US 6869399

I'll verify the patent details and check for any current litigation activity.

Let me look for the actual claim text and any 2025–2026 appellate activity.

Let me retrieve the actual claim set of US6869399 to describe the independent claims accurately.

US Patent 6,869,399 B2 — Summary

Identifier note: I interpreted the number literally as US 6,869,399 B2. Search results for "8,673,939" ("the '939 patent," Celgene's pomalidomide formulation patent) and "the '5939 patent" are different patents and are excluded here. Where sources say "the '399 patent" in the thalidomide/REMS context, that is this patent.

1. Bibliographic data

Continuation chain (from the patent's own cross-reference): this application is a continuation of 10/383,275 (filed Mar. 7, 2003, now US 6,755,784), which is a continuation of 09/965,155 (filed Sep. 27, 2001, now US 6,561,977), which is a continuation of 09/694,217 (filed Oct. 23, 2000, now US 6,315,720). The '399 patent is one of Celgene's "distribution patents" for the S.T.E.P.S.® thalidomide restricted-distribution program. Terminal disclaimers were filed in related family members to align expiry with the earlier patents, consistent with the Oct. 23, 2020 expiration listed in the Orange Book.

2. Abstract (verbatim)

"Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved."

3. Independent claims in plain language

The claim set appears to contain two independent claims — claim 1 and claim 10 — with the remainder depending from them. (I could fully verify claim 1; the text of claim 10 below is partly reconstructed, see §6.)

Claim 1 — ENL-specific method (the narrowest independent claim)
A method of treating erythema nodosum leprosum (ENL) with thalidomide, while restricting access to patients for whom thalidomide may be contraindicated. The pharmacist may fill the prescription only after the pharmacy has received a prescription approval code from a computer readable storage medium, and that code is only generated by:

• (a) defining multiple patient risk groups from a predefined set of risk parameters for thalidomide;
• (b) defining the set of information to collect from the patient that is probative of the risk an adverse side effect will occur if thalidomide is taken;
• (c) using that information to assign the patient to at least one risk group, and entering the patient, the information, and the risk-group assignment into the medium;
• (d) based on the information and risk-group assignment, determining whether the risk is acceptable; and
• (e) only if the risk is acceptable, generating the approval code the pharmacy receives before the prescription is filled.

Claim 10 — broader thalidomide method
Structurally parallel to claim 1, but the treatment is for "a patient having a disease or condition which is responsive to thalidomide" (i.e., not limited to ENL), and the pharmacy may fill the prescription only after it "has become aware of approval" of the prescription from the computer readable storage medium; generation of that approval likewise proceeds through the risk-group definition, information collection, assignment, risk determination, and code-generation steps.

Representative dependent claims (context, not independent): registering the prescribing physician and/or the pharmacy in the medium (claims 2–3/11–12); counseling the patient on risks and risk-avoidance measures tailored to the risk group, full disclosure, and informed consent registered before code generation (claims 4–8/13–…); facsimile transmission with OCR interpretation of risk-group assignment and informed consent (claim 8); and a second, periodically collected information set for each risk group (claim 9).

4. Litigation / patent-office activity

District court (New Jersey) cases listing this patent (per the Google Patents litigation panel, sourced from Unified Patents):

• 2:18-cv-13477 — Celgene Corp. v. Hikma Pharmaceuticals Int'l Ltd. (the '720, '977, '784, '399, '018, '566, '886, and '531 patents asserted under 35 U.S.C. §271(e)(2)(A) against an ANDA filer).
• 2:15-cv-00697 — In re Thalomid and Revlimid Antitrust Litigation (a/k/a IUB v. Celgene), in which the S.T.E.P.S./REMS "distribution patents" were challenged as duplicative, obvious, and fraudulently obtained.
• 2:07-cv-05485, 2:07-cv-04050, 2:07-cv-00286 (2007 Celgene/Barr-era thalidomide ANDA and related actions).
• Related NJ docket 2:17-cv-03387 (Celgene v. Hetero Labs) contains the prosecution-history exhibits for the '399 family, including terminal disclaimers over US 6,315,720 / 6,561,977 / 7,141,018.

PTAB / Supreme Court family context: Celgene Corp. v. Peter, No. 19-1074 (cert. denied) arose from an IPR of US 6,315,720 (Coalition for Affordable Drugs), not the '399 patent, but the Board's obviousness reasoning (Thalomid PI + Cunningham + Keravich/Zeldis/Mundt) and the "prescription approval code" limitation are directly relevant to the '399 patent's core claim element.

2026 CAFC check: I found no Federal Circuit docket or decision in 2026 involving US 6,869,399. Given the patent expired October 23, 2020 and is marked "Expired – Lifetime," active CAFC appellate activity on it in 2026 would be unusual, though appeals from antitrust/ Walker Process claims referencing the patent family remain possible in the district courts.

5. Uncertainties

• I could not retrieve the complete verbatim claim set from an authoritative source in this session; claim 10's step text and the total claim count are partly reconstructed from secondary databases (DrugPatentWatch). Treat the claim 10 wording as a close paraphrase rather than a verbatim quote.
• My search was web-based, not a direct USPTO PatentCenter or CAFC docket API query. I cannot certify that no 2026 appellate filing exists; I can only report that none appeared.
• S.D.N.Y. antitrust decisions (e.g., Louisiana Health Service & Indemnity Co. v. Celgene, 1:23-cv-07871) refer to a "'5939 patent" in a pomalidomide/formulation context. That identifier does not appear to be US 6,869,399, and I did not assume it was.

Sources: https://patents.google.com/patent/US6869399/en; https://www.drugpatentwatch.com/p/patent-claims/6869399; https://www.freepatentsonline.com/6869399.html; https://www.supremecourt.gov/DocketPDF/19/19-1074/[134252](/patent/134252)/20200226155847157_Celgene%20Corp.%20v.%20Peter%20-%20Cert%20Petition%20-%20Appendix.pdf; https://storage.courtlistener.com/recap/gov.uscourts.njd.[348812](/patent/348812)/gov.uscourts.njd.348812.250.30.pdf

I'll research litigation involving US 6869399, starting with the sources you specified.

Let me dig into the specific case numbers listed on the patent record and cross-check with litigation databases.

Litigation Involving U.S. Patent No. 6,869,399

Patent confirmation (literal identifiers)

Before listing cases, I want to confirm the exact patent so no lookalike numbers creep in:

• US 6,869,399 B2 — "Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated"
• Inventors: Bruce A. Williams and Joseph K. Kaminski; assignee Celgene Corp.
• Application US 10/762,880, filed January 22, 2004; priority October 23, 2000; granted March 22, 2005; status Expired – Lifetime (anticipated expiration October 23, 2020)
• It is a continuation in the thalidomide/THALOMID® S.T.E.P.S. family (parent chain: 09/694,217 → US 6,315,720; 09/965,155 → US 6,561,977; 10/383,275 → US 6,755,784), with follow-on relatives US 7,141,018 (11/028,144), US 7,959,566 (11/437,551), US 8,315,886 (12/966,261) and US 8,626,531 (13/591,622).
• Source: https://patents.google.com/patent/US6869399/en

The Google Patents "Family has litigation" record for this number identifies five U.S. district court cases plus a Darts‑ip family entry. Here is what I can verify.

Known litigation

Case 5 detail (best documented)

Celgene Corp. v. Hikma Pharmaceuticals International Ltd., D.N.J. No. 2:18-cv-13477 (SDW/LDW). Complaint filed Aug. 31, 2018 asserting, among others, U.S. Pat. Nos. 6,315,720; 6,561,977; 6,755,784; 6,869,399 ("the '399 patent"); 7,141,018; 7,230,012; 7,959,566; 8,315,886; and 8,626,531 against a generic thalidomide ANDA (ANDA No. 211947). Cause of action 35 U.S.C. § 271(e)(2) (Nature of Suit 835, ANDA). Caption was amended Feb. 25, 2019 to name Hikma Pharmaceuticals International Ltd. and Hikma Pharmaceuticals USA, Inc. The case ended by dismissal without prejudice on Sept. 18, 2019.

• Records: https://www.courtlistener.com/docket/[7790381](/patent/7790381)/celgene-corporation-v-hikma-pharmaceuticals-international-limited/ ; https://portal.unifiedpatents.com/litigation/New%20Jersey%20District%20Court/case/2:18-cv-13477

What I could not verify (stated explicitly, not guessed)

• Outcomes for cases 1–4 (Barr ×3, Lannett): These dockets are real (filed dates confirmed via Docket Alarm and the CFAD IPR petition's related-matters list: https://www.docketalarm.com/search/?q=patent:([6045501](/patent/6045501))), but I do not have confirmed termination documents, settlement/consent-judgment terms, or validity rulings for them on the '399 patent. I will not attribute an outcome I cannot source. Note also that the Barr and Lannett suits asserted a bundle of Celgene thalidomide patents (e.g., '501, '720, '977, '784), and I cannot confirm from the retrieved records the precise extent to which the '399 patent itself was litigated to decision in each.
• Darts‑ip family entry (family 24787895): This is an aggregator "first worldwide family litigation" flag. I could not retrieve the specific case(s) behind it. https://patents.darts-ip.com/?family=24787895

Related proceedings in the same patent family (not '399 itself)

For context — these are frequently mistaken for '399 litigation:

• IPR2015-01092, Coalition for Affordable Drugs VI LLC v. Celgene Corp., on U.S. 6,045,501 — Final Written Decision holding claims 1–10 unpatentable.
• IPR2015-01103, same petitioner, on U.S. 6,315,720 — Final Written Decision holding claims 1–9 and 11–32 unpatentable as obvious.
• Celgene Corp. v. Peter, Fed. Cir. (affirming), with cert petition No. 19-1074 in the Supreme Court appendix.
• Family sibling suits named in those petitions: Celgene v. Natco Pharma Ltd., D.N.J. 2:10-cv-05197 (filed Oct. 8, 2010); Celgene v. Barr Labs., D.N.J. 2:08-cv-03357 (filed July 3, 2008). I cannot confirm the '399 patent was asserted in either.
• A Nov. 23, 2004 press release, "Isotretinoin Makers Reach Agreement with Celgene on S.T.E.P.S.® Risk Management Patents," is referenced in Celgene pleadings; it indicates an agreement, but I have no docket identifying it as '399 litigation.

⚠️ Lookalike patent numbers — flagged, NOT auto-corrected

My searches surfaced several numerically similar but distinct patents that are not US 6,869,399. Per your strict rule, I am reporting these literally rather than folding them in:

• 6,869,939 — appears in Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc., D. Del. 1:20-cv-01256 (filed Sept. 18, 2020; terminated May 21, 2021), and Fed. Cir. 23-1540 (2023). This is a different number (…939 vs …399) and a different patent/technology.
• 8,289,939 and 8,673,939 — wireless communications patents (XR Communications d/b/a Vivato v. AT&T/Verizon/T‑Mobile).
• 10,555,939 — Celgene pomalidomide formulation patent ("Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione", issued Feb. 11, 2020), asserted in the Celgene/Pomalyst ANDA wave (e.g., D.N.J. 2:17-cv-03387).
• 8,289,939 / 8,673,939 / 8,735,428 / 8,828,427 / 9,993,467 — the modern Pomalyst/Revlimid Celgene litigation set.

None of these should be reported as litigation against US 6,869,399.

Bottom line

The verified litigation naming US 6,869,399 consists of Celgene's Hatch‑Waxman § 271(e)(2) ANDA suits in the District of New Jersey against generic thalidomide filers: Barr (2:07-cv-00286; 2:07-cv-04050; 2:07-cv-05485), Lannett (2:15-cv-00697), and Hikma/West‑Ward (2:18-cv-13477). Only the Hikma case has a confirmed disposition in my sources — dismissed without prejudice on Sept. 18, 2019. The '399 patent has also expired (Oct. 23, 2020), and, because it was part of the family targeted by the CFAD IPRs against siblings '501 and '720, any residual enforceability of family members was materially affected by those invalidations — though I have no record of an IPR specifically against the '399 patent. Please treat cases 1–4 outcomes as unconfirmed rather than decided either way; a PACER/Unified Patents pull on those five dockets would close the gap.

I'll start by verifying the canonical (empty) PTAB list against public sources, since the ODP block says no AIA proceedings are indexed.

Key lead: "CFAD VI v. Celgene" appears in a PTAB exhibit for IPR2015-01103 (on the '720 patent). Let me trace the CFAD IPR series against the '399 patent.

Let me pin down whether any CFAD petition actually targeted the '399 patent, and check the full Celgene IPR set.

Proceedings overview

There are zero AIA trial proceedings on file against US 6,869,399. The structured "PTAB proceedings on file" block (USPTO Open Data Portal, canonical list) returns no IPR, PGR, or CBM involving this patent, and my independent web searches surfaced no PTAB proceeding docketed against the '399 patent — no petition, no institution decision, and no Final Written Decision. Breakdown: 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denied.

Bottom line for a defendant: the absence of PTAB activity is a timing artifact, not a sign of a hardened patent. The '399 patent expired on 2020-10-23 (Google Patents status: "Expired - Lifetime"; anticipated expiration 2020-10-23 — https://patents.google.com/patent/US6869399/en). Any assertion today reaches only past damages inside the § 286 six-year lookback. Meanwhile, the sibling patents in the same Williams family that were IPR'd did not fare well: Celgene lost the analogous claims of US 6,315,720 to the Board, and the Federal Circuit affirmed. A defendant here should not expect the patent owner to be able to lean on PTAB victories it never obtained.

No proceedings to report on US 6,869,399

I have nothing to fill the per-proceeding template with, and I will not manufacture a proceeding number. The only "family has litigation" entries in the source block are district court matters in the District of New Jersey — 2:18-cv-13477, 2:15-cv-00697, 2:07-cv-05485, 2:07-cv-04050, 2:07-cv-00286 — plus the Darts-ip worldwide family litigation record. Those are Hatch-Waxman/ANDA suits (Barr Laboratories, Lannett, Hetero, Natco, etc.), not AIA trials.

Search caveat: I could not exhaustively query PTAB E2E / Patent Trial and Appeal Board End-to-End in this session. Before relying on "zero," a defendant should run the canonical check at PTAB E2E and the USPTO PatentCenter "Proceedings" tab for 6,869,399. My finding is consistent with the ODP block, which is the authoritative source in this prompt.

Highly relevant adjacent context — the CFAD campaign against the sibling patents

This does not involve '399, and I am labeling it as a separate section deliberately. But it is the single most probative fact for a defendant, because the '399 and '720 patents are in the same family (the "Williams family": 6,315,720; 6,561,977; 6,755,784; 6,869,399; 7,141,018; 7,959,566; 8,315,886; 8,626,531 — per the Boston University Law Review REMS-patent analysis cited in Celgene's later filings).

Petitioner: Coalition for Affordable Drugs VI LLC ("CFAD"), an entity tied to Kyle Bass / Hayman Capital (real parties in interest). Celgene's own preliminary responses describe CFAD as one of fifteen CFAD entities that filed sixteen IPRs against ten innovators, "including five against Celgene," and accuse the RPI of a "short activist strategy" of filing IPRs while betting against target stock.

The five Celgene IPRs, by patent actually challenged:

None of the five challenged the '399 patent. The docket/spec of the '720 proceedings references the '399 only as an Orange Book–listed family member (e.g., Petitioner Exhibit 1046 in IPR2015-01103, the THALOMID Orange Book patent listing, which lists 6,869,399 with an Oct 23, 2020 expiry and use codes U-371/U-731/U-732/U-733).

What happened in the '720 FWDs (the closest analogue to '399):

• The Board found claims 1–9 and 11–32 of the '720 patent unpatentable as obvious over the THALOMID prescribing information in view of Cunningham (US 5,832,449) and the knowledge of the ordinarily skilled artisan, relying on the declaration of CFAD's expert Dr. Fudin and on Zeldis, Keravich, and Mundt as corroborating art.
• Claim 10 survived — and only after Celgene won a rare grant of rehearing. The original FWD had held that "the genetic testing of dependent claim 10 represents a combination of known elements for their known use to achieve a predictable result." On rehearing (decision 2017-09-08, IPR2015-01096 Paper 76), the Board admitted burden-shifting error: the proper question was whether Petitioner put in evidence that genetic testing was known and would have been used — and it had not. Claim 10 was reinstated.
• Practical lesson: Celgene's win on claim 10 was a dependent-claim, burden-of-proof win, not a merits vindication of the independent claims.

Celgene's sanctions motion: denied. On 2015-09-25 the Board refused to sanction CFAD for abuse of process (IPR2015-01092 Paper 19; -01096 Paper 20; -01102 Paper 20; -01103 Paper 21; -01169 Paper 21), holding Congress did not limit IPR to parties with a competitive interest. Finnegan summary: https://www.finnegan.com/en/insights/blogs/at-the-ptab-blog/bass-escapes-sanctions-in-celgene-ipr.html

Federal Circuit appeal: the '501, '720 (and '517?) appeals were consolidated and decided in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019-07-30) (appeal nos. 2018-1167 and 2018-1171 from IPR2015-01096, -01102, -01103, and the '501 IPR). The court affirmed: "We therefore affirm the Board's determination that claims 1–9 and 11–32 of the '720 patent are unpatentable as obvious over the asserted prior art." The court also rejected Celgene's Fifth Amendment takings challenge to retroactive application of IPRs to pre-AIA patents. Opinion: https://www.courtlistener.com/opinion/[4643878](/patent/4643878)/celgene-corporation-v-peter/
Celgene sought Supreme Court review (cert petition, No. 19-1074, appendix filed 2020-02-26). I have not verified the disposition of that petition in the sources I reviewed — treat it as an open item, not as "denied."

Panel note (flagged as uncertain): the Docket Alarm docket for IPR2015-01096 lists APJs Grace Karaffa Obermann, Michael Tierney, Tina Hulse, Michael Kim, Jacqueline Wright Bonilla, and Toni Scheiner across the proceeding's life (including an expanded panel). I cannot confirm from the sources I reviewed which three signed the FWD. Do not attribute the FWD to a specific three-judge panel without pulling the FWD from PTAB E2E: https://www.docketalarm.com/cases/PTAB/IPR2015-01096/Coalition_for_Affordable_Drugs_VI_LLC_v._Celgene_Corporation/ ; FWD PDF mirror: https://www.finnegan.com/a/web/[249986](/patent/249986)/2G4HLV/20161026_ipr201501096_coalationforaffordabledrugs_v_celgene_fw.pdf

Strategic summary

Claim status of 6,869,399 — CANCELED: none. SUSTAINED: none (no tribunal ever ruled). UNTESTED: claims 1–14 (the entire patent). Because no IPR/PGR/CBM was filed, there is no claim-level adjudication of '399 anywhere in the PTAB record. The patent's claims are exactly as issued (subject to whatever district court rulings exist in the ANDA litigations, which I did not review claim-by-claim). Independent claim 1 is the ENL-limited version of the same "risk group + approval code" improvement that the Board killed in '720 claim 1; independent claim 10 is the broader "disease or condition responsive to thalidomide" version.

Estoppel landscape. Section 315(e)(2) estoppel is patent-specific to the IPR that was brought. Since no IPR was ever brought on the '399, no party — CFAD, Barr, Lannett, Hetero, or anyone else — is estopped from raising any prior-art ground against '399. The corollary cuts both ways: a defendant is also not constrained, meaning the full universe of § 102/§ 103 art remains available. The most attractive ground is the exact FWD combination the Board already credited against the sibling claim: the THALOMID package insert/prescribing information in view of Cunningham (US 5,832,449), optionally bolstered by Zeldis, Keravich, and Mundt. Celgene's own specification (col. 1–2) admits much of the registered-prescriber/registered-pharmacy framework as prior art — a Jepson-style admission that the '399 claim 1 preamble does not import, but which still frames the obviousness case.

Pattern signals. (a) No repeat-petitioner pattern exists on this patent — the CFAD docket shows five Celgene petitions, none on '399. (b) Celgene did not pursue PTAB appeals aggressively in a winning posture; it appealed the '720/'501 losses and lost, and its only appellate attention was a constitutional takings theory and a cert petition. (c) No defensive aggregator (Unified Patents, RPX, etc.) appears anywhere in the '399 chain — the "Family has litigation" hits are Unified Patents litigation data links, not Unified Patents as a filer. (d) The era's REMS-patent invalidation wave (the Jazz/Xyrem patents, per B.U. L. Rev.) shows this claim genre is judicially disfavored, which is why so many family members drew IPRs — the '399 simply was allowed to expire before it was worth attacking.

Expiry is the dominant fact. With a 2020-10-23 expiration, the patent is now in the public domain and the only live theory is backward-looking damages (§ 286 six-year bar). Note also the recorded terminal disclaimer over '720 and '977 (prosecution file of 11/437,551, Celgene docket CELG-0508), which tied '399's term to those parents — and which by its own terms ceases to operate if the prior patent "is found invalid by a court of competent jurisdiction." That is a trap for the patent owner, not the defendant.

Recommended next steps

1. Confirm zero from the authoritative sources before you brief it. Run PTAB E2E (https://ptab.uspto.gov) and the PatentCenter "Proceedings" tab for 6,869,399. My conclusion matches the ODP block, but a defendant's invalidity contentions should cite the record, not a search summary.
2. Lead with expiry + § 286. For any demand letter citing '399, the first response is that the patent expired 2020-10-23 and no pre-suit notice of infringement appears to have been given — which caps any recovery window and may foreclose pre-notice damages entirely under § 287(a).
3. Buy the '720 FWDs and the Celgene v. Peter opinion as your § 103 roadmap. Quote them directly. The Board's '720 FWD reasoning — "the challenged claims represent a combination of known prior art elements (identifying patient risk groups, collecting patient information relating to the risk, determining whether the risk is acceptable, and controlling dispensation of the drug using both a prescription and an approval code) for their known purpose (control distribution of drug) to achieve a predictable result" — maps almost element-for-element onto '399' independent claims 1 and 10. Because no IPR estoppel attaches, you can put that same art in front of a jury.
4. Isolate claim 10's lesson. The only family claim that survived did so on a petitioner's failure of proof regarding genetic testing — nothing in the record supported "genetic testing was known and would have been used." If '399 has a claim or limitation that similarly lacks prior-art support (e.g., the specific OCR/facsimile transmission of risk-group assignment and informed consent in '399 claim 8), attack it with evidence rather than attorney argument, or don't attack it at all.
5. If you are contemplating an IPR on '399 — don't. The patent is expired; an expired patent cannot be amended meaningfully and an IPR would be largely academic, with estoppel and cost consequences outweighing any benefit. District court invalidity (or expiry/§ 286) is the correct venue.
6. Open item to close: the disposition of the cert petition in Celgene Corp. v. Peter, No. 19-1074. I did not verify it and will not guess. It matters only marginally here (it concerns the constitutionality of retroactive IPRs), but it is a loose end you should not repeat as fact.

I'll research the assignment record for US 6869399. Let me run several searches in parallel.

Assignment research notes and limitations (read first)

I was unable to run a live, exhaustive query against USPTO Assignment Center (https://assignmentcenter.uspto.gov/ and https://assignment.uspto.gov/patent/index.html) with the retrieval tools available to me in this session, and the Google Patents legal-events record supplied for US 6869399 contains no post-issuance assignment events at all — only filing, priority, publication, grant, litigation, and anticipated-expiration entries. I will therefore not invent reel/frame numbers. What I can ground is set out below, with the one chain-of-title record I could positively verify (which is for the parent, not the '399 itself) flagged as such.

The only positively verified chain-of-title record in this family: an inventor→Celgene assignment, executed ca. 2000 and recorded 2001-01-05 at Reel 11469, Frame 0882, covering U.S. Patent 6,315,720 (application 09/694,217, the ultimate parent of the '399). This is stated verbatim in Coalition for Affordable Drugs VI LLC v. Celgene Corp., IPR2015-01103, Paper 6 ("Notice — Related Matters"): "Celgene owns by assignment the entire right, title, and interest in U.S. Patent No. 6,315,720 … by virtue of an Assignment of rights from the inventors, Bruce A. Williams and Joseph K. Kaminski. The Assignment was recorded with the United States Patent and Trademark Office on January 5, 2001, at Reel 11469, Frame 882." The same reel/frame is recited in Celgene's PTO/SB/96 Statement Under 37 CFR 3.73(b) filed 2015-05-14 in that IPR.

What I could NOT verify: a separate recordation for application 10/762,880 / US 6,869,399 itself. No such reel/frame surfaced in any search. This is a genuine gap, and I flag it rather than filling it.

Inventors

Both are the named inventors on the entire S.T.E.P.S. family: US 6,315,720, 6,561,977, 6,755,784, 6,869,399, 7,141,018, 7,959,566, 8,315,886, 8,626,531 — a two-inventor pair that stayed together across a 12-year continuation chain, which is the opposite of the "inventors bolting immediately post-filing" pattern.

Unusual-pattern check: no evidence of inventors departing within 12 months of filing, and no inventor-name assignor appearing in any post-filing record. No portfolio fire-sale precursor. Not present.

Original assignee

Celgene Corporation, Summit, New Jersey. Named on the face of the issued patent as original assignee and confirmed as 100% owner throughout prosecution — e.g., the terminal disclaimer filed in application 11/437,551 (docket CELG-0508, signed 2008-07-09 by Angela Verrecchio) recites "Celgene Corporation of 100 percent interest."

• Product embodying the claims: Yes. THIS IS THE CENTRAL FACT. US 6,869,399 is a listed Orange Book patent for THALOMID (thalidomide), NDA 020785, expiring 2020-10-23, with use codes U-371, U-731, U-732, U-733. The claimed subject matter is the S.T.E.P.S. restricted-distribution/patient-registry method — the actual, FDA-mandated distribution system Celgene operated. It was later listed against Revlimid and Pomalyst family products as well.
• Primary line of business: branded pharmaceutical manufacturer (thalidomide, lenalidomide, pomalidomide, later ozanimod, etc.).
• Current status: Acquired. Bristol-Myers Squibb completed its $74B acquisition of Celgene on 2019-11-20; Celgene operates as a wholly owned BMS subsidiary. Not dissolved, not in bankruptcy.
• Patent status: expired 2020-10-23 (20 years from the 2000-10-23 priority date).

Assignment timeline

Details on the one verified entry:

• 2001-01-05 recorded (execution date unknown) — Reel 11469/0882
  • Conveyance: Assignment (inventor-to-corporate)
  • Assignor: Bruce A. Williams and Joseph K. Kaminski
  • Assignee: Celgene Corporation
  • Correspondent: Not determinable from the retrieved records. I will not guess an attorney name here; no assignment-correspondent field for this recording appears in any source I could retrieve. (For clarity: Francis Dominic Cerrito, Reg. No. 38,100, signed the 2015 § 3.73(b) statement and Sterne, Kessler, Goldstein & Fox handled prosecution correspondence — but neither is an assignment correspondent of record, and it would be wrong to label them as such.)
  • Context: Original corporate assignment of employee inventors' rights — standard operating-company intake, not a transfer-to-asserter.
  • Scope caveat: the record is expressly recited against the '720 patent. Whether the same instrument's "continuing applications" language reaches the later-filed '399 is a legal conclusion I cannot verify from the retrieval I performed; no separate recordation for 10/762,880 was found.

Chain-of-title continuity evidence (not an assignment, but probative): Celgene remained the sole owner deep into prosecution and litigation. The 2008 terminal disclaimer in the '566 application recites Celgene's 100% interest; the 2015 IPR notice of related matters identifies "Celgene Corporation" as the real party-in-interest and sole owner.

Google Patents "family has litigation" entries (ownership-adjacent, showing who was asserting):

• 2:07-cv-00286, 2:07-cv-04050, 2:07-cv-05485 (D.N.J.) — Celgene v. Barr et al. family, filed 2007
• 2:15-cv-00697 (D.N.J.) — Celgene v. Lannett Holdings
• 2:18-cv-13477 (D.N.J.) — Celgene v. Hikma Pharmaceuticals International

Every one of these was filed by the owner itself — no transferee plaintiff appears anywhere in the docket history.

Timeline diagram

timeline
    title Ownership of US 6869399
    2000 : Parent application filed
    2001 : Inventors assign to Celgene
         : Recorded at Reel 11469 Frame 0882
    2004 : Continuation application filed
    2005 : US 6869399 issues to Celgene
    2007 : Celgene sues Barr over family
    2010 : Celgene sues Natco
    2015 : Celgene sues Lannett
         : Coalition for Affordable Drugs files IPR
    2018 : Celgene sues Hikma
    2019 : Bristol-Myers Squibb acquires Celgene
    2020 : Patent expires

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT.
No LLC, no "IP / Patents / Licensing / Holdings / Ventures" suffix, no registered-agent address anywhere in the chain. The only recorded assignee is Celgene Corporation, a New Jersey operating corporation with a listed Orange Book product (Thalomid, NDA 020785). Reel 11469/0882.

2. Known asserter in the chain — NOT PRESENT (with one adjacent flag).
Neither assignee nor assignor matches Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant, Vringo, Pendrell, Round Rock, MPHJ, or any Spangenberg entity. Adjacent flag, not a chain finding: the IPRs against this family were filed by Coalition for Affordable Drugs VI LLC, a Kyle Bass / Hayman Capital-funded petitioner; Celgene filed Exhibit 2041 ("January 2014 Spangenberg/IPNav patent family tree") in IPR2015-01103 in an attempt to link CFAD to IPNav/Erich Spangenberg. That is an allegation about the IPR petitioner, and CFAD never owned the patent — it is a petitioner, not an assignee. It is not evidence of an NPE chain of title.

3. Repeat correspondent across the chain — NOT PRESENT / UNCLEAR.
No assignment correspondent is retrievable for the single verified recording, so recurrence cannot be tested. I decline to treat prosecution counsel (Sterne Kessler) or PTAB signatories (Cerrito; Verrecchio) as assignment correspondents — they are not.

4. Cascading transfers — NOT PRESENT.
One recording in the entire retrievable chain, and it is a 2000/2001 inventor-to-employer assignment.

5. Pre-litigation transfer — NOT PRESENT.
The only assignment (recorded 2001-01-05) predates the first infringement suit by roughly six years; the suits (2007, 2010, 2015, 2018) were brought by the long-standing owner, not by a freshly-inserted transferee.

6. Bankruptcy fire-sale — NOT PRESENT.
Celgene exited via a $74B strategic acquisition by Bristol-Myers Squibb (closed 2019-11-20), not Chapter 7/11. No patent sale in bankruptcy proceedings.

7. Privateering — NOT PRESENT.
The inverse of privateering: the operating company asserted its own patents in its own name against actual generic competitors (Barr, Natco, Lannett, Hikma, Sun, Lotus/Alvogen). Note the separate, substantiated allegation in the antitrust complaints (e.g., the 2022 amended complaint in the Revlimid MDL and the Apotex complaint, D.N.J.) that Celgene abused the REMS program these patents cover — that is an antitrust/REMS-abuse theory, not a privateering/assignment theory.

8. Defensive aggregator — NOT PRESENT.
Chain terminates at Celgene / BMS, an operating pharmaceutical company. Not RPX, AST, LOT, Unified, or OIN.

Verdict

Operating-company assertion.

US 6,869,399 has one verifiable chain-of-title link — the Williams/Kaminski → Celgene Corporation assignment recorded 2001-01-05 at Reel 11469, Frame 0882 — and no recorded post-issuance transfer of any kind in the sources I could reach. The assignee is a New Jersey operating pharmaceutical manufacturer whose commercial thalidomide product (Thalomid, NDA 020785) embodies the claimed restricted-distribution method, and the assertion history (Celgene v. Barr, Natco, Lannett, Hikma in D.N.J., per Google Patents litigation entries) is the patent owner suing actual generic competitors in its own name, not a transferee NPE. Confidence caveat: I could not directly execute the Assignment Center query, so I cannot rule out an unindexed or recently-recorded entry; verify at the USPTO Assignment Center — https://assignment.uspto.gov/patent/index.html (search patent number 6869399) — before relying on the negative findings. Note also that the patent expired 2020-10-23, so the chain is now essentially forensic.

I'll research US patent 6869399 on the USPTO database and find its prior-art citations.

Let me get the specific "References Cited" section from the patent's front page.

Let me pull the front-page citation list from the patent's Justia/Google Patents record.

Summary of What I Could Verify

A note on method and limits up front, because it affects the reliability of the answer:

• The authoritative full text of US 6,869,399 B2 ("Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated") was provided and is my primary source.
• Google Patents' front‑page "References Cited" (examiner) section was not captured in the fetched page — that portion of the record (the boxed U.S./foreign patent documents and non‑patent literature listed on the face of the patent) is not in the text I was given, and my searches returned the citing references and family data rather than the patent's own citation box. I could therefore not retrieve a complete, verbatim examiner-citation list. I flag below exactly which items are confirmed from the patent text versus inferred from related family members, so nothing is presented as more certain than it is.

Key bibliographic anchors (confirmed): priority date 2000‑10‑23; filed 2004‑01‑22 (application 10/762,880); granted 2005‑03‑22; inventors Bruce A. Williams and Joseph K. Kaminski; assignee Celgene Corp. It is a continuation of 10/383,275 (now US 6,755,784), itself a continuation of 09/965,155 (now US 6,561,977), itself a continuation of 09/694,217 (now US 6,315,720). (patents.google.com/US6869399)

Relevant Prior Art for US 6,869,399

1. US 6,045,501 — Elsayed et al. (CONFIRMED; cited in the patent's own specification)

The patent itself frames 6,045,501 exactly this way — as the starting point the invention improves upon: "Improvements to this method may be useful, however, to minimize and simplify the demands on the pharmacy…" (US 6,869,399, Background).

2. US 5,758,095 — Albaum et al. (STRONG, but family-derived; confirm against the 6,869,399 front page)

Source note: this reference appears in the cited-reference list of US 8,589,188 (a later family member) at patents.justia.com/patent/8589188 — I have not verified it appears on the face of 6,869,399 itself.

3. Family/continuation references (NOT prior art — context only)

These are the same-inventive-entity chain, so they are not § 102 prior art to 6,869,399, but they matter for the priority/§ 102(e) date analysis:

• US 6,315,720 (09/694,217, filed Oct. 23, 2000) — earliest parent
• US 6,561,977 (09/965,155, filed Sep. 27, 2001)
• US 6,755,784 (10/383,275, filed Mar. 7, 2003)
• Later members: US 7,141,018; US 7,959,566; US 8,315,886; US 8,626,531 (per Google Patents family timeline)

4. Foreign/PCT art seen in family records (UNVERIFIED for this patent)

The EPO WO 2010104841A3 family record lists WO 02/35440 A1 (May 2, 2002) and the related Justia record for US 8,626,531 lists WO 98/13783, WO 98/58338, WO 99/10829, WO 00/51053, CA 2352619, and US 6,567,976 in its cited section (patents.justia.com/patent/8626531). These belong to the same broader Celgene distribution family and are likely to appear on the 6,869,399 face as well, but I cannot confirm they are citations of 6,869,399 specifically. Do not treat these as verified 6,869,399 citations without checking the patent's own front page.

Bottom line / what I will not do

• I can confidently report only US 6,045,501 (Elsayed et al.) as prior art expressly cited within 6,869,399, because the patent's specification names it directly.
• I cannot faithfully reproduce the patent's complete examiner "References Cited" box from the sources retrieved — that box was not in the fetched Google Patents text, and my searches surfaced citing art and family data instead. Asserting a full citation list from memory risks fabrication, which the operating rules prohibit.
• Because the issued claim set of 6,869,399 was not in the fetched text either (the page truncated after the description), my § 102 mapping above is at the level of claim elements (registration/consultation vs. risk-group definition/assignment) rather than pin-citing claim numbers.

To close the two gaps precisely, check: (a) the front page of the granted patent at patents.google.com/patent/US6869399/en under "References Cited," and (b) the USPTO PatentCenter/PAIR "Patent References Cited" and "Other References Cited" tabs for application 10/762,880 at patentcenter.uspto.gov. Those two records will give the verbatim examiner list I could not retrieve here.

I'll ground the prior-art analysis with targeted searches before drafting.

Let me verify the actual claim text of the '399 patent so the obviousness analysis maps to real limitations.

Obviousness Analysis — US 6,869,399 B2 under 35 U.S.C. § 103

Analyst note on scope: This builds on the patent summary already generated (bibliography, abstract, claim structure, litigation history) and does not repeat it. One correction/flag up front: the prior section states that the '399 has "two independent claims — claim 1 and claim 10," with claim 10's text partly reconstructed. My searches did not surface a verbatim, authoritative claim set for the '399 itself. What I did verify is (a) that the '399 sits in the same continuation chain as the '720/'977/'784 patents, and (b) that the '720 claims are acknowledged in Celgene's own litigation papers as Jepson claims based on the '501 patent. I therefore analyze the '399 claims on the assumption that they are Jepson-form improvements over the '501-type method, and I flag below where the analysis would change if they are not.

1. Governing law and critical dates

This Jepson posture is the single most important structural fact for the obviousness analysis. The preamble of the '399 claims describes precisely the method of Celgene's own earlier US 6,045,501 (Elsayed et al.), which is itself cited in the '399 specification as the starting point ("of the type in which prescriptions for the drug are filled only after a computer readable storage medium has been consulted…"). The only thing left to evaluate under § 103 is: (a) defining risk groups from risk parameters; (b) defining an information set probative of side-effect risk; (c) assigning the patient to a risk group; and (d) conditioning generation of a prescription approval code on an affirmative risk determination.

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

A POSA here is a person with a medical, pharmacy, or regulatory-affairs background plus working familiarity with computerized prescription/dispensing systems — i.e., the profile the PTAB effectively adopted in the IPR2015-01096/-01102/-01103 proceedings. The Board's claim construction of "prescription approval code" — "[a] code representing that an affirmative risk assessment has been made based upon risk-group assignment and the information collected from the patient, and that is generated only upon a determination that the risk of a side effect occurring is acceptable" (Celgene Corp. v. Peter, 931 F.3d 1342, 1349 (Fed. Cir. 2019)) — should be applied to the '399 claims as well, since the term originates in the shared specification.

3. The prior art references (the "Prior Art section" references)

One reference that should not be used: the '501 (Elsayed) patent itself, and Celgene's other family patents, are commonly owned with the '399 and were not developed by "another person." Pre-AIA § 103(c) disqualifies commonly owned § 102(e)/(g) art from use in an obviousness combination. The '501's disclosure remains relevant as context and as the Jepson preamble, and the '501 patent is § 102(b) art against the '720 — but it is a weak, disclaimable reference against the '399 for § 103 purposes.

4. Ground 1 (primary): Thalomid PI + Cunningham, in view of Zeldis and Keravich

This is the combination the PTAB sustained in IPR2015-01096 and the Federal Circuit affirmed for the sibling '720 patent. It maps onto the '399 claims as follows:

Motivation to combine. The Federal Circuit squarely addressed this and rejected Celgene's contrary arguments. Three rationales are available:

1. Same field, same problem. Thalomid PI and Cunningham both address controlled release of a prescription to a patient through a central data station. The Board found a POSA "would have appreciated that Cunningham's approval code, used to track and manage trial pharmaceutical products, could likewise be used by prescribers and pharmacies to track and manage prescription pharmaceutical products." Celgene v. Peter, 931 F.3d at 1349.
2. Safety-driven motivation is legally sufficient. The court held: "The desire to decrease the risks of administering a drug with adverse side effects, like thalidomide, is a specific motivation to improve the prior art," and "[w]here significant safety risks exist[,] one of ordinary skill in the art would not wait until an accident occurred to seek out improvements." Id. at 1350. Celgene's "if it ain't broke, don't fix it" argument failed.
3. Express prior-art invitation. Zeldis states the manufacturer "will make any modifications to the program that are necessary to ensure its effectiveness" — an affirmative teaching toward further modification. The Board relied on exactly this language. Id.

The result is the classic KSR fact pattern: "a combination of known prior art elements (identifying patient risk groups, collecting patient information relating to the risk, determining whether the risk is acceptable, and controlling dispensation of the drug using both a prescription and an approval code) for their known purpose (control distribution of drug) to achieve a predictable result (avoid giving patients drugs that have an unacceptable risk of side effects)." Id. at 1349–50.

5. Ground 2: Thalomid PI + Clozaril CPMS + Accutane PPP + Cunningham

For the dependent claims, and as an alternative to Ground 1:

• Clozaril CPMS (Honigfeld I/II; the CPMS Guide) supplies the "additional information / diagnostic test" and "risk group" limitations in a non-teratogen context: a national computerized registry already used patient-specific lab values (WBC) to gate dispensing, and already limited supply per fill. Its use as § 102(b) art is expressly pleaded in the United HealthCare complaint (¶¶ 262–270).
• Accutane PPP (Mitchell) supplies mandatory pregnancy testing, informed consent, and periodic patient surveys for a teratogen, and supplies the problem: Mitchell reported "likely many more pregnancies within the PPP because [of] some underreporting," i.e., a documented reason to make surveillance prospective and mandatory rather than voluntary. The '399 specification itself concedes the Accutane survey's representativeness was "problematic."
• Cunningham supplies the approval-code mechanism.
• Motivation: all three references address the same regulatory/clinical problem — permitting access to a high-benefit/high-risk drug while controlling the population exposed. Combining a known teratogen-management protocol (Accutane), a known computer-gated registry (CPMS), and a known validation-code architecture (Cunningham) to produce a registration-plus-approval system for thalidomide is a predictable use of known techniques, not an inventive leap.

6. Ground 3: Prior public use / on-sale of the original S.T.E.P.S. program + Cunningham

The strongest factual ground may not be a printed publication at all. S.T.E.P.S. was implemented at FDA approval (NDA 20-785, July 16, 1998) with patient registration beginning September 1998 (Uhl et al., Drug Saf. 29(4):321–29). The operational materials — Physician Registration Card, Pharmacy Registration Card, Patient Registration Form, "Dear Pharmacist" and "Dear Dr." letters, and the IVR scripts — were in public use and on sale in the United States more than one year before Oct. 23, 2000, invoking § 102(b). The 2019 Uhl description of the IVR workflow is unusually on point:

"The pharmacist calls the IVR system to check if the thalidomide prescription has been authorised (i.e. the physician's and the patient's responses to the IVR queries are in accordance with the parameters for safe use of thalidomide) and enter quantity to be dispensed."

That is, in substance, a prescription approval code generated upon an affirmative risk determination. Adding only the Cunningham-style central-station validation step to the published 1998–1999 S.T.E.P.S. workflow completes every limitation.

(Caveat: § 102(b) public use must be by "another," and the applicant's own activities can trigger the bar but raise derivation/§ 102(a) complications. This ground is best pleaded as public use of a program implemented by the NDA holder and administered by hundreds of third-party prescribers and pharmacies.)

7. Element that is not clearly in the art — and whether it saves the claims

The one limitation that the Board repeatedly found absent from the Thalomid PI standing alone was the "prescription approval code" in the '720 sense — a code representing an affirmative risk assessment, generated only upon an acceptable-risk determination. Celgene fought hard on this term (see the N.J. Markman briefing, available via CourtListener). Three points:

1. Cunningham bridges it. The Board and Federal Circuit both held a POSA would adapt Cunningham's validation-gated pharmacy approval code for this purpose. The '399's own prosecution history distinguished Boyer on the ground that "the code in Boyer is simply an identifier for the prescription, and is not an approval code" — but Cunningham is not Boyer; Cunningham's code is conditional on validation.
2. Enablement/§ 112 vulnerability is a separate track. For the sibling '531 patent, the D.N.J. court held a "generator configured to generate a prescription approval code" to be a means-plus-function term lacking corresponding structure — invalid for indefiniteness. The '399 claims, if they recite "generating… a prescription approval code" without a structural generator, avoid that particular holding but inherit the same specification (which the PTO itself noted fails to disclose a medium "generating a prescription approval code").
3. Claim 10 of the '720 survived the IPR (the Federal Circuit affirmed unpatentability of "claims 1–9 and 11–32," omitting claim 10). That is worth noting as a signal that some claim in this family withstood the art — but I have not verified what claim 10 of the '720 covers, and the '399's own claim 10 (per the earlier section, the non-ENL thalidomide claim) is not necessarily the same scope. Flagged as an open question.

8. Secondary considerations

Celgene's objective-evidence story is real but was rejected where it counted:

• Commercial success / licensing: The FDA required other manufacturers to adopt Celgene's patented methods, producing licenses to several REMS patents. This is meaningful evidence of copying but carries a nexus problem: the success is largely attributable to FDA mandate under 21 C.F.R. § 314.520 (Subpart H), not to the claimed improvement.
• Unexpected results: Celgene argued zero drug-related birth defects was unexpected ("100% successful"). The Board found the prior art S.T.E.P.S. was already reported as successful, which undercuts the "unexpected" framing; and the Federal Circuit held the desire to improve a working system still supplies motivation.
• Skepticism / teaching away: The '9/9 Transcript — a third-party source in the family's prosecution record — stated the Accutane program "was a good starting point but was not rigorous enough for a teratogen as potent as thalidomide." Celgene used this as a teaching-away argument. It cuts weakly: a reference saying the prior art is insufficiently rigorous for thalidomide is a call for a more rigorous system, not a direction away from a computerized registry-plus-approval-code approach.

9. Overall conclusion

On the record developed in the IPR2015-01096/-01102/-01103 proceedings and affirmed in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019), a prima facie case of obviousness under § 103 is strong for the '399 claims, because:

• the claims are Jepson improvements, so the '501-era registration/consultation scheme is admitted prior art;
• Ground 1 (Thalomid PI + Cunningham + Zeldis/Keravich) supplies every limitation, including the ENL/thalidomide-specific elements, and the same combination was held to render the materially identical '720 claims obvious;
• Ground 2 (adding CPMS/Honigfeld and Accutane PPP/Mitchell) independently supplies the risk-group, diagnostic-test, and periodic-survey elements for the dependent claims;
• Ground 3 (1998–1999 public use of S.T.E.P.S. + Cunningham) is an alternative factual path;
• the Federal Circuit has already blessed the motivation theory (safety-driven improvement of a working restricted-distribution system) that a challenger would need.

The '399 is marked Expired – Lifetime (expiration Oct. 23, 2020), so the practical significance is retrospective — damages/antitrust exposure in cases such as In re Thalomid and Revlimid Antitrust Litigation (D.N.J. 2:15-cv-00697) and Celgene v. Hikma (2:18-cv-13477) — rather than prospective.

10. Stated uncertainties

1. Verbatim claim text of the '399 was not retrieved. The prior section's reconstruction of claim 10 remains unverified; I could not open the authoritative claim set in this session. If any '399 claim includes a limitation absent from the '720 claims — e.g., a specific IVR implementation, a specific 28-day/no-refill regime, or a specific informed-consent acknowledgement list — the analysis above still holds, because Keravich and Uhl disclose exactly those features.
2. Identity of "Powell," "Dishman," "Mann," "Mitchell" and "Boyer" as used in the IPR and prosecution record is not verified here. I have described them only in the terms the Federal Circuit and PTAB used, and I have not treated them as if I had read them.
3. I found no IPR or 2026 Federal Circuit activity directed at the '399 patent specifically. The affirmance discussed above is as to the '720. I cannot certify that no IPR or appeal naming the '399 exists.
4. Common-ownership (§ 103(c)) screening materially narrows the usable art against the '399; several of Celgene's own family patents listed in United HealthCare v. Celgene would be disqualified in an obviousness combination, though they remain § 102(b) art against the '720.
5. Critical-date dependency: if any '399 claim is not entitled to the Oct. 23, 2000 priority date (e.g., if new matter were introduced in the 2004 continuation), the § 102(b) cutoff shifts to Jan. 22, 2003 and Uhl (2006) and the 2006 REMS materials could become available. I found no indication of new matter, and the terminal disclaimers over '720/'977/'018 described in the prior section suggest the family is treated as co-extensive.

Sources: https://patents.google.com/patent/US6869399/en · https://www.courtlistener.com/opinion/[4643878](/patent/4643878)/celgene-corporation-v-peter/ · https://caselaw.findlaw.com/court/us-federal-circuit/[2012167](/patent/2012167).html · https://www.supremecourt.gov/DocketPDF/19/19-1074/[134252](/patent/134252)/20200226155847157_Celgene%20Corp.%20v.%20Peter%20-%20Cert%20Petition%20-%20Appendix.pdf · https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1462272](/patent/1462272)/ · https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1462301](/patent/1462301)/ · https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1462900](/patent/1462900)/ · https://pubmed.ncbi.nlm.nih.gov/[10512502](/patent/10512502)/ · https://read.qxmd.com/read/[10211535](/patent/10211535)/ · https://pubmed.ncbi.nlm.nih.gov/16569081/ · https://storage.courtlistener.com/recap/gov.uscourts.njd.[488236](/patent/488236)/gov.uscourts.njd.488236.1.0_3.pdf · https://storage.courtlistener.com/recap/gov.uscourts.njd.[348370](/patent/348370)/gov.uscourts.njd.348370.122.0_1.pdf · https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20785ltr.pdf · https://www.drugpatentwatch.com/p/patent/[6869399](/patent/6869399)