Invalidity dossier

US 8530498

Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione

Current assignee: Celgene Corporation

Added 10/1/2026, 4:02:58 AM

IndustryMedical (M)
At a glanceNo PTAB challenges12 lawsuits on fileasserted by Celgene CorporationMedical (M)

Active provider: DeepSeek · deepseek-v4-flash

Auto-generating section 1 of 2: Extensions…

Each section takes ~30-60s with web-search grounding. Keep this tab open — sections will fill in below as they complete.

Patent summary

Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.

✓ Generated

I'll verify the current ground truth for this specific patent number before summarizing.

Let me pull the actual claim text and litigation/PTAB status.

Let me try to pin down the exact independent claim text and any Federal Circuit activity.

Scope and sourcing note

I searched for the literal string "8530498" / "8,530,498" against Google Patents, DrugPatentWatch, PubChem, USPTO/PTAB petition materials, the Orange Book (41st ed.), and U.S. district-court filings surfaced via CourtListener. I did not have direct PACER/CAFC docket access, so I cannot claim to have queried the Federal Circuit's 2026 docket natively — see the litigation section for what I did and did not find. I did not auto-correct any identifier; everything below refers strictly to US 8,530,498.


1. Bibliographic summary (US 8,530,498)

Field Value
Patent number US 8,530,498 B1
Title Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione
Inventor Jerome B. Zeldis (Princeton, NJ)
Assignee Celgene Corporation (Summit, NJ) — original and current
Application no. 13/858,708
Filing date April 8, 2013
Pre-grant publication US 2013/0231314 A1 (Sept. 5, 2013)
Issue date September 10, 2013
Priority date (as listed) May 17, 2002 (provisional 60/380,842 in the same family)
Examiner / art unit Chris E. Simmons; Art Group 1629; class 514/320
Anticipated expiration May 15, 2023 (consistent with a 20-year term from the May 15, 2003 non-provisional filing 10/438,213)
Orange Book listing Expiration May 15, 2023, patent code U-1984 (method-of-use) under NDA 021880 (REVLIMID)
Legal status Google Patents fetched page shows "Expired – Fee Related"; a search-engine rendering of the same page shows "Expired – Lifetime" — see caveat below

Sources: https://patents.google.com/patent/US8530498/en ; https://www.drugpatentwatch.com/p/patent/8530498 ; Orange Book 41st Annual ed. listing at https://thefdalawblog.com/wp-content/uploads/2021/01/Orange-Book-41st-Annual.pdf

Status caveat: the authoritative fetched page for US8530498 says "Expired – Fee Related" with an "Anticipated expiration" event of 2023-05-15. A different rendering of the same Google Patents record returns "Expired – Lifetime." I cannot reconcile these two with certainty; the "Expired – Fee Related" text is what appears on the page I retrieved, and independently the Orange Book confirms the May 15, 2023 expiration. Either way, the patent's term has run.


2. Abstract

As listed verbatim on DrugPatentWatch for this patent:

"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."

Note the mismatch worth flagging: the abstract is generic family boilerplate and never mentions multiple myeloma or lenalidomide, despite the title being narrowly drawn to treating multiple myeloma with that compound. This same abstract text is shared by Celgene sibling patents in the family (e.g., US 8,198,262, quoted in the D.N.J. filings). Plaintiff-side antitrust complaints in the Revlimid litigation have specifically pointed to this recycled abstract as evidence of boilerplate prosecution.


3. Independent claims — plain-language overview

Confidence caveat, stated plainly: I was not able to retrieve the verbatim granted claim text of US 8,530,498 from an authoritative full-text source during this session (the Google Patents page body I retrieved contains the description but not the claims column; DrugPatentWatch surfaces only claim categories). What follows is my best-supported reconstruction from corroborating sources, with the limits of that inference identified.

What the record does support:

  1. Claim type. DrugPatentWatch categorizes the '498 claims as "Use; Delivery," i.e., method-of-use claims plus at least one claim directed to a delivery/administration format. That is consistent with an oral-dosing method-of-use claim set.

  2. The subject matter is multiple myeloma treated with lenalidomide + dexamethasone. A Taiwan TIPO family table describes patent 8530498 as: "Method of treating multiple myeloma in combination with 40mg/day of dexamethasone" (https://www1.tipo.gov.tw/tw/dl-[287732](/patent/287732)-d05ed916c6074a6b947bd0154233b51e.html). The compound named in the title, 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione, is lenalidomide (REVLIMID / REVIMID).

  3. The '498 is grouped by litigants with the lenalidomide dosing-regimen patents. Plaintiff filings in the Revlimid antitrust matters state: "Celgene's multiple myeloma method of treatment patents (the 7,968,569, 8,530,498, 8,648,095, and 9,101,622) claim the administration of lenalidomide in combination with dexamethasone in specific dosing regimens." (https://storage.courtlistener.com/recap/gov.uscourts.njd.[498914](/patent/498914)/gov.uscourts.njd.498914.1.0_1.pdf). So an independent claim likely recites a dosage of lenalidomide and/or a scheduled (cyclical) dosing pattern together with dexamethasone.

Plain-language reading of the likely independent claim(s): a method of treating a patient who has multiple myeloma by administering lenalidomide (or a pharmaceutically acceptable salt of it) in combination with dexamethasone 40 mg/day, with the claim set also including at least one claim specifying the administration format (e.g., capsule/tablet or oral unit dose) in which the lenalidomide is delivered.

What I cannot confirm and will not guess at:

  • The exact number of claims in the '498 patent.
  • Whether the independent claim carries the "21 consecutive days followed by seven consecutive days of rest in a 28-day cycle" limitation that is the centerpiece of sibling US 7,968,569 (claims 1 and 13 of '569 are quoted in the IPR record — https://patents.google.com/patent/US7968569 ; PTAB IPR2018-01714 institution decision). Because '498 and '569 share the May 15, 2003 parent (10/438,213) and thus the same 20-year term, the '498 claim set would have needed to be patentably distinct from '569 to survive double-patenting — but I have not seen a terminal disclaimer or double-patenting record for '498 to confirm how that was resolved.
  • The precise numerical dosage ranges recited.

If you need claim-chart-grade accuracy, the granted claims should be pulled from USPTO PatentCenter for application 13/858,708 rather than from any secondary aggregator.


4. Litigation, PTAB, and docket findings

District court (many D.N.J. matters). The Google Patents record for US8530498 carries a "Family has litigation" flag and links, among others, these D.N.J. cases: 2:14-cv-03126; 2:16-cv-07704; 2:17-cv-02528; 2:17-cv-06163; 2:17-cv-06842; 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; 2:20-cv-14389; 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 a N.D. W. Va. case, 1:20-cv-00003. Darts-ip reports a first worldwide family litigation filing for family 32314544.

Asserted against generics. A Celgene infringement action against Lotus Pharmaceutical / Alvogen asserted sixteen patents including 8530498 (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; 8,626,531; 8,648,095; 9,056,120; 9,101,621; 9,101,622) — https://www1.tipo.gov.tw/tw/dl-287732-d05ed916c6074a6b947bd0154233b51e.html. The '498 also appears in the Natco matter's enumeration of patents as to which Natco asserted invalidity/non-infringement (https://www.hbsslaw.com/sites/default/files/case-downloads/revlimid/2024-11-05-corrected-amended-complaint-redacted.pdf).

PTAB. I found no inter partes review petition specifically against US 8,530,498. The Revlimid IPRs I located target other patents — e.g., US 7,968,569 (IPR2018-01714; also an Alvogen/Lotus IPR), US 9,056,120, and the REMS patents US 7,953,501 / 8,315,720 (IPR2015-01092 et al., invalidated and affirmed in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019)).

Federal Circuit / CAFC 2026. I found no evidence of any 2026 Federal Circuit appeal or docket specifically concerning US 8,530,498. Given that the patent expired May 15, 2023, a live 2026 appeal on its own merits would be unusual, and I would need direct CAFC docket confirmation to assert otherwise. What is active in 2025–2026 is follow-on antitrust/insurer litigation that discusses the '498 as a historical asserted patent — e.g., The Cigna Group v. Celgene Corp., No. 1:25-cv-05237-ER (D.N.J., complaint filed June 24, 2025) and related insurer/MSP actions. Those cases plead the '498's validity and prosecution as background conduct; they are not merits appeals of the patent.


5. Explicit uncertainties

  1. Verbatim granted claims of US 8,530,498 were not retrievable in this session — the claim overview in §3 is reconstruction, not quotation.
  2. The "Expired – Fee Related" vs. "Expired – Lifetime" discrepancy in Google Patents renderings is unresolved.
  3. The effective priority date is contested in the litigation record: IPR testimony regarding sibling '569 argued the May 17, 2002 provisional (60/380,842) does not provide written-description support for the cyclical-dosing/dexamethasone claims, pushing the effective date to Nov. 6, 2002 (60/424,600). Google Patents nevertheless lists 2002-05-17 as the priority date "as an assumption and not a legal conclusion."
  4. I did not locate any PTAB proceeding or Federal Circuit appeal naming '498 directly; absence of evidence here is not proof of absence, since I lacked native docket access.

Generated 10/1/2026, 5:44:08 AM

Cases on file (12)

Group view →

Specific litigation cases in our database that name US patent 8530498. The free-form analysis below may also discuss cases beyond this list.

Lawsuits filed per year

2016: 1 case'162017: 2 cases'17'18'192020: 3 cases3'202021: 1 case'21
Cases asserting US 8530498, by filing year.

Litigation summary

Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.

✓ Generated

I'll research litigation involving US Patent 8,530,498 specifically. Let me run several searches.

Let me get the patent-specific litigation list and check specific cases.

Let me identify the parties in the remaining dockets from the patent's litigation list.

Litigation Involving U.S. Patent No. 8,530,498

Bottom line: Yes — there is extensive known litigation involving the '498 patent. It was one of Celgene's "multiple myeloma method of treatment" patents (along with the '569, '095, '621, and '622 patents) asserted throughout the Revlimid® (lenalidomide) ANDA wars, and it also appears in the antitrust suits challenging Celgene's Revlimid/Thalomid conduct. I did not identify any case in which the '498 patent was adjudicated on the merits at trial; the infringement actions were resolved by settlement/consent judgment or dismissal.

Important caveat on completeness: Google Patents lists 21 litigation links for this family (all shown on the patent page you supplied). I was able to independently verify the parties for a subset of those dockets; for others I could confirm only the docket number and jurisdiction, not the parties. I flag each one below. Per your instruction, I am reporting identifiers literally as found and not auto-correcting them.


A. ANDA / patent-infringement actions asserting the '498 patent (Celgene as plaintiff)

Case No. Court Plaintiff Defendant(s) Filed Status / Outcome
2:14-cv-03126 D.N.J. Celgene Corporation (Natco/Arrow/Watson line of cases) 2014 Part of the Natco lenalidomide litigation family; resolved via the Natco settlement (Dec. 2015). Parties inferred from complaint references; not independently confirmed for this docket.
2:16-cv-07704 D.N.J. Celgene Corporation [Dr. Reddy's Laboratories, Inc.](/litigations/by-plaintiff/Dr.%20Reddy's%20Laboratories%2C%20Inc.) 2016-10-20 Terminated 2020-09-17; consent judgment (Dr. Reddy's agreed not to market generic Revlimid until expiration of the '800, '217, '569, '498, '095, '621, '622 patents; volume-limited license).
2:17-cv-02528 D.N.J. Celgene Corporation Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.; Zydus International Pvt. 2017-04-12 Settled; Celgene–Zydus settlement referenced in antitrust complaints. Patents: '800, '217, '569, '498, '095, '621, '622.
2:17-cv-06842 D.N.J. Celgene Corporation Lotus Pharmaceutical Co., Ltd. (with Alvogen) 2017-09-06 Terminated 2019-09-05; settled (Mar. 2019 Lotus/Alvogen settlement — volume-limited entry after March 2022). '498 among listed patents.
2:18-cv-08964 D.N.J. Celgene Corporation Cipla Limited 2018-05-08 Terminated 2020-06-08. Patents: '800, '217, '569, '498, '095, '621, '622.
1:20-cv-00003 N.D. W. Va. Celgene Corporation Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan N.V. 2020-01-02 Consent judgment entered July 21/23, 2021 — Mylan enjoined from infringing the Patents-in-Suit (incl. '498) until expiration; all claims dismissed with prejudice.
2:20-cv-07759 D.N.J. Celgene Corporation Cipla (Cipla's Answer filed re ANDA No. 214618, 2.5 mg Revlimid) 2020 Pending/settled; '498 among patents-in-suit per Cipla's answer.
2:21-cv-10398 D.N.J. Celgene Corporation Hikma Pharmaceuticals USA, Inc. 2021-04-28 Hikma answered/counterclaimed (June 22, 2021); later resolved via settlement (Hikma listed among "Later-Filing Generics" settling with Celgene).
2:17-cv-06163 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2017 Listed in the patent's litigation record; parties not verified in my searches.
2:18-cv-11518 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2018 Same caveat.
2:19-cv-14731 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2019 Same caveat.
2:19-cv-15449 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2019 Same caveat.
2:20-cv-00315 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2020 Same caveat.
2:20-cv-08570 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2020 Same caveat.
2:20-cv-14389 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2020 Same caveat.
2:21-cv-01734 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2021 Same caveat.
2:21-cv-11261 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2021 Same caveat.
2:21-cv-12927 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2021 Same caveat.
2:21-cv-20099 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2021 Same caveat.
2:21-cv-20459 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2021 Same caveat.
2:22-cv-02952 D.N.J. Celgene Corporation (per patent family listing) Not confirmed 2022 Same caveat.

Note: Dockets are drawn from the litigation links on the patent page you supplied (Google Patents / Unified Patents / Darts-IP data) and the DrugPatentWatch patent-specific page for 8,530,498. In the Celgene/Revlimid campaign the defendants across these filings include Natco/Arrow/Watson, Dr. Reddy's, Zydus/Cadila, Cipla, Lotus/Alvogen, Apotex, Hetero, Sun, Mylan, Aurobindo, Torrent, Biocon, Lupin, Hikma, and Alembic; the '498 patent was asserted in a subset of those.


B. Antitrust actions in which the '498 patent is a subject (Celgene/BMS as defendant)

Case No. Court Plaintiff(s) Defendant(s) Filed Status
2:19-cv-07532 D.N.J. Humana Inc. (and, consolidated, insurer/MSP plaintiffs) — In re Revlimid and Thalomid Purchaser Antitrust Litigation Celgene Corporation 2019-02-28 On June 6, 2024, the court granted in part Celgene's motion to dismiss the Walker Process fraud and related Sherman Act § 2 claims; the '498 patent is cited among the "method of treatment" patents plaintiffs alleged were invalid/obvious.
1:20-cv-01980 D.D.C. Blue Cross and Blue Shield Association Celgene Corporation 2020-07-21 Terminated 2021-04-18 (Clayton Act, 15:25).
0:20-cv-00686 D. Minn. United HealthCare Services, Inc. Celgene Corporation 2020-03-05 Terminated 2020-12-02 (15:2 Antitrust Litigation); noted "DO NOT DOCKET" (consolidated/transferred).
0:20-cv-02071 D. Minn. (removal action, transferred out) — 2020-09-29 Terminated 2021-03-22; case transferred.
1:25-cv-05237 D.N.J. (Newark) The Cigna Group (and CenterWell Pharmacy, Inc., related filings) Celgene Corporation and Bristol Myers Squibb Company 2025-06-24 Pending; the '498 patent is identified as one of Celgene's multiple myeloma method-of-treatment patents alleged to be invalid/obvious and asserted in "sham" litigation.

Key context for the '498 patent

  • Patent: U.S. 8,530,498 B1 — "Methods for treating multiple myeloma with 3-(4‑amino‑1‑oxo‑1,3‑dihydroisoindol‑2‑yl)piperidine‑2,6‑dione." Inventor: Jerome B. Zeldis; assignee Celgene Corp.; filed 2013‑04‑08; granted 2013‑09‑10; priority 2002‑05‑17. (Note: the patent itself states the compound is Revimid™/Revlimid®/lenalidomide — I am reporting the patent's own naming literally.)
  • Orange Book listing: listed against REVLIMID®, with an expiration date of May 15, 2023 (41st Annual Orange Book listing shown as 8530498 – May 15, 2023 – U-1984).
  • Legal status: Expired – Fee Related; anticipated expiration 2023‑05‑15.
  • Character of the litigation: The '498 patent was primarily a Hatch‑Waxman tool — asserted in ANDA suits to trigger the 30‑month stay. Across the Revlimid disputes, no Celgene patent was ever carried to a merits judgment on the '498 patent; cases ended in settlements/consent judgments (Natco, Dr. Reddy's, Zydus, Cipla, Lotus/Alvogen, Mylan, Hikma, etc.). Its validity was challenged indirectly in the purchaser/insurer antitrust suits, where plaintiffs alleged the multiple-myeloma method-of-treatment patents were obvious.

Answers to "if no litigation is known"

Litigation is known, so that branch does not apply. However, I want to be explicit about the limits of this report:

  1. I could not independently verify the parties for dockets 2:17-cv-06163, 2:18-cv-11518, 2:19-cv-14731, 2:19-cv-15449, 2:20-cv-00315, 2:20-cv-08570, 2:20-cv-14389, 2:21-cv-01734, 2:21-cv-11261, 2:21-cv-12927, 2:21-cv-20099, 2:21-cv-20459, and 2:22-cv-02952. I list them because they appear in the patent's own litigation record, but I have flagged them as unverified rather than guessing.
  2. I did not locate any PTAB/CAFC appellate decision on the merits of the '498 patent itself. (The 2017 Lotus IPR referenced in one source was directed to U.S. 7,968,569, not the '498 patent, and was denied on March 14, 2019.)
  3. Outcomes marked "settled" reflect settlements described in the antitrust complaints and secondary reporting; the settlement terms involving the '498 patent were generally confidential.
  4. Primary sources to confirm live status: Unified Patents case list (portal.unifiedpatents.com/litigation/caselist), PACER/RECAP, the DrugPatentWatch patent page for 8,530,498, and the court opinions cited (e.g., In re Revlimid & Thalomid Purchaser Antitrust Litig., D.N.J. No. 2:19‑cv‑07532, Doc. 446, June 6, 2024).

Generated 10/1/2026, 5:44:13 AM

Proceedings on file (0)

All PTAB activity →

AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.

Current assignee: Celgene Corporation

No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.

PTAB challenges

AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.

✓ Generated

I'll verify the structured data against live sources before concluding.

Proceedings overview

Total AIA trial proceedings on US 8,530,498: zero. The structured USPTO Open Data Portal block — the canonical list supplied in this prompt — reports no IPR, PGR, or CBM proceeding naming this patent, and my independent web checks surfaced none either. That is the correct bottom line, and everything below must be read against it. The defensive posture is therefore not "hardened by surviving two IPRs" and not "claims canceled" — it is untested: no PTAB panel has ever issued an institution decision or a Final Written Decision on any claim of the '498 patent, so there is no claim-level disposition to cite, no § 315(e)(2) estoppel to lean on, and no FWD to quote.

One important caveat that a defendant will care about more than the null result: the '498 patent is expired. The patent's anticipated expiration is 2023-05-15 (matching the Orange Book listing for REVLIMID use code U-1984), it granted 2013-09-10 from an application filed 2013-04-08 claiming priority to 2002-05-17, and Google Patents records its legal status as "Expired - Fee Related." Any live assertion against you would have to reach pre-2023 conduct, or rely on back damages — which changes the practical value of a PTAB filing enormously.


No proceeding — US 8,530,498

There is no docket entry to serialize. Instead of inventing a number (which the task expressly forbids), here is the structured-source disposition verbatim and its meaning:

  • Type: N/A — no AIA trial petition on file for this patent.
  • Filed: N/A.
  • Status: "The USPTO ODP API returns no AIA trial proceedings for this patent as of the most recent ingest." Plain English: nothing has been petitioned — not denied, not settled, not instituted. Absence of a docket, not an empty docket.
  • Judge panel: None assigned. APJ panels are constituted only upon a petition; none exists.
  • Petition grounds: None asserted. No § 102, § 103, or § 112 ground has been argued at the Board against these claims.
  • Institution decision: None. There has been no § 314(a) reasonable-likelihood determination.
  • Final Written Decision: None issued. No independent claim and no dependent claim of the '498 patent has been canceled or sustained by the Board.
  • Settlement / termination: N/A.
  • Appeal: No FWD → no appeal to the Federal Circuit from any PTAB proceeding on this patent.
  • Defensive value: You cannot litigate this patent at the PTAB on the strength of someone else's win, because no one has won or lost here. Any invalidity position on the '498 claims is a first-mover exercise, with the full cost of building the record from scratch.

Adjacent proceedings you should not confuse with this patent

These are different patents — the "Multiple Myeloma Patent" family siblings and patent-family relatives — and are offered only as context for why the '498's clean PTAB record is notable. None of them is a proceeding on US 8,530,498.

  • IPR2018-01714 — Alvogen Pine Brook LLC v. Celgene Corp., on US 7,968,569 (a direct sibling in the same multiple-myeloma family; the '498 and '569 share inventor Jerome B. Zeldis, the 2002-05-17 priority chain, and overlapping claim subject matter). Filed 2018-09-12; Alvogen and Lotus Pharmaceutical Co., Ltd. named as real parties-in-interest; grounds were § 103(a) over Palumbo + the May/August/October 2001 Celgene press releases, and Palumbo + Hideshima. Institution was denied on 2019-03-14 (Paper 7), and petitioner's $15,000 post-institution fee was refunded (Notice of Refund, 2019-12-17). Institution denial is not a merits validation — the Board never reached patentability. This is the proceeding that established Alvogen/Lotus as the party with a demonstrated appetite for PTAB challenges to this family.
  • Dr. Reddy's IPRs on the Celgene MDS patents (filed 2018-08-03): institution denied 2019-02-11 in three parallel decisions on a single evidentiary ground — Dr. Reddy's had not proven Celgene's own press releases were publicly available. Celgene won on the publication-date technicality, not on the merits.
  • IPR on US 5,635,517 (the Revlimid active-ingredient patent) by entities associated with Kyle Bass and Erich Spangenberg: institution denied; Celgene, represented by Quinn Emanuel, adopted nearly all of its arguments (as described in Quinn Emanuel's 2019 life-sciences résumé).

The pattern that matters: every AIA petition filed against a Celgene lenalidomide patent appears to have been denied institution. No FWD, no claim cancellation anywhere in this family. Celgene got out of the PTAB on the merits threshold and on evidentiary technicalities, and then resolved its exposure through district-court settlements ahead of any merits ruling.


Strategic summary

Claim status on US 8,530,498. No claim is canceled; no claim is sustained by the Board; all claims are UNTESTED at the PTAB. Because no FWD exists, there is no claim-by-claim disposition to list and no surviving-claim set to quote — anyone who tells you "claims 1–5 were canceled" or "claim 1 survived IPR" on this patent is misattributing a sibling reference or making it up. Note also the patent's length: it issued 2013-09-10 (a continuation off the 2002 priority chain) and expired 2023-05-15, so the enforcement window has closed absent pre-expiration damages theories.

Estoppel landscape. Because there has been no IPR/PGR on the '498 patent, § 315(e)(2) estoppel is a non-issue from AIA trials — no petitioner is barred, and no privity chain (Alvogen → Lotus, for example) has been forged against these claims. The offsetting risk is symmetric: you also get no benefit from anyone else's institution denial, and there is no estoppel to point to that would constrain a parallel district-court invalidity attack. The § 315(b) one-year bar is similarly untriggered unless you have been served with a complaint on the '498 specifically.

Pattern signals. No petitioner has filed multiple IPRs on this patent (there are none). The patent owner — Celgene Corporation, now within Bristol-Myers Squibb — has not pursued any PTAB appeal on this patent, for the straightforward reason that it never needed to: no adverse Board decision ever issued against the '498. There is no defensive aggregator in the chain; no Unified Patents or similar NPE-defense entity appears anywhere in the file for this patent. The litigation activity attached to the '498 is ordinary Hatch-Waxman ANDA litigation — Celgene asserting the MM family (including the '498) against Lotus/Alvogen, Zydus, Dr. Reddy's, Sun, Cipla and others in D.N.J. — not NPE assertion, which is exactly why it never attracted a defensive-aggregator IPR.


Recommended next steps

  1. Treat the null PTAB result as the headline. If you are a defendant and someone is asserting US 8,530,498, do not expect to ride an existing FWD to invalidity. There is none. Any validity challenge must be built from first principles.
  2. Check expiration and damages before spending anything. The patent's anticipated expiration is 2023-05-15 and its status is "Expired - Fee Related." Confirm with the Orange Book (N 021880, use code U-1984) and the USPTO PatentCenter record whether any assertion of this patent can reach your conduct. If the demand letter cites the '498 for post-expiration activity, that is a strong reason to push back hard.
  3. If you do file, you are the first mover. No petition has been filed, so there is no § 315(b) bar running against you yet and no estoppel to inherit. But there is also no institution-denial record to distinguish, and you would be litigating § 103 obviousness on a family where the Board has denied every petition it has seen — largely because the prior-art references (particularly Celgene's own 2001 press releases) carry publication-date proof problems. If you go to the PTAB, lock down public-availability evidence for every printed publication in the record before filing; that is precisely where Dr. Reddy's and others failed.
  4. Do not rely on the sibling denials. IPR2018-01714's denial on US 7,968,569 establishes nothing about the '498, and institution denial is not a merits holding — the Board never reached the patentability of the '569 claims. The same is true for the '517 and MDS denials. Cite them for background only.
  5. Verify before relying on this analysis. My conclusion rests on the structured ODP block supplied as canonical plus targeted web searches; the searches were not exhaustive of PTAB E2E. Before filing or responding to a demand, confirm directly against the PTAB E2E docket and PatentCenter for US 8,530,498, and re-run the ODP query at the current ingest date.

Key sources: Structured USPTO ODP "PTAB proceedings on file" block (canonical, states no AIA trial proceedings); IPR2018-01714 record including the 2019-03-14 institution denial and 2019-12-17 Notice of Refund (https://www.docketalarm.com/cases/PTAB/IPR2018-01714/); Celgene v. Lotus/Alvogen, No. 2:17-cv-06842 (D.N.J.) complaint identifying the '498 among the patents-in-suit; Orange Book 41st ed. listing for N 021880 (REVLIMID) — 8,530,498, expiration 2023-05-15.

Generated 10/1/2026, 5:44:14 AM

Ownership chain (1)

Asserters network →

Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.

  1. 2013-04-08 · Assignment

    ZELDIS, JEROME B.Celgene Corporation

Assignment history

Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.

✓ Generated

I'll verify what I can against live sources before reconstructing the chain.

Good — I have a directly analogous assignment record from the same family. Let me pull more specifics.

I hit the tool-call ceiling mid-verification. Below is what I could confirm, with unverified items explicitly flagged rather than filled in.


Assignment Record Reconstruction — US 8,530,498 B1

Verification note up front: Google Patents legal events for this patent (the authoritative text supplied) show exactly one recorded assignment event — the inventor-to-Celgene recordation on 2013-04-08. I was able to retrieve a sibling assignment record in the same family (Reel/Frame 021461/0407) but I could not retrieve the reel/frame for application 13/858,708 itself from live sources before exhausting my search budget. I am not going to invent that reel/frame number. Treat any reel/frame below tagged "(sibling app)" as corroborating family evidence, not as the record for this patent.

Inventors

Inventor Employer at time of filing Basis
Jerome B. Zeldis Celgene Corporation — SVP Clinical Research & Medical Affairs; named Chief Medical Officer 1999; later CEO of Celgene Global Health Google Patents lists Zeldis as the sole named inventor. SEC/10-K-derived bios and litigation filings confirm continuous Celgene employment since February 1997

Unusual-pattern check — negative. The classic fire-sale precursor (all inventors leaving the original assignee within ~12 months of filing) is absent, and in fact inverted. Zeldis remained at Celgene for roughly 19 years after the 2002-05-17 priority date and did not depart until 2016. There is no inventor-decoupling signal here.

One caveat worth logging: because this is a continuation (application 13/858,708, filed 2013-04-08) claiming 2002-05-17 priority, "employer at the time of filing" is ambiguous — but it is Celgene on both ends of that window (2002 and 2013), so the ambiguity is immaterial.

Original assignee

Celgene Corporation — Delaware corporation. Two addresses appear across the family records:

  • 7 Powder Horn Drive, Warren, New Jersey 07059 (address in the 2003-executed assignment document)

  • 86 Morris Avenue, Summit, New Jersey 07901 (address in the sibling USPTO record and in Celgene's PTAB real-party-in-interest notices)

  • Primary line of business: commercial biopharmaceutical company; the claims here read on REVLIMID® (lenalidomide), Celgene's flagship multiple myeloma / MDS drug — one of the highest-revenue small molecules in the world.

  • Did they ship a product embodying the claims? Yes, unambiguously. US 8,530,498 is listed in the FDA Orange Book against Lenalidomide/REVLIMID with a patent expiration of May 15, 2023 (Orange Book code U-1984, 41st Annual Edition). The title compound is lenalidomide itself.

  • Current status: Operating, but no longer independent. Celgene was acquired by Bristol Myers Squibb (all-stock, ~$74 B) and the deal closed in November 2019. Celgene Corporation survived as a legal entity/subsidiary, which is why — see below — no assignment was ever recorded for the BMS deal.

Assignment timeline

Chronological, with confirmed vs. corroborating items separated.

  1. 2003-09-03 (executed) / recorded 2008-08-19 — Reel 021461/0407 (sibling application 12/229,074 → US 8,198,262; SAMED inventor, SAME assignee, SAME family)

    • Conveyance: ASSIGNMENT OF ASSIGNORS' INTEREST (SEE DOCUMENT FOR DETAILS)
    • Assignor: ZELDIS, Jerome B. — 157 Christopher Drive, Princeton, NJ
    • Assignee: CELGENE CORPORATION, 86 Morris Avenue, Summit, New Jersey 07901
    • Correspondent: attorney of record Pennie & Edmonds LLP; correspondence address 222 East 41st Street, New York, New York 10017-6702. The body of the assignment expressly authorizes "my attorney, of Pennie & Edmonds, LLP" to insert application data.
    • Context: routine inventor → employer title perfection for a pharma employee invention. Nothing transactional.
  2. 2013-04-08 (executed/recorded) — reel/frame NOT VERIFIED

    • Conveyance: Assignment of assignors' interest (inferred from Google Patents event type "Assigned to CELGENE CORPORATION"; the underlying document was not retrievable)
    • Assignor: ZELDIS, JEROME B. (named as sole assignor in the Google Patents legal-events record)
    • Assignee: CELGENE CORPORATION
    • Correspondent: not retrievable from the sources I reached
    • Context: formality re-recordation at filing of the continuation. Celgene already held the entire right, title and interest; this recording perfects the chain for the newly filed 13/858,708 application. This is not a change in beneficial ownership.
  3. No further recorded assignments. Celgene Corp remains the listed current assignee on Google Patents.

Critical negative finding: the Bristol Myers Squibb / Celgene merger produced no USPTO assignment record. That is expected and not suspicious — BMS acquired Celgene by stock merger, and Celgene Corporation continued as a legal entity holding its own patents. The absence of a BMS recordation is therefore not evidence of a missing link.

Reference point for the family (not this patent, but useful for the recurring-correspondent question): US 5,635,517, the genus patent in the lenalidomide family, was assigned Muller / Stirling / Chen → Celgene, recorded 1996-07-23, Reel 8147, Frame 954 (per Celgene's own IPR2015-01169 RPI notice). Same pattern: inventor-to-operating-company, one link, no downstream transfers.

Timeline diagram

timeline
    title Ownership of US 8530498
    2002 : Priority date 17 May
    2003 : Zeldis assignment executed 3 Sep
    2008 : Family assignment recorded 19 Aug
    2013 : Continuation 13 858 708 filed 8 Apr
         : Assignment to Celgene recorded
         : Patent issued 10 Sep
    2014 : Earliest D N J case in family 2 14 cv 03126
    2017 : Asserted against generic ANDA filers
    2019 : Celgene acquired by Bristol Myers Squibb
    2023 : Patent expired 15 May

NPE / troll-pattern signals

# Signal Finding Evidence
1 Shell-entity transfer Not present No LLC, no "IP / Holdings / Ventures" suffix, no registered-agent address anywhere in the chain. Sole assignee, 2003 and 2013, is Celgene Corporation, an operating pharma with its own commercial manufacturing and an Orange-Book-listed product (Reel 021461/0407 is the family exemplar; assignee address 86 Morris Ave, Summit NJ — a corporate campus, not a service address).
2 Known asserter in the chain Not present Current assignee Celgene Corporation — a practicing entity. The Stanford NPE Litigation Database classifies Celgene Corporation v. Zydus Pharmaceuticals (USA) Inc., D.N.J. 2:17-cv-02528 (filed 2017-04-12, asserting US 8,530,498 among others) with "Patent Asserter: Celgene Corporation — 8, Product company" and "NPE Status: Practicing Entity." Celgene appears on no Acacia / Marathon / IV / IPNav / Wi-LAN / Conversant / Vringo / Pendrell list. High plaintiff volume here reflects Hatch-Waxman ANDA defense, which is the statutory posture of the reference product owner, not NPE assertion economics.
3 Repeat correspondent across the chain Not present as an NPE signal Pennie & Edmonds LLP, 222 East 41st Street, New York NY 10017-6702, is the correspondent of record on family record Reel 021461/0407. This firm (a long-standing general-practice IP firm, now absorbed into Fitzpatrick, Cella, Harper & Scinto via the 2005 Pennie & Edmonds dissolution) is operating-company prosecution counsel, not a shell-entity recording mill. A single-record firm appearance in a family where the assignee is a real manufacturer fits the rule you set: recurrence, not a lone appearance, is the finding — and recurrence across NPE links does not exist here. I could not confirm the correspondent on the 2013 record for 13/858,708, so I flag this one as partially unverified.
4 Cascading transfers Not present One assignment in the entire post-issuance life of the patent (zero, in fact). Zero transfers through chained LLCs; zero shared correspondents across multiple links. There is only one link.
5 Pre-litigation transfer Not present No assignment at all between 2013-04-08 and the earliest D.N.J. filings. Nothing was transferred into a new holder to set venue or clean up standing. The patent was asserted by its 2003-era owner, unchanged.
6 Bankruptcy fire-sale Not present Celgene never filed Chapter 7 or 11. It was acquired by Bristol Myers Squibb in a solvent, all-stock ~$74 B merger (closed November 2019) — the inverse of a fire-sale. Sibling family patents (e.g. US 7,465,800; 7,855,217) also stayed with Celgene.
7 Privateering Not present No operating-to-NPE transfer to assert on Celgene's behalf. Celgene asserted in its own name throughout — see the 16-patent assertion set against Lotus/Alvogen (including US 8,530,498) in 2017 and the Celgene-named complaints in D.N.J. 2:14-cv-03126, 2:16-cv-07704, 2:17-cv-02528, 2:20-cv-08570, etc. The 2015 Natco, 2019 Alvogen and 2020 Dr. Reddy's settlements were Celgene-signed licenses, not NPE monetization deals.
8 Defensive aggregator Not present Chain does not terminate at RPX, AST, LOT, Unified Patents or OIN. It terminates at Celgene Corporation and then, by merger, at Bristol Myers Squibb. The patent is now inert through expiration, not neutralization.

Verdict

Operating-company assertion.

US 8,530,498 has a one-link ownership chain: Jerome B. Zeldis → Celgene Corporation, on the family's standard assignment paperwork (exemplified by Reel 021461/0407, executed 2003-09-03, recorded 2008-08-19), re-recorded for the 2013 continuation. Celgene manufactured and shipped lenalidomide (REVLIMID®), the compound the claims cover, and listed this patent in the Orange Book; it then enforced the patent in its own name against generic ANDA filers — e.g. Celgene Corp. v. Zydus Pharmaceuticals, D.N.J. 2:17-cv-02528 (2017-04-12), which the Stanford NPE Litigation Database tags as "Product company / Practicing Entity" — and settled with Natco (2015), Alvogen/Lotus (2019) and Dr. Reddy's (2020). There is no shell transfer, no asserter entity, no cascading LLC chain, and no pre-litigation assignment, so zero of the eight NPE signals fire. Note the one thing I could not verify and did not guess: the specific reel/frame for the 2013 recordation on application 13/858,708. Confirm it directly at the USPTO Assignment Center (search by patent number 8530498) — https://assignmentcenter.uspto.gov/ and https://assignment.uspto.gov/patent/index.html — before relying on the chain-of-title citation in any filing.

Generated 10/1/2026, 5:44:50 AM

Prior art

Earlier patents, publications, and products that may anticipate or render the claims unpatentable.

✓ Generated

I'll research the USPTO record for US 8,530,498 and its cited prior art. Let me run several searches.

Prior-Art Analysis — US 8,530,498 B1

1. Patent identification (as-recorded, verified)

Field Value (verbatim from the record)
Patent number US 8,530,498 B1
Title Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione
Application 13/858,708, filed 2013‑04‑08
Publication US 2013/0231314 A1 (2013‑09‑05); patent granted 2013‑09‑10
Inventor Jerome B. Zeldis
Assignee Celgene Corporation
Priority / prior-art date (per Google Patents, an assumption) 2002‑05‑17
Anticipated expiration 2023‑05‑15; status Expired – Fee Related
Orange Book Revlimid (lenalidomide), NDA 021880, patent 8,530,498, code U‑1984
Litigation Numerous D.N.J./N.D. W. Va. Hatch‑Waxman suits (e.g., 2:17‑cv‑02528 Celgene v. Zydus Pharmaceuticals, which asserts 7,465,800 / 7,855,217 / 7,968,569 / 8,530,498 / 8,648,095 / 9,101,621 / 9,101,622)

URL: https://patents.google.com/patent/US8530498/en

Identifier-noise warning (per your instruction not to auto-correct): searches for the string "8530498" also surface unrelated identifiers — e.g., Australian family member "AU 8530498 A" and PubMed ID "8530498." Those are not US 8,530,498 and I have excluded them.


2. Important disclosure about the citation data (please read before relying on the list)

The authoritative full text you supplied for US 8,530,498 does not contain the front-page "References Cited / U.S. Patent Documents" table — that portion of the Google Patents record is absent from the supplied extract, and within my tool limits I could not retrieve the examiner‑cited front‑page list itself (the searches returned the description, classifications, family, and litigation data, but not the "Patent Citations" block).

Accordingly, I am not reporting an examiner-citation table I did not actually see, because doing so would be fabrication. What I can ground with confidence is:

  • (A) references expressly cited inside the specification of US 8,530,498 (these appear verbatim in the text you supplied); and
  • (B) the references cited in the search report of a sibling family member (EP 1,567,158 A4 / WO 2004/043377, Celgene "Methods and compositions using immunomodulatory compounds…"), which appears in the same DOCDB simple family as US 8,530,498 B1.

Both sets are flagged as such below. If you need the literal front-page "References Cited" list for the 8,530,498 docket, it must be pulled from USPTO Patent Center / the printed patent PDF — I could not verify it here.

Second caveat: the claim set of US 8,530,498 was not present in the supplied text. Because § 102 anticipation is claim-by-claim, my "which claims" column is keyed to claim categories implied by the title/description (a compound, a method of treating multiple myeloma, and a method using a second active agent). I cannot print verbatim claim language without seeing it.


3. Set A — References cited in the specification of US 8,530,498

These are recited in the background/section 5.1 of the patent itself.

# Full citation Date Brief description Potential § 102 relevance
A1 US 5,635,517 (Muller et al., Celgene) — "1‑oxo‑ and 1,3‑dioxo‑2‑(2,6‑dioxopiperidin‑3‑yl)isoindolines substituted with amino in the benzo ring" Issued 1997 (spec cites it as the structural basis, ¶ citing "structure I") The genus/compound patent covering the claimed active agent — discloses the 1‑oxo‑2‑(2,6‑dioxopiperidin‑3‑yl)isoindoline ring system bearing a benzo‑ring amino group, i.e., 3‑(4‑amino‑1‑oxo‑1,3‑dihydro‑isoindol‑2‑yl)‑piperidine‑2,6‑dione Strong § 102(a)/(b) art against any claim drawn to the compound per se or a composition. For method-of-treating-MM claims, it discloses the compound but (on its face) not the MM indication — so typically a § 103 base reference rather than a standalone § 102 anticipation of the method.
A2 US 6,281,230 (G. W. Muller et al.) — substituted 2‑(2,6‑dioxopiperidin‑3‑yl)phthalimides and ‑1‑oxoisoindoles Issued 2001 (spec cited) Core Celgene IMiD chemistry/utility patent; discloses the class and TNF‑α‑reduction utility § 102 against compound/composition claims; § 103 base for method claims.
A3 US 6,316,471 B1 (G. W. Muller et al.) — substituted 2‑(2,6‑dioxopiperidin‑3‑yl)phthalimides and ‑1‑oxoisoindolines, use in reducing TNF‑α 2001‑11‑13 (date confirmed by search result) Same family/teaching as A2 Same posture. Also cited as "DX" (combination) in the EP 1,567,158 search report.
A4 US 5,929,117 Spec cited (late 1990s) Cyano and carboxy derivatives of substituted styrenes (immunomodulatory compounds) Background/general-state-of-the-art; weak § 102 candidate for the MM method.
A5 US 5,874,448 Spec cited 1‑oxo‑2‑(2,6‑dioxo‑3‑fluoropiperidin‑3‑yl)isoindolines and 1,3‑dioxo‑2‑(2,6‑dioxo‑3‑fluoropiperidine‑3‑yl)isoindolines Analog chemistry; not a method-of-MM anticipation.
A6 U.S. Appl. Ser. No. 09/972,487 (isoindole‑imide compounds) Filed 2001‑10‑05 Celgene isoindole-imide application (family precursor) § 102(e)‑type art only if it published/issued with supporting disclosure; weak as standalone anticipation of the MM method.
A7 U.S. Provisional Appl. No. 60/372,348 (R. Hariri et al., stem cells) Filed 2002‑04‑12 Stem-cell disclosure for transplantation contexts Only relevant to any transplant-combination claims; provisional applications are not § 102(b) publications.
A8 U.S. Pat. Nos. 5,391,485; 5,393,870; 5,229,496 (GM‑CSF) and 4,810,643; 4,999,291; 5,528,823; 5,580,755 (G‑CSF) 1990s Hematopoietic growth factors cited for second-active-agent combinations § 102/103 only for combination claims; would not anticipate a single-agent compound method.
A9 U.S. Pat. No. 5,134,127 (cyclodextrin solubilization) and the controlled-release cluster (3,845,770; 3,916,899; 3,536,809; 3,598,123; 4,008,719; 5,674,533; 5,059,595; 5,591,767; 5,120,548; 5,073,543; 5,639,476; 5,354,556; 5,733,566) 1970s–1990s Formulation/delivery art Not § 102 art for a method-of-treatment claim; formulation-only.
A10 Stockdale, Medicine, vol. 3, Rubenstein & Federman eds., ch. 12, § 10 (1998) 1998 General oncology/chemotherapy background Background only.
A11 Penichet & Morrison, J. Immunol. Methods 248:91‑101 (2001); Emens et al., Curr. Opin. Mol. Ther. 3(1):77‑84 (2001) 2001 Antibody/cytokine combination technology § 102 only for antibody/cytokine combination claims.

4. Set B — References cited in the sibling family's search report (EP 1,567,158 A4 / WO 2004/043377, Celgene) — the most probative art

Because the EP search report was drafted against the same immunomodulatory-compound/MM subject matter, it is the best proxy for what the examiner would have considered on 8,530,498. Category codes are the EPO's (X = alone destructive; DX = document combined, "D" = cited in application).

# Full citation Date Brief description Potential § 102 relevance to the MM-method claims
B1 Richardson P.G. et al., "A phase 1 study of oral CC5013, an immunomodulatory thalidomide (thal) derivative, in patients with relapsed and refractory multiple myeloma (MM)," Blood 98(11), Part 1, p. 775a (43rd ASH Annual Meeting; Orlando, Dec 7‑11, 2001) Nov 16, 2001 (meeting Dec 2001) Phase‑1 clinical administration of CC‑5013 (= lenalidomide, the claimed compound) to relapsed/refractory multiple myeloma patients Most likely § 102 anticipation candidate for method-of-treating-MM claims. A single printed publication that expressly puts the claimed compound into MM patients. Whether it "anticipates" turns on (i) does it disclose a therapeutically effective amount, and (ii) enablement of the full claim scope (e.g., newly diagnosed patients, dose ranges). If the claim is generic to "treating multiple myeloma… administering a therapeutically effective amount," B1 is the reference to brief. Flagged X in the family search report.
B2 Lentzsch S. et al., "S‑3‑amino‑phthalimido‑glutarimide inhibits angiogenesis and growth of B‑cell neoplasias in mice," Cancer Research 62:2300‑2305 2002‑04‑15 (before the 2002‑05‑17 date) Preclinical in‑vivo inhibition of B-cell neoplasia growth/angiogenesis by an amino‑phthalimido‑glutarimide (IMiD class) § 102 if a claim is read onto B-cell neoplasias generally; more realistically § 103 (MM is a B-cell neoplasm, and a POSA would expect activity). Flagged X.
B3 D'Amato R.J. et al., "Mechanism of action of thalidomide and 3‑aminothalidomide in multiple myeloma," Seminars in Oncology 28(6):597‑601 Dec 2001 Mechanism-of-action review connecting thalidomide/3‑aminothalidomide to multiple myeloma § 102/103 support: establishes that the class (including amino-imide analogs) was known to act in MM. Flagged X.
B4 WO 02/059106 A1 (Celgene Corp. et al.) Published 2002‑08‑01 Immunomodulatory-compound use; family priority early 2002 Publication is after the 2002‑05‑17 date, so not § 102(a)/(b). However, if its international filing date precedes 2002‑05‑17 and it designates the US and was published in English, it is § 102(e) art as of its filing date (pre‑AIA). Flagged DX.
B5 US 6,316,471 B1 (Muller et al.) 2001‑11‑13 See A3 See A3. Flagged DX.
B6 US 2002/0049231 A1 (D'Amato) 2002‑04‑25 Anti‑angiogenic/thalidomide-derivative uses § 102(b)/(a) publication before priority; relevant to anti‑angiogenesis claims, less so to MM-specific claims. Flagged X.
B7 WO 02/064038 A2 (Children's Medical Center Corp. et al.) 2002‑08‑22 Angiogenesis-inhibition subject matter Post-priority publication → only § 102(e) if earlier-filed and US-designating. Flagged X.
B8 Marketletter, June 18, 2001 and Marketletter, October 9, 2001 2001 Trade-press reports (incl. "Celgene's Revimid an orphan drug, says FDA"; "Celgene drug promises activity in solid tumors") § 102(b) printed publications. Trade-press statements about Revimid can be anticipatory if they disclose the MM treatment and are enabling; more commonly they are § 103/obviousness or public-use/on-sale evidence. Flagged X.
B9 Database PHARMANI, "Celgene's Revimid an orphan drug, says FDA" (XP002369094, STN acc. 1659300) and Database NLDB, "Celgene drug promises activity in solid tumors" (XP002369095, acc. 2002‑35280) 2001–2002 Database abstracts re Revimid § 102(b) publication art of the same character as B8. Flagged X.
B10 Figg W.D. et al., "Inhibition of angiogenesis: treatment options for patients with metastatic prostate cancer," Investigational New Drugs 20(2):183‑194 May 2002 Anti-angiogenesis review Marginal — publication month straddles the 2002‑05‑17 date; and prostate, not myeloma. Flagged X but weak.

5. Bottom line — the most relevant prior art, ranked

  1. Richardson et al., Blood 98(11) Part 1:775a (Nov 16, 2001) — the single most relevant reference, because it discloses the claimed compound (CC‑5013/lenalidomide) being administered to multiple myeloma patients. This is the reference most capable of invalidating claims to "a method of treating multiple myeloma comprising administering [the compound]" under 35 U.S.C. § 102(b) (pre‑AIA).
  2. US 5,635,517 (Muller/Celgene) — the compound genus patent; § 102(a)/(b) against any compound/composition claims, and the mandatory § 103 base for all method claims.
  3. US 6,281,230 / US 6,316,471 (Muller/Celgene) — class-level chemistry and TNF‑α utility; § 103 base (US 6,316,471 expressly cited "DX" in the family search report).
  4. D'Amato, Semin. Oncol. 28(6):597‑601 (Dec 2001) and Lentzsch, Cancer Res. 62:2300‑2305 (Apr 15, 2002) — contemporaneous mechanism/preclinical art tying IMiDs to multiple myeloma / B-cell neoplasia; strongest as § 103 combinations with Richardson.
  5. Marketletter items (June 18 and Oct 9, 2001) — § 102(b) trade-press publications; corroborating and potentially anticipatory on narrower facts.

6. Analytical caveats you should carry forward

  • Anticipation is element-by-element. None of the compound patents (A1–A3, A5) disclose the multiple myeloma treatment step; conversely the Richardson abstract does not, on its face, disclose the broad dose ranges or the dexamethasone/second-agent combinations recited elsewhere in the description. Expect the real fight on 8,530,498 to be § 103, not § 102, except for the compound-overlap claims.
  • Timing matters under pre-AIA law (priority 2002‑05‑17): only references published before that date are § 102(a)/(b) art; later-published items (WO 02/059106, WO 02/064038, the 2002 Figg paper) qualify only via § 102(e) or as § 103 support.
  • I did not see the front-page "References Cited" list for US 8,530,498, nor its claim set. The above is built from (i) citations appearing verbatim in the patent's own specification and (ii) the sibling family's EPO search report. Treat Set B as the high-confidence core and Set A as intrinsic-citation context — and pull the actual USPTO front page and claims before filing anything.

Generated 10/1/2026, 5:44:55 AM

Obviousness

Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.

✓ Generated

I'll ground this in the page's prior-art record and the actual claim text before running the §103 analysis.

Let me pull the actual claim text and the cited-references record.

Now let me try to pin down the granted claims and the face-of-patent references.

Building on the prior sections — new facts surfaced, and one contradiction to flag

Newly confirmed since the earlier sections: (a) Google Patents returns "Expired – Lifetime" for application 13/858,708 in the family tables I retrieved this session — a third rendering alongside the "Expired – Fee Related" and "Expired – Lifetime" variants already noted. The status caveat in the earlier summary stands; the May 15, 2023 term (Orange Book, U-1984, NDA 021880) is uncontradicted. (b) The '498 sits in the continuation web of 10/438,213 (filed May 15, 2003 → US 7,968,569), with US 12/640,702 → US 8,198,306 (proteasome-inhibitor method claims) among its relatives — consistent with the earlier §3 inference that '498 and '569 share a specification and a term. (c) My earlier statement that I had no verbatim claim text remains true for '498 specifically. I was not able to retrieve a granted-claims column for 13/858,708 this session either. I will therefore analyze the claim scope I can support and label the rest as reconstruction, rather than importing '569's claims into '498.

What the page's "Prior Art" record actually contains. The fetched Google Patents page does not render a formal "Citations / References Cited" table. Its prior-art signal is limited to (i) the listed prior-art keywords — patients, administered, compound, cancer, immunomodulatory compound — and (ii) the references the specification itself incorporates by name. I supplemented with the family's EP search report (EP 1567158 A4), which lists the same art under "DX"/"X" categories. Everything below is tagged to which of those it came from.


1. §103 framework and the POSA

Under Graham v. John Deere Co., 383 U.S. 1 (1966), and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the inquiry is scope/content of the prior art, differences from the claims, level of ordinary skill, and secondary considerations. For method-of-treatment claims, the art must be shown to render the administering-to-treat step obvious; a mere "obvious to try" rationale needs a finite set of identified, predictable solutions with a reasonable expectation of success (In re Kubin, 550 F.3d 1351 (Fed. Cir. 2009); In re O'Farrell, 853 F.2d 894 (Fed. Cir. 1988)). Dose/cycle limitations are not automatically non-obvious, but the art must actually reach them (In re Kao, 639 F.3d 1057 (Fed. Cir. 2011)).

POSA: a team — a hematologist/oncologist with MM trial experience and a medicinal chemist/pharmacologist — with ordinary skill in thalidomide-class IMiD development as of May 17, 2002.

Claim-scope reconstruction for '498 (confidence: low-moderate): preamble "A method of treating multiple myeloma…"; administration of 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione (= lenalidomide) or a salt thereof; at least one claim reciting combination with 40 mg/day dexamethasone (per the Taiwan TIPO family description: "Method of treating multiple myeloma in combination with 40mg/day of dexamethasone"); DrugPatentWatch classifies the set as "Use; Delivery," implying at least one administration-format claim. Whether '498 carries the "21 consecutive days + 7 days rest in a 28-day cycle" limitation is unverified; that limitation is documented for sibling '569 claims 1 and 13 (IPR2018-01714 petition/exhibits; Natco Markman briefing, D.N.J. 2:17-cv-02528, ECF 252), and I will analyze it as an alternative, not an assumption.


2. The prior-art record

Ref. Date / status Teaching Source of the cite
US 5,635,517 (Muller, Celgene) Prior art 1-oxo- and 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)isoindolines substituted with amino in the benzo ring; reduces TNF-α Expressly incorporated in the '498 specification ("as described in U.S. Pat. No. 5,635,517 which is incorporated herein by reference")
US 6,281,230 / 6,316,471 (Muller et al.) Prior art Substituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and -1-oxoisoindoles, incl. cancer uses Expressly cited in the '498 specification as defining "IMiDs"
US 5,874,448; 5,929,117 Prior art Fluoro-piperidinyl isoindolines; cyano/carboxy styrenes Cited in '498 specification
WO 02/059106 A1 (Celgene) — PCT of U.S. Ser. No. 09/972,487, filed Oct. 5, 2001 §102(e)/§103 art as of its US filing date Isoindole-imide compounds and methods of use EP 1567158 A4 search report ("DX"); the '498 spec cites Ser. No. 09/972,487
US 2002/0049231 A1 (D'Amato) Pub. Apr. 25, 2002 Thalidomide/3-aminothalidomide anti-angiogenesis and cancer EP 1567158 A4 ("X")
D'Amato et al., Semin. Oncol. 28(6):597-601 (Dec. 2001) Printed publication "Mechanism of action of thalidomide and 3-aminothalidomide in multiple myeloma" EP 1567158 A4 ("X")
Richardson et al., Blood 98(11):775a (Nov. 16, 2001) (ASH abstract) Printed publication "A phase 1 study of oral CC5013 [lenalidomide] … in patients with relapsed and refractory multiple myeloma" EP 1567158 A4 ("X")
Lentzsch et al., Cancer Res. 62:2300-2305 (Apr. 15, 2002) Printed publication 3-amino-phthalimido-glutarimide inhibits angiogenesis/growth of B-cell neoplasias EP 1567158 A4 ("X")
Kyle & Rajkumar, Semin. Oncol. 28(6):583-87 (Dec. 2001); Coleman (2002) Printed publication Thalidomide + dexamethasone for MM; 40 mg dexamethasone with a thalidomide analog Identified in the Revlimid/Pomalyst antitrust pleadings (Cigna v. Celgene, D.N.J. 1:25-cv-05237; Hagens Berman Pomalyst complaint, D.N.J. 1:23-cv-07871, ¶156)
Cohen (1982) Printed publication 21 days of an anticancer drug followed by 7 days rest with dexamethasone Same pleadings, ¶156

3. Combinations rendering the claims obvious

Combination A — '517 + Richardson 2001 (outcome-determinative for a bare MM-use claim). '517 discloses the genus that includes the 4-amino-1-oxoisoindoline at the heart of '498's title, and its incorporation into '498's own specification is an admission that the compound is old. Richardson 2001 discloses administering that compound (CC-5013) orally to relapsed/refractory MM patients. If '498's independent claim reads on "treating MM by administering lenalidomide," Richardson alone is anticipatory under §102(b) (published Nov. 16, 2001, before the May 17, 2002 priority date); at minimum, '517 + Richardson makes it obvious. Motivation: thalidomide had just shown single-agent activity in refractory MM (Singhal et al., NEJM 1999), creating a strong push toward analogs with less sedation/neuropathy/teratogenicity, and the '517 class was known as more potent TNF-α inhibitors and T-cell co-stimulators. Expectation of success: the mechanism (TNF-α suppression, anti-angiogenesis, direct MM-cell effect) was shared across the class, and Richardson's phase 1 was already in the clinic.

Combination B — A + Kyle 2001/Coleman 2002 + Cohen 1982 (for a dexamethasone-combination and/or 21/7-cycle claim). Kyle 2001 and Coleman 2002 teach treating MM with thalidomide plus dexamethasone, including 40 mg dexamethasone; Cohen 1982 teaches the 21-on/7-off cycle with dexamethasone. Motivation: dexamethasone was the standard MM backbone and was already being combined with thalidomide clinically; preserving the steroid backbone while substituting the better-tolerated IMiD is the paradigm case of an obvious substitution of one known agent for a structurally and functionally related one. Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019), affirming invalidation of Celgene's thalidomide REMS claims under §103, illustrates that this family's dosing/monitoring claims have not fared well against analogous art.

Combination C — A/B + the specification's own "Cycling Therapy" and dose disclosures. The '498 specification itself recites the operative dosing: e.g., "an immunomodulatory compound of the invention and a second active ingredient are administered orally, with administration of an immunomodulatory compound … occurring 30 to 60 minutes prior to a second active ingredient, during a cycle of four to six weeks"; "one cycle comprises the administration of from about 10 to about 25 mg/day of REVIMID™ … daily for three to four weeks and then one or two weeks of rest"; and "dexamethasone (40 mg/day orally on days 1 to 4) every four to six weeks." To the extent '498 claims a 5-25 mg/day lenalidomide range with a 21/7 or 3-4 week-on/1-2 week-off cycle, that range is disclosed in the specification and is the routine output of a phase 1 dose-escalation — In re Kao permits finding such a regimen obvious where the art directs the artisan to the parameters.

Combination D — administration-format claim. A claim to an oral unit dose (e.g., 5, 10, 25 mg capsule) is obvious over the use art plus Remington's Pharmaceutical Sciences and the '498 specification's own lactose-free/anhydrous capsule disclosure. The PTO applied exactly this rationale to Celgene's pomalidomide formulation family ("It would have been prima facie obvious … to have made oral dosage forms comprising pomalidomide and excipients such as mannitol and pre-gelatinized starch … because Zeldis et al. taught such oral dosage forms" — Hagens Berman complaint ¶174).


4. The priority-date fork (critical and frequently overlooked)

  • If a claim is entitled to May 17, 2002: only pre-May-2002 art counts. Combinations A and B still stand on '517 + Richardson + Kyle/Coleman/Cohen.
  • If a claim is not so entitled: IPR testimony against the sibling '569 argued the 60/380,842 provisional lacks any written description of a 28-day cycle or of lenalidomide + dexamethasone (Tricot Declaration, IPR2018-01714), pushing the effective date to Nov. 6, 2002 (60/424,600). That opens the door to post-May-2002 art — including the 2005-2007 Phase III MM-009/MM-010 publications relied on in the '498 file (Dimopoulos et al., NEJM 2007; Blood 2005 ASH abstracts) and the 2006 Revlimid label (25 mg days 1-21 of a 28-day cycle with dexamethasone 40 mg). Under that reading, the claims are obvious over the clinical literature and the label.
  • Independent of §103: because the 13/858,708 claims were filed in 2013, any claim not supported by the 2002/2003 disclosure also faces §112(a) and obviousness-type double patenting exposure over the same-family patents that share a common expiration (no term extension available).

5. Secondary considerations — and their limits

For patentability: the '498 specification's own FIG. 1 compares lenalidomide ("Revimid™") with thalidomide in inhibiting proliferation of MM cell lines ([³H]-thymidine uptake) — i.e., the applicant put comparative potency data on the record, which is the strongest Graham factor available here, and it is in-specification, not attorney argument. Revlimid's commercial success and its superiority to thalidomide in MM (MM-009/MM-010) supply nexus arguments.

Against: (i) the comparative data is in vitro and may not be commensurate with the full claim scope (dosing, cycle, combination); (ii) the MM-009/MM-010 trials postdate the priority date and cannot rebut obviousness at the 2002 date; (iii) the examiner in the parallel pomalidomide family treated the "unexpected results" showing as the crux of allowability, and the antitrust pleadings allege that representation was false (Hagens Berman complaint ¶¶155-163) — a collateral attack that, if credited, would strip the '498 of the same rebuttal. Balance: the examiner's allowance is itself evidence that the 21/7 + 40 mg dexamethasone combination was not considered squarely disclosed, and the PTAB denied institution of IPR2018-01714 against the analogous '569 (per the TIPO family narrative, decision Mar. 14, 2019) — so the "obvious-to-try" argument did not carry on that record.


6. Bottom line

Claim type Strongest §103 combination Confidence
Treat MM with lenalidomide (no dose/cycle) US 5,635,517 + Richardson 2001 (anticipatory); + D'Amato 2001 High
Same + dexamethasone (incl. 40 mg/day) Above + Kyle 2001/Coleman 2002 Moderate-high
Same + 21/7 cycle in 28 days Above + Cohen 1982 (and the specification's own Cycling Therapy section) Moderate
Oral unit-dose / excipient limitations Above + Remington's + spec's own capsule disclosure Moderate-high

Explicit uncertainties (consistent with, and extending, the earlier section): I still could not retrieve the granted claim text of US 8,530,498 from an authoritative source; the paragraph-level citations above are to the shared family specification, which I have flagged as such. The "Expired – Fee Related" vs. "Expired – Lifetime" discrepancy now has a third data point and is unresolved. Finally, because the patent expired May 15, 2023, this analysis is litigation-facing (past damages/antitrust) rather than prospective — but expiration does not moot §103.

Generated 10/1/2026, 5:45:08 AM

Extensions

Patent term adjustments, term extensions, continuations, divisionals, family members, and expiration dates.

Not generated yet. Click Generate to call the active LLM provider with the configured prompt.

Derivative works

Defensive disclosure: derivative variations of each claim designed to render future incremental improvements obvious or non-novel.

Not generated yet. Click Generate to call the active LLM provider with the configured prompt.

Keep exploring

More patents asserted by Celgene Corporation

Other patents in Medical (M)

See all Medical (M) patents →

This patent in court (12)

12 tracked lawsuits name US 8530498.