US 8288415

I'll run targeted searches for this specific patent number across the requested sources.

US 8,288,415 B2 — Analyst Summary

Scope note / search limitations (stated up front): I could not retrieve the verbatim claim set for this patent from the sources available. The "full patent text" supplied in the prompt is genuine Google Patents content but is truncated before the claims section (it ends mid-sentence in the tablet examples). My claim discussion below is therefore an interpretation grounded in the patent's title, abstract/Definitions section, description, plus third-party characterizations — not a quotation. My searches also returned no Federal Circuit docket from 2026 involving this patent, and I say so explicitly rather than inferring one. I did not auto-correct any identifier; all numbers below are as retrieved.

Bibliographic data

Sources: https://patents.google.com/patent/US8288415/en ; https://www.drugpatentwatch.com/p/patent/[8288415](/patent/8288415)

Abstract

"Substituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines are disclosed. The compounds are useful, for example, in reducing the levels of TNFα in a mammal." (drugpatentwatch.com). This matches the patent's own "Definitions" statement that the invention "relates to substituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines, the method of reducing levels of tumor necrosis factor α in a mammal through the administration thereof, and pharmaceutical compositions of such derivatives."

Plain-language overview of the disclosure (and, to the extent determinable, the independent claims)

What the document actually contains (verified from the supplied text): the specification is the classic Muller/Stirling/Chen lenalidomide-family disclosure — a genus of Formula I compounds, a TNFα-inhibition utility section, synthesis routes (nitrophthalic anhydride + 2,6-dioxopiperidin-3-ylammonium chloride; bromomethyl nitrobenzoate + glutamine ester routes), and a long series of worked formulation examples (tablets, chewable tablets, hard gelatin capsules, injectables). Key formulation teachings: oral dosage forms such as tablets, capsules and dragees containing 1 to 100 mg of drug per unit dosage; isotonic saline at 20–100 mg/mL for parenteral use; suppositories with cocoa butter for rectal use; conventional excipients (lactose, mannitol, microcrystalline cellulose, starch, talc, magnesium stearate, PEG 6000, sodium lauryl sulfate, gelatin, saccharin, glycine, stearic acid); and unit-dose packaging of "physically discrete units."

Independent claims — plain-language characterization (with uncertainty flagged): Because the claim text was not retrievable, I am characterizing rather than reciting. The evidence supports the following:

1. Composition claim(s) — most likely the primary independent claim. Given the patent's title ("Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione") — i.e., lenalidomide — and its position as the formulation patent in the '517 family, claim 1 is almost certainly directed to a pharmaceutical composition comprising 3-(4-amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione (lenalidomide) together with a pharmaceutically acceptable carrier, diluent or excipient. This tracks the specification's statement that "compositions thus comprise one or more compounds of the present invention associated with at least one pharmaceutically acceptable carrier, diluent or excipient."
2. Unit dosage form claim(s). The specification's express unit-dose language (1–100 mg per unit dosage; capsule/tablet forms) makes a dependent or independent unit-dosage-form claim likely.
3. Possible compound and/or method claims. Plaintiff-side antitrust complaints describe the '517 family as covering, collectively, (a) methods of treating cancers with Revlimid, (b) pharmaceutical compositions, and (c) the pharmaceutical compound itself (with compound coverage attributed to the '517 patent, claim 10). drugpatentwatch lists the claim types for 8,288,415 as "Composition; Compound," which suggests the '415 patent may contain compound coverage in addition to composition coverage — but I could not verify a compound claim verbatim, so treat that as unconfirmed.

Explicit uncertainty: I do not have authoritative text for the exact number, wording, or dependency structure of the independent claims of US 8,288,415. Anyone relying on this for infringement, validity, or freedom-to-operate purposes should pull the granted claims from USPTO PatentCenter or the Google Patents "Claims" tab.

Litigation / CAFC 2026 check

• Federal Circuit 2026: My searches returned no CAFC docket in 2026 involving US 8,288,415. The litigation record I found is district-court and antitrust based: Celgene Corp. v. Natco Pharma (D.N.J. 2:10-cv-05197, the litigation linked from Google Patents), plus the Revlimid/Thalomid purchaser antitrust cases (e.g., In re Revlimid & Thalomid Purchaser Antitrust Litigation, D.N.J. 2:19-cv-07532; United Healthcare Services v. Celgene, D.N.J. 2:20-cv-18531; Walgreen Co. v. Celgene, D.N.J. 2:22-cv-06440). I cannot rule out a 2026 appellate docket that the search didn't surface, but I found no evidence of one.
• Orange Book / product linkage: The '415 patent was listed in the Orange Book for Revlimid (NDA 21-880), with a date of "Jul 24, 2016" shown in one Orange Book cumulative supplement, and was cited in Natco's March 14, 2013 Paragraph IV certification (per multiple antitrust complaints).
• PTAB: I found no IPR/PGR record specifically for the '415 patent. The PTAB petition language I surfaced concerned the related '717 patent, not the '415.

Data discrepancies worth flagging (recorded literally, not corrected)

1. One antitrust complaint's table lists 8,288,415 with issue date "Oct. 16, 2006" and app. date "Dec. 10, 2009" — internally inconsistent and contradicted by the Oct. 16, 2012 grant date in the patent record and in Justia. Likely a typographical error in the complaint; I am not substituting a value.
2. Family expiry is described in litigation as July 24, 2016, whereas Google Patents records an adjusted expiration of 2020-01-19 with status "Expired – Fee Related." These reflect different things (nominal term vs. fee-related lapse/termination); the Google Patents legal-status field is expressly labeled an assumption, not a legal conclusion.
3. Google Patents lists the prior art date as 1999-05-07, while the same page lists external priority to US 09/543,809 (filed 2000-04-06) and US 09/781,179 (filed 2001-02-12). Both are reported as-is.

Bottom line: US 8,288,415 is Celgene's lenalidomide formulation patent, issued 2012-10-16 from application 12/635,637 on a 1999-era priority chain, now showing as expired for fee reasons. Its independent claims are best understood as directed to a pharmaceutical composition of 3-(4-amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione with a pharmaceutically acceptable carrier/diluent/excipient (possibly with unit-dosage-form and/or compound claims), but I could not verify the exact claim language, and I found no 2026 Federal Circuit activity for this patent.

I'll search for litigation involving US patent 8288415.

Let me dig deeper into the specific cases referenced.

Let me verify PTAB proceedings and the remaining antitrust matters tied to this patent.

US Patent 8,288,415 — Litigation Summary

The patent itself: US 8,288,415 B2, "Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione," issued October 16, 2012 to Celgene Corp. (inventors Muller, Stirling, Chen). It is a formulation/composition patent covering REVLIMID® (lenalidomide) and was listed in the Orange Book for NDA 021880. Google Patents links the patent's "family litigation" to D.N.J. case 2:10-cv-05197.

Important framing: The '415 patent was asserted in only one infringement action (Celgene v. Natco), which settled before any merits judgment. All other identified matters are antitrust/pay-for-delay actions in which the '415 patent is cited as one of the patents-in-suit in the alleged monopolization scheme — not suits for infringement of the '415 patent. I found no PTAB (IPR/PGR) proceeding directed specifically at the '415 patent.

1. Patent infringement litigation (the only direct assertion)

2. Antitrust / "pay-for-delay" follow-on matters citing the '415 patent

(Source for the above: DrugPatentWatch patent-level docket page for 8,288,415, last updated March 25, 2026: https://www.drugpatentwatch.com/p/alphasignals/litigation/patent/8288415; and docket 2:10-cv-05197 detail page.)

3. Additional related antitrust complaint referencing the '415

• A complaint filed October 6, 2023 in case No. 3:23-cv-05144 (a purchaser/payor antitrust complaint) expressly alleges that Celgene listed the '415 patent in the Orange Book as "a formulation patent" and that Natco's March 14, 2013 Paragraph IV certification stated the '415 and '886 patents were invalid, unenforceable, and/or not infringed (see ¶¶ 322–353 of that complaint). The '415 is cited as part of the alleged Revlimid monopolization scheme, not as an asserted infringement claim.

4. Pomalyst/Cigna matter — flagging, not asserting

A June 2025 antitrust suit by Cigna against Bristol-Myers Squibb/Celgene (S.D.N.Y.) concerns POMALYST (pomalidomide) patents and sham litigation. Pomalyst is a different drug from the lenalidomide-formulation subject matter of the '415 patent. I did not confirm that the '415 patent is a patents-in-suit in that case; treat this as related corporate-litigation context only, not as '415 litigation.

Bottom line

• One infringement action ever asserted US 8,288,415: Celgene Corp. v. Natco Pharma Ltd., 2:10-cv-05197 (D.N.J., filed Oct. 8, 2010) — asserted via Fifth Amended Complaint (May 6, 2013) — settled by consent judgment January 2016; no merits ruling.
• The '415 patent is named in a series of antitrust (Clayton Act) suits (Providence; In re Revlimid & Thalomid; United HealthCare; Walgreen) spanning 2015–2022.
• No PTAB IPR/PGR specifically targeting the '415 patent was found. (IPR2015-01103 challenged the related '720 REMS patent; its exhibit listed the '415 only as an Orange Book entry.)

Caveats: Several of these antitrust dockets are sealed/consolidated and current status is not fully public. I could not complete live verification of the most recent entries for the 2022 Walgreen case or the In re Revlimid MDL/consolidated action within this session, so the "pending" characterizations reflect the latest indexed docket data rather than confirmed current status. If you need certified current docket data, pull the PACER dockets directly for 2:10-cv-05197, 2:19-cv-07532, 2:20-cv-18531, and 2:22-cv-06440.

I'll start by checking the canonical list (the structured block says ODP returns none) and then search for any PTAB activity that may not be indexed yet.

Let me search more specifically for PTAB proceedings involving this patent number and the Coalition for Affordable Drugs filings.

Let me look for the drugpatentwatch PTAB case listing page for this specific patent and any IPR number referencing it.

PTAB / AIA Trial Proceedings — US 8,288,415

Patent: US 8,288,415 B2 — "Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione"
Patent owner / current assignee: Celgene Corp.
App. No. 12/635,637 · filed 2009-12-10 · granted 2012-10-16 · priority 1999-05-07
Status per source: Expired – Fee Related; adjusted expiration 2020-01-19
Source of record: patents.google.com/patent/US8288415/en

Proceedings overview

Zero (0) AIA trial proceedings — no IPR, no PGR, and no CBM — have ever been filed against US 8,288,415; the USPTO ODP structured list is empty, and independent web searching (~8 targeted queries across PTAB dockets, aggregator databases, and litigation complaints) surfaced no petition, institution decision, FWD, or appeal naming this patent. The bottom-line defensive posture is therefore unusual for a patent in this family: the '415 patent is un-challenged at the PTAB but also expired (adjusted expiration 2020-01-19, status "Expired – Fee Related"). That means a defendant's IPR-based invalidity defense is unnecessary — the more decisive facts are that the patent's term has run, and that the claims that would matter to an assertion are the narrow formulation claims (reported as claims 1–5) plus one compound claim (reported as claim 6).

Caveat on completeness: I could not verify third-party aggregator data against a primary PTAB source, and the ODP block is authoritative for this task. If a recently filed petition exists but has not yet been accorded a filing date, it would not appear in either source. Treat "zero" as accurate as of 2026-10-01 to the best of available evidence, not as a metaphysical certainty.

Proceedings on US 8,288,415

None. There is no proceeding to report at claim-level granularity, so the format below cannot be populated for this patent without fabrication. What follows is (a) what the record does show about the '415 patent's validity challenge history, and (b) the adjacent Celgene/lenalidomide AIA proceedings that are frequently conflated with it — clearly labeled as not proceedings on the '415 patent.

What the record shows for the '415 patent

• No AIA trial. No IPR/PGR/CBM number identifies US 8,288,415. The Google Patents record for the patent shows a "family has litigation" flag and a D.N.J. case link (2:10-cv-05197) but no PTAB tab entry, corroborating the ODP result.
• Validity was challenged in district court, not at the PTAB. Celgene asserted the '415 patent against Natco/Arrow/Watson in the D.N.J. Revlimid litigation (e.g., Celgene's Fifth Amended Complaint, 2013-05-06, pleading the '517, '230, '554, '106, '800, '415, '717 and '598 patents). Natco's Paragraph IV certification (2013-03-14) and counterclaims attacked the '415 patent under §§ 101, 102, 103, 112 and double patenting. See United Healthcare Servs. v. Celgene, D.N.J. 2:20-cv-18531, Complaint ¶¶ 173, 349 and Walgreen Co. v. Celgene, D.N.J. 2:22-cv-06440, Am. Compl. ¶ 156.
• That challenge ended in settlement, not adjudication. Celgene announced the Natco settlement on 2015-12-22; the court entered a consent judgment dismissing all claims with prejudice on 2016-01-04. The '415 patent's validity was never adjudicated, by the Board or by an Article III court. No Federal Circuit appeal on the '415 patent exists.
• Expiration. The patent is recorded as expired with an adjusted expiration of 2020-01-19 (fee-related status). Note that expiration does not bar IPR — the Board has repeatedly held IPR reaches expired patents (Apple Inc. v. Gesture Tech. Partners, LLC, IPR2021-00922, Paper 26 at 25–27 (PTAB Nov. 28, 2022)) — but no party ever filed one here.

Adjacent Celgene / lenalidomide AIA proceedings — NOT on the '415 patent (context only)

These involve different Celgene patents and must not be attributed to the '415 patent:

• Coalition for Affordable Drugs VI, LLC v. Celgene Corp. — IPR2015-01092, IPR2015-01096, IPR2015-01102, IPR2015-01103, on U.S. 6,045,501 and U.S. 6,315,720 (REMS/"distribution method" patents). Institution 2015-10-27; FWDs 2016-10-26 held the challenged claims invalid, primarily on obviousness; affirmed on appeal; Celgene then stopped pressing its other REMS patents. Papers cited at IPR2015-01092 (Paper 73), IPR2015-01096 (Paper 73), IPR2015-01102 (Paper 75), IPR2015-01103 (Paper 76). Panel in the associated papers: Michael P. Tierney, Michael W. Kim, Jacqueline Wright Bonilla, Grace Karaffa Obermann, Tina E. Hulse.
• Coalition for Affordable Drugs VI, LLC also petitioned against U.S. 5,635,517 (the lenalidomide compound patent), filed 2015-05-07 per DrugPatentWatch's lenalidomide PTAB table. I could not verify the outcome or the IPR number, and I will not guess either.
• Alvogen Pine Brook LLC v. Celgene Corp. — IPR2018-01714, on U.S. 7,968,569; Celgene's Patent Owner Preliminary Response (2018) argued discretionary denial under § 314(a) and Hatch-Waxman. Different patent.
• An IPR was also petitioned on U.S. 8,404,717 (Petitioner's preliminary-response excerpts reference claims 1–10). Different patent.

Sanctions note (relevant precedent for this patent owner): Celgene moved for sanctions against Kyle Bass/The Coalition for Affordable Drugs in the REMS IPRs. The Board denied the motions, holding that "profit is at the heart of nearly every patent and nearly every inter partes review," that the IPR statute does not limit petitioners to competitors, and that Celgene had not shown the petitions were non-meritorious. That ruling is a reminder that even a well-resourced brand owner cannot obtain PTAB sanctions merely because a petitioner is a non-practicing challenger.

Claims of US 8,288,415 — what's in play

The authoritative full text supplied for this task truncates before the claims section, so I could not verify claim language from the primary source. Per DrugPatentWatch's claim listing for this patent, the claims are:

Source: DrugPatentWatch, Claims for Patent 8,288,415. Flagged: I am relaying an aggregator's rendering; confirm against the granted claims at the Google Patents link above before relying on it in a filing.

CANCELED: none — no claim of the '415 patent has ever been canceled, because no AIA trial was ever instituted.
SUSTAINED: none by the PTAB. The claims survive only as issued; their validity is untested at the Board.
UNTESTED: claims 1–6, in their entirety.

Strategic summary

1. The decisive fact is the calendar, not the PTAB. US 8,288,415 expired with an adjusted expiration of 2020-01-19 and carries an "Expired – Fee Related" status. A demand letter or complaint asserting the '415 patent today can, at best, reach pre-expiration conduct, and only within the six-year damages lookback of 35 U.S.C. § 286. Because the '415 patent is the formulation member of the Revlimid family (unit dosage form containing 1–100 mg), it was always secondary to the compound ('517) and method-of-use ('740, '569) patents — and it is Celgene's compound and polymorph estates, not the '415 patent, that drove the ANDA wars and the DOJ/FTC-adjacent antitrust suits still visible on this patent's litigation docket (the D. Minn., D.D.C. and D.N.J. antitrust matters at drugpatentwatch.com/p/alphasignals/litigation/patent/8288415).

2. Estoppel landscape — § 315(e)(2). Because no IPR or PGR was ever instituted on this patent, there is no § 315(e)(2) estoppel attaching to anyone with respect to the '415 patent. No petitioner is barred from raising any § 102/§ 103 ground on these claims, and no patent-owner-side IPR-driven narrowing exists to build around. Practically, this cuts both ways: a defendant has a clean slate for IPR art, but the more likely posture is that no IPR is worth filing on an expired patent. Note also that estoppel from the other lenalidomide IPRs (the REMS '501/'720 proceedings, IPR2018-01714 on the '569 patent, etc.) runs to those patents' grounds and claims, not to the '415 claims.

3. Pattern signals. No single petitioner has filed multiple IPRs against the '415 patent — none has filed one at all. The only serial PTAB challenger in the Revlimid ecosystem was the Coalition for Affordable Drugs VI, LLC (Kyle Bass / Erich Spangenberg), and its targets were the REMS patents and the '517 compound patent, not the '415 formulation patent. There is no defensive aggregator (e.g., Unified Patents) in the chain for this patent. Importantly, the patent owner's aggressive appeal posture applies to the REMS patents it lost — Celgene litigated those to affirmance and then abandoned the rest of its REMS portfolio — not to the '415 patent, on which it never had a PTAB loss to appeal.

Recommended next steps

1. Lead with expiration, not invalidity. If you are on the receiving end of an assertion of US 8,288,415, the fastest dispositional argument is term: adjusted expiration 2020-01-19, status "Expired – Fee Related." There is no injunctive relief and no ongoing infringement theory post-expiration. Press for the asserted claims, the accused products, and the pre-2020-01-19 damages period, and demand a § 286-compliant accounting.

2. If validity must be attacked, treat it as an open field — but weigh the cost. There is no estoppel, no FWD, and no PTAB claim construction to inherit. The obvious attack is § 103 over the lenalidomide compound art plus routine formulation art (the 1–100 mg range and "tablet/capsule" limitations in claims 2–5 look vulnerable on their face), and § 112 written-description arguments parallel to those Natco developed against the '800 polymorph patent in D.N.J. But filing an IPR on an expired patent whose claims are already unadjudicated is rarely efficient; a § 112/§ 102–103 defense in the district court or in a DJ action is usually the cheaper path.

3. Paper the "no PTAB activity" finding. If you are building an IPR-based defense strategy or a portfolio challenge, document the ODP null result and the absence of any PTAB record on the Google Patents page as of 2026-10-01. The absence is itself a signal worth explaining to a client: this is a secondary formulation patent on a drug whose primary exclusivity ran through other patents — it drew a Paragraph IV challenge and an antitrust attack, but no one spent $500K challenging it at the Board, most likely because it was never the patent doing the blocking.

4. Watch the two places a late petition could still appear. (i) The Board's E2E system at e2e.uspto.gov for any newly accorded petition; and (ii) the D.N.J. antitrust/ANDA docket, since a co-defendant's § 315(b) one-year clock runs from service of a complaint alleging infringement of the '415 patent — and history here shows the parties settled (Natco consent judgment, 2016-01-04) rather than tried validity. If a new complaint asserting the '415 patent is served, that starts a fresh one-year IPR window for that defendant notwithstanding the patent's expiration.

Bottom line for a defendant today: the troll comparison in the prompt does not fit — this patent belongs to Celgene (now BMS), it expired on 2020-01-19, and no claim of it has been canceled because no claim of it was ever tried. There is no FWD to link to and no estoppel to exploit. A defendant's case rests on the expiration date and on district-court invalidity/non-infringement, not on the PTAB.

I'll research the assignment record and litigation history for US 8288415 before building the report.

Let me dig for the assignment records and the Celgene/BMS corporate events that would affect ownership.

Ownership & Assignment Analysis — US 8,288,415 B2

Data-access caveat (read first): I had no live, authenticated access to the USPTO Patent Assignment Center (https://assignmentcenter.uspto.gov/) or to the Google Patents legal-events assignment feed during this session. I therefore could not retrieve any reel/frame records, correspondent names, or execution dates. Everything below that is not a registered assignment is labeled as such. No reel/frame entry is invented anywhere in this report. Where I say "no records," it means no assignment record was surfaced by the sources I could reach — not a positive confirmation that none exists.

Inventors

Pattern notes:

• All three inventors are the same team named on the lenalidomide compound parents from which this application claims priority — US 09/543,809 (→ US 6,281,230) and US 09/781,179 (→ US 6,555,554). This is a normal, tightly-held corporate inventorship cluster, not a sign of a distressed or orphaned portfolio.
• I found no evidence of the inventors departing Celgene within 12 months of filing, and I did not find departure/assignment-back records. Treat the "unusual departure" screen as unverified rather than negative — I simply lack the employment/assignmentbackup data.

Original assignee

• Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901 (per the patent's own front-page/registry records and the Google Patents "Original Assignee" field).
• Product embodying the claims: Yes — REVLIMID® (lenalidomide) capsules, NDA 021880. The '415 patent was listed in the FDA Orange Book for lenalidomide (Patent Code DS DP), and was asserted in Hatch-Waxman litigation. The '415 patent is a formulation/pharmaceutical-composition patent directed to compositions of 3-(4-amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione (lenalidomide).
• Primary line of business: research-based biopharmaceutical company (oncology/hematology; also immunology via OTEZLA®/apremilast at the relevant time).
• Current status: Acquired. Bristol-Myers Squibb (BMS) completed its $74 billion acquisition of Celgene on 2019-11-20, and "Celgene became a wholly owned subsidiary of Bristol-Myers Squibb Company" (BMS press release, 2019-11-20). Celgene was not dissolved and was not in bankruptcy. Whether a recorded assignment of this patent to BMS or a BMS IP-holding subsidiary exists, I could not verify (see caveat).
• Patent status: Google Patents reports "Expired – Fee Related," adjusted expiration 2020-01-19; the Orange Book credited the patent with a listed expiration of Jul 24, 2016 at the time of listing. Either way, the patent term has run — it cannot anchor new assertions today.

Assignment timeline

No assignment record (reel/frame) was retrievable for US 8,288,415 in this session. The indexed public record I could reach (Google Patents) shows Celgene Corp as both Original and Current Assignee, with a legal-events history containing only Application filed by Celgene Corp and Publication/Grant events — no "Assigned to" / assignment recitals. On its face, that is consistent with no recorded post-issuance assignment, i.e., the original assignee (Celgene, now a BMS subsidiary) still being the owner of record.

Documented corporate/legal events that would sit around a real assignment chain, shown here only as context and explicitly NOT as recorded assignments:

• 1999-05-07 — Priority application filed (Celgene). (Not an assignment.)
• 2009-12-10 — Application US 12/635,637 filed as a continuation (Celgene). (Not an assignment.)
• 2010-10-08 — Celgene sues Natco over lenalidomide patents, D.N.J. 2:10-cv-05197; the '415 patent is among the asserted family. (Litigation, not an assignment.)
• 2012-10-16 — US 8,288,415 B2 granted to Celgene. (Grant, not an assignment.)
• 2019-11-20 — BMS acquires Celgene; Celgene becomes a wholly-owned BMS subsidiary. (Corporate merger; a recorded assignment of this patent was not confirmed.)
• 2020-01-19 — Adjusted expiration. (Term event, not an assignment.)

Because the assignment center data was unreachable, and the only indexed record shows no recorded transfer, the correct plain statement is: unless a merger/assignment record exists that I could not retrieve, ownership never left Celgene. Per the constraints, I stop the assignment-specific analysis at this point rather than speculate about reel numbers, correspondents, or execution/recording dates.

Note: I am not stopping the entire report here only because the litigation and merger record is independently documented and directly answers the NPE question. The remaining sections are built on that documented record, not on assignment data.

Timeline diagram

timeline
    title Ownership and assertion of US 8288415
    1999 : Priority filed by Celgene
    2009 : Continuation filed by Celgene
    2010 : Celgene sues Natco in D NJ
    2012 : Patent issued to Celgene
    2019 : Celgene acquired by Bristol Myers Squibb
    2020 : Patent term ends

NPE / troll-pattern signals

Because assignment records were unreachable, several screens are answered on the litigation and corporate record rather than on reel/frame evidence. I mark those "unclear" only where the assignment record was actually needed; where the corporate record settles the question, I say so.

1. Shell-entity transfer — not present. No evidence the patent moved from Celgene to a licensing-only LLC. The indexed record names Celgene Corp as current assignee (no "IP / Patents / Licensing / Holdings / Ventures" successor surfaced). No single-purpose LLC, no registered-agent address, no "no products" tell.

2. Known asserter in the chain — not present. No chain entity matches the public NPE lists (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Spangenberg entities, etc.). The asserting party is Celgene, an operating pharma with its own marketed product.

3. Repeat correspondent across the chain — unclear / not assessable. No assignment records (and therefore no correspondents of record) were retrievable. I cannot cite any attorney or firm, and I will not guess one.

4. Cascading transfers — not present. No multi-hop LLC-to-LLC sequence exists on the record I could reach; there is no evidence of consecutive assignments in <24 months.

5. Pre-litigation transfer — not present. No transfer precedes the assertion. Celgene filed the first lenalidomide ANDA suit on 2010-10-08 while it was the owner; the '415 patent was asserted as part of a normal Hatch-Waxman response to a Paragraph IV notice (Natco notice ~2010-08-27; suit within the 45-day window).

6. Bankruptcy fire-sale — not present. Celgene's exit was a $74B strategic acquisition by BMS (closed 2019-11-20), not a Chapter 7/11 sale. No Kodak/Nortel-style asset liquidation.

7. Privateering — not present. Celgene asserted its own patents directly against generic ANDA filers; there is no operating-company→NPE transfer funding assertions "on behalf of" the operating company.

8. Defensive aggregator — not present. The chain does not terminate at RPX, AST, LOT, Unified, or OIN.

Verdict

Operating-company assertion.

Celgene Corporation — an operating pharmaceutical manufacturer whose REVLIMID® (lenalidomide) product is listed in the Orange Book with this patent (Patent Code DS DP) — is the original and, on the indexed record, the current assignee, with no recorded transfer to any licensing entity. Celgene asserted the lenalidomide patent family, including a formulation patent tied to this family, directly against generic ANDA filers (e.g., Celgene v. Natco, D.N.J. 2:10-cv-05197, filed 2010-10-08), which is conventional operating-company Hatch-Waxman enforcement against real competitors, not NPE activity. The chain ends not in an asserter LLC but in a BMS-subsidiary holding (BMS acquired Celgene 2019-11-20), and the patent has since expired — so all eight NPE screens read absent or non-assessable.

Confidence caveat: the verdict rests on the litigation + corporate record because I could not pull the Assignment Center reel/frame data; if a recorded merger assignment (Celgene → BMS entity) exists, it would be a routine internal reorg and would not change this verdict.

Verify independently at: https://assignmentcenter.uspto.gov/ (search patent number 8288415) and https://patents.google.com/patent/US8288415/en.

I'll search for the specific patent and its cited prior art references.

Let me search more specifically for the cited references listed on this patent.

Let me try to retrieve the actual "References Cited" / patent citations table for this patent.

Prior-Art Analysis — US 8,288,415 B2

"Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione"

Task framing / honesty note (read first). You asked me to "look at each patent citation for 8288415." I must be straight with you about a gap that also affected the earlier-generated summary: the Google Patents text supplied in the prompt is truncated before the front-page "(56) References Cited" table and before the claims. My searches returned the patent PDF (patentimages.storage.googleapis.com/.../US8288415.pdf), from which I did recover a substantial portion of the non-patent-literature (NPL) citation list, and I confirmed the patent's claim concepts (capsule, pharmaceutical excipient, dosage form, salts, diluent, drug carrier). I could not retrieve the verbatim U.S.-patent-document (56) table.

Accordingly, below I distinguish clearly between:

• [V] = verified from retrieved source material;
• [I] = inferred from the family/litigation record, not verbatim-verified on the '415 face.

I am not auto-correcting any patent number. All numbers are reproduced as retrieved.

1. USPTO record for 8,288,415 (the specific number requested)

Governing law. The application was filed 2009-12-10 and claims 1999–2001 priority, so pre-AIA 35 U.S.C. §§ 102/103 govern. The critical date is set by the effective filing date — i.e., one year before whichever priority application the claims are entitled to (the record supports 2000-04-06 / 2001-02-12, with a "prior art date" showing 1999-05-07). This matters enormously for §102(b) vs. §102(e) vs. double patenting, and I flag it again in §5.

2. The citation record — what is and is not verifiable

2.1 Claim concepts on the '415 face (useful for §102 claim-mapping) [V]

Google Patents' claim-concept extraction for the '415 shows the claims recite: capsule (14 occurrences), pharmaceutical excipient (11), acid (8), dosage form (8), salts (6), diluent (5), drug carrier (3). This refines the earlier-generated section's inference: the claims appear to include a composition claim (active + carrier/diluent/excipient), a salt limitation, and a capsule / unit-dosage-form claim. Because the verbatim claim text is still not retrieved, I map prior art to claim families, not to quoted claim language.

2.2 Patent-document (56) citations — [I], face not verified

I could not obtain the verbatim (56) list. The patent-document references that the record connects to '415 (same family; same Orange Book listing for Revlimid; recited as external priority) are:

All seven are Muller/Stirling/Chen-family or Celgene-common-owned documents. That is a legal, not merely factual, observation: same-family Celgene documents are the natural §102 targets but usually collapse into obviousness-type double patenting (ODP) rather than anticipation.

2.3 Non-patent-literature citations — [V] (recovered in part from US8288415.pdf)

Cited in the '415's specification/Information Disclosure, recovered verbatim in fragments:

3. §102 analysis, reference by reference

Framing caveat, repeated for safety: the exact wording/numbering of the '415 claims was not retrievable (see the earlier-generated summary, which reached the same conclusion). I therefore map each reference to the claim families visible from the record — (i) a composition claim of lenalidomide + carrier/diluent/excipient; (ii) a capsule/unit-dosage-form claim; (iii) possibly a compound claim (drugpatentwatch lists claim types for 8,288,415 as "Composition; Compound") — and state the §102 consequence for each.

Group A — Family/priority U.S. patents

A1. US 5,635,517 (Muller, Stirling, Chen). [I on face; relationship verified via litigation/TIPO record]

• Citation: U.S. Patent 5,635,517; TIPO survey characterizes it as "General compound formula of Lenalidomide." Orange Book lists it for Revlimid with a "DS" (drug substance) code.
• Date: issued 1997-06-03 [I]; the OB supplement shows request date Oct 04, 2019 and expiry 2019-10-04.
• Description: Genus of substituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines, including the 4-amino-1-oxoisoindoline species now named lenalidomide, and methods of reducing TNF-α.
• §102 mapping: §102(b) — issued more than one year before even the earliest claimed priority (1999/2000), so it is prior art notwithstanding shared inventorship. It is a strong §102 anticipation candidate for the composition claim only if it discloses lenalidomide together with a pharmaceutical carrier/excipient (the family's specifications do contain the "compositions thus comprise … at least one pharmaceutically acceptable carrier, diluent or excipient" boilerplate). Against a compound claim on lenalidomide it is a direct §102(b) reference. Against a capsule/unit-dosage claim it is weaker unless a finished dosage form is exemplified.

A2. US 6,281,230 B1 (Muller et al.). [V as priority document]

• Citation: U.S. Patent 6,281,230 B1; expressly named as external priority on the '415 face (application 09/543,809, filed 2000-04-06).
• Description: According to the purchaser-antitrust complaints, "the '230 claims methods of treatment involving lenalidomide to treat cancerous conditions and reduce TNFα"; it also discloses pomalidomide in combination.
• §102 mapping: Because '415 may claim the same 2000-04-06 benefit, the '230 is the parent rather than "another's" art — its realistic role is §102(b)-adjacent ODP / §102(a)-reference-in-family, not clean §102(e) art. If '415's claims are entitled only to a later date (e.g., the 2009 filing), the '230 (issued 2001-08-28) becomes §102(b) art on the same reasoning as A1.

A3. US 6,555,554 B2 (Muller et al.). [V as priority document]

• Citation: U.S. Patent 6,555,554 B2 (application 09/781,179, filed 2001-02-12).
• Description: Same genus/utility subject matter; the OB supplement lists it with a "DP" (drug product) code alongside '415 and applies the same Jul 24, 2016 date.
• §102 mapping: Identical logic to A2. Note the "DP" code is legally meaningful to your question: it signals FDA's/registrant's representation that the '554 and the '415 each claim a drug product — i.e., a composition/dosage form — which is precisely the claim family you're evaluating for §102.

A4. US 6,045,501; 6,315,720; 6,561,976; 6,755,784 (Celgene REMS/"'720 family").

• §102 mapping: These claim methods of restricting/permitting access to a drug (contraindication management), not the lenalidomide formulation. They are highly unlikely to anticipate the '415 composition claim; they are relevant only as background/common-ownership context. The antitrust complaints also state these "'501 and '720 families of patents … do not claim a drug substance, drug product, or method of use" listed for the drug — i.e., no §102 bearing on the '415 claims.

Group B — Third-party U.S. patents

I retrieved no verified third-party U.S. patent citation on the '415 face. Searches surfaced third-party documents only as random hits on the numbers you gave (e.g., unrelated barcode/US-design patents), and per your instruction I am not importing results for similar or unrelated numbers. I therefore state plainly: I cannot identify a third-party U.S. patent in the '415's (56) list with confidence. This is the single largest open item in this analysis.

Group C — Non-patent literature (§102(b) art)

C1. Jönsson (1972), Acta Pharm. Suecica 9, 521–542 — the most dangerous reference.

• §102 mapping: The '415 specification itself states that "1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline or 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-5-aminoisoindoline are known. See, e.g., Jönsson, Acta Pharma. Suecica, 9, 521-542 (1972)." That is an admission that Jönsson discloses the 4-amino (and 5-amino) dioxo analogs. To the extent the '415 claims a composition either of those phthalimide (1,3-dioxo) amino compounds — i.e., pomalidomide-type species — Jönsson is §102(b) anticipation art. Note carefully the structural distinction relevant to anticipation: Jönsson's disclosed species are 1,3-dioxo (phthalimide) amino compounds; the '415 title compound lenalidomide is the 1-oxo (isoindolinone) 4-amino compound. Whether Jönsson discloses the 1-oxo species is the decisive anticipation question, and the literature (Jönsson's own Part I paper, Acta Pharm. Suecica 9, 431–436, also cited) covers isoindolin-1-one derivatives — so this is not a frivolous line.
• Litigation corroboration [V]: A D.N.J. authority list in Celgene Corp. v. Hetero Labs (2:17-cv-03387) records that "Jönsson qualifies as prior art to the '262, '939 and '428 … § 102(b), having published in 1972, which is more than a year" before the relevant critical date. That is a court-facing, if unrelated-patent, confirmation of Jönsson's §102(b) status in Celgene's own portfolio.

C2. Muller et al. (1999), Bioorg. Med. Chem. Lett. 9, 1625–1630 ("Amino-substituted thalidomide analogs: potent inhibitors of TNF-α production").

• §102 mapping: Published June 7, 1999 (per the purchaser complaints) — within one year of an April 2000 priority date, so it is decisive under §102(a) but not §102(b) unless the critical date is the 1999-05-07 date showing on the '415 face, in which case it is not prior art at all. It discloses "4-amino substituted analogs were found to be potent inhibitors of TNF-α." It is therefore §102(a)/§103 art against the lenalidomide composition claim and its antecedent compound genus, and it is the reference Celgene's own scientists authored — meaning it cannot be "another's" work for §102(a) if inventors overlap (Muller is a named '415 inventor). Flag this.

C3. Lentzsch et al. (2002), Cancer Research 62, 2300–2305. Published April 2002 — after the 2000/2001 priority dates, so it is not §102 prior art to the '415's priority claims; it would only be §102(a) art if the '415 were forced to a 2009 effective date, and even then it is cumulative to Muller (1999).

C4. Miyachi et al. (1996, 1997, 1998); Koch (1985); Helm (1981); Gordon (1981); Hastings (1980); Gelato (1972); Menard (1963); Grabstald (1965); Mucker (1965); Heger (1989).

• §102 mapping: All pre-date the 1999/2000 critical dates and are therefore available as §102(b) art. But their subject matter is thalidomide SAR, metabolites, teratology, and TNF-α regulation by phthalimides — not lenalidomide compositions. Realistic role: §103 (motivation to substitute/modify the phthaloyl ring to modulate TNF-α, per Miyachi; anti-inflammatory expectation per Koch), not §102 anticipation of a lenalidomide composition or capsule claim. Individually they lack the "arranged as claimed" disclosure required by §102.

C5. Lendaris (2004) and "Opinion Ther. Patents" (2004). Post-priority, non-technical/landscape materials — no §102 value.

4. Ranking — most relevant prior art to US 8,288,415

5. Contradictions, flags, and what still needs verification

1. Verbatim (56) patent table not retrieved. The prompt's own text ends mid-sentence in the tablet examples; Google Patents' "Patent Citations" tab was not captured by my searches. The Group A list is [I] (family/Orange Book/priority-record derived), not a transcription of the '415 face. Anyone relying on this for an IPR or a §282 notice must pull the printed patent's (56) list from PatentCenter.
2. Verbatim claims still not retrieved. Consistent with the earlier-generated section, I have not recited any claim. My §102 mapping is to claim families inferred from Google Patents' claim-concept extraction (capsule, excipient, dosage form, salts, diluent, carrier) and the drugpatentwatch "Composition; Compound" tag.
3. Same-inventor overlap disqualifies part of the art. US 5,635,517, 6,281,230 and 6,555,554 share inventors Muller/Stirling/Chen with '415, and Muller et al. (1999) is authored by a named inventor. That does not save '517 (issued 1997, so §102(b) applies regardless), but it does weaken any §102(a)/§102(e) reliance on the 1999 Muller paper and the '230/'554.
4. Priority-date ambiguity persists. The '415 face shows a "prior art date" of 1999-05-07 alongside external priority of 2000-04-06 and 2001-02-12. Which date is critical controls whether Muller (1999) is §102(a) art or not at all. I am not resolving this by assumption.
5. Litigation-acquired — not a new contradiction: In D.N.J. 2:10-cv-05197 the parties stipulated to dismiss claims on the '230, '554, '106 and '415 patents after Natco filed a paragraph III certification, on the basis that those patents expire July 24, 2016; the Google Patents legal-status field, by contrast, shows adjusted expiration 2020-01-19 and "Expired – Fee Related." These measure different things (settlement date-of-expiry representation vs. fee lapse), and I repeat the earlier section's flag rather than harmonize it. Consistent with the earlier section, I still find no 2026 Federal Circuit activity for this patent.
6. Open item most worth closing: the Group B third-party U.S. patents. My searches could not surface a verified third-party (56) document on the '415 face; I explicitly decline to substitute unrelated results for numbers that are merely similar in appearance, per your instruction.

I'll gather the prior-art/citation record for this patent before analyzing obviousness.

Let me pull the actual cited-references and prior-art record for this specific patent.

Let me get the actual claim language and the invalidity/prior-art record from the Natco litigation.

Obviousness Analysis — US 8,288,415 B2 under 35 U.S.C. § 103

Analyst note on sources. This section builds on the prior "Patent summary" and does not repeat its bibliographic, abstract, or litigation content. Two caveats carried forward: (1) the verbatim claim set was not retrievable in the earlier pass; (2) I have now recovered a usable proxy for the claim scope from the Google Patents term-frequency metadata (below), which I flag as an inference, not a quotation. I also note a date inconsistency in the task metadata: the system date is given as 2026-10-01, while the task header says April 26, 2026. I record both literally and do not correct either.

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

Using the supplied Google Patents text literally, the "Prior Art" indicia for US8288415 are limited to:

The retrieved page did not include the "Cited By" or "Similar Documents" lists, so the two Muller/Celgene patents above plus the references cited inside the specification are the only §103 inputs the page itself supplies. I supplement with references surfaced from the specification body and from the parallel litigation/public record, and I label each source. I have not invented any reference.

References in the specification body (verified from the supplied text):

• Jönsson, Acta Pharm. Suecica 9, 521–542 (1972) — cited in the '415 specification as disclosing 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline and 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-5-aminoisoindoline ("See, e.g., Jönsson…").
• The specification's own admissions about unit dosage ("from 1 to 100 mg of drug per unit dosage"), excipient lists (lactose, mannitol, microcrystalline cellulose, starch, talc, magnesium stearate, PEG 6000, sodium lauryl sulfate, gelatin, saccharin, glycine, stearic acid), and routes of administration.

References from external sources (flagged as such):

• US 5,635,517 (Muller et al., Celgene; priority 1996-07-24) — the genus/compound patent; third-party complaints state the '517 family "claims the pharmaceutical compound for Revlimid ('517…)" (business.cch.com Cigna complaint, Table 2 and ¶¶2–4).
• EP 0 925 294 — reported to disclose "lenalidomide, process for production thereof, its use and pharmaceutical composition thereof … the composition of a capsule comprising active ingredient in admixture with non-toxic pharmaceutically acceptable excipients, which are microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate" (EP 3731817 B1, Background ¶[0008], data.epo.org). This is a direct formulation hit and, in my view, the single most dangerous reference for a lenalidomide composition claim. I could not confirm its publication date in this pass and flag that gap.
• Muller et al., Bioorg. Med. Chem. Lett. 9(11):1625–1630 (1999) and Corral et al., J. Immunol. 163(1):380–386 (1999) — amino-substituted thalidomide analogs as potent TNF-α inhibitors. These are cited in the record as "Corral (1999)" and "Muller (1999)" (Hagens Berman pomalidomide complaint ¶150). I am reasonably confident of these citations but did not re-verify bibliographic details in this pass.

2. Claim scope used for the §103 analysis (inference from metadata, flagged)

The Google Patents term-frequency block on this page tags which terms appear in the claims column. Reading that literally:

Inference (explicitly flagged as inference): claim 1 is most likely a composition claim of the form "A pharmaceutical composition comprising 3-(4-amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione, or a pharmaceutically acceptable salt/acid addition salt thereof, and a pharmaceutical excipient/carrier," with dependent claims reciting a capsule, a dosage form, a diluting agent, and a drug carrier. This is consistent with the earlier summary's characterization and with the Natco Markman brief's grouping of the '230/'554/'106/''415 patents as the family's "pharmaceutical compositions" members (courtlistener.com, D.N.J. 2:10-cv-05197, Doc. 249). It is also consistent with the Cigna complaint, which lists '415 as claiming "methods of treating cancers with Revlimid" and "pharmaceutical compositions."

If claim 1 in fact recites formulation-specific parameters (excipient ratios, dissolution, content uniformity, a named polymorph), the analysis in §5 below changes materially — see §7.

3. Level of ordinary skill and the governing framework

POSA: a formulation scientist or medicinal chemist with a Ph.D. or an M.S. plus ~2–5 years of experience in pharmaceutics of small-molecule oral dosage forms, able to consult standard references (Remington's Pharmaceutical Sciences; Introduction to Pharmaceutical Dosage Forms), familiar with the excipient classes recited in the claims, and aware of the thalidomide-analog/IMiD literature.

Framework: Graham v. John Deere Co., 383 U.S. 1 (1966) (scope and content of prior art; differences; level of skill; secondary considerations), applied through the flexible KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) rationales — combining known elements by known methods to yield predictable results; simple substitution of one known element for another; "obvious to try"; and design incentives/market forces. For formulations, the Federal Circuit has long treated the pairing of a known active with known excipients/dosage forms as a paradigm of obviousness subject matter (e.g., Merck & Co. v. Biocraft Labs., 874 F.2d 804 (Fed. Cir. 1989); In re Kao, 639 F.3d 1057 (Fed. Cir. 2011) — I cite these from general knowledge; pin cites not re-verified this pass).

Threshold issue — the effective filing date, which controls everything:

Note the family's shared nominal expiry of July 24, 2016 for the '230, '554, '106 and '415 patents (Cigna complaint ¶5), which strongly suggests terminal disclaimers tying the family together — i.e., the '415 was, in prosecution, treated as not patentably distinct in term from its siblings. That is a double-patenting posture that also colors the §103 analysis (see §6).

4. Specific §103 combinations

Combination 1 — US 6,555,554 B2 (primary) + Remington's / Jönsson (secondary)

Where each teaches: The '554 is one of the two documents the page itself lists as prior art for '415. According to the Natco Markman brief, "the '554 patent claims pharmaceutical compositions containing lenalidomide in quantities sufficient to reduce TNFα, improve oncogenic or cancerous conditions, reduce inflammation, or improve autoimmune disease, and also claims methods of using lenalidomide to reduce TNFα" (Doc. 249). Jönsson (1972) and Remington's supply the conventional carrier/diluent/lubricant teaching.
Why combined: One of ordinary skill seeking to administer the '554's disclosed TNFα-inhibiting compound to a patient has an express design incentive to place it in a pharmaceutically acceptable vehicle. The '554 itself already frames the invention in composition terms.
Result: A claim to "lenalidomide + a pharmaceutical excipient/carrier" is at most an obvious (indeed broader) variation of the '554's claimed composition — the only difference is the omission of the "quantity sufficient to reduce TNFα" limitation, and broadening a claim by deleting a functional limitation cannot confer patentability. This ground is strongest if the '415 loses its pre-2009 priority.

Combination 2 — EP 0 925 294 (primary) + routine formulation knowledge (Muller 1999 / Corral 1999 for the active)

Where each teaches: EP 0 925 294 discloses lenalidomide and a capsule thereof containing microcrystalline cellulose, sodium lauryl sulfate and magnesium stearate (per EP 3731817 B1 ¶[0008]). Muller (1999)/Corral (1999) establish lenalidomide's TNF-α potency and thus its therapeutic desirability.
Why combined: If the claims recite a capsule and a pharmaceutical excipient/diluent (as the metadata suggests), EP 0 925 294 discloses the very excipient set that the '415's own capsule examples use. There is nothing left to invent. KSR rationale (B): simple substitution of one known excipient for another to obtain a predictable result.
Result: Anticipation or, at minimum, obviousness of the composition/capsule/carrier claims. Caveat: I could not confirm EP 0 925 294's publication date in this pass; if it publishes after the operative priority date, this ground converts to a §102(e)/§102(a) analysis on its application date.

Combination 3 — US 5,635,517 (primary) + Jönsson (1972) + Remington's (secondary)

Where each teaches: The '517 is described in the litigation record as claiming the Revlimid compound; Jönsson discloses the closely related amino-isoindolinedione/dioxopiperidinyl species and their utility; Remington's teaches formulating an orally active imide with tablet/capsule excipients.
Why combined: The '517 puts the artisan in possession of the compound and its TNF-α utility; Jönsson confirms the chemical class is pharmaceutically useful; standard formulation texts supply the vehicle. Motivation is the ordinary one of reducing a known therapeutic to a dosage form. This ground is robust to the priority question because Jönsson (1972) and '517 (1997) both predate even the earliest candidate priority date.

Combination 4 — '230/‘554/'517 + clinical dosing literature, for unit-dosage claims

Where each teaches: The '415 specification concedes that "oral dosage forms include tablets, capsules, dragees … containing from 1 to 100 mg of drug per unit dosage"; the contemporaneous clinical literature discloses 5–25 mg/day lenalidomide dosing (the 2005 MDS trial and 2006 MM approval at 5/10/15/25 mg — see the FDA approval-letter record described in the Hagens Berman complaint ¶¶132–134).
Why combined: Dosage strength is a result-effective variable within a range the specification itself calls conventional; selecting 5, 10 or 25 mg for a capsule is routine optimization (In re Kao; MPEP 2144.04). Motivation: matching the unit dose to the known clinical dose.

Combination 5 ("obvious to try") — any one of the above + the acknowledgement in the '415 specification itself

The '415's own Background/Definitions admits the 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-amino-isoindolines were "known" (citing Jönsson) and that its compositions "comprise one or more compounds of the present invention associated with at least one pharmaceutically acceptable carrier, diluent or excipient." An applicant's own specification is usable as evidence of what was conventional (In re Nomiya-type reasoning — cited from general knowledge).

5. Motivation-to-combine / reasonable-expectation summary

All references are in the same field of endeavor (TNF-α modulators / thalidomide analogs / oral pharmaceutics), which satisfies the KSR/MPEP 2141.2 "field of the inventor's endeavor" and "suitable for the intended purpose" tests.

6. The double-patenting overlay (worth flagging because it is how this patent was actually attacked)

Because '415 is in the same family as the '230 and '554, a §103 ground that relies on '230/'554 is only available if '415 is not entitled to the family priority. If it is entitled to that priority, the same facts become an obviousness-type double patenting attack: '415's composition claims must be "patentably distinct" from '554's composition claims, and the shared July 24, 2016 expiry across the '230/'554/'106/'415 patents (Cigna complaint ¶5) indicates terminal disclaimers were used, which invites exactly that challenge. Either way, the practical outcome is the same: the '415 composition claims are vulnerable to a §103 or ODP challenge.

I note that in the related district-court case, defendants sought leave to add five new prior-art references against the '517, '230, '554, '106 and '415 patents; the court denied the motion as untimely (Doc. 366, Nov. 18, 2014), so the merits of those references were never adjudicated on the '415 — https://law.justia.com/cases/federal/district-courts/new-jersey/njdce/2:2010cv05197/[247596/366](https://assignmentcenter.uspto.gov/search/patent/reelFrameDetail?reelFrame=247596-0366)/. Multiple purchaser/antitrust complaints independently plead that the Revlimid patents are invalid under §§101, 102, 103, 112 and double patenting (e.g., City of Providence v. Celgene, D.N.J. 2:15-cv-01605, Complaint ¶ per courtlistener.com).

7. Where the §103 case is weak — and what would change my conclusion

1. Verbatim claims unavailable. My claim scope is inferred from Google Patents term-frequency metadata. If a claim recites a specific excipient ratio, a dissolution profile, content uniformity, a specific polymorph (e.g., hemihydrate Form B), or a coated-tablet architecture, the obviousness case weakens substantially — and, notably, later filers (JP 7585043 B2; KR 20190120094 A; EP 3 135 275 A1) built their own patentable subject matter precisely on tablet content-uniformity and bioequivalence problems with the marketed capsule, which supports the proposition that a plain capsup composition was old but a specific engineered tablet might not have been.
2. If the '415's claims are entitled to the 2000/2001 priority, '230 and '554 cannot be §102(b) art against them, and Combinations 1 and 4 must be re-based on '517 + Jönsson + Remington's (Combination 3) or on ODP.
3. Secondary considerations the patentee would assert: commercial success of Revlimid (a nexus question — the '415 covers the marketed capsule, so a nexus is plausible); long-felt need; and the unexpected MDS/deletion-5q efficacy. These are efficacy/structure-based, not formulation-based, arguments, and they map more naturally onto the method-of-use (e.g., '717) patents than onto a §103 challenge to a composition claim covering a conventional capsule. Still, under Graham they must be weighed.
4. EP 0 925 294's date is the one factual gap that could convert Combination 2 from "obviousness" to "anticipation," or remove it entirely. It should be confirmed against ESPACENET before any merits opinion is finalized.

8. Bottom line

• To the extent US 8,288,415's claims are directed to a pharmaceutical composition / capsule / dosage form comprising 3-(4-amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione and a pharmaceutical excipient, diluent or carrier, they are prima facie obvious under §103 over (i) US 6,555,554 B2 or US 6,281,230 B1 (both listed on this very page as prior documents) alone or in view of standard formulation knowledge; (ii) EP 0 925 294, which is reported to disclose a lenalidomide capsule with microcrystalline cellulose, sodium lauryl sulfate and magnesium stearate; and (iii) US 5,635,517 + Jönsson (1972) + Remington's.
• The motivation is the ordinary, predictable one of reducing a known TNF-α-inhibiting imide to a conventional oral dosage form; the recited excipients, dosage forms and (if present) 1–100 mg unit doses are result-effective variables and routine design choices under KSR.
• The single most important unresolved fact is the effective filing date of the '415's composition claims: if it is 2009-12-10, the entire family becomes §102(b) art and the §103 case is very strong; if it is 2001, the case rests on '517/Jönsson plus obviousness-type double patenting.
• I could not retrieve the verbatim claims, and I expressly decline to state their wording as fact; the claim-scope statements above are inferences from Google Patents metadata and litigation characterizations.

Sources: https://patents.google.com/patent/US8288415/en ; https://storage.courtlistener.com/recap/gov.uscourts.njd.[247596](/patent/247596).249.0.pdf ; https://law.justia.com/cases/federal/district-courts/new-jersey/njdce/2:2010cv05197/[247596/366](https://assignmentcenter.uspto.gov/search/patent/reelFrameDetail?reelFrame=247596-0366)/ ; https://business.cch.com/ald/TheCignaGroupvCelgeneCorporationComplaint.pdf ; https://www.hbsslaw.com/sites/default/files/case-downloads/pomalyst-pomalidomide/2023-09-07-complaint.pdf ; https://data.epo.org/publication-server/rest/v1.2/publication-dates/2025-01-22/patents/EP3731817NWB1/document.pdf