

Because the ’724 patent has a priority date of January 30, 2003, pre‑AIA § 103 applies. The analysis proceeds under Graham v. John Deere (scope/content of claims; differences over prior art; PHOSITA level; secondary considerations) as refined by KSR Int'l v. Teleflex (a combination need not be taught expressly; "obvious to try" and "design incentives"/"market pressure" count; predictable variation of known parameters is obvious).

Level of ordinary skill: a formulation scientist (or team) with an advanced degree and several years' experience developing aqueous injectables for 5‑HT₃ antagonists. Notably, the named inventors span Helsinn (formulation) and Roche Palo Alto (the successor to Syntex, original owner of US 5,202,333) — i.e., the two entities that between them held the compound and its first injectable formulation.


2. The prior art of record (from the page's Prior Art section)

Ref What it teaches Relevance
US 5,202,333 (Syntex) — "Tricyclic 5‑HT₃ receptor antagonists" Genus encompassing palonosetron; Example 13 discloses an IV formulation: palonosetron HCl 10–100 mg, dextrose monohydrate q.s. isotonic, citric acid monohydrate 1.05 mg, NaOH 0.18 mg, water to 1 mL, pH 3.7 The closest single reference: palonosetron + aqueous injectable + citrate/citric acid + tonicity agent
Marketed ondansetron injection (2001 PDR) / US 5,854,270 (Gambhir), US 5,952,488, US 6,063,802 (all cited) Ondansetron HCl 2 mg/mL; NaCl; citric acid monohydrate + trisodium citrate dihydrate as buffers; pH 3.3–4.0; also oral liquid compositions sweetened with polyhydric alcohol at a defined pH Sibling 5‑HT₃ antagonist formulated as a buffered, isotonic, chelation‑adjacent aqueous solution/elixir
US 4,886,808; 4,937,247; 5,034,398; 6,294,548 (granisetron); US 5,360,800; 6,284,770 (alosetron); US 5,011,846; 4,906,755 (dolasetron) Other 5‑HT₃ antagonists and their injectable/oral formulations Establish the routine nature of formulating members of the class as injectables
DE 19833119 A1 (Roche Diagnostics) "Storage‑stable injectable solution … contains buffer, organic solvent, antioxidant and complexing agent" Express motivation to add a chelating/complexing agent to an injectable to gain storage stability
US 5,272,137 (McNeil‑PFC) Aqueous pharmaceutical suspension Teaching of chelating agents/antioxidants in aqueous pharmaceuticals
US 6,132,758 (Schering) Stabilized antihistamine syrup Chelator/sweetener practices in liquid dosage forms
US 6,287,592 (Boots) Aqueous drink composition Liquid formulation practice
Adis R&D Profile on Palonosetron RS 25259 (1999); Eglen 1995 (Br. J. Pharmacol. 114:860); Wong 1995 (114:851); Sorbe 1996; Israili 2001; Stacher 2002; Piraccini (ASCO 2002) Palonosetron is "a novel, potent and selective 5‑HT₃ antagonist," an order of magnitude more potent than existing antagonists, half‑life ≈40 h; clinical IV doses in the range ~1–90 µg/kg Motivation to use low palonosetron concentrations
Won et al. 1995 (photolytic/oxidative degradation of antiemetic RG 12915); Pikal (freeze‑drying); The Theory and Practice of Industrial Pharmacy (Lachman); Modern Pharmaceutics; Pharmaceutical Dosage Forms: Parenteral Medications (Avis); Broadhead; Gatlin Oxidative/photolytic instability of 5‑HT₃ antagonists; standard parenteral formulation science (isotonicity, buffers, pH–stability profiles, chelators such as EDTA, tonicifiers such as mannitol) Supply the general knowledge that pH, buffer, chelator and tonicity agent govern injectable shelf‑life
Barton, "Citrate Buffer Calculation" (2000) Citrate buffer pKa's (~3.1/4.8/6.4) Predictable buffering in the claimed pH 4.0–6.0 window
WO 2003/100091 (Epidauros) "Setrones" treatment methods ⚠️ Published Dec 4, 2003 — after the Jan 30, 2003 priority date; not § 102/§ 103 prior art. Listed on the page but should be excluded. (Same caveat for WO 2004/045615 and WO 2004/073714.)

Important corroboration. Public PTAB petition papers surfaced in search (ptacts.uspto.gov artifacts for petition 1462972 and 1463036) show that Helsinn's own claim family was challenged using essentially this combination: "Berger '333 Ex. 13 (citric acid)" + the 2001 PDR ondansetron entry (citric acid/citrate dihydrate as buffers) + Kibbe + Avis, plus the argument that "citrate buffers had already been used in connection with other 'setrons, and in particular, ondansetron." That is an independent, on‑point articulation of the same prima facie case.


3. Ground A — Primary obviousness combination

Berger '333 (US 5,202,333) in view of the marketed ondansetron injection/PDR + Gambhir (US 5,854,270), further in view of parenteral formulation texts (Avis/Lachman), and further in view of the palonosetron potency literature (Adis/Eglen/Stacher).

Element mapping (claim 1)

Claim 1 limitation Disclosure / rationale
"pharmaceutically stable intravenous solution for reducing emesis" Berger '333 provides IV palonosetron for emesis; the invention need only be a stable version of an admitted use
palonosetron or salt, 0.03–0.2 mg/mL Berger discloses the compound; Adis/Eglen/Stacher establish that palonosetron is ~10× more potent, with clinical IV doses of µg/kg → routine to lower concentration; the specification itself calls 0.05 mg/mL a design choice for a 0.25 mg/5 mL vial
buffered pH 4.0–6.0 Berger Ex. 13 already uses citric acid/NaOH; the ondansetron injection is citrate‑buffered at pH 3.3–4.0; Barton teaches citrate's useful range spans pH 3–6. Adjusting pH into 4.0–6.0 is routine
sterile aqueous carrier Berger Ex. 13 is an aqueous ("WFJ") sterile‑grade injectable
tonicifying amount of mannitol Interchangeable tonicity agents (dextrose ↔ mannitol) are a textbook design choice; US 5,952,488 expressly uses mannitol; mannitol for isotonicity is standard
EDTA 0.005–1.0 mg/mL EDTA is the paradigmatic parenteral chelator/stabilizer (Avis; Lachman; DE 19833119's "complexing agent"; US 5,272,137; US 6,132,758). Optimizing to a stabilizing amount is routine

Motivation to combine

  • Same problem, same class, same drug. Berger '333 is the palonosetron compound reference and already presents a palonosetron IV solution; the ondansetron injection is the market leader in the same therapeutic class (5‑HT₃ antagonist antiemetics), expressly identified in the '724 background as the reference product. A PHOSITA optimizing a palonosetron injectable would naturally look to the commercial ondansetron injectable/elixir.
  • Recognized deficiency. The ’724 specification itself concedes the Berger formulation "has a pH of 3.7 and a shelf stability of less than the 1–2 year time period required." That admission frames a finite, well‑posed problem (improve shelf‑life of an existing palonosetron solution) with predictable levers: pH, buffer, chelator, tonicifier, concentration. KSR makes that "obvious to try."
  • Reasonable expectation of success. Every element is a known parameter with a known function; the petition record shows the ondansetron injection achieved pH/HPLC‑indicated stability, giving a concrete expectation that the analogous palonosetron system would too.

Dependent claims 2–7

These are range/narrowing claims — classic In re Aller/In re Woodruff situations: optimizing a result‑effective parameter (0.05 mg/mL; pH 4.5–5.5; 10–100 mM citrate; 0.3–0.7 mg/mL EDTA; 10–80 mg/mL mannitol; 10–40 mM citrate) within disclosed or routine ranges is prima facie obvious absent criticality. The claim 7 sub‑combination merely aggregates individually known excipient ranges.


4. Ground B — The broader genus (claim 8) is the weakest

Claim 8 recites only: isotonic IV solution, 0.01–5 mg/mL palonosetron, pH 4.0–6.0, and an aqueous carrier "including a chelating agent" (generic). The genus is far broader than claim 1, so it is more vulnerable:

  • Berger Ex. 13 supplies the isotonic IV palonosetron solution and a pH‑adjusting acid/base;
  • The ondansetron injection supplies a citrate‑buffered, isotonic, low‑pH 5‑HT₃ antagonist solution;
  • DE 19833119 A1 and US 5,272,137 supply the express teaching to include a chelating/complexing agent for injectable storage stability;
  • Texts (Avis/Lachman) supply isotonicity (NaCl/dextrose/mannitol) and pH‑optimization practice.

Because claim 8 imposes no chelator identity, no mannitol, and no narrow concentration, essentially every limitation is met by the routine combination above. Dependent claims 9–14 (0.05 mg/mL; HCl salt; pH 4.5–5.5; EDTA; mannitol; IV adaptation) reduce to the same "expected optimization" analysis as Ground A.

Alternative sub‑combinations that support claim 8 in the alternative:

  1. Berger '333 + DE 19833119 A1 — storage‑stable injectable with buffer + complexing agent → motivation to add a chelator to a buffered palonosetron solution.
  2. Berger '333 + Won 1995 (RG 12915 oxidative/photolytic degradation) — a 5‑HT₃ antagonist's known oxidative instability motivates an antioxidant/chelator (e.g., EDTA) even without the ondansetron label.
  3. Berger '333 + US 6,132,758 + US 6,287,592 — stabilized aqueous liquid‑dosage practice (chelators, tonicifiers, sweeteners).

5. The "criticality" attack on the numerical ranges

The patent's asserted novelty rests on three inventor data points (Examples 1–3: pH 5.0 optimum; lowest concentration most stable; mannitol superior to NaCl). Under § 103 these are result‑effective variables, and discovery of an optimum within a continuum is not automatically inventive:

  • pH 5.0 sits inside both Berger's buffered system and the ondansetron injection's pH window; Barton confirms citrate's buffering capacity across pH ~3–6, so no new effect or property is required.
  • The lowest‑concentration‑is‑most‑stable finding is a narrow, dose‑only observation that does not establish a different stability mechanism; and the claimed range (0.03–0.2 mg/mL) is broader than the single tested optimum and broader than what the data support.
  • Mannitol‑over‑NaCl is a selection among known tonicifiers (US 5,952,488 uses mannitol); the challenge (as reflected in the PTAB petition papers) is that this is optimization, not invention.

Under KSR, "the fact that a combination was obvious to try" defeats these ranges unless the applicant can show a commensurate unexpected result across the full claimed scope.


6. Secondary considerations — the counterweight (and a contradiction to flag)

The prima facie case above is strong, but it was actually tested once and failed at the district court. In Helsinn Healthcare S.A. v. Dr. Reddy's Labs., D.N.J. No. 3:11‑cv‑03962 (the litigation cited on the ’724 page), the court found the formulation claims valid and non‑obvious, crediting, among other things, unexpected 24‑month room‑temperature stability, the superiority of mannitol over NaCl, and the low‑dose advantage. The Federal Circuit then reversed on the pre‑AIA on‑sale bar (855 F.3d 1356 (Fed. Cir. 2017)), invalidating the claims on a § 102 ground without reaching § 103. So:

  • § 103 was briefed and lost for the patentee at trial; the final invalidity holding rests on § 102 (on‑sale bar), not § 103.
  • Contradiction flag: the previously generated summary correctly states no 2026 CAFC docket activity exists. The petition‑and‑trial history I found (PTAB/Trial‑and‑Appeal documents; the 2017 Fed. Cir. appeal) is historical, not pending. Nothing here changes the prior summary; it adds the specific § 103 grounds that were litigated against the related family members (e.g., US 8,729,094 / US 9,179,942).

Strength of the patentee's rebuttal:

  • Unexpected results — strongest for claim 1's specific mannitol+EDTA+pH 5.0+0.05 mg/mL combination; weak for claim 8, which claims any chelator/any concentration and captures subject matter the data do not show to be unexpectedly stable.
  • Long‑felt need / failure of others — arguable, given the admitted 1–2 year shelf‑life failure of Berger Ex. 13, but the ondansetron product shows the field had already solved analogous liquid‑stability problems.
  • Nexus — commercial success (Aloxi®) must be tied to the claimed features; the on‑sale‑bar history undercuts the inference that the claimed formulation, not earlier activity, drove success.

7. Bottom line

Claim(s) Prima facie § 103 strength Comment
Claim 8 (broad genus: chelating agent, 0.01–5 mg/mL, pH 4.0–6.0, isotonic IV) Strong Nearly every element is routine optimization; closest to KSR "obvious to try." Most likely invalid.
Claims 9–14 (dependents of 8) Moderate–strong Expected optimization of EDTA/mannitol/pH/concentration.
Claim 1 (0.03–0.2 mg/mL + mannitol + EDTA + buffered 4.0–6.0, IV) Moderate Strong prima facie case, but this is the claim the patentee defended successfully at trial with unexpected‑results evidence; the combination of specific limits is the most defensible.
Claims 2–7 (dependents of 1) Moderate Range narrowings; vulnerable absent demonstrated criticality, but bolster the claim 1 combination.

Most likely-to-succeed primary combination: US 5,202,333 (Example 13) + the marketed ondansetron injection/PDR entry (or Gambhir, US 5,854,270) + a parenteral‑formulation text (Avis/Lachman) + DE 19833119 (chelator for storage stability) + the palonosetron potency literature (Adis/Eglen) for the low‑concentration limitation. Alternative: substitute Won 1995 or US 5,272,137/US 6,132,758 for the chelator teaching.

Confidence & caveats:

  • The combination logic is directly corroborated by the PTAB petition papers retrieved in search (ptacts.uspto.gov petition 1462972/1463036), which articulate the Berger‑plus‑ondansetron‑PDR theory against a sibling patent in this family.
  • I cannot state with certainty that these grounds would have prevailed on the ’724 claims specifically: the D.N.J. court rejected the § 103 attack on the corresponding formulation claims, and the Fed. Cir. disposed of validity on the on‑sale bar instead.
  • Exclusion flag: WO 2003/100091, WO 2004/045615, and WO 2004/073714 appear on the Prior Art page but published on/after the Jan 30, 2003 priority date and are not proper § 103 art; do not rely on them.

Sources: Google Patents US7947724B2 (https://patents.google.com/patent/US7947724/en); US5202333; US5854270; US5955488; US6063802; US5272137; DE19833119A1; US6132758; ondansetron injection label (rxdruglabels.com); PTAB petition artifacts 1462972 & 1463036 (ptacts.uspto.gov); Helsinn v. Dr. Reddy's, D.N.J. 3:11‑cv‑03962 and Fed. Cir. 855 F.3d 1356.

Generated 9/27/2026, 6:14:00 PM

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