US 9562016

I'll run several targeted searches rather than rely on memory.

US 9,562,016 B2 — Analyst Summary

Scope note before the substance: I do not have direct PACER/USPTO Patent Center or CAFC docket access in this session. Everything below comes from web search results over public patent databases (Google Patents, uspto.report, drugpatentwatch, CourtListener/RECAP excerpts, FDA documents, and FDA/PACER-derived litigation summaries). Where a claim element or docket fact rests on a third-party transcription, I flag it. Also note: your prompt says "Current Date: April 26, 2026," but I was given an operating date of 2026-09-30, and several retrieved sources carry later "Last Updated" stamps (e.g., "September 12, 2026"). I report the latest available data and flag anything that may post-date your stated date.

1. Bibliographic data (high confidence)

Note on a possible Certificate of Correction: the uspto.report record displays "Please see images for: (Certificate of Correction)." I could not retrieve the content of any such certificate, so the claim text below is as transcribed by third-party databases and may not reflect any post-issue correction. Treat this as an explicit uncertainty.

2. Abstract (verbatim, as published)

"The present invention relates to processes for preparing 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxyethyoxy)-amide, processes for preparing crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxyethyoxy)-amide, and intermediates useful therefore. Also provided herein are pharmaceutical compositions comprising this crystallized compound."

The compound at issue is referred to throughout as "Compound A" — chemically, 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxyethyoxy)-amide, i.e., binimetinib (Array's MEKTOVI). The patent describes an improved synthesis of Compound A, a novel crystallization process (using an ether/alcohol/water solvent system in which water behaves counter-intuitively as a solvent rather than an anti-solvent), and an immediate-release tablet formulation.

3. Independent claims — plain-language overview

There appear to be 16 total claims, with four independent claims: 1, 3, 11, and 16. Claims 1 and 16 are product-by-process claims (a product defined by the process that made it); claims 3 and 11 are composition claims.

Claim 1 — Crystallized binimetinib, defined by its crystallization process.
Covers the crystallized form of Compound A that results from a specific sequence: (a) dissolving Compound A in a solution of (i) an ether-containing solvent system, optionally also containing an alcohol, plus (ii) water; (b) adding a seed-crystal suspension to form a suspension mixture; (c) cooling that suspension mixture; (d) adding water to the cooled suspension; and (e) cooling again to yield the crystallized product. In plain terms: a claim to the crystallized drug substance itself, but only where it was made by this water/ether(/alcohol) anti-solvent crystallization route.

Claim 3 — Three-component pharmaceutical composition.
A pharmaceutical composition comprising (i) crystallized Compound A, (ii) at least one sugar, and (iii) at least one cellulose-derivative excipient. This is the core formulation claim — the sugar (preferably lactose monohydrate) plus a cellulose derivative (preferably microcrystalline cellulose) combination.

Claim 11 — Broader pharmaceutical composition.
A pharmaceutical composition comprising crystallized Compound A and a pharmaceutically acceptable carrier or excipient — no sugar or cellulose-derivative limitation. This is the broadest composition claim.

Claim 16 — Crystallized binimetinib, defined by an alternative crystallization process with a specified heating step.
Covers crystallized Compound A made by: (a) adding Compound A to a solution of (i) an ether-and-alcohol solvent system plus (ii) water to form a suspension; (a1) heating that suspension to an internal temperature between 53 °C and 56 °C to dissolve it; (a2) cooling the solution; (b) adding a seed-crystal suspension; (c) adding water; and (d) cooling the treated mixture to crystallize the product.

Representative dependent claims:

• Claim 2 — the crystallized Compound A of claim 1, further comprising a milling step.
• Claims 4–10 — narrow claim 3: lactose monohydrate (4); listed cellulose derivatives (5); microcrystalline cellulose (6); one or more of croscarmellose sodium, magnesium stearate, silicon dioxide (7); 5–35 wt% crystallized Compound A (8); ~15 mg (9); ~45 mg (10).
• Claims 12–15 — narrow claim 11: oral administration (12); tablet (13); ~15 mg (14); the specific tablet blend of crystallized Compound A + lactose monohydrate + microcrystalline cellulose + colloidal silicon dioxide + croscarmellose sodium + magnesium stearate (15).

For comparison: the specification's marketed formulation (Example 5, Table 1) is ~6.25% or 10% crystallized Compound A with ~55.6% lactose monohydrate, ~31–35% microcrystalline cellulose, 2% croscarmellose sodium, 0.75% magnesium stearate, 0.25% colloidal silicon dioxide, and an Opadry II film coat.

4. Litigation — what the record shows

The Google Patents record itself lists three Delaware District Court matters: 1:23-cv-00625, 1:22-cv-01316, and 1:22-cv-01277. My searches surfaced details on each:

• Array BioPharma Inc. v. Sandoz Inc., D. Del. 1:22-cv-01316 (filed Oct 6, 2022). Six patents asserted, including the '016 patent, alongside US 9,314,464; 9,850,229; 10,005,761; 9,598,376; and 9,980,944. Resolved by stipulated dismissal without prejudice on January 9, 2025 following a settlement and license agreement; the court retained jurisdiction to enforce the agreement, and Sandoz's Paragraph IV certifications and FDA's ability to grant final ANDA approval were expressly preserved. No merits adjudication.
• Array BioPharma Inc. v. Alembic Pharmaceuticals Ltd. et al., D. Del. 1:22-cv-01277 (ANDA 217678). This is the case in which the key claim construction issued: on April 16, 2024 the court construed "crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxyethyoxy)-amide" (i.e., "crystallized [binimetinib]") as "binimetinib in a crystalline form resulting from the use of a solvent mixture of ether and optionally an alcohol," and held the term not indefinite. The court treated the patentee as its own lexicographer, tying "crystallized" to the claimed process. Per the Teva briefing, the parties agreed that stipulated orders of invalidity and non-infringement would be incorporated into any final judgment rather than triggering immediate Rule 54(b) entry.
• Array BioPharma Inc. v. Teva Pharmaceuticals, Inc., D. Del. 1:23-cv-00625 (Teva ANDA 217509). Teva's Paragraph IV statement asserted non-infringement of the '016, '376, and '944 patents and obviousness of claims 11–15 of the '016 patent (plus all claims of '376 and '944). Array acknowledged Teva did not infringe under the Alembic/Sandoz construction; Teva moved to stay (Nov 8, 2024) pending any Federal Circuit appeal of that construction. The docket records a stipulation of dismissal and termination of the case on July 31 / August 1, 2025.

5. Federal Circuit / CAFC 2026 dockets — negative finding

I did not find any Federal Circuit docket or 2026 appellate proceeding concerning US 9,562,016. Specifically:

• As of the Oct 2024 Teva briefing, Array itself stated that "no appeal has been filed in the Alembic/Sandoz case" and that the case was "more than a year away from being ready for appeal," with a Federal Circuit appeal projected at roughly 15 months once filed.
• The Delaware dockets I retrieved for both the Teva and Sandoz matters terminate in stipulated dismissals during 2025, not in appealed judgments.
• No search result returned a CAFC case number, appeal docket, or Federal Circuit opinion naming the '016 patent.

Because I could not query PACER or the Federal Circuit's docket system directly, I cannot rule out a 2026 appeal that is simply not reflected in indexed web content. My honest assessment is that no such appeal is confirmed to exist, and I would not assert one does.

6. Commercial significance (context)

• The '016 patent is listed in the Orange Book for MEKTOVI (binimetinib) 15 mg oral tablets, NDA 210498, approved June 27, 2018, with an Orange Book expiration of October 18, 2033 (patent codes DS and DP — drug substance and drug product). It is one of the patents driving the estimated generic launch date for Mektovi.
• The '016 patent is described in third-party analyses as covering "Composition; Compound; Process" claim types — consistent with my reading of the claims above.
• FDA ANDA correspondence (e.g., ANDA 217678) lists the '016 patent among those for which Paragraph IV certifications were filed and litigation was initiated within the 45-day window.

7. Explicit uncertainties

1. Claim text provenance. The claim language above comes from uspto.report's transcription. The authoritative Google Patents full text supplied in my context is truncated mid-specification and does not include the claims. I could not verify the claims against the USPTO Patent Center or the granted patent PDF.
2. Certificate of Correction. uspto.report indicates one exists but I could not obtain its contents; if it amended claim scope, my claim summary could be out of date.
3. CAFC 2026 dockets. As stated, no appellate record was located; the absence is a search limitation as much as a factual finding.
4. Stipulated invalidity/non-infringement orders in the Alembic/Sandoz case are reported in the parties' briefing and secondary sources; I did not retrieve the actual judgments.

Sources

• Google Patents, US9562016B2: https://patents.google.com/patent/US9562016/en
• uspto.report grant record (claims and full description): https://uspto.report/patent/grant/[9,562,016](/patent/9562016)
• DrugPatentWatch, patent 9,562,016: https://www.drugpatentwatch.com/p/patent/9562016
• CourtListener/RECAP, D. Del. claim construction opinion (1:22-cv-01277, D.I. 93): https://storage.courtlistener.com/recap/gov.uscourts.ded.80177/gov.uscourts.ded.80177.93.0.pdf
• CourtListener/RECAP, Teva stay briefing (1:23-cv-00625): https://storage.courtlistener.com/recap/gov.uscourts.ded.82712/gov.uscourts.ded.82712.15.0.pdf and .../19.0.pdf
• CourtListener docket page, Array v. Teva (1:23-cv-00625): https://www.courtlistener.com/docket/67486186/array-biopharma-inc-v-teva-pharmaceuticals-inc/
• FDA ANDA 217678 approval letter (patent listing and Paragraph IV status): https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217678Orig1s000TAltr.pdf
• FDA MEKTOVI label / NDA 210498 review documents: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210498s009lbl.pdf
• PatSnap litigation summary (Array v. Sandoz, 1:22-cv-01316, dismissal terms): https://www.patsnap.com/de/resources/blog/litigation/array-biopharma-v-sandoz-mek-inhibitor-patent-dispute-patsnap/
• Paragraph Four (complaint text, Array v. Teva): https://paragraphfour.com/wp-content/uploads/2022/09/dedc23cv0625C.pdf

I'll research litigation involving US patent 9562016. Let me run several searches.

Let me search more specifically for the litigation cases.

Let me dig into the Teva case and check for any additional defendants or appeals.

Litigation Involving U.S. Patent No. 9,562,016

Patent identification. U.S. Patent No. 9,562,016 ("the '016 patent"), titled "Preparation of and formulation comprising a MEK inhibitor," issued February 7, 2017 from application Ser. No. 14/974,655, a divisional of Ser. No. 14/057,498 (priority Oct. 19, 2012). It is listed in the Orange Book for MEKTOVI (binimetinib) 15 mg tablets, NDA No. 210498, with a listed expiration of October 18, 2033. Current assignees per the patent record: Novartis Pharma AG and Array Biopharma Inc.; the asserted patents in the Hatch-Waxman suits are held by Array BioPharma Inc. (now a Pfizer subsidiary).

I located three litigations in which the '016 patent was asserted. All three are ANDA (Paragraph IV) cases in the U.S. District Court for the District of Delaware before Judge Gregory B. Williams, and all concern the same product. The '016 patent was one of several "Crystallized Binimetinib Patents" at issue — specifically, the family consisting of the '016 patent together with U.S. Patent Nos. 9,598,376 ("'376") and 9,980,944 ("'944").

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

Alembic's ANDA No. 217678 (binimetinib tablets, 15 mg) received tentative approval (FDA letter referencing the litigation, Civil Action No. 22-01277). Key development: on April 16, 2024, the Court issued a claim construction order (D.I. 93, 94) construing the term "crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxyethyoxy)-amide" (i.e., "crystallized [binimetinib]") as "binimetinib in a crystalline form resulting from the use of a solvent mixture of ether and optionally an alcohol." Under that construction, Array stipulated that Alembic and Sandoz do not infringe the Crystallized Binimetinib Patents (which include the '016 patent). The Alembic/Sandoz docket was last retrieved April 16, 2024, and I did not find a final judgment or a Federal Circuit appeal docketed from it — the parties expressly agreed not to seek immediate entry of final judgment under FRCP 54(b), and instead to have the stipulated orders of invalidity/non-infringement incorporated into any final judgment.

2. Array BioPharma Inc. v. Sandoz Inc.

This case was consolidated with the Alembic action (C.A. No. 22-1277 designated the lead case; all filings made there). Sandoz then negotiated a confidential settlement and was dismissed, while Alembic and Teva continued to challenge the patents (per generics-industry reporting).

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

Teva's Paragraph IV notice letter was dated August 8, 2022, and its ANDA No. 217509 sought to market binimetinib tablets, 15 mg. Teva asserted non-infringement and that claims 11–15 of the '016 patent and all claims of the '376 and '944 patents are invalid as obvious (per Array's complaint). Teva filed its answer and counterclaims Aug. 4, 2023; Array answered Aug. 24, 2023. After a period of inactivity, the Court (D.I. 13) ordered the parties to meet and confer on a schedule. On Oct. 17, 2024, the parties filed a joint letter: Array conceded that "Teva does not infringe the Crystallized Binimetinib Patents under the Court's claim construction in the Alembic/Sandoz litigation," and sought to relitigate/obtain reconsideration of that construction or proceed to judgment so it could appeal. Teva moved to stay the case pending resolution of any appeal in Alembic/Sandoz (motion filed Nov. 2024; briefing through Dec. 2, 2024). The Court's Oct. 22, 2024 oral order directed any stay motion to be made by formal motion or stipulation on or before Nov. 8, 2024. I found no docket entry resolving the motion or terminating the case.

Summary of the '016 Patent's Litigation Posture

• All identified litigation is Hatch-Waxman ANDA litigation over generic binimetinib (MEKTOVI), brought by Array BioPharma (Pfizer) in the District of Delaware against three generic filers: Alembic (1:22-cv-01277, filed Sep. 28, 2022), Sandoz (1:22-cv-01316, filed Oct. 6, 2022), and Teva (1:23-cv-00625, filed Jun. 8, 2023).
• The '016 patent is legally coupled with the '376 and '944 patents — all three share the same claim term ("crystallized [binimetinib]") and the same Oct. 18, 2033 Orange Book expiration.
• Central dispositive event: the April 16, 2024 claim construction in the Alembic/Sandoz case, which effectively foreclosed infringement under those three patents. Sandoz settled; the Teva case is stayed or in limbo pending a possible appeal; Alembic's case did not go to final judgment.
• I found no Federal Circuit appeal record, no PTAB/IPR proceeding, and no litigation concerning the '016 patent outside these Delaware ANDA cases.

Caveats and Verification Notes

• Filing-date discrepancy to flag (not auto-corrected): DrugPatentWatch lists Array v. Sandoz as "filed 2022-10-06" while some docket/aggregator entries (and the Google Patents family page) associate the '016-related actions with dates of Oct. 18, 2013 / Oct. 19, 2012 that are priority dates, not filing dates. I have used the D. Del. docket filing dates (Sep. 28, 2022; Oct. 6, 2022; Jun. 8, 2023).
• I did not find a final judgment, injunction, or Federal Circuit opinion on the '016 patent; the Teva stay motion and any Alembic/Sandoz appeal remain unresolved on the record available to me. If you need confirmation of the current (late-2024 through 2026) docket status of the Teva stay motion or any appeal, that should be verified against PACER/CM-ECF for D. Del. 1:23-cv-00625-GBW and the Federal Circuit docket directly.
• Not relevant to the '016 patent: there is a separate securities class action concerning Array's binimetinib NEMO trial disclosures (e.g., D. Colo. Case No. 1:17-cv-02789-KLM), which involves the drug but not the '016 patent and is not patent litigation.

I'll check the structured source first — the ODP block says no AIA trials are on file. Let me verify with targeted web searches before concluding.

Search results are noise so far. Let me target the compound identity and any trial proceedings more precisely.

No PTAB proceedings appearing. Let me run final confirmation searches — PTAB decisions database, petitioner-side filings, and any Federal Circuit activity.

Proceedings overview

No AIA trial proceedings are on file for US 9,562,016. Count: 0 — 0 active, 0 with claims invalidated, 0 with claims sustained, 0 settled, 0 institution denials. The USPTO ODP structured block supplied in this prompt returns no AIA trials, and my independent web searches (Google Patents litigation block, PTAB petition/decision text, party-name and patent-number queries) surfaced nothing to contradict it.

Bottom line for a defendant: there is no PTAB record to lean on in either direction. This patent has never been to the Board. It has not been "hardened by surviving two IPRs" — no petitioner has ever tried — and it has not been narrowed by any Final Written Decision. All claims stand as issued. Any invalidity case you want to make lives in district court under 35 U.S.C. § 282, not in an IPR record.

Verification log (what I checked, and what it showed)

Confidence and limits: I am confident about the zero count because the canonical source says so and nothing contradicts it. I could not reach PTAB E2E/P-TACTS dockets or the CAFC docket directly within my search budget, so I cannot rule out a very recently filed petition that the ODP ingest has not yet indexed. Treat any such item as unverified rather than assuming it exists. I also found no PTAB proceeding on the two family members asserted alongside the '016 patent, US 9,598,376 and US 9,980,944 — but I did not exhaustively search those numbers, so flag that as lower-confidence.

Per-proceeding detail

There are no proceedings to detail. Rather than fabricate proceeding numbers (which I will not do), here is the non-PTAB activity that explains why the PTAB docket is empty — clearly labeled as not AIA trials:

(Non-PTAB) Array BioPharma Inc. v. Teva Pharmaceuticals, Inc. — D. Del. 1:23-cv-00625

Source: complaint PDF, paragraphfour.com; CourtListener docket

• Venue/type: Hatch-Waxman § 271(e)(2) ANDA litigation. Not an IPR/PGR/CBM.
• Procedural posture: Teva ANDA No. 217509 (binimetinib tablets, 15 mg); notice letter dated 2022-08-08. The '016 patent is asserted alongside the '376 and '944 patents (the "Crystallized Binimetinib Patents").
• Validity challenge of record: Per the complaint (¶ 29), Teva's Paragraph IV Detailed Statement asserts that claims 11–15 of the '016 patent are invalid as obvious, and that the ANDA product does not infringe any claim of the '016, '376, or '944 patents. Asserted claim: independent claim 11 (pharmaceutical composition comprising crystallized binimetinib), with the complaint reserving additional claims by pleading infringement of "at least" claim 11.
• Claim construction: Judge Gregory B. Williams construed the term "crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxyethyoxy)-amide" as "crystallized [binimetinib]," and on 2024-10-22 entered an oral order in 1:23-cv-00625 directing that any stay motion pending appeal of that construction in the related Alembic/Sandoz case be made by formal motion or stipulation. (This is a district-court claim-construction appeal, not a PTAB appeal. I could not confirm a Federal Circuit docket number from the sources available to me — do not cite one without verifying.)
• Defensive value: the claim construction is pro-patent-owner (the crystallized-form limitation is read broadly to cover crystallized binimetinib), which is why the invalidity fight matters so much. Teva's obviousness theory on claims 11–15 is on the public record and is a starting point, not a result.

(Non-PTAB) Array BioPharma Inc. v. Alembic Pharmaceuticals Ltd. and Sandoz Inc. — D. Del. 1:22-cv-01277

Source: FDA ANDA 217678 tentative-approval letter

• Type: ANDA litigation (Alembic ANDA 217678, received 2022-06-27; paragraph IV certifications to the '464, '016, '376, '229, '944 and '761 patents). Sandoz was later resolved by confidential settlement. Not an AIA trial.
• Posture at FDA: tentative approval granted, final approval blocked pending patent outcome/exclusivity; the '016 patent expiry listed at 2033-10-18.
• Defensive value: confirms a live, multi-defendant generic attack on the '016 patent with no PTAB parallel track.

(Non-PTAB) D. Del. 1:22-cv-01316 — defendant not identified in the sources I could reach

Listed in the patent's litigation block with no party name surfaced. I will not guess the defendant. Flagged as unverified.

Strategic summary

Claim status. Nothing has been canceled. The Board has never invalidated, confirmed, or even instituted on a single claim of US 9,562,016. The patent issues as granted on 2017-02-07 (divisional of Ser. No. 14/057,498, filed 2013-10-18; priority to provisional 61/716,169, filed 2012-10-19) with claims running at least through claim 15, including independent claim 1 (crystallized Compound A prepared by the recited dissolution/seed/anti-solvent crystallization) and independent claim 11 (pharmaceutical composition comprising crystallized Compound A, at least one sugar, and at least one cellulose-derivative excipient). Orange Book expiry: 2033-10-18. So the correct framing is: CANNOT SAY "canceled"; CANNOT SAY "affirmed." All claims are UNTESTED at the PTAB and must be presumed valid in the district court unless a defendant proves invalidity by clear and convincing evidence.

Estoppel landscape. Because no IPR reached a Final Written Decision, § 315(e)(2) estoppel has never attached to anyone. There is no petition record, no instituted ground, no "reasonably could have raised" bar. Practically: every prior-art ground remains available to a defendant in district court — but note the flip side. Under § 315(b), a petitioner is barred one year after being served with a complaint alleging infringement. Teva, Alembic and Sandoz were all sued in 2022–2023, so their § 315(b) clocks have long since run out; that is very likely why there is no IPR on this patent. The named generic defendants litigated validity in Delaware instead, under § 282, not at the Board.

Pattern signals. No serial petitioner. No defensive aggregator (Unified Patents, RPX, or similar) appears anywhere in the chain — unusual for a patent this commercially significant, and consistent with a small, identifiable defendant pool (ANDA filers) rather than a mass-assertion or PAE scenario. The patent owner (Array/Pfizer) has not pursued any PTAB appeal, because there is no PTAB decision to appeal. The only appellate activity indicated is a potential Federal Circuit review of the district court's "crystallized [binimetinib]" construction out of the Alembic/Sandoz case — verify the docket before relying on it.

Why the absence matters. Well-asserted, high-revenue drug patents normally attract IPRs, and this one has not — best explained by § 315(b) timing plus the economics of ANDA litigation (a district-court invalidity win gets a defendant everything an IPR would, without estoppel exposure). Do not read the clean PTAB docket as a sign the patent is weak.

Recommended next steps

1. Do not shop for an FWD — there isn't one. Any demand letter or invalidity opinion premised on "the PTAB canceled the claims" or "you're bound by an IPR result" is wrong on this patent. There is no IPR2016/2017/2018-era certificate canceling claims and no subsequent Board proceeding. If opposing counsel asserts one, ask for the proceeding number and the paper; it will not exist.
2. Your invalidity case is a district-court case. Build on the public record: Array's own complaint states that Teva's Paragraph IV statement challenged claims 11–15 of the '016 patent as obvious (complaint, ¶ 29). Those grounds are public and unrebutted by any Board ruling.
3. If you are a newly sued defendant, you have a one-year window and it is a real option. Unlike Teva/Alembic/Sandoz you would not be § 315(b) time-barred, so you could file the first-ever IPR against the '016 patent. Given the co-pending Delaware actions, you must also weigh Fintiv-type discretionary-denial risk (the Board's current practice on parallel ANDA litigation) before investing in a petition.
4. Track the claim-construction appeal. The "crystallized [binimetinib]" construction drives infringement for any ANDA whose product contains any crystallized drug substance. Confirm whether the Alembic/Sandoz appeal is docketed at the Federal Circuit and its number before citing it (CourtListener docket for 1:23-cv-00625 is the best real-time anchor).
5. Treat the ODP result as authoritative but refreshable. The Board's ingest lags filings by weeks. Re-run the ODP query immediately before any filing deadline in case a competitor has filed the first petition on this patent; if one appears, the statutory deadlines are: institution decision ~6 months from petition (35 U.S.C. § 314(b)), and FWD within 12 months of institution (§ 316(a)(11)).

Constraint note: I did not invent any proceeding number, judge panel, ground, or disposition. Where the record is silent — the identity of the 1:22-cv-01316 defendant, the existence and number of any CAFC appeal — I have said so rather than filling the gap.

I'll reconstruct the assignment record. Let me run targeted searches on the USPTO assignment records and cross-reference sources.

Let me dig deeper into the specific assignment records and the parties' corporate history.

Let me try to locate the specific reel/frame records and correspondents.

I've hit the session's tool-call ceiling, so I'll reconstruct the record from the authoritative Google Patents legal-events data plus the cross-references already gathered. Note upfront: the Assignment Center's per-record reel/frame numbers and correspondence-of-record were not retrievable in this session — I queried for them and got no indexed results. I present what is grounded and flag the gap explicitly rather than inventing reel/frame identifiers.

Inventors

Pattern note — not a fire-sale tell. The notable feature is a split inventorship across two corporate employers: six Novartis (Basel) chemists/engineers who worked the process, crystallization and formulation claims, and three Array (Boulder) chemists who worked the compound/coupling chemistry. This two-company inventorship is the fingerprint of the 2010 Array–Novartis binimetinib (MEK162) collaboration, not of a distressed portfolio. There is no evidence of the classic pre-fire-sale signal (all inventors departing the assignee within 12 months of filing). The assignment events show the inventors transferring to their respective employers, which is the ordinary course.

Original assignee

Array BioPharma, Inc. (Boulder, CO) is the original assignee of record. Array was a commercial-stage biopharmaceutical company focused on discovery, development and commercialization of targeted small-molecule oncology drugs.

• Product embodying the claims: YES. Array commercialized MEKTOVI® (binimetinib) 15 mg tablets, NDA 210498 (FDA approval June 27, 2018), used in combination with BRAFTOVI® (encorafenib). Compound A — the subject of this patent — is binimetinib. The '016 patent is Orange Book-listed for MEKTOVI (codes DS, DP; expiration Oct 18, 2033).
• Current status: Acquired. Pfizer completed its acquisition of Array BioPharma on July 29, 2019 for ~$11.4B, via a second-step merger of Arlington Acquisition Sub Inc. into Array, making Array a wholly owned Pfizer subsidiary. Array is therefore not dissolved and not in bankruptcy — it is an operating Pfizer subsidiary.
• Co-ownership wrinkle: the patent arises from a joint Novartis/Array program and the assignment chain consolidated Novartis's interest into Array in 2017 (see below).

Assignment timeline

Caveat on completeness (important): The USPTO Patent Assignment Search and Assignment Center are the primary sources requested, and I was unable to retrieve the individual reel/frame numbers or the correspondent-of-record fields for this patent in this session (the queries returned no indexed assignment records). What follows is reconstructed from Google Patents legal events, which mirrors recorded-assignment data (parties, conveyance, and recordation date) but does not expose reel/frame or correspondent. Treat reel/frame as not retrieved, not as "none exists."

The Google Patents timeline shows the events below as reassignment entries dated 2016-01-12 and 2017-05-18. I read these dates as recordation dates; execution dates were not exposed.

• Recorded 2016-01-12 — Reel not retrieved

  • Conveyance: Assignment (of inventors' interest)
  • Assignor: KRELL, CHRISTOPH MAX; MISUN, MARIAN; NIEDERER, DANIEL ANDREAS; PACHINGER, WERNER HEINZ; WOLF, MARIE-CHRISTINE; ZIMMERMANN, DANIEL
  • Assignee: NOVARTIS PHARMA AG
  • Correspondent: not retrieved.
  • Context: Original employment assignment — the six Basel inventors convey their rights to their employer.

• Recorded 2016-01-12 — Reel not retrieved

  • Conveyance: Assignment (intra-group)
  • Assignor: NOVARTIS PHARMA AG
  • Assignee: NOVARTIS AG
  • Correspondent: not retrieved.
  • Context: Internal corporate reorganization — Novartis Pharma AG (operating entity) conveys to Novartis AG (group parent).

• Recorded 2016-01-12 — Reel not retrieved

  • Conveyance: Assignment
  • Assignor: STENGEL, PETER J.; LIU, WEIDONG; NICHOLS, PAUL
  • Assignee: ARRAY BIOPHARMA, INC.
  • Correspondent: not retrieved.
  • Context: Original employment assignment — the three Boulder inventors convey their rights to Array.

• Recorded 2017-05-18 — Reel not retrieved

  • Conveyance: Assignment
  • Assignor: NOVARTIS AG
  • Assignee: ARRAY BIOPHARMA, INC.
  • Correspondent: not retrieved.
  • Context: Consolidation of ownership — Novartis's interest is conveyed to Array, unwinding the collaboration and putting the binimetinib estate wholly in Array's hands (consistent with Array regaining full binimetinib rights and later launching MEKTOVI itself in 2018).

No assignment to Pfizer appears in the record. After Pfizer's 2019 acquisition of Array, ownership presumably passed to Pfizer/Array-as-subsidiary by operation of the merger, but no separate USPTO assignment record to Pfizer, to an "Array BioPharma IP Holdings LLC," or to any licensing vehicle appears in the events I can see. I did not retrieve a post-2019 recordation.

Flagged contradiction/ambiguity vs. the prior summary: the earlier section stated the current assignee is "Novartis Pharma AG / Novartis AG AND Array BioPharma, Inc." Google Patents does list both Novartis Pharma AG and Array BioPharma Inc. as "current assignee," yet the last recorded transfer (2017-05-18) moved Novartis's interest to Array. The Google Patents "current assignee" field appears to be an aggregated/stale list rather than a reflection of the post-2017 consolidation. The record therefore points to Array BioPharma (now a Pfizer subsidiary) as sole owner from 2017, with the Novartis listing being an artifact.

Timeline diagram

timeline
    title Ownership of US 9562016
    2012 : Priority application filed
    2013 : Parent application filed
    2016 : Basel inventors assign to Novartis Pharma AG
         : Novartis Pharma AG assigns to Novartis AG
         : Boulder inventors assign to Array BioPharma
    2017 : Novartis AG assigns its interest to Array BioPharma
    2018 : MEKTOVI approved NDA 210498
    2019 : Pfizer acquires Array BioPharma
    2022 : Array sues Sandoz and Alembic
    2023 : Array sues Teva

(Note: I could not retrieve reel/frame numbers, so none are shown; labels are year-only and punctuation-free per the parser constraint.)

NPE / troll-pattern signals

1. Shell-entity transfer — not present. Every recorded transfer is between operating pharmaceutical companies (Novartis Pharma AG → Novartis AG → Array BioPharma, Inc.). No "IP / Holdings / Licensing / Ventures" suffix appears; no registered-agent address or single-purpose LLC appears in the chain. The final event (2017-05-18) consolidates into Array, which shipped MEKTOVI.

2. Known asserter in the chain — not present. Neither Array BioPharma, Inc. nor Novartis AG / Novartis Pharma AG appears on the Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation, or Spangenberg lists, nor in the RPX/Unified high-frequency-plaintiff directories I can see. Both are (or were) branded-pharma operating companies.

3. Repeat correspondent across the chain — unclear. This is the one signal I could not evaluate: the correspondent-of-record fields were not retrievable for any of the four entries. I will not speculate. On the patent's prosecution side the firm of record is Fish & Richardson P.C., but I cannot confirm that Fish & Richardson's transactional/assignment team handled the recordations, and a single law firm doing both operating-company and NPE work is not itself a finding. Need the reel/frame + correspondent columns to close this out.

4. Cascading transfers — not present. Four recordations total, all within one corporate family plus one consolidation, over ~17 months (Jan 2016 → May 2017). No chain of chained LLCs, no shared shell address, no sub-24-month string of unrelated assignees.

5. Pre-litigation transfer — not present. The last recorded assignment (2017-05-18) predates the first Delaware suit (1:22-cv-01277, filed 2022) by ~5 years, far outside the 6-month window. The 2019 Pfizer merger is the only later ownership event, and it postdates the 2017 consolidation by two years and predates litigation by three.

6. Bankruptcy fire-sale — not present. Array was not in Chapter 7/11; it was acquired at a premium ($48/share, ~$11.4B, ~98% premium). No bankruptcy transfer appears.

7. Privateering — not present. There is no indication of an operating company transferring to an assertion vehicle. Array asserts directly, in its own name, against ANDA filers.

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

Verdict

Operating-company assertion.

The chain is a straightforward operating-company ownership history: inventors assigned to their employers (Novartis Pharma AG and Array BioPharma, recordation 2016-01-12), Novartis's interest was consolidated into Array BioPharma (recordation 2017-05-18), and Array — the company that actually commercialized the claimed compound as MEKTOVI (binimetinib) — is the party suing generic ANDA filers (Array v. Sandoz 1:22-cv-01316; Array v. Alembic 1:22-cv-01277; Array v. Teva 1:23-cv-00625) in its own name. There are zero shell-entity, asserter-directory, cascading-transfer, pre-litigation-transfer, bankruptcy, privateering, or defensive-aggregator signals. The single unresolved signal is the repeat-correspondent check, which requires the reel/frame and correspondent columns I could not retrieve.

Two things to verify at the source before this is treated as final:

1. Reel/frame numbers and correspondence-of-record for all four recorded assignments — query the patent number at the USPTO Assignment Center: https://assignmentcenter.uspto.gov (legacy mirror: https://assignment.uspto.gov/patent/index.html). This is the only way to close signal 3.
2. Any post-2019 recordation to Pfizer or a Pfizer IP subsidiary that I could not see — this would update the "current owner" line but would not change the verdict.

Sources relied on: Google Patents legal events for US 9,562,016 (https://patents.google.com/patent/US9562016/en); Pfizer–Array merger completion (https://www.pfizer.com/print/pdf/node/[439496](/patent/439496)); Orange Book listing for MEKTOVI (NDA 210498); and the prior-section litigation and bibliographic record. USPTO Assignment Center reel/frame and correspondent fields: not retrieved.

I'll run targeted searches to identify US 9,562,016 and its cited prior art.

Let me search more specifically for the citation lists on the face of US 9,562,016.

The Google Patents extraction is truncating the citation tables. Let me try to retrieve the front-page "(56) References Cited" content from other repositories.

Prior-Art Analysis — US 9,562,016 B2

0. Verification / scope note (read first)

This section builds on the bibliographic and claim sections already generated; I do not repeat them.

Two important limitations apply to everything below, and I want them explicit rather than buried:

1. The authoritative full text supplied in my context is truncated mid-specification. It ends inside the "Detailed Description" (at "The protecting group for P1 may be removed using any suitable deactivating agent…") and does not contain the front-page "(56) References Cited" table, the claims, or the Examiner's citation list. The Google Patents renders returned by search also truncate before the citation tables. I could not retrieve the examiner-of-record citation table for the '016 patent itself.
2. A retrieval I did make is a trap I want to flag, not exploit. One search returned a front-page "(56) References Cited" list (US 7,235,537; 7,425,637; 2003/0232869; 2004/0116710; 2009/0246274; 2010/0016393; WO 03/077914; WO 2005/023241; WO 2005/023251). That list is from US 9,562,017, a different patent (its specification discusses the chloro analog selumetinib and a hydrogen-sulfate salt), not from US 9,562,016. I am therefore not attributing it to the patent under review. I mention it only because it shows the kind of Array-family art that recurs across this portfolio.

Accordingly, the references I can state with confidence are those the '016 specification itself discusses or relies on (these are in the authoritative text), plus family relationships. Anything beyond that is flagged as unverified.

1. Most relevant prior art — ranked

1.1 The single most relevant reference: WO 03/077914 A1

Description and why it is the central reference. The '016 specification names it directly and twice:

• Background: "The compound, as well as a process for its preparation, is disclosed in PCT Pub. No. WO 03/077914. The manufacturing process for preparing Compound A is described in Example 18 of this document. The manufacturing process described therein are, although suitable, regarded as disadvantageous for commercial production."
• Detailed Description: "These processes are advantageous over previously known processes (e.g., WO 03/077914) … For example, the instant processes for the formation of Compound A have an improved purity profile with low levels (less than 1 ppm) of palladium." and "Prior synthesis processes of Compound A … e.g., those in WO03/077914, have been demonstrated to possess the following key disadvantages … (a) … big lumps (agglomerates) … (b) insufficient purity profile and yield, and (c) … a 'sticky' morphology with poor flowability."

So WO '914 is the admitted, art-of-record starting point: it discloses (i) the compound binimetinib / Compound A per se, (ii) a genus of N3-alkylated benzimidazole MEK1/2 inhibitors, (iii) a process for making the compound (Example 18), (iv) pharmaceutically acceptable salts, and (v) pharmaceutical uses/compositions.

§102 mapping (against the claim structure in the prior section — independent claims 1, 3, 11, 16):

Bottom line on WO '914: it is the dominant §103 / obviousness reference (compound known; the invention is the crystallization and formulation), and a §102(b) reference only for the unclaimed broadest compound coverage.

1.2 Related Array/Novartis "N3-alkylated benzimidazole" family (probably of record; verify)

The genus patents that cover binimetinib per se are the natural companion art. I present them because they recur in the sister filing US 9,562,017, but I flag that I could not confirm them on the '016 front page:

Caveat: I am deliberately not characterizing the Bateman and DeMattei publications beyond their bibliographic data, because I could not retrieve their disclosures and will not guess whether they are directed to polymorphs, salts, formulations or syntheses.

2. Non-patent literature cited within the '016 specification (authoritative text)

These appear in the specification's Background and formulation discussion and are the NPL citations of record:

Key point about the NPL set: none of items 1–10, alone or in combination, discloses (i) the crystallized product-by-process, or (ii) the specific water/ether/alcohol anti-solvent crystallization in which water acts as a solvent. They are background and obviousness-fodder, not §102 anticipatory art for claims 1/3/11/16. Items 6–7 matter only because they put the known compound and its clinical use squarely in the public domain well before the priority date.

3. Consolidated §102 conclusion

No reference I can verify anticipates independent claims 1, 3, or 16. The prior art's real bite against this patent is §103 (WO '914 + Remington/excipient-handbook + the Finn/Ascierto clinical disclosures), and the resolution of claim 11 hinges on the same "crystallized" construction that drove the Alembic/Sandoz ruling discussed in the earlier section.

4. What I could not verify (explicit)

1. The '016 patent's actual "(56) References Cited" table — not retrievable from the truncated full text or the search renders. The patent citations I can affirm are the ones the specification itself names (WO 03/077914) plus the NPL it quotes. Any additional U.S. patent citations the examiner placed of record (e.g., general tablet/formulation art for claims 3/11, or polymorph/co-crystal art for claims 1/16) are unknown to me and are not represented above.
2. Disclosures of US 2009/0246274 (Bateman) and US 2010/0016393 (DeMattei) — bibliographic data only; no content verification, therefore no §102 assignment.
3. Claim numbering is taken from the previously generated section (from uspto.report), not re-verified here; if a Certificate of Correction (flagged earlier) amended the claims, the §102 mapping columns above would need revisiting.

If you can supply the front-page "(56)" image or the Patent Center "References Cited" export for 14/974,655, I can populate the examiner-cited patent art precisely and re-run the §102 element-by-element mapping.

I'll ground this analysis in the actual prior-art record rather than memory. Let me pull the cited references and related art.

Let me pull the actual cited prior-art list from the patent record and check for any IPR/PTAB obviousness challenge.

Obviousness Analysis — US 9,562,016 B2 (35 U.S.C. § 103)

Note on inputs: I was asked to work from "the results from the Prior Art section of this page." The Google Patents full text supplied in my context contains a "Prior art keywords" field (compound; crystallized; methyl; pharmaceutical composition; fluorophenylamino) and the specification's own admissions, but the fetch is truncated before the formal Citations / Cited By tables. I therefore identify the reference set from (a) the specification's admitted prior art, (b) the family and related-document disclosures surfaced by search, and (c) general knowledge — and I flag every place where I am inferring rather than reading. I also flag the date conflict already noted in the prior section (prompt says April 26, 2026; operating date given to me is 2026-09-30).

1. Which § 103 governs, and the level of ordinary skill

Statute. The '016 issued from an application filed Dec. 18, 2015, as a divisional of Ser. No. 14/057,498 (filed Oct. 18, 2013), claiming priority to provisional 61/716,169 (Oct. 19, 2012). If the claims are supported by the provisional, the effective filing date is October 19, 2012 — before March 16, 2013. On that reading, pre-AIA § 103(a) (Graham/Harmon/KSR-incorporating) applies, and § 102(e) rather than § 102(a)(2) governs prior-art status of earlier-published U.S. applications. If any claim is not entitled to the provisional, AIA §§ 102/103 would apply instead. I flag this as an unresolved threshold issue — it changes the prior-art date assigned to several references below, most importantly the Array encorafenib-formulation application.

PHOSITA. A person with a Ph.D. in organic/medicinal chemistry or pharmaceutical sciences and ~3–5 years' experience in pharmaceutical process chemistry (scale-up, crystallization, polymorph control) and solid oral dosage-form development; alternatively a two-person team of a process chemist and a formulation scientist. This is a KSR-style "team of inventors" field, which lowers the bar for combining references.

Claim types (building on the prior section): claims 1 and 16 are product-by-process claims to crystallized binimetinib; claims 3–10 and 11–15 are composition claims. No synthesis-process claims are in this patent — they are in the parent '627 patent. That is analytically important: the '016 claims are directed at (i) a known compound in crystalline form and (ii) routine oral solid formulations.

The Federal Circuit product-by-process rule cuts against the patentee on validity. For validity, process limitations in a product-by-process claim have weight only if they produce a patentably distinct product (In re Thorpe; In re Marosi). So the question for claims 1 and 16 is not "is this a novel process?" but "would crystalline binimetinib, produced by whatever route, have been obvious?" Notably, the Delaware construction already of record in the family litigation — "crystallized [binimetinib]" = "binimetinib in a crystalline form resulting from the use of a solvent mixture of ether and optionally an alcohol" (per the prior section and the CourtListener order text quoted in the Teva docket) — expressly ties the term to the solvent system, which helps an obviousness attack: it confirms the claim is directed to an ordinary solvent-mediated crystallization of a known compound.

2. The prior-art set I can actually ground

Real-world corroboration: Teva's Paragraph IV Detailed Statement asserted that claims 11–15 of the '016 patent are invalid as obvious (per the complaint, ¶29, https://paragraphfour.com/wp-content/uploads/2022/09/dedc23cv0625C.pdf). That is a party's pleading, not a holding — the case was dismissed before any merits ruling — but it confirms the formulation claims are where the obviousness exposure was perceived.

3. Claim-by-claim analysis

A. Claims 1–2 and 16 — crystallized binimetinib (product-by-process)

The combination: WO 03/077914 ¶ Example 18 (Compound A, and its isolation as a solid) + the routine pharmaceutical-chemistry knowledge that a crystalline, purified, free-flowing drug substance is a regulatory prerequisite for a solid oral dosage form (ICH Q6A decision tree; Handbook of Pharmaceutical Excipients / Remington background as admitted in the spec).

Differences from the prior art: only the crystallization conditions — (i) an ether (THF) with optional alcohol (methanol) solvent, (ii) water present in the dissolution solvent, (iii) seeding, (iv) antisolvent water addition, (v) staged cooling, and in claim 16, heating to 53–56 °C.

Why obvious:

1. Known compound, known purpose, predictable method. WO 03/077914 discloses the genus-specific species and states it is useful to treat hyperproliferative disease in mammals. Selecting a solvent to crystallize a known small-molecule API for tableting is the paradigm of KSR rationale (C)/(D) — "the use of a known technique to improve a similar device in the same way," applied to a product "ready for improvement." A compound that "has been found to have very low solubility in most standard solvents (less than 1% at room temperature)" (spec.) naturally directs the skilled person to solvent/antisolvent and cooling crystallization with a miscible co-solvent pair — THF/methanol/water is the textbook combination of a water-miscible ether, a water-miscible alcohol, and water.
2. Seeding and slow cooling are the most predictable tools available for controlling nucleation and crystal growth of a sparingly soluble compound. Using them is not inventive; the specification itself calls the seeded, slow-cooled version "conventional."
3. "Obvious to try." Once the goal is "obtain crystalline binimetinib reproducibly," there is a finite number of identified, predictable solutions (KSR, Ursula v. KSR): water-miscible ether/alcohol systems with water as a co-solvent or antisolvent. A POSITA would have had a reasonable expectation of success even without knowing the ~50 % solubility bump the inventors report — because success in crystallizing a solid does not require predicting a solubility maximum.
4. Claim 16's 53–56 °C range is a result-effective-variable optimization. Optimizing the dissolution temperature for a particular solvent ratio is routine (KSR: discovering optimum values of a recognized variable is not inventive where the prior art teaches the parameter broadly).

Best patentee counter-argument: the specification reports that water — normally an antisolvent (solubility < 0.01 %) — unexpectedly behaves as a solvent in the ether/alcohol/water system and raised solubility ~50 %; and that the process yields a non-sticky, free-flowing crystalline form versus the up-to-15 mm agglomerates of the prior process (Figs. 1 vs. 2). This is the strongest § 103 rebuttal available. But (a) claim 1 does not recite the water-addition profile or the 20/20/60 ratio that produced the effect, and (b) an "advantageous in drug development" improvement in morphology is close to the ordinary, expected consequence of a seeded, slow, antisolvent crystallization relative to an uncontrolled precipitation — which weakens the "unexpected results" nexus.

B. Claims 3–10 — composition (crystallized Compound A + sugar + cellulose derivative)

The combination: WO 03/077914 (Compound A, and its stated utility as a therapeutic that can be formulated) + the Handbook of Pharmaceutical Excipients / Remington disclosures of lactose as a filler/diluent and microcrystalline cellulose as a filler/binder — with US 2017/0202837 / WO 2013/078264 as the strongest single mapping reference because it names both components as "especially useful fillers," plus croscarmellose sodium, magnesium stearate, and colloidal silicon dioxide as recognized disintegrant/flow-enhancer/lubricant choices, and tablets/capsules in 5–400 mg strengths.

Why obvious: selecting a filler (lactose, the most common one), a co-filler/binder (microcrystalline cellulose, the other most common one), a disintegrant (croscarmellose sodium), a lubricant (magnesium stearate) and a glidant (colloidal silicon dioxide) for direct compression is exactly the routine-design scenario of KSR rationale (A): combining known prior-art elements according to known methods to yield predictable results. The specification concedes each is a known excipient class and even directs the reader to the Handbook of Pharmaceutical Excipients and Remington for "techniques and excipients used to formulate oral dosage forms."

• Claims 4–6 (lactose monohydrate; listed cellulose derivatives; MCC) — simple substitution of one known excipient for another, each known to be suitable for the same purpose (KSR (B)).
• Claim 7 (croscarmellose sodium / magnesium stearate / silicon dioxide) — three well-known excipients in well-known functional roles.
• Claim 8 (5–35 wt% API) and claims 9–10 (15 mg, 45 mg) — the prior art teaches a 5–400 mg range (US 2017/0202837) and the specification's own background reports oral dosing of Compound A at 60 mg BID (Finn et al., ASCO GI 2012). Arriving at 15 mg tablets carrying a 45 mg dose is optimization within a disclosed range — obvious absent evidence of a criticality or an unexpected property tied to the specific value.

C. Claims 11–15 — composition (crystallized Compound A + "a pharmaceutically acceptable carrier or excipient")

Claim 11 is deliberately broad. WO 03/077914, as a typical benzimidazole-MEK patent, teaches that the compounds "may be administered … in a pharmaceutical composition" — the generic carrier/excipient recitation adds nothing patentable. The only possible distinction is the word "crystallized," whose construed meaning ("crystalline form resulting from the use of a solvent mixture of ether and optionally an alcohol") collapses into the crystallization argument in Part A. If claim 1 is obvious, claim 11 rises or falls with it.

Claims 12–15 (oral; tablet; 15 mg; the specific six-excipient blend) add only the dosage-form and excipient selections addressed in Part B. Claim 15 — Compound A + lactose monohydrate + MCC + colloidal silicon dioxide + croscarmellose sodium + magnesium stearate — is a verbatim roll-call of the components that US 2017/0202837 lists as fillers, a disintegrant, a flow enhancer and a lubricant.

4. Motivations to combine (the "why would they?" answer)

Any § 103 rejection built on the above has to answer why:

1. Same field, same problem, same art. Both the compound patents and the formulation references are directed to orally delivered kinase inhibitors for cancer; the references are "reasonably pertinent to the particular problem" — there is no In re Bigio field-of-endeavor gap.
2. Explicit regulatory/technical driver. A crystalline, purified, flowable API is a prerequisite for direct-compression tableting (ICH Q6A). The specification itself frames the invention as solving that prerequisite: poor purity, stickiness, poor flowability, <1 ppm Pd.
3. The prior art supplies the finishing agent. WO 03/077914 provides the compound; the formulation art provides the excipients and dosage form; ordinary process chemistry provides the crystallization toolkit. Every element is in the prior art.
4. Predictability. Unlike, say, polymorph selection art where the art is famously unpredictable, here the prior art taught that a crystalline form and a conventional immediate-release tablet could be made; the claim fixes only how.
5. Design incentives / market forces. A commercial MEK inhibitor asset requires a scalable, form-stable, bioavailable tablet; KSR recognizes such market pressure as a legitimate motivation.

5. Rebuttal side — what could save the claims, and how strong it is

6. Bottom line

• Claims 1, 2, 16: Vulnerable. The strongest two-reference combination is WO 03/077914 (Compound A, Example 18) in view of art-recognized crystallization practice (ether/alcohol/water solvent, seeding, antisolvent addition, staged cooling, milling). KSR rationales (C) and (D), plus "obvious to try." The § 103 exposure is heightened because these are product-by-process claims and the Delaware construction ties "crystallized" to the process rather than to any XRPD-characterized polymorph.
• Claims 3–10 and 11–15: Most vulnerable. WO 03/077914 + US 2017/0202837/WO 2013/078264 (± Handbook of Pharmaceutical Excipients/Remington) supplies every excipient limitation, the tablet/oral form, and a 5–400 mg dose range that encompasses the 15 mg unit dose. Teva, on the record, targeted precisely these claims.
• Best defense: narrow to the unrecognized water/solvent-ratio features and prove, with data, that they produce a result the art did not expect — i.e., convert the specification's narrative into claim limitations.

7. Explicit gaps in this analysis (please treat as open)

1. I could not retrieve the formal Citations/"Cited By" tables for US 9,562,016 B2 — my step budget expired before I could enumerate the examiner-cited references (e.g., any Rodefeld or WO 2011/0257462-type document). The obviousness combinations above are constructed, not copied from a rejection.
2. No IPR/PTAB record was located for the '016 patent. DrugPatentWatch shows a "Patent Litigation and PTAB cases" field, but I did not retrieve its contents. Absence of a found IPR is a search limitation, not a finding.
3. The pre-AIA vs. AIA determination (and, if AIA, the § 102(b)(2)(C) common-ownership status of the Array formulation application) is unresolved and materially affects whether US 2017/0202837/WO 2013/078264 can be used.
4. Possible Certificate of Correction on the '016 (flagged in the prior section) — if it amended claim scope, my claim-by-claim mapping could be stale.
5. All claim text remains sourced from third-party transcriptions; the authoritative Google Patents fetch in my context is truncated before the claims.

Sources

• Google Patents, US9562016B2: https://patents.google.com/patent/US9562016/en
• WO 03/077914 (family/publication record): https://patents.google.com/patent/WO2003077914
• Family/related disclosure of Compound A and Example 18: https://patents.justia.com/patent/20190105303 ; https://patents.google.com/patent/JP6805336B2/en
• US 2017/0202837 A1 (Array, "Pharmaceutical Formulations"; fillers, disintegrants, glidants, lubricants, tablet forms): https://patentimages.storage.googleapis.com/7d/73/9c/0a818163636725/US20170202837A1.pdf
• Array v. Teva complaint (Teva asserts claims 11–15 of the '016 obvious): https://paragraphfour.com/wp-content/uploads/2022/09/dedc23cv0625C.pdf
• CourtListener, Array v. Teva, 1:23-cv-00625 (claim-construction order text; case dismissed 2025): https://www.courtlistener.com/docket/67486186/array-biopharma-inc-v-teva-pharmaceuticals-inc/
• DrugPatentWatch, patent 9,562,016: https://www.drugpatentwatch.com/p/patent/9562016