US 9101621

I'll search for this specific patent number and verify against the authoritative text provided.

Let me retrieve the claim text and prosecution details.

Let me verify the granted claim text and check for any 2026 CAFC activity.

US Patent 9,101,621 — Search Summary

Verification note: I matched the number literally to US 9,101,621 B2 and excluded near neighbors (e.g., 9,101,622, 9,056,120, 10,206,914). The most authoritative source I could reach is the Google Patents record (patents.google.com/patent/US9101621/en), corroborated by Justia, DrugPatentWatch, and the Orange Book listing.

Bibliographic data

Abstract (verbatim as listed)

"Methods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed."

⚠️ Worth flagging: this abstract is generic "boilerplate" carried over from the parent family and does not describe the stem-cell-transplant limitation that defines the title and the claims.

Independent claims (plain language)

There is exactly one independent claim in this patent — claim 22. Claims 1–21 are printed as (canceled); claims 23–40 all depend from claim 22.

Claim 22 — A method of treating multiple myeloma, comprising administering to a patient who has multiple myeloma about 5 to about 25 mg per day of the compound 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione (lenalidomide), or a pharmaceutically acceptable salt, solvate or stereoisomer thereof, wherein the patient has previously received stem cell transplantation.

In plain terms: a post-transplant (maintenance/salvage) method-of-use claim — give lenalidomide at 5–25 mg/day to a myeloma patient who has already had a stem-cell transplant.

Dependent claims (23–40), grouped:

• Patient/disease state: 23 (newly diagnosed MM); 24 (relapsed, refractory, or relapsed-and-refractory MM)
• Dosing schedule: 25 (cyclic administration); 26 (21 consecutive days on / 7 days off, 28-day cycle); 27 (daily and continuous)
• Route/form: 28 (oral); 29 (capsule or tablet); 30 (capsule of 5, 10, 15, or 25 mg); 31 (capsule contents: lenalidomide + anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate); 32–37 (dose amounts: ~25, ~15, ~10, ~5 mg/day, and combinations with claims 26/27)
• Transplant type: 38 (autologous); 39 (hematopoietic); 40 (peripheral blood)

Litigation / docket context

• Numerous D.N.J. suits are indexed against this patent (2016–2022), including Celgene v. Lotus (2:17‑cv‑06842), Celgene v. Zydus (2:17‑cv‑02528), 2:16‑cv‑07704, 2:17‑cv‑06163, 2:18‑cv‑08964, 2:18‑cv‑11518, 2:19‑cv‑14731, 2:19‑cv‑15449, 2:20‑cv‑00315, 2:20‑cv‑07759, 2:20‑cv‑08570, 2:21‑cv‑01734, 2:21‑cv‑10398, 2:21‑cv‑11261, 2:21‑cv‑12927, 2:21‑cv‑20099, 2:21‑cv‑20459, 2:22‑cv‑02952; plus W. Va. N.D. 1:20‑cv‑00003.
• The patent was asserted by Celgene in the Revlimid paragraph-IV litigation (listed as one of 16 asserted patents alongside 5,635,517; 6,315,720; 6,561,977; 6,755,784; 7,189,740; 7,465,800; 7,855,217; 7,968,569; 8,315,886; 8,404,717; 8,530,498; 8,626,531; 8,648,095; 9,056,120 and 9,101,622).
• Same-family continuations/reissue with identical titles include US 10,206,914 B2 and US RE48,890 E1; sibling US 9,101,622 B2 covers newly diagnosed MM with dexamethasone.

Uncertainty / limitations of this search

1. No 2026 CAFC activity found. My searches surfaced no Federal Circuit docket entry naming 9,101,621. I could not directly query the CAFC docket or USPTO Patent Center from this tool, so I cannot confirm or deny any 2026 appellate activity. Given the patent's 2023‑05‑15 expiration and "Expired – Lifetime" status, new appellate activity would be unusual but is not impossible (e.g., a reissue/reexam or a legacy appeal). Treat any 2026 docket claim as unverified.
2. Priority-date discrepancy (2002‑05‑17 vs 2002‑05‑16) exists between sources. The family traces to PCT/US03/035544 (WO 2004/043377) and provisional 60/424,600 (Nov. 6, 2002), with an earlier 2002 date relied on; the exact priority chain is asserted, not adjudicated.
3. Claim text source. The claim set above is taken from the published application/Justia record for application 14/255,211 (claims 1–21 canceled; 22–40 added). The Google Patents full text I fetched did not include the printed claim columns. I am confident in the substance but recommend confirming against the printed patent's claim column if this is used for a legal purpose.
4. Google Patents produced no search-result snippet directly quoting the granted claim language — the "granted claims" wording above should be treated as high-confidence but not independently double-sourced at claim-column level.

I'll research litigation involving US Patent 9101621. Let me start with targeted searches.

I found significant litigation data. Let me verify the specific cases and gather outcomes.

Litigation Involving U.S. Patent No. 9,101,621 ("the '621 patent")

Patent identified: US 9,101,621 B2 — "Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione after stem cell transplantation" (inventor Jerome B. Zeldis; assignee Celgene Corp.; application 14/255,211; prior-art/priority date 2002-05-17; filed 2014-04-17; granted 2015-08-11). Orange Book–listed expiry May 15, 2023; Google Patents legal status "Expired – Lifetime." Google Patents itself flags the family as "Family has litigation." (patents.google.com/patent/US9101621/en)

The '621 patent is one of the "method of treatment" patents in Celgene's REVLIMID® (lenalidomide) Orange Book family, and virtually all known litigation is Hatch‑Waxman ANDA litigation filed by Celgene against generic lenalidomide applicants in the District of New Jersey (and, for Mylan, N.D. West Virginia). Every one of these cases was resolved by settlement/consent judgment; none went to a merits judgment on the '621 patent.

A. Cases in which US 9,101,621 was expressly identified as a patent-in-suit

B. Same-family / related Celgene lenalidomide litigation (listed by Google Patents as "family litigation"; individual dockets may relate to sibling patents such as US 9,101,622)

These dockets appear on the '621 Google Patents family-litigation tab. Because the tab is family-level, I cannot confirm from the retrieved data that '621 was asserted in each one; treat them as associated, not confirmed '621 cases.

Source for the family docket list: Google Patents litigation links on US9101621 and Unified Patents sibling-patent page. The Stanford NPE database, by contrast, index only two cases as "involving" '621 (2:17-cv-06842 and 2:17-cv-02528): npe.law.stanford.edu/patent/9101621.

C. Post-settlement collateral antitrust litigation referencing the '621 patent

These are not patent infringement suits on '621, but '621 is pleaded as one of the Celgene patents at issue:

• In re Revlimid and Thalomid Purchaser Antitrust Litigation (D.N.J.) and the related insurer/MSP Recovery actions (e.g., Cigna Corp. v. Celgene Corp., D.N.J. 2:21-cv-11686; MSP Recovery Claims v. Celgene, D.N.J. 2:21-cv-20451; Humana; and the 2025 Cigna action 1:25-cv-05237). Plaintiffs characterize Celgene's serial ANDA suits on the method-of-treatment patents — including the '621 patent (expiring 2023) — as "sham" litigation and the settlements as reverse payments. (In re Revlimid/Thalomid opinion PDF; Cigna complaint)

D. PTAB / IPR

• I found no IPR, PGR, or CBM proceeding against US 9,101,621 itself. The Alvogen/Lotus IPR in this family, IPR2018-01714 (filed Sep 12, 2018 by Alvogen Pine Brook LLC), targeted US 7,968,569, not '621, and was not instituted (PTAB denied on Mar 14, 2019). It appears in "Related Cases" on the '621 family page.

Overall outcome summary

• No case involving '621 reached a trial or merits judgment. Every identified infringement action terminated by settlement and consent judgment/injunction, under which the generic defendant was enjoined from launching generic lenalidomide before patent expiry except as licensed (typically volume-limited entry beginning after March 2022, unlimited after Jan 31, 2026 — the pattern established with Natco).
• Principal settlement dates: Lotus/Alvogen — Mar 29, 2019; Cipla — Dec 14, 2020; Zydus — Mar 24, 2021; Mylan — Jul 23, 2021; Hetero — Sep 27, 2021.
• Case outcomes for Hikma (2:21-cv-10398), Aurobindo, Lupin, Biocon, Torrent, Alembic and Oncogen follow the same settlement pattern; I did not retrieve their individual termination orders.

Caveats / limits

• I could not independently confirm the exact case number for the July 3, 2019 Cipla action or verify '621's presence in each Tier B docket; those are flags from family-level litigation data.
• Some sources give ±1‑day filing-date differences (e.g., Zydus Apr 11 vs Apr 12, 2017; Mylan Jan 2 vs Jan 3, 2020; Lotus Sep 5 vs Sep 6, 2017); I have reported the complaint/consent-judgment dates where available.
• All identifiers above are transcribed literally from the retrieved sources; no patent or case numbers have been auto-corrected.

I'll verify the structured ODP finding against public sources before writing.

Proceedings overview

There are zero (0) AIA trial proceedings on file for US 9,101,621. The structured USPTO Open Data Portal block supplied for this patent returns no AIA trial proceedings as of the most recent ingest, and my independent web research found no IPR, PGR, or CBM naming the '621 patent — no petition, no institution decision, no FWD, no appeal. Breakdown by status is therefore: active 0 / claims invalidated 0 / claims sustained 0 / settled 0 / institution denied 0.

Bottom-line defensive posture: the patent is untested at the PTAB — not "hardened" by a win, and not "dead." Every claim stands exactly as issued in 2015, because no one ever asked the Board to look at them. The one piece of good news for a defendant is structural, not precedential: no § 315(e)(2) estoppel exists against anyone, so a district-court invalidity case can be built from scratch on any art, with no IPR record to argue around. The much bigger fact is that the '621 patent's term has run — the Orange Book's 41st Annual listing gives it an expiration of 2023-05-15 (patent code U-1985), and Google Patents reports an anticipated expiration of 2023-05-15. A demand letter citing the '621 patent in 2026 is citing an expired patent.

Caveat on what I could not verify: the claim text of the '621 patent was not available in the material supplied to me, and I will not invent claim numbers. Where I refer to claim scope below I am relying on how the '621 was described in litigation papers, with sources.

No proceeding on file — US 9,101,621

• Type: n/a (no IPR / PGR / CBM ever filed)
• Filed: n/a
• Status: n/a — ODP structured record: no AIA trial proceedings
• Judge panel: n/a
• Petition grounds: n/a
• Institution decision: n/a
• Final Written Decision: n/a
• Settlement / termination: n/a
• Appeal: n/a
• Defensive value: You get no free PTAB win, but you also face no IPR estoppel and no adverse Board claim construction. Any validity challenge is entirely fresh — and because the patent is expired, the practical defense is damages-focused (§ 286 six-year lookback, no injunctive exposure), not validity-focused.

Context: adjacent Revlimid IPRs (different patents — not the '621)

These matter only as pattern evidence. None of them involved US 9,101,621. Do not cite any of these as a proceeding on the '621.

Sources: Jones Day experience note, IPR2018-01714; Jones Day, IPR Nos. 2018-01504/-01507/-01509; Jones Day, IPR2018-00685; House Oversight Committee staff report (2020-09-30), p. 6 & n.81 (collecting PTAB denials); Celgene 2016 Form 10-K (REMS IPRs instituted 2015-10-27; FWD 2016-10-26); BioPharma Dive, 2019-03-14. The Federal Circuit appeal docket for the REMS FWDs is Coalition for Affordable Drugs VII LLC v. Celgene Corp.; I did not independently verify the CAFC docket number, so I am not stating one.

Strategic summary

Claim status on the '621. Because no AIA trial was ever instituted, there is no canceled claim, no sustained claim, and no Board construction of any term. Every claim is UNTESTED. Contrast that with the district-court record: the '621 has been asserted repeatedly in Hatch-Waxman litigation — against Dr. Reddy's (D.N.J. 2:16-cv-07704), Zydus/Cadila (D.N.J. 2:17-cv-02528), Lotus/Alvogen (D.N.J. 2:17-cv-06842), Cipla (D.N.J., counterclaim complaints listing the '621 among 13 patents), and Hetero — and in each case the invalidity attack ended in settlement or consent judgment, never in a merits holding of invalidity or validity. For example, the Dr. Reddy's case terminated by consent judgment entered 2020-09-17 under which Dr. Reddy's agreed not to market generic lenalidomide until the '800, '217, '569, '498, '095, '621, and '622 patents expired. The '621 patent therefore carries no adjudicated validity finding for or against it — a district court counterclaim is the only route ever used against it, and no court reached the merits.

Estoppel landscape. Clean slate. Since no IPR/PGR was instituted, no petitioner (and no privy of any petitioner) is subject to § 315(e)(2) estoppel as to the '621. Conversely, Celgene/BMS cannot invoke any IPR outcome against you — there is no FWD, no Board claim construction, and no "PTAB already rejected this art" talking point that applies to this patent (that argument exists only for the '569, '929, and the MDS patents). Practically: any prior-art ground is available — § 102 and § 103, on any reference, without the "reasonably could have raised" trap. Because the '621 has a 2002-05-17 priority date, the prior-art universe is broad (it is a post-AIA patent by filing date but claims priority to 2002, so pre-AIA §§ 102/103 apply — confirm this against the actual priority chain before finalizing any invalidity contentions).

Pattern signals. The petitioner set on Revlimid is a who's-who of generics — Apotex, Dr. Reddy's, Alvogen/Lotus, and (in earlier rounds) the Coalition for Affordable Drugs — but the challenges were aimed at the ''929, the MDS patents, the ''569 MM-dosing patent, and the REMS patents, not at the '621. Notably, no defensive aggregator (Unified Patents, RPX, AST) appears anywhere in the chain; all IPR petitioners were ANDA filers with their own commercial interest. The pattern is also consistent with what the antitrust complaints allege: the generics settled before pressing their strongest invalidity arguments to judgment. Plaintiffs in In re Revlimid and Thalomid Purchaser Antitrust Litigation allege Celgene induced those settlements with volume-limited licenses precisely to avoid an invalidity ruling, and identify the '621 as one of the "licensed" patents (consolidated/amended complaints on CourtListener).

The expiration point dominates everything. The '621 is an Orange Book–listed patent with a listed expiration of 2023-05-15 and an anticipated expiration of the same date on Google Patents. For a party being asserted against today, that means: no forward-looking injunction, damages limited by 35 U.S.C. § 286 to acts within six years of the complaint, and a strong argument that any case is stale. It also means there is essentially no commercial reason left for anyone to file an IPR. An IPR on an expired patent is legally permissible (Sony Corp. v. Iancu, 924 F.3d 1235 (Fed. Cir. 2019)), but the only real relief is a validity determination — worth it only if the '621 is still propping up a live damages claim or a parallel assertion.

Recommended next steps

1. Say the quiet part on the record. The absence of PTAB activity is itself the finding: the '621 has been asserted against at least six generic filers over eight years and nobody ever petitioned the Board on it. That is a meaningful signal that the method-of-treatment MM claims were not the generics' best invalidity target — but it also means you are the first mover if you want a Board ruling. There is no FWD to link to, because none exists; do not accept any representation to the contrary from opposing counsel.

2. Lead with the expiration defense, not validity. Confirm the expiration date directly from the USPTO Patent Center / Orange Book entry (listed 2023-05-15, code U-1985) and from the patent's own PTA calculation. Then calendar § 286: only infringement occurring within six years before the filing of any complaint is actionable, and ask for the accused-acts date range in any demand letter. A demand citing the '621 for conduct after 2023-05-15 is baseless.

3. Preserve the full invalidity case — no estoppel binds you. Confirm § 315(e)(2) does not apply by documenting that no IPR was instituted on the '621 (the ODP record and the absence of any PTAB proceeding number). Then run §§ 102/103 on all claims, using the district-court art that Celgene's opponents developed. The DRL expert work on the MM patents — Celgene press releases disclosing lenalidomide + dexamethasone dosing, and the days 1–21 of a 28-day cycle limitation — is publicly described in the antitrust pleadings and is a starting point, though you must independently establish public-availability dates (the exact defect that killed the DRL IPRs at institution).

4. If you do file an IPR: there is no time bar from § 315(b) unless you were served with a complaint on the '621 more than one year earlier — check your service date first. On an expired patent, you cannot seek claim amendments, and the Board may weigh the absence of any injunction exposure. Coordinate the IPR and the district-court case so your stay motion and your § 315(e)(2) exposure are analyzed before, not after, filing.

5. Verify the sibling. US 9,101,622 (granted the same day, same family, same 2002-05-17 priority) issued from a parallel continuation and is asserted alongside the '621 in the same complaints. Any freedom-to-operate or invalidity opinion should address both; they were treated as a pair in every settlement and consent judgment in the record (Orange Book 41st Annual, Revlimid listing).

I'll verify the assignment record and ownership chain before building the report.

Let me check for any post-issuance assignments, including the Celgene/BMS merger, and confirm the litigation record.

Let me try to pin down the specific reel/frame and confirm the sole recorded conveyance.

Ownership & Assignment Analysis — US 9,101,621 B2

Patent: Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione after stem cell transplantation
App. 14/255,211 · filed 2014-04-17 · issued 2015-08-11 · priority 2002-05-17 (provisional 60/380,842) · status: Expired – Lifetime (anticipated expiration 2023-05-15)

Sourcing caveat up front. The USPTO Assignment Center (assignmentcenter.uspto.gov) is a JavaScript single-page application that my retrieval tools cannot render; a targeted query returned no Assignment Center hit. The assignment facts below are drawn from Google Patents' legal-events tab (which mirrors Assignment Center conveyances), the PTAB records, and litigation filings, with the gaps flagged explicitly. I could not retrieve a reel/frame number for this patent's single conveyance and will not invent one. I also found a Celgene reel/frame in the wild — 013982/0697, assignee "Celgene Corporation, 7 Powder Horn Drive, Warren, New Jersey 07059" — but that document is for a different Celgene patent (dated 2003) and must not be attributed to the '621.

Inventors

Jerome B. Zeldis (Princeton, NJ) — sole named inventor. Zeldis was Celgene's Vice President and Chief Medical Officer at the relevant time; litigation filings describe him as "Celgene's then-Vice President and Chief Medical Officer" and note he signed a Rule 132 declaration during prosecution of the related '569 patent. He is a prolific named inventor across the Celgene lenalidomide/IMiD estate (e.g., US 8,198,262, same title family).

• Employer at filing: Celgene Corporation — the '621 is a continuation in the May 2002 priority family, so Zeldis was a Celgene officer throughout prosecution.
• Unusual-pattern check: None detected. There was no inventor exodus or pre-filing departure. This is the textbook employee-inventor → employer assignment, not a distressed-inventor setup. Note the assignment (2014-04-17) was executed ~12 years after the 2002 priority date because the '621 is a late continuation filed the same day it was assigned — Celgene was papering a large continuation family, not transferring a portfolio.

Original assignee

Celgene Corporation (a Delaware corporation; principal place of business 86 Morris Avenue, Summit, New Jersey 07901 — earlier filings list 7 Powder Horn Drive, Warren, NJ 07059).

• Product embodying the claims: Yes. US 9,101,621 was listed in the FDA Orange Book against REVLIMID® (lenalidomide), NDA 21-880, patent code U-1985, expiration 2023-05-15. The claims cover the lenalidomide post-stem-cell-transplant multiple myeloma dosing regimen; Revlimid was Celgene's #1 product (~$9.7B of ~$15B total 2018 revenue).
• Primary line of business: Branded biopharmaceutical discovery, development, and commercialization (oncology/hematology, immunology & inflammation).
• Current status: Operating, acquired. Celgene became a wholly owned subsidiary of Bristol-Myers Squibb on 2019-11-20 (announced 2019-01-03; $74B cash+stock; OTEZLA® divested to Amgen). Celgene was not in bankruptcy and was not dissolved. Because Celgene survived as a BMS subsidiary, the '621 likely remained titled to Celgene Corporation with no separate recordation; the Orange Book '569/'740 families are now prosecuted/maintained in Celgene's name and by "Celgene and/or Bristol Myers" in later litigation. Whether a change-of-name or merger conveyance was actually recorded against the '621 at Assignment Center is unclear from available data.

Assignment timeline

What the record shows: exactly one conveyance, plus one unreported corporate merger.

• Executed on/around 2014-04-17 / recorded 2014-04-17 — Reel/frame not retrieved (see caveat).

  • Conveyance: Assignment of assignors' interest
  • Assignor: ZELDIS, JEROME B.
  • Assignee: CELGENE CORPORATION
  • Correspondent: Not determinable from available data. No correspondent of record was surfaced for this entry, and with only a single link in the chain the "repeat correspondent" signal could not be tested.
  • Context: Ordinary employee-inventor → employer assignment executed concurrently with the continuation filing; internal, not a sale.

• 2019-11-20 (executed) / recording status unknown — no reel/frame identified.

  • Conveyance: Merger (public-company acquisition of Celgene by Bristol-Myers Squibb)
  • Assignor: Celgene Corporation (stockholders)
  • Assignee: Bristol-Myers Squibb Company (Celgene became a wholly owned subsidiary)
  • Correspondent: N/A in the source data
  • Context: Corporate merger, not a portfolio transfer. Because Celgene Corporation survived as the named subsidiary, the '621 was probably never re-titled at the USPTO — which is why Google Patents still shows "Celgene Corp" as current assignee and newer Celgene-family filings (post-merger) appear under "Bristol Myers Squibb Co."

No other conveyances — no Security Agreement, no License, no Release, no Correction, and no transfer to any third party or LLC — appear in the source data for this patent. This is itself the key finding: the patent never left Celgene's hands.

Timeline diagram

timeline
    title Ownership of US 9101621
    2002 : Priority provisional filed by Celgene
    2014 : Continuation filed by Celgene
         : Assigned by Zeldis to Celgene
    2015 : Patent issued to Celgene
    2017 : Celgene sues generic ANDA filers
    2019 : Celgene acquired by Bristol Myers Squibb
    2023 : Patent expired

Note: the 2017 suits were filed against Zydus/Cadila (2:17-cv-02528, filed 2017-04-12) and Lotus/Alvogen (2:17-cv-06842, filed 2017-09-06), both D.N.J.

NPE / troll-pattern signals

1. Shell-entity transfer — not present. No assignment to any entity bearing an "IP / Patents / Licensing / Holdings / Ventures" suffix; no registered-agent address; no single-purpose Delaware/Texas LLC anywhere in the chain. The only recorded conveyance is inventor → Celgene Corporation (2014-04-17), an operating pharma.

2. Known asserter in the chain — not present. Neither Celgene Corporation nor Bristol-Myers Squibb appears on any of the listed NPE rosters (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Erich Spangenberg entities). The Stanford NPE Litigation Database classifies Celgene Corporation as a "Product company" and the case as a "Practicing Entity / Declaratory Judgment: No" (case 2:17-cv-02528). Inverse of the signal.

3. Repeat correspondent across the chain — not present / not determinable. With exactly one recorded link there is no recurrence to measure, and no correspondent name was retrievable for that link. Reporting "not present" on the absence of recurrence, not on a positive identification.

4. Cascading transfers — not present. No chained LLC-to-LLC conveyances; no transfers in any 24-month window beyond the single 2014-04-17 employer assignment. Eight years separate the 2014 assignment from the merger (2019), and the merger is a corporate event, not an assertion-enabling hop.

5. Pre-litigation transfer — not present. The sole assignment is dated 2014-04-17; the first suit naming this patent was filed 2017-04-12 (2:17-cv-02528, Celgene v. Zydus/Cadila) — a gap of ~3 years, and in any event the "transfer" is inventor-to-employer, not to an asserter.

6. Bankruptcy fire-sale — not present. Celgene exited via a $74B solvency merger with BMS (closed 2019-11-20), not Chapter 7/11. No stalking-horse sale, no 363 sale, no distressed assignment.

7. Privateering — not present. Celgene asserted US 9,101,621 in its own name against generics; there is no NPE proxy asserting on Celgene's behalf. (Celgene's Revlimid campaign is better described as classic Hatch-Waxman ANDA § 271(e)(2) enforcement, and it was the subject of separate antitrust/patent-thicket allegations by Apotex and others — an over-enforcement theory, the opposite of privateering.)

8. Defensive aggregator — not present. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN.

Verdict

Operating-company assertion.

Celgene Corporation — the branded manufacturer of REVLIMID® (lenalidomide; NDA 21-880; Orange Book patent code U-1985 for this patent, expiry 2023-05-15) — is the only recorded assignee, per the single 2014-04-17 inventor-to-employer conveyance (ZELDIS, JEROME B. → CELGENE CORPORATION) and the absence of any post-issuance transfer. It asserted the '621 as a practicing entity against generic ANDA filers in D.N.J. (2:17-cv-02528, filed 2017-04-12; 2:17-cv-06842, filed 2017-09-06), and Stanford's NPE database classifies Celgene as a "Product company." The patent expired on 2023-05-15 and now sits at Bristol-Myers Squibb Company by virtue of the 2019-11-20 merger, not by any NPE channel.

Confidence note: high on "operating-company assertion," moderate on the completeness of the assignment record — Google Patents' legal-events tab (which mirrors Assignment Center) shows only the 2014 conveyance, but I could not directly query the Assignment Center UI to confirm no later recording exists.

Verify at:

• USPTO Assignment Center — https://assignmentcenter.uspto.gov/ (search patent 9101621)
• USPTO Patent Assignment Search (legacy index) — https://assignment.uspto.gov/patent/index.html
• Google Patents legal events — https://patents.google.com/patent/US9101621/en
• Stanford NPE Litigation Database — https://npe.law.stanford.edu/patent/9101621

Constraints honored: no assignment was fabricated, no reel/frame was invented, and no entity was labeled an NPE on naming alone.

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

Let me retrieve the "References Cited" section for this patent from USPTO/FreePatentsOnline.

Let me get the specific "References Cited" (patent and non-patent) list from Justia and Google Patents.

Prior-Art Analysis — US 9,101,621 B2

0. Method limitation (please read before relying on this)

I was asked to pull the "References Cited" table from the USPTO/Google Patents record for US 9,101,621 and analyze each citation. Two problems arose:

1. The Google Patents full text retrieved for US9101621B2 did not render the front-page citation table ("References Cited" / "Cited By"), and my tool calls to reach the FPO/Justia/USPTO full-text pages hit the search-step limit before returning the table. I therefore could not extract the examiner's/applicant's citation list verbatim from the patent's own front page.
2. Consequently, the reference list below is assembled from (a) the citation material that did surface on the PubChem patent record for US‑9101621‑B2 (non-patent literature, verbatim), and (b) the patent references that appear in the sibling member of the same family, US 9,925,207, as listed by FreePatentsOnline. The (b) items are labeled as sibling-family citations, not as confirmed front-page citations of ’621. They are highly likely to overlap but are not verified as ’621's own list.

I will not present reconstructed entries as if they were verified. Each item below carries a verification tag.

1. The reference under analysis (for claim mapping)

Claim 22 (sole independent claim) requires the concurrence of:

• (a) treating multiple myeloma;
• (b) in a patient who has previously received stem cell transplantation;
• (c) lenalidomide (3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione) or salt/solvate/stereoisomer; and
• (d) ≈5 to ≈25 mg/day.

A single reference anticipates under § 102 only if it discloses every one of (a)–(d) as arranged in the claim. This is the analytical key: the post-transplant limitation is the point of novelty, and almost none of the cited art addresses it.

Critical date caveat

On its face the effective filing date is the asserted 2002‑05‑17 priority. But the post-SCT claims (1–40 as issued) were added/prosecuted in 2014 (app. 14/255,211). If those claims are not entitled to the 2002 priority (a real question — the 2002 disclosure may not describe post-SCT lenalidomide), the effective date collapses to 2014‑04‑17, which would make the entire 2002–2014 lenalidomide-maintenance literature available as § 102 art. This priority question is the single most important driver of the anticipation analysis and should be resolved before any § 102 conclusion is drawn.

2. Candidate cited references and § 102 mapping

A. U.S. patent documents

⚠️ Contradiction to flag: the previously generated summary listed the asserted-patent set (including 8,315,886; 8,404,717; 8,626,531; 9,056,120; 9,101,622). Those are litigation co-asserted patents, not necessarily citations of ’621. Do not conflate the two lists.

B. Non-patent literature — verified as appearing on the US‑9101621‑B2 patent record (PubChem patent record)

Bottom line on § 102: None of the identified cited references anticipates claims 22–40. Every reference is missing at least one of the four claim elements, and the post-stem-cell-transplant limitation (element b) is disclosed by none of them. Anticipation is not the realistic vulnerability here — § 103 obviousness (e.g., combining the pre-2002 lenalidomide/MM art with routine post-ASCT maintenance practice) is where the art would be asserted, and only if the 2002 priority is broken.

3. What to verify next (recommended, since my table is incomplete)

1. Pull the actual front page of US 9,101,621 (USPTO Patent Public Search / Patent Center, or the PDF on Google Patents) and copy the "References Cited" and "Cited By" lists verbatim. My patent list above is drawn from a sibling, and the true ’621 list may differ.
2. Confirm the priority entitlement of the post-SCT claims against the 2002‑05‑17 application — this determines whether 2002–2014 maintenance literature is § 102 art.
3. Check the ’621 IPR/PTAB record (the NPE database shows only district-court cases: Celgene v. Lotus 2:17‑cv‑06842 and Zydus 2:17‑cv‑02528; the earlier-generated summary lists the fuller docket set). Any institution decision would contain the examiner- and petitioner-identified art.

Confidence: Compound/mechanism NPL citations (Section B) — high (verbatim from the patent record). Patent citations (Section A) — moderate (sibling-family list, plausible but unverified for ’621). § 102 conclusions — high (driven by the missing post-SCT element regardless of the exact list).

I'll ground this analysis by pulling the actual cited prior art and the state of the art as of the priority date.

Now let me pin down the cited references on the patent's face and the exact priority chain, plus the key clinical prior art.

Obviousness Analysis — US 9,101,621 B2 under 35 U.S.C. § 103

0. Scope note on the "Prior Art section of this page"

The instruction is to work from the Prior Art section of the retrieved Google Patents record. I must be transparent about what that section actually contains, because it changes how the analysis is framed:

The retrieved page contains no "Patent Citations (56)" list and no "Non-Patent Citations" list. What it does contain under prior-art headings is:

1. Five "Prior art keywords" — administered, patients, compound, cancer, amino. These are algorithmic relevance tags, not references.
2. A chemical/entity concept-annotation table with occurrence counts keyed to title / claims / abstract / description. This table is effectively the page's own statement of which prior-art classes the specification is built on. Notable entries: lenalidomide (49, title+description); compounds (224, claims+abstract+description); "immunomodulatory" (133, abstract+description); plasma cell myeloma / multiple myeloma (34, title+claims+description); stem cell transplantation (9, title+claims+description); hematopoietic stem cell transplantation (claims — 1); peripheral blood (claims — 5); doses/"maximum tolerated dose" (16, description); "dose-limiting toxicity" (21, description); "salvage therapy" (4) and "maintenance therapy" (4); pomalidomide (21, description); thalidomide (16, description); 2‑(2,6‑dioxopiperidin‑3‑yl)‑1H‑isoindole‑1,3(2H)‑dione (18, description); dexamethasone (16); doxorubicin (18); melphalan (9); cyclophosphamide (9); croscarmellose sodium, microcrystalline cellulose, magnesium stearate, lactose (claims); graft‑versus‑host disease (3).
3. Litigation/status metadata (D.N.J. and W. Va. suits; "Expired – Lifetime"; anticipated expiration 2023‑05‑15).

So the page tells us what art the patent itself treats as its field, but not what the Examiner cited. For the reference-level analysis below I therefore rely on (a) the references the patent family's own specification expressly incorporates (US 5,635,517; US 6,281,230; US 6,316,471; US 6,555,554; WO 98/03502; WO 01/87307), which the page's entity table corroborates, and (b) the contemporaneous clinical literature, which I verified by search. I could not verify the printed "References Cited" list on the face of the '621, and this is a material limitation of this analysis (see §8).

I also note the concept table's own concession: the specification's description contains maximum tolerated dose, dose-limiting toxicity, salvage therapy, maintenance therapy, thalidomide, and pomalidomide — i.e., the specification is written against a prior art in which thalidomide-class drugs had already been dose-escalated in myeloma and were already being used as salvage and maintenance therapy.

1. The claim, and the date that controls

1.1 The claim

There is one independent claim, claim 22 (claims 1–21 canceled; 23–40 depend from 22):

A method of treating multiple myeloma, comprising administering to a patient who has multiple myeloma about 5 to about 25 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 or stereoisomer thereof, wherein the patient has previously received stem cell transplantation.

The claim has exactly four substantive elements: (i) treat multiple myeloma; (ii) administer lenalidomide; (iii) ~5–25 mg/day; (iv) patient previously received a stem-cell transplant. No dexamethasone, no cycle, no line-of-therapy restriction, no efficacy threshold.

1.2 The effective filing date — three competing candidates, and why it decides the case

This is the single most consequential issue in the whole § 103 analysis, and the sources conflict:

The application itself (14/255,211) was filed 2014‑04‑17 and issued 2015‑08‑11. Under pre‑AIA § 103(a) (which governs, because the application claims benefit of pre‑16‑March‑2013 applications, see AIA § 3(n)(1)), the critical date is the date of the earliest application that provides § 112 support for all of claim 22's limitations — including the "previously received stem cell transplantation" limitation.

The distinction matters enormously:

• If the date is May 2002: Zangari 2001, Hideshima 2000, Davies 2001, Barlogie 2001, Tosi 2001, the '230 and '471 patents, and WO 98/03502 are all prior art; Richardson 2002 (Nov. 1, 2002) and Mitsiades 2002 are not § 102(b) art but are § 102(a) art only if the applicant cannot swear behind.
• If the date is Nov. 6, 2002: Richardson 2002 (Blood 100:3063‑3067, published Nov. 1, 2002 — five days earlier) becomes prior art, which is close to dispositive.
• If support for the post-transplant limitation is absent from the 2002/2003 priority documents, claim 22 is entitled only to the 2014‑04‑17 date. In that scenario the intervening literature — including the MM‑009/MM‑010 Phase III programs (2003–2005) and McCarthy et al., N. Engl. J. Med. 366:1770‑81 (2012) (lenalidomide after stem-cell transplantation for MM) — is squarely prior art, and claim 22 is very difficult to sustain.

A caveat on the "about 5 to about 25 mg per day" range: the concept table shows MTD/DLT and dose-escalation language throughout the description, which suggests the dose range is supported; the "previously received stem cell transplantation" phrase appears in the title/claims/description 9 times, suggesting support also exists. I cannot confirm from the retrieved text whether the 2002 priority document discloses the post-transplant patient population. I flag this as the key factual gate.

2. The prior-art universe

2.1 Primary references

A. Patents — the compound and its generic uses

B. Printed publications — the clinical art in myeloma

2.2 What the page's own concept map concedes

Reading the page's entity table as the patent's self-characterization, the '621 does not purport to have discovered a new compound or a new mechanism. The table shows lenalidomide in the title (i.e., the compound is named in the title but claimed as a known entity), thalidomide and pomalidomide only in the description (as background), and "hematopoietic stem cell transplantation" and "peripheral blood" in the claims as patient-selection language. That is the signature of a method-of-use continuation whose only new matter is the patient subpopulation — exactly the situation in which § 103 does its work.

3. Grounds of rejection

Ground 1 (primary): US 6,281,230 in view of Zangari 2001 and/or Richardson 2002, further in view of Singhal 1999

Why every element is supplied:

Motivation to combine (KSR, 550 U.S. 398, 417–421 (2007)):

1. Same field, same problem. All references are directed to therapy of multiple myeloma, and specifically to the patient who has relapsed after high-dose therapy/transplant — the population the claim selects. Singhal 1999 frames the problem in the claim's own words: "Patients with myeloma who relapse after high-dose chemotherapy have few therapeutic options."
2. Known structural and functional analog. Lenalidomide is a 4‑amino‑isoindoline analog of thalidomide with a shared glutarimide pharmacophore; by 2001 the art reported it as Celgene's lead IMiD with roughly 10,000‑fold greater anti‑TNF‑α potency and, unlike thalidomide, without significant somnolence, constipation or neuropathy (Zangari 2001; Richardson 2002; Marriott 2001). KSR: "if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious."
3. Express teaching to do it. Singhal 1999 concludes that "larger studies of thalidomide, its analogues, and other inhibitors of angiogenesis are therefore warranted in patients with myeloma." Hideshima 2000 and Davies 2001 supply the mechanism. The '230 patent supplies the compound and the cancer indication. That is an express, not an inferred, motivation.
4. Reasonable expectation of success. Not speculative: by the priority date lenalidomide had already been dosed in relapsed/refractory MM at 5–50 mg/day with dose-dependent responses (Zangari 2001; Richardson 2002) and had shown activity in patients who had undergone prior transplant (Richardson 2002, 15/27).
5. Predictable dosing. The 5–25 mg/day range is not a discovery; it is the residue of the prior art's own dose-escalation data (5, 10, 25 tested; 50 rejected as myelosuppressive; 25 identified as MTD). Under In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011), discovery of an optimal dose within a disclosed range, absent unexpected results, is not patentable. See also In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003); In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997).

Ground 2 (alternative): Singhal 1999 (or Tosi 2001) in view of the '517/'230 patents and Marriott 2001/Hideshima 2000

If a tribunal accepts the patient-limiting clause as the only difference, Ground 2 attacks it directly: the art had already established (i) thalidomide is active in MM patients relapsing after autologous transplant (Singhal 1999; Tosi 2001 — the latter literally titled with autologous peripheral blood stem cell transplantation), and (ii) lenalidomide is the improved analog of thalidomide, disclosed in the '517/'230 genus and lauded as the lead IMiD (Marriott 2001). Combining (i) with (ii) yields claim 22 with a reasonable expectation of success, at dosages the art had already tested.

Ground 3 (alternative): The pomalidomide track as independent corroboration

Schey (2002), D'Amato (2001), Lentzsch (2001), and Mitsiades (2002) show that the entire IMiD class — thalidomide analogs as a class — was being administered at 1–50 mg/day to relapsed/refractory MM patients as of the priority date. This is not needed for Ground 1, but it forecloses the argument that a POSA would not have "selected" lenalidomide from the genus: the art was already selecting analogs from the genus, in the claimed population, at the claimed doses.

Ground 4 (fallback, if priority is lost): the intervening art

If claim 22's "previously received stem cell transplantation" limitation lacks § 112 support in the 2002/2003 priority chain, then the 2014 filing date applies and even more devastating art becomes available — including the 2004 publication of 10/438,213 (the application that issued as 7,968,569), which is § 102(b) art as of 2014, and McCarthy et al., N. Engl. J. Med. 366:1770‑81 (2012), a Phase 3 trial of lenalidomide after stem-cell transplantation for multiple myeloma — i.e., a reference describing the claimed method almost verbatim.

4. Dependent claims 23–40

5. The best arguments against obviousness, and why they are likely to fail

I will state these fairly; they are the arguments Celgene has actually made across this family, and they are not frivolous.

(a) "No response at 5 and 10 mg — the claimed range covers doses the art taught were ineffective." Zangari 2001 expressly reports "No responses were seen at the 5 and 10 mg level," with responses only at 25 and 50 mg. Celgene could argue this teaches away from the low end of the claimed 5–25 mg/day range and that the low end is where the claim's novelty, if any, resides.

Rebuttal: (i) the claim is a range, and the full range is squarely within the art's tested and disclosed range; overlapping ranges are obvious absent evidence that the claimed range is critical (In re Peterson; In re Boesch, 617 F.2d 272 (CCPA 1980)); (ii) the 5 mg and 10 mg cohorts were 3 and 7 patients respectively — the absence of a response in a handful of patients is not a teaching away, and several Zangari patients who began at 10 mg responded after escalation; (iii) Richardson 2002 reported responses (≥25% paraprotein reduction in 71%) in a broader 5–50 mg/d population and expressly recommended earlier-stage evaluation; (iv) the asserted "discovery" that 5–10 mg/day works is a dose-response observation, and "the discovery of an optimum value of a variable in a known process is normally obvious" (Kao).

(b) "Unexpected results." Celgene's prosecution strategy across this family was to submit later clinical results as evidence of unexpected efficacy. The MM‑009/MM‑010 Phase III results and the McCarthy 2012 maintenance data post-date the invention by years.

Rebuttal: post-filing results can rebut a prima facie case (Genetics Inst. v. Novartis, 655 F.3d 1291, 1307 (Fed. Cir. 2011)), but they must be attributable to the claimed subject matter and must be unexpected relative to the closest prior art. Here the closest prior art (Zangari/Richardson) already reported responses in the same population at the same doses, so a better response rate is a difference in degree, not an unexpected property. And the claim covers no dosage form, no cycle, and no combination, so the Phase III results (25 mg on 21/28 days plus 40 mg dexamethasone) are not commensurate with claim 22's scope.

(c) Commercial success / long-felt need. Revlimid is a multi-billion-dollar product.

Rebuttal: no presumption of nexus applies where the commercial product is covered by many patents (Revlimid has been listed against 23 Orange Book patents; Celgene asserted sixteen patents, including the '621 and '622, in the paragraph‑IV litigations). The PTAB petition papers surfaced in my search make exactly this point: "where a commercial product is covered by multiple patents, no presumption applies" (Therasense v. Becton Dickinson, 593 F.3d 1289, 1299 (Fed. Cir. 2010)). Success is also attributable to Celgene's REMS distribution program and marketing. And the long-felt need — better options for MM patients relapsing after transplant — is evidence of motivation, not of nonobviousness, when the solution was a known compound already in Phase I in that population.

(d) The litigation/regulatory record. Affirmative defenses of invalidity were pleaded against the '621 by Dr. Reddy's, Zydus, Cipla, Alvogen/Lotus, and others; the In re Revlimid & Thalomid Purchaser Antitrust Litigation plaintiffs alleged that the "method of treatment" patents (including the '622) were obvious over prior art teaching lenalidomide plus steroids in cancer. Those cases were resolved by consent judgments and settlements, not by merits adjudication, and the antitrust court's dismissal of the sham-litigation theory applied a Noerr‑Pennington pleading standard — it is not a holding that the patents are valid. I found no instituted IPR, no reexamination, and no court judgment adjudicating the validity of the '621. The patent expired 2023‑05‑15, which reduces the likelihood of any future adjudication.

6. § 102 observations (for completeness)

Two references come close to a § 102 anticipation of claim 22 and should be assessed before relying on § 103:

• Zangari 2001 discloses administration of lenalidomide at 5, 10, 25 and 50 mg/day to MM patients who had relapsed after high-dose chemotherapy — which in MM practice means high-dose chemotherapy with stem-cell support. Whether this discloses the "previously received stem cell transplantation" element turns on how literally that phrase is construed. If "high-dose chemotherapy" is read as a distinct antecedent from "stem cell transplantation," Zangari is not anticipatory but is the strongest § 103 reference.
• Richardson 2002 (published 2002‑11‑01) discloses 15/27 patients with prior autologous stem-cell transplantation dosed at 5, 10, 25 and 50 mg/d. If the effective priority date is 2002‑11‑06 (per Celgene's own account of the 60/424,600 chain), Richardson 2002 is § 102(a) art and, for the "about 5 to about 25" range, close to anticipatory. If the effective date is 2002‑05‑17, Richardson is not § 102(b) art and its status depends on whether the applicant can antedate it.

7. Bottom line

On the strongest reading of the priority date, claim 22 would have been obvious under § 103(a) over US 6,281,230 in view of Zangari 2001 and/or Richardson 2002, and further in view of Singhal 1999. Every element — the compound, the myeloma indication, the 5–25 mg/day dose, and the post-transplant patient — was disclosed, in combination or in close combination, in art that predates the 2002 priority date, and the motivation was express ("thalidomide, its analogues … are therefore warranted in patients with myeloma"). Dependent claims 24–40 add nothing beyond routine optimization, disclosed values, or the marketed capsule composition, each of which is independently obvious over the same art (In re Peterson; Kao; Pfizer v. Apotex). Claim 23 (newly diagnosed MM) is the least vulnerable, but it is still weak given the pre-transplant and post-intensive-therapy thalidomide‑steroid art.

Confidence: moderate-to-high on the substance; low on the record. The substantive combination is well supported, but three factual questions I could not resolve control the outcome — the effective filing date, whether the priority document supports the post-transplant limitation, and what the Examiner actually cited.

8. Explicit limitations of this analysis

1. No verified citation list. The retrieved page's prior-art section contains keyword tags and chemical-entity annotations, not the "References Cited" list. I could not retrieve the patent's face citations. The references used above come from the family's own incorporation-by-reference statements (corroborated by the page's entity table) and from verified searches of the literature. A proper § 103 opinion must begin with the printed claim column and the (56) list.
2. Priority date is contested — 2002‑05‑17 (Google Patents), 2002‑05‑16 (Unified Patents), 2002‑11‑06 (USP 60/424,600, per the TIPO family table and Celgene's own litigation narrative). The choice determines whether Richardson 2002, Mitsiades 2002 and Schey 2002 are prior art. I did not verify the existence or filing date of any May 2002 Celgene provisional (e.g., 60/380,860), and my search for that identifier returned no results before I exhausted my search budget.
3. Written-description support for the post-transplant limitation in the 2002/2003 priority documents is unverified. If it is lacking, claim 22 gets the 2014‑04‑17 date and the analysis in Ground 4 applies — in which case the claim is far more clearly obvious.
4. The procedural posture of the IPR papers is unverified. My search surfaced P‑TACTS petition documents (IDs 1516995, 1516997) referencing IPRs concerning US 8,404,717 and US 9,056,120 in the same family. The quoted passages appear to be a patent owner preliminary response arguing against institution ("The Petition … should be denied"), not a Board decision. I could not confirm whether any IPR was instituted, and I found no IPR, reexam, or judgment concerning the '621 itself.
5. No post-filing art was searched beyond what surfaced incidentally; if the 2014 filing date governs, a full intervening-art search (2002–2014) is required.
6. Diagnostic-question answer required. The single most valuable next step for anyone relying on this analysis is to determine whether the specification of the application that issued as the '621 (and its 2002/2003 parents) discloses administering lenalidomide to a patient who has already undergone stem-cell transplantation, as opposed to disclosing transplantation generally.