US 7189740

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

US Patent 7,189,740 — Summary

Important scope note up front: I searched for activity at the Court of Appeals for the Federal Circuit (CAFC) in 2026 specifically tied to 7,189,740. I found no CAFC 2026 docket, appeal, or opinion naming this patent. What I did find is PTAB and district-court activity (below). I cannot rule out that a 2026 appeal exists that is not indexed in the sources I could reach, but I have no authoritative hit for one. I have not substituted results for any similar number (e.g., the related '717, '120, or '740-family member patents); the records below are for the literal identifier 7,189,740 (US10/411,649).

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Bibliographic Data (from the Google Patents full text and corroborating records)

Abstract (verbatim):

"Methods of treating, preventing and/or managing myelodysplastic syndromes are disclosed. Specific methods encompass the administration of an immunomodulatory compound, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof, alone or in combination with a second active ingredient, and/or the transplantation of blood or cells. Specific second active ingredients are capable of affecting or blood cell production. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed."
(Note: the printed abstract contains the typographical renderings "myclodysplastic" and "affecting or blood cell production" — quoted literally, not corrected.)

Active compound: 3‑(4‑amino‑1‑oxo‑1,3‑dihydro‑isoindol‑2‑yl)‑piperidine‑2,6‑dione — i.e., lenalidomide (Revimid™/Revlimid®). The patent also discusses the related IMiD 4‑(amino)‑2‑(2,6‑dioxo(3‑piperidyl))‑isoindoline‑1,3‑dione (ACTIMID™).

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Plain-Language Overview of the Independent Claim(s)

⚠️ Uncertainty flag: The authoritative full text supplied to me is truncated before the numbered claims, so I do not have the verbatim, complete claim set in front of me. The summary below is reconstructed from the patent's own specification plus contemporaneous USPTO/PTAB prosecution records that quote the claims. I am confident about independent claim 1; I am less certain about whether the patent contains other independent claims (e.g., composition/kit claims) and about the exact independent-claim count. Treat the specifics as high-confidence-but-not-verbatim.

Independent Claim 1 (method of treatment):
A method of treating a myelodysplastic syndrome (MDS) comprising administering to a patient in need thereof about 5 mg to about 50 mg per day of 3‑(4‑amino‑1‑oxo‑1,3‑dihydro‑isoindol‑2‑yl)‑piperidine‑2,6‑dione (lenalidomide), or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof.

In other words, claim 1 is a dose-range method-of-use claim: it is not claiming the lenalidomide molecule itself (that is claimed elsewhere, e.g., the '517 family), but the act of treating MDS by giving lenalidomide in a 5–50 mg/day range.

This is corroborated by examiners and IPR petitioners describing the '740 disclosure as "a method of treating a myelodysplastic syndrome, which comprises administering to a patient in need thereof about 5 to about 50 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione," citing Col. 4, lines 20–34 of '740 (see USPTO PTAB/patent-center filings, e.g., the double-patenting rejections quoting claims 1, 16–17, 24–27, and 32–34 of '740; and the IPR2018-01509 petition against '740).

Dependent claims (approximate structure/scope, per the specification and prosecution record):

• Sub-genus/species selections narrowing the compound and its salt/solvate/stereoisomer forms.
• Dosing sub-ranges and schedules — the specification teaches 5–25 mg/day, or 25–50 mg every other day, and cyclic dosing (e.g., ~16-week cycles, or 21 days on / 7 days off).
• Oral route and unit dosage forms (e.g., 5, 10, 25, or 50 mg capsules/tablets).
• Specific MDS sub-types: refractory anemia (RA), RA with ringed sideroblasts (RARS), RA with excess blasts (RAEB), RAEB in transformation (RAEB‑T), chronic myelomonocytic leukemia (CMML).
• The IPR petition treated claim 1 as the sole independent method claim challenged, with claims 1–6, 11–12, and 14–34 asserted unpatentable as obvious (Ground 1 over List 2001 + the '230 patent + Celgene press releases; Ground 2 over Thomas 2000a). Claims 7–10 and 13 were not addressed in that challenge — I do not have a verified explanation for their omission.

The specification also discloses pharmaceutical compositions, single-unit dosage forms, and kits comprising the immunomodulatory compound (optionally with a second active agent such as G‑CSF, GM‑CSF, EPO, dexamethasone, etc.) and combination/transplantation-therapy methods; whether any of these are captured in independent claims of '740 (rather than only in the specification/related family members) is the main point I cannot confirm without the verbatim claim listing.

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Identified Litigation / PTAB Activity (7,189,740)

No CAFC appeal of a 7,189,740 judgment was located for 2026 (or any year). The PTAB decision was a non-institution, which would not normally be appealable to the Federal Circuit, and the '740 patent expired April 11, 2023, making a fresh 2026 merits appeal of this specific patent unlikely. The Federal Circuit activity I could find in the Revlimid space in 2026 relates to other patents/parties (e.g., unrelated 2026-20xx dockets), not to 7,189,740.

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Caveats on Reliability

• The claims are reconstructed, not quoted verbatim, because the authoritative text I was given ends mid-specification. If you need the exact claim language for all 34 claims, pull the "Claims" tab of the USPTO PatentCenter record for 10/411,649 / US 7,189,740.
• The 2026 CAFC docket is a negative finding from the searches I could run; absence of evidence is not proof that no 2026 filing exists.
• Field-of-search limits: my sources were Google Patents (primary full text you supplied), Stanford NPE Litigation Database, DrugPatentWatch, Docket Alarm/PTAB records, and USPTO/PTACTS filings — not a direct live query of the USPTO PatentCenter claim text or the Federal Circuit's own docket system.

I'll research litigation involving US patent 7189740. Let me run several targeted searches.

Let me dig into the specific case numbers to identify parties and outcomes.

Litigation involving U.S. Patent No. 7,189,740

Caveat up front: I ran out of search steps before I could verify every docket, so where I could not confirm a caption I say so rather than guessing. The core list comes from the litigation data attached to the patent record itself (Unified Patents/Google Patents), supplemented by Docket Alarm, Justia, UniCourt, Stanford NPE database, and Patexia results. Note the patent is now expired — Google Patents lists an anticipated expiration of 2023‑04‑11 and legal status "Expired – Lifetime" — and none of these cases produced a final merits judgment on the '740 patent; they were ANDA/Hatch‑Waxman actions that ended in settlement, dismissal, or were not instituted at the PTAB.

District court cases listed on the patent record (all D.N.J. unless noted)

PTAB proceedings

Related PTAB filings by the same petitioner that reference the '740 patent's file history as exhibits (e.g., IPR2018‑01504, IPR2018‑01507) are directed at sibling patents (e.g., 9,056,120; 8,404,717), not at the '740 patent itself — I flag this because exhibit lists in those IPRs mention "USP 7189740" and can be mistaken for the challenged patent.

One additional case found by docket search but not on the patent's own litigation list

• Celgene Corp. v. Zydus Pharmaceuticals (USA) Inc. et al, 2:17‑cv‑02528 (D.N.J., filed Apr 12, 2017) — surfaced in a Docket Alarm search on patent:(7189740). I could not confirm from the retrieved text that the '740 patent was an asserted patent in that case (Celgene sued many generics on overlapping portfolios in 2017), so treat this as unverified rather than a confirmed '740 case.

Important context — antitrust follow‑on litigation (not a '740 infringement action)

The '740 patent features prominently in the In re Revlimid and Thalomid Purchaser Antitrust Litigation (consolidated in D.N.J., lead case 2:19‑cv‑07532, e.g., Humana Inc. v. Celgene Corp.), where purchasers/insurers allege Celgene used the '740 and related method‑of‑treatment patents plus serial "sham" suits and reverse‑payment settlements to delay generic lenalidomide. In that case the court dismissed the insurer and MSP operative complaints on June 6, 2024 (with later amended complaints filed). The '740 patent is pleaded as part of the allegedly unlawful patent fortress, not as a cause of action for infringement.

Bottom line

• US 7,189,740 was asserted by Celgene exclusively as plaintiff, against ANDA filers seeking to market generic lenalidomide (REVLIMID®).
• Confirmed defendants across the dockets: Natco/Watson/Arrow, Lotus/Alvogen, Apotex, Cipla, Hetero, and Hikma.
• No case reached a final judgment of infringement or invalidity on the '740 patent. The district cases ended in settlement/consent judgment or dismissal and licensing (delayed generic entry to 2022 and volume‑limited sales through Jan 2026); the sole '740‑specific PTAB petition (IPR2018‑01509) was denied institution.
• I could not confirm the parties for 2:17‑cv‑05314, 2:18‑cv‑11518, 2:20‑cv‑07759, 2:21‑cv‑11261, 2:21‑cv‑12927, 2:21‑cv‑20459, or 1:20‑cv‑00003; verify these on PACER or at the patent's Unified Patents litigation page: https://portal.unifiedpatents.com/patents/patent/7189740

Recommended verification sources: PACER (D.N.J. and N.D. W. Va.), Unified Patents litigation portal for patent 7189740, CourtListener/RECAP dockets (e.g., https://www.courtlistener.com/docket/[6323341](/patent/6323341)/), and Stanford NPE database (https://npe.law.stanford.edu/patent/7189740), which lists only two '740 cases (2:17‑cv‑06842 and 2:12‑cv‑04571) — narrower than the patent record, likely because it only captures certain case types.

I'll verify the PTAB record for this patent, starting with the proceeding the earlier litigation section flagged and checking for any others.

Confirmed the key proceeding. Let me check for any additional PTAB challenges to this patent and any appeal activity.

One more check for any later petitions or appeals naming this patent before I write up.

PTAB / AIA Trial Analysis — U.S. Patent No. 7,189,740

⚠️ Direct contradiction between my structured source and the record — flagged as instructed. The structured block you supplied ("PTAB proceedings on file" / USPTO Open Data Portal) states: "The USPTO ODP API returns no AIA trial proceedings for this patent... the default should be 'no PTAB activity on file.'" That is wrong for this patent. Public records establish that IPR2018-01509 was filed against, and expressly names as the challenged patent, U.S. 7,189,740. The Board's own institution decision bears the caption "Case IPR2018-01509, Patent 7,189,740 B2." The ODP result is almost certainly an indexing artifact — the ODP trial-proceeding dataset's patent linkage does not reliably capture non-instituted proceedings. I am proceeding on the public record, not on the empty structured block, and I flag this so you do not repeat the ODP "no activity" claim in a brief or client memo. (Note: the earlier-generated litigation section of this analysis correctly identified IPR2018-01509; there is no contradiction between my findings and that section.)

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Proceedings overview

Total AIA trial proceedings naming U.S. 7,189,740: one (1). Breakdown: 0 active; 0 with claims invalidated; 0 with claims sustained on the merits; 0 settled at the PTAB; 1 with institution denied. (IPR2018-01509, [Dr. Reddy's Laboratories, Inc.](/litigations/by-plaintiff/Dr.%20Reddy's%20Laboratories%2C%20Inc.) v. Celgene Corp., institution denied 2019-02-11.)

Bottom line for a defendant today: the patent never came under a PTAB trial, never had a Final Written Decision, and never lost a single claim — it is "hardened" in the narrow sense that the one IPR aimed at it died at the institution threshold. But "hardened" is the wrong frame for practical purposes: the patent expired on 2023-04-11 (anticipated expiration, per the patent record and repeated Orange Book listings), so it is no longer a live infringement vehicle. The '740 patent's remaining relevance is almost entirely retrospective — it is pleaded as part of the alleged Revlimid "patent fortress" in follow-on antitrust litigation, not asserted in any current infringement case. Do not assume the Board blessed these claims on the merits; it did not reach the merits at all.

Also important because it is not a PTAB event: Dr. Reddy's, the sole petitioner, is not estopped under 35 U.S.C. § 315(e)(2), because estoppel attaches only after a Final Written Decision. That cuts both ways (see Strategic summary).

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IPR2018-01509 — Dr. Reddy's Laboratories, Inc. v. Celgene Corp.

(This is the only proceeding; it was never instituted, so there is no claim-level outcome to rank.)

• Type: Inter Partes Review (AIA trial, Tech Center 1600, Art Unit 1618)
• Filed: 2018-08-03
• Status: Institution Denied (the docket renders the document title as "Institution Decision: Trial Instituted Document," a Docket Alarm captioning artifact — the document itself is captioned "DECISION Denying Institution of Inter Partes Review, 35 U.S.C. § 314(a)"). Institution decision date: 2019-02-11. Refund request filed 2019-06-21; Notice of Refund approved 2019-07-03 (fees returned in full — a clean marker that no trial ever opened).
• Judge panel: Grace Karaffa Obermann (writing), Tina E. Hulse, Christopher G. Paulraj. All three APJs also sat on the companion petitions (IPR2018-01504 and IPR2018-01507), which were decided the same day.
• Petition grounds (challenged claims: 1–6, 11–12, and 14–34; the petition states claim 1 is the only independent claim at issue):
  • Ground 1 — § 103 obviousness: claims 1–6, 11–12, 14–34 over List 2001 in view of the '230 patent and Celgene Press Releases 5/8/2001 and 8/28/2001.
  • Ground 2 — § 103 obviousness: the same claims over Thomas 2000a in view of the '230 patent and the same two press releases.
  • No § 102 anticipation ground and no § 112 ground was reached on the merits; secondary considerations (nexus/praise) were briefed at Pet. 58 et seq. but never adjudicated.
• Institution decision: Denied. The panel's dispositive reasoning: "we determine that Petitioner has not demonstrated sufficiently that certain press releases relied upon in its patentability challenges qualify as printed publications. We thus decline to institute an inter partes review of claims 1-6, 11-12, and 14-34 of the '740 patent." This is a § 314(a) "reasonable likelihood" denial resting on a threshold evidentiary defect (public-accessibility of the Celgene press releases), not on a merits holding that the claims are non-obvious. Celgene's counsel (Jones Day) publicly characterized the outcome as the Board finding Dr. Reddy's "had not shown a reasonable likelihood of prevailing."
• Final Written Decision: None. Not issued — the trial never instituted. ⚠️ If anyone tells you "the PTAB upheld claims 1–34 of the '740 patent," that is wrong. No claim of '740 was ever adjudicated on the merits by the Board. (In the Revlimid antitrust pleadings, plaintiffs' opponents have loosely described these denials as PTAB "rulings in Celgene's favor"; as a matter of PTAB procedure, a denial of institution is not a patentability ruling.)
• Settlement / termination: None — the proceeding terminated by operation of the denial, followed by the refund. (Contrast: the district-court 2:17-cv-05314 action against Dr. Reddy's ended in a 2018 settlement permitting limited-volume generic lenalidomide after March 2022 — a commercial resolution, not a PTAB termination.)
• Appeal: None, and none legally available as of right. A denial of institution under § 314(a) is unreviewable on the merits (35 U.S.C. § 314(d); Cuozzo Speed Techs. v. Lee). I found no Federal Circuit docket naming IPR2018-01509 or US 7,189,740. There was also no request for rehearing/precedential opinion panel review in the docket.
• Defensive value: Mixed, and now largely moot. Pro: an IPR-based attack on '740 has already been tried once and failed at the threshold — but on a fixable evidentiary point (better authentication/printed-publication proof for the Celgene press releases), so IPR2018-01509 does not meaningfully foreclose a well-built future petition. Con: the patent is expired (2023-04-11) and its Orange-Book use code (U-1215/U-1982, MDS) is spent. Cite IPR2018-01509 only for the narrow propositions that (i) the '740 claims were never invalidated, and (ii) no petitioner is estopped.

Principal sources / links:

• Institution decision (PDF, full text): https://www.docketalarm.com/cases/PTAB/IPR2018-01509/Inter_Partes_Review_of_U.S._Pat._7189740/docs/02-11-2019-Board/Institution_Decision-7-Trial_Instituted_Document.pdf
• Proceeding docket (petition + exhibits + refunds): https://www.docketalarm.com/cases/PTAB/IPR2018-01509/Inter_Partes_Review_of_U.S._Pat._7189740/
• PTAB E2E / Patent Trial and Appeal Case Tracking System, Petition record: https://ptacts.uspto.gov/ptacts/public-informations/petitions
• Case metadata (claims challenged, panel, status): https://ipverse.greyb.com/ptab-web/cases/case-details/IPR2018-01509
• Patent-owner-side account of the three companion denials: https://www.jonesday.com/en/practices/experience/2019/02/celgene-successfully-blocks-institution-of-eminter

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Companion and adjacent proceedings (NOT on patent 7,189,740 — do not conflate)

These matter because their exhibit lists cite the '740 file history and are routinely mistaken for '740 challenges:

Both -01504 and -01507 list Celgene's '740 prosecution documents as Patent Owner exhibits (e.g., Ex. 2002 "File History for USP 7189740," Ex. 2004 "Office Action dated 11/3/2005 (USP 7189740)," Ex. 2022 "Response to Office Action dated 6/23/2006 (USP 7189740)"). Those exhibit references are not challenges to '740. The IPR2018-01509 petition itself confirms the -01504 and -01507 petitions are directed at different challenged patents owned by the same party, and Celgene's mandatory notice in -01509 states the '740 patent "is not at issue in any other inter partes review or inter partes reexamination proceedings."

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Strategic summary

Claim-level status of 7,189,740. Every claim is UNTESTED. Claims 1–6, 11–12, and 14–34 were challenged (and only in a petition that was never instituted); no claim was canceled, no claim was confirmed, and claims 7–10 and 13 were never even challenged by anyone. Claim 1 — the specification's 5–50 mg/day method-of-treating-MDS claim — stands exactly as issued on 2007-03-13, and it expired on 2023-04-11 without ever being construed in a final judgment or adjudicated for validity anywhere. That is a striking data point: an Orange-Book-listed, billion-dollar-drug method claim that attracted exactly one IPR petition in its entire 16-year term, and that petition never opened a trial.

Estoppel landscape. Because IPR2018-01509 was not instituted, no § 315(e)(1) or (e)(2) estoppel attached to Dr. Reddy's Laboratories or its real parties in interest. Practically, this is academic for '740 (expired), but the pattern matters: Dr. Reddy's simultaneously filed three near-identical petitions (-01504/-01507/-01509) with substantially overlapping press-release and List 2001 / Thomas 2000a / '230-patent art. If any of those art combinations is asserted today against a live member of the same family — e.g., the '717 or '120 patents, both expiring 2023-04-11 alongside '740, or a still-valid sibling — the losing petitioners in the 2018 campaign are not barred from raising the same grounds (no FWD, no estoppel). Conversely, any defendant who wants to rely on the '740 petition's art has the full petition and its ~75 exhibits in the public record as a ready-made invalidity roadmap, at no cost.

Pattern signals. (1) No repeat petitioner, no annulment campaign. The sole petitioner was Dr. Reddy's; no defensive aggregator (Unified Patents, RPX, etc.) appears in the IPR chain — Unified appears only as the litigation-data aggregator on the Google Patents page, not as a petitioner. (2) The patent owner won by threshold procedure, not by merits victory. Celgene/Jones Day defeated all three Dr. Reddy's petitions plus Alvogen's on printed-publication and § 314(a)/§ 325(d) grounds. In the consolidated Revlimid antitrust litigation, Celgene's own briefing leverages this, arguing plaintiffs' "regurgitated attacks on the Revlimid Patents support no claim of sham litigation" because "the PTAB considered these same arguments and concluded that they failed to establish even a 'reasonable likelihood' of success." (3) No PTAB appeals by either side, ever, on this patent. (4) Post-expiration, '740 lives on only in antitrust pleadings — e.g., purchaser/insurer complaints alleging Celgene used the '740 and related method-of-treatment patents plus serial suits and reverse-payment settlements to delay generic lenalidomide, and a 2026-filed BMS/Celgene antitrust complaint in the District of New Jersey that discusses the "'740 family" and its 2023-04-11 expiry. ⚠️ I located that 2026 filing only via a secondary posting; verify the docket on PACER before relying on it.

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Recommended next steps

1. If you are being threatened or sued on 7,189,740 today: check the calendar first. The patent's anticipated expiration was 2023-04-11 and Google Patents lists legal status "Expired – Lifetime." Any demand letter predicated on ongoing infringement of '740 is facially defective; pre-expiration damages under 35 U.S.C. § 286 reach back only six years and are further bounded by the expiration date.
2. Do not over-claim the PTAB record. The correct characterizations are: "The only IPR ever filed against the '740 patent (IPR2018-01509) was denied institution on 2019-02-11 under § 314(a); the Board found the petitioner failed to show the Celgene press releases qualified as printed publications." Do not say the Board "upheld" or "confirmed" the claims, and do not cite an FWD — there is none. Quote the disposition verbatim from the decision PDF (link above).
3. If you need to attack a live sibling ('717, '120, '569, '929, or a family member with later expiry), treat IPR2018-01509's record as a tool, not a bar. Pull the full IPR2018-01509 petition (Paper 2) and exhibits; the art (List 2001, Thomas 2000a, the '230 patent, and the 5/8/2001 and 8/28/2001 Celgene press releases) is already mapped claim-by-claim. Fix the fatal defect: Dr. Reddy's lost on printed-publication proof for the press releases. Establish public accessibility with a librarian declaration (internet-archive capture, distribution lists, library holdings) before filing.
4. Check the district-court picture, not just the PTAB one. The § 315(b) one-year clock for Dr. Reddy's ran off service in Celgene Corp. v. Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc., No. 2:17-cv-05314-SDW-LDW (D.N.J.) — this fills the "caption unverified" gap in the earlier litigation section of this analysis. That case settled (announced 2018-04-13 terms; limited-volume generic entry after March 2022, unlimited from 2026-01-31) and there was no final merits judgment, so again: no claim of '740 has ever been adjudicated.
5. If your interest is antitrust, not patent. The '740 patent is central to allegations that Celgene's MDS method-of-treatment patents were a "sham" fortress. The defensive posture there is the reverse of the patent docket: the patent survived, but never faced a merits test — a point both sides have argued. Verify the 2026 BMS/Celgene antitrust docket and the consolidated In re Revlimid and Thalomid Purchaser Antitrust Litigation (D.N.J., lead case 2:19-cv-07532) directly.
6. Verify the contradiction I flagged. Before repeating the ODP "no PTAB activity" result anywhere, pull the proceeding directly from PTAB E2E (https://ptacts.uspto.gov) by proceeding number IPR2018-01509 or by challenged patent 7,189,740, and note the non-institution. If you must cite the ODP API, caveat that it under-reports non-instituted trials.

Confidence notes. High confidence: proceeding number, parties, filing date, panel, claims challenged, both grounds, denial date and reasoning, refund, absence of FWD and appeal. Medium confidence: the exact Alvogen petition number for the '569 patent (I confirmed the denial and the ~2019-03-14 date but not the IPR number in the retrieved text, so I have not invented one). I did not obtain the full text of the preliminary response or the complete exhibit list for IPR2018-01509; both are available on the docket linked above.

I'll research the assignment record for US 7,189,740, focusing on USPTO Assignment Center records and any NPE signals.

Let me dig into the specific assignment records and any post-issuance transfers (e.g., the BMS acquisition of Celgene).

Let me pin down the specific reel/frame records and check for any merger-related recordings.

Assignment & Ownership Reconstruction — US 7,189,740

Methodological caveat (read first): I was unable to complete a live query of the USPTO Assignment Center search interface (https://assignmentcenter.uspto.gov/ / https://assignment.uspto.gov/patent/index.html) before exhausting my research budget. The assignment entries below are drawn from (a) the legal-events block attached to the Google Patents record for 7,189,740 (which mirrors USPTO assignment data), and (b) assignment recordations quoted in litigation exhibits in the Celgene Revlimid cases. Where I could not independently confirm a reel/frame against the Assignment Center itself, I say so explicitly rather than filling the gap. I have not invented any reel, frame, date, correspondent, or assignee.

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Inventors

Unusual-pattern check — not present. This is the opposite of the classic "inventors bail out within 12 months" precursor to a fire-sale:

• Zeldis was a senior Celgene officer (VP/CMO), not an outside contractor.
• He remained the named inventor and assignor-of-record on the entire downstream '740 patent family (the '717, '716, '120, '207, '782 continuations all list Zeldis and all assign to Celgene).
• He personally prosecuted the '740's patentability via inventor declarations (First Zeldis Declaration, Aug 17, 2005; Second Zeldis Declaration, Jun 22, 2006) — i.e., he was still acting for Celgene long after filing.

There is no evidence of inventor departure, no co-inventor split, and no assignment to any party other than the employer.

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Original assignee

Celgene Corporation (Delaware corporation).

• Address of record at filing/assignment: 7 Powder Horn Drive, Warren, New Jersey 07059 (the address recited in Celgene's own specification, "the compounds are available from Celgene Corporation, Warren, N.J.").
• Later corporate address: 86 Morris Avenue, Summit, New Jersey 07901 (the address stated in Celgene's PTAB mandatory notices).
• Primary line of business: operating biopharmaceutical company. Celgene shipped a commercial product embodying the claims: REVLIMID® (lenalidomide), FDA-approved Dec 27, 2005 (NDA 021880), with the '740 patent listed in the Orange Book as a method-of-use patent (use codes U‑1215 and U‑769; expiry Apr 11, 2023) — see the Orange Book extract at https://www.drugfuture.com/fda/nda021880_001.html.
• Current status: operating, but no longer independent. Bristol‑Myers Squibb completed its ~$74B acquisition of Celgene on Nov 20, 2019; Celgene became a wholly owned subsidiary of BMS (BMS press release, https://adhoccommunication.it/wp-content/uploads/2019/11/[112019](/patent/112019)-BMS-Completes-Acquisition-of-Celgene.pdf). Because Celgene survived as a legal entity subsidiary, title to the '740 patent would ordinarily remain in Celgene Corporation absent a separate recorded assignment — consistent with Google Patents still listing Celgene Corp as "current assignee."

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Assignment timeline

⚠️ Uncertainty flag. The Google Patents legal-events block records exactly two post-filing assignment recordations for 10/411,649 — both to Celgene Corporation, both from Zeldis — on 2003‑11‑03 and 2004‑07‑07. I have not been able to retrieve the verbatim reel/frame for either of those two recordations. The reel/frame I did surface (below) is from a Celgene litigation exhibit and is consistent-with but not verified-as the '740 recordation. Treat the reel number as provisional pending Assignment Center confirmation.

• Executed ~2003 (likely early/mid 2003) / recorded 2003‑11‑03 — Reel 013982/0697 (provisional — see flag above)

  • Conveyance: Assignment of Assignors' Interest
  • Assignor: Zeldis, Jerome B.
  • Assignee: Celgene Corporation, 7 Powder Horn Drive, Warren, New Jersey 07059
  • Correspondent: not captured in the retrieved excerpt. For the co-pending Celgene application 10/438,213 (filed May 15, 2003, same inventor, same docket family) the correspondent of record was Pennie & Edmonds LLP, 222 East 41st Street, New York, NY 10017‑6702 (reel 021461/0407). Note the recurrence pattern: Celgene's Zeldis-family recordations were handled by Pennie & Edmonds (later succeeded by Jones Day at the same 222 E. 41st St address) — a large operating-company patent firm, not an NPE/asserter correspondent. Flag: this firm name recurs across multiple Celgene/Zeldis recordations on this site's tracked patents, but Celgene is an operating company, so recurrence here is ordinary corporate practice, not a troll tell.
  • Context: Initial owner-assignment — mandatory invention assignment from the employee-inventor to his employer. Not a sale.

• Executed ~2004 / recorded 2004‑07‑07 — Reel/frame not retrieved

  • Conveyance: Assignment of Assignors' Interest (per Google Patents legal events; the second recorded instrument)
  • Assignor: Zeldis, Jerome B.
  • Assignee: Celgene Corporation
  • Correspondent: not retrieved
  • Context: Corrective / confirmatory re-recordation of the same inventor→employer assignment (the recurring two-recordation pattern Celgene used for this family — one at filing, a second the following year). This is an internal administrative clean-up, not a transfer to a third party.

No further assignments were recorded. In particular:

• I found no recorded assignment to any "IP / Holdings / Licensing / Ventures" LLC on this patent.
• I found no recorded assignment to Bristol‑Myers Squibb on this patent (consistent with Celgene surviving as BMS's wholly owned subsidiary — title need not move).
• The only other post-issuance instruments in the file are prosecution-side, not title-side: a terminal disclaimer over U.S. App. No. 10/438,213 (invoked at issue, per the antitrust complaint ¶321), and later terminal disclaimers filed in related family applications (e.g., App. 13/070,761, terminal disclaimer filed Sep 10, 2012).

If the Assignment Center shows no additional recordations beyond these two Celgene entries, that is itself the finding: the original assignee (Celgene) still owns the patent.

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Timeline diagram

timeline
    title Ownership of US 7189740
    2002 : Provisional 60418468 filed Oct 15
    2003 : Application 10411649 filed Apr 11
         : Assigned to Celgene Corp
    2004 : Confirmatory assignment to Celgene
    2007 : Patent 7189740 issues Mar 13
    2010 : First infringement suit filed vs Natco
    2019 : Celgene acquired by Bristol Myers Squibb
    2023 : Patent expires Apr 11

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NPE / troll-pattern signals

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Verdict

Operating-company assertion.

Justification (2–3 sentences): The entire recorded chain consists of two inventor-to-employer assignments to Celgene Corporation (recorded 2003‑11‑03 and 2004‑07‑07, the first provisionally tied to reel 013982/0697), with no transfer to any third-party LLC or asserter — the patent simply remained in Celgene, which shipped the embodying product REVLIMID® (lenalidomide) and enforced the '740 in its own name against actual generic competitors (Natco 2012, Lotus/Alvogen 2017, Apotex/Cipla/Hetero 2019, Hikma 2021). Every one of the eight NPE indicators scores not present (signal 3 is unclear but benign — the recurring correspondent is Celgene's operating-company firm, Pennie & Edmonds/Jones Day). The only non-benign narrative attached to '740 in the record is antitrust/sham-litigation and inequitable-conduct pleading by purchasers and insurers, which targets the manner of enforcement, not the ownership structure — so the correct NPE-framework answer remains operating-company assertion, not NPE.

Verify at:

• USPTO Assignment Center — search "7189740": https://assignmentcenter.uspto.gov/ (legacy: https://assignment.uspto.gov/patent/index.html)
• Google Patents legal events: https://patents.google.com/patent/[US7189740B2](/patent/US7189740B2)/en
• Unified Patents portal: https://portal.unifiedpatents.com/patents/patent/7189740

Two open items to confirm against the Assignment Center (could not be closed here): (i) the exact reel/frame for the two '740 recordations (I have a provisional candidate, 013982/0697); and (ii) whether any BMS merger-related recordation was filed against this patent — I found none, which is consistent with Celgene holding title as a surviving BMS subsidiary, but should be checked directly.

I'll research the prior-art references cited on US 7,189,740. Let me run several targeted searches.

Let me get the actual cited-references list and the IPR petition's prior-art analysis.

Prior Art for U.S. Patent No. 7,189,740 — Analysis

0. Scope, method, and an honesty flag up front

What I was asked to do: search the USPTO record for 7189740 (literally) and, for each cited reference, give full citation, date, description, and the claim(s) it potentially anticipates under 35 U.S.C. § 102.

What I could and could not retrieve:

• ✅ I could reach the Google Patents full text of US 7,189,740 (https://patents.google.com/patent/[US7189740B2](/patent/US7189740B2)/en), the Espacenet original-document record (US7189740 B2, 2007‑03‑13), the IPR2018‑01509 petition text, the IPR2018‑01504 exhibit list (which attaches the '740 file history), and PTAB/CourtListener documents quoting the '740 prosecution.
• ⚠️ I could NOT retrieve the verbatim front‑page "References Cited" list (the examiner‑cited U.S. patent documents and non‑patent literature appearing in the "References Cited" box on the printed patent). Both the Google Patents and Espacenet fetches truncated before that section.
• ⚠️ I therefore distinguish three tiers of "cit" below and say which tier each item belongs to, rather than blurring them. Tier A = references cited in the '740 specification itself (values quoted from the authoritative full text I hold). Tier B = references the examiner relied on during prosecution of the '740 application (from PTAB/docket records). Tier C = references asserted by the IPR petitioner in IPR2018‑01509.

Critical framing point: No reference I could identify anticipates claim 1 under § 102 as a single reference, because claim 1 is a method claim requiring (a) treating MDS, (b) with lenalidomide specifically, (c) at about 5–50 mg/day. The art was almost entirely deployed in § 103 obviousness combinations, not § 102 anticipation. The only genuine § 102 candidates are on the prosecution/PTAB side, and their prior-art status was disputed. I flag each below.

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1. Claim reference (for the mapping below)

Per the prior section and corroborated by the PTAB/docket filings: claim 1 = method of treating MDS comprising administering about 5 to about 50 mg per day of 3‑(4‑amino‑1‑oxo‑1,3‑dihydro‑isoindol‑2‑yl)‑piperidine‑2,6‑dione (lenalidomide), or a salt/solvate/etc. (cited to Col. 4, lines 20–34 of '740). Dependent claims add MDS sub-types (RA, RARS, RAEB, RAEB‑T, CMML), dose sub-ranges, oral/unit-dose forms, and second-active-agent combinations. IPR2018‑01509 challenged claims 1–6, 11–12, 14–34; claims 7–10 and 13 were not addressed in that petition.

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2. Tier A — References cited in the '740 specification (quoted from the authoritative text)

These are the "examples include, but are not limited to…" and background citations written into the patent. They are the closest thing I can verify to "the patent's citations."

Non-patent literature cited in the specification (Tier A, NPL): The Merck Manual 953/954 (17th ed. 1999); List et al., 1990, J. Clin. Oncol. 8:1424; Bennett et al., Ann. Intern. Med. 1985;103(4):620‑5; Besa, Med. Clin. North Am. 1992 May;76(3):599‑617; Harris et al., J. Clin. Oncol. 1999 Dec;17(12):3835‑49; Goldberg et al., Cancer Res. 1990;50(21):6876‑81; *Greenberg et al., Blood 1997;89:2079‑88* (IPSS); Epstein & Slease, 1985, Surg. Ann. 17:125; Dexter 1987/1989; Moore 1991; Metcalf 1985; Golde & Gasson 1988; Tabbara & Robinson 1991; Ogawa 1989; Stanley 1976; Schrader 1981; Moore 1980; Kurland 1979; Handman & Burgess 1979; Vadas 1983 (×2); Weibart 1986; Schuster 1990; Besa 1990; Hellstrom 1990; Bowen 1991; Physicians' Desk Reference (56th ed. 2002) at 1154–1158, 587–592, 1755–1760; Koch, Prog. Med. Chem. 22:165‑242 (1985); Moller et al., J. Immunol. 159:5157‑5161 (1997); Vasiliauskas et al., Gastroenterology 117:1278‑1287 (1999); Ehrenpreis et al., Gastroenterology 117:1271‑1277 (1999); D'Amato et al., PNAS USA 91:4082‑4085 (1994); **Singhal et al., N. Engl. J. Med. 341(21):1565‑1571 (1999)**; Marx et al., Proc. Am. Soc. Clin. Oncol. 18:454a (1999); Costa et al., Blood 92(10 suppl.1):235b (1998); McCann, Drug Topics 41‑42 (1999); Kropff, Blood 96(11 pt.1):168a (2000); Munshi et al., Blood 94(10 pt.1):578a (1999); Marriott et al., Expert Opin. Biol. Ther. 1(4):1‑8 (2001); *G. W. Muller et al., J. Med. Chem. 39(17):3238‑3240 (1996)* and Bioorg. Med. Chem. Lett. 8:2669‑2674 (1998); Corral et al., Ann. Rheum. Dis. 58(Suppl I):1107‑1113 (1999); Penichet & Morrison, J. Immunol. Methods 248:91‑101 (2001); Emens et al., Curr. Opin. Mol. Ther. 3(1):77‑84 (2001); Burger's Medicinal Chemistry and Drug Discovery 172‑178, 949‑982 (5th ed. 1995); Design of Prodrugs (Bundgaard ed. 1985); Remington's Pharmaceutical Sciences (16th/18th eds.); Introduction to Pharmaceutical Dosage Forms (4th ed. 1985); USP 25‑NF20 (2002); Carstensen, Drug Stability: Principles & Practice (2d ed. 1995) at 379‑80.

§ 102 bottom line for Tier A: none of these anticipates claim 1. They disclose the compound (A1–A3, A8), formulation/excipient technology (A6, A12), prodrug/salt definitions, or background biology. Under § 102, a single reference must disclose every claim element; a compound reference (e.g., the '517 patent) does not disclose the MDS‑treatment step with a 5–50 mg/day dose. So Tier A functions as § 103 and § 112(a) enablement art, not § 102 art, for the method claims. (If the '740 claim set contained a compound per se claim, A1 would anticipate it — but the '740 method claims are not that.)

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3. Tier B — Prior art the examiner relied on during '740 prosecution

Sourced from the file-history exhibits and the antitrust pleading accounts of that prosecution (IPR2018‑01504 Exs. 2002/2004/2020/2022; In re Revlimid & Thalomid Purchaser Antitrust Litig., D.N.J. 2:19‑cv‑07532, and MSP Recovery Claims v. Celgene, 2:21‑cv‑20451, at https://www.courtlistener.com/docket/61609345/363/msp-recovery-claims-series-llc-v-celgene-corporation/).

Prosecution context (Tier B): Two Zeldis declarations were filed to swear behind / establish conception (Examiner Office Actions 11/3/2005 and 3/30/2006; Response 6/23/2006 — IPR2018‑01504 Exs. 2004, 2020, 2022). The patent issued with a terminal disclaimer over U.S. App. No. 10/438,213, indicating obviousness‑type double patenting was also at issue. The antitrust plaintiffs now allege the '740 is invalid because Zeldis "provided no support for his assertion that he conceived of the present invention before the prior art references relied on by the examiner."

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4. Tier C — Prior art asserted in IPR2018‑01509 (Dr. Reddy's v. Celgene)

From the petition (https://www.docketalarm.com/cases/PTAB/IPR2018-01509/…/Petition-2-740_Petition.pdf) and the patent owner's preliminary response (PTACTS).

Outcome: IPR2018‑01509 was Not Instituted (Merits), Feb. 11, 2019 — so the PTAB never reached the merits of these grounds. That non‑institution is not itself a merits holding on validity.

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5. § 102 anticipation — consolidated answer to the question asked

Net conclusion: Every reference I identified functions as § 103 obviousness art (compound disclosures + thalidomide‑in‑MDS clinical references, combined), not as clean § 102 anticipation, except the disputed/unverified List 2001 and WO '307 candidates. This is consistent with the fact that the decisive rejections in the family were obviousness and obviousness‑type double patenting, overcome by declaration evidence rather than by distinguishing an anticipatory reference on its face.

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6. Explicit uncertainties (do not treat as verified)

1. The front-page "References Cited" list was not retrievable through the fetches I was able to complete. Tiers A–C are reconstructed from the specification text and from prosecution/PTAB records; the examiner‑cited U.S. patent numbers (if any) and the examiner‑cited NPL on the printed face of '740 may include items not captured here.
2. The specific reference(s) behind the examiner's original § 102 anticipation rejection (B4) are unidentified in my sources — only the epithet of that rejection survives in the antitrust pleading snippet.
3. WO 01/87307 title/contents unverified — I also could not confirm its applicant (it may or may not be a Celgene filing).
4. "Thomas 2000a" (IPR Ground 2) full citation and subject matter unverified.
5. "List 2001" exact citation and date are disputed between petitioner and patent owner; I did not locate a neutral source fixing its publication date.
6. I did not auto-correct any number: the '740 patent is treated literally as US 7,189,740 B2 / App. 10/411,649, priority 60/418,468 (Oct. 15, 2002), and no sibling patent (e.g., '717, '120, '230, '517) has been substituted for it.

Best verification sources for the missing pieces: the "References Cited" tab and the Image File Wrapper for App. 10/411,649 at USPTO PatentCenter (https://patentcenter.uspto.gov), the IPR2018‑01509 and IPR2018‑01504 record at PTAB (https://ptacts.uspto.gov), and the Google Patents "Patent Citations / Cited By" panes at https://patents.google.com/patent/US7189740B2/en.

Note: the running context lists two different "current" dates (2026‑04‑26 in the task header vs. 2026‑10‑01 elsewhere); I treated the analysis as date‑agnostic because the '740 patent is expired and the relevant prior‑art cutoffs are 2001–2002.

I'll ground this analysis in the prior art actually cited against this patent (the IPR2018-01509 grounds) and the specification's own admission-based teachings. Let me verify the key references.

Excellent — I now have the IPR grounds and the prosecution history. Let me pin down the remaining reference identities (Thomas 2000a, List 2001, Raza 2001, WO 01/87307) and the claim structure.

Obviousness Analysis — U.S. Patent No. 7,189,740 under 35 U.S.C. § 103

0. Scope, sources, and a correction to the record

This section builds on the two earlier sections (Patent summary; Litigation summary) and does not repeat their bibliographic or docket findings. Everything below is grounded in the prior-art record actually developed against this patent family — principally the DRL petition in IPR2018‑01509 and the prosecution history recited in the In re Revlimid antitrust record — plus the '740 full text supplied.

One correction/refinement to the earlier Litigation summary. That section described IPR2018‑01509 as "Not Instituted – Merits." The antitrust opinion clarifies why institution was denied: DRL "could not prove that the press releases were publicized on the date that appeared on the face of the documents." In other words, the denial turned on a failure of proof on public accessibility / printed‑publication status (and the publication date) of the two Celgene press releases — the lynchpin secondary references — not on a merits holding that the claims are non‑obvious. That distinction matters a great deal for a §103 assessment: a non‑institution does not establish non‑obviousness, and it is not a merits adjudication entitled to any weight on validity. (In re Revlimid opinion; IPR2018‑01509 Petition.)

Caveat I cannot cure. As the earlier Patent summary flagged, the authoritative full text supplied to me truncates before the numbered claims. My element-by-element analysis therefore uses the claim‑1 language as repeatedly quoted in the prosecution and IPR record — "a method of treating a myelodysplastic syndrome, which comprises administering to a patient in need thereof about 5 to about 50 mg per day of 3‑(4‑amino‑1‑oxo‑1,3‑dihydro‑isoindol‑2‑yl)‑piperidine‑2,6‑dione" (quoted in the '717 double‑patenting rejection as "'740 … Col. 4, lines 20‑34"). Treat dependent‑claim specifics as reconstructed, not verbatim.

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1. Legal framework and the person of ordinary skill

Governing law. '740 has a filing date of April 11, 2003 and earliest priority of October 15, 2002 (Prov. 60/418,468). It is a pre‑AIA patent, so pre‑AIA 35 U.S.C. § 103(a) governs: obviousness is measured as of the time the invention was made (with the applicant free to swear behind art under 37 CFR 1.131 — a device Celgene actually used here). The controlling authorities are Graham v. John Deere, 383 U.S. 1 (1966); KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007); and Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (routine optimization).

Critical date for the art. Absent a successful antedating, the operative date is October 15, 2002. Every reference below predates it:

Note the internal wrinkle: Celgene's first Zeldis declaration (Aug. 17, 2005) asserted conception "prior to March 8, 2002"; the second (June 22, 2006) asserted conception "before July 19, 2001." Both dates are after the May 8, 2001 and Aug. 28, 2001 press releases, so a §1.131 swearing‑behind could not (on Celgene's own asserted dates) remove those two references as §102(b) art for an invention date later than Aug. 28, 2001. That is the doctrinal seam the invalidity case was built on.

The POSA. A clinician‑scientist (M.D., or Ph.D. with equivalent training) in hematology/oncology with several years' experience treating hematologic malignancies, familiar with the FAB and WHO MDS classifications, the IPSS risk model, thalidomide's clinical use, and the emerging IMiD class. This mirrors the level assumed by the DRL petition's expert (Ex. 1003, Levin Decl.).

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2. The claim at issue

Claim 1 (independent, method): A method of treating a myelodysplastic syndrome comprising administering to a patient in need thereof about 5 to about 50 mg per day of lenalidomide (3‑(4‑amino‑1‑oxo‑1,3‑dihydro‑isoindol‑2‑yl)‑piperidine‑2,6‑dione) or a salt/solvate/hydrate/stereoisomer/clathrate/prodrug thereof.

This is a dose‑range method‑of‑use claim. It does not claim the molecule; it claims the act of treating MDS by giving lenalidomide within a defined daily dose band. That framing drives the whole analysis: the compound was known (the '230 patent), thalidomide's use in MDS was known (Thomas 2000a / Raza 2001 / List 2001), and the only genuine question is whether (i) selecting lenalidomide and (ii) selecting the 5–50 mg/day band were within the ordinary skill and routine optimization of the POSA.

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3. The prior art references

Primary clinical references (MDS background):

• Thomas 2000a — Thomas, D., Pilot studies of thalidomide in acute myelogenous leukemia, myelodysplastic syndromes, and myeloproliferative disorders, Semin. Hematol. 2000, 37(1)(suppl.3):26‑34. (Ex. 1005). Reports the MDS thalidomide pilots (including Raza's 61‑patient experience and transfusion independence), and — critically — states that thalidomide analogues "designed for increased efficacy and decreased toxicity (eg, lack of teratogenicity and decreased sedation)" "are currently in development," specifically IMiDs "such as CDC 501, which inhibit TNF‑α with a 10,000‑fold increased potency compared with the parent compound." "CDC 501" = CC‑5013 = Revimid = lenalidomide. Thomas 2000a thus supplies both the MDS indication and the express pointer to the analog.
• Raza 2001 — Raza A., et al., Thalidomide produces transfusion independence in long-standing refractory anemias of patients with myelodysplastic syndromes, Blood 2001;98(4):958‑965. (Ex. 1023). 83 MDS patients; 10 previously transfusion‑dependent patients became transfusion‑independent; responders concentrated in RA / RARS / RAEB (i.e., low‑ and intermediate‑risk, low‑blast subtypes). This is the reference the Examiner used during prosecution ("Raza (August 2001, Blood)").
• List 2001 — the DRL primary reference in Ground 1; used for the clinical administration of thalidomide/Revimid and the characterization of Revimid as Celgene's "lead IMiD," "designed to be more potent and potentially have a better safety profile than the parent compound." (Full bibliographic form not retrievable from the sources I could reach — flagging that rather than asserting a citation.)

Compound/inventive-entity references:

• US 6,281,230 (Muller et al.), "Substituted 2‑(2,6‑dioxopiperidin‑3‑yl)phthalimides and ‑1‑oxoisoindolines…", Aug. 28, 2001 (Ex. 1006). Discloses the specific 4‑amino‑substituted 1‑oxo‑2‑(2,6‑dioxopiperidin‑3‑yl)isoindoline (claim 19) — i.e., the lenalidomide structure — as a TNF‑α inhibitor "useful in treating … oncogenic or cancerous conditions."
• US 5,635,517 (Muller et al.) — cited by the Examiner for the same purpose (structure of the 4‑amino‑1‑oxo isoindoline + TNF‑α inhibition). Same inventive entity as the '230 patent.
• Celgene Press Release 5/8/2001 — "Positive Interim Results … on Celgene Corporation's Lead IMiD REVIMID" (MM interim data).
• Celgene Press Release 8/28/2001 — announces that patent protection for "lead IMiD REVIMID" now covers "the Active Ingredient, Pharmaceutical Compositions, and Therapeutic Uses," and reproduces the Revimid structure.
• WO 01/87307 (Stein) — published Nov. 22, 2001; the Examiner's combination reference against Raza.

Optimization/ancillary references: Marriott 2001 (Expert Opin. Biol. Ther. 1(4)) — among the three then‑known IMiDs, the lenalidomide structure had the greatest anti‑TNF‑α activity; Corral 1999b (Ann. Rheum. Dis. 58(Suppl I):1107‑1113); Musto 2002 (Haematologica) — low‑dose thalidomide effective in selected transfusion‑dependent, younger MDS patients.

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4. Ground 1 — List 2001 + the '230 patent + Celgene Press Releases (5/8/2001, 8/28/2001)

This was DRL's Ground 1 against claims 1–6, 11–12, and 14–34.

4.1 Element-by-element mapping to claim 1

4.2 Motivation to combine

The petition's articulated rationale (the KSR "articulated reasoning with rational underpinning") ran as follows:

1. Same mechanism of disease. MDS is characterized by excessive cytokine‑mediated apoptosis (TNF‑α, TGF‑β, IL‑1β, IL‑6) and increased bone‑marrow neo‑angiogenesis/VEGF. Raza 2001 states this expressly. Both thalidomide and lenalidomide act on TNF‑α; lenalidomide was known to be more potent at it. A POSA targeting the MDS mechanism would therefore reach the more potent TNF‑α inhibitor.
2. Express substitution teaching. Thomas 2000a names the class ("IMiDs such as CDC 501"), quantifies the potency advantage (10,000×), and frames it as the future of thalidomide treatment.
3. Same‑source / known lead compound. The '230 patent, the 8/28/2001 press release, and Marriott 2001 all converge on the same structure as "Celgene's lead IMiD." Where a finite number of IMiDs was disclosed (three, per Marriott), and one is expressly identified as the lead, the selection is not a needle‑in‑a‑haystack — it is a "finite number of identified, predictable solutions," the KSR / In re Kubin standard.
4. Unmet need. MDS therapy was "even palliative" at best, with no curative options for transplant‑ineligible patients (Raza 2001). That supplies a strong driver.
5. Dose range. 5–50 mg/day had already been shown safe, well‑tolerated, and active in the MM and solid‑tumor programs (press releases), giving the POSA an obvious starting band; narrowing it was routine optimization per Pfizer v. Apotex.

4.3 Why it maps

On this theory, every element of claim 1 is taught or suggested, the combination is motivated, and the expectation of success is reasonable — the only "new" thing is applying a known, more potent analog of a known MDS drug at a dose range already validated in man.

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

DRL's Ground 2 substituted Thomas 2000a as the primary reference, reaching the same claims. It is essentially Ground 1 with a different anchor, and its strength is that Thomas 2000a is a peer‑reviewed journal review (fewer §102(b) public‑accessibility problems than a press release). Thomas 2000a supplies the MDS indication and the "CDC 501" pointer, and the '230 patent + press releases supply the structure and dose. The motivation analysis is identical to §4.2.

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6. The Examiner's own §103 combination (prosecution record)

This is important because it is the Office's independent determination, not a petitioner's:

• The PTO rejected the claims as anticipated/obvious over WO 01/87307 and over Stein (U.S. App. 03/0235909; 04/0067953), and later as obvious over Raza (Aug. 2001, Blood) in view of WO 01/87307. A separate provisional obviousness‑type double‑patenting rejection used '740 itself in view of Musto 2002.
• Celgene overcame these not by amending, but by filing the two Zeldis §1.131 declarations asserting prior conception, plus a terminal disclaimer.
• The antitrust plaintiffs' theory (which the court held adequately pleaded as to some patents, though not enough to defeat Noerr‑Pennington immunity) is that the Zeldis declarations were unsupported by documentation (the protocol exhibit had all date information removed; the ASH abstract post‑dated filing) and thus the claims "should not have issued." (Hagens Berman amended complaint ¶¶ 313‑322.)

For a §103 analysis, the significance is: the Raza 2001 + WO '87307 combination is a legally cognizable prima facie case that the applicant was only able to defeat by antedating — a prosecution tactic that does not immunize the patent from a later §103 challenge in litigation, where the §1.131 showing can be re‑litigated.

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7. Dependent claims

Assuming the reconstructed structure from the prior section:

• Salt/solvate/hydrate/stereoisomer/clathrate/prodrug forms — routine, conventional pharmaceutical forms; obvious. (The '230 patent discloses the free base and pharmaceutically acceptable forms.)
• Dose sub‑ranges (5–25 mg/day; 25–50 mg every other day) — routine optimization over a known safe/active band; the prior art already dosed the compound at 5, 10, 25 and 50 mg/day. Pfizer v. Apotex.
• Oral administration / unit dosage forms (5, 10, 25, 50 mg) — the compound's oral bioavailability was known; oral dosing is the default and was used in the MM/solid‑tumor trials.
• Specific MDS subtypes (RA, RARS, RAEB, RAEB‑T, CMML) — Raza 2001 reports responses specifically in RA, RARS and RAEB; Thomas 2000a covers AML/MDS/MPD (including CMML). The subtype enumeration is disclosed.
• Cyclic dosing (e.g., ~16‑week cycles; 21‑on/7‑off) — conventional oncology cycling; the '740 specification itself presents cycling as routine.
• MDS with del(5q) — caution: the del(5q)‑selectivity finding (List 2006, NEJM) post‑dates the 2002 priority date and was not known to the POSA. If the patent contains a claim to that sub‑population, that is the claim with the strongest non‑obviousness argument; a generic MDS claim is not helped by it, and the later‑discovered benefit cannot be imported into the prior‑art analysis except as rebuttal evidence (Genetics Inst. v. Novartis, 655 F.3d 1291; Sanofi v. Glenmark, 748 F.3d 1354).

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8. Secondary considerations (Celgene's non‑obviousness case) and how it fares

Celgene's Preliminary Responses in the parallel '717/'120 IPRs pressed the following (the Board did not reach the merits for '740 because institution was denied):

None of these clearly overcomes a strong prima facie case on claim 1; the del(5q)‑specific claim is the exception worth isolating.

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9. What actually happened (and what it does not decide)

• IPR2018‑01509 was denied institution (Feb. 11, 2019). Per the antitrust opinion, denial rested on DRL's inability to prove the two Celgene press releases were publicly accessible as of their face dates — an evidentiary failure on two of the five references, not a holding that List 2001/Thomas 2000a/'230 can't be combined. The '717 and '120 sibling IPRs failed institution on the same footing.
• No court ever adjudicated the validity of '740. The ANDA cases settled (with generic entry in 2022 and volume‑limited sales through Jan. 2026); the antitrust case dismissed the sham‑litigation theory as inadequately pleaded.
• The §103 merits were never tested. The In re Revlimid court expressly noted that it is not "objectively baseless" for Celgene to expect the '740 to withstand an obviousness challenge over art the applicant overcame during prosecution — which is the Walker Process / Noerr‑Pennington "objectively baseless" standard (far higher than a preponderance), and says nothing about whether the claims would survive a merits trial.

Net: the record shows a genuinely close §103 question on claim 1, a strong obviousness case on the dose/subtype/oral dependent claims, and a case that was never resolved on the merits — resolved instead by an evidentiary defect at the PTAB and by settlements below.

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10. Bottom‑line assessment

If you want a defensible invalidity theory: anchor on Raza 2001 (Blood, Aug. 15, 2001) + WO 01/87307 (Stein, pub. Nov. 22, 2001) — the Examiner's own combination — as the core, and use Thomas 2000a's "CDC 501" disclosure and the '230 patent to supply the express structural pointer. Avoid over‑reliance on the two press releases: they are exactly the references that failed public‑accessibility proof in IPR2018‑01509, and any renewed attack should independently authenticate their public availability (e.g., via PR Newswire archives with proof of dissemination).

Verification still needed: the verbatim claim set from USPTO PatentCenter for 10/411,649 (my element mapping relies on the claim‑1 language as quoted in the '717/'120 prosecution record, not a direct claim listing), and the full bibliographic identity of "List 2001."

Primary sources

• '740 full text: https://patents.google.com/patent/[US7189740](/patent/US7189740)/en
• IPR2018‑01509 petition and exhibits: https://www.docketalarm.com/cases/PTAB/IPR2018-01509/
• '230 patent (Ex. 1006) and Raza 2001 (Ex. 1023) as above
• Patent Owner Preliminary Responses (Grounds 1–2, teaching‑away, secondary considerations): https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1516995](/patent/1516995) and /1516997
• In re Revlimid antitrust opinion: http://business.cch.com/ald/InreRevlimidandThalomidPurchaserAntitrustLitigation672024.pdf
• Antitrust complaint reciting '740 prosecution history: https://www.hbsslaw.com/sites/default/files/case-downloads/revlimid/2022-05-27-amended-complaint.pdf