Invalidity dossier
US 7141018
Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
Current assignee: Celgene Corp.
Added 10/1/2026, 4:14:42 AM
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Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
I'll run targeted searches to verify the current status of US 7141018, including any recent litigation activity.
Let me pull the actual claim text and check for any Federal Circuit / 2026 docket activity.
Let me check specifically for PTAB/Federal Circuit proceedings involving the '018 patent itself.
US Patent 7,141,018 B2 — Analyst Summary
⚠️ Scope note on the two requested sources: I found authoritative records for the patent itself (USPTO/Google Patents, PubChem, FDA Orange Book citations, and litigation pleadings that reproduce the patent). However, I did not find any Federal Circuit docket or 2026 CAFC proceeding specifically docketed for US 7,141,018, and I am flagging that as an unresolved gap rather than guessing. Details below.
Bibliographic data (verified)
| Field | Value |
|---|---|
| Patent number | US 7,141,018 B2 (do not conflate with 7,141,018-family or other numbers) |
| Application no. | US 11/028,144 |
| Title | Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated |
| Inventors | Bruce A. Williams (Flemington, NJ); Joseph K. Kaminski (Hampton, NJ) |
| Assignee | Celgene Corporation (Summit, NJ); current assignee listed as Celgene Corp (now a Bristol Myers Squibb subsidiary) |
| Priority date | October 23, 2000 |
| Filing date | January 3, 2005 |
| Issue/grant date | November 28, 2006 |
| Pre-grant publication | US 2005/0176768 A1, published August 11, 2005 |
| Claims / drawings | 9 claims, no drawings |
| Status | Expired – Lifetime; anticipated expiration October 23, 2020 |
| Orange Book listing | Thalomid (thalidomide), NDA 020785 — patent use codes U-371, U-372, U-732, U-733 |
Continuation chain (from the patent's Cross-Reference section): US 11/028,144 is a continuation of US 10/762,880 (filed Jan. 22, 2004; now US 6,869,399) → continuation of US 10/383,275 (filed Mar. 7, 2003; now US 6,755,784) → continuation of US 09/965,155 (filed Sep. 27, 2001; now US 6,561,977) → continuation of US 09/694,217 (filed Oct. 23, 2000; now US 6,315,720).
Sources: Google Patents US7141018B2; PubChem US-7141018-B2; DrugPatentWatch claims page for 7,141,018.
Abstract (verbatim)
"Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved."
Independent claim — plain-language overview
The patent has exactly one independent claim (claim 1); claims 2–9 all depend from it (claims 2, 3, 4 and 9 directly; claims 5–8 in a chain off claim 4).
Claim 1 — "A method for treating a patient having a disease or condition which is responsive to thalidomide while restricting access to thalidomide…" In plain terms:
- The method is a thalidomide-specific treatment-and-distribution method. A prescription may be filled by a pharmacy only after the pharmacy becomes aware that a "prescription approval code" was generated from a computer-readable storage medium. (Note the claim's careful phrasing — the pharmacy need only learn of the code's generation; it need not itself perform the risk analysis.)
- Generating that code requires five steps (a)–(e):
- a. Define multiple patient risk groups from a predefined set of risk parameters for thalidomide.
- b. Define an information set to be obtained from the patient, which must include the result of a determination of the patient's ability to become pregnant (i.e., child-bearing potential) and optionally whether the patient is currently pregnant or not.
- c. Using that information, assign the patient to at least one risk group, and enter the patient, the information, and the risk-group assignment into the medium.
- d. Based on the information plus the risk-group assignment, determine whether the risk that the adverse side effect will occur is acceptable.
- e. If the risk is acceptable, generate the prescription approval code before the prescription is filled.
Key drafting notes: The granted claim is narrower than the general "Summary of Invention" language earlier in the specification (which frames the invention generically around "a drug"). As issued, claim 1 is hard-coded to thalidomide and requires the "ability to become pregnant" determination as a mandatory element, with the current-pregnancy determination only optional. This matches the prosecution-posture discussion in the family's later litigation (the patent sits in the Celgene "REMS/distribution" family).
Dependent claims (brief)
| Claim | Requires | Depends on |
|---|---|---|
| 2 | Register the prescribing physician in the medium | 1 |
| 3 | Register the pharmacy in the medium | 1 |
| 4 | Counsel the patient on risks and risk-avoidance measures, responsive to the risk-group assignment | 1 |
| 5 | Counseling includes full disclosure of the risks | 4 |
| 6 | Prescription filled only following that full disclosure | 5 |
| 7 | The fact of full disclosure is registered in the medium before the approval code is generated | 6 |
| 8 | Risk-group assignment + full-disclosure fact transmitted by facsimile and read via OCR software | 7 |
| 9 | Defines, for each risk group, a second set of information collected at periodic intervals, obtained from the patient and entered in the medium | 1 |
Litigation / post-grant activity
- Litigation flag: Google Patents marks this family as having litigation, naming several D.N.J. cases (see the litigation listing in the family record).
- A case expressly asserting the '018 patent: Celgene Corporation v. Hikma Pharmaceuticals International Limited, D.N.J. No. 2:18-cv-13477, filed Aug. 31, 2018, reproduces the '018 patent among the asserted authorities (CourtListener docket).
- Related PTAB/Supreme Court activity is on the sibling '720 patent, not the '018: IPR2015-01103 (and companion IPRs -01096/-01102) concerned US 6,315,720, and the resulting Celgene Corp. v. Peter cert petition (No. 19-1074) addressed the '720. I did not locate an IPR or Federal Circuit appeal specifically docketed on the '018 patent.
- 2026 activity: The 2025–2026 filings I found are antitrust / monopolization complaints (e.g., CenterWell Pharmacy v. Celgene/BMS, S.D.N.Y.; Cigna v. Celgene; NY Hotel Trades Council v. Celgene, S.D.N.Y. No. 1:24-cv-02230; and a D.N.J. BMS/Celgene antitrust complaint) that reference the Thalomid/Revlimid REMS-distribution patent family — not a CAFC appeal of the '018.
Uncertainty disclosure: Because the '018 patent expired October 23, 2020, a 2026 Federal Circuit appeal specifically docketed on US 7,141,018 appears unlikely, and my searches returned none. I cannot confirm the absence of such a docket with the authority of a direct CAFC PACER/Docket search — treat the "no CAFC 2026 docket found" statement as a search-result limitation, not a verified negative.
Generated 10/1/2026, 4:33:16 AM
Cases on file (12)
Group view →Specific litigation cases in our database that name US patent 7141018. The free-form analysis below may also discuss cases beyond this list.
Lawsuits filed per year
- Celgene Corp. v. Hikma Pharmaceuticals International Ltd.filed Aug 31, 20182:18-cv-13477D.N.J.terminated Sep 18, 2019terminated
Defendants: Hikma Pharmaceuticals International Ltd.
Other patents asserted: 6755784, 6315720, 6561977, 6869399, 7230012, 7959566, 8315886, 8626531
- Celgene Corporation v. Lotus Pharmaceutical Co., Ltd. et al.filed Sep 6, 20172:17-cv-06842-SDW-LDWU.S. District Court for the District of New Jerseyactive
Defendants: Lotus Pharmaceutical Co., Ltd., Alvogen Pine Brook, LLC
- Celgene Corporation v. Lannett Holdings, Inc.filed Jan 30, 20152:15-cv-00697-SDW-SCMU.S. District Court for the District of New Jerseyterminated Oct 30, 2017settled
Defendants: Lannett Holdings, Inc.
- Celgene Corporation et al. v. Barr Laboratories, Inc.filed Jul 3, 20082:08-cv-03357U.S. District Court for the District of New Jerseyterminated May 21, 2010dismissed
Defendants: Barr Laboratories, Inc.
Other patents asserted: 6045501, 6315720, 6420399, 6561976, 6561977, 6673784
- Celgene Corp. et al. v. Barr Laboratories, Inc.filed Jan 18, 20072:07-cv-00286D.N.J.terminated May 26, 2010dismissed
Defendants: Barr Laboratories, Inc.
Other patents asserted: 6755784, 6045501, 6315720, 6561976, 6561977, 6869399
- 2:14-cv-06997U.S. District Court for the District of New Jerseyconsolidated
Defendants: Celgene Corporation
Other patents asserted: 6045501, 6315720, 6420399, 6561976, 6561977, 6673784
- 2:21-cv-20451U.S. District Court for the District of New Jerseyactive
Defendants: Celgene Corp.
- 2:21-cv-00090U.S. District Court for the Eastern District of Pennsylvaniaactive
Defendants: Celgene Corp.
- unknown
Defendants: Celgene Corp.
- 2:10-cv-05197unknown
- IPR2015-01103USPTO Patent Trial and Appeal BoardPTAB proceeding
- 19-1074Supreme Court of the United Statescert. petition
Defendants: Peter
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
I'll research litigation involving US patent 7141018.
Let me dig into the specific cases and confirm which asserted this patent.
Litigation Involving U.S. Patent No. 7,141,018
Important caveats up front: I ran out of tool steps partway through verification. The list below reflects what I could confirm from court records, Google Patents' litigation metadata, PTAB filings, and litigation trackers. Where a case is confirmed to assert the '018 patent I say so; where the '018 patent is only mentioned (e.g., in Orange Book listings or in the recitation of a patent family in an antitrust complaint) I flag that separately. I could not independently verify every case number against PACER, and I note one numbering discrepancy below rather than "correcting" it.
1. Confirmed infringement suits asserting the '018 patent
Celgene Corp. v. Barr Laboratories, Inc. — D.N.J.
- Plaintiff: Celgene Corporation
- Defendant: Barr Laboratories, Inc. (Barr Pharmaceuticals, Inc. also named as a party in the complaint)
- Jurisdiction / case number: U.S. District Court for the District of New Jersey, No. 2:07-cv-00286-SDW-MCA (Judge Susan D. Wigenton; Mag. J. Madeline Cox Arleo)
- Filed: January 18, 2007
- '018 involvement — confirmed: The complaint expressly identifies "the '018 patent" (issued Nov. 28, 2006 to Celgene, inventors Williams and Kaminski) and lists the '501, '720, '976, '977, '784, '399 and '018 patents as covering methods of use/delivery of thalidomide (THALOMID®, NDA No. 20-785), all listed in the Orange Book. The suit arose from Barr's ANDA and paragraph IV certification for generic thalidomide capsules (50/100/200 mg).
- Outcome: Stipulated dismissal. Barr withdrew its ANDA for lack of commercial visibility. On May 21, 2010, the parties stipulated to dismissal: all claims/counterclaims in 07-286 and consolidated actions dismissed without prejudice, while Barr's federal and New Jersey antitrust counterclaims (Counts XX, XXI, XXII) were dismissed with prejudice. Each side bore its own costs.
- Source: CourtListener docket 4309132 (complaint and docket entries); Barr stipulation of dismissal filed as Ex. 1042 in IPR2015-01103.
Celgene Corp. v. Barr Laboratories, Inc. — D.N.J.
- Case number: 2:07-cv-04050 (D.N.J.), filed August 23, 2007
- Parties: Celgene Corp. v. Barr Laboratories, Inc. et al.
- Outcome: Consolidated into 07-286 and dismissed without prejudice per the May 21, 2010 stipulation.
Celgene Corp. v. Barr Laboratories, Inc. — D.N.J.
- Case number: 2:07-cv-05485 (D.N.J.), filed November 14, 2007 (listed on Google Patents' litigation tab for US7141018 as a New Jersey District Court case)
- Parties: Celgene Corp. v. Barr Laboratories, Inc. et al.
- Outcome: Consolidated with 07-286 and dismissed without prejudice per the May 21, 2010 stipulation.
- Note on a discrepancy (not corrected): The May 21, 2010 stipulation text as reproduced in the PTAB exhibit refers to "Civil Action Nos. 07-4050, 07-5458 and 08-3357 consolidated therewith," whereas Google Patents and Docket Alarm list 2:07-cv-05485. I am reporting both identifiers literally and cannot resolve which is the operative docket.
Celgene Corp. and Children's Medical Center Corp. v. Barr Laboratories, Inc. — D.N.J.
- Case number: 2:08-cv-03357 (D.N.J.), filed July 3, 2008 (Judge Wigenton)
- Identified in PTAB/SCOTUS filings as one of six district court actions relating to the '501 patent; consolidated with the Barr actions above and dismissed without prejudice on May 21, 2010.
- Whether the '018 patent was separately asserted in 08-3357 (as opposed to the consolidated family) is unconfirmed.
Celgene Corp. v. Lannett Holdings, Inc. et al. — D.N.J.
- Plaintiff: Celgene Corporation
- Defendant: Lannett Holdings, Inc. (and related Lannett entities)
- Jurisdiction / case number: D.N.J., No. 2:15-cv-00697-SDW-SCM (Judge Wigenton; Mag. J. Leda D. Wettre / SCM)
- Filed: January 30, 2015
- Basis: Lannett's ANDA No. 206601 and paragraph IV certification for generic thalidomide (THALOMID®). Celgene asserted fifteen patents.
- '018 involvement: Celgene's Thalomid patent family that it asserted in this campaign includes the distribution-method patents; the '018 patent is among the patents Celgene listed in the Orange Book for Thalomid. I could not independently confirm from the retrieved excerpts that '018 was one of the fifteen asserted patents — treat this as probable but unverified.
- Outcome: Settled. On October 10, 2017 the parties stipulated that Lannett would change its paragraph IV certification to a paragraph III certification and Celgene would dismiss its infringement claims. On October 30, 2017, Celgene and Lannett announced a settlement/license permitting Lannett to market generic thalidomide as of August 1, 2019 (terms confidential). Lannett also filed counterclaims alleging monopolization, conspiracy to monopolize, and sham litigation.
Celgene Corp. v. Lotus Pharmaceutical Co., Ltd. and Alvogen Pine Brook, LLC — D.N.J.
- Case number: 2:17-cv-06842-SDW-LDW (D.N.J.), filed September 6, 2017 (Judge Wigenton)
- Basis: Defendants' ANDA No. 210480 for lenalidomide (REVLIMID®); Celgene's § 101 challenge to its "REMS Patents" — the '720, '977, '784, '886 and '531 patents.
- '018 involvement: The '018 patent is not listed among the patents challenged in the Rule 12(c) motion (the REMS patents there are '720, '977, '784, '886, '531). So the '018 patent appears not to have been asserted in this action. Outcome: motion for judgment on the pleadings denied without prejudice (Opinion, Dec. 14, 2018).
- Separate note: Google Patents' litigation tab for US7141018 also lists a New Jersey case 2:18-cv-13477. I was unable to identify its parties or outcome before running out of search steps — do not assume it is a continuation of the Lotus case.
2. Antitrust suits in which the '018 patent is referenced (not asserted for infringement)
Humana Inc. v. Celgene Corporation — D.N.J.
- Case number: 2:19-cv-07532 (D.N.J.), filed February 28, 2019 (Judge Esther Salas; Mag. J. Michael A. Hammer)
- Antitrust action (Cause 15:1). The complaint's patent list includes 7,141,018 along with 7,189,740; 7,465,800; 7,668,730; 7,855,217; 7,968,569; 8,315,886; 8,404,717; 8,530,498; 8,648,095; 9,056,120; 9,101,621; 9,101,622. Plaintiff: Humana Inc.; Blue Cross Blue Shield Association also appears in the parties list.
- Status: antitrust/overcharge theories, not a patent-infringement suit against '018.
In re Thalomid and Revlimid Purchaser Antitrust Litigation — D.N.J.
- Case number: 2:14-cv-06997 (D.N.J.) (also cited as 2:14-cv-06997-ES-MAH in later filings)
- Consolidated purchaser/insurer antitrust claims alleging Celgene improperly listed its "distribution method" patents (the '501, '720, '976, '977, '784, '399, '018 and related family) in the Orange Book and pursued sham litigation. The '018 patent is referenced in the recounting of the distribution-method patent family.
Related later antitrust complaints referencing the same Thalomid distribution-method patent family (and referencing 2:15-cv-00697 and 2:07-cv-00286): e.g., MSP Recovery Claims, Series LLC v. Celgene Corp., D.N.J. 2:21-cv-20451; Cigna Corp. v. Celgene Corp., E.D. Pa. 2:21-cv-00090; The Cigna Group v. Celgene Corp. These mention '018 within the family narrative rather than asserting it.
3. PTAB proceedings
The IPRs I can identify in this family (IPR2015-01103 and related) challenged U.S. 6,315,720 ('720) and U.S. 6,045,501 ('501) — not the '018 patent specifically. The SCOTUS case Celgene Corp. v. Peter, No. 19-1074 (cert. petition), arose from the Federal Circuit affirmance that all claims of the '501 patent and claims 1–9 and 11–32 of the '720 patent were invalid as obvious. The district-court actions listed in that record were the six noted above (Lannett 2:15-cv-00697; Natco 2:10-cv-05197; Barr 2:08-cv-03357; Barr 2:07-cv-05485; Barr 2:07-cv-04050; Barr 2:07-cv-00286).
Notably, the '018 patent's Orange Book expiration date is October 23, 2020, and Google Patents lists its legal status as "Expired – Lifetime."
Summary table
| Case | Court / No. | Filed | '018 asserted? | Outcome/status |
|---|---|---|---|---|
| Celgene v. Barr Laboratories | D.N.J. 2:07-cv-00286 | 2007-01-18 | Yes (confirmed) | Dismissed w/o prejudice 2010-05-21; Barr antitrust counterclaims w/ prejudice |
| Celgene v. Barr Laboratories | D.N.J. 2:07-cv-04050 | 2007-08-23 | Family/consolidated | Dismissed w/o prejudice 2010-05-21 |
| Celgene v. Barr Laboratories | D.N.J. 2:07-cv-05485 (per Google Patents) | 2007-11-14 | Family/consolidated | Dismissed w/o prejudice 2010-05-21 |
| Celgene & Children's Medical Center v. Barr | D.N.J. 2:08-cv-03357 | 2008-07-03 | Unconfirmed | Dismissed w/o prejudice 2010-05-21 |
| Celgene v. Lannett Holdings | D.N.J. 2:15-cv-00697 | 2015-01-30 | Probable, unverified | Settled Oct 2017; generic entry Aug 1, 2019 |
| Celgene v. Lotus / Alvogen | D.N.J. 2:17-cv-06842 | 2017-09-06 | No (REMS patents only) | 12(c) motion denied without prejudice, 2018-12-14 |
| Humana v. Celgene | D.N.J. 2:19-cv-07532 | 2019-02-28 | No — antitrust reference | Pending/antitrust |
| In re Thalomid & Revlimid Antitrust Litig. | D.N.J. 2:14-cv-06997 | 2014 | No — antitrust reference | Consolidated antitrust |
Bottom line: The only suit in which I can confirm the '018 patent was actually asserted is Celgene Corp. v. Barr Laboratories, Inc., D.N.J. No. 2:07-cv-00286, together with its consolidated Barr companion cases (07-04050, 07-05485, 08-03357), all dismissed without prejudice on May 21, 2010. The '018 patent also appears in Celgene's Lannett thalidomide campaign (2:15-cv-00697) and throughout the Thalomid/Revlimid antitrust litigation, but in those matters I verified only that it is listed/described, not that it was a pleaded patent-in-suit. I was unable to identify the parties in the Google Patents–listed case 2:18-cv-13477; that remains an open item.
Generated 10/1/2026, 4:33:20 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 Corp.
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.
PTAB / AIA Trial Proceedings — US 7,141,018
Bottom line up front: The canonical USPTO Open Data Portal list for this patent is empty — "no AIA trial proceedings on file." My independent web search corroborates this: the Kyle Bass / Coalition for Affordable Drugs VI IPR campaign against Celgene's REMS patents targeted only the sibling patents 6,045,501 (the '501) and 6,315,720 (the '720) — never the '018. The '018 appears in PTAB records only as exhibit material (e.g., a family tree and a district-court complaint), never as the challenged patent.
Proceedings overview
Total AIA trial proceedings naming US 7,141,018 as the challenged patent: 0. Breakdown by status: active 0 / claims invalidated 0 / claims sustained 0 / settled 0 / institution denied 0. There is nothing to defend on this patent's own PTAB record — because nothing was ever filed. That said, the defensive posture is unusually strong for a collateral reason: two sibling patents in the same family ('501 and '720) had all of their claims canceled in IPR and the invalidation was affirmed by the Federal Circuit. The '018 shares the same specification/spec-lineage and near-identical claim scope, and it expired on 2020-10-23. A troll citing the '018 today is citing an expired patent whose entire patent family has been held obvious.
⚠️ Do not conflate the family. The IPRs below are on different patent numbers. They do not, as a formal matter, cancel any claim of the '018. I flag them because they are the most impactful PTAB facts bearing on this family, and they are the ammunition a '018 defendant actually has.
IPR2015-01092 — Coalition for Affordable Drugs VI LLC v. Celgene Corp.
(challenged patent: US 6,045,501 — the '501, NOT the '018)
- Type: Inter Partes Review
- Filed: 2015-04-23
- Status: Final Written Decision; all claims unpatentable (affirmed on appeal)
- Judge panel: Michael P. Tierney (Vice Chief), Grace Karaffa Obermann, Tina E. Hulse
- Petition grounds: All 10 claims of the '501; § 103 obviousness over Powell, Mitchell, and Dishman
- Institution decision: Instituted 2015-10-27 (Paper 20), single ground — obviousness over Powell + Mitchell + Dishman
- Final Written Decision: 2016-10-26 (Paper 73). Board held CFAD showed by a preponderance that claims 1–10 of the '501 are unpatentable as obvious. Rehearing denied 2017-09-08.
- Appeal: Appeals consolidated at the Federal Circuit as Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019); panel affirmed. Rehearing en banc denied 2019-12-09; mandate issued 2019-12-16. Cert petition filed (S. Ct. No. 19-1074). The court rejected Celgene's Fifth Amendment "taking" challenge to IPR of pre-AIA patents.
- Defensive value (context only): The '501 and '018 are closely related REMS-distribution claims; the same prior-art rationale (Powell/Mitchell/Dishman) is a strong starting point for attacking any surviving family claim. But this FWD did not cancel any '018 claim.
IPR2015-01096 / IPR2015-01102 / IPR2015-01103 — Coalition for Affordable Drugs VI LLC v. Celgene Corp.
(challenged patent: US 6,315,720 — the '720, NOT the '018)
- Type: Inter Partes Review (three co-pending petitions)
- Filed: 2015-04-23
- Status: Final Written Decision; claims 1–32 unpatentable (claim 10 modified on rehearing)
- Judge panel: Michael P. Tierney, Grace Karaffa Obermann, Tina E. Hulse
- Petition grounds: All 32 claims of the '720, multiple § 103 grounds — e.g., Thalomid Package Insert + Cunningham + Zeldis (IPR2015-01096); Powell + Dishman in view of Cunningham in further view of Mann (another petition)
- Institution decision: Instituted 2015-10-27 on all three; claims 1–32 reviewed. Oral hearing 2016-07-21.
- Final Written Decision: 2016-10-26 — all of claims 1–32 unpatentable as obvious. On rehearing granted 2017-09-08, the Board modified its decision as to claim 10 only (holding Petitioner failed to prove claim 10 unpatentable).
- Settlement / termination: None — litigated to FWD and appealed.
- Appeal: Consolidated at the Federal Circuit (Celgene Corp. v. Peter, No. 2018-1167; decision reported at 931 F.3d 1342). Affirmed. Rehearing en banc denied 2019-12-09. Cert petition S. Ct. No. 19-1074.
- Defensive value (context only): The '720 is the direct parent of the '018 in the continuation chain (09/694,217 → … → 11/028,144). Whole-family invalidation of the '720 by obviousness is potent, if non-binding, § 103 ammunition against the '018.
Strategic summary
Which '018 claims are CANCELED vs. SUSTAINED vs. UNTESTED: For US 7,141,018 itself — all claims are UNTESTED. No PTAB trial ever issued a Final Written Decision on the '018. No '018 claim has been canceled by the Board. (Claims 1–10 of the related '501 and claims 1–32 of the related '720 were canceled, but those are different patents.) Critically, the '018 expired 2020-10-23, so its claims are no longer enforceable going forward and cannot support prospective injunctive relief; only past-damages theories (6-year lookback) are even theoretically live.
Estoppel landscape: No § 315(e)(2) estoppel attaches to the '018, because no IPR/PGR was ever instituted against it. That cuts both ways for a defendant: it means there is no PTAB estoppel shielding the patent owner, but it also means no petitioner has preserved/foreclosed grounds. Practically, the estoppel is irrelevant — the operative defenses are (a) expiration, (b) the Federal Circuit's affirmance that the sibling REMS claims are obvious over Powell, Mitchell, Dishman, Cunningham, Zeldis, etc., and (c) the shared specification. A defendant can freely raise the Powell/Mitchell/Dishman/Cunningham/Zeldis art against the '018 without any estoppel constraint, because no one has used it against this patent in an AIA trial.
Pattern signals: The same petitioner (Coalition for Affordable Drugs VI LLC, the Kyle Bass entity) filed four IPRs against this family on 2015-04-23, but only against the '501 and '720 — a deliberately bounded campaign, not a family-wide sweep. There is no defensive aggregator (e.g., Unified Patents) in the '018 chain; the family was attacked by a hedge-fund-funded petitioner, not a competitor or aggregator. The patent owner (Celgene) appealed aggressively (Federal Circuit + rehearing en banc + cert petition), so it is a patent owner that litigates to the end. Note the two 2018 Hikma/Apotex-era district-court suits (e.g., Celgene v. Hikma, 2:18-cv-13477) asserted the '018 against generics, but those defendants chose district-court invalidity/Paragraph IV defenses rather than filing an IPR on the '018.
Cross-cutting Federal Circuit outcome: Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019) — FindLaw opinion — affirmed the PTAB and held IPR of pre-AIA patents is constitutional. This is the family's controlling appellate law.
Recommended next steps
- Lead with expiration. US 7,141,018 expired 2020-10-23 (see Google Patents). If anyone is asserting it today, the threshold questions are standing and whether any actionable past infringement exists within the § 286 six-year window. An expired patent supports neither prospective relief nor a live royalty.
- If you need invalidity, you are estoppel-free. Because no AIA trial touched the '018, you may raise any § 102/§ 103 ground without § 315(e)(2) constraints. Start from the family's winning art: Powell, Mitchell, Dishman, Cunningham, Zeldis, Mann, and the Thalomid Package Insert — the exact references that killed the '501 and '720.
- Cite the family FWDs as persuasive, not binding. Quote the disposition: claims 1–10 of the '501 and claims 1–32 of the '720 were held unpatentable as obvious; the Federal Circuit affirmed (931 F.3d 1342). A district court cannot give these collateral-estoppel effect against the '018, but they are strong evidence of obviousness given the shared specification.
- No pending trial milestones to track on this patent. With no institution, there is no 1-year FWD clock, no oral hearing, and no appeal deadline for the '018. Do not represent otherwise.
- If you are evaluating a different Celgene REMS patent, re-run this analysis on that number. The '018's siblings ('977, '784, '399, '566, '886, '531) are separate patents; only '501 and '720 went through PTAB.
Confidence note: I am highly confident there is no AIA trial proceeding on US 7,141,018 (structure block empty; search corroborates). I could not retrieve a USPTO PTAB E2E docket page for the '501/'720 IPRs directly within my search budget, so the proceeding numbers and outcomes above are sourced from the Federal Circuit decision and the printed Board decisions reproduced in court filings (see the S. Ct. cert appendix reproducing the FWDs and rehearing decision and the Law360 case page). I did not find and will not invent any '018-specific proceeding number.
Generated 10/1/2026, 4:33:25 AM
Ownership chain (1)
Asserters network →Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.
? · recorded 2001-01-05 · reel 11469/882 · Assignment
Bruce A. Williams and Joseph K. KaminskiCelgene Corporation
founding assignment
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.
I'll research the assignment record for US 7141018. Let me start with targeted searches.
Let me dig into specific assignment records and the litigation details.
Found a key record. Let me confirm the assignment reel/frame and check for any post-issuance transfers.
Assignment & Ownership Analysis — US Patent 7,141,018 B2
Scope note / methodology caveat (read first). My only research tool for this task was general web search, not a direct query of the USPTO Assignment Center API. I was able to surface litigation filings and PTAB papers that quote assignment records, but I could not run a live patent-number lookup against https://assignmentcenter.uspto.gov/ before my tool budget was exhausted. Accordingly, the reel/frame numbers below are reported exactly as they appear in a primary litigation document (a PTAB "Notice of Related Matters"), and I flag explicitly where I could not confirm a record. I did not find — and am not asserting — any separate post-issuance assignment recorded against 7,141,018 itself. Verification link: https://assignmentcenter.uspto.gov/ (search Patent Number 7141018; also try application 11/028,144).
Inventors
| Inventor | Stated residence (at filing) | Employer at filing |
|---|---|---|
| Bruce A. Williams | Flemington, NJ | Celgene Corporation (per prosecution docket "CELG-0508" and assignee-of-record) |
| Joseph K. Kaminski | Hampton, NJ | Celgene Corporation |
Only two named inventors appear on this patent (PubChem/Patent record: "WILLIAMS BRUCE A (US); KAMINSKI JOSEPH K (US)"). Both are Celgene personnel — the application carries an internal Celgene docket number (CELG-0508) and Celgene itself filed the terminal disclaimer as "Celgene Corporation … 100 percent interest in the instant application."
Unusual-pattern note: I found no evidence that either inventor departed Celgene around filing, and no signal of a pre-fire-sale inventor exodus. The "all inventors leaving" red flag is not present. What is present is an intra-family proliferation pattern (see below) rather than inventor churn.
Original assignee
Celgene Corporation (Warren, NJ at issuance; later Summit, NJ).
- Business: Operating branded pharmaceutical manufacturer.
- Product embodying the claims: Yes — directly. US 7,141,018 is listed in the FDA Orange Book for THALOMID® (thalidomide), NDA 020785, with patent-use codes U-731, U-732, U-733 (also U-371/372/373 in earlier Orange Book editions), expiration Oct 23, 2020 (per Orange Book 41st ed. and FDA EOB data). The claimed subject matter — a restricted-distribution / risk-group patient-management method — is the very STEPS-style distribution program Celgene actually ran for THALOMID.
- Patent-family context: 7,141,018 is the fourth member of a continuation chain:
09/694,217 → 6,315,720;09/965,155 → 6,561,977;10/383,275 → 6,755,784;10/762,880 → 6,869,399;11/028,144 → 7,141,018; and11/437,551 → 7,959,566. All share the same two inventors and the Oct 23, 2000 priority date. - Current status: Operating, but no longer independent. Celgene was acquired by Bristol-Myers Squibb in a deal that closed November 2019; Celgene continues as a BMS subsidiary/brand. No bankruptcy, no dissolution.
Assignment timeline
Caveat: no standalone assignment reel/frame was located for 7,141,018 or for application 11/028,144. The closest confirmed recorded instrument is the assignment of the parent patent in the same family, which is the instrument that conveys title to the shared invention chain. I am reporting it because it is the only assignment I could ground in a primary source; I am not claiming it is a separate 7,141,018-specific recording.
Executed date not stated / recorded 2001-01-05 — Reel 11469 / Frame 882
- Conveyance: Assignment (of inventors' rights)
- Assignor: Bruce A. Williams and Joseph K. Kaminski (co-inventors)
- Assignee: Celgene Corporation
- Correspondent: Not stated in the source I obtained — I could not retrieve the correspondent of record for this reel/frame. (This is the one field your brief specifically flagged as highest-value; it remains unresolved and should be pulled directly from Assignment Center.)
- Source of record: IPR2015-01103, Paper 6 (Patent Owner's Notice of Related Matters), in which Celgene states it "owns by assignment the entire right, title, and interest in U.S. Patent No. 6,315,720 … by virtue of an Assignment of rights from the inventors, Bruce A. Williams and Joseph K. Kaminski. The Assignment was recorded with the United States Patent and Trademark Office on January 5, 2001, at Reel 11469, Frame 882."
- Context: Founding assignment — inventors to their employer. Ordinary, pre-issuance, non-adversarial.
No further recorded assignment identified through the 2019 BMS acquisition. If the BMS/Celgene combination generated a recorded instrument (change-of-name, merger, or intra-group assignment), I did not find it, and I am not asserting one exists. Because Celgene survived as a named BMS subsidiary rather than being merged away, the absence of a recorded assignment is plausible — but this is unverified.
Bottom line for this section: The patent chain shows one recorded, author-grounded assignment (the 2001 inventor→Celgene instrument at Reel 11469/Frame 882, recorded against the parent '720), and no confirmed subsequent transfers. If Assignment Center returns additional rows for 7141018, they should be reported as new findings — I could not confirm their absence with a live query.
Timeline diagram
timeline
title Ownership of US 7141018
2000 : Parent app filed by two inventors
2001 : Inventors assign to Celgene
: Recorded at Reel 11469 Frame 882
2005 : Continuation app 11 028 144 filed
2006 : US 7141018 grants to Celgene
2018 : Celgene sues Hikma and West-Ward
2019 : Bristol-Myers Squibb acquires Celgene
NPE / troll-pattern signals
- Shell-entity transfer — Not present. No transfer to an "IP / Holdings / Ventures / Licensing" LLC appears anywhere in the chain. The only recorded assignee is Celgene Corporation, an operating pharma manufacturer.
- Known asserter in the chain — Not present. Neither Celgene nor its acquirer BMS appears on the cited NPE lists (Acacia, Marathon, IV, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Round Rock, etc.). The asserting party is a product company.
- Repeat correspondent across the chain — Unresolved / no finding. I could not recover the correspondent of record for Reel 11469/Frame 882. Without that field I cannot assess recurrence, so this stays unclear rather than "present." (Note for the record: the litigation counsel names — Francis D. (Frank) Cerrito and Eric Stops of Quinn Emanuel, Charles Lizza of Saul Ewing — are Celgene's litigators, not assignment-record correspondents, and should not be counted as a repetitive-recording signal.)
- Cascading transfers — Not present. No chained LLC-to-LLC conveyances. What does cascade is the patent family (five continuation patents, mother-and-daughters all retained by Celgene) — that is portfolio layering by an operating company, not an NPE shell chain.
- Pre-litigation transfer — Not present. No assignment is dated within six months before any of the tracked suits (2:07-cv-00286, 2:07-cv-04050, 2:07-cv-05485, 2:15-cv-00697, 2:18-cv-13477). Celgene asserted as owner-of-record, not via a freshly assigned shell.
- Bankruptcy fire-sale — Not present. Celgene was sold at a premium in a strategic acquisition (BMS, 2019), not through Chapter 7/11. No Kodak/Nortel-style asset auction.
- Privateering — Not present. Celgene asserted these distribution-method patents in its own name to defend its own THALOMID/REVLIMID Orange Book listings. In 2:18-cv-13477 (filed 2018-08-31, D.N.J., Celgene v. Hikma Pharmaceuticals Int'l / West-Ward), the asserted patents include 7,141,018 alongside 6,315,720, 6,561,977, 6,755,784, 6,869,399, 7,230,012, 7,959,566, 8,315,886 and 8,626,531 — a classic brand-vs-generic ANDA fight, the opposite of privateering.
- Defensive aggregator — Not present. The chain does not terminate at RPX, AST, LOT, Unified Patents or OIN; the patent remained a Celgene/BMS assertion asset (now near expiration, Orange Book expiry Oct 23, 2020).
Verdict
Operating-company assertion.
The only author-grounded assignment in this chain is inventors Bruce A. Williams and Joseph K. Kaminski → Celgene Corporation, recorded 2001-01-05 at Reel 11469 / Frame 882 (spoken to under oath in IPR2015-01103 Paper 6 for the parent '720). No shell LLC, no known NPE, no cascade, and no pre-litigation flip ever appear; Celgene/its acquirer BMS instead asserted US 7,141,018 in its own name in ANDA litigation such as 2:18-cv-13477 against West-Ward/Hikma, on a patent Orange-Book-listed for Celgene's own THALOMID product. Zero NPE signals are present, so this cannot be scored as an NPE pattern. Residual gap: I could not execute a live Assignment Center lookup, so the correspond
Generated 10/1/2026, 4:33:34 AM
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
I'll search the USPTO and patent databases for the specific prior-art citations appearing on the face of US 7,141,018.
Let me retrieve the actual front-page "References Cited" list and the claimed prior-art documents.
Let me try to confirm the exact front-page "References Cited" list on US 7,141,018 itself and gather descriptions/dates for each cited reference.
Prior-Art Analysis — US 7,141,018 B2
Analyst note on scope and sources. I searched for the specific number US 7,141,018 B2 (application 11/028,144; "Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated"; Celgene; priority Oct 23, 2000). I did not substitute results for the many similar-numbered family members (6,755,784; 6,869,399; 6,561,977; 6,561,976; 6,767,326; 6,908,432; 6,315,720), which I treat separately below.
Two source caveats before the citations:
- I could not open the raw USPTO PatentCenter "References Cited" panel directly in this session; the citation list below is reconstructed from the Google Patents record for US 7,141,018 B2, the PubChem mirror of the USPTO citation data for US-7141018-B2 (30 patent + ~35 non-patent entries), and the front page of the granted parent US 6,315,720 (same examiner, Max F. Hindenburg / Michael Astorino, same art unit 3736, near-identical disclosure). Where I describe a reference's contents rather than just its title, I flag confidence.
- ⚠️ Date discrepancy: the task states the current date as April 26, 2026, whereas the environment date stamps are 2026-10-01. I flag this rather than silently pick one; it does not change the prior-art analysis, which is anchored to the '018 patent's Oct 23, 2000 effective date.
1. The single most important framing point
US 7,141,018 shares its priority date (Oct 23, 2000) with a whole cluster of Celgene patents/applications. Consequently, most of the "patent citations" printed on its face are its own family members — they are not § 102 prior art to the '018 claim 1. The examiner in this family used them for obviousness-type double patenting (ODP), which Celgene cured by terminal disclaimer (I confirmed an executed terminal disclaimer over 6,315,720, 6,561,977, 6,755,784, 6,869,399 and 7,141,018 in the prosecution of Ser. No. 11/437,551).
The true § 102 prior art is the third-party patents and printed publications that predate Oct 23, 2000 and are not commonly owned/priority-linked.
2. Patent citations on US 7,141,018 B2
Legend: [APP] = cited by applicant (IDS); [SEA] = cited by the searcher/examiner; dates are issue/publication dates; "?" = I am not fully confident of content/date and you should verify against the printed front page.
(A) Genuine third-party § 102 references (predate Oct 23, 2000)
| Citation | Pub./Filing date | Brief description | Claim(s) potentially anticipated under § 102 |
|---|---|---|---|
| US 5,299,121 (Brill et al.) [SEA] | Issued Mar 29, 1994 | Interactive patient-assistance/medication-dispensing device (600/301). Content confidence: moderate. | No claim; device/medication-delivery art, relevant at most to the "dispense to a patient" environment. |
| US 5,594,637 (Eisenberg et al.) [SEA] | Issued Jan 14, 1997 | Computerized health-care data processing (395/202). Content confidence: low — verify. | None; background only. |
| US 5,619,991 (Sloane) [SEA] | Issued Apr 15, 1997 | Medical/physiological data monitoring system (128/630). Content confidence: low. | None; background. |
| US 5,660,176 (Iliff) [SEA] | Issued Aug 26, 1997 | Computer-assisted medical history/diagnostic system (600/300). Confidence: moderate-high. | No claim 1 element; would at most touch "information obtained from the patient." |
| US 5,832,449 [APP] | 1998 (date uncertain) | Cited on the '018 face; content not confirmed — verify. | Cannot assess; flagged. |
| US 5,845,255 (Mayaud) [APP] | Issued Dec 1, 1998 | Electronic prescription creation/management system (705/3); database-checked prescribing. | Potentially anticipates the prescription-processing spine of claim 1 ("prescription filled only after storage medium consulted"), but not the "risk groups" or "approval code" steps — so claim 1 as a whole is not met; § 103 candidate against claims 2–3. |
| US 5,974,203 (Tadokoro et al.) [APP] | Issued Oct 26, 1999 | Medical/drug data processing. Confidence: low. | None specifically. |
| US 6,014,631 (Teagarden et al.) [SEA] | Issued Jan 11, 2000 | Health-care/prescription data system (705/3). | Touches registration/data-entry elements; not risk-groups/approval-code. § 103 candidate for claims 2–3. |
| US 6,045,501 (Elsayed et al.) [SEA] | Issued Apr 4, 2000 | The key reference. Teratogenic-drug distribution: register prescribers/pharmacies/patients in a computer-readable medium; counsel on fetal risk; obtain informed consent; determine pregnancy; authorize the registered pharmacy to fill. | See detailed § 102 analysis in § 4. Discloses the registration/counseling/consent/pregnancy/authorization core but not a "plurality of risk groups" nor a "prescription approval code." Best § 102(a)/(e) art; likely § 103 with another reference. |
| US 6,055,507 (Cunningham) [APP] | Issued Apr 2000 | Prescription verification/monitoring system (verifies before dispensing). | Could touch the "pharmacy consults medium before filling" element (claim 1 tail), not the risk-group/approval-code steps. |
| US 6,063,026 (Schauss et al.) [SEA] | Issued May 16, 2000 | Health-assessment/monitoring (600/300). Confidence: low. | Background only. |
| US 6,128,620 (Pissanos et al.) [APP] | Issued Oct 3, 2000 | Data organization/management (707/102). | None specifically. |
| US 6,131,090 (Basso, Jr. et al.) [SEA] | Issued Oct 10, 2000 | Rule-based decision system (706/23). | Could touch the "compare info to predefined risk parameters" idea in claim 1(b), but not the full claim. |
| US 6,202,923 (Boyer et al.) [SEA] | Issued Mar 20, 2001 (filed pre-Oct 2000) | Pharmacy/medication verification system (235/375). | Possible § 102(e) art for an "approval-before-dispense" step; verify filing date to confirm § 102(e) availability. |
| WO 98/13783 [APP] | Apr 1998 | PCT — computerized medical/drug administration. Content low confidence. | Background. |
| WO 98/58338 A2 [APP] | Dec 1998 | PCT — patient/medication data system. | Background. |
| WO 99/10829 A1 [APP] | Mar 1999 | PCT — drug/prescription management. | Background; possibly the "consult a database before dispensing" element. |
| WO 00/51053 A1 [APP] | Aug 2000 | PCT published just before the '018 priority date; cited on the '018 face. Content low confidence. | Possible § 102(a) art if it discloses database-authorized dispensing; verify. |
(B) Family members that are NOT § 102 prior art to the '018 (ODP / common-priority only)
| Citation | Date | Relationship | Why NOT § 102 art |
|---|---|---|---|
| US 6,315,720 B1 (Williams et al.) [APP] | Nov 13, 2001; filed Oct 23, 2000 | Parent of the '018 chain (09/694,217) | Shares the '018 priority date — cannot be "before the invention by the applicant." Cited for ODP. Note: it does recite "risk groups," which the '018 claim 1 also requires. |
| US 6,561,976 B2 (Elsayed/Williams) | May 13, 2003 | Continuation (09/964,068, filed Sep 26, 2001) | Filed after the '018 priority date; family/ODP. |
| US 6,561,977 B2 (Williams) | May 13, 2003 | Continuation (09/965,155) | Family/ODP. |
| US 6,755,784 B2 (Williams/Kaminski) [SEA] | Jun 29, 2004 | Continuation (10/383,275) | Family/ODP; claim 1 is nearly verbatim the '018 claim 1 without the thalidomide/pregnancy limitations. |
| US 6,767,326 B2 (Elsayed/Williams) [APP] | Jul 27, 2004 | Continuation (10/383,665) | Family/ODP. |
| US 6,869,399 B2 (Williams/Kaminski) [SEA] | Mar 22, 2005 | Immediate parent (10/762,880) | Family/ODP. |
| US 6,908,432 B2 (Elsayed/Williams) [APP] | Jun 21, 2005 | Sibling (10/762,897) | Family/ODP. |
| US 2005/0090425 A1; US 2005/0216309 A1; US 2005/0222874 A1 [APP] | 2005 | Family publications | Family/ODP. |
| WO 02/35440 A1; CA 2352619 A1 | May 2002 / 2001 | Celgene family PCT/CA | Family. |
3. Non-patent literature on the face of the '018 (all printed publications under § 102(b)/(a))
The '018 face carries a substantial NPL list, dominated by clozapine-registry and teratogen-pregnancy-prevention literature:
| NPL reference | Date | Brief description | Claim(s) potentially § 102 |
|---|---|---|---|
| Bastani et al., Psychopharmacology 99:S122 (1989) | 1989 | Clozaril Patient Management System — centralized drug monitoring/registry. | § 102(b) printed publication; touches registration of prescribers/pharmacies/patients (claims 2–3). |
| Powell et al., Postgrad. Med. J. 70:901 (1994) | 1994 | "Guideline for the clinical use and dispensing of thalidomide" — patient selection, counseling, pregnancy testing. | Most on-point non-patent art; touches counseling/disclosure (claims 4–6) and pregnancy determination. |
| Mitchell et al., NEJM 333(2):101 (1995) | 1995 | Accutane (isotretinoin) pregnancy-prevention program. | Counseling/pregnancy-test elements (claims 4–6). |
| Honigfeld, Psychiatric Services 47:52 (1996) | 1996 | Clozapine National Registry — effect on agranulocytosis deaths; computerized database of MDs, pharmacies, patients. | Registration elements (claims 2–3); prior-art backbone the petitioners relied on in the sibling IPRs. |
| Black et al., Psychiatric Services 47(1):81 (1996) | 1996 | Centralized clozapine monitoring (British Columbia). | Registration/monitoring (claim 3). |
| Freeman et al., Clin. Pharmacokinetics 32(2):93 (1997) | 1997 | Therapeutic drug monitoring in clozapine therapy. | Background; diagnostic-testing concept (claim 9). |
| CDC Public Meeting, "Preventing Birth Defects Due to Thalidomide Exposure," Atlanta (Mar 26, 1997) | 1997 | Public discussion of a thalidomide accounting/registry/informed-consent program. | Counseling/consent/registry (claims 4–7). Also cited by the examiner in 11/437,551. |
| NIH/FDA/CDC Thalidomide Workshop Transcript (Sep 9, 1997) | 1997 | Public workshop transcript. | Used by examiner as § 102(a) anticipation in the sibling application (traversed by applicant). |
| Bakken et al., Tidsskr Nor Laegeforen 118:1076 (1998) | 1998 | Local monitoring center for clozapine therapy. | Registration/monitoring (claims 2–3). |
| Bender, Psychiatric Times XV(5) (1998) | 1998 | Reduced clozapine monitoring / access vs. risk. | Background. |
| Bruera & Neumann, Psycho-Oncology 7:346 (1998) | 1998 | Psychotropics in advanced cancer. | Background. |
| Clark et al., Drug Safety 24(2):87 (2001) | 2001 — postdates priority | Thalidomide post-marketing surveillance. | Not § 102 (post-priority); § 102(a) only if within-1-year and pre-invention, unlikely here. |
| Dimopoulos & Eleutherakis-Papaiakovou, Am. J. Med. 117:508 (2004) | 2004 — postdates | Thalidomide adverse effects in neoplastic disease. | Not § 102 for the '018. |
4. Direct § 102 mapping against US 7,141,018 claim 1
Claim 1 requires, in combination: (i) treating a patient with a thalidomide-responsive disease; (ii) pharmacy fills only after learning a "prescription approval code" was generated from a computer-readable medium; and generation of that code via steps (a) define multiple patient risk groups; (b) define an information set that includes a determination of the patient's ability to become pregnant (pregnancy status optional); (c) assign the patient to a risk group and enter patient/info/assignment in the medium; (d) determine whether the risk is acceptable; (e) generate the approval code.
Bottom line: no single cited reference anticipates claim 1. Every candidate fails on at least the "plurality of risk groups" and "prescription approval code" limitations:
- US 6,045,501 (Elsayed) — § 102(a)/(e). Closest genuine prior art. Discloses registration of prescribers/pharmacies/patients, counseling, informed consent, pregnancy determination, and pharmacy authorization. Fails claim 1 because it does not disclose (a) a plurality of risk groups or (e) a prescription approval code. → Properly a § 103 reference (alone or with an electronic-prescribing reference such as Mayaud '255 or Cunningham '507), and a possible § 102 reference only against dependent-claim concepts (claims 2–3 registration; claims 4–7 counseling/consent), which nevertheless incorporate claim 1.
- US 6,315,720 and the family ('784, '399, '977, '976, '326, '432). These do recite risk groups and approval codes, but they are common-priority/common-ownership references — not § 102 art; they were resolved by terminal disclaimer (ODP).
- US 5,845,255 (Mayaud), US 6,055,507 (Cunningham), US 6,202,923 (Boyer). § 102(b)/(e) electronic-prescription/verification art. They can touch the "consult the medium before dispensing / approval" element but disclose no risk-group assignment → no anticipation of claim 1; § 103 fodder.
- Powell (1994) and Mitchell (1995). Teratogen pregnancy-prevention/dispensing guidelines; § 102(b) printed publications. Touch counseling/disclosure (claims 4–6) but are not a computerized approval-code system → no anticipation of claim 1.
- Clozapine-registry NPL (Honigfeld, Bastani, Black, Bakken). Computerized registries of physicians/pharmacies/patients → registration elements (claims 2–3), not risk groups/approval code.
- Claim 8 (facsimile + OCR transmission). I found no single cited reference that discloses this specific combination for risk-group/consent data; it appears non-anticipated and is more likely a § 103/§ 112 drafting point.
Most relevant prior art, ranked: (1) US 6,045,501 (Elsayed); (2) the '018's own parent US 6,315,720 (ODP, not § 102); (3) Powell 1994 and (4) Mitchell 1995 (NPL § 102(b)); (5) clozapine-registry NPL and electronic-prescription patents (Mayaud, Cunningham, Boyer) as § 103 complements.
5. Uncertainties / items to verify against the printed front page
- I could not retrieve the raw USPTO "References Cited" panel; the list above is reconstructed from Google Patents + the PubChem USPTO citation mirror + the granted '720 front page. Verify the exact front-page list on the '018 PDF.
- Content/date confidence is low for US 5,594,637, US 5,619,991, US 5,832,449, US 5,974,203, US 6,014,631, US 6,063,026, US 6,128,620, US 6,131,090, WO 98/13783, WO 98/58338, WO 99/10829, WO 00/51053 — I have flagged these "?"; do not cite my one-line descriptions as authoritative.
- § 102(e) availability for US 6,202,923 (Boyer) depends on its filing date predating Oct 23, 2000; confirm.
- Two references on the '018 face (Clark 2001; Dimopoulos 2004) postdate the Oct 23, 2000 priority date and are therefore not § 102 prior art for the '018 (they may be relevant only to later family members).
- I did not find any IPR or Federal Circuit appeal docketed on US 7,141,018 itself; the family's PTAB activity (IPR2015-01103 and companions) targeted US 6,315,720, and those proceedings supply useful § 102/§ 103 mappings (Petitioner's main § 102/§ 103 references there were Powell 1994, Mitchell 1995, Honigfeld 1996, Bastani 1989, and Dishman 1994) — highly probative context for the '018's own prior-art field, though not the '018's face citations. Treat this as a search-result finding, not a certified negative.
If you want, I can (a) pull the verbatim front-page "References Cited" block from the '018 PDF image once a direct full-text source is reachable, and (b) build a claim-by-claim § 102/§ 103 chart against Powell, Mitchell and Elsayed '501.
Generated 10/1/2026, 4:34:20 AM
Obviousness
Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.
I'll gather the prior art references cited on the patent page and in the specification, then run targeted searches to ground the § 103 analysis.
Excellent — this surfaced the actual IPR record. Let me pin down the specific prior-art references relied on against this patent family (Powell, Mitchell, Dishman) and their bibliographic details.
Let me nail down two more references the record relies on — the "Cunningham" approval-code art and any other cited references on the '018 page — plus confirm the sibling‑patent IPR outcomes.
Obviousness Analysis — US 7,141,018 B2 under 35 U.S.C. § 103
Building on the earlier bibliographic, claim, and litigation sections. This section assumes and does not repeat that material. Where the claim characterization below is drawn from the prior section rather than the raw claim text, I flag it.
0. Threshold: which § 103 regime applies, and a scope caveat
Because US 7,141,018 has a priority date of October 23, 2000 and was filed January 3, 2005, it is a pre‑AIA patent governed by pre‑AIA §§ 102/103 (the first‑inventor‑to‑file provisions apply only to applications filed on or after March 16, 2013). Pre‑AIA § 103(a) therefore controls, and the Graham/KSR framework applies as elaborated by the Federal Circuit in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019).
⚠️ Caveat on claim text. The element‑by‑element mapping below uses the claim construction set out in the previous section (claim 1 as a thalidomide‑specific method with mandatory steps (a)–(e) and a mandatory "ability to become pregnant" determination). I did not independently re‑verify every word of the granted claim 1 in this pass. If claim 1 is instead the generic "a drug" version (as the specification's Summary suggests), the analysis is a fortiori easier to sustain against the patentee, because the narrower thalidomide‑specific claim is squarely covered by the prior art discussed below. Either way the conclusion is the same; I note the dependency rather than paper over it.
Relevance check. The patent is Expired – Lifetime (anticipated expiration Oct. 23, 2020), so this is a retrospective/validity‑study analysis, not a live invalidity threat. No IPR or Federal Circuit appeal docketed specifically on the '018 was located (consistent with the earlier section). However — and this is the decisive point — the '018 sits inside the same continuation family as two patents that were actually invalidated for obviousness, which supplies unusually authoritative guidance rather than speculation.
1. Person of ordinary skill in the art (POSA)
The PTAB, in the parallel IPRs, defined the POSA as a pharmacist and/or physician with knowledge of computer systems used to regulate access to prescription drugs (or, in the alternative, someone with pharmaceutical risk‑management experience). See Celgene v. Peter, 931 F.3d at 1350–51 (discussing the Board's POSA findings). That definition matters here because the '018 claims a distribution/risk‑management workflow, not a new drug or a new chemical entity. The claimed subject matter is squarely within a pharmacist's or physician's ordinary skill set.
2. Prior art corpus relevant to the '018
| Ref. | What it discloses | Date | § 102 basis vs. '018 (priority 10/23/2000) |
|---|---|---|---|
| US 6,045,501 (Elsayed et al.) — cited in the '018's own Background | Register prescribers, pharmacies, patients in a computer‑readable medium; information on ability of female patients to become pregnant / male patients to impregnate; counseling to subpopulation; determine pregnancy; authorize registered pharmacies to fill if non‑pregnant | Filed 8/28/1998; issued 4/4/2000 | § 102(a)/(b) — "patented … before the invention." Not removed by § 103(c) because it is not § 102(e)/(f)/(g) art. |
| Powell & Gardner‑Medwin, Guideline for the clinical use and dispensing of thalidomide, Postgrad. Med. J. 70(830):901–904 (Dec. 1994) | Thalidomide‑specific dispensing guideline; "pregnancy should be excluded before instituting therapy"; adequate contraception throughout and 3 months after; patient information sheet; periodic monitoring (nerve conduction) | 1994 | § 102(b) (printed publication >1 yr. pre‑priority) |
| Mitchell et al., A Pregnancy‑Prevention Program in Women of Childbearing Age Receiving Isotretinoin, N.E.J.M. 333(2):101–106 (1995) | Accutane PPP: physician warnings, patient qualification checklist assigning patients to risk groups (women of childbearing age / high risk of pregnancy), informed consent, pregnancy testing, contraceptive counseling, patient survey; expressly says thalidomide experience could follow the Accutane model | 1995 | § 102(b) |
| Dishman et al., Pharmacists' role in clozapine therapy at a VA medical center, Am. J. Hosp. Pharm. 51:899–901 (1994) | National clozapine registry; registration of prescribers/patients; pharmacist verification; computerized prescription "lockout" tying a lab database to outpatient pharmacy dispensing software, limiting dispensing to a one‑week supply | 1994 | § 102(b) |
| Honigfeld et al., Clozaril National Registry / CPMS papers & "Guide to the Clozaril Patient Monitoring Service" | Registry for patients, prescribers, pharmacies; WBC data used as risk factor; limited supply; refills only after criteria met; discontinue protocols | 1997–1998 | § 102(b) (pre‑10/23/1999) |
| Thalomid® Package Insert (1998) | Thalidomide distribution with mandatory pregnancy testing, counseling, registered pharmacies/prescribers | July 1998 | § 102(b) |
| Cunningham (U.S. patent; Ex. 1009 in the '720 IPRs) | Dispensing/tracking system: pharmacy uploads defined information to a central computing station, which — only if the information is valid — issues a pharmacy approval code authorizing dispensation | pre‑2000 | § 102(a)/(b) |
| Keravich; Zeldis; Mundt (used in the '720 IPRs) | S.T.E.P.S. program details; ≤28‑day supply, no refills; mandatory periodic patient survey; telephone/fax registration; IVR systems for collecting sensitive patient information | 1999 and later | Mixed (§ 102(a)/(b)) — some are Celgene's own later publications and must be dated carefully against the Oct. 23, 2000 priority |
Sources: Google Patents US7141018; Powell (PubMed 7870638); the reference identities and the Board's treatment are reproduced verbatim in the IPR2015‑01092 Final Written Decision and the cert‑petition appendix reproducing the '720 IPR decisions.
3. Element‑by‑element mapping of independent claim 1
| Claim‑1 element (per earlier section) | Disclosing reference(s) |
|---|---|
| Preamble — treating a patient with a thalidomide‑responsive disease while restricting access | Powell (thalidomide use/ENL); Thalomid PI; Elsayed '501 claim 2 ("said drug is thalidomide") |
| Prescription filled only after the pharmacy becomes aware a prescription approval code was generated | Cunningham (central station issues pharmacy approval code before dispensing); Dishman (lockout prevents filling absent verification) |
| (a) Define a plurality of risk groups from predefined risk parameters | Mitchell (risk groups: women of childbearing age; high‑risk‑of‑pregnancy); Honigfeld/CPMS (risk stratification by WBC) |
| (b) Information set including a determination of ability to become pregnant (current pregnancy optional) | Elsayed '501 (information "concerning the ability of female patients to become pregnant"); Powell/Mitchell (pregnancy exclusion/testing) |
| (c) Assign patient to a risk group and enter patient, information, and assignment in the medium | Mitchell (qualification checklist → assignment); Dishman (registry storage) |
| (d) Determine whether the risk is acceptable based on information + assignment | Powell ("pregnancy should be excluded before instituting therapy"); Thalomid PI; CPMS (continue only if WBC acceptable) |
| (e) Generate the approval code if risk acceptable, before filling | Cunningham |
Every element is disclosed; the inquiry therefore collapses to whether the combination was motivated and predictable.
4. The three grounds that make the claims obvious
Ground 1 — Elsayed '501 in view of Mitchell and Dishman (the "distribution‑workflow" ground)
This is the strongest ground because the '501 is the reference the '018's own specification identifies as the starting point ("of the type in which prescriptions … are filled only after a computer readable storage medium has been consulted …"). The '501 already discloses: registering prescribers, pharmacies, and patients; collecting "ability to become pregnant"/"ability to impregnate" information; counseling a subpopulation; determining pregnancy; and authorizing filling. The '018's only material additions over the '501 are (i) plural risk groups with assignment, (ii) an affirmative risk‑acceptability determination, and (iii) a prescription approval code.
Each addition is supplied by an independent, dated reference directed to the same problem:
- Mitchell supplies risk‑group definition and assignment (Accutane PPP checklist) and — critically — expressly points the artisan to thalidomide: "experience gained with [Accutane] can serve as a basis for considering how [thalidomide] should be used and monitored, with a view to ensuring that pregnancies and malformations are reduced to an absolute minimum" (quoted at Ex. 1006, 105; reproduced in the cert appendix).
- Dishman (and Honigfeld/CPMS) supplies the computerized registry storing prescriber/pharmacy/patient records and gating dispensation on a verification step.
Ground 2 — Thalomid Package Insert in view of Cunningham and further in view of Keravich/Zeldis/Mundt (the "approval‑code" ground)
This is the exact combination the Board adopted against the parent '720 patent (IPR2015‑01096 / ‑01102 / ‑01103), and the Federal Circuit affirmed that all challenged claims were obvious. Celgene v. Peter, 931 F.3d at 1344–45, 1355. The Board reasoned that "it would have been obvious to modify the methods for limiting distribution of drugs with adverse side effects to high risk groups, disclosed in Thalomid Package Insert, Powell, or Mitchell, to require issuance of an approval code prior to dispensing the drug as disclosed in Cunningham." Because the '018 is a continuation of that same '720 line and its claim‑1 subject matter is a subset of what the '720 claimed, Ground 2 applies transitively — the '018 adds nothing to the '720's approach beyond specifying thalidomide (which the Thalomid PI and Powell are entirely about).
Ground 3 — Powell + Mitchell + Dishman (the "teratogen‑program" ground)
The Board held the '501's claims unpatentable over precisely these three references, finding "a person of ordinary skill in the art would have been led to combine, in the manner claimed, the disclosures … to address the problem of limiting thalidomide access to patients likely to suffer serious adverse side effects, including birth defects in a developing fetus." Coalition for Affordable Drugs IV v. Celgene, IPR2015‑01092, Paper 73, at 23–24 (P.T.A.B. Oct. 26, 2016). Powell handles thalidomide dispensing; Mitchell handles risk groups + surveys; Dishman handles the computer registry. This trio supplies elements (a)–(d) directly and (e) via the registry/lockout concept.
Takeaway: the '018's independent claim is covered by at least three independent combinations, two of which were actually adjudicated against sibling patents in the same family and resulted in invalidation that was affirmed on appeal.
5. Motivation to combine (the § 103 "why")
The motivation is not hindsight — it is stated in the art itself and was accepted by the Board and the Federal Circuit:
- Explicit cross‑reference in Mitchell. Mitchell itself directs the artisan from the Accutane program to thalidomide. That is an express teaching, not an inference.
- Common problem, common field. Powell, Mitchell, Dishman, the Thalomid PI, and the CPMS all address the same problem — restricting a hazardous drug to patients for whom it is not contraindicated — and all sit in the pharmaceutical risk‑management field. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (combination of known elements for their known purpose yielding predictable results is obvious).
- Predictable result. Adding a computer registry (Dishman) and an approval‑code gate (Cunningham) to a known counseling/pregnancy‑testing program yields nothing more than the expected benefit of the known components: enforcement of an existing rule. The Board characterized this as "a combination of known prior art elements … for their known purpose … to achieve a predictable result."
- Specific safety motivation. The Federal Circuit held "the desire to decrease the risks of administering a drug with adverse side effects, like thalidomide, is a specific motivation to improve the prior art," and that "where safety is a concern and where the potential adverse side effects are so severe, the Board did not err in finding that the desire to improve a system that is working well qualifies as a valid motivation." Celgene v. Peter, 931 F.3d at 1354–55.
6. Dependent claims 2–9
Because claim 1 is the narrowest independent base and it is obvious, the dependents fall with it unless one adds a genuinely non‑obvious limitation. They do not:
- Claims 2–3 (register prescriber / register pharmacy): core disclosures of Elsayed '501, Dishman, and the CPMS/Honigfeld registry. The Board expressly found Dishman suggests a registry of pharmacies (dispensation "only upon the pharmacist's verification").
- Claim 4–6 (counseling → full disclosure → fill only after full disclosure): Powell's patient information sheet and Mitchell's physician warnings/informed consent. Mitchell discloses "physicians were given instructions 'to warn patients of risks.'"
- Claim 7 (register the fact of full disclosure before generating the code): the natural marriage of Mitchell's informed consent with Dishman's registry‑verification‑before‑dispensing step.
- Claim 8 (facsimile submission + OCR entry): a routine data‑entry expedient; Zeldis/Keravich disclose telephone/fax registration and approval services. The Federal Circuit upheld analogous "paper vs. electronic" choices as within ordinary skill.
- Claim 9 (periodic second information set): Mitchell's and Powell's periodic surveys/monitoring, and the CPMS weekly WBC re‑testing with refill gating. The Board upheld the periodic‑IVR‑survey limitation as "known elements being used for their known purpose."
7. Secondary considerations (and how the record treated them)
Celgene advanced long‑felt need, industry praise, and unexpected results (the S.T.E.P.S. program's 100% success in preventing thalidomide‑type birth defects). These were considered and rejected:
- The Board found no unmet need because other controlled‑distribution methods (Mitchell, Dishman) were readily available to meet the need for a controlled thalidomide program.
- The Federal Circuit affirmed that "the desire to improve a system that is working well" is a valid motivation, and rejected the "if it ain't broke, don't fix it" argument. 931 F.3d at 1354–55.
- Praise (e.g., NORD's commendation of Celgene's "numerous safeguards for pregnancy prevention") was not enough to overcome the strong prima facie case.
Litigator's note: the '018's claim 1 is narrower than the '720's (thalidomide‑specific + mandatory ability‑to‑become‑pregnant), so a patentee would argue the narrower claim captured something the broader invalid claims did not. But the narrowing limitation — thalidomide — is the subject of Powell and the Thalomid PI, which are themselves thalidomide‑specific. Narrowing to the very drug the primary references address does not inject an inventive step.
8. Conclusion
US 7,141,018 would have been obvious under pre‑AIA § 103(a). The independent claim is disclosed by, and the dependent claims are rendered obvious by, at least:
- Ground 1: Elsayed '501 + Mitchell + Dishman (mirrors the '501 IPR, IPR2015‑01092, FWD affirmed);
- Ground 2: Thalomid PI + Cunningham + Keravich/Zeldis/Mundt (mirrors the '720 IPRs, IPR2015‑01096/‑01102/‑01103, affirmed in Celgene v. Peter, 931 F.3d 1342 (Fed. Cir. 2019));
- Ground 3: Powell + Mitchell + Dishman (+ Honigfeld/CPMS) for the teratogen‑program elements.
The motivation is express (Mitchell's own thalidomide cross‑reference), specific (severe teratogenic risk), and accepted by both the Board and the Federal Circuit; the result is the predictable aggregation of known distribution‑control elements.
Explicit uncertainties / limitations
- No IPR or CAFC docket specifically on the '018 was located. Its invalidation exposure is inferred from its position as a continuation of the '720 (invalidated) and its overlap with the '501 (invalidated). Treat "would have been obvious" as a strong, well‑grounded prediction, not an adjudicated holding on the '018 itself.
- Claim‑text dependency: element mapping relies on the prior section's claim 1 characterization; I did not re‑verify the granted claim wording in this pass.
- Cunningham's patent number was not confirmed in this pass (it appears in the record as Ex. 1009 to the '720 IPRs); I cite it by name rather than risk a mis‑cited number.
- Dates: Honigfeld/CPMS and Keravich/Zeldis/Mundt qualify as prior art only to the extent their public availability predates Oct. 23, 1999 (for § 102(b)) or Oct. 23, 2000 (for § 102(a)); some are Celgene's own later publications and their dates should be verified before being relied on against the '018.
Sources: Google Patents US7141018; Powell, Postgrad Med J 70(830):901; IPR2015‑01092 FWD; Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019); cert‑petition appendix reproducing the '720 FWDs.
Generated 10/1/2026, 4:34:15 AM
Extensions
Patent term adjustments, term extensions, continuations, divisionals, family members, and expiration dates.
Derivative works
Defensive disclosure: derivative variations of each claim designed to render future incremental improvements obvious or non-novel.
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