US 6315720

I'll search for authoritative information on US patent 6315720, including any 2026 CAFC docket activity.

Let me verify the claim set and check specifically for any 2026 Federal Circuit activity.

Let me confirm the exact claim set and check for any appellate activity.

US Patent 6,315,720 — Analyst Summary

Verification note: The search results I retrieved confirm the bibliographic data below (Google Patents, DrugPatentWatch, FDA Orange Book listings, and USPTO/PTAB docket records). I did not find any 2026 CAFC docket naming this patent — see the litigation section for details and caveats.

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Bibliographic Data (confirmed)

Sources: Google Patents; DrugPatentWatch; uspto.report

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Abstract (verbatim)

"Improved methods for delivering to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug are disclosed. The methods are of the type in which prescriptions for the drug are filled only after a computer readable storage medium has been consulted to assure that the prescriber, pharmacy and patient have been properly registered in the medium before the patient is approved to receive the drug. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to the 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."

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Plain-Language Overview of the Claims

Field context: This is the foundational patent behind Celgene's S.T.E.P.S.® thalidomide risk-management distribution program. It is expressly framed as an improvement on U.S. Pat. No. 6,045,501 (Elsayed et al.), which required prescriber/pharmacy/patient registration in a computer-readable medium before dispensing.

Claim 1 (the independent claim) — improvement format. The claim is a "method of the type in which" a drug prescription is filled only after a computer-readable storage medium is consulted to confirm the prescriber is registered and qualified to prescribe, the pharmacy is registered and qualified to fill, and the patient is registered and approved. The improvement consists of four steps:

• (a) defining a plurality of patient risk groups based on a predefined set of risk parameters for the drug;
• (b) defining a set of information to be obtained from the patient that is probative of the risk the adverse side effect will occur if the drug is taken;
• (c) in response to that information, assigning the patient to at least one of the risk groups; and
• (d) entering the risk-group assignment into the medium before the patient is approved to receive the drug.

In plain terms: it adds risk stratification to the pre-existing registration gate — patients are sorted into risk categories (e.g., the specification describes female of childbearing potential, female of non-childbearing potential, sexually active male, sexually inactive male, and a group for whom the drug is strictly contraindicated), and that categorization is recorded in the database as a precondition to approval.

Dependent claims (≈claims 2–4). Based on the specification, I understand the dependents narrow the risk parameters (e.g., for teratogenic drugs, using age/sex/reproductive status; requiring additional information such as surveys or diagnostic test results, and re-assignment to a different risk group based on that additional data). Uncertainty flag: the sources I retrieved reproduce the Summary language (which mirrors claim 1) but did not reproduce the verbatim dependent-claim text or the exact claim count. I cannot fully confirm the precise number of claims or their exact wording from the retrieved material. It is also possible (based on the '720 family's prosecution history) that intervening amendments occurred, but claim 1's substance above is well supported by the "improved methods comprising the steps of" passage in the patent and by the sibling '784 patent's parallel claim.

Notably not claimed in the '720 patent: the retrieval of a prescription approval code by the pharmacy. That "approval code" limitation appears in the continuation US 6,755,784 ("...permitting prescriptions for the drug to be filled by a pharmacy only after the pharmacy has received an approval code..."), not in the '720 independent claim as described.

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Litigation and Post-Grant History

• PTAB inter partes reviews (Petitioner: Coalition for Affordable Drugs VI LLC v. Celgene): IPR2015-01096, IPR2015-01102, IPR2015-01103 — each listing patent 6315720; IPR2015‑01103 reached a Final Written Decision on Oct. 26, 2016, followed by a decision granting Patent Owner's request for rehearing (Sep. 8, 2017). Sources: Unified Patents portal; Docket Alarm.
• District court actions naming this patent in D.N.J. include Celgene v. Barr (2:07-cv-00286), the Natco/Potomac cases (e.g., 2:10-cv-05197), and Celgene v. Hikma Pharmaceuticals International (2:18-cv-13477), plus other D.N.J. and E.D. Tex. dockets. Source: CourtListener D.N.J. 2:18-cv-13477.
• Orange Book listings: Thalomid (thalidomide, NDA 020785, use codes U‑442 and U‑731) and Revlimid (lenalidomide, NDA 021880, use code U‑1210), each with expiration Oct. 23, 2020.

On the requested "CAFC 2026 docket" check

I found no evidence of any 2026 Federal Circuit activity involving US 6,315,720. My searches surfaced 2026 CAFC dockets for unrelated patents (e.g., Contour IP Holding LLC v. GoPro, Inc., Fed. Cir. No. 2026‑2012, and various 2026 district-court matters), but nothing linking 6315720 to a 2026 appeal. Given the patent expired October 23, 2020 and its appeals history (PTAB FWD 2016, rehearing 2017) predates 2026 by years, a new 2026 CAFC appeal would be unusual. However, I cannot affirmatively certify a negative — my searches were targeted, not an exhaustive docket-by-docket sweep, so I flag this as unconfirmed rather than an authoritative "no CAFC 2026 docket exists."

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Caution on Number Confusion

Per your strict rule on literal interpretation, note that search results contained several different identifiers that must not be conflated with US 6,315,720:

• US 6,356,700 / 6355720 (appears in a transcribed 2007 Orange Book excerpt) — not the same patent.
• EPA study ID "Jin, 2020, 6315720" and the PFOA/EPA docket numbers are unrelated fact/study identifiers, not this patent.
• "6315730" (a PFAS mortality study) — distinct.

I used only the literal identifier 6315720 = US 6,315,720 B1.

I'll research this systematically, starting with the litigation data already embedded in the patent record and then verifying/expanding via targeted searches.

Good — the '720 patent is US 6,315,720. Now let me verify the remaining docket numbers from the patent record and the PTAB proceedings.

Now let me verify the remaining dockets and the PTAB outcomes.

Summary

US Patent 6,315,720 ("the '720 patent"), Methods for Delivering a Drug to a Patient While Avoiding the Occurrence of an Adverse Side Effect Known or Suspected of Being Caused by the Drug (Williams & Kaminski), issued Nov. 13, 2001, expired Oct. 23, 2020, is one of Celgene Corporation's so‑called "Distribution Method Patents" / "REMS patents," asserted in connection with THALOMID® (thalidomide) and REVLIMID® (lenalidomide). Because it is a method-of-use patent tied to an FDA-mandated restricted-distribution program, it appears in a large number of Hatch‑Waxman ANDA suits, and it was also the subject of three 2015 IPRs that ended with the claims being held unpatentable.

The Google Patents litigation record for this patent (the authoritative source supplied) lists 13 district‑court/PTAB proceedings. Below I separate what I could independently verify through searches from what appears only in the patent record and could not be confirmed.

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1. District Court Litigation — Verified

Note on "Texas Eastern District Court 2:18-cv-00461": the patent record lists a Texas E.D. entry with the same case number as the D.N.J. Apotex case. This is almost certainly a venue artifact — Apotex filed a Motion to Change Venue or Dismiss (D.I. 14, Apr. 2, 2018) in that case — rather than a separate Texas action. I could not confirm a separate Texas E.D. case on the docket.

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2. D.N.J. Entries Appearing Only in the Patent Record (Not Independently Verified)

These appear in the Google Patents "Family has litigation" list but I could not confirm their parties, dates, or outcomes:

• 2:18-cv-13477 (D.N.J.)
• 2:18-cv-06378 (D.N.J.)
• 2:07-cv-05485 (D.N.J.) — Literal-identifier note: the Barr stipulated dismissal expressly references consolidated case 07‑5458, not 07‑5485. Do not assume these are the same number; the record as given lists 2:07-cv-05485.
• 2:07-cv-04050 (D.N.J.) — this one is corroborated by the Barr stipulation, which lists consolidated action 07‑4050, so it is confirmed to exist; I did not retrieve its docket details separately.

Given the pattern (Celgene filed successive ANDA suits against thalidomide/lenalidomide generics), the 2018 D.N.J. entries are most likely part of Celgene's lenalidomide ANDA wave (e.g., against Cipla, Zydus, Dr. Reddy's or similar), but I am not asserting that without confirmation.

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3. PTAB / IPR Proceedings — All on U.S. Patent 6,315,720

Celgene filed a motion for sanctions against the petitioner (CFAD VI) under 35 U.S.C. § 316(a)(6), alleging abuse of process / improper real-party-in-interest conduct; CFAD opposed (Aug. 11, 2015). The '720 patent's claims were held unpatentable, and the district courts' stays of the REMS-patent claims in the Apotex case were expressly tied to this outcome. The PTAB invalidation was affirmed by the Federal Circuit on July 30, 2019 (per the Apotex stipulation/order referenced in the record; I believe this is Celgene Corp. v. Peter, but I flag that citation as not verified in this search window).

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4. Related Antitrust Litigation Where the '720 Patent Is Implicated but Not the Patent-In-Suit

The '720 patent features prominently as an accused "sham litigation" / monopoly-maintenance patent in the consolidated In re Thalomid and Revlimid Antitrust Litigation (D.N.J.), including:

• International Union of Bricklayers and Allied Craft Workers Local 1 Health Fund v. Celgene Corp., No. 2:14-cv-06997-KSH-CLW (D.N.J., filed Nov. 7, 2014)
• Related putative class actions consolidated in D.N.J. (e.g., Nos. 2:14-cv-06997, 2:18-cv-13477, 2:18-cv-06378 area) and a parallel action in D. Minn. (No. 0:19-md-02904 area)

These are antitrust cases, not infringement suits asserting the '720 patent, but the '720 is directly at issue in the liability theory.

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5. Bottom Line

• Yes, there is substantial known litigation involving US 6,315,720.
• The most important proceedings: three IPRs (IPR2015-01096, -01102, -01103) in which the patent was invalidated and the invalidation affirmed on appeal (July 30, 2019); and numerous D.N.J. ANDA suits by Celgene against thalidomide/lenalidomide generics (Barr, Natco, Lannett, Lotus/Alvogen, Apotex), all of which ended in settlement/consent judgment or dismissal — the '720 claims were bifurcated and stayed in these cases because of the IPR.
• Given the IPR outcome and the patent's Oct. 23, 2020 expiration, the '720 patent is no longer enforceable.

Caveats: (1) Docket entries 2:18-cv-13477, 2:18-cv-06378, and 2:07-cv-05485 are taken verbatim from the Google Patents litigation list and were not independently confirmed; (2) the "Texas Eastern 2:18-cv-00461" entry appears to duplicate the D.N.J. Apotex case number and likely reflects Apotex's venue motion rather than a separate suit; (3) my Federal Circuit case-name citation for the July 30, 2019 affirmance is offered with low confidence.

I'll research the PTAB proceedings referenced in the structured data for this patent.

Strong results. Let me pin down the rehearing modification, the appeal, and the third IPR's details.

Let me confirm the rehearing date, the Federal Circuit panel, and the Supreme Court disposition.

PTAB Proceedings — US 6,315,720 ("Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect…")

Note on sources. The ODP API block in this prompt reports "no AIA trial proceedings on file." That is an ODP indexing gap — the structured data captured from the patent record itself (Google Patents litigation block) lists three PTAB cases, each marked "Final Written Decision," and the public PTAB/CAFC record confirms all three. I treat the three IPRs below as the canonical list: IPR2015-01096, IPR2015-01102, IPR2015-01103. No PGR or CBM was ever filed on this patent.

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Proceedings overview

Three AIA trial proceedings were filed — all three are inter partes reviews (0 PGRs, 0 CBMs), all three were instituted, all three reached a Final Written Decision holding claims unpatentable (claims 1–9 and 11–32 canceled), and only one dependent claim (claim 10) survived on rehearing — leaving 0 proceedings active, 0 settled on the merits, and 0 institution denials. Bottom line for a defendant: this patent is effectively dead. Claims 1–9 and 11–32 — including independent claim 1 and independent claim 28 — were canceled. If a demand letter cites claim 1, 2, 3, 4 or 5, the patent owner has no case. The only claim that survived is claim 10, a narrow dependent claim requiring genetic testing results, and the patent expired 2020-10-23.

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IPR2015-01096 — Coalition for Affordable Drugs VI, LLC v. Celgene Corporation

• Type: Inter Partes Review (35 U.S.C. §§ 311–319, pre-AIA patent)
• Filed: 2015-04-23 (Petition challenging all 32 claims)
• Status: Final Written Decision (Paper 73, 2016-10-26) — claims unpatentable; subsequently modified on rehearing (2017) so that claim 10 is not unpatentable. CEO/patent-owner-side gloss: patent largely canceled, one claim survives.
• Judge panel: Michael P. Tierney (Vice Chief APJ), Grace Karaffa Obermann, Tina E. Hulse
• Petition grounds: § 103 obviousness against all of claims 1–32. Instituted art: the THALOMID® Package Insert (Ex. 1006, Jul. 15, 1998), Cunningham (U.S. Pat. No. 5,832,449), Zeldis ("S.T.E.P.S.™: A Comprehensive Program for Controlling and Monitoring Access to Thalidomide," Clinical Therapeutics 21:2, 319–30 (1999)), and other prior art; Petitioner's expert was Dr. Fudin. No § 102 or § 112 grounds were the basis of the disposition.
• Institution decision: Instituted 2015-10-27 (Paper 21) on all of claims 1–32. Panel found a reasonable likelihood Petitioner would prevail on the obviousness ground. (Petitioner's own statements of the record at Paper 21.)
• Final Written Decision: Paper 73, 2016-10-26. Verbatim: "we determine that Petitioner has shown by a preponderance of the evidence that claims 1–32 are unpatentable." Independent claim 1 (Jepson-format: risk groups → information set → risk-group assignment in the medium → risk-acceptability determination → prescription approval code) was held obvious, as was independent claim 28; claims 2–27 and 29–32 fell with their parents. Claim 10 (genetic-testing information set) was initially held obvious as "a combination of known elements for their known use to achieve a predictable result."
• Settlement / termination: None. No adverse-judgment or settlement termination — the case ran to FWD.
• Appeal: Celgene's Request for Rehearing (Paper 74) was granted in part, and the FWD was modified to hold that Petitioner failed to prove claim 10 unpatentable. The Board's revised reasoning: "the proper focus is not whether Patent Owner disputed that fact, but whether Petitioner came forward with evidence sufficient to demonstrate that genetic testing was known and would have been used in the combination required by claim 10… the lack of disclosure in the prior art of record—coupled with the record's disclosure of other types of tests—cuts against a finding 'that genetic testing would be used, let alone that it would have been common.'" The merits then went up on Celgene Corp. v. Peter, Nos. 2018-1167, -1168, -1169 (consolidated with -1171), 931 F.3d 1342 (Fed. Cir. July 30, 2019) — a unanimous panel opinion authored by Chief Judge Prost — which affirmed the obviousness holdings and additionally rejected Celgene's Fifth Amendment takings challenge to retroactive IPR of pre-AIA patents. Celgene's petition for rehearing en banc was denied 2019-12-09; certiorari was denied in June 2020 (Celgene Corp. v. Peter, No. 19-1074, cert. filed 2020-02-26).
• Defensive value: Claim 1 is dead and claim 1 was the broadest claim in the patent. Any infringement theory built on claims 1–9 or 11–32 is unsupportable — those claims no longer exist. The only live theory would be claim 10, and it requires all of claim 1's limitations plus genetic testing results.

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IPR2015-01102 — Coalition for Affordable Drugs VI, LLC v. Celgene Corporation

• Type: Inter Partes Review
• Filed: 2015-04-23 (Petition challenging all 32 claims)
• Status: Final Written Decision (Paper 75, 2016-10-26) — claims unpatentable; modified on rehearing (2017) as to claim 10.
• Judge panel: Same panel — Tierney, Obermann, Hulse. (Oral hearing held 2016-07-21, Tr. Paper 74.)
• Petition grounds: § 103 obviousness against all of claims 1–32. Instituted art: Powell ("Guideline for the clinical use and dispensing of thalidomide," Postgrad. Med. J. (1994) 79, 901–904) and Dishman ("Pharmacists' role in clozapine therapy at a Veterans Affairs medical center"), in view of Cunningham, and further in view of Mann and other prior art.
• Institution decision: Instituted 2015-10-27 (Paper 21) on claims 1–32.
• Final Written Decision: Paper 75, 2016-10-26. Verbatim: "we determine that Petitioner has shown by a preponderance of the evidence that claims 1–32 are unpatentable." All 32 claims initially canceled, including independent claims 1 and 28.
• Settlement / termination: None — ran to FWD.
• Appeal: Rolled into the same consolidated Federal Circuit appeal (Nos. 2018-1167/-1168/-1169, 931 F.3d 1342) and affirmed on the merits. Claim 10 modified to survive. On appeal the court rejected Celgene's argument that "computer readable storage medium" required a centralized/single database — the panel held the broadest reasonable interpretation does not require centralization, and that Dishman meets the limitation under that construction.
• Defensive value: Same as above — the Powell/Dishman-based invalidation is now a final, appeal-exhausted determination that the core claims are obvious. A defendant facing claim 1 today has a Federal Circuit-affirmed holding that claim 1 is unpatentable.

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IPR2015-01103 — Coalition for Affordable Drugs VI, LLC v. Celgene Corporation

• Type: Inter Partes Review
• Filed: 2015-04-23 (Petition challenging all 32 claims)
• Status: Final Written Decision (Paper 76, 2016-10-26) — claims unpatentable; modified on rehearing (2017) as to claim 10.
• Judge panel: Same panel — Tierney, Obermann, Hulse.
• Petition grounds: § 103 obviousness against all of claims 1–32. Instituted art: the same reference set as IPR2015-01102 but with Mitchell substituted for Powell as the base reference — i.e., Mitchell et al., New Eng. J. Med. (1995) 333:2, 101–06, with Dishman, Cunningham, Mann and other prior art.
• Institution decision: Instituted 2015-10-27 (Paper 22) on claims 1–32.
• Final Written Decision: Paper 76, 2016-10-26. Verbatim: "we determine that Petitioner has shown by a preponderance of the evidence that claims 1–32 are unpatentable."
• Settlement / termination: None — ran to FWD.
• Appeal: Consolidated into the same Federal Circuit appeal and affirmed (931 F.3d 1342).
• Defensive value: The third, independent obviousness pathway. Even if a future challenger attacked the Powell/Dishman combination, the Mitchell-based combination independently knocked out the same 31 claims and was affirmed. That redundancy is why the invalidation of claims 1–9 and 11–32 is very hard to unwind.

Correction to a common secondary-source error. Several law-firm write-ups (e.g., the Foley & Lardner client alert on the rehearing decision) refer to the first proceeding as "IPR2015-01098." That is a typo. The Board's own rehearing decision, the Federal Circuit opinion, and the structured patent-record data all identify the first IPR as IPR2015-01096.

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Strategic summary

Claim-status picture. Of 32 claims, 31 are canceled and 1 survives. Canceled: independent claim 1, independent claim 28, and all dependents except claim 10 — i.e., claims 1–9 and 11–32. Sustained: claim 10, the dependent claim reciting that the information set on which the risk determination is made "includes genetic testing results." The cancelation is final: it was confirmed at FWD, survived a request for rehearing, was affirmed by the Federal Circuit on 2019-07-30, survived en banc rehearing denial on 2019-12-09, and is not undermined by the two independent obviousness theories that were affirmed in parallel (a rare degree of redundancy for an invalidation). Net: the only assertable claim is claim 10, and asserting it means proving every limitation of claim 1 (risk groups, information set, risk-group assignment entered in the medium, risk-acceptability determination, and generation of a prescription approval code retrieved before the prescription is filled) plus genetic testing results.

Estoppel landscape. The only PETITIONER is Coalition for Affordable Drugs VI, LLC (a Kyle Bass / Hayman Capital-affiliated entity; its founder-adjacent entities also filed the parallel challenges to Celgene's '501 patent). Under 35 U.S.C. § 315(e)(2), CFAD and its privies are estopped from raising in district court any ground CFAD raised or reasonably could have raised in these three IPRs. That estoppel does not run to an unrelated defendant. So a new defendant is not estoppel-barred — but it also does not need to relitigate anything: the claims it would be sued on have already been canceled by the Board and affirmed by the Federal Circuit. For the single surviving claim 10, all prior-art grounds remain available to any defendant other than CFAD, although the § 103 art CFAD ran (Powell, Dishman, Mitchell, Cunningham, Mann, the THALOMID Package Insert, Zeldis) is now public and reusable, and the Board's finding that CFAD failed to show genetic testing was known for the claimed purpose is a specific, identified evidentiary gap a better-prepared challenger could attack on the merits.

Pattern signals. One petitioner (CFAD) filed three simultaneous IPRs on the same patent, challenging all 32 claims in each and running three independent obviousness combinations in parallel — a deliberate belt-and-suspenders strategy that survived Patent Owner's motion for sanctions (Celgene filed a Patent Owner Motion for Sanctions alleging abuse of process / improper real-party-in-interest disclosure; CFAD filed an opposition; the sanctions motion did not derail the proceedings). The patent owner litigated hard: Celgene filed a request for rehearing in all three proceedings (unusually, it won as to claim 10, with the Board acknowledging it had improperly shifted the burden to Celgene), then appealed to the Federal Circuit, sought en banc rehearing, and petitioned the Supreme Court on a constitutional takings theory — all unsuccessful. This was not a Unified Patents-style defensive aggregator action; it was an investment-driven "short-the-stock" challenge. Separately, the '720 patent was asserted by Celgene in a long string of Hatch-Waxman and REMS-patent suits (Barr 2007/2008/2010, Natco 2010, Lannett 2015, and later generic-lenalidomide cases against Dr. Reddy's and others in 2017–2018), and it belongs to Celgene's 14-patent S.T.E.P.S./REMS family ('501, '977, '784, '399, '018, '566, '886, '531, etc.) — so a defendant facing this family should assume the same Bass/CFAD invalidation template may have been run against siblings.

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Recommended next steps

1. If you are a defendant and the demand letter cites claims 1–5 (or any of 1–9, 11–32): say so directly in your response. Those claims have been canceled. The controlling disposition is the Board's Final Written Decision, as modified on rehearing, which states: "This Decision does not disturb our holding, stated in the Final Written Decision, that Petitioner establishes by a preponderance of the evidence that claims 1–9 and 11–32 are unpatentable." Cite it and link the decisions below.
2. Do not over-rely on the FWD alone — pull the modified decision. The original 2016-10-26 FWDs (Papers 73, 75, 76) held all 32 claims unpatentable. The operative holding after Celgene's granted Request for Rehearing is that only claim 10 is patentable. If you cite the original FWD for "all claims canceled," the patent owner will correct you.
3. The CAFC affirmance is your strongest cite. Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019) (Nos. 2018-1167, -1168, -1169, consolidated with -1171) affirmed the obviousness determinations and rejected the takings challenge; rehearing en banc denied 2019-12-09; cert. denied June 2020. This is final and non-appealable.
4. On claim 10 specifically, the Board's reasoning is narrow and evidence-driven — it turned on CFAD's failure to put in proof that genetic testing was known and would have been used in the claimed combination. Evaluate whether you can close that evidentiary gap (new art showing genetic testing in a risk-management/drug-dispensing context, or a § 112/§ 101 theory not reached by the Board), keeping in mind § 315(e)(2) does not bind a non-CFAD defendant.
5. Commercial reality check. The patent's anticipated expiration was 2020-10-23 (expired — lifetime). Any assertion now is a past-damages play with a very short window, and the surviving claim is a single narrow dependent claim.
6. Watch the siblings. The same CFAD challenge template was run against Celgene's '501 patent (IPR2015-01092, consolidated on appeal as No. 2018-1171), where claims 1–10 were all held unpatentable. If you are being asserted on other patents in the S.T.E.P.S./REMS family, run the same Powell/Dishman/Cunningham/Mann/Mitchell/Thalomid-PI analysis first.

Links to the key opinions:

• IPR2015-01102 Final Written Decision (Paper 75, 2016-10-26): https://www.docketalarm.com/cases/PTAB/IPR2015-01102/Inter_Partes_Review_of_U.S._Pat._6315720/docs/10-26-2016-Board/Final_Decision-75-Final_Written_Decision.pdf
• IPR2015-01103 Final Written Decision (Paper 76, 2016-10-26): https://www.finnegan.com/a/web/[250046](/patent/250046)/2G4HLV/20161026_ipr201501103_coalationforaffordabledrugs_v_celgene_fw.pdf
• Board decision granting rehearing and modifying the FWDs (Paper 74 in -01096; Paper 76 in -01102; Paper 77 in -01103), reproduced at p. 207a of the cert. appendix: https://www.supremecourt.gov/DocketPDF/19/19-1074/[134252](/patent/134252)/20200226155847157_Celgene%20Corp.%20v.%20Peter%20-%20Cert%20Petition%20-%20Appendix.pdf
• Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019): https://app.midpage.ai/case/celgene-corporation-v-peter-[4421131](/patent/4421131) (Harvard JOLT summary: http://jolt.law.harvard.edu/assets/digestImages/fed-cir-celgene-v.-peter_SL_PDF_format.pdf)
• USPTO PTAB E2E / Patent Trial and Appeal Board docket (search by proceeding number): https://ptacts.uspto.gov/ptacts/

Two items I could not fully verify and flag rather than assert: (i) the exact calendar date of the Board's rehearing/modification decision (reported September 2017, but I did not confirm the precise date from a primary source); and (ii) the disposition of Celgene's motion for sanctions against CFAD (the motion and CFAD's opposition are in the record; I could not confirm from the sources reviewed whether it was denied outright or denied as moot following the FWDs). Also note (iii) the precise mapping of Federal Circuit docket numbers 2018-1167 / -1168 / -1169 to the three individual IPRs is not confirmed in the sources reviewed; 2018-1171 is confirmed as IPR2015-01092 (the '501 patent).

I'll research this patent's ownership history carefully, starting with the sources you named.

Strong lead: the PTAB record cites a specific reel/frame. Let me verify and look for any post-issuance transfers, including the Bristol-Myers Squibb acquisition.

Let me dig for the actual assignment record details and any later transfers.

Inventors

Both inventors are named jointly on the application filed 2000-10-23, and both executed the same assignment to Celgene. The subject matter — the S.T.E.P.S. controlled-distribution program for thalidomide — is a regulatory/healthcare-informatics invention, not a chemistry invention, which is consistent with both being Celgene program/informatics personnel rather than medicinal chemists.

Unusual-pattern check — NOT present. The textbook "inventors exit the original assignee" tell does not appear. Kaminski and Williams continued to be named as the same inventive pair on later members of this family, including US 8,315,886 (app. 12/966,261, filed 2010-12-13) and US 8,626,531 (app. 13/591,622, filed 2012-08-22) — i.e., they were still contributing to Celgene's distribution-program filings roughly a decade after the '720 filing. That is a continuity signal, not a fire-sale precursor.

Original assignee

Celgene Corporation, a Delaware corporation. Address as recorded on the assignment: 7 Powder Horn Drive, Warren, New Jersey 07059 (later 86 Morris Avenue, Summit, NJ 07901; later Princeton, NJ).

• Primary line of business: branded biopharmaceuticals — thalidomide analogs and hematology/oncology products.
• Did they ship a product embodying the claims? Yes, unambiguously. US 6,315,720 is listed in the FDA Orange Book against Thalomid (NDA 020785, thalidomide) with expiry Oct 23, 2020, and later against Revlimid (NDA 021880, lenalidomide) as a method-of-use patent under use codes U-694 / U-731 / U-1210. The claimed subject matter is the registry/risk-group/prescription-approval-code workflow that Celgene actually ran as S.T.E.P.S. (Thalomid) and RevAssist (Revlimid). The specification itself says the FDA had recently approved Celgene's application to market thalidomide for ENL.
• Current status: Operating. Celgene was acquired by Bristol-Myers Squibb; the merger (announced January 2019, ~$74B cash-and-stock plus a CVR) completed in late 2019, and Celgene has since operated as a BMS subsidiary. Celgene was not in bankruptcy at any point relevant here. I found no USPTO assignment record transferring this patent to Bristol-Myers Squibb — consistent with a stock acquisition where the subsidiary survives as titleholder. Google Patents still lists "Celgene Corp" as current assignee.

Assignment timeline

Caveat on method, stated up front: I could not execute a live query against Assignment Center from this session. The entries below come from documents that themselves cite the Assignment Center records — principally Celgene's own 37 CFR 3.73(b) statement and Power of Attorney filed in IPR2015-01103 on 2015-05-14, which cites the reel/frame explicitly, plus a USPTO Notice of Recordation of Assignment Document produced by Celgene as an exhibit in D.N.J. litigation. Where a datum is unverified, I say so rather than filling it in.

• 2001-01-05 (executed; document date on the assignment instrument) / recorded 2001-01-05 per Celgene's PTAB filing — Reel 11469 / 0882

  • Conveyance: Assignment (assignment of assignors' entire right, title and interest; nominal $1.00 recited)
  • Assignor: Bruce A. Williams and Joseph K. Kaminski (joint inventors)
  • Assignee: Celgene Corporation, 7 Powder Horn Drive, Warren, New Jersey 07059, a Delaware corporation
  • Correspondent: Not established. I could not retrieve the cover sheet for reel 11469/0882, so I will not name an attorney for this record. This is the single most useful data point you asked for and it is the one I could not confirm — treat it as open.
  • Context: Ordinary inventor-to-employer assignment at the outset of employment-created subject matter; not a sale, reorg, or transfer to an asserter.
  • Date discrepancy to flag: Celgene's PTAB filing states the assignment "was recorded ... on January 5, 2001." Google Patents' legal-events tab for US6315720 shows a single "Assigned to CELGENE CORPORATION" event dated 2001-01-23. The 2001-01-05 date also matches the executed document date carried on the assignment instrument, so there is a real possibility the PTAB filing collapsed the execution date into the recording date. Either way, the reel/frame is 11469/0882 and the transfer is inventor→Celgene.

• Related-family record, not a record against the '720 patent — recorded 2003-04-23 — Reel 013982 / 0697 (5 pages)

  • Conveyance: Assignment of assignor's interest
  • Assignor: Bruce A. Williams (doc date 01/05/2001) and Joseph K. Kaminski
  • Assignee: Celgene Corporation, 7 Powder Horn Drive, Warren, New Jersey 07059
  • Correspondent: Woodcock Washburn LLP — Stephen C. Timmins, One Liberty Place, 46th Floor, Philadelphia, PA 19103-7301 (named as the addressee on the USPTO Notice of Recordation, i.e., the filing correspondent of record for this recordation). Flag: this is a single appearance in this chain; Woodcock Washburn was Celgene's outside patent counsel of record in the early 2000s, not an NPE-facing recording firm. No recurrence, so no signal.
  • Context: Same inventor→Celgene instrument re-recorded against application 10/383,275 (filed 2003-03-07, later US 6,755,784), a continuation in this family. The instrument's recitals name Serial No. 09/694,217 — i.e., the '720 application — but the recordation was made against the continuation. This is not an assignment of the '720 patent; I list it because it is the only other reel/frame in this family and because a reader running the family in Assignment Center will see it and assume it is a separate link in the '720 chain. It is not.

That is the entire chain. There is no recorded post-issuance assignment of US 6,315,720: no transfer to a holding company, no security agreement, no license recorded, no merger deed, no change of name, no release, no correction. The patent has been held by Celgene (now a Bristol-Myers Squibb subsidiary) continuously since the January 2001 inventor assignment, through issuance (2001-11-13) and through statutory expiry (2020-10-23). Google Patents' legal status for the patent is "Expired – Lifetime."

Adjacent counsel of record (prosecution and litigation, not assignment correspondents, listed so they are not mistaken for chain players): Angela Verrecchio (Reg. No. 54,510), Celgene prosecution counsel who signed a 2008-07-09 terminal disclaimer over the '720 patent in a continuation; Francis Dominic Cerrito (Reg. No. 38,100), who signed the 2015-05-14 Rule 3.73(b) statement in IPR2015-01103.

Timeline diagram

timeline
    title Ownership of US 6315720
    2000 : Filed by Celgene Corporation
         : Inventors Williams and Kaminski
    2001 : Assigned to Celgene Corporation
         : Reel 11469 Frame 0882
         : Patent issued November 13
    2003 : Same instrument re-recorded
         : Reel 013982 Frame 0697
    2007 : First district court suits filed
    2015 : IPR2015-01096 -01102 -01103 filed
    2017 : Celgene sues Alvogen and Lotus
    2019 : Celgene acquired by Bristol-Myers Squibb
    2020 : Patent expires October 23

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The only recorded conveyance is inventor→operating corporation at reel 11469/0882 (recorded January 2001). There is no LLC or holding-entity transferee anywhere in the chain, and therefore no basis to examine a registered-agent address, single-member structure, or absence of products.

2. Known asserter in the chain — NOT PRESENT. Neither assignor (Williams, Kaminski) nor assignee (Celgene Corporation) matches any public NPE roster (Acacia, Marathon, IV, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, DGC, Spangenberg entities). Important directional point: the closest name to that list in this patent's record is Coalition for Affordable Drugs VI LLC — a Kyle Bass / Hayman Capital vehicle — but it appears as the IPR petitioner (IPR2015-01102, IPR2015-01103, and the companion IPR2015-01096), i.e., it attacked this patent. It is not in the chain of title. Similarly, the Taiwanese PHARMA-industry analysis surfaced in search results lists US 6,315,720 among 16 patents Celgene asserted against Lotus/Alvogen. Every litigation and PTAB event I found on this patent has Celgene as patent owner/plaintiff and generics or a hedge fund as the adverse party.

3. Repeat correspondent across the chain — NOT PRESENT (structurally impossible here). The chain contains one assignment link; recurrence cannot be assessed. Woodcock Washburn LLP / Stephen C. Timmins appears once, as addressee on the 2003-04-23 recordation at reel 013982/0697 for the continuation. Celgene's later prosecution attorney (Verrecchio) and IPR attorney (Cerrito) are a different role entirely. No correspondent in this record is a known NPE recording attorney. The correspondent for the primary record, reel 11469/0882, remains unverified — that is the one gap worth closing if you want a definitive negative.

4. Cascading transfers — NOT PRESENT. One conveyance in twenty-plus years, at reel 11469/0882, executed 2001. There is no sequence of chained LLCs, no shared correspondent addresses, and nothing occurring in under 24 months.

5. Pre-litigation transfer — NOT PRESENT. The assignment is dated January 2001. The earliest suit surfaced in Google Patents' legal-events list is the 2007 New Jersey filing (2:07-cv-00286 and related 2:07-cv-04050 / 2:07-cv-05485), and the PTAB's own 2015 Notice of Related Matters identifies the then-pending matters as Celgene Corp. v. Lannett Holdings, Inc. et al., 2:15-cv-00697 (D.N.J.) and Celgene Corp. v. Natco Pharma Limited et al. (D.N.J.). The transfer precedes the first assertion by roughly six years — the opposite of a venue/standing-engineering transfer.

6. Bankruptcy fire-sale — NOT PRESENT. Celgene was acquired by Bristol-Myers Squibb in a going-concern, investment-grade transaction completed in late 2019. No Chapter 7 or Chapter 11 proceeding involving Celgene or this patent was found. The patent expired on its own terms (2020-10-23) rather than being sold out of an estate.

7. Privateering — NOT PRESENT. Privateering is an operating company transferring to a third party that asserts on its behalf. Here the operating company asserted in its own name: Celgene's 2015-05-14 Rule 3.73(b) statement and Notice of Related Matters both affirm that "Celgene owns by assignment the entire right, title, and interest in U.S. Patent No. 6,315,720," that "Celgene Corporation ... is the real party-in-interest," and that title traces directly from Williams and Kaminski. There is no intermediary asserting on Celgene's behalf.

8. Defensive aggregator — NOT PRESENT. The chain terminates at Celgene/BMS, not at RPX, AST, LOT Network, Unified Patents, or OIN. The patent was never neutralized by a defensive purchase; it simply expired in place. (Note: the IPR petitioners here, the Coalition for Affordable Drugs entities, are in the same "anti-patent-assertion" cultural space as the defensive aggregators, but they filed petitions rather than acquiring title — this does not convert signal 8 into a finding about the chain of title.)

Verdict

Operating-company assertion.

The entire recorded chain is a single inventor-to-employer assignment at reel 11469/0882, executed/recorded on or about 2001-01-05 (Google Patents shows the recordation as 2001-01-23), from Bruce A. Williams and Joseph K. Kaminski to Celgene Corporation — and Celgene then held the patent continuously for its full statutory life, confirming ownership on the PTAB record in 2015 ("Celgene owns by assignment the entire right, title, and interest") and asserting it against actual generic competitors (Lannett, Natco, Alvogen/Lotus, Sun Pharma). Celgene shipped products practicing the claims — Thalomid and Revlimid, both Orange Book–listed against this patent under use codes U-694/U-731/U-1210 — which is the definitional opposite of an NPE. No shell transfer, no known asserter, no cascading LLCs, no bankruptcy sale, and no defensive-aggregator termination appears anywhere in the record, so this fails all eight NPE signals decisively.

Two honest limitations: (a) I could not query Assignment Center directly from this session, so the chain above is reconstructed from documents that cite Assignment Center records rather than from the live database; and (b) the correspondent of record for reel 11469/0882 is unverified — if you need a fully clean negative, that cover sheet is the one item to pull.

Verification:

• USPTO Patent Assignment Search — https://assignment.uspto.gov/patent/index.html (search patent number 6315720; also https://assignmentcenter.uspto.gov/)
• Google Patents legal events — https://patents.google.com/patent/[US6315720B1](/patent/US6315720B1)/en#legalEvents
• Primary reel/frame citation — IPR2015-01103, Paper 6, Notice of Related Matters (P.T.A.B. May 14, 2015), and Paper 5, Power of Attorney / Rule 3.73(b) statement: https://www.docketalarm.com/cases/PTAB/IPR2015-01103/Inter_Partes_Review_of_U.S._Pat._6315720/05-14-2015-Patent_Owner/Notice-6-Related_Matters/
• Secondary reel/frame citation (family recordation, reel 013982/0697) — USPTO Notice of Recordation exhibit in D.N.J. 2:17-cv-03387, Doc. 250-30: https://storage.courtlistener.com/recap/gov.uscourts.njd.[348812](/patent/348812)/gov.uscourts.njd.348812.250.30.pdf

I'll research US Patent 6,315,720 and its cited prior art references.

Let me search for the specific "References Cited" (prior art citations) listed on the patent's face.

Let me retrieve the front-page "References Cited" list from the patent document directly.

US Patent 6,315,720 — Prior Art Analysis

1. Patent Identification (verified)

This matches the record returned for the exact number 6315720 and no similar number.

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2. Important limitation on scope of this answer

I was not able to retrieve a verbatim, complete front‑page "References Cited" (U.S. Patent Documents) list for US 6,315,720 from the sources available. The Google Patents full‑text rendering supplied in the authoritative text lists only "Prior art keywords: patient, drug, risk, information, side effect" and does not reproduce the front‑page citation table. My searches did not surface the front‑page list either. Rather than fabricate a citation table, I report below only the prior art I could verify is cited in the patent itself, and I flag the gap explicitly.

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3. Most relevant prior art — verified citations

Reference A — U.S. Pat. No. 6,045,501 (Elsayed et al.) ★ Primary/closest prior art

• Full citation: U.S. Patent 6,045,501, "Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug," Elsayed, M. and Williams, B., assigned to Celgene Corporation.
• Application/filing: Application No. 09/143,569, filed 1998‑08‑28.
• Publication/grant date: 2000‑04‑04 (i.e., granted before the 2000‑10‑23 filing of US 6,315,720 — properly prior art).
• Brief description (from the reference's own disclosure, as surfaced): A method for delivering a teratogenic/hazardous drug while preventing fetal exposure, comprising: registering qualified prescribers in a computer readable storage medium; registering pharmacies; registering patients (including information on female patients' ability to become pregnant and, optionally, male patients' ability to impregnate); retrieving identifying information for the subpopulation capable of becoming pregnant / capable of impregnating; providing counseling to that subpopulation; determining whether the patient is pregnant; and, upon a determination of non‑pregnancy, authorizing the registered pharmacy to fill the registered prescriber's prescription.
• Relationship to the patent-in-suit: US 6,315,720 expressly describes US 6,045,501 as teaching the base method — "of the type in which prescriptions for the drug are filled only after a computer readable storage medium has been consulted to assure that the prescriber is registered… that the pharmacy is registered… and the patient is registered… and approved to receive the drug." US 6,315,720 is expressly framed as an improvement on that method.
• Potential § 102 relevance:
  • US 6,045,501 discloses the entire preamble of independent claim 1 (and the parallel preambles of the other independent claims) — the registration of prescriber, pharmacy, and patient, and the authorization-to-fill architecture. Because claim 1 is drafted in Jepson/"improvement" form, this base subject matter is effectively admitted prior art.
  • It does not, on the disclosure surfaced, teach the improvement steps actually claimed — namely (a) defining a plurality of patient risk groups from a predefined set of risk parameters, (b) defining an information set probative of side‑effect risk, (c) assigning the patient to a risk group in response to that information, and (d) entering the risk‑group assignment before approval.
  • Conclusion: US 6,045,501 is the most relevant prior art and anticipates the admitted-prior-art preamble of the independent claims, but on the record surfaced it would not by itself anticipate the full independent claims (the risk‑group/improvement limitations are absent). It is better characterized as the § 103 springboard reference than a standalone § 102 anticipatory reference for the claimed invention as a whole.

Reference B — Accutane (isotretinoin) Pregnancy Prevention Program / Slone Epidemiology Unit survey (non‑patent literature)

• Citation as described in the patent: The prior Accutane (isotretinoin) pregnancy‑prevention program and the survey designed/implemented by the Slone Epidemiology Unit of Boston University, with "more than about 325,000 women enrolled." No formal journal cite is given in the patent text.
• Date: Described as pre‑existing at the 2000‑10‑23 filing (dates not specified in the patent).
• Brief description: A voluntary pregnancy‑prevention/enrollment program and patient survey used to monitor pregnancy rates among users of the teratogen isotretinoin.
• Potential § 102 relevance: This is background art describing a voluntary monitoring survey. The patent itself criticizes it (enrollment voluntary; not representative; no compliance mechanism; no distribution control). On the record available, it does not disclose the claimed risk‑group assignment and computer‑medium registration/authorization steps, so it is at most a secondary § 103 reference — not an anticipatory § 102 reference for any claim. Because I could not verify a formal citation/date, treat any § 102 characterization as low confidence.

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4. What I could NOT verify

• The complete front‑page "References Cited" list (other U.S. patent documents, foreign patent documents, and other publications) for US 6,315,720. I found no authoritative reproduction of that table in the sources retrieved, so I am not listing additional numbered references — doing so would risk fabrication.
• Cited family members such as WO 02/35440 A1, EP 1 330 765 A1, US 6,561,977, US 6,755,784, US 6,869,399, US 7,141,018, US 7,959,566, US 8,315,886, US 8,626,531 — these are same‑family continuations/divisionals or later publications, not prior art to US 6,315,720. WO 02/35440 (published 2002) and the EP/US family members post‑date the 2000‑10‑23 priority and therefore are not § 102 prior art.

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5. Analytical summary

Bottom line: On the verifiable record, U.S. Pat. No. 6,045,501 (Elsayed et al.) is the single most relevant piece of prior art for US 6,315,720, and US 6,315,720's independent claims are drafted as an improvement over it. If you need the complete front‑page citation table (which very likely contains additional U.S. patent references that I could not retrieve here), I recommend pulling the patent's front page directly from USPTO Patent Center / Patent Public Search (App. 09/694,217) or the granted-PDF front page — I can analyze each item against the claims if you supply that list.

Would you like me to pull the specific claim set (claim 1 and the other independent claims) and map each limitation element-by-element against US 6,045,501 for a formal § 102/§ 103 chart?

I'll ground this obviousness analysis in the prior art actually surfaced by the patent page and by targeted searches for the cited/related references.

Strong results. Let me pin down the specific primary references (Powell, Mitchell, Zeldis, Thalomid Package Insert) and the claim-level outcomes.

Let me confirm what the secondary references actually disclose (Cunningham, Keravich, Dishman), since these carry the "approval code" and "lockout" elements.

Obviousness Analysis — US 6,315,720 B1 under 35 U.S.C. § 103

Note on scope and on a contradiction with the earlier section. The previously generated section reproduced claim 1 as having four improvement steps (a)–(d) and expressly stated: "Notably not claimed in the '720 patent: the retrieval of a prescription approval code by the pharmacy." That is incorrect and must be flagged. The Federal Circuit in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019), quotes issued claim 1 verbatim, and it has five improvement steps, (a)–(e), the last of which is: "upon a determination that said risk is acceptable, generating a prescription approval code to be retrieved by said pharmacy before said prescription is filled." The earlier section was quoting the four-step Summary of the Invention language, not the issued claim. The '720 patent has 32 claims, not "≈2–4." This correction is material, because the approval-code element is precisely where the prior-art fight was fought.

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1. Legal framework and the operative claim

Claim 1 is a Jepson-format improvement claim. Its preamble admits the prior art of the type described in U.S. Pat. No. 6,045,501 (Elsayed et al.) — which the page's Background section identifies by name as the starting point, and whose substance is also reflected in the page's prior-art keywords (patient, drug, risk, information, side effect). The improvement:

• (a) defining a plurality of patient risk groups from a predefined set of risk parameters;
• (b) defining a set of information to be obtained from the patient probative of the side-effect risk;
• (c) assigning the patient to a risk group and entering that assignment in the medium;
• (d) based on the information and the assignment, determining whether the risk is acceptable;
• (e) upon acceptable risk, generating a prescription approval code to be retrieved by the pharmacy before the prescription is filled.

Two constructions controlled the analysis:

• "prescription approval code" — construed (adopting Celgene's own proposed construction) as "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." This construction was favorable to the patent, and the Board nonetheless found the element met by combining primary references with Cunningham.
• "computer readable storage medium" — not limited to a centralized database (BRI). The specification expressly contemplates separate media for prescribers, pharmacies, and patients. Under this construction, Dishman's decentralized "computerized lockout system" satisfied the limitation.

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2. The prior art references actually relied on

These are the references the Board instituted on and that the Federal Circuit reviewed. All are § 102(b) art relative to an October 2000 effective date.

Provisional caution: a 2018–2019 district-court complaint (Hagens Berman / D. Md.–D.D.C. filings) alleges that Celgene failed to disclose the Accutane "PPP Package" and the September 4–5, 1997 CDER meeting transcript during prosecution and asserts fraud on the USPTO. Those are allegations in a pleading, not adjudicated findings, and I do not rely on them for the § 103 analysis; I flag them only as an indication that additional § 102/§ 103 art (a 1997 FDA public meeting on thalidomide) may exist and was litigated as a disclosure issue rather than an invalidity issue.

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3. Ground 1 (IPR2015-01096) — Thalomid PI + Cunningham + Keravich + Zeldis + Mundt

Mapping to claim 1:

Board's holding: claims 1–32 unpatentable over Thalomid PI in view of Cunningham, and further in view of Keravich, Zeldis, and Mundt. The Board also held the IVR/automated-response combination to be "a combination of known elements being used for their known purpose to achieve a predictable result, obtaining patient information through an automated process to aid in assessing risk group assignment for prescribing drugs."

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4. Ground 2 (IPR2015-01102) — Powell + Dishman + Cunningham + Mann

This ground is the strongest, because Dishman supplies the entire registration/lockout architecture including patient registration and periodic diagnostic monitoring, which is closer to the claim than the labeling-based Ground 1.

Holding: claims 1–32 unpatentable over Powell and Dishman in view of Cunningham and further in view of Mann and other art. On appeal, Celgene attacked the male-counseling element via Powell's "no effects on male sperm" sentence; the Court upheld the Board's reading of Powell in context, and held substantial evidence supported the finding that a POSA "would have understood the necessity of counseling males, capable of impregnating females, about the risks that attend fetal exposure to a teratogenic drug."

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5. Ground 3 (IPR2015-01103) — Mitchell substituted for Powell

Mitchell is the single most damaging reference because it is a teratogen pregnancy-prevention program — i.e., the same problem (fetal exposure to a teratogenic drug) in the same regulatory context, just a different molecule (isotretinoin). It supplies, in one document: risk stratification by sex and childbearing potential, mandatory pregnancy testing, counseling and informed consent, and systematic patient surveys — essentially claim elements (a)–(d).

Holding: claims 1–32 unpatentable over the same references as Ground 2 but with Mitchell as the base reference.

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6. Why a POSA would have been motivated to combine

This is the crux, and the Board and Federal Circuit articulated several independent, legally cognizable motivations:

1. Same field, same problem. All references address controlling distribution of drugs whose adverse side effects are severe — thalidomide (teratogen), isotretinoin (teratogen), clozapine (agranulocytosis), and, in Cunningham, prescription handling generally. Mitchell and Powell are directly on point for the teratogen problem; Dishman is a working template for registry-plus-monitoring.

2. "Continuous search for safer ways" (the Board's motivation finding). "[W]here significant safety risks exist with a drug, one would continuously search for safer ways to control the distribution of the drug… one of ordinary skill in the art would not wait until an accident occurred to seek out improvements." The Court held this was a specific, not generic, motivation, and rejected Celgene's "if it ain't broke, don't fix it" argument.

3. The patentee's own words as motivation evidence. In Zeldis (1999), Celgene published: "Celgene is committed to making the S.T.E.P.S. program succeed and will make any modifications to the program that are necessary to ensure its effectiveness." The Federal Circuit expressly cited this as substantial evidence of motivation. This is a notable and reusable point: the patentee's own prior publication supplies the reason to modify.

4. KSR-style predictable combination of known elements for known purposes. The Board held the improvement "represents 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)."

5. Reasonable expectation of success. Every individual measure was already proven in analogous programs: pregnancy-prevention programs worked for isotretinoin (Mitchell); registry/monitoring programs worked for clozapine (Dishman); approval-code lockout was a known pharmacy-network technique (Cunningham); IVR data capture was validated (Mundt). Nothing in the combination required unpredictable engineering.

6. Regulatory backdrop. Thalidomide was re-entering the U.S. market under FDA-imposed access controls; the art and the agency were pressing in the same direction. Art-recognized computer tools (Shinn's interaction database; Linnarsson; Gronroos) and behavioral-risk screening literature (Soyka, Hamera, Kosten) further show the field was already using computers to screen prescriptions for risk.

Why Cunningham specifically would be picked up: Cunningham discloses the exact mechanical predicate the claim needs — a pharmacy terminal that cannot dispense without a central-station validation, and a "pharmacy approval code" issued only upon validation. A POSA seeking to enforce a thalidomide risk assessment at the point of dispensing, rather than trusting the prescriber, would naturally reach for a pharmacy-side lockout/approval-code mechanism.

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7. The limits of the obviousness case: claim 10 (and the reasoning that failed)

Not everything fell. Claim 10 (depending from claim 7, which depends from claim 1) requires that the information to be obtained from the patient "includes the results of diagnostic testing," and that "said diagnostic testing comprises genetic testing."

• The Board initially found claim 10 obvious despite conceding that "the references of record do not disclose or suggest genetic testing," relying solely on a conclusory expert statement plus FDA meeting minutes.
• On rehearing (Sept. 8, 2017), the Board vacated that holding. The proper question was not what Celgene disputed, but whether Petitioner put in evidence that genetic testing was known and would have been used in the claimed combination. The FDA minutes "do not refer to genetic testing, much less suggest using genetic testing in the combination required by claim 10," and "the lack of disclosure in the prior art of record — coupled with the record's disclosure of other types of tests — cuts against" a finding of commonality.
• Result: claim 10 survived as the only claim of the 32 not held unpatentable.

Analytical takeaway for a § 103 analysis: the record affirmatively disclosed other diagnostic tests (WBC counts in Dishman, pregnancy tests in Mitchell/Thalomid PI). That diversity of known tests is what defeated the assertion that genetic testing was the obvious choice — a classic "teaching away from the unpredicted species by disclosing a different genus" dynamic. If you were building an obviousness case today, claim 10 is the claim to attack with a dedicated reference (a § 102(b) publication placing genetic/prenatal screening in the teratogen-counseling pathway), not by expert assertion.

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8. Secondary considerations (and why they failed)

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9. Adjudicated outcome and status

• PTAB Final Written Decisions, Oct. 26, 2016 (IPR2015-01096/-01102/-01103): claims 1–32 unpatentable as obvious.
• Rehearing granted Sept. 8, 2017: claim 10 held not shown obvious; claims 1–9 and 11–32 remain unpatentable.
• Fed. Cir., July 30, 2019, Celgene Corp. v. Peter, 931 F.3d 1342 (Nos. 2018-1167/1168/1169, with companion 2018-1171 on the '501 patent): AFFIRMED. Also held retroactive IPR application to pre-AIA patents is not a Fifth Amendment taking.
• Rehearing and rehearing en banc denied Dec. 9, 2019; cert petition filed Feb. 2020 (No. 19-1074).
• The '720 patent is expired (anticipated expiration October 23, 2020), so any residual validity question is of historical, defensive, or royalties/settlement relevance rather than prospective injunctive relevance.

So the practical answer to "does § 103 render the claims obvious?" is not hypothetical: a tribunal has already so held for 31 of 32 claims, and the Federal Circuit affirmed. The combination that carried the day was, in order of force:

1. Mitchell + Dishman + Cunningham (+ Mann) — risk stratification for a teratogen, plus a registry/lockout with monitoring, plus a pharmacy approval code;
2. Powell + Dishman + Cunningham + Mann — same, with a thalidomide-specific clinical dispensing guideline as the base;
3. Thalomid PI + Cunningham + Keravich + Zeldis + Mundt — the approved labeling plus the approval-code mechanism plus the patentee's own S.T.E.P.S. publication as motivation evidence.

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10. Explicit uncertainties and caveats

1. Keravich — named in the -01096 ground, but I could not verify its citation or disclosure from the retrieved material. Do not attribute substance to it without the exhibit.
2. "Prior Art section of this page" — the Google Patents page as fetched exposes only the prior-art keyword set (patient, drug, risk, information, side effect) and the Background's citation of U.S. Pat. No. 6,045,501 (Elsayed et al.). The substantive art list above comes from the PTAB filings and the Federal Circuit opinion, which are the authoritative records of what was actually asserted against this patent.
3. Claim construction standard — the Board applied BRI, including to "computer readable storage medium" and "prescription approval code." The PTO has since aligned IPR construction with Phillips. A Phillips-standard tribunal could construe "prescription approval code" and "computer readable storage medium" differently, which is the most plausible route to a different outcome on the Cunningham-based element. The Board's alternative holding (that a centralized database would also have been obvious) partially insulates the result.
4. Cunningham's weakness. Celgene's strongest substantive point was that Cunningham's "pharmacy approval code" authenticates prescriber and pharmacy, not patient risk, and that the '720 claim-construction requires the code to represent an affirmative, patient-specific risk assessment. The Court upheld the combination because the Board imported the "affirmative risk assessment" requirement into the construction and located that teaching in the primary references (Thalomid PI, Powell, Mitchell), using Cunningham only for the code/lockout mechanism. If a future tribunal rejected that division of labor, the (d)–(e) pairing would be the vulnerable seam.
5. Date discrepancy. The task header states "Current Date: April 26, 2026," while the session metadata states today's date is 2026-10-01. I note this rather than silently reconciling it. Either way, both post-date the December 2019 mandate, so nothing in this analysis turns on the discrepancy.
6. No 2026 activity found. Consistent with the earlier section, I found no 2026 CAFC docket involving 6,315,720; the appellate history ends with the denied en banc rehearing (Dec. 9, 2019) and the Feb. 2020 cert petition. This remains an unconfirmed negative.