US 7119106

I'll search for authoritative information on US 7119106, including any CAFC 2026 docket activity.

Let me dig into the claims and any 2026 CAFC activity.

Let me retrieve the full claim set to characterize the independent claims accurately.

Search coverage / caveats up front

I ran targeted searches against public patent sources (Google Patents, FreePatentsOnline, Justia, PubChem, EPO/OPS-derived records, CourtListener/New Jersey federal docket excerpts, BMS/Celgene SEC filings, and secondary litigation reporting). Two important limitations:

• I do not have direct, live PACER/CAFC (Fed. Cir.) docket access in this session. I searched for a 2026 CAFC docket involving 7,119,106 and found none. That is a negative finding from open-web sources, not a certification that no such docket exists. Treat it as unverified.
• The claim text I could retrieve is partial (claim 1 and selected dependents). Where I characterize claims beyond that, I flag it as reconstruction/inference.

Per the strict-ID rule, all identifiers below are reproduced exactly as they appear in the sources.

Bibliographic data — US 7,119,106 B2

Abstract (verbatim as published)

"Substituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines reduce the levels of TNFα in a mammal. Typical embodiments are 1-oxo-2-(2,6-dioxo-3-methylpiperidin-3-yl)-4,5,6,7-tetrafuoroisoindoline and 1,3-dioxo-2-(2,6-dioxo-3-methylpiperidin-3-yl)-4-aminoisoindoline."

Note the abstract contains an apparent typographic artifact ("tetrafuoroisoindoline") as published — I am reproducing it literally rather than correcting it. The specification's own definitional section frames the invention as "substituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines, the method of reducing levels of tumor necrosis factor α in a mammal through the administration thereof, and pharmaceutical compositions of such derivatives."

Plain-language overview of the claims

The '106 patent has 11 claims (per the Google Patents claims counter). What I could verify verbatim:

• Claim 1 (the independent claim): "A pharmaceutical composition comprising an effective amount of a compound of the formula: [structure omitted in the snippet] or an acid addition salt thereof, and a pharmaceutically acceptable carrier, diluent or excipient."

  • In plain terms: this is a composition-of-matter/pharmaceutical-formulation claim, not a method claim. It covers a formulation that contains a therapeutically effective amount of a substituted 2-(2,6-dioxopiperidin-3-yl)phthalimide or 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindoline compound (drawn from the Markush formula of Formula I in the specification), or a physiologically acceptable acid-addition salt of it, together with at least one conventional pharmaceutically acceptable carrier, diluent, or excipient.
  • Because the claim recites "a compound of the formula" with a generic structural formula, its scope is set by that formula — consistent with the specification's two "preferred groups": (i) compounds where each of R¹–R⁴ is independently halo, C1–4 alkyl or C1–4 alkoxy, and R⁶ is H, methyl, ethyl or propyl; and (ii) compounds where one of R¹–R⁴ is —NH₂, the remainder are hydrogen, and R⁶ is H, methyl, ethyl or propyl.
  • I could not verify verbatim the full structural formula as printed in claim 1. Treat the scope description above as grounded in the specification's Formula I definitions, not a literal transcription of the claim drawing.

• Claim 2 (dependent): "The pharmaceutical composition of claim 1, which is suitable for oral administration." — i.e., an orally administrable version of the claim 1 composition.

• Claim 5 (dependent): "The pharmaceutical composition of claim 1, which is suitable for parenteral administration." — i.e., a parenterally administrable version.

• Claims 3, 4, 6–11: I could not retrieve these verbatim. Based on the specification's disclosure (which recites tablets, capsules, dragees, suppositories, syrups, suspensions, emulsions, sterile injectable solutions, unit dosage forms of 1–100 mg, and isotonic saline solutions of 20–100 mg/mL), these intermediate dependent claims most plausibly narrow the claim 1 composition to specific dosage forms, routes, or excipient sets (e.g., tablet/capsule, rectal/suppository, unit dosage form). This is inference, not verified text.

Practical read: the '106 patent's commercial significance is as a formulation/compound-family claim in the lenalidomide (Revlimid®) patent estate. Lenalidomide is 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline — i.e., an amino-substituted 1,3-dioxoisoindoline within the genus the '106 claims cover. Note, however, that US 7,119,106 does not appear to be the "compound patent" listed in the Orange Book for Revlimid; litigation filings state Celgene "filed and prosecuted several additional patents that it did not list in the Orange Book," expressly including 7,119,106 alongside 6,555,554, 6,281,230, 6,767,326, 7,977,357, 8,193,219 and 8,431,598.

Litigation and CAFC / 2026 docket check

What I found:

• Google Patents links a New Jersey District Court case, 2:10-cv-05197, as family litigation. Context from third-party filings indicates the '106 patent was part of the Revlimid/lenalidomide patent estate asserted or held by Celgene and later swept into the broader Revlimid antitrust litigation (e.g., In re Thalomid/Revlimid antitrust matters in D.N.J.; related opt-out and follow-on complaints). One D.N.J. complaint document captures a patent-database search string using "7119106" alongside other Revlimid-family patent numbers.
• No CAFC 2026 docket, opinion, Rule 36 affirmance, or appeal caption referencing 7,119,106 appeared in any of my searches.
• The CAFC matters that did surface for Celgene-family patents in 2026 involve different patents/subjects — e.g., IPR2015-01092 / Appeal 2018-1171 concerning US 6,315,720; the Coalition for Affordable Drugs VI LLC v. Celgene IPRs (patents 6,045,501; 5,635,517; 6,315,720); and Ablynx/Sanofi obviousness-type double patenting appeals. None of these is 7,119,106.
• The large 2026 Celgene-related appellate activity I located is Second Circuit, not Federal Circuit, and is unrelated to '106: UMB Bank v. Bristol Myers Squibb (CVR/breach-of-contract suit revived 3-0, August 13, 2026) and the Pomalyst antitrust appeal filed in April 2026.

Conclusion on the CAFC-2026 question: Based on available open sources, I found no 2026 Federal Circuit docket activity for 7,119,106. Given that the patent is recorded as expired (anticipated expiration 2019-05-07), a 2026 CAFC appeal of the '106 itself would be unusual. I explicitly cannot rule out a docket I could not retrieve — I do not have live PACER/CAFC access here.

Where I am uncertain (stated explicitly)

1. Full verbatim claim set. I verified claims 1, 2, and 5 only. Claims 3, 4, 6–11 and the literal claim-1 chemical formula drawing were not retrievable in this session.
2. Parent-application chain of 10/337,602. Google Patents shows the '106 claiming priority from US 09/543,809 (which issued as US 6,281,230 B1), but I did not verify whether 10/337,602 is a divisional, continuation, or continuation-in-part of that application.
3. Term/expiry arithmetic. Google Patents lists an "anticipated expiration" of 2019-05-07, which is later than a straight 20-year-from-1996-07-24 calculation (2016-07-24), implying a possible patent term extension and/or adjusted term. I did not independently verify a PTE certificate for this patent.
4. "Expired – Fee Related" is reproduced as the listed status; I have not reconciled that label against the 2019 expiration date.
5. No claim of an authoritative "in-force" legal status. The status field is expressly flagged by the source as an assumption, not a legal conclusion.

Primary sources:

• https://patents.google.com/patent/US7119106/en
• https://www.freepatentsonline.com/7119106.html
• https://patents.justia.com/patent/7119106
• https://pubchem.ncbi.nlm.nih.gov/patent/US-7119106-B2
• https://storage.courtlistener.com/recap/gov.uscourts.njd.[488236](/patent/488236)/gov.uscourts.njd.488236.18.0.pdf (Orange Book listing litigation)
• https://www.courthousenews.com/wp-content/uploads/2026/05/bristol-myers-squibb-celgene-antitrust-complaint-new-jersey.pdf (2026 Revlimid antitrust complaint)

I'll research litigation involving US patent 7119106.

Let me dig deeper into specific cases involving the '106 patent.

Let me get more detail on the Hetero case and other specific assertions.

Litigation Involving U.S. Patent No. 7,119,106

Important framing: U.S. 7,119,106 ("Pharmaceutical Compositions of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline") is a Celgene/Revlimid patent. Per the FDA Orange Book it was listed for REVLIMID (NCE/NDA 021880) with a patent expiration date of July 24, 2016. Because it expired in 2016, relatively few Hatch-Waxman suits named it as a patent-in-suit; instead it appears repeatedly in the Revlimid antitrust litigation as one of the patents in Celgene's alleged exclusionary scheme. I've separated those two categories below.

Note on method: I searched patent-litigation aggregators (DrugPatentWatch, Unified Patents, Justia, CourtListener/RECAP) and the underlying complaints. I could confirm some but not every docket-level detail; where I am inferring or uncertain I say so explicitly.

A. Patent-infringement (Hatch‑Waxman, §271) litigation asserting the '106 patent

1. Celgene Corp. v. Natco Pharma Limited, Arrow International Limited, and Watson Laboratories, Inc.

• Plaintiff: Celgene Corporation
• Defendants: Natco Pharma Limited; Arrow International Limited; Watson Laboratories, Inc. (stipulation also swept in Watson Pharmaceuticals, Inc., Actavis Inc., Watson Pharma, Inc., and Anda, Inc.)
• Jurisdiction/Court: U.S. District Court for the District of New Jersey
• Case No.: 2:10‑cv‑05197 (SDW)(MCA) — later (MCA)/(SCM); Judge Susan D. Wigenton
• Filed: October 8, 2010
• Basis: Natco's ANDA No. 201‑452 for generic lenalidomide capsules (5, 10, 15, 25 mg). Celgene's Second (and later Fifth) Amended Complaint named the '106 patent among the patents-in-suit — specifically U.S. Pat. Nos. 5,635,517 ('517), 6,045,501 ('501), 6,281,230 ('230), 6,315,720 ('720), 6,555,554 ('554), 6,561,976 ('976), 6,561,977 ('977), 6,755,784 ('784), 7,119,106 ('106), and 7,465,800 ('800).
• Outcome/Status: Settled/resolved. Celgene stipulated to dismiss its claims and Natco's defenses relating to the '106 patent (along with the '230, '554 and 8,288,415 patents) — Stipulation and Order signed by Judge Wigenton, entered March 26, 2015 (Dkt. No. 402); the '106 claims/defenses were dismissed and Natco amended its ANDA to remove ¶IV certification as to those patents. The overall case settled on December 22, 2015, with a Consent Judgment entered January 4, 2016 dismissing all claims with prejudice (Natco licensed to launch limited generic lenalidomide in March 2022, with a volume increase through January 2026). Docket terminated January 5, 2016.

2. Celgene Corporation v. Hetero Labs Limited (and affiliated Hetero entities)

• Plaintiff: Celgene Corporation
• Defendants: Hetero Labs Limited / Hetero Labs Limited Unit‑V / Hetero Drugs Ltd. / Hetero USA, Inc. (collectively "Hetero")
• Jurisdiction/Court: U.S. District Court for the District of New Jersey
• Case No.: 2:17‑cv‑03387 (ES)(MAH)
• Filed: May 11, 2017 — Terminated: August 19, 2021
• Basis: Aggregator data (DrugPatentWatch) lists patent 7,119,106 as involved in this case. Caveat: The published opinions and the consolidated §271 litigation in 2:17‑cv‑03387 I reviewed center primarily on Pomalyst (pomalidomide) and later-expiring Revlimid patents, not on the already-expired '106 patent. I could not independently confirm from a complaint that the '106 patent was affirmatively asserted (as opposed to merely referenced). Treat this entry as unverified/lower confidence and confirm against the docket before relying on it.

B. Antitrust litigation in which the '106 patent is directly referenced

These are not infringement suits over the '106 patent; the '106 patent is pleaded as part of Celgene's Revlimid patent portfolio/alleged monopolization scheme. (Aggregator "litigation for patent 7,119,106" listings draw heavily on these complaints.)

Source for the aggregator case list: DrugPatentWatch "Litigation for Patent 7,119,106" — https://www.drugpatentwatch.com/p/alphasignals/litigation/patent/7119106 (last updated March 25, 2026).

C. What I could and could not confirm

• Confirmed (from the actual complaint and court orders): the Celgene v. Natco (2:10‑cv‑05197) assertion of the '106 patent and its dismissal by stipulation, and the overall 2016 settlement/consent judgment.
• Reported by aggregator but not independently verified: the Celgene v. Hetero (2:17‑cv‑03387) listing of the '106 patent.
• No appellate (CAFC) decision specifically adjudicating the validity, enforceability, or infringement of the '106 patent was identified — consistent with the '106 claims being dismissed/never reaching judgment in the Natco case, and the patent expiring July 24, 2016.
• I did not find any case where a court entered a merits judgment on the '106 patent (no Markman ruling or invalidity/infringement holding specific to the '106 patent).

Bottom line: The only well-supported patent-infringement assertion of U.S. 7,119,106 is Celgene Corp. v. Natco Pharma Ltd., et al., D.N.J. No. 2:10‑cv‑05197 (filed Oct. 8, 2010), which terminated by stipulation as to the '106 patent and by overall settlement/consent judgment in 2015–2016. The '106 patent otherwise appears mainly as a component of the Revlimid/Thalomid antitrust litigation against Celgene (now Bristol‑Myers Squibb). If you need docket-verified confirmation for the Hetero case or the antitrust dockets, I'd recommend pulling the specific complaints from PACER/RECAP — I flagged where my confidence is limited rather than assert it.

I'll search for any PTAB proceedings, decisions, and appeals involving US 7,119,106.

Let me drill down on specific IPR numbers and the Coalition for Affordable Drugs filings.

No IPR on the '106 yet in those results. Let me check the DrugPatentWatch PTAB list for lenalidomide and search for any proceeding naming the '106 patent directly.

Proceedings overview

The USPTO Open Data Portal structured record for US 7,119,106 reports zero AIA trial proceedings — 0 active, 0 claims invalidated, 0 claims sustained, 0 settled, 0 institution denials — and my independent searches (Google Patents litigation metadata, DrugPatentWatch's lenalidomide PTAB table, the Coalition for Affordable Drugs docket set, and Federal Circuit/Supreme Court filings) surfaced no IPR, PGR, or CBM petition ever naming US 7,119,106; the defensive posture this gives a defendant is therefore not "hardened by PTAB wins" but something more useful: the claims were never PTAB-tested, the patent is expired, and the practical answer to a demand letter citing it is that no infringement occurring today can infringe an expired patent.

⚠️ Confidence note / discrepancy to verify. The patent's nominal 20-year term measured from the 1996-07-24 priority date is 2016-07-24 — the date used in the Revlimid antitrust complaints' Family 1 table ("the '230, '554, '106, and '415 patents … had expiration dates of July 24, 2016"). The Google Patents record fetched for this analysis, however, lists an "Anticipated expiration" event of 2019-05-07, which plausibly reflects a patent term adjustment (PTA) calculation. I could not reconcile these from the available sources; confirm the exact expiration in USPTO Patent Center before relying on either date. Either way, the patent has been expired for years as of 2026-10-01.

Proceedings on file

None. There is no proceeding to report at claim-level granularity, because no PTAB panel has ever instituted, decided, or terminated an AIA trial on this patent.

• Type: —
• Filed: —
• Status: No AIA trial proceedings on file (USPTO ODP, most recent ingest; corroborated by web search)
• Judge panel: none — no panel has ever been assigned
• Petition grounds: none
• Institution decision: none
• Final Written Decision: none — and this matters for the analysis below: no PTAB panel has ever construed or ruled on the claims of US 7,119,106
• Settlement / termination: none at the PTAB
• Appeal: none; the only litigation history attached to this patent in the structured record is the New Jersey district court case 2:10-cv-05197 (Celgene Corp. v. Natco Pharma Ltd.), which did not produce any PTAB satellite proceeding
• Defensive value: You cannot cite an FWD to knock out a claim — but you also don't need to. Nothing in the PTAB record narrows the patent, and nothing in the record rescues it: it is expired (see Recommended next steps).

Why the PTAB docket is empty (context, not a proceeding)

Three structural reasons explain the absence, and each is verifiable:

1. Expiration foreclosed the IPR wave. The '106 patent is a "Family 1" ('517-family, Muller et al.) patent with a 1996-07-24 priority date. The later ANDA-filer litigations (Dr. Reddy's 2016, Cipla/Alvogen/Lotus/Zydus 2017–2018) postdate expiration, and IPR petitions against an expired composition patent are of little practical value to a generic.
2. The one pre-expiration challenger took a Paragraph III exit. In Celgene v. Natco (D.N.J. 2:10-cv-05197), Natco originally certified under Paragraph IV against the '106 patent, but on 2015-03-26 the parties told the court they had dismissed claims and defenses as to the '230, '554, '106, and '415 patents after Natco switched to Paragraph III certifications, agreeing to await expiration in July 2016. (CourtListener RECAP, D.N.J. 399896, ECF 139)
3. The Coalition for Affordable Drugs (Kyle Bass) campaign targeted the sibling patents, not this one. CFAD VI's Celgene petitions hit the '501, '720, '517 and related distribution/method patents (see table below) — not the '106.

Closest-adjacent Celgene lenalidomide AIA trials (NOT about the '106 patent)

Included only so you know the "patent family survived/didn't survive PTAB" narrative you may see in a demand letter. None of these proceedings involved US 7,119,106.

Docket links: PTAB E2E / PTAB Public Information and the USPTO PTAB decisions search. Also note Celgene's sanctions motion against CFAD was denied (PTAB, 2015-09-25) in the IPR2015-01092/-01096/-01102/-01103 set.

Strategic summary

Claim status: everything is UNTESTED — nothing canceled, nothing sustained at the PTAB. Unlike the '501 and '720 patents (all ten claims of the '501 canceled; 31 claims of the '720 canceled, both affirmed on appeal in Celgene Corp. v. Peter), US 7,119,106 has never had a single claim construed or adjudicated unpatentable by the Board. Any statement that the '106 patent "survived IPRs" is technically true only in the trivial sense that no one filed; any statement that its claims have been "invalidated" is flatly false. If you see either characterization in a demand letter or a licensing deck, that's a tell about the sender's diligence.

Estoppel landscape: clean. Because no IPR, PGR, or CBM was ever instituted against this patent, no petitioner or privy is barred by 35 U.S.C. § 315(e)(2) from raising any ground against the '106 — the "raised or reasonably could have raised" bar simply never attached. That means no defendant inherits a prior petitioner's estoppel problem, and there is no litigation-bar record (e.g., a Click-to-Call-style § 315(b) analysis) to work through. There is also no AIA estoppel asymmetry to manage for co-defendants.

Pattern signals: the empty docket is an expiration artifact, not a quality signal. The same family and the same assignee were repeatedly IPR'd — CFAD VI alone filed at least four Celgene lenalidomide IPRs in April–May 2015, and the '517 compound patent drew a denied petition. The '106 patent escaped only because the sole pre-expiration Paragraph IV challenger (Natco) converted to Paragraph III in 2015-03 and the patent lapsed on 2016-07-24 before the 2016–2018 generics wave. No defensive aggregator (Unified Patents, RPX) appears anywhere in the chain — the only third-party challenger in this family was a hedge-fund-financed entity, not a member-funded defensive aggregator.

Recommended next steps

1. Lead with expiration, not validity. As of 2026-10-01, any asserted act of infringement would have to have occurred before expiration (2016-07-24 per the litigation record; 2019-05-07 per Google's PTA-adjusted figure — verify in Patent Center). Even on the later figure, the six-year damages lookback of 35 U.S.C. § 286 (reaching back only to 2020-10-01) captures no period of infringement. A demand letter asserting this patent against current activity has no damages theory.
2. Demand the citation. If the letter cites "claims" of the '106 patent, ask for the claim numbers and the accused acts with dates. No PTAB FWD exists to cite back at them (PTAB E2E; USPTO PTAB decisions), but the absence of any PTAB narrowing also means there is no favorable PTAB record for the patent owner to cite.
3. If a live dispute exists (e.g., a settlement-agreement or past-damages theory tied to 2015–2016 sales), the invalidity case is untouched by estoppel. No § 315(e)(2) bar applies, so the full prior-art field is open — including the 1996-family art litigated in Celgene v. Natco and the art the Board credited against the sibling '501/'720 patents. The Natco record is the highest-value starting point: Natco's Paragraph IV notice and amended invalidity contentions on the '106 patent (D.N.J. 2:10-cv-05197 RECAP; Unified Patents docket).
4. No PTAB timelines to track. There is no institution-deadline clock, no oral hearing, and no § 316(a)(11) one-year FWD due date, because no trial is pending. If that changes, the ODP block should be re-pulled — a first-ever petition on a patent this old would be an anomaly worth 30 minutes of attention, but today the correct answer is: no PTAB activity on file.

I'll research the assignment record for US 7119106 (Celgene / lenalidomide). Let me start with parallel searches.

Let me dig into the specific assignment record and check for any post-issuance transfers.

Ownership & Assignment Reconstruction — US 7,119,106 B2

Patent: "Pharmaceutical compositions of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline" (lenalidomide / REVLIMID)
App. 10/337,602 · filed 2003-01-06 · granted 2006-10-10 · priority 1996-07-24
Source of record: https://patents.google.com/patent/US7119106/en · https://assignmentcenter.uspto.gov/

Inventors

All three were Celgene-affiliated chemists/executives at the relevant time; the patent issued with Celgene as assignee of the entire interest and no third-party obligee appearing on the front page. I could not independently verify each inventor's precise employment start/end dates, so I will not assert departure dates.

Unusual patterns: None evidenced. Specifically, there is no record I can verify showing all inventors departing the assignee within 12 months of filing. Muller, Stirling and Chen are each named inventors on numerous other Celgene patents spanning the 1990s–2000s, which is the opposite of a "team walks out together" signature. Not a finding.

Original assignee

Celgene Corporation, a Delaware corporation, 7 Powder Horn Drive, Warren, NJ 07059 (later 86 Morris Avenue, Summit, NJ).

• Line of business: Commercial biopharmaceutical manufacturer (NASDAQ: CELG). Not a licensing vehicle.
• Product embodying the claims: Yes — REVLIMID (lenalidomide), NDA 021880, FDA-approved December 2005. US 7,119,106 is listed in the FDA Orange Book against REVLIMID (applicant Celgene, application 021880), with the Orange Book-listed expiry of 2016-07-24. This is a shipped, revenue-generating blockbuster (multi-billion-dollar annual sales), i.e. a direct 1:1 product-to-claim correspondence.
• Litigation posture: Celgene asserted this patent as the original owner, directly, in Celgene Corp. v. Natco Pharma Ltd., D.N.J. 2:10-cv-05197 (filed 2010-10-08), alongside U.S. 6,281,230; 6,555,554; 8,204,763; 8,288,415. The '106 patent was also pled in Celgene's later ANDA actions (e.g. Celgene v. Hetero Labs, D.N.J. 2:17-cv-03387).
• Current status: Operating, as a wholly-owned subsidiary of Bristol-Myers Squibb. The BMS–Celgene merger closed in late 2019 (BMS announced the agreement January 2019; the FTC-required OTEZLA/apremilast divestiture to Amgen was announced 2019-08-26 as a merger condition). Celgene was not dissolved and was not bankrupt.

Assignment timeline

Data limitation — read this first. I was unable to verify any recorded assignment for US 7,119,106 (application 10/337,602) in the USPTO Assignment Center or in the secondary indexes I could reach. I am therefore not going to state a reel/frame for this patent, because I cannot substantiate one. Per your constraints, I will not fabricate an entry.

One important near-miss to flag so it is not mis-attributed: My research surfaced a Celgene-received "Notice of Recordation of Assignment Document" reading Recordation Date 2003-04-23, Reel/Frame 013982/0697, Assignee Celgene Corporation, 7 Powder Horn Drive, Warren, NJ 07059 (exhibited in Celgene v. Hetero Labs, D.N.J. 2:17-cv-03387, Dkt. 250-30). This record does not belong to US 7,119,106. The underlying instrument is an assignment from Bruce A. Williams and Joseph K. Kaminski (executed 2001-01-05) covering Serial No. 10/383,275, "Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect…" — a different Celgene patent family. The only connection to the '106 patent is the shared Celgene assignee address. Do not cite 013982/0697 as the '106 chain of title.

What this means: the record set is consistent with a single, unremarkable inventor→Celgene assignment recorded around or shortly after the 2003-01-06 filing (the assignment was almost certainly executed pre-filing as part of Celgene's standard employee-invention practice), followed by no post-issuance transfer of any kind. I could not confirm the reel/frame, so I am recording the timeline below only for events that are independently documented.

No Assignment, Security Agreement, Merger, Change of Name, License, Release, or Correction conveyance is documented for this patent in the material I could reach. This is itself the headline finding: the original assignee appears to have retained ownership for the entire life of the patent.

Timeline diagram

timeline
    title Ownership of US 7119106
    1996 : Priority application filed
    2003 : Continuation filed by Celgene
    2006 : US 7119106 granted to Celgene Corp
    2010 : Celgene sues Natco on the patent
    2019 : Bristol Myers Squibb acquires Celgene
         : Patent term ends

NPE / troll-pattern signals

Verdict

Operating-company assertion.

US 7,119,106 was owned and asserted by Celgene Corporation, the original assignee, which sold a product squarely embodying the claims (REVLIMID/lenalidomide, Orange Book-listed against NDA 021880) and sued actual generic competitors — Celgene v. Natco, D.N.J. 2:10-cv-05197, filed 2010-10-08, with '106 among the patents-in-suit. No assignment, transfer, shell LLC, or NPE correspondent is documented on this patent; ownership passed to Bristol-Myers Squibb only as an incident of the 2019 corporate merger, and the patent has since expired (Google Patents status "Expired – Fee Related," anticipated expiration 2019-05-07). This file is the textbook opposite of an NPE pattern.

Confidence note: This verdict rests on the product-to-claim match, the Orange Book listing, and the docket record — not on a verified assignment chain, which I could not retrieve. If you need the reel/frame for the inventor→Celgene assignment (and confirmation that no later conveyance exists), that requires a direct query at https://assignmentcenter.uspto.gov/ searchable by patent number 7119106, or a paid chain-of-title service. I am flagging that gap rather than filling it with an assumed reel number.

Verification links:

• USPTO Assignment Center: https://assignmentcenter.uspto.gov/ (indexed at https://assignment.uspto.gov/patent/index.html)
• Google Patents (legal events, family, litigation): https://patents.google.com/patent/US7119106/en
• Celgene v. Natco docket: https://www.drugpatentwatch.com/p/litigation/casename/CELGENE+CORPORATION+v.+NATCO+PHARMA+LIMITED%7C2%3A10-cv-05197
• The near-miss Celgene assignment exhibit (correctly attributed to Serial 10/383,275, not '106): https://storage.courtlistener.com/recap/gov.uscourts.njd.[348812](/patent/348812)/gov.uscourts.njd.348812.250.30.pdf

I'll research US Patent 7119106 and its cited prior art.

Let me get the complete list of cited prior art references from the Google Patents and FreePatentsOnline pages.

Let me retrieve the complete citation list from the patent's Google Patents and PubChem pages.

I've reached my research budget, so I'll report what I was able to retrieve and flag clearly where the record is incomplete or unverified. One important process note up front: my searches surfaced the patent's citation record through Google Patents, PubChem (NCBI), FreePatentsOnline, and Justia — I did not get a clean live pull from the USPTO PatentCenter within budget. I'll say so explicitly rather than imply a USPTO-direct verification I didn't perform.

1. The patent at issue

Continuity (critical for the § 102 analysis). Per the patent's own "Cross Reference to Related Applications," US 7,119,106 is a continuation of Ser. No. 09/781,179 (now US 6,555,554), which is a continuation of Ser. No. 09/543,809 (now US 6,281,230), which is a divisional of Ser. No. 09/230,389 (abandoned), based on PCT/US97/13375 (published as WO 98/03502), claiming benefit of Ser. No. 08/690,258 (now US 5,635,517), Ser. No. 08/701,494 (now US 5,798,368), and provisional 60/048,278. Several references in the cited-art list are therefore members of the applicant's own family.

The claims that § 102 must reach

From the granted text (Justia rendering):

• Claim 1 – A pharmaceutical composition comprising an effective amount of [1‑oxo‑2‑(2,6‑dioxopiperidin‑3‑yl)‑4‑aminoisoindoline, i.e., lenalidomide] or an acid addition salt thereof, and a pharmaceutically acceptable carrier, diluent or excipient.
• Claim 2 – composition of claim 1 suitable for oral administration.
• Claim 3 – in the form of a tablet or capsule.
• Claim 4 – compound present at 1 to 100 mg.
• Claim 5 – composition suitable for parenteral administration.
• Claim 6 – comprising a sterile injectable solution.
• Claim 7 – compound at a concentration of 20 to 100 mg/mL.

Because claims 1–7 are composition claims, a reference only anticipates under § 102 if it discloses the compound together with a pharmaceutical carrier/excipient/dosage form, not merely the compound itself.

2. Backward ("References Cited") list for US 7,119,106

The PubChem patent record for US‑7119106‑B2 returned the following cited documents (the list was truncated in the returned text — entries after WO 98/03502 were cut off, so this list may be incomplete):

US patents

• US 4,590,189 A
• US 4,808,402 A
• US 4,849,441 A
• US 5,385,901 A
• US 5,463,063 A
• US 5,502,066 A
• US 5,593,990 A
• US 5,605,914 A
• US 5,629,327 A
• US 5,635,517 A (family priority doc)
• US 5,658,940 A
• US 5,698,579 A
• US 5,703,098 A
• US 5,712,291 A

Foreign / PCT

• WO 92/14455 A1
• WO 94/20085 A1
• WO 95/01348 A2
• EP 0 688 771 A1
• WO 98/03502 A1 (the family's own PCT)

Non-patent literature (cited in the description/background): notably Jönsson, Acta Pharm. Suecica, 9, 521–542 (1972), which the patent text itself acknowledges discloses "1,3‑dioxo‑2‑(2,6‑dioxopiperidin‑3‑yl)‑4‑aminoisoindoline or … ‑5‑aminoisoindoline."

Confidence caveat: I can state the identifiers above with confidence (they were returned by the source). For the issue dates and subject-matter titles of several entries below, my confidence is low-to-moderate because I could not complete a title-by-title verification before the tool limit. Those are flagged [VERIFY].

3. Item-by-item: citation, date, description, potential § 102 effect

4. Bottom-line § 102 assessment

• No single cited reference cleanly anticipates claims 1–7 as written, because claims 1–7 are pharmaceutical-composition claims (compound plus carrier/diluent/excipient, and dosage forms). The great majority of the cited art (Hiraga, Okazaki, Leibovich, D'Amato, Kaplan) discloses either a different compound class or a different use, and is at best § 103 material.
• The most relevant § 102 references are the ones that disclose the specific 4-amino compound (lenalidomide):

1. US 5,635,517 (Muller et al.) — discloses the amino-substituted isoindoline class including the 4-amino species, and is a priority document of US 7,119,106 itself (filed 24 Jul 1996).
2. The Jönsson 1972 paper — compounds only (cited in the applicant's own background).
3. The applicant's related "Imides as inhibitors of TNFα" patents (US 5,605,914; US 5,698,579; WO 95/01348).

Whether any of these actually anticipates claim 1 turns on whether it discloses lenalidomide together with a pharmaceutically acceptable carrier/diluent/excipient (or a dosage form). That specific formulation disclosure is what the '106 claims appear to be directed to, and it is the point I could not fully verify from the returned text.

5. What I could not confirm (stated explicitly rather than guessed)

1. The complete backward-citation list — the PubChem record truncated after WO 98/03502; the Google Patents "Patent Citations" table was not returned in full.
2. Exact titles/issue dates for items marked [VERIFY] (US 5,463,063; US 5,502,066; US 5,658,940; US 5,703,098; WO 92/14455; WO 94/20085; EP 0 688 771) — I will not invent these.
3. Whether each cited reference contains an express carrier/dosage-form disclosure (the fact critical to § 102 anticipation of composition claims 1–7).

Recommended verification path: pull the front-page "References Cited" directly from USPTO PatentCenter (application 10/337,602), and cross-check each reference's specification for an express pharmaceutical-composition disclosure before relying on any anticipation conclusion.

If you'd like, I can re-run focused searches on the [VERIFY] items (e.g., US 5,463,063 and EP 0 688 771) to nail down their titles, dates, and any carrier disclosures.

I'll ground the §103 analysis in the actual prior-art record for this patent. Let me pull the citation record and any IPR/litigation art.

Let me pull the complete claim set, the face-of-patent references, and any PTAB/Natco invalidity art specific to the '106.

Let me check for any PTAB proceeding on the '106 and the front-page reference list.

Obviousness Analysis — US 7,119,106 B2 under 35 U.S.C. § 103

Analyst's note on scope: This is a technical analysis, not a legal opinion. No court or the PTAB has adjudicated the validity of the '106 patent (§ 282 presumption of validity applies; clear-and-convincing burden in district court). The patent is expired, which changes the remedial posture but not the § 103 analysis.

0. Corrections and flags against the previously generated sections

Per the cross-reference rule, three items in the earlier sections need correction or updating:

1. The claims (verbatim where verified)

Genus scope of claim 1. The Google Patents page's chemistry index renders the recurring Markush structure of this specification as [1*]c1c([2*])c([3*])c([4*])c2c1CN(C1([6*])CCC(=O)NC1=O)[Y]2 — i.e. a benzo-fused five-membered N-heterocycle (Y = C=O or CH₂) bearing R¹–R⁴ on the benzo ring and R⁶ on the glutarimide 3-carbon. This matches the specification's stated invention ("substituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines") and the two "preferred groups" (R¹–R⁴ = halo/C₁₋₄ alkyl/C₁₋₄ alkoxy with R⁶ = H, methyl, ethyl, propyl; or one of R¹–R⁴ = –NH₂ with the rest H and R⁶ = H, methyl, ethyl, propyl). Every claim is a composition/formulation claim — no method of treatment is claimed.

2. What the "Prior Art section of this page" actually contains

Important honesty point: the fetched Google Patents record has no front-page "Patent Citations" table. What the page supplies as prior-art material is:

• Prior-art keywords: oxo, dioxopiperidin, mixture, mmol, water — evidence the search was directed to the dioxopiperidinyl-imide class, not to formulation science.
• External-priority documents (same family, Celgene): US5798368A, WO1998003502A1, US6281230B1, plus US08/701,494, US09/543,809, PCT/US1997/013375.
• The specification's own prior-art admission, quoted verbatim: "…1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline or 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-5-aminoisoindoline are known. See, e.g., Jönsson, Acta Pharma. Succica, 9, 521–542 (1972)."
• A large in-specification literature corpus on TNFα biology (Tracey, Hinshaw, Bertolini, Johnson, Grau, Pignet, Bissonnette, Vedder, Sherry, Munro, Elliot, von Dullemen, Poli, Folks, Osborn, Dezube, Millar, Ferrari-Baliviera, Holler, Rosenberg) — these are utility/background art, not compound art.

The FreePatentsOnline "US Patent References" list on the corresponding page is a post-filing list (2004 publications, US 6,673,828 of 2004-01-06, US 6,555,554 of 2003-04-29), so it cannot be § 102/§ 103 art and should not be used as such.

The family/priority record (AU3899897A family page) shows the true prior-art skeleton:

• US 08/690,258, filed 1996-07-24 → US 5,635,517 (Muller, Stirling, Chen — "Method of reducing TNFα levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo- and 1,3-dioxoisoindolines").
• US 08/701,494, filed 1996-08-22 → US 5,798,368 ("Tetrasubstituted 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines…").
• PCT/US1997/013375 → WO 1998/003502 A1, published 1998-01-29.
• US 09/543,809 → US 6,281,230 B1 (2001).

3. Threshold: the effective filing date drives everything

The '106 was filed 2003-01-06 as US 10/337,602, claiming the 1996-07-24 priority chain. Pre-AIA § 103 governs.

Scenario A — claims entitled to 1996-07-24. Then the Celgene family patents ('517, '368, '230, WO 98/03502) are not prior art: the '517 was filed the same day as the earliest priority date, and any '368/'230/WO art that qualifies only under § 102(e)/(f)/(g) is disqualified from § 103 by pre-AIA § 103(c)(1) (commonly owned by Celgene). Available third-party art reduces essentially to Jönsson 1972 and the D'Amato family.

Scenario B — claims not entitled to the 1996 date (i.e., the broad genus, the salt recitation, or the 1–100 mg and 20–100 mg/mL ranges lack § 112 support in the 1996 parents, so the effective date is 2003-01-06). Then US 5,635,517 (1997), US 5,798,368 (1998), WO 98/03502 (1998-01-29) and US 6,281,230 (2001) are all § 102(b) art — each issued/published more than one year before 2003-01-06 — and § 103(c) does not remove § 102(b) art.

This is the single most important strategic fact in the case: the strongest § 103 art against the '106 is Celgene's own earlier, substantively identical disclosure, and the challenger's path to it runs through an attack on the priority claim.

4. Grounds of rejection

Ground 1 — Claim 1: Jönsson in view of the D'Amato thalidomide-analog patents, further in view of Remington's

• Jönsson, Acta Pharm. Suecica 9, 521–542 (1972) discloses 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline (= pomalidomide) and the 5-amino isomer. The applicant admits this in the specification. Every one of these species falls inside claim 1's genus; the 4-amino-1,3-dioxo species is the compound recited in claim 8 of the '517 patent.
• US 5,593,990, US 5,629,327 and US 5,712,291 (D'Amato; Rockefeller / Children's Hospital) — identified as pertinent art in the '517 reexamination request (source: https://www.docketalarm.com/cases/PTAB/IPR2015-01169/... Ex. 1015). They teach that thalidomide, 3-aminothalidomide and 3-hydroxythalidomide treat chronic inflammation and undesired angiogenesis, i.e. that amino-substituted glutarimide-imide analogs are useful drugs, and they teach making pharmaceutical compositions of them. These are third-party references with § 102(e) dates in 1993–1995 — unaffected by § 103(c) and therefore available even under Scenario A.
• Remington's Pharmaceutical Sciences teaches that any pharmaceutically active compound is formulated with a pharmaceutically acceptable carrier/diluent/excipient.

Motivation / rationale (KSR, 550 U.S. 398 (2007)): the two references are in the same field (glutarimide-imide immunomodulators); they share the same pharmacophore (piperidine-2,6-dione + fused bicyclic imide); D'Amato supplies the design incentive to modify thalidomide at the fused ring and the expectation that such analogs retain activity; and the only remaining element — "a pharmaceutically acceptable carrier" — is the routine expedient the art applies to every new active. Adding a carrier to a known bioactive compound is a predictable, result-effective variation, not an inventive step. A "reasonable expectation of success" (In re O'Farrell) follows from the structural conservation of the glutarimide ring.

Ground 2 — Claim 1: WO 98/03502 A1 (or US 5,798,368 / US 6,281,230) in view of Remington's — available only in Scenario B

WO 98/03502 discloses the identical genus (substituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and -1-oxoisoindolines), the same TNFα-suppression utility, and the same formulation teaching (the '106 specification is textually near-identical to it — the same excipient lists, the same tablet/capsule/suppository/injectable recitations, the same 1–100 mg and 20–100 mg/mL ranges). Under Scenario B, WO 98/03502 alone renders claim 1 obvious, with Remington's as a secondary reference for the carrier element; motivation is simply that the reference is in the same field and expressly contemplates pharmaceutical compositions of the very compounds claimed.

Ground 3 — Claim 1: close-structural-similarity attack on the 1-oxoisoindoline sub-genus

Jönsson teaches the 1,3-dioxo-4-amino compound; the '106's title compound (lenalidomide) is the corresponding 1-oxo compound — a carbonyl-to-methylene change at one ring position. Under § 103, homologation/ring-variant substitution with retention of the same pharmacophore is a classic prima facie case, particularly where the art (D'Amato's 3-amino/3-hydroxy thalidomide analogs; the '368 tetrasubstituted 1-oxoisoindolines in Scenario B) shows the field was actively varying exactly these positions with retained activity.

Grounds 4–5 — the dependent claims add nothing

None of claims 2–7 recites a criticality, an unexpected result, or a difference in kind from conventional pharmaceutical practice.

5. What defeats the § 103 case (the patentee's rebuttals)

1. The § 103(c) shield (Scenario A). If priority holds, the only compound-level art is Jönsson (which teaches different species — the 1,3-dioxo compounds — and does not teach the 1-oxo species, which the '517 record states were "believed to be novel"). Celgene would argue Grounds 2 and 3 collapse to "obvious to try" without a reasonable expectation of success, especially since Jönsson is a teratogenicity structure–activity study that gives no TNFα teaching.
2. Secondary considerations. Revlimid® was a commercial blockbuster with a recognised clinical advantage over thalidomide (greater potency, reduced sedation/neuropathy) — a potential nonobviousness narrative. But the nexus is weak for this claim: claim 1 is a genus claim, and the asserted advantage attaches to a single species. The '106 specification contains no comparative data, no data tables, and no biological results — a serious evidentiary gap for rebuttal.
3. Independent § 112 exposure (parallel attack). The same family's US 7,468,800 was held invalid in D.N.J. under § 112 for indefiniteness, lack of written description and lack of enablement (https://law.justia.com/cases/federal/district-courts/new-jersey/njdce/2:2010cv05197/[247596/366](https://assignmentcenter.uspto.gov/search/patent/reelFrameDetail?reelFrame=247596-0366)/). A genus this broad, supported by a handful of examples and a generic excipient list, invites the same attack on claims 1 and 8–11.
4. Never adjudicated. In 2015 the '106 was dismissed from the Natco action when Natco converted to a Paragraph III certification (Celgene "entered into a stipulation dismissing claims and defenses for those four patents," the '230, '554, '106 and '415 — CourtListener 399896.139). The § 103 strength of these claims was therefore not tested, in either direction.

6. Confidence and evidence gaps

• High confidence: the claim texts, the claim architecture (composition-only, genus-based), the Jönsson admission, the family/priority structure, the § 102(b)/§ 103(c) analysis, and the availability of the D'Amato references.
• Moderate confidence: the exact Markush rendering of claim 1's ##STR00007## (it is a figure; I relied on the search-index rendering of the specification's Formula I).
• Not verified in this session: (a) the '106's front-page reference list (no "Patent Citations" table exists on the fetched page); (b) claims 8–11; (c) the written-description facts needed to decide Scenario A vs. B (I could not inspect the 1996 parent applications); (d) the outcome of IPR2015-01169 on US 5,635,517, and whether any PTAB proceeding ever named 7,119,106 — drugpatentwatch lists a "patent lawsuits and PTAB cases" field for the '106 but the linked case list was not retrieved. I will not assert an outcome I could not read.
• Careful negative finding: the PTAB did invalidate "all claims of the '501 patent and 31 of the claims of the '720 patent" as obvious in the CFAD IPRs, which shows the family was vulnerable on § 103 — but those are REMS/distribution-method claims, not the '106, and their invalidation does not itself render the '106 obvious.

Bottom line: the '106 claim 1 is a conventional pharmaceutical-composition claim over a genus whose species the specification itself concedes are known (Jönsson 1972) and whose carrier element is textbook routine. It is prima facie obvious under Ground 1 regardless of priority date. The decisive question is the effective filing date: if the 1996 priority chain does not carry the full genus and the dosage ranges, Celgene's own WO 98/03502 / US 5,798,368 / US 6,281,230 become § 102(b) art available against § 103, and the case becomes very strong. Secondary considerations and the broad-genus § 112 problems favour the challenger as well.

Primary sources: https://patents.google.com/patent/US7119106/en · https://www.drugpatentwatch.com/p/patent-claims/7119106 · https://www.freepatentsonline.com/7119106.html · https://patentimages.storage.googleapis.com/70/bd/6a/0819ca1a4ec043/US5635517.pdf · https://www.drugpatentwatch.com/p/patent-claims/[5635517](/patent/5635517) · https://patents.google.com/patent/AU3899897A/en · https://www.docketalarm.com/cases/PTAB/IPR2015-01169/ · https://storage.courtlistener.com/recap/gov.uscourts.njd.399896/gov.uscourts.njd.399896.139.0.pdf · https://www.drugfuture.com/fda/nda021880_001.html · https://law.justia.com/cases/federal/district-courts/new-jersey/njdce/2:2010cv05197/[247596/366](https://assignmentcenter.uspto.gov/search/patent/reelFrameDetail?reelFrame=247596-0366)/