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.

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.

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."

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.

Prosecution and Litigation Activity (as of the search date)

• PTAB — [Dr. Reddy's Laboratories, Ltd.](/litigations/by-defendant/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.

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 litigation involving US Patent 9,173,942. Let me run several targeted searches.

I have strong leads. Let me dig into the specific district court cases involving this patent.

Let me search for the specific district court cases that asserted the '942 patent.

Litigation Involving U.S. Patent No. 9,173,942

Preliminary note on scope

U.S. Patent 9,173,942 ("the '942 patent," Liquid pharmaceutical formulations of palonosetron) issued November 3, 2015, to Helsinn Healthcare S.A. / Roche Palo Alto LLC (Roche later assigned its interest to Helsinn), and is listed in the Orange Book for Aloxi® (palonosetron HCl injection, NDA 021372). Because it issued in late 2015, it was not part of the earlier 2011–2015 Helsinn/Roche v. Teva, DRL, Sandoz cases (those asserted the '724, '725, '424, '219, '094 and '980 patents). The '942 patent was asserted in a later wave of cases. Below is what I could confirm, with explicit flags where I could not verify.

Also note: the '942 patent expired January 30, 2024 (anticipated expiration), with pediatric exclusivity running to July 30, 2024. Its status on Google Patents is "Expired – Lifetime."

1. District Court litigation

Helsinn Healthcare S.A. (and Roche Palo Alto LLC) v. [Dr. Reddy's Laboratories, Ltd.](/litigations/by-defendant/Dr.%20Reddy's%20Laboratories%2C%20Ltd.) and Dr. Reddy's Laboratories, Inc.

• Plaintiff(s): Helsinn Healthcare S.A. (with Roche Palo Alto LLC as co-plaintiff at the time)
• Defendant(s): Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. (collectively, "DRL")
• Jurisdiction: U.S. District Court for the District of New Jersey (D.N.J.)
• Case number: Civil Action No. 15-8662 (listed in the PTAB decisions; the Google Patents family-litigation listing shows a D.N.J. case 3:15-cv-08662)
• Filing date: December 15, 2015
• Outcome/status: This is the case the PTAB expressly identified as the district-court assertion of the '942 patent. It arose from DRL's 505(b)(2) NDA No. 203050 for generic palonosetron injection. DRL and Helsinn had previously settled the earlier ANDA litigation (stipulated dismissal entered Oct. 16, 2015 in Civ. A. No. 11-3962, with DRL enjoined from launching except as permitted by the settlement, allowing launch on Sept. 30, 2018 or earlier under certain circumstances). I could not independently confirm the final disposition of the 15-8662 '942-specific case from the sources retrieved; the source I confirmed only establishes its filing and that it was the '942 assertion.

Source: PTAB Decisions Denying Institution, PGR2016-00007 and PGR2016-00008, both entered Aug. 17, 2016 ("The '942 patent has been asserted against Petitioner in Helsinn Healthcare S.A. v. Dr. Reddy's Labs., Ltd., Civil Action No. 15-8662 (D.N.J.), filed December 15, 2015.") — e.g., https://www.docketalarm.com/cases/PTAB/PGR2016-00007/ and the PGR2016-00008 decision PDF.

Other D.N.J. / E.D. Pa. cases listed on the '942 patent family page

Google Patents' "Family has litigation" section for this patent number lists the following, but does not identify which specific patent in the family each case asserted — so I cannot confirm the '942 patent itself was asserted in each:

• D.N.J. case 3:15-cv-08663
• D.N.J. case 2:15-cv-02077 (this docket is associated with patent 6,294,548 and appears to be Helsinn v. Teva, filed 2015-03-23 — likely not a '942 case)
• D.N.J. case 3:15-cv-08132
• D.N.J. case 2:15-cv-08663
• E.D. Pa. case 2:15-cv-06392 (U.S. District Court for the Eastern District of Pennsylvania)
• D.N.J. case 3:15-cv-08662

I could not retrieve party names, exact filing dates, or dispositions for these docket numbers within the search limits, and I will not guess. Source: https://patents.google.com/patent/[US9173942](/patent/US9173942)/en (litigation section).

2. PTAB proceedings (administrative, not district-court litigation)

Two post-grant reviews were filed by DRL against the '942 patent. Although the user asked about "litigation," these are the only other adversarial proceedings I confirmed that are captioned to Patent No. 9,173,942 and should be noted:

• PGR2016-00007 — Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. v. Helsinn Healthcare S.A., challenging claims 1–6, 10, and 11 of the '942 patent.

  • Filed: February 5, 2016
  • Outcome: Institution denied August 17, 2016 (Board found DRL failed to show it was more likely than not that at least one claim is unpatentable)
  • Sources: https://ipverse.greyb.com/ptab-web/cases/case-details/PGR2016-00007 ; docketalarm PGR2016-00007 decision PDF

• PGR2016-00008 — Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. v. Helsinn Healthcare S.A., challenging claims 1–19 of the '942 patent.

  • Filed: February 5, 2016
  • Outcome: Institution denied August 17, 2016
  • Source: docketalarm PGR2016-00008 decision PDF

Both petitions also raised an on-sale-bar challenge based on the 2001 Helsinn/MGI Pharma supply and license agreements.

3. Related to the same drug but NOT involving the '942 patent (to avoid confusion)

The following well-known Helsinn/Roche matters concern other palonosetron patents and should not be attributed to the '942 patent:

• Helsinn Healthcare S.A. v. Dr. Reddy's Labs., Ltd., No. 11-3962 (D.N.J.) (consolidated with 11-5579 and 13-5815) and No. 12-2867 (D.N.J.) — asserted the '724, '725, '424, '219, '094, '980 patents.
• Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., Fed. Cir. No. 16-1284 (appeal), and the related Supreme Court on-sale-bar case — involving the '724/'725/'424/'219 patents.
• The many 2015–2016 ANDA actions against Hospira, Sagent, Aurobindo, Cipla, Mylan, Exela, etc. — asserted other Orange Book patents.

Caveats / limitations

• I was not able to query PACER or the Unified Patents litigation portal directly in this session; the Unified Patents links on the Google Patents page (e.g., the D.N.J. and E.D. Pa. case URLs and the two PGR URLs) confirm that those dockets exist but did not themselves yield party-level detail in the retrieved results.
• For the docket numbers in Section 1's second group, I have docket numbers but no confirmed party names, filing dates, or outcomes, so I have not supplied them.
• The patient/product-level outcome (e.g., settlement terms, entry dates) I cite (Sept. 30, 2018 launch option) comes from the earlier ANDA settlement in 11-3962, not specifically from a '942-patent judgment.
• If you need court-verified dispositions (e.g., a final judgment or dismissal order specifically in 15-8662/3:15-cv-08662), that would require pulling the docket from PACER/CourtListener, which I could not complete here.

Bottom line: The only district-court case I can confirm specifically asserted the '942 patent is Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories, Ltd., No. 15-8662 (D.N.J.), filed December 15, 2015; the '942 patent was also the subject of two DRL post-grant reviews (PGR2016-00007 and -00008), both of which were denied institution on August 17, 2016. Additional D.N.J./E.D. Pa. dockets for this patent family are listed on Google Patents, but I could not verify they specifically assert the '942 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.

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.

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"

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)

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.

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 using the USPTO Assignment Center and cross-referencing sources.

Let me search for the specific assignment records and reel/frame data.

I found key assignment references. Let me dig deeper into the specific reel/frame numbers and correspondents.

Assignment & Ownership Analysis — US 9,173,942 (Liquid pharmaceutical formulations of palonosetron)

Source note / limitation: The USPTO Assignment Center interface is a JavaScript application and could not be scraped by the tools available in this session; the USPTO PatentCenter and PACER portals were likewise not directly accessible. The reconstruction below is built from (a) the authoritative full patent text supplied, (b) the Google Patents "reassignment" event list for US 9,173,942, (c) the terminal disclaimer filed in application 13/901,830 (which recites specific recorded reel/frame citations for the family), and (d) federal court filings that recite the Roche→Helsinn transfer. Where a reel/frame could not be confirmed, I say so rather than supplying a placeholder. Every reel/frame number below is quoted from a primary document, not inferred.

Inventors

⚠️ Discrepancy to flag: The Google Patents bibliographic block for the '942 lists seven inventors — it omits Carmine Panuccio. However, Panuccio appears (i) as a named inventor on the sibling patents in the same family (e.g., the face of the '094/'424 patents as reproduced in the D.N.J. claim-construction record) and (ii) as an assignor in the 2018-11-14 recorded assignment to Helsinn Healthcare SA. The previously-generated summary's 7-inventor list therefore mirrors an incomplete Google Patents field; the operative inventorship entity count appears to be eight. This should be reconciled against the official USPTO record.

Unusual pattern — title-cleanup, not attrition: The inventors did not leave the assignees within 12 months. To the contrary: the inventor→assignee assignments for the '942 chain were recorded on 2018-11-14 — roughly fifteen years after the 2003 priority date and three years after issue — and they split cleanly along employer lines (Helsinn inventors → Helsinn Healthcare SA; Roche inventors → Roche Palo Alto LLC). That is the signature of a retroactive recordation/confirmatory assignment campaign tied to the 2018 internal Helsinn co-ownership reorganization, not of an inventor exodus preceding a sale.

Also noted (possible family-relationship tell, not a finding of wrongdoing): the related '094/'424 front pages list Simone Macciocchi and Giulio Macciocchi as additional applicants (not inventors) — apparently related to Alberto Macciocchi. This may explain why the Macciocchi family interest is bundled into the 2018 confirmatory recordation group.

Original assignee

Named assignees on the issued '942 patent: Helsinn Healthcare SA (Pambio-Noranco / Lugano, CH) and Roche Palo Alto LLC (Palo Alto, CA, US). Prosecution was conducted jointly — the terminal disclaimer in 13/901,830 states both entities "represent that they are the owners of 100% of the instant application."

Products shipped: Yes — Aloxi® (palonosetron HCl injection), NDA 021372, FDA-approved July 25, 2003. The '942 claims read directly onto the commercial Aloxi vial (0.05 mg/mL palonosetron, 41.5 mg/mL mannitol, 0.5 mg/mL EDTA, pH 5.0 ± 0.5, 0.25 mg/5 mL). The '942 is listed in the Orange Book against NDA 021372.

Primary line of business:

• Helsinn Healthcare SA — family-owned, family-run Swiss pharmaceutical group (founder Gabriele Braglia; sons Enrico and Riccardo Braglia). Business model is in-licensing/completion of development plus partnering for distribution (it in-licensed palonosetron from Roche/Syntex in 1998 for ~$10M plus royalties). It holds its own U.S. sales/marketing through affiliates including Helsinn Birex Pharmaceuticals Ltd. (Ireland manufacturing), Helsinn Advanced Synthesis SA (Swiss API plant), and Helsinn Therapeutics (U.S.), Inc.
• Roche Palo Alto LLC — U.S. subsidiary of the publicly traded Roche group (F. Hoffmann-La Roche). Roche had terminated palonosetron development after Phase II and licensed it out; its residual co-ownership was extinguished in 2016.

Current status: Helsinn group is operating (no bankruptcy; co-ownership reorganized 2018; a 2022 security interest was released in 2023). Roche is operating/acquisitive; Roche Palo Alto LLC's interest in the '942 was conveyed out in 2016.

Assignment timeline

Reel/frame legend: entries marked [RF confirmed] carry a reel/frame recited in a primary document; entries marked [RF not retrieved] are confirmed ownership events whose reel/frame I could not verify with the tools available.

2004-01-30 — PCT/EP2004/000888 filed; applicants Helsinn Healthcare SA and Roche Palo Alto LLC.
(No reel/frame; this is the priority filing, not an assignment.)

2003-05-23 [recorded] — Reel 030478 / Frame 0960 and Reel 030479 / Frame 0001 [RF confirmed]

• Conveyance: Assignment (inventor → assignee); recited in the '830 terminal disclaimer as the title basis for parent U.S.S.N. 13/901,437.
• Assignor / Assignee: as recited, establishing Helsinn Healthcare SA and Roche Palo Alto LLC as 100% owners.
• Correspondent: not retrieved.
• Context: original title recordation for the family; the '942 (filed one day later, 2013-05-24) inherited this chain as a continuation.

2013-05-24 — Application 13/901,830 filed (continuation of 13/901,437); published 2013-10-03 as US 2013/0261149 A1.

2015-11-03 — Patent issues as US 9,173,942 B2.

2016-05-02 (executed) / 2016-05-11 (recorded) — Reel/Frame not retrieved

• Conveyance: Assignment (Google Patents records it as "ASSIGNMENT OF ASSIGNORS INTEREST").
• Assignor: Roche Palo Alto LLC → Assignee: Helsinn Healthcare SA.
• Corroboration: the D.N.J. stipulation of dismissal (Civil Action 15-8663) states that "on or around May 2, 2016, Plaintiff Roche assigned to Helsinn all rights, title and interest in and to U.S. Patent No. 9,173,942 … including the right to control this litigation."
• Correspondent: not retrieved.
• Context: post-filing consolidation of standing — Roche exited the pending Hatch-Waxman litigation and was dismissed as a party on 2016-07-05.

2018-11-14 (recorded) — Reel/Frame not retrieved

• Conveyance: Assignment (confirmatory/recordation of inventor→assignee).
• Assignors: MACCIOCCHI, ALBERTO; BONADEO, DANIELE; CALDERARI, GIORGIO; CANNELLA, ROBERTA; PANUCCIO, CARMINE → Assignee: Helsinn Healthcare SA.
• Context: internal/confirmatory title cleanup (Helsinn-employed inventors).

2018-11-14 (recorded) — Reel/Frame not retrieved

• Conveyance: Assignment (confirmatory/recordation of inventor→assignee).
• Assignors: MALEFYT, THOMAS; MIKSZTAL, ANDREW; LEE, KATHLEEN M → Assignee: Roche Palo Alto LLC.
• Context: internal/confirmatory title cleanup (Roche-employed inventors). Note the two-year lag behind the 2016 Roche→Helsinn transfer, i.e., the Roche inventor paperwork was recorded after Roche had already divested.

2018-11-14 (recorded) — Reel 047534 / Frame 0024 [RF confirmed]

• Conveyance: Patent Co-Ownership Agreement.
• Assignor: Helsinn Healthcare SA → Assignees: Helsinn Advanced Synthesis SA; Helsinn Therapeutics (U.S.), Inc.; Helsinn Birex Pharmaceuticals Ltd. (rendered "PHARMACEUTIALS" in the original record).
• Correspondent: not retrieved (this is the entry where the correspondent would be most informative — see below).
• Context: internal corporate reorganization within the Helsinn family of operating companies.

2018-11-21 (recorded) — Reel/Frame not retrieved (corrects Reel 047534 / Frame 0024)

• Conveyance: Corrective Assignment — "to correct the 1. spelling of assignee name HELSINN BIREX PHARMACEUTICALS LTD.; 2. addresses of assignees."
• Assignor: Helsinn Healthcare SA → Assignees: Helsinn Birex Pharmaceuticals, Ltd.; Helsinn Therapeutics (U.S.), Inc.; Helsinn Advanced Synthesis SA.
• Context: administrative correction of the 2018-11-14 co-ownership record.

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

• Conveyance: Security Interest (grant of security).
• Assignors: Helsinn Birex Pharmaceuticals Limited; Helsinn Healthcare SA; Helsinn Therapeutics (U.S.), Inc. → Secured party: Hamilton SA LLC.
• Context: securitization / collateral financing — a security interest, not a title transfer. No operating product or NPE relationship to the asserted claims.

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

• Conveyance: Release by Secured Party.
• Assignor: Hamilton SA LLC → Released grantors: Helsinn Healthcare SA; Helsinn Birex Pharmaceuticals Limited; Helsinn Therapeutics (U.S.), Inc.
• Context: satisfaction / release of the 2022 security interest — the encumbrance was extinguished; title remained with the Helsinn family throughout.

Timeline diagram

timeline
    title Ownership of US 9173942
    2004 : PCT filed by Helsinn and Roche
    2013 : US application 13 or 901830 filed
    2015 : Patent issues as US 9173942
    2016 : Roche assigns its interest to Helsinn
    2018 : Inventor assignments recorded
         : Co ownership pact with Helsinn units
         : Corrective assignment recorded
    2022 : Security interest to Hamilton SA LLC
    2023 : Release by secured party

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. Every assignee in the chain is an operating Helsinn pharmaceutical entity (Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals Ltd., Helsinn Therapeutics (U.S.), Inc.). None carries an "IP / Patents / Licensing / Holdings / Ventures" suffix; none is a single-purpose Delaware/Texas licensing LLC. The 2018 transfer (Reel 047534/0024) is expressly a "Patent Co-Ownership Agreement" among affiliates of one family-owned group, not a transfer to a detached licensing vehicle.

2. Known asserter in the chain — NOT PRESENT. No assignee matches any public NPE roster (Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN, Converso/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities). The only third party named in the record — Hamilton SA LLC — appears solely as a secured lender in a 2022-12-30 security interest released on 2023-09-20, i.e., a collateral position, not ownership, and it does not appear on Unified/RPX high-frequency-plaintiff directories I can access.

3. Repeat correspondent across the chain — UNCLEAR / NOT RETRIEVABLE. I could not obtain the correspondent-of-record for any of the recorded assignments from the sources available in this session. This is the single most probative field for the "one lawyer behind multiple shells" pattern, and here the honest answer is that the field is blank in my data. Two structural observations substitute for it: (a) the two 2013-05-23 recordations (Reel 030478/0960 and 030479/0001) and the 2018 co-ownership record (Reel 047534/0024) form a small, tightly clustered set typical of a single house counsel/prosecution firm handling all filings for one family, and (b) litigation counsel of record was Paul Hastings LLP (per the D.N.J. 11-3962 declaration of counsel) — but litigation counsel is not the assignment correspondent, and I will not treat it as one.

4. Cascading transfers — PRESENT, but benign on these facts. Four recorded events land on/around 2018-11-14–2018-11-21 (two inventor confirmatory assignments + the co-ownership agreement + the corrective assignment), and a two-step security-interest pair follows in 2022–2023. Read in isolation the 2018 cluster looks like rapid churn; read with the underlying documents it is a single corporate reorganization plus its clerical correction among entities sharing the Helsinn corporate family — not transfers through unrelated chained LLCs, and the assignees do not share a registered-agent address in the record. Signal present as a pattern, neutral as an indicator.

5. Pre-litigation transfer — NOT PRESENT (sequence is the inverse). The '942 was first asserted in Helsinn v. Dr. Reddy's, D.N.J. 15-8662/15-8663, filed 2015-12-15, and Roche's assignment to Helsinn was executed ~2016-05-02 — approximately four to five months after the suit was filed, expressly to consolidate control of the litigation so Roche could be dismissed (stipulated 2016-07-05). There is no assignment within six months before the filing. This is a post-filing standing cleanup, not pre-suit venue/standing engineering.

6. Bankruptcy fire-sale — NOT PRESENT. No Chapter 7/11 of any Helsinn or Roche entity appears in the record. The 2022 security interest (Hamilton SA LLC) was released in full in 2023, indicating the financing performed rather than defaulted.

7. Privateering — NOT PRESENT. The transfers run toward consolidation, not away from an operating company toward an asserting NPE. Helsinn is itself the operating company that commercializes Aloxi® and that directly sues ANDA filers under 35 U.S.C. § 271(e)(2)(A). Roche's exit was an unwinding of a 1998 in-license co-ownership, not the launching of an assertion proxy.

8. Defensive aggregator — NOT PRESENT. The chain does not terminate at RPX, AST, LOT, Unified, or OIN. It terminates in the Helsinn family, which actively asserted the patent (and lost the on-sale-bar fight on the sibling '219 claim, Helsinn v. Teva, 855 F.3d 1356 (Fed. Cir. 2017), aff'd 139 S. Ct. 628 (2019)).

Verdict

Operating-company assertion.

The ownership chain never leaves the Helsinn family of pharmaceutical operating companies: it runs from joint inventors (Helsinn + Roche employees) → Helsinn Healthcare SA / Roche Palo Alto LLC, through Roche's 2016-05-02 assignment of its interest to Helsinn (recorded 2016-05-11, per the D.N.J. 15-8663 stipulation), through the internal Reel 047534/0024 co-ownership agreement with Helsinn Advanced Synthesis SA, Helsinn Therapeutics (U.S.) Inc., and Helsinn Birex Pharmaceuticals Ltd., to a 2022 security interest whose sole third party (Hamilton SA LLC) is a secured lender released in 2023. There is no shell LLC, no known NPE/asserter, no pre-suit transfer, no bankruptcy, and no defensive aggregator — only internal reorganizations and one financing encumbrance. Helsinn itself ships the claimed product (Aloxi®, NDA 021372) and asserts the patent directly against generic competitors, which is the textbook operating-company posture.

Verification link: https://assignmentcenter.uspto.gov/ (search "9173942"); the same records are indexed at https://assignment.uspto.gov/patent/index.html.

Residual gaps to close on direct USPTO access: (i) the exact reel/frame for the 2016-05-11 Roche→Helsinn assignment, the 2018-11-14 inventor assignments, the 2018-11-21 corrective assignment, and the 2022/2023 Hamilton SA LLC security-interest pair; and (ii) the correspondent-of-record on each — the one field that would definitively rule the "repeat correspondent" signal in or out. Both were unavailable in this session and neither can be inferred from the naming evidence. The one confirmed post-2016 reel/frame, 047534/0024, is the internal co-ownership agreement — which itself argues against an NPE reading.

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).

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.

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.

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.

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.

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.

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.

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.)

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).

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.

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.

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.

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.

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.

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.