US 8828427

I'll verify the patent details against live sources and check for any CAFC 2026 docket activity.

Let me specifically check for any 2026 Federal Circuit docket activity involving this patent.

US Patent 8,828,427 — Verification Summary

Note on date: You stated "current date: April 26, 2026" while my session metadata reads 2026‑10‑01. Both are treated as 2026; the distinction does not materially affect the findings below.

I verified the identifier 8828427 literally against the Google Patents full-text record (the authoritative copy supplied), Justia, DrugPatentWatch, and the Orange Book-derived listings. No search results for a different number were substituted.

1. Bibliographic data (verified)

Front-page references cited: US 5,593,696 (McNally); US 2007/0155791 A1 (Zeldis); WO 2006/058008 A1; Remington's Pharmaceutical Sciences 17th ed. (pp. 1613–1615, 1625–1626); Crane & List, Cancer Investigation 23(7):625–634 (2005).

2. Abstract (verbatim)

"Pharmaceutical compositions and single unit dosage forms of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate, are provided herein. Also provided are methods of treating, managing, or preventing various disorders, such as cancer or an inflammatory disease."

The disclosed compound is pomalidomide (CC-4047), marketed as POMALYST (NDA 204026, approved Feb. 8, 2013).

3. Independent claims in plain language

There are six independent claims (claims 1, 3, 5, 7, 9, 11), each directed to a finished oral capsule of a specified total weight containing a four-component fill: pomalidomide (as free base or a pharmaceutically acceptable salt/solvate), pregelatinized starch, sodium stearyl fumarate (PRUV®) as lubricant, and spray-dried mannitol as the q.s. diluent to the target weight.

Key constructional points:

• Each independent claim is a closed, numerically exact composition claim — the total capsule weight is a literal claim limitation (62.5 / 125 / 250 / 180 / 240 / 300 mg). This is the reason the patent is described in later antitrust pleadings as "easy to design around" (a generic capsule of any other weight arguably falls outside).
• The active-ingredient limitation is expressed as potency ("an amount that provides X mg of 100% pure pomalidomide"), not as an as-is weight, which accommodates assay/purity variation in the drug substance.
• The mannitol limitation is a q.s. ("brings the total weight to…") clause, making spray-dried mannitol the residual filler rather than a fixed weighed amount.

4. Dependent claims

The remaining six claims (2, 4, 6, 8, 10, 12) are size limitations only:

• Claim 2 (on cl. 1) and claim 4 (on cl. 3) — size 4 or larger capsule.
• Claims 6, 8, 10 (on cl. 5, 7, 9 respectively) — size 2 or larger capsule.
• Claim 12 (on cl. 11) — size 1 or larger capsule.

No method-of-treatment or kit claims were granted, despite the specification's extensive disclosure of indications and combination/second-active-agent subject matter.

5. Prosecution and status notes

• The specification describes a direct-blend / low-moisture manufacturing process (screening at 200–750 µm for API, ~150–250 µm for lubricant; diffusion mixing ~15 min; optional 0.039-inch milling), with stated advantages over roller compaction (less airborne dust) and a stated 12/24/36-month shelf life without refrigeration.
• The granted claims are narrow relative to the specification, which supports a much broader genus (0.1–100 mg doses; 0.1–10 wt% API; mannitol:starch 1:1 to 1:1.5; 70–99 wt% carrier; lubricant 0.01–5 wt%).
• Legal status: Active. Maintenance fee (8th year, large entity) paid Feb. 23, 2022. Orange Book lists the patent with drug-product (DP) and drug-substance (DS) codes, expiring June 21, 2031 (Dec. 21, 2031 with PED).
• The patent issued only after an examiner's repeated §103 rejections were overcome with a Rule 132 declaration by inventor Tutino. That declaration is the subject of inequitable-conduct/fraud-on-the-PTO allegations in later antitrust and consumer complaints (see below).

6. Litigation check — USPTO and "CAFC 2026 dockets"

I could not identify any 2026 Federal Circuit docket naming US 8,828,427. I searched for CAFC 2026 appeals and IPRs referencing the '427 patent and found none. My explicit findings:

1. Federal Circuit: The only Court of Appeals for the Federal Circuit entry associated with this patent's family in the Google Patents litigation record is CAFC case 21‑1154 — a 2021 appeal, not a 2026 filing. I do not have authoritative confirmation of that appeal's scope or outcome for the '427 patent specifically, and I flag that as uncertain.

2. District court (D.N.J., Hatch-Waxman): Multiple cases, including 2:17‑cv‑03159, 2:17‑cv‑03387 (Celgene v. Hetero), 2:18‑cv‑10775, 2:19‑cv‑05802, 2:21‑cv‑02111, and 2025 filings 2:25‑cv‑01147, 2:25‑cv‑06320, 2:25‑cv‑13687, 2:25‑cv‑16878. Also 1:18‑cv‑00540 (M.D.N.C.).

3. Notable: In Celgene v. Hetero, No. 17‑3387 (D.N.J.), Special Discovery Master Order No. 14 (Dec. 31, 2020) states "Celgene is not asserting the '427 patent against defendants." Celgene therefore withdrew its '427 infringement claims in the Pomalyst ANDA litigation, reportedly because the exact-weight claims were readily designed around.

4. Antitrust / consumer actions referencing the '427 patent: The Cigna Group v. Celgene Corp., No. 1:25‑cv‑05237‑ER (D.N.J., filed June 24, 2025) and related complaints allege the '427 patent was obtained through a false Tutino Declaration and was asserted as part of a sham-litigation/30-month-stay strategy. These are allegations in pleadings, not adjudicated findings.

7. Caveats and uncertainties (stated explicitly)

• Assignee is now effectively Bristol Myers Squibb, via the 2019 Celgene acquisition, even though the patent and assignment records name Celgene Corporation. Google Patents' "current assignee" field still shows Celgene Corp; drug-patent databases show "Bristol."
• Inventor residence for Kelly is printed as "Lake Hopatcong, OH" in the granted patent's front page. Ohio is geographically implausible for a Lake Hopatcong address (New Jersey), but per your rule I am reporting the printed identifier literally and not correcting it.
• The full patent text you supplied is truncated mid-sentence in §4.1 of the detailed description and omits the Tables 1–6 batch/single-dose formulations. I therefore cannot independently restate those tables from the supplied record; the claim set above is drawn from the granted claims as reproduced in the verified front page and the DrugPatentWatch claim listing.
• The specification's examples refer to passing "sodium fumarate" through a 60-mesh screen, whereas the claims recite sodium stearyl fumarate. This appears to be a rendering/typographical artifact in the source text; I am not correcting it, but note the inconsistency between examples and claims.
• Several specification sentences are internally garbled in the fetched rendering (e.g., "the dosage form comprises about 35 mg of starch, and the remaining weight is filled by starch," which should read mannitol). These are transcription artifacts, not substantive disclosures.

Sources: https://patents.google.com/patent/US8828427/en ; https://patents.justia.com/patent/8828427 ; https://www.drugpatentwatch.com/p/patent-claims/8828427 ; https://thefdalawblog.com/wp-content/uploads/2021/01/Orange-Book-41st-Annual.pdf ; https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf ; https://storage.courtlistener.com/recap/gov.uscourts.njd.[348812](/patent/348812)/gov.uscourts.njd.348812.63.0.pdf

I'll research the litigation involving US Patent 8,828,427 using the sources you specified.

Let me search for the remaining specific case numbers to confirm parties and outcomes.

Litigation Involving U.S. Patent No. 8,828,427

Bottom line: Yes — U.S. 8,828,427 ("the '427 patent," Celgene's Pomalyst®/pomalidomide formulation patent) has been asserted in a substantial body of Hatch-Waxman ANDA litigation, almost all of it in the District of New Jersey, plus a Federal Circuit appeal and follow-on antitrust suits in which the '427 is attacked as a "sham" patent. Celgene (now a Bristol Myers Squibb subsidiary) is the plaintiff/assignee throughout.

Important caveat on scope: The Google Patents "family litigation" list for this patent includes cases involving the broader pomalidomide patent family. Google Patents' family-litigation data does not always distinguish which specific family member was asserted in a given case, so a few entries below may involve sibling patents (e.g., 8,198,262; 8,673,939; 8,735,428; 9,993,467; 10,555,939) rather than the '427 specifically. I flag confidence levels where relevant.

A. Cases listing the '427 in the patents-in-suit (confirmed)

B. Other D.N.J. / other-district case numbers listed on the patent page (parties not fully confirmed)

These docket numbers appear in the patent's family-litigation record but I could not fully confirm parties/outcomes within the sources retrieved:

• 2:18-cv-10775 (D.N.J.) — Celgene pomalidomide ANDA matter; not confirmed.
• 2:19-cv-05802 (D.N.J.) — identified in the Cigna complaint as Celgene Corp. v. Mylan (opinion at 2020 WL 12570814 (D.N.J. Sept. 25, 2020), granting Mylan's motion to dismiss for improper venue).
• 2:21-cv-02111 (D.N.J.) — not confirmed.
• 2:25-cv-06320, 2:25-cv-13687 (D.N.J.) — 2025 filings; not confirmed.
• 1:18-cv-00540 (M.D.N.C.) — a North Carolina Middle District case; parties not confirmed.
• Fed. Cir. 21-1154 — a Federal Circuit appeal; the underlying district case and outcome were not confirmed. (Appeal number is from the patent page.)

C. Follow-on antitrust litigation attacking the '427 as a "sham" patent

The '427 is central to a wave of antitrust suits alleging Celgene/BMS used the pomalidomide formulation patents to delay generic entry:

• The Cigna Group v. Celgene Corp., D.N.J. 1:25-cv-05237-ER (filed June 24, 2025) — Sherman Act § 2 monopolization claims. The complaint alleges the '427 "was expressly taught in the prior art" and issued only after a purportedly false Tutino Declaration, and that Celgene "withdrew its infringement claims as to this patent before most, if not all, of the settlements occurred" (citing the Hetero Special Discovery Master Order).
• Pomalyst/Pomalidomide antitrust class actions (Hagens Berman filed the operative consolidated complaint/opposition papers; NYSD docket 1:25-cv-…/gov.uscourts.nysd.628251 and related) — allege Celgene/BMS paid would-be generic competitors (Natco/Breckenridge, Aurobindo, Hetero, etc.) to delay entry to early 2026, and challenge the formulation patents including the '427.
• Note: The frequent "sham litigation" narrative also reflects that Celgene stopped asserting the '427 before the bulk of the 2020–2021 settlements and that the '427 was never adjudicated on the merits.

D. What is not established (to be candid)

• I did not find any judgment holding the '427 valid, invalid, infringed, or not infringed on the merits. The Hatch-Waxman cases involving it resolved by consent judgments / stipulated injunctions (MSN, Sandoz, Cipla) or by withdrawal of the '427 claims (Hetero/Aurobindo/Apotex/Mylan/Breckenridge group).
• The '427's listed expiration of June 21, 2031 (with PED to Dec. 21, 2031) is from Orange Book records, not from any court ruling.

Sources

• Google Patents, US8828427B2 (litigation links): https://patents.google.com/patent/[US8828427](/patent/US8828427)/en
• PatSnap Eureka, Celgene v. Sandoz consent judgment: https://www.patsnap.com/resources/blog/litigation/celgene-v-sandoz-pomalyst-pomalidomide-patent-consent-judgment-patsnap/
• PatSnap Eureka, Celgene v. Cipla consent judgment: https://www.patsnap.com/resources/blog/litigation/celgene-vs-cipla-consent-judgment-in-pomalidomide-patent-dispute-patsnap-eureka/
• DrugPatentWatch — Celgene v. MSN Labs (2:22-cv-01993): https://www.drugpatentwatch.com/p/litigation/casename/index.php?query=CELGENE+CORPORATION+v.+MSN+LABORATORIES+PRIVATE+LIMITED%7C2%3A22-cv-01993
• CourtListener — Celgene v. MSN (2:22-cv-01993): https://www.courtlistener.com/docket/63218364/celgene-corporation-v-msn-laboratories-private-limited/
• CourtListener — Hetero answer/counterclaims (2:17-cv-03387, Doc. 26, seeking DJ of invalidity/non-infringement of the '427): https://www.courtlistener.com/docket/[6323341](/patent/6323341)/26/celgene-corporation-v-hetero-labs-limited/
• Joint Claim Construction Statement (17-cv-3159 / 17-cv-3387): https://storage.courtlistener.com/recap/gov.uscourts.njd.[348812](/patent/348812)/gov.uscourts.njd.348812.211.0.pdf
• The Cigna Group v. Celgene Corp. complaint (1:25-cv-05237-ER), ¶¶ 146–147, 306–317: https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf
• Stanford NPE Litigation Database — Celgene (lists 2:17-cv-03159 and 2:17-cv-03387): https://npe.law.stanford.edu/party/celgene-corporation
• Robbins Kaplan case note, Celgene Corp. v. Hetero Labs Ltd., 17-3387 (D.N.J. Mar. 2, 2018): https://www.robinskaplan.com/newsroom/insights/celgene-v-hetero-labs

Verification recommendation: For the entries marked "not confirmed" (especially the 2025 dockets 2:25-cv-06320, 2:25-cv-13687, 2:25-cv-01147, the M.D.N.C. case 1:18-cv-00540, and Fed. Cir. 21-1154), pull the PACER dockets directly, since Google Patents' litigation list occasionally maps family-wide cases to each member patent without confirming which patent was actually asserted.

I'll research this systematically. Let me start with searches on PTAB proceedings for this patent.

Let me check the PTAB-specific databases and CourtListener for any AIA trials on the '427 patent.

Let me confirm definitively whether any AIA trial was ever filed on the '427 patent specifically.

PTAB / AIA Trial Analysis — US 8,828,427

Proceedings overview

Total AIA trial proceedings on US 8,828,427: 0.

Breakdown by status: 0 active / 0 with claims invalidated / 0 with claims sustained / 0 settled / 0 institution-denied. The USPTO Open Data Portal returns no IPR, PGR, or CBM proceeding naming this patent as the challenged patent, and independent web searches (PTAB docket aggregators, Darts-IP family litigation data, and the Pomalyst/thalidomide patent-family IPR record) surface nothing contradicting the ODP null result.

Bottom-line defensive posture: This is not a "the patent has survived IPRs and is hardened" situation, and it is not a "claims 1–10 have been canceled" situation either. It is a zero-precedent patent — no Article III or PTAB body has ever adjudicated the validity of its claims on the merits. The patent came out of prosecution only over a Rule 132 declaration (the Tutino Declaration) and was never actually asserted through to judgment — Celgene withdrew its infringement claims as to the '427 patent before the generic settlements (D.N.J. Special Discovery Master Order No. 14, 2020-12-31). So the claims are untested, not hardened, and every ground § 102/§ 103/§ 112 remains available to the first defendant willing to file.

There are no proceedings to list

The task calls for a per-proceeding breakdown "most-impactful first." With a count of zero, the honest output is an explanation of the null result, plus the confusable family proceedings that a defendant will encounter when researching this patent space.

Why the null result is credible (and not a data gap)

• The patent issued 2014-09-09 and has been Orange-Book-listed on POMALYST (NDA 204026) since the 2013 approval, with a listed expiry of 2031-06-21 (and 2031-12-21 with pediatric exclusivity).
• It was asserted in the 2017–2020 Pomalyst ANDA wave (first-wave suits filed beginning 2017-05-04 against Apotex, Teva, Hetero, Mylan, Breckenridge, Aurobindo, Synthon, and others). Those defendants litigated invalidity by counterclaim in district court, not by IPR. See, e.g., Celgene v. Hetero, No. 17-cv-3387 (D.N.J.), and the Teva non-infringement/§ 103 contentions in the case record.
• Celgene dropped the '427 patent from the litigation before settlement (Special Discovery Master Order No. 14 (ECF No. 821) in 17-cv-3387: "Celgene is not asserting the '427 patent against defendants"). No FWD, no IPR estoppel, no claim-level validity holding exists.

2015 "near-miss" family IPRs — NOT on the '427 patent

These are frequently misattributed to the pomalidomide formulation patent. They target different Celgene patents and should not be reported against US 8,828,427:

Source: PTAB/IP Verse CFAD VI case list; drugpatentwatch pomalidomide PTAB table. None of these names US 8,828,427. The '517 institution denial (2015-11-16) is the closest thing to a PTAB signal in this portfolio, and its reasoning — that specific thalidomide analogs' TNFα activity was not obvious — turned on compound chemistry, not on formulation excipients. It gives a '427 defendant essentially nothing.

Related Article III activity (not PTAB)

• D.N.J. ANDA litigation (multiple consolidated matters, 2017–present) — invalidity counterclaims on §§ 102/103/112; the patent dropped from the case pre-settlement.
• S.D.N.Y. antitrust "sham litigation" MDL-style actions (In re Pomalyst (Pomalidomide) Antitrust Litigation, e.g., 1:23-cv-07871, 1:24-cv-02230, 1:24-cv-06924) — plaintiffs allege the '427 was procured through the allegedly false Tutino Declaration (submitted 2013-06-17). This is an inequitable-conduct narrative, not a PTAB holding, and is unadjudicated.
• CAFC 21-1154 appears in the patent family's litigation block; it is a district-court appeal in the family, not an appeal of any PTAB Final Written Decision on this patent.

Strategic summary

Claim status on 8,828,427 for a defendant today: all claims are UNTESTED — none canceled, none sustained by any tribunal. The patent has one independent claim per capsule strength — claims 1, 3, 5, 7, 9 (62.5 mg / 125 mg / 250 mg / 180 mg / 240 mg) with dependent size-limitation claims 2, 4, 6, 8, 10. These are narrow, closed-formulation claims (pomalidomide potency + specified pregelatinized starch + specified sodium stearyl fumarate + spray-dried mannitol q.s. to a fixed total weight). They are easy to design around and, per the ANDA defendants, vulnerable to § 103 over Zeldis + Remington's + McNally + Schey, and to § 112 indefiniteness/written-description attacks. Procuring the claims took a Rule 132 declaration after repeated § 103 rejections — a fragile prosecution history that reads as an admission against validity.

Estoppel landscape: Because no IPR/PGR was ever instituted, there is no § 315(e)(2) estoppel against anyone on this patent. A defendant is free to raise any prior-art ground — § 102, § 103, or § 112 — in either the district court or a new IPR. There is no petitioner-privity chain, no institution-denial estoppel (which would only bind the CFAD, on other patents anyway), and no FWD-driven narrowing to litigate around. The only estoppel pressure comes from prosecution-history estoppel and disclosure-dedication, which the Teva defendants already mapped in detail — those cut against the patent owner's infringement case, not against the defendant's invalidity case.

Pattern signals: The same petitioner did not file multiple IPRs on this patent — there is only one petitioner worth noting in the family (CFAD/Kyle Bass, 2015, on REMS and compound patents), and it never touched the formulation patent. There is no defensive aggregator (no Unified Patents / RPX IPR) in the chain for the '427. The patent owner has pursued district-court assertion rather than PTAB defense and withdrew the patent from the one litigation where it could have been tested — i.e., the owner itself has avoided a merits validity ruling. That asymmetry (asserted, then abandoned) is a signal of low owner confidence, not of a hardened patent.

Recommended next steps

• No PTAB activity exists on US 8,828,427 — say so plainly in any opinion letter. The absence is itself the signal: a patent asserted against eight-plus ANDA filers in a multi-billion-dollar market that never attracted a single IPR, and that the owner pulled from the case before judgment, has not been validated by anyone. Do not treat the zero count as "hardened."
• If you are a defendant being asserted today: there is no FWD to link to (none was ever issued), so any demand letter or complaint that cites claims 1–10 should be met with (a) an IPR at the first opportunity, which carries no estoppel baggage, and (b) § 103 contentions built from the Zeldis + Remington's + McNally + Schey combination the examiner repeatedly used — the same art that forced the Rule 132 declaration. Because the patent is still Active (adjusted expiry 2031-06-21; pediatric 2031-12-21), a PGR is unavailable (issued 2014-09-09; the 9-month window closed 2015-06-09), and CBM is unavailable (technological-invention hurdle in a Unwired Planet posture — pharmaceutical formulation claims generally fail the CBM technical-feature test). IPR under §§ 102/103 is the vehicle.
• Watch for a new IPR window: if the patent owner re-asserts the '427, § 315(b)'s one-year bar runs from service of a complaint alleging infringement of this patent; a defendant served in a fresh wave should docket its IPR deadline immediately (statutory 1-year PTAB trial deadline from institution under § 316(a)(11)).
• Verify the "no proceedings" state yourself before relying on it: confirm at USPTO Patent Trial and Appeal Board E2E and cross-check drugpatentwatch's PTAB table for pomalidomide. If a recently-filed proceeding appears there that ODP has not yet indexed, treat the above analysis as needing a refresh — but as of the ODP ingest date, the count is zero.

Caveat on sourcing: the per-proceeding metadata fields requested (judge panels, institution reasoning, FWD claim-level verdicts, settlement terms, appeal dispositions) are inapplicable — there is no proceeding on this patent to populate them. I have not fabricated proceeding numbers; the four CFAD IPRs listed above are real and are attached to other Celgene patents, and I have flagged them expressly as not on US 8,828,427.

I'll search for the assignment records for this patent.

US 8,828,427 — Ownership Chain Reconstruction

Sourcing note (read first): The task specifies the USPTO Assignment Center (https://assignmentcenter.uspto.gov/) and the legacy Assignment Search (https://assignment.uspto.gov/patent/index.html) as primary sources, with each hit exposing reel/frame, conveyance type, assignor, assignee, execution date, recording date, and correspondent of record. In this session I could not reach the Assignment Center's result payload — the searches returned the Google Patents Legal Events feed, Orange Book listings, and secondary aggregators (TheraRadar, PharmaKB, DrugPatentWatch) but no reel/frame data. I am therefore reporting the assignment events with high confidence and flagging the reel/frame identifiers and correspondent as unverified. I will not invent reel/frame numbers. This is a sourcing limitation, not a finding that the records are missing.

Two cross-checks do hold: (a) the Google Patents Legal Events list for US 8,828,427 contains exactly one reassignment entry, and (b) Celgene Corporation is still shown as current assignee on Google Patents as of the live fetch — i.e., no post-issuance assignment out of Celgene is recorded, including after the Bristol-Myers Squibb acquisition.

Inventors

Pattern check — inventors departing within 12 months of filing: not determinable. The record I can reach contains no information about either inventor's subsequent employment. I found no evidence of a post-filing inventor exodus, and equally no evidence affirmatively ruling one out. I am explicitly declining to infer a fire-sale precursor from silence.

Note on the printed residence: "Lake Hopatcong, OH" is geographically anomalous (Lake Hopatcong is in New Jersey, where Celgene was headquartered). Per the operating rule, I am reporting the identifier literally and not correcting it.

Original assignee

Celgene Corporation (Summit, NJ) — named as original assignee on US 8,828,427 and the recorded assignee on the 2010-11-04 conveyance.

• Primary line of business: branded biopharmaceuticals; Celgene was an operating company (not a licensing vehicle), with an in-house R&D, manufacturing, and regulatory organization.
• Product embodying the claims: Yes. The claimed capsules are the commercial POMALYST® (pomalidomide) capsules, NDA 204026, approved Feb. 8, 2013. The Orange Book lists US 8,828,427 against POMALYST with drug-product (DP) and drug-substance (DS) codes, expiring June 21, 2031 / Dec. 21, 2031 with pediatric exclusivity. The marketed strengths (0.5, 1, 2, 3, 4 mg) map onto the claimed 62.5 mg, 125 mg, 250 mg, 180 mg, and 240 mg capsule weights.
• Current status: Operating, but no longer independent. Celgene was acquired by Bristol-Myers Squibb Company in a $74B cash-and-stock transaction that closed November 20, 2019, becoming a wholly owned subsidiary of BMS. Critically for ownership analysis: this was a stock acquisition, not an asset or patent conveyance. Celgene Corporation survived as a legal entity and retained record title to its patents. This is corroborated by Google Patents' continued listing of Celgene Corp as current assignee, and by the absence of any merger-type assignment on the '427 record.
• Secondary databases (PharmaKB, TheraRadar) list the POMALYST patent estate under "Bristol" as owner — an economic-interest label reflecting the BMS parent, not a recorded USPTO assignment. This distinction matters for the NPE analysis below.

Assignment timeline

One (1) recorded assignment event is reflected in the sources reachable this session — the initial inventor-to-corporate assignment. There are no recorded post-issuance assignments.

Event 1 — Inventors → Celgene Corporation

• 2010 (executed; exact date not retrieved) / recorded 2010-11-04 — Reel/Frame: NOT VERIFIED
  • Conveyance: Assignment (of assignors' interest). Google Patents Legal Events renders the entry as "ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)."
  • Assignor: TUTINO, ANTHONY and KELLY, MICHAEL (the two named inventors), assigning 100% of their right, title, and interest.
  • Assignee: CELGENE CORPORATION, Summit, NJ.
  • Correspondent: NOT VERIFIED. I could not retrieve the correspondent-of-record field. I will not supply a name, because a fabricated correspondent would defeat the single most useful analytical field in this task.
  • Context: Routine employment/obligation assignment — the standard pre-issuance capture of inventor rights by the corporate employer. Recorded ~5.5 months after the May 19, 2010 filing date, which is typical timing for a new pharmaceutical filing.

Events 2–N — None recorded

• No merger assignment to Bristol-Myers Squibb Company appears on the '427 record. Consistent with the stock-acquisition structure described above, Celgene Corporation remains the record owner.
• No security agreement, license, release, correction, or change-of-name filing is reflected.
• No transfer to any entity with an "IP / Patents / Licensing / Holdings / Ventures" suffix.
• No defensive-aggregator (RPX / AST / Unified / LOT / OIN) conveyance.

Cross-reference with Google Patents Legal Events: the events list for US 8,828,427 shows the 2010-11-04 reassignment plus prosecution/publication events (2010-05-19 filing; 2011-02-24 publication of US 2011/0045064 A1; 2014-09-09 grant), domestic-priority child filings (14/447,450; 14/998,262 → US 9,993,467; 15/976,808 → US 10,555,939; 16/745,240; 17/115,672), and a 2031-06-21 adjusted expiration. None of the child filings carries an ownership entry that changes title to the '427 patent.

Verification links:

• USPTO Assignment Center: https://assignmentcenter.uspto.gov/
• Legacy Assignment Search (patent number query): https://assignment.uspto.gov/patent/index.html — search 8828427
• Google Patents Legal Events: https://patents.google.com/patent/US8828427/en

Timeline diagram

timeline
    title Ownership of US 8828427
    2009 : Provisional application filed
    2010 : Application 12 783 390 filed
         : Assigned to Celgene Corporation
    2011 : Pre-grant publication
    2013 : Pomalyst approved
    2014 : Patent issued
    2017 : First New Jersey suits filed
    2019 : BMS acquires Celgene as subsidiary
    2021 : CAFC appeal 21 1154
    2025 : New New Jersey suits filed

NPE / troll-pattern signals

One ownership fact worth flagging for the assertion-strategy picture (not an NPE signal): per a Special Discovery Master Order in Celgene v. Hetero, No. 17-cv-3387 (D.N.J.), "Celgene is not asserting the '427 patent against defendants" — Celgene reportedly dropped the '427 from the ANDA litigation, consistent with the exact-total-weight claim limitations being readily engineered around. Ownership stayed put; only the assertion was withdrawn.

Verdict

Operating-company assertion.

The chain is a single, unremarkable inventor-to-employer assignment recorded 2010-11-04 from Tutino and Kelly to Celgene Corporation, with no subsequent recorded conveyance of any kind, no shell or licensing entity, no asserted-transfer to a third party, and no defensive-aggregator terminus. The claims are practiced by a real, FDA-approved commercial product — POMALYST capsules, NDA 204026 — and all infringement activity was brought by the owner itself against generic competitors; the 2019 BMS/Celgene transaction changed economic control but, as a stock deal, left record title with Celgene Corporation. Caveat: the reel/frame numbers and the correspondent of record could not be retrieved in this session, so the assignment chain is reconstructed from Google Patents Legal Events and Orange Book data rather than from the Assignment Center payload itself; the "no post-issuance assignment" conclusion should be re-confirmed directly at https://assignment.uspto.gov/patent/index.html (query 8828427) before it is relied on for standing or diligence purposes.

I'll research the prior-art citations for US 8,828,427, starting with the references identified on the patent's face and the key incorporated-by-reference documents.

Let me pull the exact front-page citation lists and research the key references in more depth.

Prior Art for US 8,828,427 — Analyst Report

Tool-limitation note (stated up front): I confirmed the patent's identity and front-page data, but my document-retrieval budget was exhausted before I could pull the complete USPTO "References Cited" table for the '427 that appears on the printed front page (that table is not in the truncated full text supplied, and Google Patents/Justia render it in a field my fetches did not fully return). The list below is therefore assembled from three verified sources: (a) the front-page patent references already identified in the earlier section of this analysis, (b) the specification's own incorporated-by-reference documents, and (c) citations that appear in the closely related family members (US 10,555,939 / US 9,993,467) and in the litigation record. Where I could not verify a reference's subject matter, I say so explicitly rather than guess.

0. Patent identity (verified, not auto-corrected)

• US 8,828,427 B2 — Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
• App. 12/783,390; priority Provisional 61/179,678, May 19, 2009; filed May 19, 2010; granted Sept. 9, 2014.
• 12 claims, no drawings; six independents (1, 3, 5, 7, 9, 11), each a closed capsule of exact total weight (62.5 / 125 / 250 / 180 / 240 / 300 mg) with pomalidomide + pregelatinized starch + sodium stearyl fumarate + spray-dried mannitol (q.s.).
• Source: https://patents.google.com/patent/US8828427/en

This matters because the claim set is formulation-specific: to anticipate any claim under §102, a single reference must disclose all four components at the recited amounts and the exact total capsule weight. As shown below, no cited reference does — so the realistic prior-art attack on the '427 is §103 (obviousness), which is consistent with the reported prosecution history (repeated §103 rejections overcome by a Rule 132 declaration).

1. Patent references cited on the face of the '427 (per verified front page)

R1. US 5,593,696 — McNally

R2. US 2007/0155791 A1 — Zeldis (Celgene)

R3. WO 2006/058008 A1 — the single most material cited reference

2. References incorporated into the '427 specification (not on the face, but expressly relied upon)

R4. US 5,635,517 — Muller, Stirling & Chen (Celgene) — the pomalidomide compound patent

R5. US 6,281,230 and US 6,555,554 — Muller (Celgene), "Isoindolines… and pharmaceutical compositions"

3. Non-patent literature cited

R6. Remington's Pharmaceutical Sciences, 17th ed. (Mack Publishing, 1985), pp. 1613–1615, 1625–1626

R7. Crane & List, Cancer Investigation 23(7):625–634 (2005)

R8. Muller et al., Bioorg. Med. Chem. Lett. 9(11):1625–1630 (June 7, 1999); and Corral et al., J. Immunol. 163(1):380–386 (July 1, 1999)

4. §102 conclusion (per-reference, in one place)

Bottom line: On the verified record, no cited reference anticipates any of claims 1–12 under §102, because each independent claim is a closed, numerically exact capsule (specific mg quantities of pomalidomide potency, pregelatinized starch, sodium stearyl fumarate, and spray-dried mannitol q.s. to an exact total weight) and none of the cited references discloses that complete combination. The only reference that could support a §102 theory is WO 2006/058008 A1, whose full text I was unable to retrieve; it is the same-title, pre-2009 Celgene PCT and is the reference I would read first. Everything else operates as §103 obviousness art — consistent with the reported history in which the '427 issued only after §103 rejections were overcome with a Rule 132 declaration (the declaration at the center of the inequitable-conduct allegations in The Cigna Group v. Celgene, D.N.J. 1:25-cv-05237-ER).

5. What I could not verify (explicit caveats)

1. The complete USPTO "References Cited" front-page table for the '427 — my fetches returned the abstract/keywords, not the full citation box. The three patent references above (US 5,593,696; US 2007/0155791; WO 2006/058008) are those previously verified from the front page; there may be additional cited US/foreign patent documents and NPL I did not see.
2. The subject matter of US 5,593,696 (McNally) — not verified; described as an excipient/formulation reference by inference only.
3. The full text of WO 2006/058008 A1 — critical gap; the title match with the '427 makes this the highest-value reference to pull next.
4. The exact article title for Crane & List, Cancer Investigation 23(7):625–634 (2005) — citation confirmed; full text not opened.
5. I did not auto-correct any identifier; all numbers are reported as printed. Where the record (e.g., US 2007/0155791 vs. the AU Zeldis lenalidomide member) required inference about subject matter, I say so rather than assert.

Recommended next retrieval (to close the §102 question): the full text and claims of WO 2006/058008 A1 (June 2006), plus the USPTO PatentCenter "References Cited" and the File Wrapper (Rule 132 declaration and examiner's §103 rejections) for App. 12/783,390.

I'll research the specific prior-art references listed on this patent's front page before building the § 103 analysis.

Strong leads. Let me pin down the specific prior-art references and the prosecution history details.

Obviousness Analysis — U.S. Patent 8,828,427 under 35 U.S.C. § 103

Scope note. This builds on the verified claim set and litigation sections above and does not repeat them. I re-verify the prior-art citations against the sources retrieved today. No court or the PTAB has ever adjudicated the validity of the '427; everything below is a technical analyst's § 103 assessment, not a legal opinion. Dates: your prompt says April 26, 2026; my session metadata reads 2026‑10‑01 — same flag as in the earlier sections.

1. Governing framework and temporal law

The '427 issued from Application No. 12/783,390, filed May 19, 2010, claiming priority to provisional 61/179,678 (May 19, 2009). Because the application was filed before March 16, 2013, pre-AIA 35 U.S.C. § 103(a) governs. That matters here:

• Zeldis (US 2007/0155791 A1, pub. July 2007) and WO 2006/058008 A1 (pub. June 2006) both published more than one year before either the May 19, 2009 priority date or the May 19, 2010 filing date. They are therefore § 102(b) art, not merely § 102(e) art.
• Consequently, the common-ownership exception of pre-AIA § 103(c) — which could otherwise disqualify a commonly owned § 102(e)/(f)/(g) reference — is unavailable, because § 103(c) by its terms does not reach § 102(b) art. Celgene's own earlier pomalidomide-formulation publications are therefore squarely available as § 103 prior art against the '427. This is, in my view, the single most under-appreciated fact in the obviousness picture.
• The governing legal tests are Graham v. John Deere, KSR Int'l v. Teleflex (2007) (combination of known elements; "obvious to try"; design incentives/market forces; predictable variations), In re Aller (optimizing a known parameter), In re Peterson (overlapping/adjacent ranges), Pfizer v. Apotex (routine optimization of a known process), and for secondary considerations, In re Greenfield / In re Clemens (unexpected results must be commensurate in scope with the claims and measured against the closest prior art).

2. Level of ordinary skill (PHOSITA)

A formulator with a B.S./M.S. in pharmacy, pharmaceutical sciences, or chemical engineering and 2–5 years' hands-on experience developing immediate-release oral solid dosage forms (capsules/tablets), including excipient compatibility screening, blend design, filler/lubricant selection, and capsule-size selection; or a Ph.D. with ~1–2 years of the same. This is an unusually low PHOSITA threshold relative to, e.g., a medicinal-chemistry case, and it cuts strongly toward obviousness.

3. The claims, restated as a formulation identity (not a repeat of the earlier table)

The six independent claims are not six different inventions — they are two blend compositions, each filled at three weights:

Two observations that frame the whole analysis:

1. All six claims fall inside the specification's own disclosed genus (API 0.1–10 wt %, carrier 70–99 wt %, mannitol:starch "about 1:1 to about 1:1.5," lubricant 0.01–5 wt %). The claims are therefore a narrow selection from the applicant's own disclosed range — the classic In re Peterson / In re Aller posture.
2. The ratios in the granted claims are the very numbers later recited in the '467 patent's claim 1 as "1:1.30402385" and "1:1.33069307" (as quoted in the Cigna complaint, ¶ 289) — i.e., the claimed "invention" is two arithmetic blend ratios and a shelf of fill weights.

4. Prior art of record and what it discloses

5. The differences to be bridged

Taking Zeldis/Example 8 as the closest art, the claims differ only in:
(a) selection of pregelatinized starch + spray-dried mannitol as the filler/binder system, instead of the MCC-containing system; (b) selection of sodium stearyl fumarate as lubricant at ~0.25 wt %; and (c) the six specific fill weights at two fixed ratios.

Every one of (a)–(c) is the subject of a distinct, well-trodden motivation.

6. Combination 1 (strongest): Zeldis + Remington + art-recognized hydrolysis problem + KSR common sense

Motivation to combine — the references are in the same field, address the same problem, and Zeldis itself supplies the candidate list.

1. Same compound, same purpose, same route. Zeldis and the '427 both concern oral dosage forms of pomalidomide. KSR holds that where a reference teaches a list of candidate elements and the claimed solution is a selection from that list, the selection is obvious absent a teaching away.
2. Excipient selection. Zeldis's list expressly includes the claimed classes and species — binders/fillers (starches, pregelatinized starch, mannitol, MCC), disintegrants, and lubricants (sodium stearyl fumarate). The Board's characterization of the Zeldis-family D1 places starch, pregelatinized starch, and mannitol in the filler paragraph and Examples 4–7 using mannitol alone (Ex. 6) or starch alone (Ex. 4, 5, 7) — i.e., the two components of the claimed filler system were individually disclosed for this compound, and their combination is a combination of two known filler alternatives each known to work (KSR; In re Peterson on adjacent ranges).
3. Choosing mannitol over MCC is not an invention — the art pointed there. Thalidomide analogs are hydrolytically labile (glutarimide ring; well documented, including in the pleadings). Remington and the '427's own specification (§ on anhydrous compositions; "lactose-free" discussion) teach that for hydrolysis-sensitive amines one avoids water-bearing excipients. MCC carries ~5 % loss-on-drying; mannitol (spray-dried) and pregelatinized starch are low-moisture, non-hygroscopic alternatives. The artisan therefore had a reason (hydrolysis) and a finite, identified set of predictable solutions (the non-aqueous fillers in Zeldis's list). KSR expressly makes this obvious.
4. The applicant's own data confirm the predictability. The Rule 132 declaration states that 1:1 compatibility testing showed pomalidomide compatible with every excipient tested — including pregelatinized starch, spray-dried mannitol, and (as OCR'd) "sodium starch fumarate"/magnesium stearate. So the POSA screening per Remington had no expectation of failure for either claimed excipient. A declaration that says "everything looked compatible in the standard screen" cannot simultaneously establish that the final selection was unpredictable.
5. Converting the blend to a filled capsule of a chosen weight is routine. Remington (and the '427's own examples: 35-mesh API screen → 25-mesh excipient screens → pre-blend → 0.039″ mill → blend → 60-mesh lubricant → encapsulate) describes exactly the conventional direct-blend/capsule-fill protocol. Capsule size is dictated by fill weight/volume — a result-effective engineering constraint, not a patentable selection.
6. The fill weights are dictated by the dose. Pomalidomide is a 0.5–5 mg high-potency API; at 0.8–1.67 wt % load the blend is overwhelmingly diluent, which is what the "q.s. mannitol" clause accomplishes. Selecting 62.5/125/250 mg (common-blend, dose-proportional) and 180/240/300 mg (intermediate load, capped so as to fit a size 2 or size 1 shell, per dependent claims 6/8/10/12) is optimization of a known parameter (In re Aller; In re Kao) with a known design incentive (KSR): keep the capsule small enough to swallow while hitting six dose strengths off a minimum number of blends.
7. Sodium stearyl fumarate. A known commercial lubricant (PRUV®), expressly named in Zeldis's excipient list, used at a conventional lubricant level (~0.25 wt %), and recommended for moisture-sensitive actives and as a sodium/moisture-tolerant alternative to magnesium stearate. Selecting it and dosing it at a routine level is, again, In re Aller-style optimization.

Result: claims 1, 3, 5, 7, 9, 11 would have been prima facie obvious over Zeldis in view of Remington and the art-recognized hydrolytic instability of the thalidomide class.

7. Combination 2: WO 2006/058008 + US 5,635,517 (Muller) + Remington

If (as I believe, but have not verified) the Board's D1 is the WO 2006/058008/U.S. '791 family, then the mannitol + starch filler system for a pomalidomide dosage form was already expressly disclosed, and the only remaining difference is the numeric selector. Muller (US 5,635,517) supplies pomalidomide per se — the '427 specification itself incorporates US 5,635,517 by reference and names it as the source of the compound and its synthesis. A genus of one compound plus a genus of conventional fillers plus Remington's capsule-formulation chapter = all limitations. Where the only distinction is a numerical fill weight selected from a disclosed range for a disclosed purpose, the claim is obvious (In re Peterson; In re Aller).

8. Combination 3: the pre-2009 clinical capsules + Remington + known hydrolysis

The Cigna/Hagens Berman pleadings assert that Schey I–III dosed pomalidomide capsules to multiple myeloma patients at 1–10 mg/day before 2009, and argue pointedly that "a stable formulation must have been created previously as used in Schey III." This is an on-sale/public-use theory: if a stable pomalidomide capsule for human dosing existed in the prior art, the "unexpected stability" premise collapses. Note the evidentiary gap: clinical use does not, by itself, place the excipient identity in the public domain. This combination is suggestive of the state of the art, but by itself it is the weakest of the three for a § 103 chart.

9. Dependent claims 2, 4, 6, 8, 10, 12

Each adds only a capsule shell size ("size 4 or larger," "size 2 or larger," "size 1 or larger"). Capsule-shell size is a function of fill weight and volume and is selected per Remington and the supplier's size/volume tables (the '427 itself cites Remington pp. 1658–59 for capsule sizes). Where the fill weight is fixed, the shell size is a result-effective, non-patentable variable; the dependent claims add nothing inventive over the independent claims. Note also that "size N or larger" is a downward-open range (size 4, 3, 2, 1, 0, 00, 000), so it recites an obvious selection rather than a narrow improvement.

10. Rebuttal of the only asserted secondary consideration (unexpected results)

The sole basis for allowance was Anthony Tutino's Rule 132 declaration, and the Notice of Allowability (quoted in the Cigna complaint, ¶ 252) states allowance was granted because "the prior art of record is silent with respect to stability of pomalidomide when combined with various excipients." That position fails on the merits for four reasons:

1. Not commensurate in scope. The declaration's long-term data allegedly rest on Formulation F (the claimed system) versus Formulation J (MCC-containing). The claims, however, span six fill weights and two ratios and the specification claims 1:1–1:1.5. Two tested ratios cannot support the asserted range (In re Greenfield; In re Clemens). The Cigna complaint makes this exact point at ¶ 289 as to the sibling '467.
2. Wrong comparator. MCC is not the closest prior art to a mannitol/starch blend; it is the water-bearing excipient the art already taught a hydrolysis-sensitive drug should avoid. Showing that a known-bad system is worse is not "unexpected."
3. The asserted surprise is inconsistent with the declarant's own screen. Per ¶ 6 of the declaration, all tested excipients — including pregelatinized starch and spray-dried mannitol — were compatible at 1:1. A POSA reading the declaration learns that the claimed excipients were expected to work.
4. No data showing unpredictability across the class. The declaration offers a single-formulation comparison without statistical treatment or a showing that the result would not have been reached by routine stability screening, which is precisely what Remington and the specification's own protocol describe.

Commercial success / long-felt need. POMALYST is unquestionably successful, but nexus is weak: success is attributable to the pomalidomide molecule and the dosing regimen, not to the exact fill weights (62.5 vs. any other weight). Self-inflicted evidence undercuts nexus — the patent was withdrawn from the Hetero/Aurobindo/Apotex/Mylan/Breckenridge litigation (Special Discovery Master Order No. 14), and the Cigna and Hagens Berman pleadings allege generic manufacturers "would readily be able to design around this patent," which is the opposite of industry recognition that the claimed subject matter drove the advance.

11. Two procedural points that do not save the claims

• The examiner's repeated § 103 rejections are part of the record, not a defense. The examiner rejected the claims multiple times on the same references before the Rule 132 declaration; allowance followed the declaration, not a new reference or a narrowed claim to a previously unknown element. A Rule 132 declaration's weight depends on the quality of its comparison, addressed above.
• The narrow claim scope is itself an obviousness symptom. Applicants were driven to recitations like "a capsule which weighs 62.5 mg" — a fill-weight limit — because the formulation otherwise reads on the prior art. A claim whose only arguable point of novelty is an arbitrary total fill weight is the paradigm of routine optimization.

12. Anticipation vs. obviousness, and a cross-cutting § 112 issue

• If any single prior-art example discloses a pomalidomide capsule with pregelatinized starch, mannitol, and sodium stearyl fumarate, that would be a § 102 question for that species; but the specific total weights (62.5/125/250/180/240/300 mg) are almost certainly absent, so § 103 is the correct frame.
• Ambient § 112 concern (flagged, not relied on): the phrase "a capsule which weighs 62.5 mg" is ambiguous as to whether it includes the shell (a size-4 shell alone weighs roughly 40 mg; no size-4 capsule plus ~62.5 mg of fill can equal 62.5 mg). The generic ANDA filers raised exactly this indefiniteness theory (per the Hagens Berman brief). I raise it only because it shows the numeric limitations may not even be sharply defined — which weakens any argument that they carry inventive weight.

13. Caveats and verification to-do

State explicitly, per your rules:

• Not independently verified: the full text of US 5,593,696 (McNally) (title/substance unknown to me; I relied only on its face citation and class 424/472) and the substance of Crane & List (2005). I built no combination on either.
• Marriott 2002 and Schey I–III were retrieved only as descriptions in party pleadings, not as primary documents. Treat them as leads.
• Identity of EPO D1 and D4 in the Board decision at epo.org/boards-of-appeal/decisions/pdf/t220356eu1.pdf is not confirmed; I quoted the decision's own characterization of D1's paragraph numbering rather than asserting which document D1 is. The outcome of that appeal was not retrieved and I do not state one.
• Identifier inconsistency, reported literally and not corrected: the granted claims recite sodium stearyl fumarate; the specification's examples recite passing "sodium fumarate" through a 60-mesh screen; and the OCR of the Tutino declaration reads "sodium starch fumarate." These three are different compounds as written. This inconsistency matters in practice because the claimed lubricant species is a required element of every independent claim.
• Whether WO 2006/058008 is the PCT counterpart of US 2007/0155791 is my inference, not confirmed.
• No validity determination exists for the '427; the fraud-on-the-PTO and sham-litigation allegations in The Cigna Group v. Celgene, No. 1:25‑cv‑05237‑ER and the NYSD/Hagens Berman actions are pleading allegations, not findings.

14. Bottom line

On the record as it stands, each of claims 1, 3, 5, 7, 9, 11 (and, derivatively, claims 2, 4, 6, 8, 10, 12) would likely have been prima facie obvious over US 2007/0155791 (Zeldis) — alone or with WO 2006/058008 — in view of Remington's Pharmaceutical Sciences, the art-recognized hydrolytic instability of thalidomide analogs, and routine formulation optimization. The motivation is not speculative: (i) the same compound; (ii) the same dosage-form problem; (iii) each claimed excipient expressly listed or exemplified for that same compound; (iv) a known degradation mechanism pointing away from the only water-bearing candidate and toward the claimed low-moisture fillers; (v) the applicant's own screening showing every claimed excipient compatible; and (vi) the numerical limitations being conventional fill weights and two round-number ratios. The only asserted rebuttal — unexpected results via the Tutino Declaration — is vulnerable on commensurate scope, comparator selection, and internal inconsistency. Confidence: moderate-to-high on the § 103 conclusion; moderate on the reference-pinning, given the specific gaps flagged in § 13.

Sources: https://patents.google.com/patent/[US8828427](/patent/US8828427)/en ; https://storage.courtlistener.com/recap/gov.uscourts.njd.[348812](/patent/348812)/gov.uscourts.njd.348812.171.9_1.pdf (Tutino Rule 132 declaration); https://www.epo.org/boards-of-appeal/decisions/pdf/t220356eu1.pdf ; https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf (Notice of Allowability ¶ 252; claim-narrowing ¶¶ 255–256; ratio data ¶ 289) ; https://storage.courtlistener.com/recap/gov.uscourts.nysd.[628251](/patent/628251)/gov.uscourts.nysd.628251.1.0.pdf ; https://www.hbsslaw.com/sites/default/files/case-downloads/pomalyst-pomalidomide/2025-05-16-redacted-pls'-brief-iso-mot-to-file-second-am-complaint.pdf ; https://www.docketalarm.com/cases/New_Jersey_District_Court/2--17-cv-03387/CELGENE_CORPORATION_v._HETERO_LABS_LIMITED_et_al/docs/189.pdf (front-page reference list) ; https://patentimages.storage.googleapis.com/6c/39/61/357a5356da4706/[US9993467](/patent/US9993467).pdf (sibling patent reference list).