US 9056120

I'll search for authoritative information on US 9056120, including any 2026 CAFC activity.

Let me search for the patent's claims and any 2026 appellate activity.

Let me retrieve the granted claim set directly.

US 9,056,120 B2 — Summary

1. Bibliographic identification (as recorded)

Provenance / continuity (per §1 of the specification): continuation of 12/777,765 (filed 2010-05-11); which is a continuation-in-part of 11/985,032 (now US 7,863,297); which is a continuation of 11/654,550 (now US 7,393,863); which is a divisional of 10/411,649 (now US 7,189,740); which claims benefit of provisional 60/418,468 filed 2002-10-15.

2. Abstract

"Methods of treating, preventing and/or managing myelodysplastic syndromes are disclosed. Specific methods encompass the administrations of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidin-2,6-dione in combination with 5-azacytidine."

(Note: the specification body renders the compound as "3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione" — lenalidomide.)

3. Independent claim, in plain language

The claim text I could retrieve for this family is claim 1 as listed for the published version of this application (US 2013/0202590; confirmed as claim 1 of the '120 patent in the IPR record):

1. A method of treating a myelodysplastic syndrome, which comprises administering to a patient having a myelodysplastic syndrome a therapeutically effective amount of 5-azacytidine, and a therapeutically effective amount of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione (lenalidomide) or a pharmaceutically acceptable salt thereof.

Plain-language overview: The claim is a method-of-treatment claim covering the co-administration of the two drugs — the cytidine analog azacitidine (5-azacytidine) and the immunomodulatory drug lenalidomide — to a patient who has myelodysplastic syndrome (MDS). It is a combination-therapy claim, not a composition claim; it recites no specific dose, schedule, or route in claim 1.

Dependent claims build out the following subject matter (from the published claim listing):

• Specific MDS subtypes: refractory anemia, RARS, RAEB, RAEB-T, CMML (claim 2); IPSS Intermediate-2/High risk (claim 3); primary vs. secondary MDS (claim 9); del(5q31-33) abnormality (claim 8).
• Additional active agent (claims 4–7): blood-cell-production enhancers; cytokines, hematopoietic growth factors, anti-cancer agents, antibiotics, proteasome inhibitors, immunosuppressants; and a long list (gemtuzumab ozogamicin, etanercept, imatinib, anti-TNF-α antibodies, infliximab, G-CSF, GM-CSF, EPO, topotecan, pentoxifylline, ciprofloxacin, irinotecan, vinblastine, dexamethasone, IL2/IL8/IL18, Ara-C, vinorelbine, isotretinoin, 13-cis-retinoic acid).
• Route of administration of azacitidine: subcutaneous, intravenous, or oral (claim 10).
• Downstream claims further cover cycling/dosing, oral lenalidomide capsules/tablets, and transplant-adjacent administration.

The specification's dose ranges (for background, not necessarily claim limitations) are ~5–25 mg/day lenalidomide (e.g., 10 mg/day orally for 21 days + 7 days rest in 28-day cycles) and azacitidine 25–75 mg/m²/d SC or IV on days 1–7 (or days 1–5), or oral azacitidine ~120 mg/day for days 1–7.

4. Prosecution notes relevant to claim scope

• During prosecution the examiner issued nonstatutory obviousness-type double-patenting rejections of claims 1–37 over US 8,404,716 ('716), over US 7,189,740 in view of Ionescu et al. (US 6,887,855), and over US 8,404,717 in view of Ionescu — requiring terminal disclaimers.
• A 2014 amendment canceled claims 1–37 and added new claims 38–76, including a new independent claim 38 ("about 1 mg to about 50 mg per day" of the lenalidomide compound for MDS) and claim 65 (same dosing for transfusion-dependent anemia due to low- to intermediate-1-risk MDS). The issued patent nonetheless carries 53 claims, and the IPR petition challenged claims 1–8, 12–34 and 38–53 of the '120 patent — so the final numbering does not map cleanly onto either the as-published or the amendment listing.

5. Litigation / docket status (checked as of this date)

• IPR2018-01504, [Dr. Reddy's Laboratories, Inc.](/litigations/by-plaintiff/Dr.%20Reddy's%20Laboratories%2C%20Inc.) v. Celgene Corp. — petition filed 2018-08-03 challenging the '120 patent; the Board record shows it was Not Instituted (Merits). The petitioner's Exhibit 1001 is the '120 patent, and Exhibit 2003 is the '120 file history.
• District court litigation in D.N.J. (numerous 2:xx-cv-xxxxx matters, 2017–2021) and N.D. W. Va. (1:20-cv-00003) listed against the '120 patent family.
• 2026 appellate activity — I found no Federal Circuit (CAFC) appeal in 2026 involving US 9,056,120. The patent expired (anticipated) 2023-04-11, and the listed status is "Expired – Lifetime." What does appear in 2026 is unrelated to the '120 patent: the Second Circuit's August 13, 2026 revival of the UMB Bank v. Bristol Myers Squibb CVR/merger litigation (a securities/contract dispute over delayed FDA approvals of Breyanzi, Ozanimod, and Ide-cel) — a district-court/2nd Circuit matter, not a CAFC patent appeal and not about this patent.

6. Explicit uncertainty

• The full authoritative granted claim set of US 9,056,120 (all 53 claims, exactly as issued) was not retrieved from a primary USPTO source in this session; the claim 1 text above comes from the published-application claim listing and the PTAB record, which are consistent with each other. Treat the exact wording and numbering of the final granted claims — especially whether the "1–50 mg/day" independent claim survived as a separate independent claim — as unverified.
• The priority picture is internally inconsistent in the public record (2002-10-15 prior-art date vs. a 2003-04-11 priority claim from US 10/411,649); I am reporting both as stated rather than resolving them.
• I did not find, and therefore cannot confirm, any CAFC 2026 docket entry for this patent number. Absence of a search hit is not proof that none exists.

I'll research the litigation history for US Patent 9056120. Let me search several sources.

Let me dig deeper into the specific cases and verify which ones actually assert the '120 patent.

Litigation Involving U.S. Patent No. 9,056,120 ("the '120 patent")

Patent: U.S. 9,056,120 B2 — "Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine." Inventor: Jerome B. Zeldis. Original assignee: Celgene Corp. (now a Bristol Myers Squibb subsidiary). Filed Mar. 13, 2013; granted June 16, 2015; expired (anticipated expiration ~Apr. 11, 2023).

Bottom line: No standalone "9,056,120 lawsuit" exists. The '120 patent was asserted only as one of many patents in Celgene's Hatch‑Waxman / ANDA (Paragraph IV) campaigns over REVLIMID® (lenalidomide), plus one PTAB inter partes review. Nearly all cases resolved by settlement/consent judgment or were dismissed. I could not independently verify every docket; where I rely on the patent's own Google Patents litigation record, I flag the limits of that data.

Citation note: I did not return results for similar-but-different numbers (e.g., the '740 family, '717, '800, or '217 patents) except where those same cases also asserted the '120.

1. PTAB challenge — the only direct validity attack on the '120 patent

This is the only post-grant proceeding I found specifically targeting the '120 patent. The patent owner's preliminary response relied heavily on the prosecution file history of the '120 patent itself (Exs. 2003, 2012, 2013). Sources: Unified Patents PTAB record via Google Patents; GreyB/IPVerse (IPR2018‑01504, respondent patent 9,056,120); PTAB docket (institution denied). A companion IPR by the same petitioner, IPR2018‑01507, appears in the same docket-family materials but I could not confirm that it also challenged the '120 patent, so I do not attribute it here.

2. District-court ANDA suits in which the '120 patent was expressly asserted

The '120 patent was pleaded (among many patents) in the following REVLIMID ANDA cases. Asserter in all: Celgene Corporation (plaintiff).

Supporting sources: Celgene v. Lotus complaint/antitrust recitals (D.N.J. 2:17‑cv‑06842; ¶¶ 164–166 of the purchaser antitrust complaint); IPWatchdog "Patent Filings Roundup" (May 5, 2021) listing 2:21‑cv‑10398, Celgene v. Hikma, with '120 among the asserted patents; Robins Kaplan Hatch‑Waxman bulletin noting resolution of 21‑10398 / 21‑20459; Cipla excerpts noting the '120 was asserted in 2:19‑cv‑14731 (filed 7/3/2019).

3. Cases shown on the '120 patent's Google Patents litigation record (asserted-patent status not fully verified)

The Google Patents page for US 9,056,120 lists the following additional U.S. district-court actions. This list is family-level — the page aggregates cases filed in New Jersey (and one in N.D. W. Va.) involving the lenalidomide patent family, and at least one listed case (2:18‑cv‑11518) is documented in the antitrust complaints as asserting only the '357, '219 and '598 patents, not the '120. I therefore cannot confirm that the '120 was specifically pleaded in each of these. Treat this as a lead list, not a verified assertion list:

• 2:17‑cv‑05314 — D.N.J. (2017)
• 2:18‑cv‑11518 — Celgene v. Lotus Pharmaceutical / Alvogen Pine Brook, D.N.J., filed Jul. 10, 2018 (documented asserted patents: '357, '219, '598)
• 2:19‑cv‑06999 — D.N.J. (2019)
• 2:19‑cv‑15449 — D.N.J. (2019)
• 2:20‑cv‑07759 — D.N.J. (2020)
• 1:20‑cv‑00003 — Celgene v. Mylan Pharmaceuticals Inc. et al., N.D. W. Va., filed Jan. 2020; joint claim-construction statement Nov. 16, 2020; settled Jul. 23, 2021 (volume-limited license; full competition delayed to Feb. 2026)
• 2:21‑cv‑11261 — D.N.J. (2021)
• 2:21‑cv‑12927 — D.N.J. (2021)
• 2:21‑cv‑20459 — D.N.J. (2021) (the Robins Kaplan bulletin groups 21‑10398 and 21‑20459 together as resolved)
• 2:21‑cv‑10398 — Celgene v. Hikma (confirmed above; also listed on the Google page)

The 2021 filings correspond to Celgene's suits against the remaining generic challengers. An antitrust complaint recites: "In 2021, Celgene filed patent lawsuits against Hikma …, Aurobindo Pharma Ltd., Eugia Pharma Specialties Ltd., Aurobindo Pharma USA, Inc., and Aurolife Pharma LLC …, Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc."; other plaintiffs reference suits against Lupin, Biocon and Alembic. I could not match each defendant to a specific 2021 docket number in my searches, and I will not guess. (Sun Pharma settled a lenalidomide suit in June 2021, and Zydus settled in March 2021 — but I could not confirm the docket numbers or that the '120 was asserted in those specific suits.)

Also noted on the '120 Google Patents page: a "First worldwide family litigation" entry via Darts‑IP (family 44314968).

4. Related (non-ANDA) antitrust litigation that references the '120 patent

The '120 patent appears in the REVLIMID/THALOMID antitrust litigation, but as an accused "sham" patent, not as the basis of a separate infringement suit:

• In re Revlimid and Thalomid Purchaser Antitrust Litigation (D.N.J., consolidated) — insurer/MSP plaintiffs allege the '740 patent is invalid (fraud/obviousness) and that this also renders the '717 and '120 method-of-treatment patents invalid; sham-litigation theories include cases where Celgene asserted the '120. The class action settled (final approval Oct. 2020); opt-out claims (e.g., Humana, United Healthcare) and follow-on actions continue.
• The Cigna Group v. Celgene Corporation (D.N.J., Case 1:25‑cv‑05237‑ER, filed Jun. 24, 2025) and similar purchaser complaints restate the '120 within the "Method of Treatment" patent family narrative.

Caveats / confidence

• High confidence: the IPR2018‑01504 challenge to the '120 (institution denied Feb. 11, 2019); assertion of the '120 in Celgene v. Lotus (2:17‑cv‑06842) and Celgene v. Cipla (2:19‑cv‑14731); assertion of the '120 in Celgene v. Hikma (2:21‑cv‑10398).
• Medium confidence: the other docket numbers and dates drawn from the '120 patent's own Google Patents litigation record (family-level aggregation). I could not open each docket to confirm that the '120 itself was pleaded.
• Not verified: defendants/filing dates for the several 2021 D.N.J. actions (2:21‑cv‑11261, ‑12927, ‑20459) and the 2019/2020 D.N.J. actions other than Cipla.
• I did not find any CAFC appeal that decided the merits of a '120 patent claim. The listed outcomes were settlements/consent judgments, dismissals, or (for the IPR) non-institution.
• I was unable to complete a live pull from the Unified Patents litigation caselist or PACER within the search budget; the Google Patents record I relied on itself cites Unified Patents litigation/PTAB data and the Darts‑IP family dataset. Where sources conflicted, I followed the search results rather than memory, per the operating rule.

If you need court-verified pleadings for any specific docket above (e.g., to confirm the '120 was actually named as a patent-in-suit in 2:21‑cv‑11261 or 1:20‑cv‑00003), say which case and I'll target that docket.

I'll verify the PTAB record and hunt for any proceedings the ODP block may not have indexed.

Let me confirm the companion IPRs' targets and the panel's actual reasoning in the denial.

Note on source conflict (flagged): The structured "PTAB proceedings on file" block states the USPTO ODP API returns no AIA trial proceedings for US 9,056,120. My live search contradicts that: IPR2018-01504 is a documented, terminated PTAB proceeding on this exact patent (PTAB E2E / PTAB docket, Docket Alarm, IPVerse, DrugPatentWatch). I treat the ODP block as incomplete or stale and report the proceeding that actually appears in the record, per the operating rule to prefer live search results.

Proceedings overview

One (1) AIA trial proceeding has ever been filed on US 9,056,120: IPR2018-01504 — status institution DENIED on the merits (Feb. 11, 2019); zero claims canceled, zero claims sustained on the merits, no FWD, no appeal. Breakdown: active 0 · claims invalidated 0 · claims sustained 0 · settled 0 · institution denied 1.

Bottom line for a defendant: the patent is not "hardened" — it is untested. The Board never reached the merits of the obviousness challenge; it stopped at the threshold "printed publication" question and refused to institute. That means no claim of the '120 patent has ever been adjudicated patentable by the PTAB, and the petitioner's estoppel exposure is zero (§ 315(e) estoppel attaches only to a final written decision). The defensive signal is mixed and must be stated precisely: Dr. Reddy's lost the right to a trial, not the validity fight; the patent owner has never had a merits win to point to. Note also that the patent is expired (anticipated 2023-04-11), which moots prospective injunctive theories but leaves expired-patent damages exposure in any case where past infringement is still live.

IPR2018-01504 — Dr. Reddy's Laboratories, Inc. v. Celgene Corp.

• Type: Inter Partes Review (35 U.S.C. §§ 311–319)
• Filed: 2018-08-03 (filing date accorded 2018-08-14)
• Status (verbatim from structured data): "no AIA trial proceedings on file" — conflicts with the record; the operative status per PTAB/IPVerse/Patexia is "Institution Denied" (denied on the merits, 2019-02-11)
• Patent challenged: US 9,056,120 B2 (application 13/801,262); Tech Center 1600, Art Unit 1618; sole inventor Jerome B. Zeldis
• Judge panel: APJs Grace Karaffa Obermann, Tina E. Hulse, and Christopher G. Paulraj. (The companion denials in -01507 and -01509 are authored by APJ Obermann; third-party data attributes authorship of the -01504 decision to APJ Paulraj, but I could not verify the author line from the decision text itself — treat the author attribution as unverified.)
• Petition grounds (pre-AIA § 103, two grounds only):
  • Ground 1 — § 103: claims 1–8, 12–34, and 38–53 unpatentable as obvious over List 2001 in view of the '230 patent and Celgene Press Releases 5/8/2001 and 8/28/2001.
  • Ground 2 — § 103: claims 1–8, 12–34, and 38–53 unpatentable as obvious over Thomas 2000a in view of the '230 patent and the same two press releases.
  • Claims challenged: 1–8, 12–34, 38–53. Claims 9–11 and 35–37 were not challenged.
• Institution decision: DENIED — 2019-02-11 (Paper 7). The panel never reached obviousness. It framed the gating question as: because "a petitioner in an inter partes review may request to cancel . . . claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications" (§ 311(b)), the Board "must address whether Petitioner has provided a sufficient threshold showing that the Celgene Press Releases constitute prior art under section 102." Applying Dynamic Drinkware, Frontier Therapeutics (IPR2016-00649), Symantec v. Columbia (IPR2015-00371) and related cases, the panel held Petitioner failed that threshold showing of public accessibility and therefore declined institution. The decision also noted the parties agreed no claim term required express construction, and that "no explicit construction of any claim term is necessary to determine whether to institute trial in this case."
  • Celgene's POPR had additionally pressed: § 314(a) efficiency (advanced parallel D.N.J. litigation; Hatch-Waxman balance); insufficient petition specificity; § 325(d) (same art/arguments already before the Office in the '120, '717 and '740 prosecutions); and that List 2001 was not prior art at all. The Board's denial rests on the printed-publication defect; I could not confirm from the record that it adopted any of the alternative POPR theories.
• Final Written Decision: None. Not instituted, so no trial, no FWD, no claim-level outcome. Do not represent that any claim of the '120 patent was canceled or confirmed by the PTAB.
• Settlement / termination: No settlement. Case terminated by the denial of institution; Petitioner's refund request filed 2019-06-21 and Board refund approved 2019-07-03 (Paper 10); PTAB docket reflects "Not Instituted – Merits."
• Appeal: None. There is no FWD to appeal, and a denial of institution is effectively unreviewable under § 314(d) (cf. Cuozzo). No CAFC docket on the '120 patent exists.
• Defensive value: The petition is a road map, not a victory. It shows the exact prior-art theory a challenger would run (List 2001 or Thomas 2000a + the '230 patent + Celgene's own 2001 press releases) and shows exactly where it died — the press releases as "printed publications." A defendant today can re-file that theory with proper public-accessibility proof (declarations, Internet Archive captures, distribution records) without any § 315(e)(2) estoppel, because no FWD ever issued. The corollary warning: the patent owner has no merits precedent to hide behind, and cannot fairly call this a "PTAB victory on the merits."

Companion proceedings (different patents, same petitioner/panel/window — context only)

These do not involve the '120 patent, but they are the same Dr. Reddy's campaign, filed the same day against three related Zeldis MDS patents, all denied on the same printed-publication rationale on the same date by the same panel (APJ Obermann authoring):

Source for the three-case grouping: Jones Day experience note (Celgene counsel), https://www.jonesday.com/en/practices/experience/2019/02/celgene-successfully-blocks-institution-of-eminter. Institution decisions: https://www.docketalarm.com/cases/PTAB/IPR2018-01507/Inter_Partes_Review_of_U.S._Pat._8404717/ and https://www.docketalarm.com/cases/PTAB/IPR2018-01509/Inter_Partes_Review_of_U.S._Pat._7189740/ ; '504 record: https://www.docketalarm.com/cases/PTAB/IPR2018-01504/Inter_Partes_Review_of_U.S._Pat._9056120/ and PTAB E2E, https://ptacts.uspto.gov/ptab .

No PGR, no CBM, and no ex parte/inter partes reexamination on the '120 patent were found in any source. The structured ODP block's "none on file" is therefore correct as to PGR/CBM/reexam but not as to IPR.

Strategic summary

Claim status. No claim of US 9,056,120 has been canceled, narrowed, or sustained by the PTAB, because no IPR was ever instituted. Claims 1–8, 12–34 and 38–53 were challenged but never reviewed; claims 9–11 and 35–37 were never even challenged. If your adversary's demand letter or complaint says the PTAB "upheld" or "confirmed" the '120 claims, that is overstated — the Board expressly declined to reach the merits. Conversely, if a defendant assumes the '120 is invalid because it was "IPR'd," that is equally wrong: the only PTAB event is a threshold denial and a refund. The only real-world constraint on validity is the expiration of the patent (anticipated 2023-04-11, "Expired – Lifetime"), which limits damages to past acts and eliminates any forward-looking injunction theory.

Estoppel landscape. Section 315(e)(1)/(2) estoppel is triggered only by a final written decision. There was none here, so no party — including Dr. Reddy's — is statutorily estopped on any ground as to the '120 patent. Practically, though, DRL itself is § 315(b) time-barred from filing a fresh IPR on the '120: DRL was sued in Celgene v. Dr. Reddy's, D.N.J. 2:17-cv-05314 (2017), and the one-year window has long closed for that defendant. A different defendant sued later (or not yet sued) is not time-barred and can raise the full § 102/§ 103 field — including the List 2001 / Thomas 2000a / '230 patent / press-release combination — subject to General Plastic follow-on-petition discretion (weaker here because the first petition never got to trial) and § 325(d) (weaker for a challenger who cures the public-accessibility defect the first petitioner failed to cure).

Pattern signals. One petitioner (Dr. Reddy's), one shot at this patent, three coordinated petitions filed 2018-08-03 across the MDS method-of-treatment family, all defeated the same way. No defensive aggregator (e.g., Unified Patents) appears in the '120 chain — the PTAB activity is generic-ANDA-driven, not troll-driven. Celgene never had to defend a merits FWD on the '120; it also never obtained one. In the collateral antitrust litigation, insurer/MSP plaintiffs characterized these denials as a "technicality" and the district court held the sham-litigation theory failed as to the '740, '717 and '120 method-of-treatment patents. I found no Federal Circuit appeal on this patent.

Recommended next steps

1. If you are a defendant and want to invalidate the '120 in an IPR: the path is open but narrow in time. Confirm you are not § 315(b) time-barred (has an infringement complaint been served on you more than one year ago?), then build the petition around the same two grounds DRL used, with the one missing element cured: hard evidence that Celgene Press Releases 5/8/2001 and 8/28/2001 were publicly accessible printed publications before the critical date (web-archive captures, SEC/company distribution records, third-party library or newswire proof, declarant testimony). Absent that, expect the exact same § 311(b) threshold denial. The institution decision is the controlling road map: Paper 7, 2019-02-11, in IPR2018-01504.
2. If you are relying on the IPR as a defensive citation: quote the actual disposition, not the label. The Board "decline[d] to institute an inter partes review" and reached the merits in neither ground. There is no FWD to link. The closest citable public documents are the institution decision (Paper 7) and the Board's refund approval (Paper 10, 2019-07-03).
3. If you are the patent owner: the absence of any merits adjudication cuts both ways. You may truthfully say no claim has been canceled; you should not say a claim has been upheld. Any statement of "PTAB victory on the merits" is vulnerable to correction by the record.
4. Because there are no active proceedings, there are no trial-stage milestones (no institution deadline, no oral hearing, no FWD due date) to track. The absence of any later IPR — despite the '120 being asserted in multiple 2017–2021 ANDA suits — is explained by the 2023-04-11 expiry and by litigation-wide settlements, not by any adjudicated strength of the claims.

Explicit uncertainty: (a) I could not retrieve the full author line of the '504 institution decision, so the "judge writing" attribution is unverified; (b) the structured ODP block contradicts the documented IPR, and I have flagged rather than reconciled it; (c) I did not open every docket page for the '504 proceeding, so procedural details beyond the accord date, POPR date, institution denial, and refund are drawn from secondary aggregators (IPVerse, Patexia, Docket Alarm, DrugPatentWatch) that may lag PTAB E2E.

I'll research the assignment record for US 9,056,120. Let me run several targeted searches.

Let me dig into the specific assignment records and the Celgene–BMS merger effects.

Let me try to pin down the specific reel/frame records and check the Stanford NPE database entry.

Ownership Reconstruction — U.S. Patent No. 9,056,120 B2

Verification caveat up front (read before relying on Section 3): I was unable to complete a live pull from USPTO Assignment Center (assignmentcenter.uspto.gov / assignment.uspto.gov) within this session's search budget — the reel/frame detail pages for application 13/801,262 did not surface in indexed results, and the search tool capped out before I could open them. I therefore report the assignment events that are independently documented (Google Patents legal-events record; PTAB mandatory notice; D.N.J. docket exhibits) and explicitly mark every field I could not verify (reel/frame numbers, correspondent of record, execution dates). I have not invented reel/frame values or correspondent names. Where I extrapolate from the family, I say so.

Inventors

Pattern check — "inventor departs within 12 months of filing": Not present. Zeldis remained at Celgene roughly three years past the 2013 filing and did not exit until 2016. There is no departure-then-fire-sale precursor here. (Contrast the parent '740 prosecution, where Zeldis was the declarant of both the First and Second Zeldis Declarations — he was the central inventive and swear-behind figure for the whole lenalidomide-in-MDS family, which is consistent with a single-executive-inventor portfolio rather than an inventor team that dispersed.)

Original assignee

Celgene Corporation (Delaware corporation) — Summit, NJ. Two addresses appear across the family's recordation documents: 86 Morris Avenue, Summit, NJ 07901 (the address recited in the IPR mandatory notice) and the earlier 7 Powder Horn Drive, Warren, NJ 07059 (used in earlier filed assignments).

• Did it ship a product embodying the claims? Yes. REVLIMID® (lenalidomide) is FDA-approved for myelodysplastic syndromes; the '120 patent was Orange-Book listed for lenalidomide/REVLIMID (N 021880, patent code U-1982). The patent was asserted in Hatch-Waxman ANDA suits against generic challengers — the classic signature of an operating company defending a marketed drug.
• Primary line of business: fully integrated biopharmaceutical company (oncology/hematology/immunology).
• Current status: Acquired. Bristol-Myers Squibb completed its $74B acquisition of Celgene on 2019-11-20; Celgene became a wholly-owned subsidiary of BMS and its common stock ceased trading. Solvent acquisition — no bankruptcy, no Chapter 7/11. Whether the Celgene→BMS corporate combination was ever recorded against this patent at USPTO is unverified (see below).

Assignment timeline

Confirmed event (1 of 1) on the '120 patent itself

• Execution date: not retrieved / recorded 2013-03-13 — Reel/Frame: NOT RETRIEVED (could not open the Assignment Center record)
  • Conveyance: Assignment of Assignors' Interest (see document for details) — i.e., a prosecution-time inventor assignment, not a post-issuance transfer.
  • Assignor: ZELDIS, JEROME B.
  • Assignee: CELGENE CORPORATION
  • Correspondent of record: NOT RETRIEVED — cannot identify the filing attorney/firm or their address; therefore the repeat-correspondent test (Signal 3) cannot be scored. This is a data gap, not a negative finding.
  • Context: Obligation-to-assign / original vesting — the same-day-as-filing assignment by which Celgene took title from its officer-inventor. Source: Google Patents legal-events entry for US 9,056,120 ("2013-03-13 — Assigned to CELGENE CORPORATION … Assignors: ZELDIS, JEROME B.").

Family context — NOT an assignment of the '120 patent (do not attribute to the '120):
In IPR2018-01509, Celgene's mandatory notice states that ownership of U.S. 7,189,740 (the '120 patent's ultimate grandparent in this continuation chain) came "by virtue of an assignment from the inventor, Jerome B. Zeldis," recorded 2003-11-03 at Reel 014655/0001 and 2004-07-07 at Reel 016204/0173. These are the parent patent's records; the '120 patent, filed 2013-03-13, would carry its own later reel/frame. I flag them because they show the same inventor→assignee pattern recurring across the family, and because they are the only verified reel/frame numbers I could retrieve anywhere in this chain.

• No post-issuance assignments were surfaced. I found no evidence of any assignment, security agreement, license, or change-of-name recorded against the '120 patent after grant, and none evidencing a Celgene→BMS transfer. Given that Celgene survived the 2019 merger as a wholly-owned subsidiary (rather than being merged out of existence), the owner of record plausibly remains Celgene Corporation — but I could not confirm that against a primary USPTO record, so treat it as unverified.

Timeline diagram

timeline
    title Ownership of US 9056120
    2002 : Priority provisional filed
    2003 : Parent patent assigned to Celgene
    2013 : Continuation filed by Zeldis
         : Assigned to Celgene Corporation
    2015 : Patent issued
    2017 : First ANDA suit asserting patent
    2019 : Celgene acquired by Bristol Myers Squibb
    2023 : Anticipated expiration

NPE / troll-pattern signals

Verdict

Operating-company assertion.

Every verified fact drives to a single conclusion. The owner of record is Celgene Corporation, which took the patent by an inventor assignment recorded 2013-03-13 from its own officer (Zeldis) and shipped an FDA-approved product (REVLIMID® / lenalidomide) covered by the claims — the '120 patent even carried an Orange Book listing (N 021880, code U-1982). Celgene then asserted the patent as plaintiff against generic competitors in Hatch-Waxman ANDA litigation (e.g., 2:17-cv-06842, Celgene v. Lotus Pharmaceutical/Alvogen), and the Stanford NPE Litigation Database independently tags that asserter as a "Product company," not an NPE. There is no shell entity, no asserter-chain, no bankruptcy sale, no pre-litigation transfer, and no defensive-aggregator endpoint — Celgene's later absorption into Bristol-Myers Squibb (closed 2019-11-20) is an ordinary pharma acquisition, not a monetization vehicle.

Two honest limits on this verdict: (a) I could not retrieve the reel/frame or correspondent of record for the single recorded assignment, so Signal 3 is unscored rather than rebutted; and (b) I could not confirm whether the Celgene→BMS combination was ever recorded at USPTO against this patent.

Verify at: USPTO Assignment Center — search by patent number 9056120 (equivalent legacy index: assignment.uspto.gov). The reel/frame and correspondent fields I flagged as "NOT RETRIEVED" are exactly what to pull there.

I'll search for the specific patent and its cited references.

I have the partial U.S. reference list. Let me get the complete citation lists (foreign documents and non-patent literature) and verify dates.

Let me retrieve the remaining cited references (foreign documents and non-patent literature) and verify key reference details.

Prior-Art Analysis — US 9,056,120 B2 (Zeldis / Celgene)

Search calibration note. I searched for the literal string "9056120." Every hit that is relevant concerns US 9,056,120 B2 ("Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine"). Hits for other numbers (e.g., US 9,991,056 — a KLA/Tencor semiconductor patent; the IEEE DOI 10.1109/MEMS46641.2020.9056120; JP 2004-035064) were discarded as non-matches. No auto-correction of any identifier was performed.

Date note (flagging an inconsistency): the task header sets "Current Date: April 26, 2026," while the analysis sections previously produced use 2026-10-01. Nothing below turns on the difference, but I flag it per the cross-reference rule.

1. The threshold problem with any §102 analysis of this patent

Before mapping references to claims, three structural facts control everything:

(a) Effective filing date — and it is genuinely contested. The '120 application (13/801,262, filed 2013-03-13) is a continuation of 12/777,765 (2010-05-11) → CIP of 11/985,032 (2007-11-12, now US 7,863,297) → continuation of 11/654,550 (2007-01-16, now US 7,393,863) → divisional of 10/411,649 (2003-04-11, now US 7,189,740) → provisional 60/418,468 (2002-10-15).

The lenalidomide + azacitidine combination subject matter is the salient question: whether it is supported as far back as 10/411,649 (2003-04-11) or the provisional (2002-10-15), or was first added in the 2007 CIP (11/985,032). This is not a formality — it determines which of the cited references are even eligible to be §102 art. I could not resolve it from a primary source in this session and am flagging it rather than assuming.

(b) Pre-AIA §102 governs if the claims carry their earlier priority (effective filing date well before 2013-03-16). That means: §102(a) (knowledge/use by others before invention), §102(b) (printed publication/patent more than one year before the effective U.S. filing date), and §102(e) (U.S. patent or published application by another, filed before the applicant's invention date).

(c) Anticipation requires a single reference disclosing every recited element. Claim 1 requires, in one reference: (i) treating MDS; (ii) a therapeutically effective amount of 5-azacytidine; and (iii) a therapeutically effective amount of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione (lenalidomide) or a salt. No dose, schedule, or route is recited in claim 1. To anticipate, a reference must disclose that specific two-drug combination for MDS.

2. U.S. patent-document citations

The list below is what I could verify from the patent's "References Cited" record as reproduced by FreePatentsOnline (freepatentsonline.com/9056120.html). That capture was truncated, so this is not certified as the complete front-page list (see §5, uncertainty).

Bottom line on the U.S. patent citations

Not one of the cited U.S. patent documents discloses, in a single reference, the administration of both lenalidomide and 5-azacytidine to an MDS patient. Accordingly, none of them anticipates claim 1 (or its dependents) under §102. Most are also disqualified on timing (post-priority) or identity (applicant's own family), and several are directed to unrelated subject matter (azacitidine polymorphs, excipients, delivery systems). The examiner's actual rejections bear this out — see §4.

3. Foreign patent documents

The dominant foreign family member is WO 2004/035064 A1 (Celgene, published 2004-04-29; PCT/US2003/011323, filed 2003-04-13; priority US 60/418,468, 2002-10-15) — "Methods of using and compositions comprising immunomodulatory compounds for the treatment and management of myelodysplastic syndromes" (Google Patents WO2004035064A1; EPO bibliographic record, EP 1487461 A4). Its EPO search report cites, as background, List, "New approaches to the treatment of myelodysplasia," Oncologist 7(Suppl 1):39–49 (2002) and Corral et al., J. Immunol. 163:380–386 (1999).

Critically, WO 2004/035064 is not third-party prior art against the '120 patent: it is the PCT counterpart of Celgene's own 10/411,649 filing, sharing the 2002-10-15 priority and the same inventive entity. It cannot anticipate its own U.S. continuation. The EPO also cited the '120 patent's own publication family (e.g., US 2010/0278779) as "X,P" art against a later Celgene application (EP 3,219,317) — again family-internal, not art against the '120.

I could not verify a complete, certified list of every foreign document on the '120 front page within this session; the foreign citations I confirmed are family members and background art.

4. Non-patent literature — and the references that actually mattered

The NPL cited in the '120 specification (and confirmed via Google Patents and the PubChem patent record for US-9056120-B2) includes:

• Kornblith et al., J. Clin. Oncol. 20(10):2441–2452 (2002) and Silverman et al., J. Clin. Oncol. 20(10):2429–2440 (2002) — the NCI-sponsored azacitidine monotherapy trials in MDS. These are the closest NPL to the claimed subject matter and are squarely pre-priority. They disclose azacitidine alone for MDS, not the lenalidomide combination — so they do not anticipate claim 1, but they are central §103 background (and were the kind of evidence in play in the IPR).
• Disease-background literature: Besa, Med. Clin. North Am. 76(3):599–617 (1992); Greenberg et al., Blood 89:2079–88 (1997); Epstein & Slease, Surg. Ann. 17:125 (1985); List et al., J. Clin. Oncol. 8:1424 (1990); Bennett et al., Ann. Intern. Med. 103(4):620–5 (1985); Harris et al., J. Clin. Oncol. 17(12):3835–49 (1999); Goldberg et al., Cancer Res. 50(21):6876–81 (1990).
• Thalidomide/IMiD literature: Koch, Prog. Med. Chem. 22:165–242 (1985); Moller et al., J. Immunol. 159:5157–61 (1997); Corral et al., Ann. Rheum. Dis. 58(Suppl I):1107–13 (1999); Marriott et al., Expert Opin. Biol. Ther. 1(4):1–8 (2001); Muller et al., J. Med. Chem. 39(17):3238–40 (1996) and Bioorg. Med. Chem. Lett. 8:2669–74 (1998); Singhal et al., N. Engl. J. Med. 341(21):1565–71 (1999); D'Amato et al., PNAS 91:4082–85 (1994).
• Growth-factor/cytokine background: Metcalf, Science 229:16 (1985); Dexter, J. Cell Sci. 88:1 (1987); Moore, Annu. Rev. Immunol. 9:159 (1991); Schrader et al., PNAS 78:323 (1981); Moore et al., J. Immunol. 125:1302 (1980); Kurland et al., PNAS 76:2326 (1979); Handman & Burgess, J. Immunol. 122:1134 (1979); Vadas et al., Blood 61:1232 (1983); Schuster et al., Blood 76(Suppl 1):318a (1990); Besa et al., Blood 76(Suppl 1):133a (1990); Hellstrom et al., Blood 76(Suppl 1):279a (1990); Bowen et al., Br. J. Haematol. 77:419 (1991).
• Penichet & Morrison, J. Immunol. Methods 248:91–101 (2001); Emens et al., Curr. Opin. Mol. Ther. 3(1):77–84 (2001) — protein/vaccine background.
• The CIP-era literature added Fenaux et al. (the AZA-001 phase III results, Blood 2007 and Lancet Oncol. 2009) and related azacitidine survival papers — but these postdate even the 2007 CIP and are background, not §102 art.

None of this NPL anticipates. The closest (Kornblith/Silverman) teach azacitidine as a single agent in MDS.

5. What the record actually shows about the "most relevant" art

Directly answering the question "which claim(s) does each reference potentially anticipate": the honest answer is that no cited reference anticipates any claim. The '120 patent's validity was instead litigated on different theories:

1. Obviousness-type double patenting during prosecution — the examiner rejected claims 1–37 over US 8,404,716; over US 7,189,740 in view of Ionescu et al. (US 6,887,855); and over US 8,404,717 in view of Ionescu — requiring terminal disclaimers. This is why Ionescu appears in the cited list: it is double-patenting art, not §102 art.
2. IPR2018-01504 (Dr. Reddy's v. Celgene) — the only direct validity attack on the '120 patent. The petition (Ex. 1001 = the '120 patent; Ex. 1002 = its file history) relied on a large clinical/patent-art set, including List 2001 ("Hematology 2001"), Thomas 2000a, Raza 1995/1996/2000/2001, Corral 1999, Muller 1999, D'Amato 1994, Singhal 1999/2001, Cheson 2000, Greenberg 1997/2002, the '517, '230, and '346 patents, and Celgene press releases — i.e., the challenge was an obviousness attack, not pure anticipation. Institution was denied on the merits (Feb. 11, 2019), and the proceeding terminated with a petitioner refund (July 2019). See the PTAB docket record (IPR2018-01504, Patent Owner Exhibits 2001–2033).

If forced to name the single most relevant prior-art documents for a hypothetical anticipation theory on claim 1, they would be (i) Kornblith 2002 / Silverman 2002 for the azacitidine-for-MDS element and (ii) Muller's lenalidomide/isoindoline patents (e.g., US 5,635,517; US 2004/0122052) for the lenalidomide element — but these are separate references teaching the individual halves of the combination, which supports at most a §103 combination argument, never §102 anticipation.

6. Explicit uncertainties and limits

• Completeness of the citation list: the FreePatentsOnline "References Cited" capture I retrieved was truncated; the full front-page list (all U.S. patents, U.S. publications, foreign documents, and NPL exactly as printed) was not obtained from a primary USPTO source. Treat the tables above as a verified-in-part reconstruction, not a certified reproduction of the '120 front page.
• US 2004/0152632 (Feingold) is the only cited document whose title ("Combination therapy for the treatment of acute leukemia and myelodysplastic syndrome") suggests it could touch the claimed combination. I could not verify the specific drugs it discloses. Do not treat it as anticipatory without pulling the document.
• Effective filing date of the combination claims (2002-10-15 vs. 2003-04-11 vs. 2007-11-12) is unresolved here and is outcome-determinative for which references qualify as prior art. I flag it rather than assume.
• §102(e) dates (actual filing dates) for the cited U.S. patents/publications were not individually confirmed; I list their publication/issue dates as recorded. Any §102(e)/§102(a)(2) theory requires the underlying filing dates.
• I found no Federal Circuit decision on the merits of any '120 claim. The patent expired (anticipated) 2023-04-11 and is listed "Expired – Lifetime," so this analysis is historical.

I'll verify the identity of the prior-art references named in the IPR petition (List 2001, Thomas 2000a) and any other references in the record before building the § 103 analysis.

Let me try to confirm the granted claim set of the '120 patent from a primary source, since the IPR record appears to conflict with the earlier summary.

Obviousness Analysis — U.S. Patent No. 9,056,120 B2 (35 U.S.C. § 103)

Prepared: April 26, 2026. Subject: U.S. 9,056,120 ("the '120 patent"), Zeldis, Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine, issued 2015‑06‑16, app. 13/801,262, Celgene Corp., expired 2023‑04‑11.

§0. Threshold correction to the earlier-generated sections (flagged contradiction)

The earlier "Patent summary" section states that claim 1 of the '120 patent is the combination claim ("...a therapeutically effective amount of 5‑azacytidine, and a therapeutically effective amount of 3‑(4‑amino‑1‑oxo‑1,3‑dihydro-isoindol-2‑yl)-piperidine-2,6‑dione...") and asserts that text was "confirmed as claim 1 of the '120 patent in the IPR record."

That is contradicted by the primary-source IPR filings, and I flag it here rather than repeat it. Both the petitioner's mapping table and Celgene's own Preliminary Response — quoting Ex. 1001 at 21–22, i.e., the '120 patent itself — state that the '120 patent has two independent claims, 1 and 28, and that both are lenalidomide‑dosing claims, not combination claims:

• Claim 1: "A method of treating myelodysplastic syndrome, which comprises administering to a patient in need thereof about 1 mg to about 25 mg per day of a compound having the formula: [lenalidomide structure] or a pharmaceutically acceptable salt, solvate or stereoisomer thereof."
• Claim 28: "A method of treating transfusion dependent anemia due to low to intermediate‑1‑risk myelodysplastic syndrome, which comprises..." (same about‑1‑to‑25 mg/day lenalidomide limitation).

Sources: petitioner's petition, Docket Alarm, https://www.docketalarm.com/cases/PTAB/IPR2018-01504/Inter_Partes_Review_of_U.S._Pat._9056120/docs/08-03-2018-Petitioner/Petition-2-120_Petition.pdf; patent owner's preliminary response, https://www.docketalarm.com/cases/PTAB/IPR2018-01504/Inter_Partes_Review_of_U.S._Pat._9056120/docs/11-14-2018-Patent_Owner/Preliminary_Response-6-Patent_Owners_Preliminary_Response.pdf. The petition states it plainly: "Specifically, the '120 patent claims the use of about 1‑25 mg/day of lenalidomide to treat myelodysplastic syndromes (MDS) and transfusion dependent anemia due to low to intermediate‑1‑risk myelodysplastic syndrome" (https://ptacts.uspto.gov/ptacts/public-informations/petitions/1516995/download-documents?artifactId=FdHLl3-vyPR3UNV5wvg5rxv6GadAhvvERUH0_xQPpZMmW-9n8H72iEY).

Reconciliation: Celgene's pre‑grant publication US 2013/0202590 and the '120 specification/title/abstract (which do recite azacitidine + lenalidomide) differ from the granted claim set. The earlier summary appears to have used the as‑published claim listing. For § 103 purposes I analyze (A) the granted claims and (B) the combination subject matter reflected in the title/abstract, since the task asks about the patent as a whole.

Residual uncertainty (unverified): Claims 9–11 and 35–37 appear in neither the petition's dependent‑claim map nor the challenged set (the petition challenged 1–8, 12–34 and 38–53). Symmetric gaps (9–11; 35–37) suggest a parallel pair of claims whose subject matter I could not retrieve. Given the title, a plausible hypothesis is that they capture the lenalidomide + azacitidine combination, but I cannot verify this and do not rely on it.

§1. The claims to be analyzed

Claim-construction notes: the ONLY numerical limitation in the independents is "about 1 mg to about 25 mg per day." "Treating MDS" and "TDA due to low to intermediate‑1‑risk MDS" are conventional clinical terms; the parties in IPR2018‑01504 agreed no term required express construction (institution decision, Paper 7, 2019‑02‑11).

§2. Legal framework and POSA

• Governing standard: Graham v. John Deere Co., 383 U.S. 1 (1966); KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (predictable solutions to known problems; "obvious to try" where the prior art identifies a finite number of identified, predictable solutions).
• Structural analogy: In re Papesch, 315 F.2d 381 (CCPA 1963) (a structurally similar compound with known, shared properties is prima facie obvious); see also In re Fleshner line for substituting a known compound for a known purpose.
• Dose/range optimization: In re Aller, 220 F.2d 454 (CCPA 1955); In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003); In re Kao, 639 F.3d 1057 (Fed. Cir. 2011) (dosing‑regimen claims).
• Teaching away: In re Gurley, 27 F.3d 551 (Fed. Cir. 1994).
• Secondary considerations/nexus: In re Kao; Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299 (Fed. Cir. 2006).
• POSA (per the petition): a physician (M.D.) or Ph.D. in hematology/oncology or medicinal chemistry with several years' experience treating hematologic malignancies and with access to the then‑current MDS literature. I adopt this as consistent with the field.

§3. Prior‑art inventory used in this analysis

Drawn from (i) the Google Patents "Prior Art" metadata on the '120 page — prior‑art date 2002‑10‑15, prior‑art keywords "compound, administered, amount, per day, pharmaceutically acceptable" (https://patents.google.com/patent/US9056120/en); and (ii) the '120 patent's own References Cited / Other Publications as reproduced in IPR Exhibit 1001 (https://gaeflexstaging-dot-docketupdate.appspot.com/cases/PTAB/IPR2018-01504/Inter_Partes_Review_of_U.S._Pat._9056120/08-03-2018-Petitioner/Exhibit-1001-Ex_1001___120_Patent/); and (iii) the two grounds asserted in IPR2018‑01504.

§4. Ground 1 — List 2001 + the '230 patent + Celgene Press Releases 5/8/2001 & 8/28/2001

(This is exactly the combination Dr. Reddy's ran. Source: the '120 Petition, §§V.G, https://www.docketalarm.com/cases/PTAB/IPR2018-01504/Inter_Partes_Review_of_U.S._Pat._9056120/docs/08-03-2018-Petitioner/Petition-2-120_Petition.pdf.)

Claim 1 chart

Motivation / legal rationale. Combine (i) a known disease (MDS), (ii) a known mechanism (TNF‑α inhibition / anti‑angiogenesis — the '230 patent; Kitagawa 1997; Peddie 1997), (iii) a known working drug in that disease (thalidomide; Raza 2001), and (iv) a known, more potent, better‑tolerated analog explicitly named in the '230 patent and reported in human trials in Celgene's own press releases. Under KSR, this is a predictable substitution of a structurally similar compound known to share the mechanism and the utility — the classic Papesch/structural‑analogy situation. The art supplies a finite, identified set of candidate drugs (the '230 genus), a known purpose (MDS), and a starting dose from published clinical data. That is an "obvious to try" case with a reasonable expectation of success.

§5. Ground 2 — Thomas 2000a + the '230 patent + the Celgene Press Releases

(The petitioner's second, parallel ground; same claim set.)

Thomas 2000a teaches thalidomide's anti‑angiogenic and anti‑TNF‑α mechanisms and its use in hematologic malignancy, and discusses structurally related analogs. The '230 patent supplies lenalidomide as a disclosed, more potent analog; the press releases supply Revimid's human dosing and safety. The motivation is the same as Ground 1: a POSA seeking a thalidomide replacement (to avoid neuropathy and teratogenicity — expressly disclosed in the '120 spec, §3.3) would look to the '230 genus and select the compound already in the clinic.

Celgene's two factual counterpoints (POPR, same URL as above) — which go to motivation, not to the disclosure:

1. Thomas 2000a "suggested that only a SelCID (CDC‑801)… was entering a trial for MDS," and SelCIDs were described as "more similar to thalidomide than IMiDs" — so the art arguably pointed away from lenalidomide.
2. "The compound now known as lenalidomide was one of the least potent TNF‑α inhibitors" among the analogs, and petitioner's "most potent" premise rests on a "fundamental misunderstanding of TNF‑α IC₅₀ data."

These are genuine questions of fact. They do not defeat Ground 1 or Ground 2 as a matter of law, but they are the reason the Board might have found (had it reached the merits) a disputed issue of motivation.

§6. Ground 3 (alternative, and arguably the strongest for claim 28) — Raza 2001 and Thomas 2000 + the '230 patent + the press releases

Raza 2001 is listed on the face of the '120 patent (Ex. 1001, "Other Publications"). It reports that thalidomide "produces transfusion independence in long‑standing refractory anemias of patients with MDS" — i.e., it achieves the precise therapeutic outcome recited in claim 28 ("transfusion dependent anemia due to low to intermediate‑1‑risk MDS").

Why this combination is strong:

• The outcome of claim 28 (transfusion independence in TDA) is literally disclosed by Raza 2001.
• The patient subset ("low to intermediate‑1‑risk MDS") is a routine application of the IPSS, which the '120 specification itself reproduces as a standard of care (spec Table 1; Greenberg 1997, also on the face).
• The compound and dose come from the '230 patent + press releases.
• A patent owner cannot call Raza 2001 "non‑analogous art" — it is the applicant's own cited art, which defeats the "field of endeavor / reasonable expectation" defense.

Motivation: A clinician treating a low‑risk MDS patient with transfusion‑dependent anemia, aware that thalidomide produces transfusion independence (Raza 2001) but causes neuropathy and is teratogenic, would substitute the more potent, better‑tolerated, structurally related analog that Celgene's own press releases said was in trials at 5–25 mg/day.

§7. Obviousness of the combination subject matter (title/abstract; possibly claims 9–11 / 35–37)

If any claim requires co‑administration of azacitidine + lenalidomide (the patent's title and abstract; the previously generated summary's characterization of the published claims), the § 103 showing is, if anything, easier:

Caveat: Because I could not retrieve the text of any granted claim that recites azacitidine, this section is framed on the specification/title and flagged as unverified as to claim scope. If in fact no granted claim recites azacitidine, this ground is academic.

§8. Dependent claims

Under KSR, once the independents are obvious, the dependents fall with them unless they add a non‑obvious, unexpected limitation (the petitioner made precisely this argument, Petition § V.G.2–8):

• Specific MDS subtypes (2): the FAB/WHO subtype taxonomy is standard (Bennett 1985; Harris 1999 — both on the '120 face).
• Salt / solvate / stereoisomer (3–6 / 29–32): the '230 patent discloses pharmaceutically acceptable forms; selecting a salt/solvate is routine formulation.
• Orally / oral capsule/tablet (24–27 / 50–51): the '120 spec's own preferred route is oral; capsules are conventional (In re dosage‑form cases).
• 28‑day cycle = 21 days on / 7 days off (16–21 / 42–47): azacitidine's approved schedule in the cited Silverman 2002 is "every 28 days"; 21/7 lenalidomide‑dexamethasone cycling was known in MM (the '569‑family patents); one‑week rest periods for IMiDs were known. In re Kao warns that dosing‑regimen claims must show an unexpected result, not mere optimization.
• Fixed doses 5/10/15/20/25 mg (22–23 / 48–49; 26–27 / 52–53): directly disclosed/telegraphed by the press releases (5–25, 5–50, "up to 25" mg/day).
• "Until unacceptable disease progression or toxicity" (15 / 41): the standard clinical endpoint for any chronic therapy.
• Transplantation‑adjacent administration (12 / 38): the '120 spec treats transplant as a standard adjunct; a POSA would administer before/during/after a stem‑cell transplant as a matter of clinical routine.

§9. Rebuttal landscape — what could defeat the prima facie case

Celgene's POPR articulates the strongest non‑obviousness theory (POPR, §§VIII–X, same URL). A challenger must anticipate it:

1. No link between TNF‑α inhibition and MDS at the critical date. Celgene argues the etiology of MDS was unknown, targets were speculative, and "TNF‑α inhibitors did not work in treating MDS" — pointing to the failed etanercept (Enbrel) MDS trials (Deeg 2002; Maciejewski 2002), both on the '120's own face. This attacks the reasonable expectation of success and is the most potent defense.
2. Teaching away via cytopenias. Celgene argues thalidomide analogs (CC‑5013) were known to cause cytopenias — the very symptom set of MDS — so the art taught away. Under In re Gurley a reference must "criticize, discredit, or otherwise discourage" the solution; whether a toxicity signal rises to that level is a factual question.
3. Wrong‑compound argument. Thomas 2000a allegedly pointed to CDC‑801 (SelCID), not lenalidomide; and lenalidomide was among the least potent TNF‑α inhibitors — so the art did not single it out.
4. Secondary considerations. Celgene would plead commercial success of Revlimid and long‑felt need. The petitioner's answer (Petition §X) is no nexus (success attributable to Celgene's marketing and the REMS/thalidomide‑class safety apparatus), no unexpected results, and no long‑felt unmet need. Nexus is the whole ballgame: Ormco.

Weighing: Grounds 1–3 are legally sufficient to make out a prima facie case; items 1–3 raise genuine factual disputes that the PTAB never reached because institution was denied on the threshold § 311(b) "printed publication" issue (the press releases). That is the key practical takeaway from §4 of the Litigation section above: the merits of this obviousness theory have never been adjudicated.

§10. Bottom line

Common motivation thread: MDS was a disease with a thin therapeutic armamentarium; thalidomide was a known MDS therapy with serious drawbacks (neuropathy, teratogenicity); its mechanism (TNF‑α/angiogenesis) was linked to MDS pathology; and the '230 patent expressly names a structurally related, more potent, better‑tolerated analog that Celgene's own press releases placed in human trials within the claimed dose range. Under KSR and Papesch, substituting that analog for thalidomide in MDS (claims 1–27) and in MDS‑associated transfusion‑dependent anemia (claims 28–53), at a dose chosen by routine optimization, would have been obvious to try.

Confidence & open items.

• High confidence: the granted independent claims 1 and 28 are lenalidomide‑dosing claims; the two asserted IPR grounds and their references; the identity of List 2001, Thomas 2000a, the '230 patent, and the Celgene press releases.
• Flagged contradiction: the earlier "Patent summary" section's claim‑1 text (combination) conflicts with the primary‑source IPR record; I have resolved it in favor of the IPR record (granted claims) while analyzing the combination subject matter separately.
• Unverified: the subject matter of claims 9–11 and 35–37; whether the granted claims recite azacitidine at all; the exact text of claim 28's "about 1–25 mg/day" limitation (quoted here only in part from the POPR snippet).
• Not adjudicated: no tribunal has ruled on the § 103 merits — IPR2018‑01504 was denied institution on the printed‑publication threshold, with no final written decision and no estoppel.