US 9314464

I'll search for authoritative information on US 9,314,464, including any CAFC 2026 docket activity.

Let me search for the specific litigation and any CAFC 2026 docket involving this patent.

Let me verify whether any 2026 Federal Circuit appeal exists for this patent, and check the Orange Book listing.

US Patent 9,314,464 — Analyst Summary

Search scope note: I ran targeted searches against Google Patents, Justia Patents, USPTO/Orange Book data, USPTO assignment records, CourtListener/PACER (D. Del.), Unified Patents' litigation portal, and the CAFC opinions/orders database. I did not find any Federal Circuit 2026 docket or opinion involving this patent (details in §5). Where I lack authoritative data, I say so explicitly.

1. Bibliographic Record

Record discrepancy flagged (not reconciled): the U.S. patent's own cross-reference recites provisionals 61/238,073 and 61/313,039, whereas the corresponding PCT/AU family record (WO 2011/023773 / AU 2010288455) lists provisionals 61/238,083 and 61/313,061. I am reporting both literally rather than correcting either.

2. Abstract (verbatim)

"The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf."

3. Disclosure Overview

• Chemistry: Pyrazol-4-yl-pyrimidin-2-ylamines bearing a substituted phenyl ring on the pyrazole. Markush Formula I: [1*]NC1=NC=CC(C2=CN([7*])N=C2C2=C([5*])C(CS([4*])(=O)=O)=[Y]C([3*])=C2[2*])=N1, with Y = N or CR⁶; R¹ typically an —X¹NHC(O)OR⁸ᵇ carbamate side chain; R⁴ a sulfonyl group.
• Lead compound: Compound 9 = (S)-methyl 1-(4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-ylamino)propan-2-ylcarbamate — i.e., encorafenib.
• Biology: Inhibits B-Raf and mutant B-Raf (V600E); assayed by AlphaScreen p-MEK luminescence proximity (IC₅₀ target < 500/250/100/50 nM), A375 cellular proliferation, A375 xenograft, microsomal clearance, and (notably) a paradoxical Raf-inhibitor–induced pMEK/pERK and cell-growth effect in wild-type B-Raf cells that is reversible by co-administered MEK inhibitor (FIG. 1).
• Synthesis: Suzuki coupling of a 3-iodo-pyrazole with an aniline/boronate, then sulfonylation (Schemes I–IX); the specification gives routes to encorafenib and to intermediate building blocks.
• Indications: Melanoma (BRAF V600E/V600K), solid tumors, GBM, AML, lung, prostate, gastric, pancreatic, bladder, colon, thyroid, ovarian low-grade carcinoma, colorectal.
• Combinations: Explicit Raf + MEK1/2 inhibitor combinations claimed; MEK inhibitors named include AS703026, MSC1936369B, GSK1120212, AZD6244, PD-0325901, ARRY-438162 (binimetinib), RDEA119, GDC0941, GDC0973, TAK-733, RO5126766, XL-518.

4. Independent Claims (Plain Language)

The independent claims of the '464 patent are method-of-treatment claims (not compound claims — the genus/species compound claims sit in related family members). Based on the sources retrieved:

1. Lead independent claim (claim 1). A method of treating a B-Raf protein kinase–mediated cancer selected from lung carcinoma, pancreatic carcinoma, bladder carcinoma, colon carcinoma, myeloid disorders, prostate cancer, thyroid cancer, melanoma, adenomas and carcinomas of the ovary, eye, liver, biliary tract, and nervous system, by administering an effective amount of a compound of Formula (Ia) (or a tautomer, stereoisomer, or pharmaceutically acceptable salt thereof), where Formula (Ia) is the pyrazolyl-pyrimidinyl-phenyl sulfonamide scaffold recited above. Dependent claims narrow R⁴ to alkyl/cycloalkyl (claim 2), specify R₂/R₃/R₅/R₆/Y substitutions (claim 3), recite named compounds (claim 4), and further narrow to particular cancers.
2. Additional independent method claims exist in the claim set covering the same therapy with further limitations — including claim groups that add a second therapeutic agent (a different Raf kinase inhibitor or an inhibitor of MEK, mTOR, HSP90, AKT, PI3K, CDK9, PAK, PKC, a MAP kinase, a MAPK kinase, or ERK), and at least one claim that refers to a compound of Formula (Ib) administered with the additional agent (see claim 27, which specifies sequential administration).
3. Combination claims naming "ARRY-438162." Claim groups 11–13, 18–20, and 25–27 recite the MEK inhibitor "ARRY-438162" (including a list of MEK inhibitors in claim 25 and ARRY-438162 specifically in claim 26). The remaining asserted claims in the Delaware litigation were 7–10, 14–17, and 21–24.

Uncertainty: I could not retrieve the complete verbatim claim set from the sources available in this session, so I cannot authoritatively enumerate the exact numbering of every independent claim or reproduce each one word-for-word. Claim 1's scope, the combination-claim content, and the claim-group boundaries above are supported by the retrieved records; finer claim-tree details should be verified against the USPTO full-text (PatentCenter) or the printed patent.

5. Litigation / CAFC 2026 Status

District court (D. Del., Judge Gregory B. Williams) — the '464 patent was a patent-in-suit in two consolidated ANDA actions:

• Array BioPharma Inc. v. Sandoz Inc., No. 1:22-cv-01316 (filed Oct. 6, 2022). Patents-in-suit: 9,314,464, 9,850,229, 10,005,761, 9,562,016, 9,598,376, 9,980,944. Terminated Jan. 9, 2025 by stipulated dismissal without prejudice pursuant to a settlement and license agreement — expressly not an adjudication on the merits.
• Array BioPharma Inc. v. Alembic Pharmaceuticals Ltd., No. 1:22-cv-01277 (filed Sept. 28, 2022; consolidated with Sandoz).
• Key merits event: In an April 16, 2024 claim-construction ruling (D.I. 93/94), the court held the term "ARRY-438162" indefinite under 35 U.S.C. § 112. Based on that, the parties stipulated (D.I. 131, entered May 28, 2024) that claims 11–13, 18–20, and 25–27 of the '464 patent are invalid for indefiniteness (same for corresponding claims of the '229 and '761 patents), and that certain '016/'376/'944 claims were not infringed. Array expressly disagreed with and objected to the construction and reserved all appellate rights.
• Post-2024: The remaining '464 claims (7–10, 14–17, 21–24) stayed in suit; on May 23–27, 2025 the court entered a stipulated order of infringement of certain claims of the '464, '229 and '761 patents as to Alembic.

CAFC 2026 dockets — no match found. Searches of the CAFC opinions/orders database for 2026 returned no appeal involving U.S. 9,314,464. The only 2026 Federal Circuit item surfaced was IdeaHub Inc. v. Unified Patents, LLC, No. 2024-1684 (Fed. Cir. Apr. 10, 2026) (Rule 36 affirmance of a PGR), which is unrelated to this patent. Given the reserved appellate rights and the May 2025 stipulated judgment of infringement, a future or pending appeal is plausible, but I found no authoritative evidence of a Federal Circuit appeal docket for the '464 patent as of this search, and my CAFC coverage (opinions/orders) may not capture every live docket. This should be confirmed directly against the Federal Circuit's PACER docket and the USPTO/PTAB record if a definitive appeal status is required.

No PTAB proceeding (IPR/PGR) specifically for 9,314,464 was surfaced in the searches performed.

6. Sources

• Google Patents full text: https://patents.google.com/patent/US9314464/en
• Justia Patents: https://patents.justia.com/patent/9314464
• uspto.report: https://uspto.report/patent/grant/9,314,464
• Orange Book (BRAFTOVI, NDA 210496): https://www.accessdata.fda.gov/Scripts/cder/ob/patent_info.cfm?Product_No=002&Appl_No=210496&Appl_type=N
• D. Del. stipulated invalidity order (D.I. 131): https://storage.courtlistener.com/recap/gov.uscourts.ded.80177/gov.uscourts.ded.80177.131.0.pdf
• D. Del. claim-construction opinion (D.I. 93, Apr. 16, 2024): https://storage.courtlistener.com/recap/gov.uscourts.ded.80177/gov.uscourts.ded.80177.93.0.pdf
• Sandoz docket: https://www.courtlistener.com/docket/65406191/array-biopharma-inc-v-sandoz-inc/
• Alembic docket: https://www.courtlistener.com/docket/65382822/array-biopharma-inc-v-alembic-pharmaceuticals-limited/

I'll research litigation involving US Patent 9,314,464. Let me start with targeted searches.

Let me search for additional cases and details on each.

Litigation Involving U.S. Patent No. 9,314,464 ("the '464 patent")

Bottom line: I identified three known U.S. district court litigations naming the '464 patent, all in the District of Delaware, all Hatch-Waxman/ANDA cases brought by Array BioPharma, Inc. (now a Pfizer subsidiary) over generic binimetinib (MEKTOVI). All three were terminated by settlement/stipulated dismissal — no merits trial occurred. I found no Federal Circuit appeal and no PTAB (IPR/PGR) proceeding specifically reaching the '464 patent, though my searches on that point were cut short and should be re-verified.

Note on scope: the three Delaware suits asserted overlapping families of patents; the '464 patent is the genus/compound-type ("Compounds and compositions as protein kinase inhibitors") patent listed in the Orange Book against NDA 210498 (MEKTOVI) and NDA 210496 (BRAFTOVI), expiring July 4, 2031, and it was asserted method/compound-wise via the defendants' proposed labeling.

1. Array BioPharma, Inc. v. Alembic Pharmaceuticals Limited (and Alembic Pharmaceuticals, Inc.)

Sources: CourtListener docket & Stipulation of Dismissal (D.I. 187) — https://www.courtlistener.com/docket/65382822/187/array-biopharma-inc-v-alembic-pharmaceuticals-limited/; D. Del. opinion page, Case 22-1277 (Apr. 16, 2024 claim construction) — https://www.ded.uscourts.gov/opinion/array-biopharma-inc-v-alembic-pharmaceuticals-limited-et-al; Justia docket — https://dockets.justia.com/docket/delaware/dedce/1:2022cv01277/80177; DrugPatentWatch — https://www.drugpatentwatch.com/p/alphasignals/litigation/patent/9314464

Notable merits-adjacent development in this litigation (affecting the '464 patent): On May 28, 2024, Judge Williams signed a "Joint Stipulated Order Between Array and Sandoz of Invalidity of Certain Claims of U.S. Patent Nos. 9,314,464, 9,850,229, and 10,005,761, and Noninfringement of Certain Claims of U.S. Patent Nos. 9,562,016, 9,598,376, and 9,980,944" (D.I. 133/134 in C.A. 22-1277). The court and parties treated 22-1277 as the lead of the "Alembic/Sandoz litigation." See https://www.courtlistener.com/docket/65382822/134/array-biopharma-inc-v-alembic-pharmaceuticals-limited/. Caution: This stipulated invalidity order did not ripen into a final, appealable judgment — the parties expressly declined to seek Rule 54(b) entry of final judgment, and the cases were later dismissed on settlement. Do not treat it as an adjudicated invalidity of the '464 claims.

2. Array BioPharma Inc. v. Sandoz Inc.

Sources: PACER docket and stipulated dismissal order quoted in PatSnap case analysis — https://www.patsnap.com/fr/resources/blog/litigation/array-biopharma-v-sandoz-mek-inhibitor-patent-dispute-patsnap/; Google Patents litigation entry for 1:22-cv-01316 — https://patents.google.com/patent/[US9314464](/patent/US9314464)/en; Citeline/Generics Bulletin (Sandoz settlement) — https://insights.citeline.com/generics-bulletin/legalandip/sandoz-strikes-settlement-on-us-binimetinib-anda-IP2AVI65A5DWDLS72HEUPTCV6E/

Note the literal citation in the dismissal order reads "9,850, 299" — reproduced as found; the corresponding patent in this family is U.S. 9,850,229.

3. Array BioPharma Inc. v. Teva Pharmaceuticals, Inc.

Important scope caveat: Although the '464 patent appears on the § 8 Patent/Trademark Report filed in this case, the parties' October 17, 2024 joint letter states that Array asserted only the three "Crystallized Binimetinib Patents" (U.S. 9,562,016; 9,598,376; 9,980,944) against Teva, and that Teva's Paragraph IV notice did not address the '464 patent (nor five other Orange Book patents). So the '464 patent was formally listed in the case but was not a substantive basis of the asserted claims.

Sources: CourtListener docket — https://www.courtlistener.com/docket/67486186/array-biopharma-inc-v-teva-pharmaceuticals-inc/; joint scheduling letter (Oct. 17, 2024) — https://storage.courtlistener.com/recap/gov.uscourts.ded.82712/gov.uscourts.ded.82712.15.0.pdf; complaint (Teva Notice Letter, ANDA 217509) — https://paragraphfour.com/wp-content/uploads/2022/09/dedc23cv0625C.pdf; DrugPatentWatch — https://www.drugpatentwatch.com/p/alphasignals/litigation/casename/index.php?query=Array+BioPharma+Inc.+v.+Teva+Pharmaceuticals%2C+Inc.%7C1%3A23-cv-00625

Related family / worldwide litigation signals (not separate '464 suits)

• Google Patents flags "Family has litigation" for the '464 patent family, listing exactly the two Delaware cases above (1:22-cv-01316 and 1:22-cv-01277) plus a Darts-IP "First worldwide family litigation filed" family link (family 42782253). See https://patents.google.com/patent/US9314464/en — these are the same suits, not additional ones.
• Later, unrelated-patent ANDA suits (e.g., Array BioPharma Inc. et al. v. Alembic Pharmaceuticals Limited et al., D. Del. 1:25-cv-01016, filed Aug. 13, 2025, asserting U.S. 9,782,414; 10,172,861; 10,285,993; 10,799,505; 10,813,936) do not involve the '464 patent and are excluded here. See https://dockets.justia.com/docket/delaware/dedce/1:2025cv01016/90305.

PTAB / IPR status

Based on the sources retrieved (including DrugPatentWatch's combined "district court and PTAB cases" page for U.S. 9,314,464, which lists only the three district court cases and no AIA proceedings), I found no inter partes review or post-grant review of the '464 patent. I was unable to complete a full PTAB/PatentCenter and Federal Circuit docket check before my research budget expired — treat the "no IPR/no appeal" conclusion as unverified and confirm directly at https://ptacts.uspto.gov and via the Federal Circuit docket if this matters for your analysis.

Key takeaways

1. All three suits were Hatch-Waxman ANDA cases over generic binimetinib (MEKTOVI), brought by Array BioPharma (assignment history on the face of the '464 patent runs IRM LLC → Novartis → Novartis AG → Array BioPharma, Inc., with a current-assignee listing of Novartis AG and Array BioPharma Inc.).
2. None produced a merits ruling on the '464 patent; each ended in a confidential settlement and license agreement with a stipulated dismissal expressly "not an adjudication on the merits."
3. The only merits-adjacent event touching the '464 patent was the stipulated invalidity of certain '464 claims between Array and Sandoz (May 28, 2024), which was never converted into a final judgment and was overtaken by the settlements.
4. Current status of the '464 patent itself: Active, with an adjusted expiration of July 4, 2031, and Orange Book listings against MEKTOVI (NDA 210498) and BRAFTOVI (NDA 210496).

Recommended verification steps: pull the PACER dockets for 1:22-cv-01277-GBW, 1:22-cv-01316-GBW, and 1:23-cv-00625-GBW; check the D. Del. docket for any vacatur of the May 28, 2024 stipulated order; and run the '464 patent number through Unified Patents' litigation portal (https://portal.unifiedpatents.com/litigation/caselist), USPTO PTAB, and the Federal Circuit docket to catch anything outside the three cases identified here.

I'll verify against live sources before writing up, since the structured block says ODP shows no AIA proceedings.

Let me run a few more targeted checks before concluding.

One more round to be thorough on PTAB and appellate activity specific to the '464 patent.

PTAB / AIA Trial Report — US Patent 9,314,464 B2

Patent: US 9,314,464 B2 ("Compounds and compositions as protein kinase inhibitors") — Novartis AG / Array BioPharma Inc. (now Pfizer); Orange Book listing for BRAFTOVI (encorafenib), expiration 2031-07-04.
Canonical source queried: USPTO Open Data Portal "PTAB proceedings on file" block supplied with this task.

Proceedings overview

Total AIA trial proceedings on file: 0. The ODP structured block returns no Inter Partes Review, Post-Grant Review, or Covered Business Method proceeding for US 9,314,464, and therefore the breakdown by status (active / claims invalidated / claims sustained / settled / institution denied) is 0 / 0 / 0 / 0 / 0. My independent web checks (see "Verification performed" below) surfaced only Hatch-Waxman district court litigation and Orange Book/FDA records — no PTAB docket number for this patent. Bottom line for a defendant: nothing on this patent has been canceled, and nothing has been sustained. Every claim is UNTESTED at the PTAB. That is not a hardened patent and it is not a dead one — it is an untested composition-of-matter patent with roughly five years of listed term remaining, and there is no prior petitioner whose estoppel you can free-ride on.

I want to flag the mismatch in the task framing: the output template asks me to rank "claims-invalidated" proceedings at the top and to quote an FWD's claim dispositions. There are no proceedings to rank and no FWD to quote. I have not invented proceeding numbers, panels, grounds, or outcomes to fill the template. The template's informational slots below are marked as not applicable rather than silently populated.

Proceedings

None. No IPR20xx-#####, PGR20xx-#####, or CBM20xx-##### proceeding on US 9,314,464 appears in the structured data or in my searches. There is correspondingly no institution decision, no Final Written Decision, no termination-by-settlement, and no Federal Circuit appeal of an FWD to report.

Verification performed (so you can audit the negative)

Caution on false-positive hits — do not be misled by these:

• The search hit "Petition for Inter Partes Review of U.S. Patent No. 9,584,464 B2" is a different patent (a vehicle-information patent). Four-digit suffix overlap, not this patent.
• Takeda Pharm. Co. v. Array BioPharma, Inc., IPR2015-00754, involved U.S. Patent 8,592,454 — a different patent, and Array was the petitioner there, not the patent owner. Neither the patent nor the party posture carries over.
• Noven Pharm. v. Novartis AG, IPR2014-00549/-00550, concerned Exelon/rivastigmine patents — unrelated.

Adjacent litigation context (district court, not PTAB — useful for posture, not for estoppel)

The '464 patent's enforcement history is entirely Article III:

Sources: CourtListener docket, 1:22-cv-01277; Google Patents litigation panel for US9314464B2.

Two things follow. First, the only validity rulings in those cases concerned the binimetinib patents (U.S. 9,562,016; 9,598,376; 9,980,944), not the '464 patent — the D. Del. construction of "crystallized [binimetinib]" drove stipulated invalidity/non-infringement on those patents, and that has no bearing on '464 claim scope. Second, both cases ended in settlement/dismissal, not judgment, so there is no district court invalidity holding on '464 and no collateral estoppel against it. (I could not confirm the settlement terms — in Hatch-Waxman cases these are typically confidential; treat as unknown.)

One genuinely useful signal: in ANDA 217635 (Teva), FDA's tentative-approval letter records that Teva filed paragraph III certifications to the '464 patent (among others), i.e. Teva certified it will not market before expiration rather than challenging validity. At least one significant ANDA filer has chosen to wait out this patent instead of attacking it.

Strategic summary

Claim status — CANCELED vs. SUSTAINED vs. UNTESTED. Zero claims of US 9,314,464 have been canceled; zero have been confirmed by the Board; all claims are UNTESTED at the PTAB. I am deliberately not stating a total claim count — the authoritative materials in front of me do not establish it, and the description's internal cross-reference to "claim 12 or 13" only proves the count is at least 13. Any assertion that "claims 1–5 are canceled" or "the patent survived two IPRs" would be fabricated, and a defendant receiving either claim from opposing counsel should demand the docket numbers.

Estoppel landscape — wide open. Because no petition has ever been filed on this patent, no § 315(e)(2) estoppel has attached to anyone. There are no privies of prior petitioners to worry about, no Sotera stipulations, and no Board record to overcome. A defendant today can bring any § 102/§ 103 ground on any claim, on any prior-art combination — subject only to the ordinary constraints: the § 315(b) one-year bar running from service of the complaint, § 325(d) discretionary denial if the art was before the examiner, and § 314(a) / Fintiv discretion if there is a parallel district court case at an advanced stage. The practical consequence is double-edged: you are free to attack, but you also get no head start — you would be the first petitioner, paying full freight and creating the record that all later challengers borrow.

Pattern signals. No repeated-petitioner pattern (no petitioner at all). The patent owner has never had to defend at the PTAB in roughly ten years of enforceability, and has not pursued any PTAB appeal. No defensive aggregator (Unified Patents, RPX, etc.) appears anywhere in the chain — the two D. Del. cases were conventional branded-vs-ANDA-filer suits, and Unified's litigation portal entries for the family appear to be data aggregation, not Unified-initiated challenges. The patent's real-world posture is that of a mid-life composition-of-matter patent that generics have chosen to design around, settle, or wait out rather than kill.

Recommended next steps

1. Confirm the negative yourself before relying on it. Pull PTAB E2E / Patent Center for US 9,314,464 and re-run this check, since new petitions can be filed at any time and ODP ingest lags. Search link: PTAB E2E — search by patent number 9,314,464. If a proceeding now exists, everything above changes.
2. If you are a defendant being asserted against: you cannot cite an FWD, because none exists. Do not let an adversary tell you the patent has been "narrowed by the PTAB" — it has not been touched. Your leverage comes instead from (a) the untested state of the composition-of-matter claims, which means prior-art estoppel is nil and you can file broadly, and (b) the fact that you would be the first mover, so consider filing early rather than after the § 315(b) clock forces your hand.
3. Budget the § 315(b) clock. If a complaint asserting '464 has been served on you, your IPR petition deadline is one year from service. Given a pending D. Del. case, expect a Fintiv/§ 314(a) discretionary-denial fight and consider a Sotera-type stipulation to neutralize it.
4. Watch the sibling patents, not just this one. Encorafenib is protected by a large Orange Book family with later expirations than '464 (e.g., U.S. 9,474,754 to 2033-08-05; U.S. 10,258,622 and U.S. 9,387,208 to 2032-11-21, per FDA's ANDA 217635 letter). FTO and IPR strategy that targets only '464 will leave you exposed — the binimetinib-patent construction fight in D. Del. is a live reminder that the portfolio's pressure points are not where the earliest-expiring claim sits.
5. The absence of PTAB activity is itself the finding. Well-asserted Orange Book patents typically attract at least one IPR; this one has been asserted twice in D. Del. and attracted none, and at least one filer certified paragraph III rather than challenge. Read that as the patent being commercially costly to litigate but not perceived as weak enough to be worth a validity attack — or as challengers having chosen the settlement/design-around path. Either way, treat '464 as live and unharmed.

Confidence and limits: I am highly confident there are no AIA trial proceedings on US 9,314,464 B2 on file as of the most recent ODP ingest. I could not directly query USPTO PTAB E2E in this session, and my searches are not a substitute for a direct docket pull; I am also unable to state the total number of claims, the exact asserted claims in the D. Del. cases, or the settlement terms of the Alembic/Sandoz matters. Where I do not know something, I have said so rather than filling the gap.

I'll start by gathering the primary assignment records and cross-references.

Let me pin down the recorded assignment details (reel/frame, correspondent) and check for any Pfizer/security-interest recordings.

Ownership & Assignment Reconstruction — US 9,314,464 B2

Patent: US 9,314,464 B2 ("Compounds and compositions as protein kinase inhibitors")
App. No.: 13/931,111 (filed 2013‑06‑28; divisional of 12/870,130, filed 2010‑08‑27)
Priority: 2009‑08‑28 (US provisional 61/238,073) / 2010‑03‑11 (61/313,039)
Issued: 2016‑04‑19 · Adjusted expiration: 2031‑07‑04 (PTA)
Orange Book: listed against BRAFTOVI (encorafenib, NDA 210496; use codes U‑2336, U‑2802, U‑2803, U‑3738, U‑4051, U‑4440) and MEKTOVI (binimetinib, NDA 210498; U‑2332)

Method note: the Assignment Center record view is behind a session‑based UI and is not directly indexable here. The chain below is reconstructed from the USPTO‑derived legal‑events data on Google Patents plus third‑party mirrors of the same USPTO assignment records (Dimensions, PlainSite, litigation dockets). Where I could not see the recorded reel/frame or the correspondent for a specific link, I say so rather than infer it.

Inventors

Eight named inventors. The recorded inventor assignments split them across two different Novartis entities, which is the most notable feature of this record:

• Employer at filing: all eight are Novartis‑affiliated; IRM LLC was the Novartis Bermuda entity that held the San Diego–originated IP (the Novartis/GNF research complex), while Jin and Poon assigned directly to Novartis AG. The assignment records establish the assignee, not the employment contract — I did not find a primary source confirming job titles or the specific Novartis site for each inventor, so I am not asserting site‑level employment.
• Unusual pattern check: I found no evidence of inventors departing the assignee within 12 months of filing, and no inventor‑retained rights or reversion. The 2015 recording of these two inventor assignments (five years after the 2010 parent filing) is a timing anomaly — most consistent with confirmatory/re‑recording during the Novartis corporate restructuring, but the execution dates of those two documents are not visible in the sources reviewed, so I cannot confirm the reason.

Original assignee

Novartis AG (Basel, Switzerland) is the assignee of record printed on the issued patent — consistent with Google Patents' "Original Assignee: Novartis AG."

• Primary line of business: global pharmaceutical R&D and commercialization (operating company).
• Product embodying the claims: At the time the '464 patent issued, Novartis had not commercialized the compound. The claimed compound (compound 9 in the specification) is encorafenib (LGX818), a BRAF inhibitor. It was divested to Array BioPharma under the European Commission's merger remedy in Case M.7275 (Novartis/GSK oncology transaction, decision 2015‑01‑28), and first approved as BRAFTOVI on 2018‑06‑27 — i.e., the product shipped under a different owner downstream in the chain.
• Current status: Novartis AG remains an operating company but is no longer the owner of this patent. Note that the original assignee and the current owner are different operating companies — this is a divestiture chain, not a shell chain.

Assignment timeline

Source of record: USPTO assignment records as surfaced through Google Patents legal events, cross‑checked against third‑party mirrors. Reel/frame shown only where corroborated; elsewhere marked "not determined."

1. Executed 2015‑01‑05 / recorded 2015‑04‑22 — Reel 035469/0260

   • Conveyance: Merger
   • Assignor: IRM LLC (Bermuda)
   • Assignee: Novartis International Pharmaceutical Ltd. (Bermuda)
   • Correspondent: not shown in the sources I could access for this recording. A duplicate recordation of the same instrument (same assignor/assignee, same executed date 2015‑01‑05, recorded 2020‑01‑16) appears as USPTO assignment 51532/0015 with correspondent Banner & Witcoff, Ltd., 1100 13th Street NW, Suite 1200, Washington, DC 20005. Banner & Witcoff appears once in this chain — below the recurrence threshold, so no repeat‑correspondent finding.
   • Context: internal reorg (Novartis corporate consolidation).
   • Caveat: the reel/frame 035469/0260 is corroborated from a third‑party database on a sibling Novartis/IRM patent carrying the identical merger chain; confirm this patent's appearance on that instrument's schedule directly in the Assignment Center.

2. Executed 2015‑03‑30 / recorded 2015‑04‑22 — Reel 035469/0858

   • Conveyance: Merger
   • Assignor: Novartis International Pharmaceutical Ltd.
   • Assignee: Novartis AG
   • Correspondent: not determined (same caveat as above).
   • Context: internal reorg — completion of the two‑step Bermudan/Swiss consolidation. Same reel‑corroboration caveat.

3. Recorded 2015‑09‑10 — Reel not determined

   • Conveyance: Assignment of assignors' interest
   • Assignor: Huang, Shenlin; Liu, Zuosheng; Tellew, John; Wan, Yongqin; Wang, Xing; Xie, Yongping
   • Assignee: IRM LLC
   • Correspondent: not determined. Execution date not visible.
   • Context: inventor‑to‑employer assignment (recorded late, during the restructuring).

4. Recorded 2015‑09‑10 — Reel not determined

   • Conveyance: Assignment of assignors' interest
   • Assignor: Jin, Xianming; Poon, Daniel
   • Assignee: Novartis AG
   • Correspondent: not determined.
   • Context: inventor‑to‑employer assignment to the ultimate parent rather than to IRM LLC.

5. Recorded 2016‑07‑13 — Reel not determined

   • Conveyance: Assignment of assignors' interest
   • Assignor: Novartis AG
   • Assignee: Array BioPharma, Inc. (Boulder, Colorado)
   • Correspondent: not determined.
   • Context: divestiture — expressly contemplated by the LGX818 Asset Transfer Agreement dated as of 2015‑01‑19 between Novartis Pharma AG and Array BioPharma, executed to satisfy the European Commission's M.7275 remedy (the EC file records that Array "acquired worldwide rights to encorafenib" and that Novartis would "assign … all patent and other intellectual property rights … to the extent relating to encorafenib").

6. Executed 2015‑01‑05 / recorded 2020‑01‑16 — Reel 51532/0015

   • Conveyance: Merger (duplicate/confirmatory recordation of entry 1 above)
   • Assignor: IRM LLC
   • Assignee: Novartis International Pharmaceutical Ltd.
   • Correspondent: Banner & Witcoff, Ltd., 1100 13th Street NW, Suite 1200, Washington, DC 20005 (single appearance — flagged, not a recurrence finding)
   • Context: confirmatory chain‑of‑title recordation; the schedule visible on the mirror covers the continuing "Compounds and compositions as protein kinase inhibitors" family (e.g., app. 16/741,937, pub. 2020/0323852).

7. No assignment recorded for the Pfizer/Array acquisition. Pfizer acquired Array BioPharma in July 2019 (widely reported at ~$11.4B; I have not verified the deal value from a primary filing), but Array BioPharma, Inc. remains the assignee of record on the USPTO register — consistent with Google Patents' "Current Assignee: Novartis AG, Array BioPharma Inc." Array's Rule 7.1 corporate disclosure in the Delaware litigation identifies Pfizer Inc. as its corporate parent, which is the documentary evidence of the parent‑subsidiary relationship.

8. No security agreement, license, or release recorded was found in the accessible record. If Array has encumbered the portfolio under a credit facility, no such instrument surfaced for this patent.

Chain of title (current): Inventors → IRM LLC → Novartis International Pharmaceutical Ltd. → Novartis AG → Array BioPharma, Inc. (Pfizer subsidiary).

Timeline diagram

timeline
    title Ownership of US 9314464
    2009 : Priority date 28 Aug 2009
    2010 : Parent application filed
    2013 : Divisional application filed
    2015 : Inventors assign to IRM LLC
         : IRM LLC merger to Novartis Intl Pharma
         : Novartis Intl Pharma merger to Novartis AG
    2016 : Novartis AG assigns to Array BioPharma
         : Patent issues 19 Apr 2016
    2019 : Array acquired by Pfizer
    2022 : Array sues Alembic and Sandoz
    2024 : Certain claims stipulated invalid

NPE / troll-pattern signals

1. Shell-entity transfer — not present. No assignee in the chain carries an "IP / Patents / Licensing / Holdings / Ventures" suffix, and every link is either an operating pharmaceutical group (Novartis AG; Array BioPharma, Inc.) or a corporate subsidiary formed by merger (IRM LLC → Novartis International Pharmaceutical Ltd., recorded 2015‑04‑22 at reels 035469/0260 and 035469/0858). IRM LLC is a Novartis research/IP affiliate, not a single‑purpose assertion vehicle. The 2016‑07‑13 Novartis→Array transfer is a consent‑decree divestiture to a competitor/purchaser, the opposite of a shell transfer.

2. Known asserter in the chain — not present. Neither at any recorded link nor in the current registrant does the chain touch Acacia, Marathon, Intellectual Ventures, IPNav, Wi‑LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, or any Spangenberg vehicle.

3. Repeat correspondent across the chain — not present (insufficient recurrence). The only correspondent visible anywhere in this chain is Banner & Witcoff, Ltd. on the 2020‑01‑16 confirmatory merger recordation (USPTO assignment 51532/0015). A single appearance is not a finding, and Banner & Witcoff is a general‑practice IP firm, not an NPE recording mill. No correspondent data was retrievable for the 2015‑09‑10 or 2016‑07‑13 links.

4. Cascading transfers — not present as an NPE pattern. Three recordings occur inside ~15 months (2015‑04‑22, 2015‑09‑10, 2016‑07‑13), which superficially looks like a cascade. But the assignees do not share a common correspondent address or attorney, the transfers run through a single corporate parent rather than chained unrelated LLCs, and the final step is documented in an SEC‑filed asset transfer agreement driven by a European Commission remedy. That is a divestiture, not aggregation.

5. Pre-litigation transfer — not present. The Novartis→Array assignment recorded 2016‑07‑13 precedes the first infringement suits by roughly six years (2022‑09‑28 and 2022‑10‑06). Array's suits are ordinary Hatch‑Waxman ANDA actions filed after Paragraph IV notice — Alembic's notice is dated 2022‑08‑16 per the docket — not a transfer timed to create standing or venue.

6. Bankruptcy fire‑sale — not present. No Chapter 7/11 proceeding involving Novartis, IRM LLC, or Array BioPharma appears in the record. Array was acquired as a going concern by Pfizer (July 2019), not liquidated.

7. Privateering — not present. The direction of the 2016 transfer is the reverse of privateering: Novartis transferred the asset out under regulatory compulsion and retained no assertion role. The later suits are brought by the product owner (Array/Pfizer), not by an NPE asserting on a manufacturer's behalf.

8. Defensive aggregator (anti‑NPE) — not present. The chain terminates at Array BioPharma, Inc., a commercial manufacturer — not at RPX, AST, LOT, Unified Patents, or OIN.

Additional litigation note (not an NPE signal, but material to value): both 2022 complaints assert the '464 patent alongside US 9,850,229, 10,005,761, 9,562,016, 9,598,376 and 9,980,944. In Array BioPharma, Inc. v. Alembic Pharmaceuticals Ltd., No. 1:22‑cv‑01277 (D. Del., Judge Gregory B. Williams), the court entered a joint stipulated order on 2024‑05‑28 holding certain claims of US 9,314,464, 9,850,229 and 10,005,761 invalid and certain claims of the crystallized‑binimetinib patents not infringed (D.I. 133/134). The Alembic action terminated 2025‑06‑10; the Sandoz action (1:22‑cv‑01316) terminated 2025‑01‑09. Array has separately asserted the crystallized‑binimetinib patents against Teva (C.A. 23‑625‑GBW).

Verdict

Operating-company assertion.

Justification: the chain of record runs inventors → IRM LLC → Novartis International Pharmaceutical Ltd. (reel 035469/0260) → Novartis AG (reel 035469/0858) → Array BioPharma, Inc. (recorded 2016‑07‑13), and the current registrant is a drug manufacturer whose Rule 7.1 disclosure in D. Del. 1:22‑cv‑01277 identifies Pfizer Inc. as its corporate parent. Array sells the claimed subject matter as BRAFTOVI/MEKTOVI — the '464 patent is Orange Book‑listed with use codes U‑2332 and U‑2336/U‑2802/U‑2803/U‑3738/U‑4051/U‑4440 — and has sued actual generic competitors (Alembic, Sandoz, Teva) under § 271(e)(2), which is textbook operating‑company assertion rather than NPE activity. Not one of the eight NPE/privateering signals is present; the closest thing to an anomaly is the 2020‑01‑16 confirmatory re‑recording of the 2015 IRM LLC merger (reel 51532/0015, correspondent Banner & Witcoff, Ltd.), which is an ordinary chain‑of‑title housekeeping entry.

Verify at: USPTO Assignment Center — search "9314464" · legacy Patent Assignment Search · Google Patents US9314464B2 legal events · D. Del. 1:22‑cv‑01277 · D. Del. 1:22‑cv‑01316

Confidence and gaps

• High confidence: the identity and sequence of assignees, the divestiture context, the current owner (Array BioPharma / Pfizer), and the operating‑company verdict — all supported by USPTO‑derived legal events plus court dockets and the EC M.7275 file.
• Medium confidence: reels 035469/0260 and 035469/0858 — corroborated on a sibling Novartis/IRM patent via a third‑party database rather than viewed on this patent's own record.
• Not established: executed dates for the 2015‑09‑10 inventor assignments; reel/frame and correspondent for the 2015‑09‑10 and 2016‑07‑13 recordings. I have deliberately not guessed at these. If you need the correspondent names on the Array‑side recording, that requires a direct pull of the Assignment Center record for patent 9,314,464.

I'll research US Patent 9314464 and its cited prior art references.

I need to find the specific prior art citations listed on the face of US9314464. Let me search USPTO/patent databases for the "References Cited" section.

Let me look for the specific citations section and related family documents.

Analysis of US Patent 9,314,464 B2 — Prior Art Identification

1. Patent Identification (interpreted literally)

Sources: https://patents.google.com/patent/US9314464/en ; https://uspto.report/patent/grant/9,314,464 ; https://pharsight.greyb.com/ingredient/binimetinib-patent-expiration ; https://www.accessdata.fda.gov/Scripts/cder/ob/patent_info.cfm?Product_No=002&Appl_No=[210496](/patent/210496)

2. Important Limitation on This Analysis (stated explicitly per operating rules)

I could not retrieve the definitive front-page "References Cited" (U.S. Patent Documents / Foreign Patent Documents) list for US 9,314,464 from the searches performed. The authoritative full text supplied in the prompt begins at the "Cross-Reference to Related Applications" section and does not include the examiner-cited reference list that normally appears on the face of the granted patent. My searches on Google Patents, USPTO.report, Espacenet, Unified Patents, and general web queries returned the specification, claims, classification, family, and litigation data — but not the specific citations block.

I therefore cannot assert, with high confidence, the exact set of references the examiner cited against this application, and I will not fabricate a citation list. What follows is (a) the reference set that is verifiably connected to this patent/family from the search results, and (b) a § 102 framework for evaluating it — clearly labeled as preliminary pending retrieval of the actual citation block.

3. References Identified as Connected to US 9,314,464 / Its Family

A. WO 2008/042639 A1 — "Compounds and compositions as protein kinase inhibitors"

• Citation: WO 2008/042639 A1 (Novartis AG / IRM LLC), PCT/US2007/079340.
• Publication date: 2008-04-10.
• Priority: US 60/827,873 P (2006-10-02).
• Inventors overlap: Includes Shenlin Huang, Xing Wang, Yongping Xie, Zuosheng Liu, and Daniel Poon — the same inventor group as US 9,314,464.
• Brief description: Discloses a class of pyrimidine/pyrazole compounds (3,4-diaryl-type pyrazoles) as kinase inhibitors, including inhibition of Abl, ARG, BCR-Abl, BRK, EphB, Fms, Fyn, KDR, c-Kit, LCK, PDGF-R, b-Raf, c-Raf, SAPK2, Src, Tie2 and TrkB.
• Source: https://patents.google.com/patent/WO2008042639A1 ; https://worldwide.espacenet.com/publicationDetails/biblio?CC=WO&NR=2008042639
• § 102 relevance: This is the most structurally and inventively adjacent reference located. Because it published 2008-04-10 — before the 2009-08-28 priority date — it is prior art as to the present claims. A § 102 anticipation analysis would turn on whether WO 2008/042639 discloses the specific 2-(methoxycarbonylamino)-1-propyl pyrimidin-2-ylamino / aryl-sulfonamido pyrazole compounds recited in claims 4 and 6 of US 9,314,464 (including the encorafenib species). Self-collision within a common-inventor family is normally addressed under § 102(e)/§ 103(c) rather than clean § 102(a), so this requires the actual filing/prosecution record to assess.

B. Sibling family members (same specification family — not prior art, but relevant to claim scope)

• US 2013/0296318 A1 (pre-grant pub. of the present application)
• US 9,593,099 B2; US 9,593,100 B2; US 10,005,761 B2; US 9,850,229 B2; US 9,850,230 B2; US 10,576,080 B2; US 10,568,884 B2
• Note: These share the same priority date and are divisional/continuation siblings, so they are not prior art to one another — they are useful only to confirm the claimed genus/species.
• Source: https://portal.unifiedpatents.com/patents/patent/US-[10568884](/patent/10568884)-B2

C. "Sulfonamido Derivatives of 3,4-diarylpyrazoles as Protein Kinase Inhibitors"

• Appears in the Unified Patents citation graph for the US 10,568,884 family member.
• Status: I could not confirm its publication number or date from the available results, so I cannot give a full citation or a reliable § 102 date. Listed here only as a lead to verify.

4. Preliminary § 102 Framework (what must be matched)

The operative claims of US 9,314,464 are method-of-treatment claims directed to compounds of Formula (Ia)/(Ib). Per USPTO.report:

• Claim 1 — method of treating a B-Raf-associated disease by administering a Formula (Ia) compound (Y = N or CR₆; R₂, R₃, R₅, R₆ as defined, with the proviso that when R₅ is fluoro, R₃ and R₆ are not both hydrogen; R₄ = —R₉ or —NR₁₀R₁₁; R₇ as defined).
• Claims 4 and 6 — enumerate specific species, including methyl N-[(2S)-1-({4-[3-(5-chloro-2-fluoro-3-methanesulfonamidophenyl)-1-(propan-2-yl)-1H-pyrazol-4-yl]pyrimidin-2-yl}amino)propan-2-yl]carbamate (encorafenib).
• Claims 7–11 — combination methods with an additional agent (including MEK/PI3K inhibitors).

For a § 102 anticipation challenge, a single reference must disclose each and every limitation, including (i) the pyrazole-pyrimidine core, (ii) the specific 2-(methoxycarbonylamino)-1-propyl side chain at R₁, (iii) the aryl-sulfonamido substitution pattern at R₃/R₅/R₄, and (iv) the method-of-treatment use limitation. A genus-level disclosure of "3,4-diarylpyrazoles" or "pyrimidine kinase inhibitors" would generally be insufficient for anticipation absent a species falling within the claim.

5. Bottom Line

• US 9,314,464 is confirmed as the Novartis/Array "protein kinase inhibitors" patent (encorafenib Orange Book listing, expiration 2031-07-04).
• The most relevant verifiable prior-art reference located is WO 2008/042639 A1 (Novartis/IRM, pub. 2008-04-10), a same-inventor family document disclosing pyrazole-pyrimidine kinase inhibitors — worth examiner-level scrutiny under § 102, though its common-inventor relationship complicates a straightforward § 102(a) rejection.
• I was unable to obtain the actual examiner-cited "References Cited" block for this patent. To give you a complete, per-reference § 102 mapping, I recommend pulling the citation list directly from the USPTO Patent Public Search / PatentCenter file wrapper for 13/931,111, or the "Citations" tab on the Google Patents page (https://patents.google.com/patent/US9314464/en). If you can supply that list (or the PDF front page), I will map each cited reference to the specific claims it potentially anticipates under § 102.

I want to be transparent: rather than inventing a citation table, I have flagged exactly what I could and could not verify, per the instruction not to fabricate.

I'll start by pulling the actual prior-art citations and claim set for US 9,314,464, since the page dump you supplied includes a "Prior Art keywords" block but no citations list.

Let me pull the actual cited references and claim 1 text.

Let me get claim 1's text and any cited references from secondary sources.

Bottom line first

I can give you the § 103 framework, the claim/subject-matter picture, the critical-date and common-ownership gatekeeping issues, and the types of combinations a challenger would run. What I cannot do — without fabricating — is name the specific reference pairs with confidence, because the "Prior Art" section of the page you supplied contains no reference citations at all. There is no "(56) References Cited" block, no cited patent documents, and no non-patent literature in the material you pasted.

Per your operating rule, I am not going to invent reference numbers to fill that gap. Below I flag exactly what is on the record, what I verified independently, and where the uncertainty lies.

1. What the "Prior Art" record actually contains

From the authoritative page text (https://patents.google.com/patent/US9314464/en), the entire prior-art-related content is:

Three important caveats:

• "Prior art keywords" are not references. They are Google's auto-extracted text tokens from the document (propan, pyrazol, methyl, pyrimidin, chloro). They have no evidentiary value for § 103. Do not mistake them for a prior-art disclosure.
• The "Definitions," "Landscapes," chemical-structure tables, and "Images" blocks on that page are the patent's own disclosure and CPC classifications — not prior art.
• The family/priority entries are later-filed continuations. They post-date 2009-08-28 and therefore are not § 102/§ 103 prior art against this patent; they are relevant only to obviousness-type double patenting.

Verified externally (search results, not the patent text):

• Orange Book listing ties US 9,314,464 to ENCORAFENIB (BRAFTOVI), expiry 2031-07-04, use codes U-2336, U-2802, U-2803, U-3738, U-4051, U-4440 — https://www.accessdata.fda.gov/Scripts/cder/ob/patent_info.cfm?Product_No=002&Appl_No=[210496](/patent/210496)&Appl_type=N
• The D. Del. cases correspond to Array BioPharma v. Sandoz, a Paragraph IV / ANDA dispute asserting US 9,314,464 among six patents (9,850,229; 10,005,761; 9,562,016; 9,598,376; 9,980,944) — https://www.patsnap.com/fr/resources/blog/litigation/array-biopharma-v-sandoz-mek-inhibitor-patent-dispute-patsnap/
• Identifier caution: that PatSnap piece labels these six patents "MEK inhibitor" patents, whereas the patent's own text states the compounds "inhibit the activity of B-Raf or mutant forms thereof (for example V600E)." The Orange Book use codes and the encorafenib link agree with the patent text. I treat the "MEK" characterization as a third-party error and note it rather than adopt it.

2. Subject matter to be tested

The supplied text gives the genus (Formula I: 4-(pyrazol-4-yl)pyrimidin-2-amine, with R¹–R⁷ and Y defined, including the two provisos) and a narrower Formula Ia/Ib embodiment, plus a specific species:

• Compound 9 = ((S)-methyl 1-(4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-ylamino)propan-2-ylcarbamate) — this is encorafenib.

The issued claim set as granted is not reproduced in the pasted page. A secondary source (https://uspto.report/patent/grant/[9,314,464](/patent/9314464)) shows claim 4 beginning "The method of claim 1, wherein the compound of Formula (Ia) is selected from: …" and listing a large Markush set of species (including 3-chloro-5-methanesulfonamidophenyl, 3-chloro-2-methanesulfonamidopyridin-4-yl, 2-chloro-3-ethanesulfonamido-4,5-difluorophenyl, and the 1-(oxan-2-yl) analog, among others). Two inferences follow, which I flag as inferences because that source snippet is truncated:

1. Claim 1 is likely a method-of-treatment claim ("method of treating … comprising administering"), consistent with the six Orange Book use codes and with the specification's third aspect.
2. The granted claims are narrower than the "Formula I" genus recited in the summary — a sub-genus plus enumerated species.

Practical consequence: an obviousness attack must be aimed at (a) the sub-genus, (b) the enumerated species (including encorafenib), and (c) the method limitation. Each has a different strength of attack.

3. Legal framework I am applying

• Pre-AIA § 103(a) governs (priority 2009-08-28, well before 2013-03-16); KSR Int'l v. Teleflex, 550 U.S. 398 (2007), supplies the operative test: a claimed combination is obvious where the prior art yields "predictable solutions," the elements are known, and there is a "finite number of identified, predictable solutions."
• Motivation to combine may come from the references themselves, the nature of the problem, or common knowledge. Reasonable expectation of success is the key battleground for a narrow-subgenus/species claim.
• For a single-species claim rescued from a broad prior-art genus, the challenger typically argues In re Peterson / In re Baird (small genus, limited options) and In re Aller (routine optimization of ranges). The patentee counters with In re Hoeksema / In re Gosteli / In re Goodman (a prior-art genus must be enabled to anticipate or render obvious a species) and with unexpected results.
• Method claims do not save an otherwise obvious compound: a method of treating a cancer with an obvious compound is itself obvious where the indication is known (In re Kao-type reasoning; cf. the Federal Circuit's treatment of method-of-use claims as adding nothing when the compound and use are both known).

4. Gatekeeping issues that must be resolved before any § 103 combination is reached

These are decisive and are grounded directly in the supplied record:

(a) Critical date. The patent is a divisional of Ser. No. 12/870,130 (2010-08-27) claiming benefit of 61/238,073 (2009-08-28) and 61/313,039 (2010-03-11). If any reference relied on was published between 2009-08-29 and 2010-08-27, the challenger must first show the claim at issue is not entitled to the provisional priority date (a written description attack on the priority chain). If the priority claim holds, that entire window is unavailable as § 102(b) art and available only as § 102(e)/§ 102(a) subject to the exceptions below.

(b) Common ownership / § 103(c) disqualification (now § 102(b)(2)(C) under AIA for transition cases). The supplied record shows an unusual chain of title: inventors assigned to IRM LLC → IRM LLC merged into Novartis International Pharmaceutical Ltd. → Novartis AG → and only on 2016-07-13 assigned to Array BioPharma, Inc. The patent's framing consistently refers to "the present invention" in Novartis/IRM voice. Therefore any candidate § 103 reference that is a commonly owned Novartis/IRM application or patent at the time the invention was made is disqualified as prior art under pre-AIA § 103(c)(1) (or § 102(e) art that is commonly owned). This is a very common and very effective patentee rebuttal in this family's technology area, and it cannot be evaluated without the (56) list.

(c) Effective filing-date shift for individual claims. Because this is a divisional, each claim's effective date must be traced to § 112 support in the 2010 parent and the two provisionals. A single species claim (encorafenib) will almost certainly trace to 61/238,073 or 61/313,039; a broad genus claim may not.

5. The combinations a challenger would run

Below I give the architecture of each obviousness case: what each reference must teach, why a POSITA would combine, the expectation-of-success argument, and the patentee's rebuttal. I have flagged every reference I could not verify.

Combination A — Pyrimidine-amino-pyrazole chemotype + sulfonamido-diarylpyrazole B-Raf tail

Motivation: Both scaffolds converge on the same pharmacophore hypothesis (2-aminopyrimidine hinge binder + pyrazole linker + hydrophobic aryl tail). The problem addressed — improving B-Raf V600E potency and metabolic stability — is the same problem each reference addresses. Under KSR, "if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious."

Expectation of success: Strong for the genus. Weaker for the specific substitution pattern, because the patent's own data show non-monotonic behavior across near neighbors (see § 6).

Combination B — Known B-Raf inhibitor + the 5-chloro-2-fluoro-3-(methylsulfonamido)phenyl fragment as a disclosed aniline/boronate intermediate

If a prior-art reference discloses 3-bromo-5-chloro-2-fluoroaniline or the corresponding pinacol boronate (the patent itself lists "3-Bromo-5-chloro-2-fluoroaniline" as an intermediate), a challenger argues the boronate is a "known building block" and its Suzuki coupling to the known pyrimidine-pyrazole iodide is routine. The patent's own reaction schemes (Reaction Scheme III: PdCl₂(dppf)/K₂CO₃ Suzuki coupling) are concededly conventional, and the specification itself states the sulfonylation "as described for Reaction Scheme II" with methanesulfonyl chloride/pyridine. I could not verify from the supplied record that any such aniline/boronate reference pre-dates 2009-08-28. The external search surfaced unrelated intermediate vendors (BenchChem entries citing US 9,314,464 itself, which are not prior art).

Combination C — Prior-art disclosure of the R¹ side chain + the core

The specification states the R¹ group is 2-(methoxycarbonylamino)-1-propyl. A challenger needs a reference teaching (S)-methyl 2-aminopropylcarbamate or an analogous alkoxycarbonyl-protected diamine side chain on a 2-aminopyrimidine. The patent's own Scheme IX prepares (S)-benzyl 2-(methoxycarbonylamino)propylcarbamate from (S)-1,2-diaminopropane dihydrochloride — a textbook sequence. If a prior-art kinase-inhibitor genus recites the R¹ variable to include "—X¹NHC(O)OR⁸ᵇ" (which this patent does), the combination is a species selection from a disclosed list.

Combination D — Compound + known indication (for the method claim)

For the method claims specifically: a reference disclosing a B-Raf V600E inhibitor + the well-known clinical association with metastatic melanoma / papillary thyroid carcinoma / colorectal cancer. The patent's own specification recites these associations as background ("activating alleles of B-Raf and N-Ras have been identified in ~70% of melanomas, 40% of papillary thyroid carcinoma, 30% of ovarian low-grade carcinoma, and 10% of colorectal cancers"). A challenger would characterize that as admitted state of the art. Method claims premised on an obvious compound and a known use are typically vulnerable. Patentee's counter: the claim requires a therapeutically effective amount of this compound, and the specification supplies the dose range and efficacy data.

6. What the patentee will say — and why the supplied record helps them

The specification contains unusually explicit internal comparative data that reads as a prepared defense to § 103:

Also note the two provisos in claim 1 ("with the proviso that when R₅ is fluoro… R₃ and R₆ are not both hydrogen" and "with the proviso that R⁸ᵇ is not hydrogen when…"). Provisos of this kind are typically added during prosecution to escape art. Their presence is circumstantial evidence that the examiner found close prior art. I cannot confirm this without the file history — it is an inference, not a finding.

7. Secondary considerations and the "paradoxical activation" wrinkle

The specification devotes substantial space to Raf-inhibitor-induced pMEK/pERK activation and cell growth ("Raf inhibitors… also induce cell growth in cancer cell lines and cause transformation and growth in fibroblasts… biphasic pattern… low compound concentrations (0.01–0.1 µM) causing maximal induction"), and to MEK-inhibitor combinations (FIG. 1; compound 9 tested with MEK inhibitor A3 = PD0325901).

Two implications:

• For the patentee: the paradoxical-activation phenomenon is a recognized unpredictability in the field, supporting a "no reasonable expectation of success" argument against a challenger's assumption that structural analogs will behave predictably at the pathway level.
• For the challenger: the same passage, plus the recitation of named MEK inhibitors (AS703026, MSC1936369B, GSK1120212, AZD6244, PD-0325901, ARRY-438162, RDEA119, GDC0941, GDC0973, TAK-733, RO5126766, XL-518), is argued to show that combining a Raf inhibitor with a MEK inhibitor was a known, published strategy — narrowing the inventive contribution to the compound itself.

8. What I need to complete this analysis

To move from framework to a defensible reference-by-reference § 103 chart, I need:

1. The (56) References Cited list from the US 9,314,464 front page (and the cited-by list).
2. The ISRs for the parent 12/870,130 and its PCT equivalent. The patent's external family references point to WO2011/025927 as a likely PCT publication of this family (surfaced via a third-party intermediate-sourcing page) — https://patents.google.com/patent/US9314464/en does not itself list it.
3. The prosecution file history for 13/931,111 and 12/870,130 (to confirm whether claim 1 was rejected and the provisos added).
4. The D. Del. pleadings in 1:22-cv-01316 / 1:22-cv-01277 to see which references Sandoz has actually pled.

9. Honest confidence statement

• High confidence in: the statutory framework, the critical-date and common-ownership gatekeeping issues, the description of the claimed subject matter, the patentee's secondary-considerations posture from the specification text, and the family/litigation/Oracle Book facts I verified by search.
• Low confidence in: the identity of the specific primary references. The page's Prior Art section supplies keywords, a date, and a family — no citations. I will not name expected references such as Plexxikon pyrazolo-pyrimidine applications, AstraZeneca/OSI, or others, because I could not verify them here and several identifiers I would otherwise reach for are exactly the kind the "do not auto-correct" rule warns against.
• Explicitly flagged as unverified: WO 2007/023382 (Pyrimidine amino pyrazole compounds, Pfizer/Agouron, 2007-03-01) is a real document I retrieved, and it is a plausible primary reference on the chemotype — but I have not confirmed it appears in this patent's citation record or prosecution history.

If you paste the "(56) References Cited" section (or the ISR/office actions), I will produce the full combination-by-combination § 103 chart with claim-charting, motivation, expectation of success, and the rebuttals, reference by reference.