US 10980795

I'll search for authoritative information on this patent number, including any 2026 CAFC docket activity.

Let me dig further into claim text and 2026 litigation/appeal activity.

Let me verify the full claim set and check for any 2026 Federal Circuit activity specific to this patent.

US Patent 10,980,795 (US10980795B2) — Analyst Summary

Sources: the authoritative patent text you supplied (Google Patents fetch of https://patents.google.com/patent/[US10980795](/patent/US10980795)/en), plus targeted searches of USPTO materials (PTAB/PTACTS filings), DrugPatentWatch, and NJ District Court pleadings. Note that the Google Patents text you provided was truncated before the claims section, so claim language below is taken from DrugPatentWatch's claims listing; I flag uncertainty accordingly.

1. Bibliographic Data (from the authoritative text)

Continuity (from the patent's Cross-Reference section): This application is a continuation of 15/652,513 (Jul 18, 2017) → continuation of 15/341,377 (Nov 2, 2016) → continuation of 14/851,111 (Sep 11, 2015, now US 9,492,442) → continuation of 14/406,776 (Dec 10, 2014, now US 9,452,162) → §371 national phase of PCT/US2013/045495 (Jun 12, 2013) → provisionals 61/659,211 and 61/784,382.

2. Abstract (verbatim)

"Provided are methods for treating pancreatic cancer in a patient by administering liposomal irinotecan (MM-398) alone or in combination with additional therapeutic agents. In one embodiment, the liposomal irinotecan (MM-398) is co-administered with 5-fluorouracil and leucovorin."

3. Independent Claim — Plain-Language Overview

⚠️ Uncertainty flag: The claims section was not present in the authoritative text supplied. The claim set below is from DrugPatentWatch's "Patent Claims" listing for 10,980,795 (https://www.drugpatentwatch.com/p/patent-claims/10980795), which lists only two claims. I could not independently corroborate the complete claim set against a USPTO claim listing within this session, so treat the claim text as high-confidence-but-not-fully-verified.

Claim 1 (the sole independent claim): A method of treating metastatic adenocarcinoma of the pancreas in a human patient who has previously been treated with gemcitabine. The method involves intravenously administering an antineoplastic therapy once every two weeks (a q2w schedule), where the therapy "consists of" exactly three components:

1. Irinotecan sucrose octasulfate salt liposome injection (i.e., the liposomal irinotecan product MM-398/nal-IRI) at a dose providing the equivalent of 70 mg/m² of irinotecan free base;
2. Leucovorin at 200 mg/m² of the (l) form or 400 mg/m² of the (l+d) racemic form; and
3. 5-fluorouracil (5-FU) at 2400 mg/m².

Plain-language reading: This is a narrow, closed ("consisting of") second-line dosing-regimen claim. It is tied to a specific patient population (gemcitabine-pretreated metastatic pancreatic adenocarcinoma), a specific dosing interval (every 2 weeks), and specific doses of each of the three agents. Notably, the claim recites a 70 mg/m² free-base-equivalent liposomal irinotecan dose, which is lower than the 80 mg/m² liposomal-irinotecan dosing described in the specification's q2w combination protocol — consistent with a salt/free-base conversion rather than a different numerical regimen. (I note this as an observation; the patent text I have does not expressly spell out an 80 mg/m² salt = 70 mg/m² free-base equivalence for this claim.)

Claim 2 (dependent): The method of claim 1, wherein the metastatic adenocarcinoma of the pancreas has progressed after treatment with gemcitabine (i.e., limiting the population to gemcitabine-progressors, as opposed to merely gemcitabine-pretreated patients).

4. Litigation and Post-Grant Activity

District court (New Jersey):

• Ipsen Biopharm Ltd. v. Conjupro Biotherapeutics, Inc. / CSPC — Civil Action No. 3:24-cv-04991 (RMB)(MJS), filed April 15, 2024, in the District of New Jersey (matching the "New Jersey District Court case 3:24-cv-04991" litigation link on the Google Patents page). The complaint asserted infringement of the '795 patent together with U.S. Patents 8,329,213; 9,339,497; 9,364,473; 9,452,162; 9,492,442; 9,717,724; and 11,369,597, based on Conjupro's Paragraph IV certification regarding its irinotecan NDA No. 218923 (per the counterclaim pleadings at paragraphfour.com).
• Two later suits were consolidated into it: 24-8723 (Aug 23, 2024, asserting US 12,059,497) and 25-13647 (Jul 22, 2025, asserting the "'691 patent"), consolidated Oct 18, 2024 and Aug 21, 2025 respectively.

PTAB (2026 activity — note: on a DIFFERENT patent, not the '795):

• IPR2025-00505, CSPC Pharmaceutical Group Ltd., CSPC Ouyi Pharmaceutical Co., Ltd., Conjupro Biotherapeutics, Inc., and Apotex Inc. v. Ipsen Biopharm Ltd., challenging U.S. Patent No. 11,344,552 (claims 1–15). Oral hearing scheduled May 19, 2026 (Ipsen's 37 C.F.R. § 42.70(a) request filed Apr 6, 2026). A related joinder, IPR2025-01531 (same '552 patent), had a motion for joinder granted by Paper 16 entered March 12, 2026.

CAFC 2026 dockets — negative finding: I found no Federal Circuit 2026 appeal docket specifically for 10,980,795. My searches surfaced 2026 CAFC-adjacent activity only for the related Ipsen patent 11,344,552 at the PTAB, and the NJ district court case for the '795. I cannot state that no appeal exists; I simply have not located one, and I am flagging that explicitly rather than inferring.

Orange Book listing: Patent 10,980,795 is listed in the Orange Book in connection with NDA 207793 for ONIVYDE® (irinotecan hydrochloride, liposomal; intravenous; approved Oct 22, 2015), with the patented use described as "TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN" (DrugPatentWatch). This use statement aligns with claim 1's population and combination but not its specific 70 mg/m² free-base dose.

5. Items I Could Not Confirm with High Confidence

1. Complete claim set. Only claims 1–2 appear in the claims source I retrieved. If the patent actually contains additional dependent claims beyond claim 2, my overview is incomplete.
2. No CAFC 2026 docket for '795 — confirmed only as an absence of search results, not as a definitive negative.
3. Whether any IPR petition has been filed against the '795 patent itself. The 2026 IPRs I located are directed to the '552 patent (a later Ipsen patent covering the NALIRIFOX regimen), not to '795.

I'll search litigation databases for US 10,980,795 specifically.

Let me check for other defendants, consolidated cases, ITC actions, and appeal activity.

Let me check the Unified Patents caselist and whether any appeal or additional cases exist.

Litigation Involving U.S. Patent No. 10,980,795 — Search Results

Bottom line: Only one litigation has been identified that asserts U.S. Patent No. 10,980,795 — the Hatch‑Waxman action Ipsen Biopharmaceuticals, Inc. et al. v. Conjupro Biotherapeutics, Inc. et al., pending in the U.S. District Court for the District of New Jersey. No other district court case, ITC action, or Federal Circuit appeal asserting or challenging the '795 patent was located.

Case Summary Table

'795 asserted in Count VII. The complaint pleads infringement of the '795 patent as Count VII (¶¶104–112), alleging that "Conjupro/CSPC's submission of the Conjupro NDA, including the Conjupro PIV Certification, constitutes infringement of the '795 patent under 35 U.S.C. § 271(e)(2)(A)." The complaint does not identify specific asserted claims or provide a claim chart. (Source: RPX Insight litigation document 15650730; Ex Parte complaint analysis.)

Patents asserted alongside the '795 (per the DrugPatentWatch case page): 8,329,213; 9,339,497; 9,364,473; 9,452,162; 9,492,442; 9,717,724; 10,980,795; 11,369,597. Additional Ipsen patents were later added by the consolidated complaints (below).

Consolidated Cases (same parties, same court, judge — asserted different patents, not the '795)

These are "related" matters consolidated into 3:24-cv-04991. The '795 patent is not asserted in them, but they matter because they are the same litigation and bear on scheduling/§ 315(b) analysis.

(Sources: paragraphfour.com Onivyde entry; defendant counterclaim/answer at njdc25cv13647A.pdf and njdc24cv8723A.pdf; DrugPatentWatch case page.)

Counterclaims touching the '795

Conjupro/CSPC's counterclaims (filed in the consolidated action) seek declaratory judgments of non‑infringement and invalidity of the '795 patent, and recite that Conjupro's NDA No. 218923 was submitted with a Paragraph IV certification that, inter alia, the claims of "the '795 patent" (along with the '213, '497, '473, '162, '442, '724, '597, '867, '360, and '914 patents) "are invalid, unenforceable, and/or will not be infringed by Conjupro's NDA product." The notice letter was received by Ipsen at the latest by March 7, 2024. (Source: paragraphfour.com counterclaim.)

Related PTAB Proceedings — NOT against the '795 patent (flag this)

For completeness, and to prevent misattribution: two AIA trials exist in the same Onivyde patent family, but both target U.S. Patent No. 11,344,552 — a different Ipsen patent, not the '795:

• IPR2025-00505 — CSPC Pharmaceutical Group Ltd., CSPC Ouyi Pharmaceutical Co., Ltd., and Conjupro Biotherapeutics, Inc. v. Ipsen Biopharm Ltd. (filed Jan. 2025; instituted; oral argument scheduled May 19, 2026).
• IPR2025-01531 — Apotex Inc. v. Ipsen Biopharm Ltd. (filed Sept. 2025; joinder-track).

No IPR, PGR, or CBM proceeding directed to U.S. Patent No. 10,980,795 was identified. (Sources: paragraphfour.com; PTACTS IPR2025-00505 documents.)

Negative findings (explicitly flagged as "searched, not found")

1. No second/independent district court action anywhere else (no other jurisdiction, no other defendant imaged) asserting the '795 patent was located. Only the D.N.J. Conjupro/CSPC action.
2. No ITC Section 337 investigation involving the '795 patent was located.
3. No Federal Circuit appeal captioned to the '795 patent was located. Note: my prior (earlier-generated) section already reported this as an absence of results rather than a verified negative, and that remains the case here. Caveat: a query for a 2026 Ipsen/CSPC CAFC appeal returned no results because I exhausted my search-step budget before completing that check — this is a research-stop artifact, not a confirmed absence. Verify at the CAFC docket (https://cafc.uscourts.gov) and CourtListener.
4. No outcome, judgment, settlement, stay, or dismissal for 3:24-cv-04991 was located. The case remains pending.

Contradictions / cross-reference flags with prior sections

• Plaintiff caption. The previously generated sections referred to this case as "Ipsen Biopharm Ltd. v. Conjupro Biotherapeutics, Inc. / CSPC." The docket caption is the plural "Ipsen Biopharmaceuticals, Inc. et al. v. Conjupro Biotherapeutics, Inc. et al." — both Ipsen Biopharmaceuticals, Inc. and Ipsen Biopharm Ltd. are plaintiffs, and CSPC Pharmaceutical Group Ltd. and CSPC Ouyi Pharmaceutical Co., Ltd. are co‑defendants. Use the fuller caption.
• Case-number variance. 3:24-cv-04991 (Justia/D.N.J.) vs. 1:24-cv-04991 (DrugPatentWatch, paragraphfour, Ex Parte). Same case; the discrepancy is a database docket-convention difference. Do not auto-correct — cite the source-specific form.
• Filing-date consistency. The previously generated sections stated filing 2024‑04‑15; confirmed by Justia, DrugPatentWatch, paragraphfour, and the defendants' counterclaims.

Sourcing caveat. This list is built from a single search pass and rests on: Justia Dockets, DrugPatentWatch (patent-specific litigation page for 10,980,795, last updated 2026-07-27/08-03), paragraphfour.com's Onivyde litigation entry, RPX Insight, and the defendants' own pleading PDFs. Web search results have been treated as current ground truth where they conflict with prior assumptions. Before relying on this in a filing, confirm the '795 docket's current status directly on PACER (D.N.J. 3:24-cv-04991) and confirm no CAFC appeal is pending, since commercial trackers lag live dockets and PTAB/§ 315(b) events can post-date the ingested data.

I'll start by checking the structured record and then hunting for any AIA trial activity the ODP may not have indexed.

The structured block says no AIA proceedings are indexed. But the web results show Ipsen/Onivyde IPR activity — I need to pin down which patents those target.

Let me pin down whether any AIA trial targets the '795 patent specifically.

Proceedings overview

Total AIA trials against US 10,980,795: 0 — the USPTO Open Data Portal returns no IPR, PGR, or CBM proceeding on this patent (0 active, 0 claims invalidated, 0 claims sustained, 0 settled, 0 institution denials), so the entire claim set of the '795 patent is UNTESTED at the PTAB, which cuts both ways for a defendant: no American Invents Act estoppel (35 U.S.C. § 315(e)(2)) has been generated by anyone on this patent, so the full universe of § 102/§ 103 grounds remains available to a first-filer; but there is also no PTAB precedent, no adverse Board claim construction, and no cancellation to point to, and Ipsen has shown it will litigate the Onivyde family hard (it is currently asserting the '795 patent in D.N.J. and defending sibling patent claims at the Board).

No proceedings to report at claim level

Because the canonical list in the structured "PTAB proceedings on file" block is empty, there is no proceeding number, judge panel, institution decision, final written decision, settlement, or appeal to describe for the '795 patent. I will not manufacture one. The per-proceeding template below is therefore populated only for the two AIA trials that exist in the same Onivyde patent family — on a different patent (U.S. 11,344,552, "the '552 patent") — because they are the materially relevant intelligence for anyone assessing the '795 patent. Do not attribute their outcomes to the '795 patent.

IPR2025-00505 — CSPC Pharmaceutical Group Ltd., CSPC Ouyi Pharmaceutical Co., Ltd., and Conjupro Biotherapeutics, Inc. v. Ipsen Biopharm Ltd. (targets U.S. 11,344,552 — NOT the '795 patent)

• Type: Inter Partes Review
• Filed: 2025-01-17 (Google-published sources 2025-01-17; GreyB lists 2025-01-16)
• Status: Trial instituted; per GreyB's case tracker the proceeding reached Final Written Decision with a termination date of 2026-08-12 (I have not verified the claim-level disposition and will not characterize it).
• Judge panel: Jeffrey N. Fredman, Timothy G. Majors, Zhenyu Yang (per Ex Parte's case page for IPR2025-00505)
• Petition grounds: Obviousness (§ 103) of claims 1-15 of the '552 patent. Ground 1 (claims 1, 3-6, 8-14): Conroy, Conroy Protocol, Conroy Appendix, and Mahaseth in view of Bayever (WO 2013/188586 — the PCT publication of the same 2012-06-13 priority family as the '795 patent), Saif, Ko, and Cantore. Ground 2 (claims 2, 7, 15): same set plus Masi and Ginocchi. Ground 3 (claims 1-15): Carnevale and Dean. Core theory: replace free irinotecan in FOLFIRINOX with liposomal irinotecan and drop oxaliplatin to 60 mg/m².
• Institution decision: Instituted (2025-08-13/14; sources differ by one day). The Director denied Ipsen's request for discretionary denial on 2025-07-16, finding CSPC "provides persuasive evidence that the Office erred in a manner material to the patentability of the challenged claims." Ipsen had argued § 325(d) (same art overcome during prosecution) and that the Conroy Protocol translation was uncertified. Ipsen's discretionary-denial request
• Final Written Decision: Not verified by me. If an FWD issued on/about 2026-08-12, the CAFC appeal clock (63 days from entry of judgment, Rule 4(a)) would be running or run by today, 2026-09-28.
• Settlement / termination: None disclosed; the proceeding appears to have run to judgment.
• Appeal: Not verified. No CAFC docket identified for the '552 IPR.
• Defensive value (for the '795 patent): Indirect only. The art CSPC assembled is a ready-made § 103 scaffold a defendant can reuse, but it is pitched at the '552 patent's first-line NALIRIFOX claims (liposomal irinotecan + oxaliplatin + 5-FU/LV, 60/60 mg/m², 2,400 mg/m² 5-FU). The '795 patent's claim 1 is a second-line, post-gemcitabine, oxaliplatin-free regimen at a different liposomal-irinotecan dose. Mapping CSPC's grounds onto the '795 claims is a nontrivial reconfiguration, not a copy-paste.

IPR2025-01531 — Apotex, Inc. v. Ipsen Biopharm Ltd. (targets U.S. 11,344,552 — NOT the '795 patent)

• Type: Inter Partes Review (filed as a would-be "silent understudy" / joinder petition to IPR2025-00505)
• Filed: 2025-09-12 (Notice of Filing Date Accorded)
• Status: Pending / joinder-track. Petitioner moved for joinder to IPR2025-00505; Ipsen initially opposed, then withdrew its opposition on or about 2025-12-09-16 after Apotex agreed not to seek extra briefing pages, not to depose Ipsen's expert Dr. Oberstein separately, and not to argue at oral hearing. PTACTS correspondence
• Judge panel: Not separately constituted; would ride on the IPR2025-00505 panel.
• Petition grounds: Obviousness of the '552 patent claims; Ground 1 on claims 1, 3-6, 8-14 over Conroy/Conroy Protocol/Conroy Appendix/Mahaseth + Bayever, Saif, Ko, Cantore; Ground 2 on claims 2, 7, 15 (Masi, Ginocchi); Ground 3 on claims 1-15 (Carnevale, Dean). Ipsen's preliminary response attacks Ground 3 (Carnevale/Dean not prior art) and Apotex's uncertified translation. POR
• Institution decision: Not verified.
• Final Written Decision: None.
• Settlement / termination: No settlement; the December 2025 agreement is a litigation-conduct stipulation, not a substantive resolution.
• Appeal: None.
• Defensive value (for the '795 patent): Shows the generic cohort (CSPC/Conjupro, Apotex, and CSPC's licensee Cipla) is coordinating Board attacks rather than each filing serially — a signal that a fresh, well-funded petition against the '795 patent is plausible if anyone still has a § 315(b) window.

Strategic summary

Claim status on the '795 patent: everything is UNTESTED. No claim of U.S. 10,980,795 has been canceled, confirmed, or even construed by the PTAB. Claim 1 (independent) as listed in DrugPatentWatch for the '795 patent is a narrow, label-matching method claim: "A method of treating metastatic adenocarcinoma of the pancreas in a human patient who has previously been treated with gemcitabine, comprising intravenously administering an antineoplastic therapy to the patient once every two weeks, the therapy consisting of i) irinotecan sucrose octasulfate salt liposome injection in a dose providing the equivalent of 70 mg/m² of irinotecan free base, ii) 200 mg/m² of the (l) form of leucovorin or 400 mg/m² of the (l+d) racemic form of leucovorin, and iii) 2400 mg/m² of 5-fluorouracil." (DrugPatentWatch claim listing; note the authoritative Google Patents text supplied to me contains the specification but no claims section, so I have not independently verified the granted claim set.) The "consisting of" language and the 70 mg/m² dose (which matches the Onivyde® label dose of 70 mg/m² IV q2w) make the claim narrow — that is the Patent Owner's defense, and it is also the defendant's non-infringement handle.

Estoppel landscape. No petitioner has taken a final written decision on the '795 patent, so no § 315(e)(2) estoppel exists against anyone on this patent, and the field is wide open: the FOLFIRINOX art Chen et al. reused in the '552 IPRs, plus the full Bayever/Conroy/Ko/Saif/Mahaseth/Cantore corpus, plus the Wainberg/Nichetti/Nevala-Plagemann post-filing literature on NALIRIFOX (Exs. 1010-1011 in the '552 proceeding), remain fair game as § 103 combinations against the '795 claims. The catch is the § 315(b) one-year bar. Ipsen filed its first D.N.J. action asserting the '795 patent on 2024-04-15 (C.A. No. 24-04991, later consolidated with 24-08723 and 25-13647). If Conjupro/CSPC were served with that complaint in 2024, their § 315(b) window on the '795 patent closed in 2025 — which is a plausible reason the family's PTAB challenge landed on the '552 patent (a patent asserted later, 2025-01-17 petition) rather than on the '795. That service-date inference is unverified and must be checked against the docket before anyone relies on it. A newly served co-defendant, a customer/inducer further down the chain, or a party not in privity with Conjupro would have a fresh clock.

Pattern signals. (1) Same-patent serial filings: CSPC filed first (IPR2025-00505), Apotex followed as a "silent understudy" joinder (IPR2025-01531) — the classic generic-cohort pattern. (2) Ipsen fights PTAB institutions hard: it filed a § 325(d)/discretionary-denial request in the '552 case (denied 2025-07-16) and a full opposition to Apotex's joinder (later withdrawn). (3) No defensive aggregator (Unified Patents, RPX, etc.) appears anywhere in this chain; the challengers are all generic-drug entrants — CSPC's licensee Cipla USA took an exclusive license to irinotecan liposome injection in May 2025, per Ipsen's own Exhibit 2010. (4) The related European counterpart took three oppositions and was revoked by the opposition division, now on appeal (EPO Boards of Appeal decision) — evidence the family's dosage/regimen claims are contested worldwide, though that is an EPO proceeding, not an AIA trial, and I have not confirmed which EP member it corresponds to.

Recommended next steps

1. Do not represent to a court or counterparty that the '795 patent has been invalidated in an IPR — it has not. There is no FWD to cite, no canceled claim, and no § 315(e)(2) estoppel. Any brief asserting otherwise is sanctionable.
2. Verify the PTAB docket directly before relying on the "no proceedings" default. Run the patent number, the application number (16/012,351), and the family members (9,452,162; 9,492,442; 9,714,724; 9,339,497; 9,364,473; 11,369,597; 11,344,552) through USPTO PTAB E2E and the PTAB Decisions site, and check CourtListener for any CAFC appeal captioned Ipsen or CSPC in 2026.
3. Confirm the IPR2025-00505 outcome. GreyB's tracker shows status "Final Written Decision" with termination 2026-08-12. Pull the FWD and check (a) the claim-level verdict on '552 claims 1-15, and (b) whether either side appealed — an appeal would be docketed at the Federal Circuit within 63 days of judgment, i.e., by roughly 2026-10-14.
4. Clock the § 315(b) window. Pull the service dates for C.A. No. 24-04991 (filed 2024-04-15, which asserted the '795 patent) and the later consolidated complaints. If you are a defendant who has not been served with a complaint on the '795 patent, your one-year window is open — file the petition on the '552/IPR2025-00505 model art set plus art specific to the '795's "consisting of" 70 mg/m², oxaliplatin-free, post-gemcitabine limitations. If you were served in 2024, assume you are time-barred and litigate invalidity in D.N.J. rather than at the Board.
5. Attack the narrow claim, not the family. Because claim 1 of the '795 patent is drafted as a closed "consisting of" method with a single 70 mg/m² dose and a specific patient population (previously treated with gemcitabine), the strongest non-infringement and invalidity theories are claim-differentiating: the accused NDA product's label dose, sequencing, and premedication instructions must meet every element exactly. Note that the specification filed in this patent describes an 80 mg/m² q2w regimen (Arm C), so there is a real prosecution-history and written-description record to mine regarding how and why the claim landed at 70 mg/m².
6. Pull the '795-specific Paragraph IV contentions. Conjupro's notice letter certified invalidity of the '795 patent, and its counterclaims recite the factual and legal bases (see the consolidated counterclaim, njdc25cv13647A.pdf). Those contentions are the best available proxy for the grounds an eventual '795 petition would assert — and, if you are aligned with that cohort, an estoppel-risk map, since positions taken in the notice letter and district court can be used against the petitioner later.

Caveat on sourcing: the "no AIA proceedings" conclusion rests on the USPTO ODP structured block and a web search that surfaced only '552-patent IPRs for the Onivyde family (DrugPatentWatch Onivyde PTAB list shows exactly two entries, both on U.S. 11,344,552). Because PTAB filings can take weeks to index, treat this as "none on file as of the most recent ingest," not as a negative finding of fact.

I'll research the assignment record for US 10,980,795, starting with the USPTO Assignment Center records and the corporate history of the assignees.

Found the key Ipsen acquisition reel/frame. Let me dig into the specific assignment records and correspondent details.

I have the Ipsen acquisition reel. Let me try to pin down the specific reel/frame entries and the correspondent of record.

I hit my research-step limit, so the section below distinguishes clearly between verified, inferred, and not-retrieved facts. The Assignment Center remains the authoritative source; I flag every field I could not pull directly.

Assignment & Ownership Analysis — US 10,980,795 (US10980795B2)

Verification entry point: https://assignmentcenter.uspto.gov/ — search by patent number 10980795 or application 16/012,351. Mirrored at https://assignment.uspto.gov/patent/index.html.

Retrieval caveat: The Assignment Center records are behind a search UI/API that I could not query directly in this session. The chain below is reconstructed from (a) the Google Patents "Legal Events / Assigned to" records for this patent, which are populated from the USPTO assignment database, and (b) the family-level assignment record that surfaced on related Merrimack/Ipsen patents. Firm-level fields — reel/frame for the 2020-04-16 recordings, and the correspondent (attorney) fields for every record — I could not retrieve. Those are flagged as such and should be pulled directly from Assignment Center before any of this is relied upon.

Inventors

Basis: The earliest priority is 2012‑06‑13 (provisional 61/659,211) with a second provisional 61/784,382 (2013‑03‑14), and the PCT (PCT/US2013/045495) was filed 2013‑06‑12 — at which time the ONIVYDE/MM‑398 program was Merrimack's. The inventors' own assignment to Merrimack Pharmaceuticals, Inc. is confirmed by the USPTO assignment record surfaced by Google Patents (see timeline below), which lists all seven as assignors and Merrimack as assignee. I could not independently confirm each inventor's employment title; treat the column as probable rather than certain.

Unusual patterns:

• All seven inventors assigned to Merrimack, not to Ipsen. This is the classic inventor→company assignment; it means Ipsen's title depends on the Merrimack→Ipsen link alone (a single point of failure in the chain, which is presumably why confirmatory re-recordings appear in 2020).
• No evidence of inventors departing within 12 months of filing as an NPE-preceding fire-sale pattern. Instead, the relevant corporate event is much later and is a program-level divestiture: Merrimack announced a ~30% headcount reduction on 2017‑01‑08, and Ipsen subleased Merrimack's manufacturing space at the closing of the ONIVYDE asset sale on 2017‑04‑03 (Merrimack Form 10‑K FY2017 / Form 10‑Q). That is a program carve-out, not a portfolio fire-sale.

Original assignee

Two entities need to be distinguished, because the "face of the patent" and the "originator of the rights" are not the same.

(1) Entity named on the issued patent — Ipsen Biopharm Ltd.

• Google Patents lists Ipsen Biopharm Ltd as both the Original Assignee and the Current Assignee of US 10,980,795. This is consistent with the fact that application 16/012,351 was filed 2018‑06‑19, i.e. after Ipsen had already acquired the ONIVYDE patent estate from Merrimack (April 2017). The continuation was therefore filed by Ipsen from day one.
• Primary line of business: pharmaceutical manufacturing/marketing; UK subsidiary of Ipsen S.A. (Euronext Paris: IPN), a publicly traded global specialty-pharma group.
• Product embodying the claims: yes. Ipsen markets ONIVYDE® (irinotecan liposome injection) — NDA 207793 (FDA initial approval 2015‑10‑22). The Orange Book lists 10,980,795 against NDA 207793 with a use code corresponding to treatment of metastatic adenocarcinoma of the pancreas that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin (DrugPatentWatch / FDA.report; patent listed 2021‑05‑11, expiration 2033‑06‑12).
• Status: operating. Actively commercializing ONIVYDE and actively enforcing the patent in Hatch‑Waxman litigation (below).

(2) Original owner of the inventive rights — Merrimack Pharmaceuticals, Inc.

• Formerly NASDAQ: MACK; developed MM‑398/ONIVYDE and the MM‑398 + 5‑FU/LV Phase 3 program (NAPOLI‑1) that underlies this specification.
• Status: divested / substantially wound down. It sold the ONIVYDE business to Ipsen for a $575.0 million upfront payment (closed 2017‑04‑03), cut headcount ~30%, later repurchased its convertible notes, and refocused on non-ONIVYDE pipeline assets. I could not verify Merrimack's present-day corporate status (whether it remains listed, has merged, or has been dissolved) with high confidence in this session — verify via SEC EDGAR filer CIK 1274792. I found no evidence of a Chapter 7 or Chapter 11 filing, so I do not characterize the 2017 deal as a bankruptcy sale.

Assignment timeline

Two records are dated 2020‑04‑16 in Google Patents' USPTO-derived "Assigned to" events for this patent. One family-level record carries reel/frame 042377/0696, effective 2017‑04‑03. I could not obtain the reel/frame numbers for the 2020‑04‑16 entries, and I could not obtain the correspondent of record for any entry. Everything else below is grounded in the cited records.

• 2017‑04‑03 (effective) / recorded on or about 2017 — Reel 042377/0696 (family-level record; surfaced on related Merrimack→Ipsen patents such as the "Liposomes useful for drug delivery to the brain" family, US 2011/0003160 / US 8,658,203 lineage)

  • Conveyance: Assignment (asset sale — transferred as part of the ONIVYDE Asset Sale Agreement)
  • Assignor: Merrimack Pharmaceuticals, Inc.
  • Assignee: Ipsen Biopharm Ltd. (United Kingdom)
  • Correspondent: not retrieved. (This is the single most diagnostic field for an ownership-chain review and it is missing; pull it from Assignment Center.)
  • Context: negotiated carve-out/acquisition of Merrimack's ONIVYDE patent estate and related agreements (Baxalta, PharmaEngine, Actavis) for $575M upfront — not a fire-sale, not an internal reorg, not a transfer to an asserter.

• Recorded 2020‑04‑16 — Reel not retrieved

  • Conveyance: Assignment of assignors' interest (appears to be a confirmatory/chain-perfecting filing; the Google Patents entry reads "ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)")
  • Assignors: Jaeyeon Kim; Clet Niyikiza; Victor Moyo; Eliel Bayever; Jonathan Basil Fitzgerald; Navreet Dhindsa; Peter Laivins (the seven named inventors)
  • Assignee: Merrimack Pharmaceuticals, Inc.
  • Correspondent: not retrieved.
  • Context: chain-completion for a continuation application (16/012,351) filed after the 2017 asset sale; recorded years after the underlying 2012–2013 invention. Execution date not retrieved.

• Recorded 2020‑04‑16 — Reel not retrieved

  • Conveyance: Assignment of assignors' interest
  • Assignor: Merrimack Pharmaceuticals, Inc.
  • Assignee: Ipsen Biopharm Ltd.
  • Correspondent: not retrieved.
  • Context: chain-completion / confirmatory transfer tying application 16/012,351 into the 2017 asset sale (reel 042377/0696). Because the continuation was filed in 2018 — after the 2017 bulk assignment — Ipsen appears to have recorded a fresh assignment specific to this application to perfect title.

Note on the reason there is no "no records" finding: Assignment Center does have records for this patent (at minimum the entries above). The correct caveat is not "no records" but "records exist and are incomplete as retrieved."

Timeline diagram

timeline
    title Ownership of US 10980795
    2012 : Priority filing by Merrimack
         : Inventors assign rights to Merrimack
    2013 : PCT application filed
    2017 : Asset sale Merrimack to Ipsen Biopharm
    2018 : Continuation filed by Ipsen Biopharm
    2020 : Inventor to Merrimack assignment recorded
         : Merrimack to Ipsen assignment recorded
    2021 : Patent issued to Ipsen Biopharm
    2024 : Ipsen sues Conjupro in New Jersey

(Event text intentionally free of parentheses, slashes and commas for parser safety. The 2012 inventorship assignment line reflects the inventors' assignment of record to Merrimack, which was recorded in 2020; the 2012 execution date is the probable but unverified execution period.)

NPE / troll-pattern signals

Verdict

Operating-company assertion.

The chain terminates at Ipsen Biopharm Ltd., the entity named on the face of the '795 patent and the holder of the ONIVYDE NDA (207793) that the patent is Orange-Book-listed against — i.e. the current assignee ships a product embodying the claims. The only transfers in the record are the 2017‑04‑03 Merrimack→Ipsen asset sale (reel 042377/0696) plus two 2020‑04‑16 confirmatory recordings perfecting title in a continuation filed post-acquisition; none involve a shell LLC, a known NPE, a bankruptcy estate, or a defensive aggregator. Ipsen is enforcing against generic competitors (CSPC/Conjupro) in D.N.J. 3:24‑cv‑04991 (filed 2024‑04‑15) — the textbook operating-company posture, and the inverse of a troll pattern.

Residual verification items (do these before relying on the section): (i) pull the reel/frame for the two 2020‑04‑16 recordings; (ii) pull the correspondent of record for all three records and check for recurrence against Unified Patents / RPX assertion lists (signal 3 is currently unclear only because of the data gap); (iii) confirm Merrimack Pharmaceuticals, Inc.'s current corporate status via SEC EDGAR CIK 1274792.

I'll research the prior-art citations of US 10,980,795, focusing on the patent's front-page references and the specific claim language at issue.

Let me retrieve the patent's "References Cited" and "Cited By" sections directly, plus the prosecution history and any PTAB prior-art analysis.

Let me pull the actual front-page reference list from the patent document itself (PDF) and cross-check the counts.

Prior-Art Analysis — US 10,980,795 (Bayever et al., Ipsen Biopharm)

Important methodological caveat up front (read before relying on the list below). The authoritative Google Patents text supplied for US 10,980,795 was truncated before the claims and before the "References Cited" / "Cited By" tables (it ends mid-Detailed-Description at "VII. Treatment Protocols"). I therefore could not machine-read the patent's own front-page citation list within this session. Google Patents renders that list dynamically, and my HTML fetches returned only the abstract/specification and a stray unrelated ISA table (the JP 11 077795 / PCT-US2008/000303 search report that surfaced in the searches belongs to a different application and is not a citation of the '795 patent — I flag it so it is not mistaken for prior art of record here).

What follows is therefore a reconstructed, source-grounded prior-art list: references that (a) appear in the '795 family's prosecution/opposition record (verified via the PTAB petition exhibits for sibling patent 11,344,552 and the EP 2 861 210 opposition), (b) are themselves listed Orange Book/patent-family members relevant to the MM-398 product, and (c) are the standard clinical/technical references a POSA or examiner would cite. Each entry is labeled by confidence. I have not auto-corrected any identifier.

0. The reference date that governs everything

The '795 patent claims earliest priority to June 13, 2012 (provisional 61/659,211) and March 14, 2013 (61/784,382), via PCT/US2013/045495. It is post-AIA (effective filing after March 16, 2013 is the continuation, but it claims pre-AIA priority). Any true § 102(a)(1) prior art must have been publicly available before June 13, 2012. This date is the single most important constraint on the analysis below, and it eliminates several references that are often (incorrectly) cited against this family.

1. Composition / platform prior art

2. Clinical / regimen prior art predating the priority date (the substantive § 102(a)(1) field)

3. The applicant's own earlier family members — NOT § 102 art (flag this explicitly)

Under the prior summary, this family includes US 9,452,162; 9,492,442; 9,339,497; 9,364,473; 9,717,724 (all sharing the June 13, 2012 priority). Because:

• they share the same effective filing date as the '795, and
• they are commonly owned (Merrimack → Ipsen),

they are excepted from § 102(a)(2) by § 102(b)(2)(C) (common ownership) and are not "by another" under § 102(a)(1). They should not be counted as § 102 prior art against '795. The PTAB IPR2025-00505 petition labels the family's own disclosure as "Bayever" (Ex. 1006) — but that is against the later '552 patent (priority 2015), where the 2013 Bayever publication is prior art. That reasoning does not transfer to '795. This is the most common error in outside prior-art lists for this patent, and I flag it as a contradiction to watch for in any search-result set you receive.

Likewise, WO 2013/188553 (the PCT publication of this very application) published Dec 19, 2013 — after the priority date, so it is not § 102(a)(1) art against '795.

4. Post-priority references sometimes (wrongly) cited

5. Bottom-line § 102 assessment

For the independent claim as summarized (a method of treating gemcitabine-pretreated metastatic pancreatic adenocarcinoma with a q2w regimen "consisting of" liposomal irinotecan [70 mg/m² free-base equivalent] + leucovorin [200 mg/m² l-form or 400 mg/m² l+d] + 5-FU [2400 mg/m²]):

• No single reference in the list anticipates. The closest is Ko 2011 (#5) — same drug, same population — but it is monotherapy, failing the "consisting of … leucovorin … 5-FU" limitation, and it does not specify the q2w 70-mg/m²-base regimen. Under § 102, a reference must disclose all limitations arranged as claimed; Ko does not.
• US 8,147,867 (#1) discloses the liposomal irinotecan composition but no pancreatic dosing regimen → no § 102.
• Conroy 2011 (#4) supplies the q2w 5-FU/LV backbone and the leucovorin/5-FU doses but uses free (non-liposomal) irinotecan at 180 mg/m² plus oxaliplatin, and is first-line → no § 102.
• The realistic attack is § 103, not § 102: Conroy (#4) + Ko/Chen (#5/#6) + US 8,147,867 (#1), optionally + Hoskins (#7) for the UGT1A1 dose adjustment. This is precisely the "Conroy + Bayever" template the PTO used against the sibling '552 patent.

Best single-reference candidate for a § 102 challenge: none is clean. If forced to name the reference with the highest anticipatory overlap with the population + drug elements, it is Ko 2011 (#5); the reference with the highest overlap with the regimen/q2w + 5-FU/LV doses is Conroy 2011 (#4). Neither, alone, reads on the full claim.

6. Explicit uncertainties (do not treat as verified)

1. The patent's actual front-page "References Cited" list was not retrievable from the truncated authoritative text. The 12 references above are reconstructed from the family's prosecution/opposition record and are not a verbatim reproduction of the '795 face citations.
2. Exact grant/publication dates for US 8,147,867 and the WO 2010/135785 publication are stated to the best of available records; verify against the USPTO/EPO register before relying on them for a § 102 date argument.
3. Infante 2012 (#11) is date-critical and may post-date the priority date — verify its epub date.
4. I could not confirm whether additional U.S. patent citations (e.g., specific Merrimack liposome patents) appear on the '795 face. If you can supply the untruncated claim + citation pages, I can convert this reconstructed list into an exact, element-by-element § 102 chart.
5. No § 102(a)(2) "secret prior art" (earlier-filed, later-published U.S. applications) was identified with an effective filing date before Jun 13, 2012 and outside common ownership; absent the full citation list I cannot exclude one.

I'll research the prior art cited on this patent's page and the relevant field literature before building the § 103 analysis.

Let me pull the specific prior-art citations on this patent and check for any IPR challenging the '795 specifically.

Obviousness Analysis Under 35 U.S.C. § 103 — US 10,980,795 B2

Patent: US 10,980,795 B2 ("Bayever et al.") — Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Assignee: Ipsen Biopharm Ltd. | Effective priority date (per patent): 2012-06-13 | Application: US 16/012,351 (filed 2018-06-19)
Analyst date: 2026-04-26
Governing law: Pre‑AIA 35 U.S.C. § 103(a), because the application is a continuation in an unbroken chain reaching a 2012 priority claim (AIA § 3(n)(1) does not shift the analysis absent any claim having an effective filing date on/after 2013‑03‑16).

⚠️ Threshold caveats (do not skip)

1. Claim text is not from the authoritative document. The Google Patents text supplied earlier was truncated before the claims. The limitations analysed below are taken from the prior section's DrugPatentWatch listing of claims 1–2 only (https://www.drugpatentwatch.com/p/patent-claims/[10980795](/patent/10980795)). If the patent contains dependent claims beyond claim 2, this analysis is incomplete. Verify against the printed claims before relying on any conclusion.
2. The "Prior Art" section on the Google Patents page is only partially usable. The page lists Prior art keywords: dose, irinotecan, patients, leucovorin, patient and a "Patent Citations (35)" table (reproduced in the US 9,339,497 record at https://patents.google.com/patent/US9339497/en). The 35 citations are dominated by liposome platform art (e.g., US 4,604,463 Yakult Honsha camptothecin derivatives; US 5,077,056; US 5,193,549 & US 5,316,771 Yissum ion-gradient loading; US 5,013,556; US 5,595,362 / US 5,673,971 / US 5,846,458 Terumo PEG-liposomes; US 6,355,268 Alza "Liposome-entrapped topoisomerase inhibitors"; US 5,785,987 UBC vesicle loading). I could not retrieve the full 35-row table or the non-patent-citation list verbatim in this session; treat individual rows as partially verified.
3. No IPR against the '795 itself was located. The 2026 PTAB activity I found (IPR2025-00505 / IPR2025-01531, petitions at https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1557313](/patent/1557313)/) is directed to US 11,344,552, a later, different Ipsen patent. Arguments in that record are instructive but are not an attack on the '795 and rely in part on "Bayever" as prior art — a document that, if it is the '795 family's own WO 2013/138371, cannot be prior art against the '795.

A. Claim decomposition (claims 1–2 as reported)

Construction note (important and favourable to an obviousness attack). The written description supplied earlier describes the q2w combination arm as 80 mg/m² liposomal irinotecan. The claim's 70 mg/m² free base is consistent with a salt-vs-free-base conversion: a sibling Ipsen document states MM‑398 doses are quoted as "the amount of irinotecan corresponding to 60–120 mg/m² of irinotecan hydrochloride trihydrate" (US 10,894,044 B2 snippet via Google Patents). The molecular-weight ratio (irinotecan HCl trihydrate ≈ 677; irinotecan free base ≈ 587) makes 80 mg/m² salt ≈ 70 mg/m² free base. I flag this as an arithmetic observation, not something the '795 text I hold spells out.

Consequence: E4–E6, E3 and E1 are, on their face, the published NAPOLI‑1 Arm C / "MM‑398 + 5‑FU/LV q2w" regimen and the simplified FOLFIRI (LV5FU2) backbone — a regimen structure well known in the art before 2012.

B. Prior-art inventory

C. Ground 1 (primary): US 8,147,867 + Conroy 2011 + simplified FOLFIRI (Douillard/Tournigand) in view of second-line post-gemcitabine FOLFIRI (PMC3435778)

Element-by-element:

• E1–E2 (metastatic pancreatic adenocarcinoma, gemcitabine-pretreated/progressed): Conroy 2011 establishes the disease and the irinotecan/LV/5‑FU combination in it; PMC3435778 (and the CONKO‑003/OFF second-line literature discussed in the FDA NDA review) establish that irinotecan- or 5‑FU/LV-based second-line therapy after gemcitabine was an accepted clinical path.
• E3, E5, E6 (q2w; LV 200/400; 5‑FU 2400 mg/m²): Literally the simplified FOLFIRI / LV5FU2 parameters. No new dosing science is required — these are the art's standard values.
• E4 (liposomal irinotecan at ~70 mg/m² free base): US 8,147,867 supplies the exact drug form ("irinotecan sucrose octasulfate salt liposome injection") and the substitution rationale: the '867 patent itself asserts the liposomal form is at least 4–10× more active than free irinotecan at the same dose and schedule. The remaining difference is the numerical dose — a result-effective variable reached by (i) using the free-base equivalent of the art-known 80 mg/m² and/or (ii) routine Phase 1 dose-finding (the 60/80/100/120 mg/m² ladder is the PEP0203 design).

Motivation to combine (KSR rationales):

1. Substitution of a known, art-recognized-improved form. Where a reference teaches that a new formulation of the same active is 4–10× more active at equal dose/schedule, substituting it into a known regimen is the paradigm "use of a known technique to improve a similar device" (KSR; M.P.E.P. 2143).
2. Finite, predictable set of options. For irinotecan-based metastatic pancreatic cancer regimens pre-2012, the identified universe was essentially FOLFIRI and FOLFIRINOX. Selecting the three-drug (oxaliplatin-free) backbone is a narrowing choice, not a new direction.
3. Design incentive / toxicity sparing. FOLFIRINOX is notoriously toxic (neutropenia, neuropathy); a gemcitabine-progressed, likely lower-performance-status population creates a finite design incentive to retain irinotecan + 5‑FU/LV while dropping oxaliplatin — and to use a formulation the art already credited with improved therapeutic index.
4. Same utility, same mechanism. The MM‑398 depot/EPR rationale in the specification (tumor-associated macrophage conversion of irinotecan to SN‑38) is presented as inherent to the '867 formulation; no new mechanism or new biological principle is claimed.

Reasonable expectation of success: High for the structural/regimen elements — the three-drug combination and the q2w/LV5FU2 backbone were proven, and the '867 patent affirmatively taught superiority of the liposomal form. The residual uncertainty is quantitative (whether the survival gain would materialize in this exact population), which is the classic ground on which this family has been defended (see §E).

D. Ground 2 (alternative for E4): Alza US 6,355,268 (liposome-entrapped topoisomerase inhibitors) + Yissum US 5,193,549/5,316,771 (ion-gradient remote loading) + PEG-liposome art (Terumo, US 5,013,556) + Conroy/FOLFIRI

This ground is weaker in absolute terms but useful as a fallback where the '867 patent's asserted superior-activity data are attacked: it shows that encapsulating topoisomerase‑I inhibitors (camptothecins/irinotecan) in long-circulating, remote-loaded liposomes was a known technique with a known purpose (EPR/sustained release). Combined with Conroy/FOLFIRI, this supports obviousness of substituting a liposomal irinotecan for free irinotecan even without the '867 patent's specific MM‑398 embodiments.

E. Ground 3: PEP0203-type disclosure + Conroy/FOLFIRI (optimization of schedule)

If the PEP0203 Phase 1 (MM‑398 60→120 mg/m² + 5‑FU/LV) qualifies as prior art, it discloses: (a) the same three-drug combination; (b) dose ranges bracketing the claimed dose (80 mg/m² was the MTD and the recommended Phase 2 dose); and (c) evidence of activity in pancreatic patients. Converting a q3w dose-escalation experience into the art-standard q2w FOLFIRI backbone is routine schedule optimization (cf. Rothenberg 1998, "Alternative Dosing Schedules for Irinotecan," cited in the family's reference lists). The obviousness case here turns entirely on the publication date of the PEP0203 disclosure.

F. Weaknesses of the prima facie case (where a patent owner would attack)

1. Priority date of the specific claimed regimen. The Phase 3 protocol's q2w mm‑398 arm appears to have been added by a protocol amendment dated 2012‑06‑14 (per the FDA NDA cross-discipline review), one day after the 2012‑06‑13 provisional. If the claim's written-description support for the q2w/80 mg/m² (≈70 mg/m² free base) regimen derives only from provisional 61/784,382 (2013‑03‑14), then the prior-art window shifts and NCT01494506 (ClinicalTrials.gov archive dated 2012‑08‑09, cited on the EPO search report for EP 3 266 456 at https://data.epo.org/publication-server/rest/v1.0/publication-dates/20180110/patents/EP3266456NWA1/document.pdf) becomes available. This is the single most consequential factual question for the § 103 analysis, and I cannot resolve it from the text I hold.
2. "70 mg/m² … free base" as a numeric limitation. If the specification only expresses dosing as "mg/m²" of salt, a patent owner may argue the free-base figure is not squarely disclosed/rendered obvious, or (conversely) that it is a new and unexpected dose. Expect this to be litigated as a written-description-enablement point as much as an obviousness point.
3. "Consisting of" closure. The closed transition narrows E4–E6, but it does not add an element the art lacks; it merely excludes additional actives (e.g., oxaliplatin). Dropping oxaliplatin from FOLFIRINOX while keeping the LV5FU2 backbone is itself an obvious simplification, so the closed transition arguably helps the obviousness case rather than defeats it.
4. Population limitations. "Previously treated with gemcitabine" and "progressed after gemcitabine treatment" are clinical-status limitations. Prior art need not have administered the regimen to that exact subgroup if the group is an obvious one to treat (the entire second-line pancreatic field was defined by gemcitabine failure).

G. Secondary considerations / rebuttal evidence, and how each is answerable

H. Bottom line

• Claim 1 — prima facie obvious: YES, moderately strong. The strongest combination is US 8,147,867 + Conroy 2011 (FOLFIRINOX) + simplified FOLFIRI (Douillard 2000/Tournigand 2004), optionally + the gemcitabine-refractory FOLFIRI reference (PMC3435778) and + liposomal-irinotecan efficacy art (Messerer 2004; Ramsay 2008; Matsuzaki 2011/2012). Every limitation maps: the disease and combination (Conroy/FOLFIRI), the q2w interval and the exact LV and 5‑FU doses (LV5FU2/FOLFIRI), the drug form (the '867 patent), and the population (second-line post-gemcitabine practice). Motivation flows from the '867 patent's own teaching that the liposomal form is 4–10× more active at equal dose/schedule, from the finite two-option universe of irinotecan regimens, and from the toxicity-sparing design incentive.
• Claim 2 — obvious if claim 1 is. It merely narrows E2 from "previously treated" to "progressed after" gemcitabine — the ordinary clinical consequence of gemcitabine failure.
• The decisive factual battleground is not the chemistry or the regimen — it is (i) the reference dates, and (ii) the priority entitlement of the q2w/free-base-dose features. If the q2w arm's support traces only to the 2013‑03‑14 provisional, the Aug‑2012 ClinicalTrials.gov archive of NCT01494506 supplies the regimen as a printed publication, and the case becomes substantially stronger still.

I. Verification actions I recommend before this analysis is relied upon

1. Retrieve the printed claims of US 10,980,795 from USPTO PatentCenter/Patent Public Search (the supplied text omitted them). Confirm whether claims exist beyond 1–2.
2. Pull the complete "Patent Citations (35)" and all non-patent citations from the Google Patents page's prior-art section, which I could only partially retrieve.
3. Confirm publication dates for: PMC3435778; the PEP0203 disclosure; Ko et al. — each is dispositive for inclusion/exclusion under §102(b).
4. Resolve the priority question for the q2w / 70 mg/m² free-base limitations against provisionals 61/659,211 and 61/784,382.
5. Confirm the salt ↔ free-base conversion (80 mg/m² irinotecan HCl trihydrate ≈ 70 mg/m² free base) from the Onivyde prescribing information.

Explicit uncertainty statements: I have not verified the complete claim set of US 10,980,795; I have not verified the full prior-art citation table on its Google Patents page; and I have not verified the publication dates of several references in §B. Statements above marked "uncertain" or "verify" should not be treated as findings. No IPR, PGR or Federal Circuit proceeding directed to the '795 patent was located in this session — that is an absence of search results, not a confirmed negative.