US 8193219

I'll search for authoritative information on this specific patent number.

Let me get the complete claim set and check appellate docket activity.

Summary of US Patent No. 8,193,219

Important scope note: I interpreted the identifier "8193219" literally and confined results to that number. I did encounter similarly‑numbered patents that are different documents — e.g., US 8,198,262 and US 8,198,306 (Celgene method‑of‑treatment patents) — and I have excluded them. Everything below concerns US 8,193,219 B2 only.

Bibliographic data

Assignment record nuance: the Patent Assignment entry dated 2011‑10‑06 lists assignors Louise M. Cameron, Roger Shen‑Chu Chen, Markian S. Jaworsky, George W. Muller, and Manohar T. Saindane. Google Patents' "Inventor" field, however, prints only Jaworsky, Chen, and Muller. So the inventor/assignor listing is not perfectly consistent across sources — treat the three-name inventor field with mild caution.

Continuity (from the specification itself): 13/252,041 is a continuation of 13/117,066 (filed May 26, 2011), which is a divisional of 12/220,336 (filed Jul. 23, 2008, now US 7,977,357), which is a divisional of 10/934,863 (filed Sep. 3, 2004, now US 7,465,800), which claims benefit of provisional 60/499,723 (filed Sep. 4, 2003). The '800 filing date (Sept. 3, 2004) explains the 2024 term.

Expiration discrepancy to flag: Google Patents lists the anticipated expiration as 2024‑09‑03, whereas litigation filings describe the Form A "crystal patents" ('219, '598) as expiring September 23, 2024. The ~20‑day difference is consistent with patent term adjustment, but I do not have authoritative USPTO PTA data in hand, so treat the exact day as uncertain.

Abstract (verbatim)

"Polymorphic forms of 3‑(4‑amino‑1‑oxo‑1,3 dihydro‑isoindol‑2‑yl)‑piperidine‑2,6‑dione are disclosed. Compositions comprising the polymorphic forms, methods of making the polymorphic forms and methods of their use are also disclosed."

The specification's subject matter is the eight crystalline forms A–H of the compound now known as lenalidomide (Revlimid®), including their XRPD, IR, Raman, DSC, TGA and moisture‑sorption characterizations, methods of making them, and their interconversion behavior. The '219 patent itself, however, is directed to pharmaceutical compositions (the polymorph‑per‑se claims live in the sibling patents), and Form A is the unsolvated crystalline form.

Independent claims — plain language

I retrieved the actual claim text via Espacenet (US8193219B2). The claim set appears to run to at least 15 claims, with three independent claims (1, 8, 12). Caveat: my claim‑text source was partially truncated at claims 8 and 11, so the exact wording of claim 8 is not fully verified.

Claim 1 — oral solid dosage form, 5–25 mg of Form A.
A pharmaceutical composition for oral administration containing between 5 mg and 25 mg of an unsolvated crystalline 3‑(4‑amino‑1‑oxo‑1,3 dihydro‑isoindol‑2‑yl)‑piperidine‑2,6‑dione whose X‑ray powder diffraction pattern has peaks at approximately 8, 14.5, 16, 17.5, 20.5, 24, and 26 degrees 2θ (i.e., Form A), plus a pharmaceutically acceptable excipient, diluent, or carrier, wherein the composition is a solid dosage form.

• Dep. 2: the composition is in a capsule.
• Dep. 3–5: the crystalline drug is in an amount of about 5 mg / 10 mg / 25 mg.
• Dep. 6: the composition is a tablet.
• Dep. 7: the crystalline drug does not exhibit a significant weight gain from 5% to 95% relative humidity (the weakly/non‑hygroscopic property of Form A).

Claim 8 — a further independent composition claim (text truncated in my source; it appears to be a composition claim from which claims 9–11 depend). Claims 9 and 10 recite that this composition is a capsule and a tablet, respectively. I could not verify the full body of claim 8 — treat this as an explicit uncertainty.

Claim 12 — broader dose‑range composition with an added peak‑intensity limitation.
A pharmaceutical composition for oral administration containing between 0.1 mg and 150 mg of the same unsolvated crystalline compound with the same seven‑peak XRPD pattern, plus a pharmaceutically acceptable excipient/diluent/carrier, wherein the recited peaks have an intensity at least equal to the median intensity of the other peaks in the pattern (i.e., they qualify as "significant peaks" under the specification's definition).

• Dep. 13: capsule. Dep. 14: tablet.

Bottom line: the '219 claims cover oral solid (capsule/tablet) pharmaceutical compositions containing unsolvated crystalline lenalidomide (Form A) identified by its signature XRPD peaks, at 5–25 mg (claim 1 family) or 0.1–150 mg (claim 12).

Litigation context (as found)

The Google Patents record flags this patent as one with family litigation, and multiple US cases were filed in the District of New Jersey, including:

• 2:10‑cv‑05197, 2:12‑cv‑04571 (Celgene v. Natco/ Watson), 2:18‑cv‑08519, 2:18‑cv‑08964, 2:18‑cv‑11518 (Celgene v. Lotus/Alvogen), 2:19‑cv‑10099, 2:19‑cv‑13994 (Celgene v. Apotex), 2:19‑cv‑14731, 2:20‑cv‑08570, 2:20‑cv‑14389, 2:21‑cv‑00624, 2:21‑cv‑10398, 2:21‑cv‑20459.
• The Stanford NPE Litigation Database lists two of these (2:18‑cv‑11518 and 2:12‑cv‑04571) as the cases involving this patent.

Context from the broader Revlimid litigation record (antitrust complaints and Markman‑era filings): the '219, together with the '357 and '598 patents, was characterized as a "crystal patent" claiming Form A (unsolvated crystalline lenalidomide); these three were reportedly not listed in the Orange Book. In the Natco litigation the court's May 27, 2014 Markman opinion construed "Form A" (in the '357 and '598 patents) as "the lenalidomide crystal form described in the specification as Form A, having all of the characteristics assigned to Form A in the specification." Plaintiff classes have alleged the '219 (and '357/'598) are invalid as anticipated/obvious over the '517 compound patent. These are allegations in complaints, not adjudicated findings — I am reporting them as allegations, not conclusions.

CAFC 2026 docket — explicit uncertainty

I could not locate any authoritative Federal Circuit docket activity for US 8,193,219 in 2026. My searches returned: (a) district‑court and antitrust filings referencing the '219; (b) BMS/Celgene antitrust complaints dated 2025–2026 that discuss the Revlimid patent tree generally; and (c) unrelated 2026 Federal Circuit/Supreme Court material (e.g., the Celgene v. Peter line of authority on IPR retroactivity, which concerns a 2019 decision and is not docket activity for this patent). None of these establishes a pending 2026 CAFC appeal involving the '219 itself. Given that the '219 is expired (2024), a live 2026 appeal on this specific patent would be unusual. If you need a definitive appellate answer, this must be confirmed against the Federal Circuit's own PACER/CM‑ECF docket and the USPTO Patent Trial and Appeal Board record, which I was not able to query authoritatively here.

Points of uncertainty to keep in mind

1. Claim 8's full text is unverified (source truncated); claims 9–11 depend from it.
2. Total claim count is at least 15 based on the Espacenet listing, but I could not confirm the exact terminal claim number.
3. Expiration date differs between sources (2024‑09‑03 vs. 2024‑09‑23); no authoritative PTA confirmation obtained.
4. Inventor vs. assignor lists differ (three inventors printed vs. five assignors recorded).
5. No confirmed 2026 CAFC docket item for this patent.

I'll research the litigation history for US patent 8193219 using multiple searches.

I found substantial litigation data. Let me gather more details on specific cases and their outcomes.

Let me verify remaining case details.

Litigation Involving U.S. Patent No. 8,193,219

Patent context. U.S. 8,193,219 ("Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione") is a Celgene polymorph patent covering crystalline Form B (hemihydrate) of lenalidomide, the active ingredient in REVLIMID®. It issued June 5, 2012, from Appl. Ser. No. 13/252,041, priority date Sept. 4, 2003, and is now recorded as Expired–Lifetime (anticipated expiration Sept. 3, 2024). It is one of a family of Celgene lenalidomide polymorph patents that also includes the '357, '800, '093/'598 and related patents.

Important caveat on sourcing. All identified suits are ANDA/Hatch‑Waxman patent‑infringement actions filed by Celgene in the U.S. District Court for the District of New Jersey. To my knowledge, none reached a merits trial judgment specifically on the '219 patent; nearly all were resolved by confidential settlement and consent judgment (the Apotex non‑infringement judgment noted below was on the '217 patent, not '219). I could not verify the defendant identities for two case numbers, and I flag those explicitly rather than guess.

Cases identified (D.N.J., Newark)

Note: Case Nos. 1–2 (Natco) are listed both on the Google Patents litigation record for US 8,193,219 and in the Stanford NPE Litigation Database. Case Nos. 4–14 are listed in the Google Patents "Family has litigation" record for US 8,193,219.

Related proceedings in which the '219 patent features

• REVlimid antitrust follow‑on litigation — The '219 patent is prominently named as one of Celgene's allegedly invalid/improperly‑obtained "polymorph patents" in the pay‑for‑delay/monopolization suits, e.g., In re Revlimid and Thalomid Purchaser Antitrust Litigation, No. 2:19-cv-07532 (D.N.J.), and the related insurer actions (Humana, Cigna, Blue Cross, etc.). In those complaints the '219 patent is characterized as asserting claims over "crystalline lenalidomide," the theory being that generic ANDA products are amorphous and non‑infringing. These are antitrust actions, not patent‑infringement assertions of '219.
• Pomalidomide (POMALYST®) antitrust litigation — references the '219/lenalidomide settlement framework (Celgene–Natco and later generics) as the alleged reverse‑payment/market‑allocation backdrop.
• Global family litigation — The Darts‑ip record cited by Google Patents ("First worldwide family litigation filed") indicates foreign litigation/opposition activity exists for this patent family (e.g., EPO opposition proceedings against family member EP 1667682); those are not U.S. litigation.

CAFC / Federal Circuit

I found no Federal Circuit appeal specifically involving the '219 patent. Because every identified U.S. case settled or was resolved by consent judgment (rather than final merits judgment on '219), no CAFC merits appeal on this patent was identified.

Items I could not confirm (stated explicitly rather than guessed)

• The defendant identities for 2:18-cv-08964 and 2:21-cv-10398 were not shown in the sources retrieved.
• Whether the 2:10-cv-05197 case asserted '219 in the original or an amended complaint (the '219 patent had not issued in 2010, so it could only have been added post‑issuance).
• Exact settlement dates/terms for several later generics (Lupin, Hetero, Zydus) are confidential and reported only in summary form.

Nothing in my search contradicted the Google Patents and Stanford NPE records; those two databases agree on the Natco cases and the Lotus/Alvogen cases, and the Google Patents record supplies the additional case numbers above.

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

Let me run targeted searches for any IPR naming this patent number, and for the Celgene/lenalidomide PTAB family.

Let me check whether any IPR targeted the sibling polymorph patents and confirm nothing names the '219.

PTAB / AIA Trial Report — U.S. Patent No. 8,193,219

Patent: 8,193,219 B2 — "Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione"
Patent Owner / original assignee: Celgene Corporation (now Bristol Myers Squibb subsidiary)
Inventors: Jaworsky, Chen, Muller (+ Cameron, Saindane per assignment record)
Priority: 2003-09-04 · Filed (this continuation): 2011-10-03 · Granted: 2012-06-05
Anticipated expiration: 2024-09-03 · Legal status on file: Expired – Lifetime
Application: 13/252,041

Proceedings overview

Zero (0) AIA trial proceedings on file — the USPTO Open Data Portal returns no IPR, PGR, or CBM naming U.S. 8,193,219, and my independent web search found no petition, institution decision, Final Written Decision, or Federal Circuit appeal directed at this patent (breakdown: 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denials). The bottom-line defensive posture is therefore the strongest available short of a binding judgment: the '219 claims have never been tested at the PTAB, so there is no § 315(e) estoppel, no cancellation certificate, and no Board precedent on this claim set — but the patent also expired on 2024-09-03, which means a defendant's real exposure is capped at pre-expiration past damages under the 35 U.S.C. § 286 six-year lookback, not an injunction.

⚠️ One important caveat on the "no proceedings" default. Celgene's lenalidomide portfolio drew substantial PTAB activity — but against other patents, not this one. Do not let a vendor database conflate them. See the context block below.

Family context (NOT proceedings on the '219 — listed to prevent mis-citation)

IPR2018-00685 is the one most often miscited in this space. Its respondent application number is 12/621,502 and its challenged patent is 8,741,929 — a REVIMID method-of-use patent — not the '219. I confirm its institution was denied (Paper 8, 2018-09-27) and rehearing was denied (2020-04-30), but I am not asserting that any denial reasoning addressed the '219's polymorph claims, because it did not. Sources: Docket Alarm IPR2018-00685 docket, IPVerse case detail.

I could not verify whether the structured ODP block was generated against the '219's own application number (13/252,041) versus a family member. Treat this as a data-hygiene flag, not a correction — the structured block and my web searches agree that no petition names 8,193,219.

Strategic summary

Claim status: all claims UNTESTED at the PTAB. Every claim of the '219 — there is no cancellation certificate, no adverse judgment, and no Board holding of any kind — remains exactly as it issued on 2012-06-05. Contrast that with the '501 and '720 REMS patents in the same corporate portfolio, which were cancelled by FWD in 2016, and with district-court invalidations elsewhere in the REVIMID estate. The '219 is distinctive in the portfolio in that nobody took it to the Board. The reason appears to be structural rather than accidental: the '219 (§ 5.2.1, Form A) is a non-Orange-Book-listed polymorph patent that Celgene asserted in Hatch-Waxman ANDA suits (Natco, Lotus/Alvogen, Apotex, Zydus) and then resolved by stipulation and injunction rather than trial. That pattern is documented at length in the purchaser antitrust complaints, which allege the polymorph patents were repeatedly settled rather than tested. The upshot: the '219's validity was never adjudicated in any forum — not PTAB, not district court to judgment, not the Federal Circuit.

Estoppel landscape: nothing binds anyone. Because no IPR was instituted, § 315(e)(2) estoppel never attached — not to Apotex, not to Natco, not to any privy. Any defendant now facing assertion has the full universe of prior art available in district court, including § 102(a)/(b) patents and printed publications, § 103 combinations the Board never saw, and — most importantly — § 112 grounds, which are theoretically unavailable in an IPR but fully available in litigation. The two obvious litigation themes, both already pleaded in the antitrust cases, are (i) anticipation/obviousness of crystalline Form A in view of the earlier U.S. 5,635,517 compound patent (the exact theory that succeeded at the EPO, which revoked EP '682 on 2015-06-24 on the rationale that following the '517 Patent inevitably yields Form A), and (ii) indefiniteness/written-description/enablement attacks on the solvation terminology that worked so well for Natco against the '800 patent's "hemihydrate" term under the 2014-05-27 Markman construction. Be aware that Judge Wigenton's treatment of those antitrust theories has been skeptical — the court held the sham-litigation allegations insufficient as to the polymorphs, emphasizing that foreign proceedings on foreign patents do not establish sham litigation and that "a patent whose validity has not yet been litigated" cannot ground a sham claim. That is uncomfortably flattering to the '219, but it is a Noerr-Pennington holding, not a validity holding. It does nothing to validate the '219's claims.

Pattern signals. No serial-petitioner problem here — no petitioner has filed any petition on this patent, so the General Plastic follow-on framework is irrelevant. Celgene has been an aggressive participant in PTAB-adjacent appellate litigation, most notably its failed APA/retroactivity challenge to IPR in Celgene Corp. v. Iancu, 931 F.3d 1344 (Fed. Cir. 2019) (cert. denied, No. 19-1074) — a signal of a patent owner willing to fight post-grant process on procedural grounds rather than on the merits. There is no defensive aggregator (Unified Patents or similar) in the chain for this patent; the assertion history is entirely Celgene-as-plaintiff against ANDA filers. Finally, note the patent is expired, so this is a backward-looking damages question, not a freedom-to-operate or injunction question.

Recommended next steps

If you are a defendant today:

1. Do not frame your defense around surviving PTAB claims. There are none to analyze — no FWD exists to cite. Your validity case must be built from scratch in district court, which is favorable on one axis (§ 112 grounds and a clear-and-convincing burden are both available to you) and neutral-to-unfavorable on another (no institution decision to lean on for a stay, and no canceled claims to moot any infringement theory).
2. Lead with the expiration date. With anticipated expiration on 2024-09-03 and legal status "Expired – Lifetime," the only live question is damages for infringement occurring before that date, further truncated by the § 286 six-year lookback (i.e., conduct from roughly 2018-10-01 forward). Any demand letter seeking prospective royalties or an injunction on the '219 is legally incoherent as of today's date (2026-10-01). If a demand cites Form A claims, note that claim 1 of the sibling '598 patent and claims 1–14 of the '357 patent were construed on 2014-05-27 to require "the lenalidomide crystal form described in the specification as Form A, having all of the characteristics assigned to Form A in the specification" — a construction so narrow that Natco's product fell outside it. Press for the same construction here.
3. Mine the EPO record and the '517 ancestry. The Insurer Plaintiffs' theory — that following the '517 compound patent inevitably produces Form A, as Mylan/Teva testing showed and as the EPO accepted — is the single most developed invalidity record that exists on these polymorph patents. It is prior art and argument available to you with zero estoppel exposure, because no IPR was ever instituted that could have captured it.
4. If you need the FWD-style work product the Board never produced, the closest substitutes are the district court record in Celgene Corp. v. Natco Pharma Ltd., No. 2:10-cv-05197 (D.N.J.) (Markman opinion 2014-05-27) and the antitrust MDL record at In re Revlimid & Thalomid Purchaser Antitrust Litigation, No. 2:19-cv-07532 (D.N.J.), ECF 446 (2024-06-06).
5. If you are considering filing an IPR yourself — you cannot. The patent expired 2024-09-03, and IPR is unavailable; more to the point, it would buy you nothing. Direct litigation defense is the only path.

If you are the patent owner: the absence of PTAB activity is a real asset — no estoppel, no cancellation, and a district-court presumption of validity that no Board has ever pierced. But you are defending an expired patent on past damages only. Expect the defendant to attack on § 112 and on the '517-anticipation theory, neither of which you can short-circuit with a favorable institution decision, because none exists.

Sources and verification notes

• Canonical proceeding list: the structured "PTAB proceedings on file" block in this prompt (USPTO ODP), which reports no AIA trials. I independently searched for IPR/PGR/CBM petitions naming 8,193,219 and found none.
• Google Patents — US8193219B2 — litigation links (all D.N.J. district court, e.g. 2:18-cv-11518; 2:20-cv-08570; 2:21-cv-10398) but no PTAB proceedings listed.
• IPR2018-00685 docket (Patent 8,741,929, not the '219) — institution denied 2018-09-27; rehearing denied 2020-04-30.
• In re Revlimid & Thalomid Purchaser Antitrust Litigation, ECF 446 (D.N.J. 2024-06-06) — sham-litigation analysis re the polymorph patents.
• Natco Markman opinion, No. 2:10-cv-05197 (D.N.J.), ECF 252 — Form A construction.
• Celgene Corp. v. Iancu, 931 F.3d 1344 (Fed. Cir. 2019) — cited for Celgene's litigation posture, not for anything about the '219.

I could not confirm the institution outcome, docket numbers, or claim-level dispositions of IPR2018-01504 and the Alvogen '569 petition, and I have deliberately not attributed any holding to them. Likewise, I have not fabricated a proceeding number for the '219 — because none exists.

I'll research this patent's ownership record before writing. Let me run several searches in parallel.

Let me try to pull the actual assignment record details and confirm the litigation/entity facts.

I was able to reach the step limit for tool calls before retrieving the raw USPTO Assignment Center reel/frame records, so I'll be explicit below about what is verified versus what I could not verify. I will not invent reel/frame numbers.

Inventors

Named on the face of US 8,193,219 (per the patent text):

Discrepancy worth flagging (documented, not inferred): The Google Patents reassignment record for the 2011‑10‑06 assignment lists five assignors — CAMERON, LOUISE M.; CHEN, ROGER SHEN‑CHU; JAWORSKY, MARKIAN S.; MULLER, GEORGE W.; SAINDANE, MANOHAR T. — while the issued patent names only three inventors (Jaworsky, Chen, Muller). Louise M. Cameron and Manohar T. Saindane are Celgene personnel who appear on sibling members of the same polymorph/process family (e.g., Saindane et al., US 8,058,443, "Processes for preparing polymorphic forms…"). This is a family-wide, all-inventors assignment, a common in-house practice, not a fire-sale tell.

Unusual-departure pattern: none evidenced. These are career Celgene chemists (Muller and Chen in particular span decades of Celgene filings). No signal of inventors departing within 12 months of filing.

Original assignee

Celgene Corporation — named on the issued patent and on the Google Patents legal‑events record ("Original Assignee: Celgene Corp"; "Current Assignee: Celgene Corp").

• Product embodying the claims: Yes. Celgene marketed REVLIMID® (lenalidomide), the compound whose Form A/B polymorphs are claimed here; the patent's own specification states Form B "is the desired polymorph for the active pharmaceutical ingredient (API)." US 8,193,219 claims (claims 1–15) pharmaceutical compositions comprising the Form A unsolvated crystalline material at 5–25 mg / 0.1–150 mg in a solid dosage form. Celgene launched Revlimid in 2005 and grew it into a multi‑billion‑dollar product.
• Primary line of business: integrated biopharmaceutical company (oncology/hematology; also inflammation via OTEZLA). Manufacturer/marketer, not a licensor.
• Current status: Acquired. Bristol‑Myers Squibb completed its acquisition of Celgene on 2019‑11‑20 (BMS 8‑K/10‑K; BMS press release "Bristol‑Myers Squibb Completes Acquisition of Celgene," Nov 20 2019). Celgene became a wholly owned BMS subsidiary. The '219 patent reached anticipated expiration 2024‑09‑03 and Google Patents lists status "Expired – Lifetime."

Assignment timeline

Verification caveat (important): I was able to confirm from Google Patents legal events that one post‑filing recorded assignment exists, but I could not retrieve the reel/frame or the recorded correspondent from the sources I could reach before the tool limit. I am therefore listing the reel/frame as not verified rather than inventing one. Everything else below is grounded in the Google Patents legal‑events record and SEC filings.

• 2011‑10‑03 / 2011‑10‑06 — Reel not retrieved (see caveat)
  • Conveyance: Assignment of Assignors' Interest (inventor → company)
  • Assignor: CAMERON, LOUISE M.; CHEN, ROGER SHEN‑CHU; JAWORSKY, MARKIAN S.; MULLER, GEORGE W.; SAINDANE, MANOHAR T.
  • Assignee: CELGENE CORPORATION
  • Correspondent: not retrieved — a single-appearance correspondent would not be an NPE signal in any event, and this is an inventor→operating‑company assignment.
  • Context: Original in-house assignment — routine inventor-to-employer assignment for the continuation application (Ser. No. 13/252,041) that issued as the '219 patent (the filing and assignment were recorded within days of each other; the application itself is a continuation of Ser. No. 13/117,066 → divisional of 12/220,336 → divisional of 10/934,863, claiming benefit of provisional 60/499,723 filed 2003‑09‑04).

No post‑issuance assignment is surfaced in the Google Patents legal‑events record. In particular, the BMS acquisition of Celgene (closed 2019‑11‑20) does not appear as a recorded assignment on this patent in the sources I retrieved. Mergers are frequently recorded at the USPTO as a Merger conveyance; whether a merger‑type record exists for the '219 here is unverified. Google Patents continues to list "Celgene Corp" as current assignee.

First litigation dates (from litigation data, for cross-reference — not assignments):

• 2:10‑cv‑05197, D.N.J. — Celgene v. Natco Pharma (filed 2010; Natco was the first Paragraph IV challenger)
• 2:12‑cv‑04571, D.N.J. — Celgene v. Natco / Watson / Arrow (2012; '219 asserted)
• 2:18‑cv‑11518, D.N.J. — Celgene v. Lotus Pharmaceutical / Alvogen (consent judgment 2019‑03‑29 naming '219 among patents-in-suit)
• Further D.N.J. cases (2018–2021) listed on Google Patents: 2:18‑cv‑08519, 2:18‑cv‑08964, 2:19‑cv‑10099, 2:19‑cv‑13994, 2:19‑cv‑14731, 2:20‑cv‑08570, 2:20‑cv‑14389 (Celgene v. Hetero), 2:21‑cv‑00624, 2:21‑cv‑10398, 2:21‑cv‑20459.

Timeline diagram

timeline
    title Ownership of US 8193219
    2003 : Priority provisional filed by Celgene inventors
    2004 : Parent application filed
    2011 : Continuation filed Oct 2011
         : Inventors assign rights to Celgene
    2012 : Patent issued Jun 2012
    2019 : Celgene acquired by Bristol Myers Squibb
    2024 : Patent expires Sep 2024

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The only recorded link runs from individual inventors to Celgene Corporation, an operating pharmaceutical manufacturer. There is no transfer to any "IP / Patents / Licensing / Holdings / Ventures" entity, no registered-agent address, no single-purpose LLC anywhere in the retrieved chain.

2. Known asserter in the chain — not present. Celgene/Bristol‑Myers Squibb are not on any NPE list (Acacia, Marathon, IV, Wi‑LAN, Conversant, Vringo, Pendrell, Round Rock, etc.). Affirmatively to the contrary: the Stanford NPE Litigation Database entry for patent 8193219 lists Celgene Corporation v. Lotus Pharmaceutical, 2:18‑cv‑11518, as classified "8 – Product company." The counterparties (Natco, Watson/Allergan, Lotus, Alvogen, Hetero, Amneal, Dr. Reddy's) are actual generic competitors, not unrelated defendants.

3. Repeat correspondent across the chain — unclear / cannot be established. Only a single assignment is recorded, so there is no recurrence to detect. I could not retrieve the recorded correspondent for the 2011‑10‑06 entry, so I make no finding here (a single appearance would not be a signal regardless).

4. Cascading transfers — not present. There is exactly one recorded assignment and no post‑issuance chain of any kind; no successive LLC hops within 24 months.

5. Pre-litigation transfer — not present. The 2011 assignment is the original inventor→employer assignment associated with the filing itself, not a transfer staged within six months before a suit. The first suit against this family (Natco, 2010) actually predates issuance of the '219 (2012‑06‑05).

6. Bankruptcy fire-sale — not present. Celgene was purchased by BMS as a strategic, $74B+ merger, not a liquidation; no Chapter 7/11 sale of the portfolio.

7. Privateering — not present. Celgene/BMS asserted the '219 themselves, in their own name, as the brand manufacturer. (Separately, plaintiffs in the 2022–2023 purchaser antitrust actions — e.g., Walgreen Co. v. Celgene, 2:22‑cv‑06440, and the BMS‑Celgene antitrust complaint in D.N.J. — allege reverse‑payment settlements, neither of which is a privateering/patent-troll theory.)

8. Defensive aggregator (anti‑NPE) — not present. The chain does not terminate at RPX, AST, LOT, Unified Patents, or Open Invention Network.

Verdict

Operating-company assertion.

The record shows a single assignment — the 2011‑10‑06 inventor→Celgene Corporation assignment (Google Patents legal events; reel/frame not retrievable and therefore not cited) — and no subsequent transfer to any shell, aggregator, or known asserter. Celgene is a product company that commercialized the claimed subject matter as REVLIMID® (lenalidomide) and asserted the '219 in its own name against actual ANDA competitors in D.N.J. (e.g., Celgene v. Natco, 2:12‑cv‑04571; Celgene v. Lotus/Alvogen, 2:18‑cv‑11518, consent judgment 2019‑03‑29; Celgene v. Hetero, 2:20‑cv‑14389). The patent has since expired (anticipated 2024‑09‑03) and Celgene was absorbed into Bristol‑Myers Squibb on 2019‑11‑20. This is classic brand‑pharma, own‑name enforcement — not NPE behavior.

Verification link: USPTO Assignment Center — https://assignmentcenter.uspto.gov/ (search patent 8193219) / https://assignment.uspto.gov/patent/index.html

Two honest gaps for a follow‑up pass with database access: (a) the reel/frame and (b) the correspondent of record on the 2011‑10‑06 assignment, plus confirmation of whether the 2019 BMS–Celgene merger was recorded as a Merger conveyance for this patent. None of those gaps, on the evidence available, would change the verdict.

I'll research the prior-art citations for US 8,193,219 from authoritative patent databases.

Let me retrieve the actual "References Cited" list from the patent front page and Espacenet's cited-documents view.

I hit my tool-call ceiling before I could re-verify every entry against USPTO Patent Center full-text, so I am flagging provenance and confidence explicitly rather than over-claiming.

Prior Art Cited in / Of Record for US 8,193,219 B2

A. What the citation record actually is — and its limits

US 8,193,219 B2 issued June 5, 2012 from Appl. Ser. No. 13/252,041, filed Oct. 3, 2011, as a continuation of 13/117,066 → divisional of 12/220,336 → divisional of 10/934,863 (filed Sept. 3, 2004) → provisional 60/499,723 (filed Sept. 4, 2003). Because the '219 is a continuation in a long chain, its face-of-patent "(56) References Cited" list is essentially the parent '800/'357 list carried forward, and no new substantive art was added to it in 2011.

Provenance caveat (important): I retrieved the (56) reference list as reproduced inside a District of New Jersey litigation filing (D.N.J. No. 2:19-cv-07532-series filing, gov.uscourts.njd.364322.1.0.pdf — https://storage.courtlistener.com/recap/gov.uscourts.njd.[364322](/patent/364322)/gov.uscourts.njd.364322.1.0.pdf). That reproduction carries the '219 abstract verbatim ("Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione are disclosed…"). However, the same filing bundle also contains the front page of an unrelated later Celgene patent (US 10,093,649 B1), so I cannot certify that every listed entry is on the '219's own § 56 list rather than on a same-specification sibling (the '800, '217, '357, '499 and '219 share one specification and therefore substantially overlapping citation lists). Treat the list below as "references of record in the '219's family, as retrieved," with the identification confirmed for the two references the specification itself discusses by name.

B. Statutory frame (pre-AIA § 102 applies)

• The '219 was filed in 2011 but claims benefit back to a Sept. 2004 non-provisional / Sept. 2003 provisional, so pre-AIA 35 U.S.C. § 102 governs.
• § 102(b) critical date: one year before the parent's U.S. filing → ≈ Sept. 3, 2003.
• § 102(a)/(e) critical date: invention/priority → ≈ Sept. 4, 2003.
• Consequence: every reference below (all issued 1970–2001) is comfortably § 102(b) prior art. Anything published after Sept. 2003 (e.g., Seddon, Crystal Growth & Design 2004; DiMartino's 1997 paper is fine, but 2004–2005 polymorph literature is not) cannot be § 102 prior art against this patent.

C. Table 1 — The substantive Celgene / lenalidomide-family citations

These are the only citations that disclose the molecule; they are the only ones with any § 102(f) argument against the '219 claims.

Titles for the 5,6xx,xxx / 6,02x,xxx Muller entries above are not individually re-verified in this pass; I am characterizing them by family and assignee rather than certifying exact titles.

D. Table 2 — Angiogenesis-inhibition citations (D'Amato)

Note: these D'Amato references were themselves the "earlier research" cited against the '517 compound patent in its reexamination (per the antitrust record) — they are relevant to the '517's validity, not to the '219's polymorph claims.

E. Table 3 — Dosage-form / excipient citations (cited for the "solid dosage form," "capsule," "tablet" and "pharmaceutically acceptable excipient, diluent or carrier" limitations)

§ 102 bottom line for this group: none of these can anticipate any claim of the '219. Each element of an independent claim must be found in a single reference; these references disclose conventional oral solid-dosage-form technology but wholly lack (i) 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione, and (ii) any XRPD pattern. They are § 103 "secondary/background" art at most.

F. Foreign patent documents

G. Non-patent literature cited in the specification

Both are § 102(b)-date-qualifying but disclose nothing about lenalidomide. They are cited as general technical background only and cannot anticipate.

H. § 102 claim-by-claim mapping (the honest answer)

The only § 102 theory with any traction is inherency over US 5,635,517 (Mylan's and Teva's EPO testing; accepted by the EPO when it revoked EP 1667682 on June 24, 2015). Per the previously generated sections of this analysis, that theory is pleaded in the Revlimid purchaser/insurer antitrust complaints but was rejected as a predicate for sham litigation by Judge Wigenton — a Noerr-Pennington holding that is not a validity holding and does not validate the '219 claims.

I. Explicit uncertainties in this pass

1. Source-of-list caveat: the (56) list was retrieved from a litigation filing; the two references the '219 specification names — US 5,635,517 and US 6,281,230 — are verified; the remaining entries are verified as family references but not individually confirmed as printed on the '219's face.
2. Exact titles for the Muller-family and dosage-form references were not re-verified; they are characterized here by function/assignee.
3. No IPR/PGR art exists to list — no AIA trial ever named the '219 (per the prior PTAB section).
4. Nothing in the cited art expressly discloses a polymorph of lenalidomide, which is the point: the '219's own citation list contains no anticipatory polymorph reference, and the substantive § 102 exposure is therefore the single-reference-inherency argument over the '517 patent, plus a § 112 written-description/indefiniteness attack — neither of which appears anywhere in the citation list.
5. To close this out definitively, the '219's own Patent Center "References Cited" and any IDS submissions should be pulled directly (https://patentcenter.uspto.gov, Appl. Ser. 13/252,041) — I was unable to complete that verification before reaching my tool limit.

I'll ground this analysis in the prior-art record available on the patent page and verify the cited references before writing.

Obviousness Analysis — U.S. Patent No. 8,193,219 (35 U.S.C. § 103)

0. Ground rules and a contradiction to flag first

Scope of the claims (verified). The asserted independent claim terms are confirmed by the claim text and by the litigation record: claim 1 recites "an unsolvated crystalline 3‑(4‑amino‑1‑oxo‑1,3 dihydro‑isoindol‑2‑yl)‑piperidine‑2,6‑dione having an X‑ray powder diffraction pattern comprising peaks at approximately 8, 14.5, 16, 17.5, 20.5, 24, and 26 degrees 2θ" — which the specification identifies as Form A (the unsolvated form). Natco's Markman brief in Celgene v. Natco, No. 2:10‑cv‑05197 (D.N.J.), ECF 252, quotes this exact '219 claim term and asks the court to construe it to "cover Form A lenalidomide." (https://storage.courtlistener.com/recap/gov.uscourts.njd.[247596](/patent/247596).252.0.pdf) The Espacenet claim listing confirms claims 1–7 and 12–15 and the dependency structure.

⚠️ Contradiction with the earlier "Litigation summary" section. That section states the '219 "covers crystalline Form B (hemihydrate)." That is inconsistent with the claim text (XRPD peaks 8/14.5/16/17.5/20.5/24/26 = Form A), with the Markman record, and with the "Patent summary" and "PTAB" sections, which both correctly say Form A. The "Form B" statement appears to conflate the commercial API form ("Form B is the desired polymorph for the API," per the specification) with the claimed form. I treat claims 1 and 12 as directed to Form A, and I flag the Litigation-section statement as an error for downstream correction.

Claim 8 remains unverified (truncated in every source I can reach); claims 9–11 depend from it. Nothing in this analysis turns on claim 8.

1. Governing framework

Under KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), a claim is obvious if the differences between the claimed subject matter and the prior art are such that the subject matter as a whole would have been obvious to a person of ordinary skill — including where the claimed advance is a "predictable variation" of the prior art, a "combination of familiar elements according to known methods," or a solution that was "obvious to try" from a finite set of identified options. For pharmaceutical polymorphs and crystalline forms the operative line of authority is Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (Norvasc): the discovery of a new crystalline form of a known, pharmaceutically useful compound is not presumptively inventive, and a claim limitation describing the crystal (e.g., an XRPD or DSC signature) is a mere characterization of the same physical product and adds no separate patentable weight. Accord Titanium Metals Corp. v. Banner, 778 F.2d 775 (Fed. Cir. 1985) (a newly discovered property of a known composition does not render it patentable).

2. Person of ordinary skill in the art ("POSA")

A solid‑state/analytical chemist or pharmaceutical formulation scientist holding a Ph.D. (or M.S. plus several years) in chemistry, pharmaceutics, or a related field, with practical experience in (a) organic recrystallization and solvent/slurry screening, (b) solid‑form characterization (XRPD, DSC, TGA, IR/Raman, moisture sorption), and (c) oral solid‑dosage development. This is not a hypothetical — it is exactly the skill set described in the '219's own Examples 6.3–6.7 (Shimadzu XRD‑6000, TA 2050/2950 TGA, TA 2920 DSC, VTI moisture balance, Karl Fischer), all of which are described as routine.

3. The prior art of record

The §103 case is built entirely from the record the applicant itself cited or admitted, which is important: these are not post‑hoc art.

The '517 patent's own claims confirm lenalidomide is a named species: claim 4 recites "1‑oxo‑2‑(2,6‑dioxopiperidin‑3‑yl)‑4‑aminoisoindoline," and claim 10 claims the compound per se (https://patentimages.storage.googleapis.com/70/bd/6a/0819ca1a4ec043/US5635517.pdf; https://www.drugpatentwatch.com/p/patent-claims/5635517). Accordingly, the compound and its utility are admitted prior art; the only question is whether selecting one of its crystalline forms was non‑obvious.

4. The differences over the prior art

5. Combination 1 — the core §103 case

Primary references: US 5,635,517 and/or US 6,281,230 (the compound).
Secondary references: DiMartino (1997) and/or Knapman (2000) (the polymorph-screening motivation).
Routine-technique evidence: the '219 specification's own admissions of conventional crystallization and characterization methods.

Why a POSA would combine them. The '517/'230 references supply the known drug candidate, its known utility, and (in the '230) a known oral dosage form. DiMartino and Knapman supply the express, articulated reason to act: a compound can exist in multiple polymorphs; the polymorph chosen materially affects dissolution, stability, flowability, and compressibility — the very properties that determine whether a solid dosage form is manufacturable and bioavailable. A POSA developing the '517/'230 compound into an oral solid therefore had every incentive to recrystallize or slurry the compound and identify the resulting solid forms. Form A is precisely what that routine exercise yields: the specification itself reports Form A "obtained from various solvents, including … 1‑butanol, butyl acetate, ethanol, ethyl acetate, methanol, methyl ethyl ketone, and THF" — i.e., ordinary solvents, ordinary recrystallization, no critical or unexpected process parameter.

Why the expectation of success was reasonable. The applicant conceded that polymorph isolation and characterization techniques were "known in the art." Polymorph screening is a routine, finite, and predictable exercise — the very situation KSR identifies as obvious to try. Solvent choice in a recrystallization is a classic result‑effective variable amenable to routine optimization. In re Aller; In re Boesch.

Why the claim limitations add nothing. The seven‑peak XRPD pattern, the "unsolvated" descriptor, and (claim 12) the "significant peaks" intensity requirement are characterizations of the same physical product. Once the POSA's routine screen produces Form A, each of those limitations is satisfied inherently. Under Pfizer v. Apotex, the crystalline/XRPD limitations "do not render the claims nonobvious."

6. Combination 2 — inherency/"inevitable result" (anticipation, and a fortiori obviousness)

A second, stronger theory was actually litigated — abroad — and is documented in the D.N.J. antitrust record:

"On June 24, 2015, the EPO issued a decision revoking EP '682 based on the rationale that Form A claimed by EP '682 was anticipated by the '517 Patent … Celgene['s] failure to present evidence to rebut Mylan and Teva's testing results, which indicated that following the teachings of the '517 Patent inevitably leads to Form A of lenalidomide …"
— In re Revlimid & Thalomid Purchaser Antitrust Litig., No. 2:19‑cv‑07532 (D.N.J.), ECF 446 at 234–235 (2024‑06‑06) (https://www.courtlistener.com/docket/14599654/446/in-re-revlimid-thalomid-purchaser-antitrust-litigation/); accord the Insurer‑Plaintiff allegations reproduced at http://business.cch.com/ald/InreRevlimidandThalomidPurchaserAntitrustLitigation672024.pdf.

The predicate is the '219's own admission that the compound "can be prepared through catalytic hydrogenation of 3‑(4‑nitro‑1‑oxo‑1,3 dihydro‑isoindol‑2‑yl)‑piperidine‑2,6‑dione," a route traceable to the '517/'230 disclosures. If the '517 synthesis plus routine isolation/drying yields Form A, then Form A is inherent in the prior art and the claims are anticipated under §102 — and necessarily obvious under §103. The recognized weakness of this theory is the "always, without exception" requirement for inherency (see, e.g., the apremilast inherency findings in the D.N.J. record: "an example has to always produce … the patented crystal form, every time without exception," https://storage.courtlistener.com/recap/gov.uscourts.njd.[378788](/patent/378788)/gov.uscourts.njd.378788.501.0.pdf ¶ 1432). A §103 framing is therefore more robust than a §102 framing: even if the '517 route does not invariably give Form A, a POSA following it and routinely screening the product would obvious‑ly arrive at Form A — obtaining all claimed compositions with a reasonable expectation of success.

7. Combination 3 — the dosage/solid‑dosage‑form limitations

References: US 6,281,230 (compositions, unit dosage forms) in view of DiMartino/Knapman (motivation to select a physically stable, non‑hygroscopic form), and the specification's own reported dosing range (0.10–150 mg/day; 5–25 mg/day).

Motivation. Once a POSA has selected a solid form of a known, potent oral drug, the unit strengths (5, 10, 25 mg on the one hand; anything within 0.1–150 mg on the other) and the tablet/capsule presentation are design choices optimized by routine experimentation against known efficacy/toxicity endpoints. Nothing in the claims recites a criticality, a threshold, or an unexpected dose–response; it is the paradigm of In re Aller-type optimization. Claim 7's "does not exhibit a significant weight gain from 5% to 95% relative humidity" merely recites the weakly hygroscopic behavior DiMartino teaches will characterize some polymorph of any given compound — a predicted result, not an unexpected one.

8. Anticipated objective indicia (and why they are weak here)

No teaching away was identified in the record: neither the '517 nor the '230 patent disparages crystallization, and neither teaches that lenalidomide cannot be crystallized (contrast the "viscous oil / taught away" fact pattern that has occasionally defeated polymorph obviousness, e.g. Aventis Pharma v. Lupin, 636 F.3d 1337 (Fed. Cir. 2010) — I note that case only for the doctrinal point and do not rely on its specific facts).

9. Claim‑by‑claim conclusion

10. Explicit uncertainties / what would change the analysis

1. Claim 8's full text is unverified; claims 9–11 depend from it. If claim 8 recites something beyond the Form A composition (e.g., a method or a specific excipient matrix), a separate §103 treatment is needed.
2. The inherency theory depends on empirical proof that following the '517 route "always" yields Form A. The EPO accepted Mylan/Teva's data; Celgene disputed it. I cannot independently verify the replication data.
3. I could not confirm whether the examiner ever raised a non‑statutory double‑patenting rejection over the sibling Form A patents ('357, '598) during prosecution of the '219 — a related but distinct validity vector I flag without asserting it.
4. No Federal Circuit merits holding on the '219's validity exists (per the PTAB section, no AIA trial ever reached the Board, and all district‑court cases settled), so there is no controlling adjudication either way — my conclusions are the prima facie §103 case, not a judgment.
5. As before, the applicant's §112 exposure on the solvation terminology (the "hemihydrate"/"crystalline" claim‑construction fight that sank the '800 patent at Markman) is a separate ground from §103 and is not addressed here.

Bottom line: the strongest §103 combination is US 5,635,517 / US 6,281,230 (compound + compositions) in view of DiMartino (1997) and Knapman (2000) (express motivation to screen for polymorphs and select for stability/hygroscopicity/manufacturability), optionally with the '517 synthesis as an inherency anchor. The only element absent from the prior art — the unsolvated crystalline Form A identified by its seven XRPD peaks — is a routine, predicted result of applying admitted conventional crystallization methods to an admitted known drug, and the claim's crystalline/XRPD/dissolution limitations are inherent characterizations that add no patentable weight under Pfizer v. Apotex.