US 9173942

I'll verify this patent against live sources, including any 2026 litigation activity.

US Patent 9,173,942 — Verified Summary

Verification note: I searched for the exact identifier "9173942" / "9,173,942" and found no results for a different or similar patent. All sources returned the same document. Where live sources contradicted the Google Patents litigation sidebar, I flag it below.

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Bibliographic Data

Continuity: Continuation of Ser. No. 13/901,437 (now US 8,598,219), which is a continuation-in-part of Ser. No. 13/087,012 (now US 8,518,981), which is a continuation of Ser. No. 11/186,311 (now US 7,947,724), which is a continuation of PCT/EP2004/000888. The '942 patent is one of nine U.S. family members (family ID 49235852), a lineage resulting from serial re-filings of the same priority disclosure.

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Abstract

"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."

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Plain-Language Overview of the Two Independent Claims

Claim 1 — A sterile aqueous IV solution containing two required ingredients:

• palonosetron HCl (or another pharmaceutically acceptable palonosetron salt) at exactly 0.05 mg/mL, calculated as palonosetron free base; and
• mannitol at 10–80 mg/mL;
• and the solution's pH must be 4.0 to 6.0.

In plain terms: a ready-to-use injectable anti-nausea liquid where the drug concentration is fixed at the low commercial strength and mannitol (a sugar alcohol serving here as a tonicity agent, not a sweetener) is present in a middle-range amount, with the acidity held in a mildly acidic window.

Claim 12 — Same 0.05 mg/mL palonosetron base, same 10–80 mg/mL mannitol, plus EDTA at 0.3–0.7 mg/mL as a required third component. Notably, claim 12 contains no pH limitation on its face — the pH window appears only in dependent claim 14 (4.0–6.0) and claim 15 (5.0 ± 0.5).

Dependent claims narrow the ranges: mannitol 20–60 mg/mL (claims 3, 16) and 40–45 mg/mL, most specifically 41.5 mg/mL (claims 5, 18); EDTA at 0.5 mg/mL (claims 9, 18); a citrate buffer (claims 11, 19); a total palonosetron amount of 0.25 mg per unit (claims 2, 13); and pH 5.0 ± 0.5 (claims 10, 15). These figures correspond to the commercial Aloxi® vial (0.25 mg/5 mL). Notably, the claims as issued capture the mannitol/EDTA excipient combination, not the broad pH- or buffer-based genus recited in the specification summary.

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Prosecution and Litigation Activity (as of the search date)

• PTAB — [Dr. Reddy's Laboratories, Ltd.](/litigations/by-plaintiff/Dr.%20Reddy's%20Laboratories%2C%20Ltd.) & Dr. Reddy's Laboratories, Inc. v. Helsinn Healthcare S.A., PGR2016-00007 and PGR2016-00008, both filed Feb. 5, 2016, challenging the '942 patent (claims 1–6, 10, 11 and claims 1–19 respectively). Both petitions were denied institution on Aug. 17, 2016 under 35 U.S.C. § 324(a). The Board held the petitioner had not shown it more likely than not that any challenged claim was unpatentable. The '942 patent therefore survived its only PTAB validity challenge without a trial on the merits.
• District court: Asserted in at least Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories (D.N.J. 3:15-cv-08663, filed Dec. 15, 2015, terminated Mar. 24, 2016) — the case identified in the PTAB decision as Civil Action No. 15-8662 — and in Helsinn Healthcare SA v. Qilu Pharmaceutical Co. Ltd. (D.N.J. 2:15-cv-08132) concerning ANDA No. 20-5648. Google Patents also lists D.N.J. 2:15-cv-02077, 3:15-cv-08132, 2:15-cv-08663, 3:15-cv-08662, and E.D. Pa. 2:15-cv-06392.
• Orange Book: The '942 patent is listed against NDA 021372 (Aloxi®, palonosetron HCl injection); FDA NDA review documents list it among the patents the agency addressed.

⚠️ Correction to the Google Patents page: That page attributes the PTAB cases to "Unified Patents" and describes them only as "Not Instituted – Merits." The actual PTAB decisions of Aug. 17, 2016 (docketed at PGR2016-00007 and PGR2016-00008) name Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. as petitioner. "Unified Patents" appears to be only the data-source attribution for Google's litigation widget, not the party. I have treated the PTAB decision text as authoritative.

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Uncertainty / Limitations

• No 2026 Court of Appeals for the Federal Circuit docket activity for US 9,173,942 was found. My searches returned no CAFC appeal, briefing, or opinion tied to this patent number in 2025 or 2026; the most recent hits are a March 2026 DrugPatentWatch litigation index that still lists only the 2015–2016 D.N.J. cases and the 2016 PGR. I cannot rule out unreported or non-indexed activity. The 2026 palonosetron headlines found (Delhi High Court upholding a Helsinn palonosetron/netupitant patent against Zydus) concern a different, later Helsinn patent and a foreign jurisdiction — not the '942 patent.
• I could not access USPTO PatentCenter or PACER directly. The bibliographic data above is drawn from the authoritative full patent text supplied and from Google Patents/Justia/PubChem/FDA NDA documents. Inventor and assignee lists should be confirmed against the official USPTO record, particularly the current assignee list, which has changed through several recorded assignments (2022 security interest to Hamilton SA LLC, released 2023).
• Expiration: Google Patents lists an anticipated expiration of Jan. 30, 2024 (20 years from the Jan. 30, 2004 PCT filing) and status "Expired – Lifetime." The prosecution history records a patent term adjustment figure on application 13/901,830; I have not independently computed the final expiration including any PTA or terminal disclaimer, so the Jan. 30, 2024 date should be treated as an indication rather than a verified legal conclusion.
• Claim-scope caveat: The specification's four summarized "aspects" (broad concentration range, pH range, citrate/EDTA combination, chelating agent + mannitol) are broader than what issued. The granted independent claims are limited to the 0.05 mg/mL concentration and the mannitol requirement.

I'll research the litigation history for US 9,173,942 using multiple sources.

Let me search for the specific district court cases and any recent activity.

Let me search for the specific case numbers listed on the patent page and the '942-specific assertions.

I've compiled the litigation record for US 9,173,942 from the sources available. Note that I hit a tool-step limit before I could run a final round of verification searches on a few peripheral case numbers, so those carry explicit confidence flags below.

Litigation Involving US Patent 9,173,942

Bottom line: Patent 9,173,942 was never the subject of an appellate opinion. Its known litigation footprint is narrow — two district court actions filed the same day (Dec. 15, 2015) and two PTAB post-grant reviews filed the same day (Feb. 5, 2016), all four short-lived. The famous Helsinn v. Teva / Supreme Court on-sale-bar fight concerned the sibling '219 patent, not the '942 patent, and should not be attributed to this patent number.

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A. District Court Cases Directly Asserting the '942 Patent

1. Helsinn Healthcare S.A. v. [Dr. Reddy's Laboratories, Ltd.](/litigations/by-plaintiff/Dr.%20Reddy's%20Laboratories%2C%20Ltd.) and Dr. Reddy's Laboratories, Inc.

2. Helsinn Healthcare S.A. and Roche Palo Alto LLC v. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd.

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B. PTAB AIA Trials on the '942 Patent (patent-office proceedings, not district court litigation)

Both were filed the same day by the same petitioner against the same patent, and both died at the § 324(a) institution threshold.

3. Dr. Reddy's Laboratories, Ltd. et al. v. Helsinn Healthcare S.A. — PGR2016-00007

4. Dr. Reddy's Laboratories, Ltd. et al. v. Helsinn Healthcare S.A. — PGR2016-00008

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C. Cases That Involve Related Family Patents but NOT the '942 Patent (do not conflate)

These appear in Google Patents' litigation sidebar because Google associates all family members, and they appear in the PTAB mandatory notices because the notice sweeps in "the '942 patent, or other patents claiming their earliest priority date to the same provisional application" (U.S. Prov. 60/444,351). They did not assert the '942 patent:

• Helsinn v. Dr. Reddy's, D.N.J. Nos. 11-3962, 11-5579, 13-5815 (consolidated), and 12-2867, and 14-4274 — asserted the '724, '725, '424, '981, '218, '219, and/or '094 patents.
• Helsinn v. Teva, D.N.J. No. 14-6341 — the on-sale-bar/obviousness case litigated through trial, the Federal Circuit (Helsinn v. Teva, 855 F.3d 1356 (Fed. Cir. 2017)), and the Supreme Court (Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 586 U.S. 123 (2019)). The patent before the Supreme Court was the '219 patent — not the '942 patent.
• Helsinn v. Fresenius Kabi USA, LLC, D.N.J. Nos. 15-7015 and 15-7378.
• Helsinn v. Hospira, Inc., D.N.J. No. 15-2077 and D. Del. No. 15-264.
• Helsinn v. Exela Pharma Sciences, LLC, et al. (D. Del.).
• Sagent actions, D.N.J. Nos. 16-173 and 16-681 (Sagent settlement-enforcement litigation; asserted the '724, '725, '424, '219, and '094 patents).

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D. Case-Number Discrepancies to Flag

The patent page's own litigation sidebar lists six matters — D.N.J. 3:15-cv-08663, D.N.J. 2:15-cv-02077, D.N.J. 3:15-cv-08132, D.N.J. 2:15-cv-08663, D.N.J. 3:15-cv-08662, and E.D. Pa. 2:15-cv-06392 — plus the two PGRs. Two cautions:

1. Numbering inconsistency. The PTAB decision text uses 15-8662 for Dr. Reddy's and 15-8663 for Teva. Google/DrugPatentWatch render the Dr. Reddy's case as 3:15-cv-08662 and DrugPatentWatch additionally shows a second D.N.J. entry dated 2015-12-14 terminated 2016-03-24. I treat the PTAB decision text as authoritative for the 15-8662/15-8663 split.
2. The sidebar sweep is broader than the '942 patent. The 2:15-cv-02077 entry corresponds to the Hospira case, 3:15-cv-08132 is not verified by me as an '942 assertion (the earlier summary attributed it to Qilu Pharmaceutical, which I could not confirm), and E.D. Pa. 2:15-cv-06392 I could not attribute to a defendant within my search steps. These may well be sibling-patent matters surfaced by Google's family-level association rather than '942-specific actions.
3. No Unified Patents challenge exists. The "Unified Patents" label on the Google sidebar is the CC-BY data-source attribution for Google's litigation widget — not a party. The petitioner in both PGRs was Dr. Reddy's Laboratories.

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E. What I Could Not Confirm

• No 2025 or 2026 activity tied to the '942 patent surfaced in my searches. The most recent dated index entry I retrieved is a DrugPatentWatch litigation page (last updated March 10, 2026) listing only the 2015–2016 D.N.J. cases and the 2016 PGR.
• The '942 patent's listed expiration is January 30, 2024 (20 years from the Jan. 30, 2004 PCT filing), status "Expired – Lifetime." That forecloses prospective relief and leaves only potential back-damages exposure in any still-open case.
• I could not verify the E.D. Pa. 2:15-cv-06392 defendant/caption, whether 3:15-cv-08132 asserted the '942 patent (or only family patents), or the exact docket-level disposition of 15-8663 beyond the March 24, 2016 stay order and the July 5, 2016 Roche-dismissal stipulation.

Sources consulted: Google Patents full text for US 9,173,942; PTAB PGR2016-00007 and PGR2016-00008 records (PTACTS/Docket Alarm, including the Aug. 17, 2016 institution denials and the Oct. 25, 2017 withdrawal order); the PTAB mandatory notices (Feb. 26, 2016) enumerating related district court actions; the D.N.J. 15-8663 stipulation of dismissal (CourtListener RECAP); DrugPatentWatch litigation index for patent 9,173,942; and the Supreme Court opinion in Helsinn v. Teva, 586 U.S. 123 (2019) confirming that the on-sale-bar case concerned the '219 patent.

I'll reconcile the structured ODP block against the web record before writing.

Let me pin down the panel reasoning in both denials and check for any other AIA challenges to the '942 patent.

One more check for any additional AIA challenges to the '942 patent itself, and the timeliness angle.

AIA Trial Proceedings — US 9,173,942

⚠️ Conflict flagged, and resolved against the structured block. The "PTAB proceedings on file" block in this prompt (USPTO ODP ingest) states that no AIA trial proceedings exist for this patent. That is incorrect as a matter of public record. Two post-grant reviews were filed against US 9,173,942 on 2016-02-05 and both were decided on 2016-08-17. The ODP block appears to be a stale/incomplete ingest — possibly because both proceedings terminated at the institution stage without an appealable final decision. Per the task instructions, I have adopted the web-sourced record (which the earlier-generated summary also already reported) and flagged the discrepancy rather than defaulting to "no PTAB activity." Anything below sourced to the ODP block should be treated as understated.

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Proceedings overview

Two AIA trial proceedings on file, both Post-Grant Reviews, both filed by Dr. Reddy's Laboratories on the same day and both decided on the same day by the same three-APJ panel: both were DENIED INSTITUTION. Zero claims canceled, zero claims sustained — because no claim was ever tested on the merits (no Final Written Decision issued in either case).

The bottom-line defensive posture is therefore more nuanced than "hardened," and considerably more dangerous for a patent owner than the raw 2–0 record suggests: Helsinn won twice at the § 324(a) threshold, but neither win is a merits adjudication, and the reasoning that carried PGR2016-00008 on the on-sale-bar ground was later rejected by the Supreme Court in the very same drug family (Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 17-1229 (U.S. 2019-01-22)). Separately, the patent's listed expiration (2024-01-30) means US 9,173,942 is now expired, so no new petition is realistic and the practical question is whether a pending case still has a live back-damages claim to defend.

Not on this patent: IPR2015-01550, -01551, -01553 and -01554 (Dr. Reddy's, filed 2015-07-03) attack US 8,729,094, a sibling patent in the same family — not the '942 patent. Do not conflate them; any estoppel from those IPRs does not run to the '942 patent.

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PGR2016-00008 — Dr. Reddy's Laboratories, Ltd. & Dr. Reddy's Laboratories, Inc. v. Helsinn Healthcare S.A. (and Roche Palo Alto LLC)

• Type: Post-Grant Review (35 U.S.C. §§ 321–329)

• Filed: 2016-02-05 (filing date accorded 2016-02-18)

• Status: Institution Denied (petition denied 2016-08-17; proceeding terminated 2017-10-25)

• Judge panel: Jacqueline Wright Bonilla (Vice Chief APJ), Toni R. Scheiner, and Lora M. Green. Scheiner authored.

• Petition grounds (as recited verbatim in the Board's 2017-10-25 order):

  Basis	Claims challenged
  § 112(a) Written Description	1–19
  § 102(a)(1) On-Sale Bar	1–19

  The on-sale bar theory was built on the April 2001 Helsinn–MGI Pharma license and supply/purchase agreements, publicly disclosed only as redacted SEC Form 8-K exhibits and press releases. Petitioner's express position was that "the AIA did not change the law to require that 'on sale' activity be 'public' in order to qualify as invalidating prior art."

• Institution decision: Denied, 2016-08-17 (Paper 11), under 35 U.S.C. § 324(a) — the Board determined "Petitioner has failed to demonstrate that it is more likely than not that at least one claim of the '942 patent is unpatentable." On the on-sale ground the panel held that the phrase "otherwise available to the public" in § 102(a)(1) modifies "on sale," so "the sale must make the claimed invention available to the public in order to trigger the on-sale bar," and found that the heavily redacted 8-K filings and press releases — which omitted dosage and concentration details recited in the claims — did not make the claimed invention available to the public. The panel followed the district court's then-controlling decision in Helsinn Healthcare S.A. v. Dr. Reddy's Labs. Ltd., No. 11-3962, 2016 WL 832089 (D.N.J. 2016-03-03).

• Final Written Decision: None issued. No claim of US 9,173,942 has ever been adjudicated on the merits in an AIA trial.

• Settlement / termination: Not a settlement. Patent Owner preliminary response filed 2016-05-18 (Paper 9). Petitioner filed a Request for Rehearing on 2016-09-15 (Paper 12) directed only to the § 112(a) written-description ground. Petitioner requested withdrawal of that request by email on 2017-10-17, representing that Patent Owner did not oppose; the Board granted withdrawal by Order on 2017-10-25 (Paper 13). Petitioner abandoned its rehearing bid entirely — it never obtained review of either ground.

• Appeal: None. Institution denials are non-appealable (35 U.S.C. § 324(e)), and Petitioner withdrew the only avenue it had. No Federal Circuit docket exists for this proceeding.

• Defensive value: Two-edged, and on balance the worse of the two denials for a defendant's purposes — but only because it is legally obsolete. A patent owner citing this decision today for the proposition that the AIA on-sale bar requires public availability would be citing superseded law: the Supreme Court unanimously rejected that reading in Helsinn v. Teva (2019-01-22), holding "the reenactment of the phrase 'on sale' in the AIA did not alter [its] meaning" and that a confidential sale can be invalidating prior art. The same MGI agreements and the same 2003-01-30 priority date sit behind the '942 patent; on the same theory the Court invalidated the sibling '219 patent. The Board's denial therefore gives US 9,173,942 no defensive comfort against an on-sale-bar invalidity theory — it only shows the Board's 2016 view, which the Supreme Court vacated as a matter of law. Note the practical constraints: PGR was the only vehicle for an on-sale challenge at the PTAB, that window closed nine months after the 2015-11-03 grant, and the patent is now expired.

  • Decision: PGR2016-00008 decision denying institution (Paper 11)
  • Withdrawal order (Paper 13): 2017-10-25 Order granting Petitioner's request to withdraw request for rehearing
  • Secondary source on the on-sale holding: Buchanan, "PTAB Lessons on Scope of On-Sale Art"

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PGR2016-00007 — Dr. Reddy's Laboratories, Ltd. & Dr. Reddy's Laboratories, Inc. v. Helsinn Healthcare S.A.

• Type: Post-Grant Review
• Filed: 2016-02-05 (Paper 1; filing date accorded 2016-02-18)
• Status: Institution Denied (Terminated-Denied)
• Judge panel: Toni R. Scheiner, Lora M. Green, and Jacqueline Wright Bonilla. Scheiner authored. (Identical panel to PGR2016-00008 — the two petitions were effectively a coordinated pair.)
• Petition grounds: Ground 1 — claims 1–6, 10 and 11 are invalid as obvious under § 103 over U.S. Patent No. 5,202,333 (Berger) in view of Eglen, Gibson, and PDR 2001. The petition also contested the pH limitation, the citrate/chelating-agent limitations, and the 0.25 mg amount, and relied on the declarations of Dr. Joanne Broadhead (Ex. 1012) and Dr. Christopher A. Fausel (Ex. 1026). Patent Owner's preliminary response argued (i) a POSA would not have selected palonosetron at all in 2003 given waning 5-HT₃ interest and NK-1 focus; (ii) Tang 1998 teaches away from the claimed 0.05 mg/mL concentration and 0.25 mg dose; and (iii) objective indicia (industry skepticism, unexpected results, commercial success, failure of others, copying). Patent Owner also asked the Board to deny under § 325(d) and attacked the grounds as redundant.
• Institution decision: Denied, 2016-08-17 (Paper 12). The Board applied § 324(a) and concluded Petitioner had not shown it more likely than not that at least one challenged claim was unpatentable. Because the Board disposed of the petition on the § 324(a) threshold, no claim construction or merits ruling on the Berger/Eglen/Gibson combination exists.
• Final Written Decision: None.
• Settlement / termination: None in the proceeding itself — it simply terminated on the institution denial (PO preliminary response and updated mandatory notices filed 2016-05-18, Papers 9–11). Notably, Patent Owner's 2016-05-18 mandatory notices confirm that Roche Palo Alto LLC had by then assigned all right, title and interest in the '942 patent to Helsinn, so Helsinn was the sole remaining real party-in-interest. In parallel, the underlying D.N.J. litigation Helsinn had brought against Dr. Reddy's on the '942 patent (No. 15-8662, filed 2015-12-15) was terminated 2016-03-24, consistent with the parties' 2015 settlement of the broader palonosetron dispute.
• Appeal: None. No FWD, no appealable order; no Federal Circuit docket.
• Defensive value: This is the more durable of the two denials, but it is a threshold ruling, not a validity holding. The Board never said the claims are patentable over Berger + Eglen + Gibson + PDR 2001 — it said Dr. Reddy's had not carried § 324(a)'s "more likely than not" burden, with Tang 1998's alleged teaching-away and Helsinn's objective-indicia evidence doing real work. Because it is non-precedential and issued without a trial, a defendant cannot use it to win anything; but a patent owner cannot credibly call its claims "PTAB-validated" either. Also note the scope gap: claims 7–9 and 12–19 — including the two independent-claim set anchored on EDTA and the 41.5 mg/mL mannitol/0.5 mg/mL EDTA combination — were never challenged in any AIA proceeding. Untested is not the same as valid, but there is no PTAB paper to attack them with.
  • Decision: PGR2016-00007 decision denying institution (Paper 12)
  • PTAB E2E petition record: ptacts.uspto.gov petition 1458462 (PGR2016-00007)

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Strategic summary

Claim-level status of US 9,173,942. Claims 1–19 — all 19 claims stand, none canceled. But the accurate framing is "untested," not "sustained." No AIA trial ever reached a Final Written Decision on this patent, so there is no claim-level merits finding in any PTAB paper. Claims 1–6, 10 and 11 were the subject of an obviousness petition that failed at the § 324(a) threshold; claims 1–19 were the subject of a § 112(a)/§ 102(a)(1) petition that likewise failed at the threshold; claims 7–9 and 12–19 were never challenged in any AIA trial at all. The only substantive public adjudication touching this family came from the Article III courts: the Federal Circuit (855 F.3d 1356 (2017)) and the Supreme Court (No. 17-1229, 2019-01-22) invalidated the sibling '219 patent under the AIA on-sale bar on the strength of the 2001 MGI agreements — the identical transactional facts and the identical 2003-01-30 priority date that underpin the '942 patent. I have found no reported decision invalidating the '942 patent itself, and I am not asserting one exists.

Estoppel landscape: essentially none, in either direction. Statutory estoppel under 35 U.S.C. § 325(e)(2) (PGR) and § 315(e)(2) (IPR) attaches only after a final written decision. Because both proceedings died at institution, no estoppel attached to Dr. Reddy's or its privies, and no ground was "raised or reasonably could have been raised" and thereby foreclosed. Practically: (a) a defendant is not blocked from running the Berger/Eglen/Gibson/PDR-2001 obviousness theory or any § 112 theory; (b) conversely, Dr. Reddy's own prior-art record (Exs. 1006–1042 in PGR2016-00007, and the Broadhead/Fausel declarations) is public and reusable. The hard bars a defendant now faces are temporal and statutory, not estoppel-based: the PGR window closed nine months after the 2015-11-03 grant; the § 315(b) one-year bar relative to the 2015-12-15 complaint ran on 2016-12-15; on-sale-bar art is unavailable in an IPR by § 311(b) (patents and printed publications only); and the patent itself expired 2024-01-30. Any live invalidity fight is therefore a district-court § 282 fight (or a back-damages defense in a still-open case), not a PTAB fight.

Pattern signals. (1) One petitioner, two petitions, same day, same panel — Dr. Reddy's filed PGR2016-00007 (obviousness, subset of claims) and PGR2016-00008 (written description + on-sale bar, all claims) on 2016-02-05 and lost both on 2016-08-17; this is coordinated, not organic, serial filing. (2) Patent owner was not an aggressive PTAB appellant here — there was nothing to appeal — but Helsinn was an aggressive litigant: the '942 patent is one of a nine-member family asserted in at least a dozen D.N.J. and D. Del. actions against roughly fifteen ANDA sponsors. (3) No defensive aggregator is in the chain. The "Unified Patents" label the earlier summary flagged on the Google Patents sidebar is the data-source attribution for Google's litigation widget (Unified Patents Litigation/PTAB Data is CC-BY licensed), not a petitioner. The real petitioner is Dr. Reddy's. I could find no Unified Patents-filed challenge to this patent. (4) Redundancy of counsel is a tell: the same Paul Hastings/Finnegan/Loeb team appears in both PGRs, and petitioner-side counsel (Mentlik/Teschner/Fuller of Lerner David) is the same across both.

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Recommended next steps

If you are defending an assertion of US 9,173,942:

1. Do not build a defense on the PTAB record, because there isn't one to build on. Both proceedings are cited in the earlier summary as "Not Instituted – Merits." Verify the institution decisions directly (links above) but expect no merits guidance — there is no FWD, so no claim construction, no obviousness holding, and no claim-level disposition to quote. Say this plainly to the client: the 2–0 PTAB record is a record of threshold denials, not of validity.
2. Attack the on-sale bar point head-on rather than being lulled by PGR2016-00008. The Board's holding that "the sale must make the claimed invention available to the public in order to trigger the on-sale bar" is no longer good law — Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 17-1229 (U.S. 2019-01-22) (unanimous), affirming 855 F.3d 1356 (Fed. Cir. 2017). If an on-sale defense is available to you, plead it in district court; it cannot be raised at the PTAB. See Supreme Court docket/cert page for 17-1229.
3. Check whether any case is still open with a live back-damages claim. The listed expiration is 2024-01-30 and status is "Expired – Lifetime." That does not automatically moot a pending action, but it does foreclose prospective relief. The 2018 "at-risk" launches (Teva 2018-03-23; Dr. Reddy's 2018-03-26; Sandoz 2018-04-02) and the Sagent settlement-enforcement litigation in D.N.J. are documented at CourtListener RECAP, D.N.J. 2:16-cv-00173, D.I. 71.
4. If you do consider a PTAB filing, confirm the deadline arithmetic first. For an AIA patent, an IPR may not be filed until nine months after grant (here 2016-08-03) or, if a PGR was filed, after its termination; and § 315(b) gives one year from service of a complaint alleging infringement. Dr. Reddy's had an IPR path on the Berger/Eglen/Gibson theory open from roughly 2016-08-03 until 2016-12-15 and did not take it — a fact worth understanding before assuming a petition is still viable. Given the 2024-01-30 expiration, I would assess the window as closed absent a specific, still-pending case.
5. If you are representing the patent owner, resist over-reading these denials. Helsinn survived; it did not win a merits finding. The strongest uses of the record are procedural (no FWD, no estoppel, no adjudicated invalidity of the '942 patent), and the weakest is any citation to PGR2016-00008 for the on-sale-bar public-availability rule.

Uncertainty I cannot resolve from available sources: the full text of the PGR2016-00007 decision beyond its caption and § 324(a) conclusion; whether either panel expressly invoked § 325(d) (both petitions raised it and Helsinn argued for it, but the denials appear to rest on § 324(a)); the Paper 11 page-pin for the on-sale reasoning; and whether any transaction-level settlement between Helsinn and Dr. Reddy's covered the '942 patent specifically (the 2015-10-16 dismissal order I found relates to Civil Action No. 2:11-cv-03962, not 15-8662). Verify any of these against PTAB E2E before filing.

I'll research the assignment record for US 9,173,942 across USPTO and cross-reference sources.

Let me dig into the specific assignment records and the security-interest party.

Assignment and Ownership Analysis — US 9,173,942 B2

Source note: the reel/frame and conveyance data below is taken from the authoritative full patent text (Google Patents legal-events feed, which mirrors USPTO assignment records) and cross-checked against the PTAB record. I could not open USPTO Assignment Center (assignmentcenter.uspto.gov) or the legacy assignment.uspto.gov index directly within this session, so executive dates vs. recording dates and the correspondent of record are incompletely captured — flagged explicitly where that matters. Only one reel/frame is quoted on the face of the patent itself (047534/0024).

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Inventors

Seven named inventors on the issued patent (72):

Patterns worth noting:

• Split inventorship tracks the 1998 Helsinn–Roche/Syntex deal. Four Helsinn-side inventors (Swiss/Italian) and three Roche Palo Alto inventors (California) — the compound came from Syntex/Roche (US 5,202,333, Berger et al.) and the formulation work was done by Helsinn. This is a co-development / license-and-develop pattern, the opposite of an inventor-dump or assign-a-shell pattern.
• Inventor list and assignor list do not match exactly. The 2018-11-14 recorded assignment to Helsinn Healthcare SA names assignors Alberto Macciocchi, Daniele Bonadeo, Giorgio Calderari, Roberta Cannella, and Carmine Panuccio — i.e., four of the seven inventors plus Carmine Panuccio, who is not a named inventor on the '942 patent. Panuccio is a Helsinn-side assignor carried into the '942 record as part of a family-wide confirmatory assignment. The 2018-11-14 assignment to Roche Palo Alto LLC names Thomas Malefyt, Andrew Miksztal, Kathleen M. Lee — exactly the three Roche-side inventors.
• These are late-recorded confirmatory inventor assignments, not originals. The '942 application was filed 2013-05-24 from a 2003 priority chain that had already issued as US 7,947,724 (2011). Recording inventor assignments in November 2018 — eight years after the first family patent issued and simultaneously with the internal co-ownership split — indicates a chain-of-title cleanup, not a genuine contemporaneous employment assignment.
• Departure analysis: not determinable. I found no evidence of any inventor leaving Helsinn or Roche Palo Alto within 12 months of filing, and I could not verify employment tenure. No fire-sale precursor signal is supported by the record.
• Front-page applicant anomaly (flagging, not a finding): a CourtListener OCR of the '942 front page renders the (71) applicants as including "Simone Macciocchi, Melide (CH); Giulio Macciocchi, Breganzona (CH)" alongside the two corporate assignees. This is likely OCR bleed from a sibling publication in the family (the family recursory filings list a "Giulio Macciocchi" as applicant/inventor on other members). Do not treat it as an '942 applicant without confirming against the official front page.

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Original assignee

Two entities named as assignees on the issued patent (73):

1. Helsinn Healthcare SA — Pambio-Norano / Lugano, Switzerland.

• Business: privately held Swiss pharmaceutical group focused on cancer supportive care; business model is in-licensing/development/licensing, with its own manufacturing and commercial operations.
• Product embodying the claims: Yes — Aloxi® (palonosetron HCl) injection, 0.25 mg/5 mL and 0.075 mg/1.5 mL, listed in the Orange Book under NDA 021-372 against the '942 patent. U.S. distribution was via Eisai; the group's U.S. R&D entity is Helsinn Therapeutics (US) Inc. (New Jersey).
• Status: Operating. No insolvency, bankruptcy, or wind-down of the Helsinn group appears in the record.

2. Roche Palo Alto LLC — Palo Alto, California.

• Business: pharmaceutical research/development; the entity is the successor to Syntex (U.S.A.) Inc., which discovered palonosetron and whose US 5,202,333 is the closest cited prior art. Roche was originally a co-inventor/co-assignee, not the formulation owner — it held an undivided interest alongside Helsinn.
• Products: Roche Palo Alto did not ship the claimed palonosetron formulation; Aloxi is the Helsinn product. Roche Palo Alto is a research entity within Roche Holding AG.
• Status: Operating (as a Roche group entity), but no longer an owner of the '942 patent — it conveyed its entire interest to Helsinn in 2016 (see timeline). I could not verify within this session the current operational status of the Palo Alto site or any Roche-site restructuring; treat that question as unverified.

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Assignment timeline

Timing caveat. Google Patents' legal-events feed reports a single date per reassignment. That date is generally the recordation date derived from USPTO assignment data; the underlying record also carries an execution date. I could not retrieve both for these entries. Where execution timing is independently corroborated by the PTAB/litigation record, I say so.

1. ~2016-05-02 (executed) / recorded 2016-05-11 — Reel/frame not retrievable

• Conveyance: Assignment of assignors' interest
• Assignor: Roche Palo Alto LLC
• Assignee: Helsinn Healthcare SA
• Correspondent: Not retrieved. (PTAB counsel of record for patent owner in this period was Paul Hastings LLP — Eric W. Dittmann, Naveen Modi, Michael A. Stramiello — with Thomas L. Irving (Finnegan) and Mark E. Waddell (Loeb & Loeb). That is litigation/PTAB counsel, not the assignment correspondent; do not conflate.)
• Context: Consolidation of co-owned title into the brand owner — Roche conveyed its undivided interest to Helsinn following the broader 2015 Helsinn–Dr. Reddy's settlement; corroborated by Helsinn's Updated Mandatory Notices filed 2016-05-18 in PGR2016-00008 (Paper 8), which state Roche "has assigned to Helsinn all right, title, and interest in and to the '942 patent." This is the transfer that makes Helsinn the sole real party-in-interest.

2. 2018-11-14 — Reel/frame not retrievable

• Conveyance: Assignment (confirmatory inventor assignment)
• Assignors: Alberto Macciocchi; Daniele Bonadeo; Giorgio Calderari; Roberta Cannella; Carmine Panuccio
• Assignee: Helsinn Healthcare SA
• Correspondent: Not retrieved.
• Context: Chain-of-title cleanup — recording the Helsinn-side inventors' interest years after the fact, contemporaneously with the co-ownership split.

3. 2018-11-14 — Reel/frame not retrievable

• Conveyance: Assignment (confirmatory inventor assignment)
• Assignors: Thomas Malefyt; Andrew Miksztal; Kathleen M. Lee
• Assignee: Roche Palo Alto LLC
• Correspondent: Not retrieved.
• Context: Same cleanup, Roche-side inventors — recorded even though Roche had already divested its interest to Helsinn in 2016.

4. 2018-11-14 (recorded) — Reel 047534 / Frame 0024 (confirmed: the 2018-11-21 corrective assignment expressly identifies "reel 047534 frame 0024" as the prior recordation)

• Conveyance: Patent Co-Ownership Agreement (recorded as an assignment)
• Assignor: Helsinn Healthcare SA
• Assignees: Helsinn Advanced Synthesis SA; Helsinn Therapeutics (U.S.), Inc.; Helsinn Birex Pharmaceuticals Ltd. (as misspelled on the original record: "Helsinn Birex Pharmaceutials Ltd.")
• Correspondent: Not retrieved — but this is the reel/frame an examiner or challenger would pull to identify the recording attorney.
• Context: Internal corporate reorganization — Helsinn Healthcare SA split title in the '942 patent among three Helsinn group operating entities (Swiss API manufacturing; U.S. therapeutics/R&D; Irish pharma). Not a sale; no consideration to a third party; no change in ultimate control.

5. 2018-11-21 (recorded) — Reel 047534 / Frame 0024 (correcting entry)

• Conveyance: Corrective Assignment — "CORRECTIVE ASSIGNMENT TO CORRECT THE 1. SPELLING OF ASSIGNEE NAME HELSINN BIREX PHARMACEUTICALS LTD.; 2. ADDRESSES OF ASSIGNEES PREVIOUSLY RECORDED ON REEL 047534 FRAME 0024. ASSIGNOR(S) HEREBY CONFIRMS THE PATENT CO-OWNERSHIP AGREEMENT."
• Assignor: Helsinn Healthcare SA
• Assignees: Helsinn Birex Pharmaceuticals, Ltd.; Helsinn Therapeutics (U.S.), Inc.; Helsinn Advanced Synthesis SA
• Correspondent: Not retrieved.
• Context: Typographical/address correction only — no change in ownership.

6. 2022-12-30 (recorded) — Reel/frame not retrievable

• Conveyance: Security Interest
• Assignors (grantors): Helsinn Birex Pharmaceuticals Limited; Helsinn Healthcare SA; Helsinn Therapeutics (U.S.), Inc.
• Assignee (secured party): Hamilton SA LLC
• Correspondent: Not retrieved.
• Context: Securitization — a collateral grant to a lender, not an ownership transfer. Note the grantor set omits Helsinn Advanced Synthesis SA, which is a co-owner under entry 4 — an inconsistency in the collateral description that should be verified (either Advanced Synthesis was not a pledgor, or its interest was addressed elsewhere).

7. 2023-09-20 (recorded) — Reel/frame not retrievable

• Conveyance: Release by Secured Party
• Assignor: Hamilton SA LLC
• Assignees (released parties): Helsinn Healthcare SA; Helsinn Birex Pharmaceuticals Limited; Helsinn Therapeutics (U.S.), Inc.
• Correspondent: Not retrieved.
• Context: Extinguishment of the 2022 security interest — the secured financing was repaid or refinanced within ~9 months. Confirms the 2022 entry was routine collateral, not a distressed sale.

8. 2024-01-30 — no conveyance; anticipated expiration event (20 years from the 2004-01-30 PCT filing). Status: Expired – Lifetime.

Net effect: four owners of record (Helsinn Healthcare SA and the three co-owning Helsinn subsidiaries), with a released security interest. The patent has never left the Helsinn corporate family after the 2016 Roche buy-in.

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Timeline diagram

timeline
    title Ownership of US 9173942
    2003 : Priority application filed
         : Helsinn and Roche co-developed
    2015 : Patent issued Nov 3
         : First 942 suits filed Dec 15
    2016 : Roche conveys interest to Helsinn
         : Dr Reddy files two PGR petitions
    2018 : Inventor assignments recorded
         : Co-ownership split among three Helsinn units
         : Corrective assignment fixes assignee name
    2022 : Security interest to Hamilton SA LLC
    2023 : Security interest released
    2024 : Patent expires Jan 30

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NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT.
No licensing-only LLC anywhere in the chain. The 2018-11-14 co-ownership split (Reel 047534/0024) moved title to Helsinn Advanced Synthesis SA (Swiss API manufacturing), Helsinn Therapeutics (U.S.), Inc. (U.S. R&D/operations, New Jersey) and Helsinn Birex Pharmaceuticals Ltd. (Irish pharma operations). All three are operating group companies with physical facilities, not registered-agent addresses; the instrument is a Patent Co-Ownership Agreement between affiliates, i.e., an internal reorganization. No "IP / Holdings / Ventures / Licensing" suffix appears on any assignee, and no single-member Delaware or Texas vehicle is present.

2. Known asserter in the chain — NOT PRESENT.
No assignee of record matches any of the listed NPE families (Acacia, Marathon Patent Group, Intellectual Ventures, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio IP Ventures, MPHJ, Lumen View, Round Rock, Document Generation Corp, or any Erich Spangenberg entity). Assignees of record are Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Therapeutics (U.S.) Inc., Helsinn Birex Pharmaceuticals Ltd., and Roche Palo Alto LLC — all operating companies. The 2022 secured party, Hamilton SA LLC, is a lender taking collateral, not an owner, and its interest was released 2023-09-20; there is no evidence it is a patent assertion entity. Caveat: I could not query the Unified Patents or RPX asserter directories within this session — this call rests on the named parties being, on their face, operating pharmaceutical companies and a released secured lender.

3. Repeat correspondent across the chain — UNCLEAR / INSUFFICIENT DATA.
This is the one signal I cannot responsibly score, because the Assignment Center correspondent-of-record field was not retrievable for entries 1–7. What I can say: Reel 047534/Frame 0024 is the recordation that would identify the attorney who filed the 2018 co-ownership agreement and its 2018-11-21 correction — the same correspondent necessarily appears on both. That is a single-affiliate filing pair, not the multi-shell recurrence pattern this signal is designed to catch. Separately, Paul Hastings LLP (Eric W. Dittmann / Naveen Modi / Michael A. Stramiello) appears on the patent-owner side of the PGR filings and Finnegan (Thomas L. Irving) and Loeb & Loeb (Mark E. Waddell) also appear — but that is litigation counsel, not assignment correspondent, and Paul Hastings' relevant PGR role was partly on the petitioner side. Do not infer this signal from that appearance. Recommend pulling Reel 047534/0024 and the 2022/2023 recording entries in Assignment Center to close this out.

4. Cascading transfers — NOT PRESENT.
There is one dense cluster (four recordings in eight days, 2018-11-14 to 2018-11-21), but it consists of two confirmatory inventor assignments and one internal co-ownership agreement plus its typographical correction — all intra-family, all to entities under common Helsinn control, with no chained LLC pass-through and no shared registered-agent address among unrelated assignees. There is no sequence of transfers through successive unrelated shell entities.

5. Pre-litigation transfer — NOT PRESENT.
The first '942-specific suits were filed 2015-12-15 (D.N.J. 15-8662 and 15-8663, the day before the patent page's sidebar dates), by the then-current assignees of record. The only nearby transfer, Roche → Helsinn (executed ~2016-05-02, recorded 2016-05-11), came after the suits and is a co-owner consolidation following settlement, not a transfer into an asserting vehicle. No assignment occurred within six months before the first assertion.

6. Bankruptcy fire-sale — NOT PRESENT.
No Chapter 7/11 proceeding involving Helsinn Healthcare SA, the Helsinn group entities, or Roche Palo Alto LLC appears in the record, and no patent sale in bankruptcy is documented. The closest credit event is the 2022-12-30 security interest to Hamilton SA LLC, which was released 2023-09-20 — a performing secured financing, not a distress liquidation.

7. Privateering — NOT PRESENT.
The patent has never been transferred to a third-party assertion vehicle. The inverse pattern holds: Helsinn, the operating brand owner, asserted its own Orange Book–listed product against ANDA filers itself, in its own name, from 2011 through 2016. Nothing in the chain shows a transfer to an NPE to assert against the transferor's competitors.

8. Defensive aggregator — NOT PRESENT.
The chain does not terminate at RPX, Allied Security Trust, LOT Network, Unified Patents, or Open Invention Network. It terminates in the Helsinn group co-owners, with a released security interest. Note for clarity: the "Unified Patents" label on the Google Patents sidebar is the CC-BY data-source attribution for Google's litigation widget, not a party — no Unified Patents acquisition or challenge to this patent exists.

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Verdict

Operating-company assertion.

Justification: the chain of title runs Roche Palo Alto LLC → Helsinn Healthcare SA (recorded 2016-05-11) → co-ownership split among Helsinn Advanced Synthesis SA, Helsinn Therapeutics (U.S.) Inc. and Helsinn Birex Pharmaceuticals Ltd. (Reel 047534/Frame 0024, 2018-11-14, corrected 2018-11-21) — an unbroken line of operating pharmaceutical companies, with the only outside party being secured lender Hamilton SA LLC, whose 2022-12-30 security interest was released on 2023-09-20. The patent has never been held by a licensing-only shell or a known NPE, no aggregator appears, and the infringement suits against ANDA filers were brought by Helsinn and Roche as the brand owner/co-inventor themselves, not by an acquirer asserting purchased paper. Every "shell," "fire-sale," "pre-litigation transfer" and "defensive aggregator" signal scores not present; the sole open item is the correspondent of record, which I could not retrieve and which should not be scored on litigation-counsel appearances.

Verification link: USPTO Assignment Center → search patent number 9173942 (legacy interface: assignment.uspto.gov/patent). Pull Reel 047534/Frame 0024 and the 2022-12-30 / 2023-09-20 security-interest and release entries to capture execution dates, reel/frame for entries 1–3 and 6–7, and the correspondent of record.

I'll research US 9,173,942 against live sources, focusing on its cited prior art.

Let me gather details on the key cited references.

Prior-Art Analysis — US 9,173,942 B2

Note on the tool limit: I was able to retrieve the authoritative full patent text (which contains the complete front-page citation lists) plus detailed records for several of the most important references. I could not open the full text of every one of the 46 patent citations and 429 non-patent citations individually. Where my confidence is lower, I say so explicitly rather than asserting an anticipation I cannot support.

Also flagging a discrepancy with the earlier section: Google Patents lists the "Prior art date" as 2003‑01‑30. That is the priority date. For § 102 purposes the effective filing date is Jan. 30, 2003 (U.S. Prov. 60/444,351, via PCT/EP2004/000888). Any reference dated before that date is § 102(a)/(b) art; later-published references must be analyzed under § 102(e)/§ 102(a) by their filing dates. This matters for several cited items (e.g., WO 2003/100091, published Dec. 4, 2003).

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1. The anticipation test — element charts

Anticipation under 35 U.S.C. § 102 requires a single reference disclosing every limitation arranged as claimed. The issued claims of the '942 patent are narrow:

Claim 1 (independent):

Claim 12 (independent):

Dependent claims 2–11 and 13–19 further narrow to: 0.25 mg total palonosetron; mannitol 20–60, 40–45, or 41.5 mg/mL; a chelating agent/EDTA (0.5 mg/mL); pH 5.0 ± 0.5; and a citrate buffer.

Critical observation: the claims require mannitol. The only pre-2003 palonosetron intravenous formulation in the cited art — Example 13 of US 5,202,333 — uses dextrose, not mannitol, and is at pH 3.7. That single fact is the fulcrum of the entire prior-art picture.

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2. The primary reference

US 5,202,333 A — Berger, Clark, Eglen, Smith, Weinhardt (Syntex (U.S.A.) Inc.)

• Full citation: U.S. Patent 5,202,333, "Tricyclic 5-HT₃ receptor antagonists," filed May 22, 1991 (priority Nov. 27/28, 1989), issued April 13, 1993.
• Description: Genus claims to tricyclic 5-HT₃ antagonists, expressly encompassing palonosetron; claims pharmaceutical compositions and a method of treating emesis. Example 13 is a "representative pharmaceutical formulation[] containing a compound of Formula I," including an intravenous solution of the palonosetron compound with dextrose monohydrate, citric acid monohydrate (1.05 mg), sodium hydroxide (0.18 mg), and water for injection.
• § 102 analysis: Does not anticipate any claim of the '942 patent.
  • Element A (sterile aqueous IV) — arguably disclosed (though Example 13 does not recite sterility or terminal sterilization).
  • Element B — fails: the '333 disclosure contemplates 10–100 mg of palonosetron HCl, i.e., a concentration far above 0.05 mg/mL, and gives no fixed 0.05 mg/mL unit.
  • Element C — fails: no mannitol; dextrose is the tonicity agent.
  • Element D — fails: the patent's own specification states this formulation "has a pH of 3.7," outside the claimed 4.0–6.0.
  • Claim 12's EDTA element — entirely absent.
• Status: § 102(b) art (issued 1993), but only as background/§ 103 art. It is the closest single reference and the jumping-off point of the '942 specification, which expressly criticizes it for insufficient shelf stability. It cannot support a § 102 rejection of claims 1 or 12.

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3. Full check of the cited U.S. and foreign patent references

Dates are filing/publication as listed in the patent. "§ 102 status" indicates availability as prior art relative to the Jan. 30, 2003 effective date.

Family-citation block (patents cited within the family, listed on the '725/'724 front pages)

Result: none of the 46 patent citations discloses a palonosetron intravenous solution at 0.05 mg/mL containing mannitol at 10–80 mg/mL, let alone with EDTA at 0.3–0.7 mg/mL and pH 4.0–6.0. No single cited reference anticipates claims 1–19.

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4. Non-patent literature of note

The '942 citation list is dominated by litigation documents (Paragraph IV letters, expert reports, briefs). A handful of substantive publications are relevant to § 103 rather than § 102:

• C. M. Won et al., "Photolytic and Oxidative Degradation of an Antiemetic Agent, RG12915," Int'l J. Pharmaceutics 121:95–105 (1995). Discloses oxidative/photolytic degradation of a different antiemetic (RG 12915). Relevant to the motivation to add a chelator (EDTA) and control pH, but does not disclose the claimed composition, and the trial testimony (D.N.J. 3:11‑cv‑03962, Doc. 343) shows the structural dissimilarity between RG 12915 and palonosetron was disputed.
• Sabra, K., "Choice of a 5‑HT₃ Receptor Antagonist for the Hospital Formulary," EHP Oct. 1996; 2(suppl 1):S19–24. General 5‑HT₃ formulary review — no palonosetron formulation.
• Barton, "Citrate Buffer Calculation," 2000, 2 pp. A buffer-calculation reference, cited in several family members — teaches making citrate buffers generally, not the claimed combination.
• Gandara et al., Support Care Cancer 6:237–243 (1998); Gregory & Ettinger, Drugs 55(2):173–189 (1998); Israili, Curr. Med. Chem. CNS Agents 1:171–199 (2001) — antiemetic pharmacology reviews; background only.
• FDA approval letter of Aloxi (July 25, 2003) and Aloxi Full Prescribing Information (2008, 2014) — post-date the Jan. 30, 2003 priority date; not § 102 prior art to the claims, though relevant to the commercial embodiment.

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5. Bottom line

1. No cited reference anticipates claims 1–19. The defining limitations — palonosetron HCl at exactly 0.05 mg/mL, mannitol 10–80 mg/mL, and (in claim 12) EDTA 0.3–0.7 mg/mL — are collectively absent from every cited patent and publication.
2. The closest single reference is US 5,202,333 (Syntex), Example 13. It discloses palonosetron but in a dextrose vehicle at pH 3.7 — missing the mannitol and pH limitations of claim 1 and the mannitol + EDTA limitations of claim 12. It is § 102(b) art but supports only a § 103 argument, and even that combination was rejected: the '942 specification itself distinguishes the '333 formulation as insufficiently shelf-stable.
3. The real § 103 cluster is the generic-excipient art: US 5,272,137 (mannitol and edetate as known excipients in an aqueous suspension), US 6,284,749 (EDTA as a chelating agent in a preserved composition), US 2,836,541 (mannitol as a stabilizer), and Won 1995 (oxidative degradation motivation). None of these supplies the palonosetron-specific composition.
4. Consistency with the record: This conclusion aligns with the PTAB's denial of institution in PGR2016‑00007 and PGR2016‑00008 (Aug. 17, 2016), where the Board found the petitioner had not shown it more likely than not that any challenged claim of the '942 patent was unpatentable. (As noted in the earlier section, the Google Patents sidebar's "Unified Patents" attribution is a data-source label, not the party; the petitioner was Dr. Reddy's Laboratories.)

Confidence and limitations

• High confidence in the claim elements (drawn from the authoritative claim text) and in the anticipation analysis for the two independent claims.
• Moderate confidence in the descriptions of cited references I could not open in full (items 1–7, 9, 11–16, 18–20, 22, 24, 27 in the table). Their titles, dates, and assignees are taken verbatim from the patent's own front-page lists; their subject matter is characterized from those titles, so a few characterizations are inferred rather than verified against full text.
• I could not verify that later-published cited items (WO 2003/100091, WO 2004/045615, WO 2004/073714) have qualifying U.S. counterparts or § 102(e) dates; treat those statuses as provisional.
• I did not locate any 2025–2026 prior art or reexamination activity adding a new § 102 reference against the '942 patent beyond those already on the face of the document.

I'll ground this obviousness analysis in the prior-art references cited on the patent page, verifying key reference disclosures against live sources.

Let me verify the specific prior-art disclosures relied on (commercial setron IV labels, Won 1995, and the DRL PGR record against the '942 patent).

Obviousness Analysis of U.S. Patent 9,173,942 under 35 U.S.C. § 103

Analyst note on scope and method. This analysis is built from the prior-art references cited on the face of US 9,173,942 (the "Citations (28)," "Patent Citations (46)," "Family Cites Families (7)," and "Non-Patent Citations (429)" sections of the patent page) plus the portions of the record that discuss those references. Where a reference proposition comes from the litigation/PTAB record rather than my independent reading of the reference, I say so and flag confidence. I do not repeat the bibliographic, claim-construction, or litigation-status content already generated in the "Patent summary" section above; I build on it.

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1. Governing framework

Under Graham v. John Deere, 383 U.S. 1 (1966), and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the analysis proceeds: (1) scope and content of the prior art; (2) differences between the prior art and the claims; (3) level of ordinary skill; (4) secondary considerations. KSR adds that where a claimed element is a known element used for its known purpose to obtain a predictable result, or where the difference is a substitution of one known element for another or obvious design/optimization of a prior-art formulation, the claim is likely obvious even without an explicit "teaching, suggestion, or motivation." in re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), governs claimed numeric ranges that overlap or are optimized within the prior art.

POSA. Per the D.N.J. court's own construction in the parallel Helsinn v. Dr. Reddy's (Teva) litigation, the POSA is a team including a clinician, a marketing person, a formulator, and a pharmaceutical development scientist, with a 2003 timeframe (the Jan. 30, 2003 priority date). The patent's own field statement ("shelf-life stable liquid formulations of palonosetron… injectable and oral medicaments") confirms that IV formulation science is the relevant art.

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2. The prior-art landscape, organized by criticality

The page's cited art is unusually rich because this patent sits at the top of a nine-member U.S. family and was the subject of a large Hatch-Waxman record. Two cautions:

(a) Date discipline. The effective critical date is Jan. 30, 2003 (US Prov. 60/444,351; PCT/EP2004/000888 filed Jan. 30, 2004). Several items cited on the page postdate that date and are therefore date-sensitive and should not be relied on without confirming their §102(a)/(e) status: WO 2004/045615 (pub. June 3, 2004), WO 2004/073714 (pub. Sept. 2, 2004), WO 2003/100091 (pub. Dec. 4, 2003), US 2003/0095926 A1 (pub. May 22, 2003), US 2004/0147510 A1 (pub. July 29, 2004), and the Aloxi FDA correspondence (2002–2003). These are not the load-bearing references for §103.

(b) Status. Google Patents labels the two 2016 PTAB matters as "Unified Patents" filings with a status of "Not Instituted – Merits." As corrected in the earlier section, the petitioner was Dr. Reddy's Laboratories, and "Unified Patents" is only Google's data-source label. That distinction matters because DRL's petition papers are themselves a detailed §103 roadmap against this patent number.

Pre-critical-date references actually cited on the page

(I verified the Zofran/granisetron/dolasetron-style label chemistry from current FDA/ASHP labeling for the same molecules; the pH 3.3–4.0 and citrate/NaCl composition of ondansetron injection is confirmed in the ASHP monograph. I could not independently pull the 2001 PDR pages within this session — the Anzemet mannitol and Kytril citrate points are drawn from how both the patentee and DRL characterized those labels in the record. Treat those two as high-but-not-certain confidence.)

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3. The claims and the differences from the closest art

Closest prior art = US 5,202,333 (Berger), Example 13. It is the same drug, same therapeutic class, same dosage form, disclosed by the patentee's own predecessor-in-interest — and the '942 specification itself uses it as the foil ("The formulation has a pH of 3.7 and a shelf stability of less than the 1-2 year time period required by health authorities").

So the entire delta for claim 1 is: (i) a 200–2000× lower drug concentration, (ii) mannitol substituted for dextrose as the tonicity agent, and (iii) pH raised from 3.7 into 4.0–6.0. For claim 12 it is: (i) lower concentration, (ii) mannitol for dextrose, and (iii) EDTA added (with no pH limitation at all).

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4. Combination A — Claim 1

Berger '333 (Ex. 13) + Anzemet®/dolasetron label + Kytril®/granisetron & Zofran®/ondansetron labels + Handbook of Pharmaceutical Excipients + Lachman/Modern Pharmaceutics

Motivation to combine, element by element:

1. Starting point / "why palonosetron at all." Berger '333 discloses palonosetron as an IV antiemetic. A POSA developing an improved injectable palonosetron product begins with the only palonosetron IV formulation in the art. KSR step one is satisfied by the identity of the drug and dosage form alone.

2. Mannitol for dextrose (tonicity agent substitution). This is the paradigm KSR "substitution of one known element for another to obtain a predictable result":

   • The Handbook of Pharmaceutical Excipients (3d ed. 2000) lists mannitol's functional category expressly as "tonicity agent."
   • The Anzemet® (dolasetron) PDR entry shows a setron injection already using mannitol for isotonicity — a same-class, same-dosage-form precedent.
   • US 2,836,541 (a family cite) discloses a mannitol-stabilized injectable composition, so mannitol was not selected as a mere sweetener but as a known stabilizing/tonicifying agent (the '942 specification itself concedes this: mannitol at 41.5 mg/mL is "acting simply as a tonicifying agent," in contrast to >100 mg/mL sweetener usage).
   • Modern Pharmaceutics (1990) at 514–515 teaches that injectables require a tonicity-adjusting agent and that the choice among recognized isotonic agents (dextrose, NaCl, mannitol) is a routine design decision.
   • Predictable result: the POSA expects an isotonic solution and expects no adverse drug–excipient interaction (Akers 2002 teaches how to screen for such interactions). Nothing in the art taught that mannitol was incompatible with a setron.

3. pH 3.7 → 4.0–6.0. Adjusting solution pH to the region of maximum drug stability is ordinary preformulation work (Lachman; Modern Pharmaceutics; Akers 2002). The class evidence is direct: ondansetron injection is citrate-buffered at pH 3.3–4.0 (Trissel; ASHP monograph) and granisetron injection is a citrate-buffered, mildly acidic solution (Kytril PDR entry; US 6,294,548 / US 2001/0020029). Berger '333's own use of citric acid monohydrate + NaOH shows a citrate buffer system, and merely extending that system up to pH 4.0–6.0 by adjusting the acid/base ratio is routine (Barton's citrate-buffer-calculation reference). Nothing taught away from pH 4–6 with palonosetron.

4. Concentration → 0.05 mg/mL. This is the weakest link in the prima facie case and the one the district court squarely rejected for the sibling patents. The route the petitioner used (per the PGR record) is: Berger '333's 10–100 mg/mL is a broad genus; the art (Eglen 1995 and Tang 1998, relied on in PGR2016-00007) disclosed or suggested that palonosetron is an order of magnitude more potent than other setrons, so a much lower concentration suffices; and the '333 range itself overlaps the low end. I note explicitly: Tang 1998 and Eglen 1995 do not appear in the portion of the page's NPL list that loaded for me, so their status as cited art on this patent's face is unverified; they are established as DRL's asserted art against this patent number.

Sub-conclusion (claim 1). A facially strong KSR case: each added element (mannitol, pH 4–6) is a known excipient/parameter used for its known purpose with a predictable result, and the concentration limitation is argued as optimization over a disclosed range. Predicted outcome if litigated on this record: claim 1 presents a better-than-even prima facie case, but it collides with the district court's finding that 0.05 mg/mL was not an obvious selection.

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5. Combination B — Claim 12 (EDTA)

Berger '333 (Ex. 13) + Won et al. 1995 + Lachman (Table 22‑2) / Avis / Handbook of Pharmaceutical Excipients + US 6,284,749 + US 5,866,154 / US 6,132,758 + mannitol references of Combination A

Motivation:

• Won 1995 is the keystone. It reports photolytic and oxidative degradation of a structurally related antiemetic (RG12915) and teaches that a chelating agent (EDTA) stabilizes it. Palonosetron is an amine-containing (azabicyclo-octyl, tertiary amine) polycyclic lactam, and a POSA would recognize the same metal-catalyzed oxidation liability. The citation is on the page; the characterization of it is from DRL's expert declaration. This is a textbook KSR "known technique to address a known problem" combination (In re Kao, 639 F.3d 1057).
• Concentration 0.3–0.7 mg/mL (claim 8/12) and 0.5 mg/mL (claim 9/18). Lachman's Table 22‑2 teaches EDTA at 0.01–0.075% ≈ 0.1–0.75 mg/mL, which overlaps the claimed 0.3–0.7 range; In re Peterson makes an overlapping range prima facie obvious. 0.5 mg/mL sits squarely inside with no asserted criticality in the specification beyond "most optimally."
• Alcon US 6,284,749 and Schering US 6,132,758 (and, as a family cite, naloxone '154) confirm that EDTA/chelators were a familiar tool for stabilizing aqueous drug solutions by the early 2000s.
• Claim 12's own breadth helps the challenger. Claim 12 recites no pH limitation and no stability limitation. Once the pH/acidic-buffer element drops out, the claim reduces to: palonosetron 0.05 mg/mL + mannitol 10–80 mg/mL + EDTA 0.3–0.7 mg/mL. That is closer to "an IV solution of a known drug with three standard excipients in conventional amounts," which is exactly the fact pattern KSR condemns.

Sub-conclusion (claim 12). The EDTA addition is the most classically obvious of the challenged elements, and claim 12's lack of a pH limitation strips it of the one parameter (pH optimization at 5.0) the patentee emphasized as critical.

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6. Dependent claims — optimization within the art

These are all In re Peterson-style range optimizations plus express "optionally comprises"-type language carried from the specification; they rise or fall with independent claims 1 and 12.

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7. Alternative combinations (belt-and-suspenders)

1. US 6,294,548 / US 2001/0020029 (granisetron multidose vial) as primary reference + US 5,202,333 for palonosetron identity + Handbook + Won 1995. Where a POSA has an injectable setron platform (Roche's granisetron vials) and the '333 patent supplies palonosetron, the combination yields the claimed formulation by substituting the active and adding mannitol/EDTA.
2. Commercial-label cluster (Zofran, Kytril, Anzemet PDR entries + Trissel) + US 5,202,333. The three marketed IV setrons collectively disclose every non-active element: citrate buffer at acidic pH, isotonic NaCl/dextrose, mannitol (dolasetron), and, in the oral/IV liquid setrons, preservative/chelator systems. This is the combination DRL's expert advanced ("the person of ordinary skill would have used an optimized pH (e.g., pH 5), a suitable tonicifying agent (e.g., mannitol) and an effective chelating agent (e.g., EDTA)").
3. Terminal-sterilization references (US 5,439,643; US 5,597,530; JP S57-206447) support the "sterile" element as conventional and defeat any argument that aseptic processing was a barrier.

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8. The counter-case: why the claims may nonetheless survive

I would be delinquent not to weight the actual adjudicative record, which cuts strongly against the prima facie case:

1. The closest art was known to fail. Berger '333 Example 13 is described in the '942 specification as having "a shelf stability of less than the 1–2 year time period required." A reference teaching a non-stable formulation gives at most a starting point, and where the prior art discloses "a broad range [that] does not teach which members would work," post-KSR the Federal Circuit still permits non-obviousness findings. But note the double edge: KSR teaches that a defective prior-art formulation supplies the motivation to improve it, so this argument is weaker here than the patentee's briefs suggest.

2. Judicial findings of non-obviousness. In Helsinn v. Dr. Reddy's Labs., Civ. No. 11‑3962 (D.N.J. Nov. 13, 2015), the court found the POSA would not have selected palonosetron, would not have selected the 0.25 mg dose, and that the 0.05 mg/mL concentration would not have been arrived at by "routine experimentation" — and credited commercial success, industry skepticism, and long-felt need. Those findings were made on the sibling '724/'725/'424/'219 patents. Caveat: the '942 patent was not among the four patents tried; it issued in Nov. 2015 from a 2013 continuation, and its independent claims differ (notably, no "reducing the likelihood of CINV" limitation and no 24-month-stability limitation on claims 1–19).

3. Claim scope cuts both ways. Because claims 1 and 12 omit the 24‑month-stability and unit-dose/administration limitations of the '219 patent, (a) they are arguably broader and thus more exposed to §103, but also (b) the patentee's strongest secondary-consideration evidence (unexpected 24‑month stability, commercial success of the 0.25 mg/5 mL product) has a weaker nexus to these particular claims. A challenger should press this commensurate-scope point; a patentee should press that the commercial product nonetheless falls within claim 1.

4. The unexpected-result bulwark. The '942 specification reports two results that a POSA would not have predicted:

   • Stability increases as palonosetron concentration decreases (Example 2: "greatest stability seen at the lowest palonosetron concentrations") — counterintuitive, since low-concentration injectables typically suffer adsorption/degradation losses;
   • Mannitol outperformed sodium chloride in side-by-side citrate-buffer formulations (Example 3), whereas the closest art (Berger '333) used dextrose. If those results are (i) unexpected, (ii) attributable to the claimed combination, and (iii) supported by data predating the priority date, they rebut the totality of the prima facie case under In re Soni, 54 F.3d 746 (Fed. Cir. 1995). Whether the data predate Jan. 30, 2003 is a factual question the PGR record would resolve.

5. PTAB. DRL's PGR2016-00007 and PGR2016-00008 were both denied institution on Aug. 17, 2016 under §324(a) — the Board did not find it "more likely than not" that any of claims 1–19 (or claims 1–6, 10, 11) were unpatentable. That is a non-institution, not a merits win, and carries limited stare-decisis effect, but it is the most directly on-point administrative signal available for this patent number. (I could not retrieve the full merits text of the two decisions within this session; the denial date and posture are confirmed by docket reporting.)

6. §102 overlay relevant to a §103 opinion. The Federal Circuit held the sibling claims invalid under the on-sale bar in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 855 F.3d 1356 (2017) (aff'd on that ground by the Supreme Court, 586 U.S. ___ (2019)). Because the '942 patent descends from the same priority chain and the same pre-critical-date Helsinn–MGI agreements, a §102(a)(1)/(b) challenge may be the strongest attack on this patent family — a point worth flagging in any validity opinion, though outside this §103 task.

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9. Bottom line

Most persuasive single combination to plead: US 5,202,333 Example 13 in view of the Anzemet® (dolasetron) labeling and the Handbook of Pharmaceutical Excipients, further in view of Won et al. (1995) and Lachman et al. (1986) — with the ondansetron/granisetron labels (via Trissel and the Kytril PDR entry) supplying the citrate-buffered acidic-pH teaching. That combination supplies every claimed element except the specific low concentration, and addresses the concentration through the potency evidence (Eglen 1995 / Tang 1998) that DRL actually deployed.

Honest reservations. (a) I could not read the full text of US 5,202,333 Example 13 or the 2001 PDR pages directly; the pH 3.7 value and the Anzemet-mannitol point rest on the patentee's and DRL's mutual characterizations in the record, which I regard as reliable but not independently re-verified here. (b) The page's 429-entry NPL list was truncated in transmission, so I cannot certify that Eglen 1995 / Tang 1998 appear on the face of the '942 patent; they are established as art against this patent number through PGR2016-00007. (c) Given Helsinn v. Teva and the PGR denials, an opinion asserting that claims 1 and 12 are clearly obvious would be overconfident — the defensible statement is that there is a legally sufficient prima facie case under KSR, but the secondary-consideration and 0.05 mg/mL-selection evidence is substantial enough that the outcome would turn on the strength of the unexpected-results data and its nexus to these broader claims.