Litigation

Merck Sharp & Dohme Corp. v. Apotex Inc. et al.

settled

1:19-cv-00313-RGA

Filed
2019-02-13

Patents at issue (1)

7326708

Summary

Action asserting the '708 patent; resolved by settlement/consent judgment.

Case overview & background

Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.

I'll research this case using web search to verify the details.

Case Overview and Background

Parties. Plaintiff Merck Sharp & Dohme Corp. ("MSD") is the U.S. operating/pharmaceutical subsidiary of Merck & Co., Inc. and the record owner by assignment of U.S. Patent No. 7,326,708; in its PTAB mandatory notices MSD described itself as "a wholly owned subsidiary of Merck & Co., Inc.," which has no parent, and confirmed it is "the owner and assignee of the '708 patent." Defendants Apotex Inc. (the Canadian parent generic manufacturer) and Apotex Corp. (its U.S. affiliate) are ANDA filers, not an NPE — the case is a conventional Hatch-Waxman Paragraph IV dispute between a brand company and a generic manufacturer. Counsel of record in the consent judgment were Williams & Connolly LLP (Bruce R. Genderson, Jessamyn S. Berniker, Stanley E. Fisher, Alexander S. Zolan, Shaun P. Mahaffy, Anthony H. Sheh, Jingyuan Luo) and McCarter & English LLP (Michael P. Kelly, Daniel M. Silver, Alexandra M. Joyce) for Merck, and Phillips, McLaughlin & Hall, P.A. (John C. Phillips, Jr., David A. Bilson) for Apotex (consent judgment; Apotex/Merck MDL docket).

Accused product and patent. The accused technology is Apotex's proposed generic versions of Merck's sitagliptin blockbusters — JANUVIA (sitagliptin phosphate), JANUMET (sitagliptin/metformin HCl) and JANUMET XR (sitagliptin/metformin HCl extended-release) — filed under ANDA Nos. 202425, 202426 and 214494. The complaint pleaded that Apotex submitted a Paragraph IV certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting the '708 patent is invalid, unenforceable and/or not infringed, and that this submission constituted infringement under 35 U.S.C. § 271(e)(2). Federal records confirm ANDA 214494 is Apotex's sitagliptin/metformin HCl extended-release tablet (FDA/ANDA 214494). Only one patent is asserted in this action: U.S. 7,326,708, "Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor," issued Feb. 5, 2008, naming Cypes, Chen, Ferlita, Hansen, Lee, Vydra and Wenslow as inventors. Technically, the '708 patent claims the 1:1 dihydrogenphosphate ("DHP") salt of sitagliptin — the DPP-IV inhibitor used to treat Type 2 diabetes — including hydrates, the (R)- and (S)-enantiomers, the crystalline monohydrate polymorph, pharmaceutical compositions, a process for preparing that monohydrate, and a method of treating Type 2 diabetes (Markman opinion, In re Sitagliptin Phosphate ('708 & '921) Pat. Litig., 2020 WL 6743022 (D. Del. Nov. 17, 2020)). This is the later-expiring "salt/polymorph" patent that extends sitagliptin protection well beyond the compound patent; Merck has stated it expires Nov. 24, 2026, extended by pediatric exclusivity to May 24, 2027 (Merck press release, Sept. 22, 2022) — one N.D. W. Va. opinion recites March 24, 2027, so the precise expiry date varies by source.

Procedural posture and venue. Merck filed this action on Feb. 13, 2019 in the U.S. District Court for the District of Delaware, assigned to Judge Richard G. Andrews. It was one of fourteen parallel Merck suits (13 in Delaware plus one in the N.D. W. Va. against Mylan) filed after generics submitted 26 sitagliptin ANDAs. On Aug. 8, 2019, the JPML centralized pretrial proceedings as MDL No. 2902, In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, before Judge Andrews in Delaware, expressly crediting his experience in complex patent litigation and the need for "swift progress in this litigation that involves the potential entry of generic diabetes drugs into the market" (JPML transfer order). Delaware mattered both because it is the dominant Hatch-Waxman forum and because consolidation produced a single, binding claim construction: Judge Andrews' Nov. 17, 2020 Markman order construed "the salt of claim 1 [or 2]" to include hydrates, defined "crystalline monohydrate" as "a repeating unit cell incorporating a 1:1 ratio of water to a dihydrogenphosphate salt of sitagliptin," and rejected the generics' effort to narrow "sitagliptin." This case was resolved by consent judgment entered Sept. 29, 2021 (covering both C.A. No. 19-313 and the later-filed Apotex action, C.A. No. 20-749-RGA): the '708 patent was deemed a "Licensed Patent," Apotex was enjoined from infringing it other than as authorized by three settlement agreements, and all claims and counterclaims were dismissed with prejudice. The MDL itself was terminated on Feb. 27, 2023 (JPML MDL statistics).

Why it is notable. The case sits at the center of one of the largest Hatch-Waxman consolidations over a single molecule, with sitagliptin generating billions in annual sales for Merck. Its significance is threefold. First, it is a textbook example of a brand relying on a later-expiring salt/polymorph patent rather than the compound patent to hold off generic entry — and the resulting settlements set the U.S. generic entry dates: Merck has disclosed that, as a result of these agreements, "Januvia and Janumet lost market exclusivity in the U.S. in May 2026 and Janumet XR lost market exclusivity in the U.S. in July 2026" (or earlier under certain circumstances) (Merck 10-Q/10-K disclosures). Second, it is tightly linked to PTAB proceedings: IPR2020-00040 (Mylan Pharmaceuticals, with Teva, Watson, Dr. Reddy's and Sun joining via joinder requests in IPR2020-01045 and IPR2020-01060) challenged the '708 patent on anticipation/inherency and obviousness grounds; the Board's final written decision of May 7, 2021 found the challenged claims not unpatentable, and Merck's 2022 press release notes Viatris's appeal to the Federal Circuit was then pending. Third, the litigation tracks the broader sitagliptin lifecycle — a parallel N.D. W. Va. bench trial against Viatris/Mylan ended in a Sept. 22, 2022 ruling for Merck that both the '708 and '921 patents were valid and infringed, with an injunction tying ANDA approval to the '708 patent's expiry (N.D. W. Va. amended final judgment).

Sourcing caveats: The specific asserted claims in the Apotex Delaware action, the docket entry numbers for the consent judgment, and the final Federal Circuit disposition of Viatris/Mylan's appeal of IPR2020-00040 could not be confirmed from the sources retrieved here; I have not stated an outcome for that appeal. The mapping of each individual Apotex ANDA number to a specific branded product (beyond 214494 = sitagliptin/metformin ER) is also not confirmed.

Key legal developments & outcome

Major rulings, motions, claim construction, settlements, and the present posture or final disposition.

I'll research this case systematically, starting with the docket and the patent at issue.

Let me dig into the specific docket for 19-313 and the parallel IPRs.

Let me pull the 19-313 docket entries and check for any dispositive motions or stays.

In the news

What the press has reported about this case, summarized with links to the source articles.

Press coverage of Merck v. Apotex — what actually exists

The one item in the index does not concern this case — flagging a mismatch. I verified the supplied Patently-O item and it is mis-indexed: "Pfizer v. Sanofi: Applying the Results-Effective Variable Doctrine in Obviousness Analysis" (Dennis Crouch, 2024-03-05) analyzes Pfizer Inc. v. Sanofi Pasteur Inc., No. 19-1871 (Fed. Cir. Mar. 5, 2024), 94 F.4th 1341, and U.S. Patent No. 9,492,559 (pneumococcal glycoconjugates). Merck Sharp & Dohme appears in that piece only as a co-petitioner in the five Sanofi IPRs against Pfizer's vaccine patent — a different patent, different technology, and a different Merck entity role (patent challenger, not patent owner). The article says nothing about sitagliptin, the '708 patent, Apotex, or MDL 2902. It should not be treated as coverage of this litigation. (Confirmation of its subject matter also appears in the Patently-O March 2024 archive at patentlyo.com/patent/2024/03/page/2.)

What the trade press actually covered: the MDL/sitagliptin campaign, not the Apotex docket. I found no Reuters, Bloomberg Law, Law360, IPWatchdog, Ars Technica, or mainstream coverage of Merck Sharp & Dohme Corp. v. Apotex Inc., No. 1:19-cv-00313-RGA specifically — consistent with a case that ended in a stipulated consent judgment rather than a ruling. The press instead reported on the consolidated fight. Williams & Connolly (Merck's counsel of record in 19-313) framed the September 22, 2022 N.D. W. Va. bench-trial win against Viatris as following "a settlement on the eve of trial of related matters that had been coordinated as an MDL proceeding in the District of Delaware," and noted the May 2021 PTAB decision "finding all challenged claims valid" — the only attorney-side public statement located that describes the disposition of the Delaware MDL that swallowed Apotex's case. World Pharmaceutical Frontiers tied the outcome to the '708 patent's term (expiry 24 November 2026, pediatric exclusivity to 24 May 2027) and reported that Merck's settlements would let generics launch Januvia and Janumet in May 2026 and Janumet XR in July 2026, "or prior to that under certain circumstances."

Market impact and settlement numbers. FiercePharma reported that Merck had settled with "nearly two dozen drugmakers" — "at least 21 settlements" permitting May 2026 launches — and put combined 2021 Januvia/Janumet sales at roughly $5.3 billion, while flagging Merck's own earlier concession that the 2027 "salt/polymorph patent" was what stood between it and generic entry. FiercePharma later reported that Januvia and Janumet generated $4.5 billion in 2022 (a 15% decline) and that the Viatris deal was confidential, granting a license to launch "on specific dates prior to the expiration of the relevant patents-in-suit." No outlet reported any dollar figure for the Apotex settlement; the terms remain sealed, and the monetary exposure was never litigated in 19-313. A Taiwanese trade summary of the FiercePharma coverage at Genetinfo went further than U.S. reporting, asserting "at least 25" settlements and citing $1.27 billion in 2025 U.S. sales for the franchise — figures I could not corroborate against Merck's filings or the English-language outlets.

Apotex-specific coverage is about launch, and the accounts conflict. Citeline's Generics Bulletin reported Apotex as "the first generic manufacturer to publicly confirm a US commercial launch" of sitagliptin and sitagliptin/metformin generics, describing a 180-day shared exclusivity period alongside Sandoz and Watson. That conflicts with the launch-dating in other trackers: a DrugPatentWatch analysis dates Sandoz to May 26, 2026 and Apotex to June 2, 2026; an Optum first-time-generic bulletin credits the May 28, 2026 launch to Teva and lists Apotex as approved but "launch pending"; and the Robbins Kaplan Generically Speaking launch chart attributes a 5/28/2026 Januvia launch to Apotex. Whichever is right, the takeaway for this case is that the 2021 consent judgment's practical effect was a licensed, date-certain Apotex entry roughly five years later, not an injunction to the 2027 expiry. The same firm's Q1 2022 settlement bulletin tracks the parallel Merck stipulations (e.g., Merck v. Annora, 21-1006) as enjoining infringement of the '708 patent "[u]nless specifically authorized under the settlement agreement" — the identical structure used in the Apotex judgment, though I did not locate an Apotex entry in that bulletin.

Sourcing note: the launch-date conflict above is genuine and unresolved across the four trackers; the Citeline piece appears to be the outlet closest to Apotex's own announcement, but I could not retrieve its full text or date. Nothing located suggests any outlet reported the terms of the Apotex settlement, and no damages were awarded in this case.

Sources

Plaintiff representatives

Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

I'll research the plaintiff-side counsel of record, starting with the consent judgment and docket.

Excellent — I now have the full 19-cv-313 docket. Let me verify the firms for the pro hac vice attorneys and check the MDL master docket.

I have the MDL master docket and the case docket. Let me verify the current firms/roles of the key Williams & Connolly and McCarter attorneys.

Counsel of Record for the Plaintiff — Merck Sharp & Dohme Corp., No. 1:19-cv-00313-RGA (D. Del.)

Bottom line. Merck was represented by a two-firm combination that is now fully confirmable from the docket I retrieved for this case:

  • McCarter & English, LLP (Wilmington, DE) — Delaware local counsel and the only registered CM/ECF filers, per D. Del. L.R. 83.5(d). Three attorneys appeared: Michael P. Kelly, Daniel M. Silver, and Alexandra M. Joyce.
  • Williams & Connolly LLP (Washington, DC) — lead national trial/patent counsel, appearing pro hac vice. The W&C contingent grew over the life of the case from six (Feb. 2019) to as many as twelve attorneys.

This confirms, and materially expands on, the counsel list recited in the "Case overview" section (which correctly identified the W&C + McCarter pairing from the consent judgment but did not capture the full PHV roster).

Delaware local counsel — McCarter & English, LLP

Attorney Role Firm / Office Notes
Michael P. Kelly (D. Del. #2295) Lead Delaware counsel McCarter & English, LLP — Renaissance Centre, 405 N. King St., 8th Fl., Wilmington, DE 19801 Listed as LEAD ATTORNEY for Merck on the MDL 2902 master docket. Senior Delaware IP trial lawyer; McCarter's Delaware IP/ANDA practice. Signed the 19-313 consent judgment.
Daniel M. Silver (D. Del. #4758) Delaware local counsel; principal filer of record McCarter & English, LLP — Wilmington, DE The de facto docket driver: filed Merck's PHV motions, stipulations, scheduling/protective-order papers, the joint claim-construction brief, case-management letters, and the proposed consent judgment (D.I. 196, 9/28/2021). Signed the consent judgment.
Alexandra M. Joyce (D. Del. #6423) Delaware local counsel McCarter & English, LLP — Wilmington, DE Co-signed the consent judgment; filed redacted versions of sealed Merck papers (e.g., D.I. 189, 199) and the stipulated infringement/protocol orders. Still at McCarter on later Merck/AstraZeneca ANDA matters in D. Del. (e.g., Acerta v. MSN, 22-cv-154/155-RGA).

National / lead counsel — Williams & Connolly LLP (all pro hac vice)

Attorney Role Firm / Office Admission in 19-313 & note
Bruce R. Genderson Lead national counsel / senior trial lawyer Williams & Connolly LLP — 725 Twelfth St., N.W., Washington, DC 20005 Admitted PHV by stipulation at D.I. 6 (filed 2/21/2019, so-ordered 2/22/2019). Long-time W&C head of the Merck relationship; co-counsel in the co-pending IPR2020-00040.
Stanley E. Fisher (Reg. No. 55,820) Lead counsel of record / principal merits advocate W&C — Washington, DC Designated lead counsel in IPR2020-00040 (Merck's mandatory notices) and identified as the attorney who argued for Merck in the Markman opinion, In re Sitagliptin Phosphate ('708 & '921) Pat. Litig., 2020 WL 6743022 (D. Del. Nov. 17, 2020). Admitted via D.I. 6.
Jessamyn S. Berniker (Reg. No. 72,328) Backup/lead trial counsel W&C — Washington, DC First backup counsel in IPR2020-00040; admitted via D.I. 6; signed the consent judgment.
Alexander S. Zolan Trial counsel W&C — Washington, DC Admitted PHV by D.I. 16 (so-ordered 4/29/2019); listed in the IPR2020-00040 notices; signed the consent judgment.
Elise M. Baumgarten Trial counsel W&C — Washington, DC Admitted PHV by D.I. 59 (so-ordered 5/18/2020); named in W&C's 2022 sitagliptin trial-team release; signed the Anchen consent judgment in the MDL.
Shaun P. Mahaffy (Reg. No. 75,534) Trial counsel W&C — Washington, DC Admitted via D.I. 6 (PHV added for notice 3/8/2019). Patent-litigation focus in pharma/biotech; former federal judicial clerk; W&C bio credits the Merck sitagliptin district-court and PTAB matters.
Anthony H. Sheh (Reg. No. 70,576) Trial counsel W&C — Washington, DC Admitted via D.I. 6 (PHV added for notice 3/8/2019).
Jingyuan Luo Trial counsel W&C — Washington, DC Admitted via D.I. 6 (PHV added 3/7/2019); identified as an attorney who argued in the Nov. 17, 2020 Markman opinion; signed the 19-313 consent judgment.
Jihad J. Komis Trial counsel W&C — Washington, DC Admitted PHV by D.I. 123 (so-ordered 11/4/2020); named on W&C's sitagliptin trial team.
Sarahi Uribe Trial counsel W&C — Washington, DC at the time Admitted PHV by D.I. 126 (so-ordered 11/6/2020); joined the W&C sitagliptin team in the MDL and the N.D. W. Va. trial. Affiliation caveat: aggregator data suggests she later moved to Covington & Burling (and an unrelated 2023 D.N.J. PHV order lists her on a Boehringer Ingelheim team); for this case she was W&C.
Vanessa O. Omoroghomwan Trial counsel W&C — Washington, DC Admitted PHV by D.I. 163 (so-ordered 6/24/2021) — i.e., after the Anchen judgment but before the 19-313 consent judgment; listed on W&C's sitagliptin trial team (docket sometimes spells "Omoroghowman").
David M. Krinsky (Reg. No. 72,339) Trial counsel W&C — Washington, DC Admitted PHV by D.I. 177 (so-ordered 9/8/2021), filed shortly before the Sept. 29, 2021 consent judgment; also on the Merck IPR team and the W&C sitagliptin trial team.
Jeffrey G. Ho Trial counsel (short-lived) W&C — Washington, DC Admitted PHV by D.I. 144 (so-ordered 1/25/2021); Merck removed him as co-counsel on 5/25/2021 (D.I. 161). He is also named as additional counsel on the MDL consent judgments in sister cases.

Docket grounding

  • Complaint: D.I. 1 (filed 2/13/2019); ANDA form D.I. 3; Rule 7.1 disclosure D.I. 5 (identifying Merck & Co., Inc. as parent). All merits papers were filed through McCarter (Silver/Joyce).
  • Plaintiff's PHV admissions in this case (D.I. in 19-313): D.I. 6 (Genderson, Berniker, Fisher, Mahaffy, Sheh, Luo — 2/2019); D.I. 16 (Zolan — 4/2019); D.I. 59 (Baumgarten — 5/2020); D.I. 123 (Komis — 11/2020); D.I. 126 (Uribe — 11/2020); D.I. 144 (Ho — 1/2021); D.I. 163 (Omoroghomwan — 6/2021); D.I. 177 (Krinsky — 9/2021).
  • Resolution: proposed consent judgment D.I. 196 (9/28/2021); Consent Judgment D.I. 197 (entered 9/29/2021); patent report D.I. 198. Signed for Merck by McCarter (Kelly/Silver/Joyce) and W&C (Genderson, Berniker, Fisher, Zolan, Mahaffy, Sheh, Luo) — consent judgment. The parallel MDL/Anchen consent judgment signature block additionally lists Baumgarten, Uribe, Komis and Ho.
  • MDL master docket, 1:19-md-02902-RGA: Michael P. Kelly listed as LEAD ATTORNEY for Merck, with the W&C attorneys as PRO HAC VICE.

Caveats

  • I did not have direct PACER access; the docket detail above is drawn from the Patexia docket sheet for 1:19-cv-00313, the consent-judgment PDF, and the MDL 2902 docket excerpt reproduced in a USPTO filing. Docket-entry numbers and dates are internally consistent across those sources, but I would verify against PACER before quoting them in a filing.
  • No in-house Merck attorney appears on the 19-cv-313 docket. (Merck in-house IP counsel such as Richard C. Billups appear in PTAB papers for other patents, but no in-house lawyer entered an appearance here.)
  • Sandra K. Law (Schrader, Byrd & Companion, PLLC, Wheeling, WV) appears on the MDL master docket for Merck, but that reflects the N.D. W. Va. action (Merck v. Mylan, 1:19-cv-00101-IMK) — she is not counsel of record in 19-cv-313.

Defendant representatives

Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

I'll research the docket and counsel appearances for this case.

I found a promising lead. Let me verify against the docket and the actual filings in this case.

Let me pull the actual CourtListener docket for this case to confirm appearances and check for any additional counsel.

Counsel of Record for Defendants Apotex Inc. and Apotex Corp.

Case No. 1:19-cv-00313-RGA (D. Del.) — later consolidated into In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 2902 (D. Del.), before Judge Richard G. Andrews, and resolved with Apotex's co-pending case No. 1:20-cv-00749-RGA.

The defense team was a two-firm combination: a Delaware local-counsel firm (Phillips) that made the CM/ECF appearances, and Katten Muchin Rosenman LLP as Apotex's national patent/ANDA counsel.

Attorney Role Firm & Office Notes
John C. Phillips, Jr. (D. Del. Bar #110) Delaware / local counsel (de facto co-lead) Phillips, McLaughlin & Hall, P.A. — 1200 North Broom Street, Wilmington, DE 19806 (the firm is now styled Phillips, Goldman, McLaughlin & Hall, P.A.) Dean of Delaware's ANDA defense bar; long-time Delaware counsel for Apotex across dozens of Hatch-Waxman suits. Filed the defense-side stipulations in this case (D.I. 9, 11, 12) and signed the consent judgment.
David A. Bilson (D. Del. Bar #4986) Delaware local counsel Phillips, McLaughlin & Hall, P.A.

— Wilmington, DE | Entered the first defense appearance (Notice of Appearance, D.I. 10, filed 03/08/2019) for both Apotex entities. Delaware IP litigator; co-counsel on Apotex's Delaware ANDA docket. |
| Joseph M. Janusz | Lead counsel (national/outside counsel) | Katten Muchin Rosenman LLP — 550 South Tryon Street, Suite 2900, Charlotte, NC 28208-4213 | Katten IP partner and Apotex's principal relationship partner; signed the consent judgment for Apotex. Noted Apotex wins include the Horizon Medicines v. Apotex (Pennsaid 2%) summary-judgment/license defense in D. Del. and other Apotex ANDA matters. |
| Guylaine Hache | Of counsel / additional defense counsel | Katten Muchin Rosenman LLP — 525 W. Monroe Street, Chicago, IL 60661 | Chicago-based Katten attorney who co-signed the consent judgment for Apotex; also listed as Apotex counsel in the related sitagliptin actions (e.g., 19-cv-00311 and the Zydus case). |

How this is sourced

  • D.I. 10 — Notice of Appearance by David A. Bilson on behalf of Apotex Corp. and Apotex Inc. (entered 03/08/2019); D.I. 9/11/12 stipulations to extend Apotex's answer deadline, filed by John Phillips (docket recap at unicourt.com and CourtListener).
  • Consent Judgment, In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, No. 19-313-RGA / 20-749-RGA (D. Del., entered Sept. 29, 2021), which is signed "Attorneys for Defendants Apotex Inc. and Apotex Corp." by the Phillips firm (Phillips, Bilson) and Katten (Janusz, Hache): https://paragraphfour.com/wp-content/uploads/2011/04/dedc19cv0313CJ.pdf
  • The same judgment enjoins Apotex (ANDA Nos. 202425, 202426, 214494) as to U.S. Patent No. 7,326,708 and dismisses all claims and counterclaims with prejudice — consistent with the "settled" status in the case metadata.

Caveats / things I could not verify

  • No PACER docket sheet was directly retrievable in this session. My docket citations come from the consent judgment PDF and secondary docket aggregators (UniCourt/Patexia) rather than PACER itself. The CM/ECF "attorney of record" list (as of the last aggregator update) shows only John C. Phillips, Jr. and David A. Bilson, because Delaware Local Rule 83.5(d) requires Delaware counsel to be the registered filers; Katten's Janusz and Hache signed the dispositive consent judgment but I did not locate a pro hac vice motion for them on this docket.
  • No in-house counsel for Apotex was identified on the docket; none appears in the sources reviewed.
  • I saw no evidence that Katten's Deepro Mukerjee or Lance Soderstrom (the firm's IP practice leaders who handle other Apotex matters) appeared in 19-cv-313, nor Megan C. Haney of the Phillips firm, who appears alongside Phillips in several other Apotex Delaware cases. I am therefore not listing them.
  • No sealed filings bearing on counsel identity were identified; the pleadings and consent judgment reviewed are public.
  • I did not find a standalone opinion in 19-cv-313 itself — after the claim-construction ruling in the related 19-cv-00311 action, see Merck Sharp & Dohme Corp. v. Anchen Pharms., No. 19-cv-00311-RGA (D. Del. Nov. 17, 2020), Apotex (represented by the same Phillips + Katten team) resolved its case via the September 2021 consent judgment.