Actavis Elizabeth LLC et al. v. Novartis AG

Case Overview & Background

Note on framing. This matter is not a district-court infringement action; it is an inter partes review (IPR) at the PTAB — the administrative validity challenge that Teva/Actavis and other generic filers waged against the dosing-regimen patent for Novartis's Gilenya® (fingolimod), and it sits at the center of a broader Hatch-Waxman/ANDA infringement campaign over that multi-billion-dollar multiple-sclerosis drug.

Parties. Petitioners were Actavis Elizabeth LLC and Teva Pharmaceuticals USA, Inc. (collectively "Teva") — generic pharmaceutical operating companies (Actavis Elizabeth is the ANDA-filing entity within Teva's post-2016 acquisition of Actavis; Teva's mandatory notices disclosed the full Actavis/Teva corporate chain as real parties in interest). Patent owner was Novartis AG, the Swiss innovator; Novartis disclosed that the '405 patent had been assigned to Novartis Pharmaceuticals Corporation, the real party in interest (assignment recorded at Reel 043314/Frame 0800). Both sides are operating companies — no NPE/PAE is involved. Petitioners were represented by Kirkland & Ellis (lead counsel Amanda Hollis per the updated mandatory notices, with the Unified Patents portal listing Winston & Strawn on the petition and Gibson, Dunn & Crutcher for the patent owner).

Patent and accused technology. The sole patent at issue is U.S. Patent No. 9,187,405 B2, "S1P Receptor Modulators for Treating Relapsing-Remitting Multiple Sclerosis," issued November 17, 2015 (application 14/257,342; inventors Peter C. Hiestand and Christian Schnell; Orange Book–listed for Gilenya, NDA No. 022527). Claims 1–6 are method-of-treatment claims covering oral administration of fingolimod (2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol) at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen, to reduce/prevent/alleviate relapses, treat RRMS, or slow its progression. The "accused" instrumentality in the underlying dispute is Teva's generic fingolimod 0.5 mg capsule (ANDA No. 208008) — i.e., a generic copy of Gilenya, the first oral therapy approved for relapsing MS (FDA-approved 2010). The IPR itself challenges validity rather than infringement, but it is the direct predicate for Novartis's later infringement suits.

Procedural posture. Teva filed the petition on August 15, 2017, together with a motion for joinder under 35 U.S.C. § 315(c), because its petition was "substantively identical" to Apotex's earlier petition in IPR2017-00854 (instituted July 18, 2017). On September 11, 2017, the Board (APJs Lora M. Green, Christopher M. Kaiser, and Robert A. Pollock; Pollock authoring) instituted review of claims 1–6 on the same three grounds as the lead case — (1) obviousness over Kovarik + Thomson; (2) obviousness over Chiba + Kappos 2005 + Budde; and (3) anticipation by Kappos 2010 — and granted joinder, with Apotex as lead petitioner (Argentum in IPR2017-01550 and Sun in IPR2017-01929 were joined on the same terms). On July 11, 2018, the Board issued its Final Written Decision in the joined proceeding (IPR2017-00854, Paper 109), holding that petitioners failed to prove claims 1–6 unpatentable: no prior art disclosed 0.5 mg daily fingolimod without a loading dose (the art arguably taught away), and the Kappos 2010 NEJM article was not prior art against the patent's June 27, 2006 priority date. Teva/Actavis appealed to the Federal Circuit (No. 18-2260) but settled before argument; the appeal was dismissed and closed March 25, 2019 (the Federal Circuit's later Argentum opinion notes the Teva/Actavis and Sun appeals were dismissed after settlement). Venue is the PTAB in Alexandria, Virginia — the significance of the proceeding's structure, rather than geography, is the § 315(c) joinder that consolidated four substantively identical generic challenges into one lead-captained trial.

Why it matters. This IPR is a landmark in the Gilenya lifecycle and in Hatch-Waxman strategy. It came on the heels of IPR2014-00784, which invalidated Novartis's fingolimod composition patent (U.S. 8,324,283), affirmed by the Federal Circuit in April 2017 — making the '405 dosing-regimen patent Novartis's key follow-on defense. The PTAB's 2018 decision upholding the '405 patent immediately triggered a wave of Delaware ANDA infringement suits by Novartis (18-cv-1038 against Apotex, 18-cv-1039 against Teva/Actavis, 18-cv-1040 against Sun, 18-cv-1043 against Accord/HEC). The saga continued after this IPR: in the HEC/Accord litigation, the Federal Circuit initially affirmed validity (Jan. 2022) but, on panel rehearing, reversed in June 2022 (2022 WL 2204163), holding the "absent an immediately preceding loading dose" negative limitation lacked written-description support under § 112(a); the Supreme Court denied review, and generic fingolimod entered the U.S. market. The case is thus notable both as a coordinated multi-petitioner joinder play and as the opening act of the leading modern authority on written description for negative claim limitations.

Key sources: PTAB Institution Decision, IPR2017-01946, Paper 9 (Sept. 11, 2017); Final Written Decision, IPR2017-00854, Paper 109 (July 11, 2018); Teva/Actavis Updated Mandatory Notices (Aug. 16, 2017); Jones Day/PTAB Litigation Blog, "PTAB Upholds GILENYA™ Method of Treatment Patent, Prompting New ANDA Litigation" (July 2018); Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., No. 18-2273 (Fed. Cir. 2020) (dismissal footnote re: 18-2260); Novartis Pharms. Corp. v. Accord Healthcare, Inc., 2022 WL 2204163 (Fed. Cir. June 21, 2022); D. Del. complaint, Novartis Pharms. Corp. v. Teva Pharms. USA, Inc., No. 18-cv-1039; Unified Patents and Docket Alarm PTAB docket pages for IPR2017-01946.

Scope note (important)

The case you've identified — IPR2017-01946, Actavis Elizabeth LLC et al. v. Novartis AG — is not itself a district-court patent infringement action. It is an inter partes review (IPR) before the PTAB challenging U.S. Patent No. 9,187,405 (the "Gilenya®" 0.5 mg fingolimod dosing-regimen patent). The actual patent infringement litigation involving these same parties over the '405 patent is the Hatch-Waxman ANDA suit Novartis Pharmaceuticals Corp. v. Teva Pharmaceuticals USA, Inc. et al., No. 1:18-cv-01039-LPS (D. Del.), which was filed immediately after the PTAB's Final Written Decision. Below I cover both tracks chronologically, flagging which docket each event belongs to.

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Track 1 — The PTAB IPR (the named case)

Filing & initial pleadings (IPR equivalents)

• 2017-08-15 — Actavis Elizabeth LLC and Teva Pharmaceuticals USA, Inc. (collectively "Teva") filed the IPR petition challenging claims 1–6 of the '405 patent (Paper 2), a Motion for Joinder to IPR2017-00854 (Paper 3), and supporting exhibits including the expert declaration of Dr. Barbara S. Giesser (Ex. 1002) and prior art (Kovarik WO 2006/058316, Thomson, Chiba U.S. 6,004,565, Kappos, Budde, Kappos 2010). Counsel: Winston & Strawn LLP. (Unified Patents PTAB portal; Patexia docket)
• 2017-08-16 — Accorded filing date; supplemental power of attorney and updated mandatory notices filed (Papers 4–5).
• 2017-08-25 — Notice of Accord Filing Date (Paper 6).
• 2017-09-05 — Novartis's Power of Attorney and Mandatory Notices (Papers 7–8); Patent Owner represented by Gibson, Dunn & Crutcher LLP (Jane Love).

Institution / joinder (the IPR analogue of a dispositive pre-trial ruling)

• 2017-09-11 — Decision Instituting Inter Partes Review and Granting Motion for Joinder (Paper 9): the Board joined Teva's proceeding to lead case IPR2017-00854 (Apotex Inc. v. Novartis AG), instituting on the same three grounds: (1) obviousness over Kovarik + Thomson; (2) obviousness over Chiba + Kappos 2005 + Budde; and (3) anticipation by Kappos 2010. Joinder was conditioned on Apotex serving as lead petitioner. (IPR2017-01946, Paper 9; IPR2017-00854 FWD, Paper 109)

Claim construction (in the IPR)

• In the lead case's Institution Decision (2017-07-18, Paper 11), the Board construed the preambles of claims 1, 3, and 5 as limiting ("reducing or preventing or alleviating relapses in," "treating," and "slowing progression of" RR-MS "in a subject in need thereof"), giving them ordinary and customary meaning under Phillips; no other terms required express construction. That construction carried into the joined trial. (IPR2017-00854, Paper 11)

Discovery milestones

• 2017-09-26 — Patent Owner noticed the deposition of Petitioners' expert Dr. Barbara Giesser (Paper 10).
• 2017-11-30 — Petitioners noticed depositions of Novartis inventor Christian Schnell and declarant Fred D. Lublin, M.D. (IPR2017-00854, Papers 32–33).
• 2018-01-11 — Board order on discovery under 37 C.F.R. § 41.51(b)(1) and ordering briefing on additional discovery under § 41.52(b)(2) (IPR2017-01946, Paper 11), following a dispute over Novartis's supplemental evidence.
• Substantive merits papers in the joined case: Novartis's Patent Owner Response (2017-11-13, Paper 26), Petitioners' Reply (Paper 49), authorized Sur-Reply (Paper 63), and Novartis's Corrected Contingent Motion to Amend (Paper 61) with opposition/reply/sur-reply (Papers 51, 64, 85).

Final Written Decision — the outcome of the IPR

• 2018-07-11 — In IPR2017-00854, Paper 109, the Board (APJ Robert A. Pollock; Judges Kaiser and Sawert) held that Petitioners failed to prove claims 1–6 unpatentable on all three grounds; Novartis's contingent motion to amend was denied as moot. The Board found none of the asserted prior art disclosed a 0.5 mg/day fingolimod dosing regimen without an immediately preceding loading dose, and credited Novartis's evidence that the art taught away. (FWD text; Jones Day/PTAB Litigation Blog, July 30, 2018)
• 2018-08-07 — Copy of the FWD entered on the IPR2017-01946 docket (Paper 12), formally terminating the joined case (metadata lists termination 2018-07-11; the joined docket entry was docketed 2018-08-07).

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Track 2 — The district court ANDA infringement litigation

Filing & initial pleadings

• 2018-07-13 — Novartis Pharmaceuticals Corp. v. Teva Pharmaceuticals USA, Inc. and Actavis Elizabeth LLC, 1:18-cv-01039 (D. Del.), filed before Judge Leonard P. Stark — a Hatch-Waxman action under 35 U.S.C. § 271(e)(2) based on Teva/Actavis's ANDA for generic Gilenya, asserting infringement of the '405 patent (at least claim 1: 0.5 mg daily fingolimod absent an immediately preceding loading dose). The complaint expressly invoked the just-issued PTAB FWD upholding validity. (Complaint, D.I. 1; Ex Parte complaint analysis; CourtListener docket)
• Novartis filed parallel suits the same day against Apotex (18-cv-01038), Sun Pharma (18-cv-01040), and Accord (18-cv-01043); the four cases were coordinated/consolidated for discovery and scheduling before Judge Stark. (Jones Day blog; CourtListener entries citing "Associated Cases")
• Teva and Actavis answered and asserted invalidity/non-infringement defenses and counterclaims (the docket reflects their active participation by October 2018 — pro hac vice motion for James H. McConnell (D.I. 32), discovery letters, and a scheduling/discovery teleconference on 2018-10-16). I do not have a verified docket-entry date for the answer itself; it was filed in the late summer/fall of 2018.

Pre-trial proceedings and discovery

• 2018-10-11/12/16 — Discovery and scheduling disputes over the proposed scheduling order, ESI and protective orders, resolved at a teleconference before Judge Stark (D.I. 25–30).
• 2018-10-17 — Novartis served responses to defendants' first joint interrogatories and requests for production (D.I. 33).
• 2019-02-14 / 02-21 — Defendants served First Supplemental Consolidated Invalidity Contentions regarding the '405 patent and supplemental identification of invalidity references (D.I. 43, 45).
• 2019-02-28 — Stipulation extending Teva's document production deadline to 2019-03-15 (D.I. 46).
• 2019-03-04 — Teva/Actavis served objections/responses to Novartis's second set of common interrogatories (D.I. 47).
• The case did not reach Markman, summary judgment, or trial.

Final disposition — settlement / consent judgment

• 2019-03-15 — Novartis filed a Proposed Consent Judgment and Order of Injunction (sealed; D.I. 48), with a redacted version filed 2019-03-21.
• 2019-03-19 — Case terminated (per DrugPatentWatch litigation data for patent 9,187,405), reflecting a stipulated judgment against Teva/Actavis with injunction — i.e., a settlement under which Teva/Actavis took a license or were enjoined from launching generic fingolimod under the '405 patent before its expiration.

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Track 3 — Federal Circuit appeals of the IPR FWD (and their effect)

• 2018-08-16 — Teva/Actavis filed Appeal No. 2018-2260 (Actavis Elizabeth LLC v. Novartis AG), part of the consolidated appeal group led by **2018-2209 (Apotex Inc. v. Novartis Pharmaceuticals Corp.)**; Sun's appeal was 18-2230 and Argentum's was 18-2273. (RPX Insight; Federal Circuit opinion in Argentum)
• Teva, Actavis, and Sun settled before argument, and their appeals were dismissed — 18-2260 closed 2019-03-25; Apotex settled after argument and its appeal was dismissed. (Argentum Pharm. LLC v. Novartis Pharm. Corp., 956 F.3d 1374 (Fed. Cir. 2020))
• 2020-04-23 — The Federal Circuit dismissed Argentum's appeal (18-2273) for lack of Article III standing (no ANDA filed; no imminent injury), so the Board's merits ruling was never reviewed. (Argentum Pharm. LLC v. Novartis Pharm. Corp., 956 F.3d 1374 (Fed. Cir. 2020))
• Net effect: the PTAB's FWD — claims 1–6 valid over the asserted grounds — stands as the final word on invalidity in these proceedings.

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Overall outcome and the IPR's effect on the litigation

• The IPR (IPR2017-01946, joined into IPR2017-00854) ended in a complete win for Novartis: all claims survived on all three grounds, and the contingent motion to amend was moot. (FWD, Paper 109, 2018-07-11)
• The FWD directly triggered the wave of ANDA infringement suits Novartis filed on 2018-07-13 (18-cv-1038/1039/1040/1043), since the generics' principal invalidity theory had been rejected. (Jones Day, "PTAB Upholds GILENYA™ Method of Treatment Patent, Prompting New ANDA Litigation," July 30, 2018)
• The district court litigation against Teva/Actavis (18-cv-01039) settled via consent judgment and injunction in March 2019, before any Markman order or trial; the parallel Federal Circuit appeal was dismissed as part of the settlement (2019-03-25).
• No claims of the '405 patent were ever cancelled, and no district court ever invalidated it in this dispute; the only appellate merits ruling in the broader Gilenya fight was Argentum's standing dismissal, which left the PTAB's validity determination intact.

Caveats on sourcing: Exact docket-entry dates for the Teva/Actavis answer and counterclaims in 18-cv-01039 were not verified in the available search results (the CourtListener/Patexia excerpts cover mainly late-2018 through March 2019); the 2019-03-19 termination date is from DrugPatentWatch's litigation dataset. The IPR docket entries, institution/joinder decision, and FWD are corroborated by the PTAB papers and the FWD text itself (IPR2017-00854, Paper 109).

Important framing note

This docket (IPR2017-01946) is a PTAB inter partes review, not a district court infringement action. The parties the metadata labels "plaintiffs"—Actavis Elizabeth LLC and Teva Pharmaceuticals USA, Inc.—are the petitioners (challengers) in the IPR against Novartis AG (patent owner) over U.S. Patent No. 9,187,405 (Gilenya/fingolimod). The IPR was instituted and joined into lead case IPR2017-00854 (Apotex et al. v. Novartis) on Sept. 11, 2017, and was terminated with the Final Written Decision of Aug. 7, 2018 (IPR2017-00854, Paper 12), in which the Board found claims 1–6 not shown unpatentable. Teva/Actavis's appeal (Fed. Cir. No. 18-2260) was dismissed after settlement (Argentum Pharms. LLC v. Novartis Pharms. Corp., 956 F.3d 1374 (Fed. Cir. 2020)). There is also a related Delaware infringement action, Novartis Pharms. Corp. v. Teva Pharms. USA, Inc. et al., No. 1:18-cv-01039 (D. Del.), where Novartis is the plaintiff.

Counsel of record for Actavis/Teva (petitioner side)

At filing — Kirkland & Ellis LLP (per Petitioners' Power of Attorney and Updated Mandatory Notices, Aug. 15–16, 2017, IPR2017-01946, Papers 1 & 5; PTAB documents hosted at ptacts.uspto.gov and docketalarm.com)

• Amanda Hollis (Reg. No. 55,629) — Lead Counsel. Kirkland & Ellis LLP, 300 North LaSalle, Chicago, IL 60654. Kirkland IP litigation partner who has served as lead counsel in numerous IPRs and federal-court/ITC patent trials; her clients have included Teva (per her Kirkland bio), and she led high-stakes IPR challenges to the Herceptin patents; named a Law360 "Top Attorney Under 40" (2018).
• Eugene Goryunov (Reg. No. 61,579) — Back-up Counsel. Kirkland & Ellis LLP, Chicago. Patent litigator active in PTAB practice and Hatch-Waxman-style challenges.
• Gregory Springsted — Back-up Counsel (pro hac vice motion forthcoming as of the notices). Kirkland & Ellis LLP, 601 Lexington Avenue, New York, NY 10022. IP litigator in Kirkland's New York office.

The Power of Attorney was executed by Lauren Rabinovic, VP & General Counsel, North America Generic IP, Teva Pharmaceuticals (the in-house signatory).

During the joined proceeding — Winston & Strawn LLP (by early/mid-2018, Teva/Actavis were being served as counsel of record)

• Samuel Park — Winston & Strawn LLP, 35 W. Wacker Drive, Chicago, IL 60601. Listed "For Teva" on service of Patent Owner's Notice of Deposition of Leslie Z. Benet (IPR2017-00854, Paper 59, Mar. 2, 2018); also listed for petitioner Sun Pharma in the Board's Jan. 25, 2018 Conduct-of-Proceeding order. Active in Hatch-Waxman and PTAB litigation.
• Charles B. Klein — Winston & Strawn LLP (Chicago/DC). Listed on the same Teva service list; senior IP litigator (former USPTO Solicitor), well known for IPR and appellate patent work.
• Sharick Naqi — Winston & Strawn LLP (Chicago). Listed on the same Teva service list.

The Unified Patents PTAB portal likewise records petitioner's counsel of record for IPR2017-01946 as Winston & Strawn LLP (and patent owner's counsel as Gibson, Dunn & Crutcher LLP—Jane M. Love and Robert W. Trenchard, New York—per the service copies on the Teva filings).

Caveats

• I did not locate a separate docket entry in IPR2017-01946 formally substituting Winston & Strawn for Kirkland; the Winston & Strawn appearance is documented in the joined lead proceeding's filings (service lists and Board orders) and in Unified Patents' counsel field, which are strong but secondary evidence. If the docket sheet (PTAB end-to-end) shows an "Updated Mandatory Notices" paper after Aug. 2017, that would be the confirmatory entry.
• No filings appear to be sealed, and all counsel above are a matter of public record in the PTAB filings cited.

I'll research the counsel of record for Novartis AG (patent owner/defendant in this IPR context) in IPR2017-01946.

I have strong leads. Let me dig deeper into the patent owner's mandatory notices, power of attorney, and the full Gibson Dunn team in IPR2017-01946 and the joined proceeding.

I have the core record. Let me verify the full team — additional back-up counsel, pro hac vice admissions, and in-house Novartis counsel — from the joined proceeding and hearing transcript.

Counsel of Record — Novartis AG (Patent Owner / "Defendant" in IPR2017-01946)

Important framing note: IPR2017-01946 is a PTAB inter partes review (petition filed Aug. 15, 2017), not a district-court patent infringement suit. The "defendant" in the caption — Novartis AG — is the Patent Owner/Respondent. In its Patent Owner's Mandatory Notices, Novartis identified Novartis Pharmaceuticals Corporation as the real party-in-interest (Novartis AG assigned the '405 patent to Novartis Pharmaceuticals Corp. on Aug. 16, 2017). The names below are the counsel of record for the patent owner in the IPR, as reflected in PTAB filings.

Lead counsel

Jane M. Love, Ph.D.

• Role: Lead counsel for Patent Owner (designated in the Patent Owner's Mandatory Notices, Paper 5, filed Sept. 5, 2017; USPTO Reg. No. 42,812)
• Firm/Location: Gibson, Dunn & Crutcher LLP, 200 Park Avenue, 47th Floor, New York, NY 10166
• Experience: Gibson Dunn partner and Chair of the firm's Life Sciences and IP Litigation practices; three-time Law360 Life Sciences MVP (2017, 2019, 2021); lead counsel for Novartis in the Gilenya® (fingolimod) ANDA/IPR wars over U.S. Patent No. 9,187,405, including the PTAB defense and the Delaware district-court preliminary injunction against launch-at-risk generics. Her Sept. 5, 2017 email to the Board (non-objection to joinder with IPR2017-00854) is signed "Lead Counsel for Patent Owner."

Back-up counsel

Robert W. Trenchard

• Role: Back-up counsel for Patent Owner (designated in the Mandatory Notices, pro hac vice admission to follow; admitted pro hac vice in the lead case IPR2017-00854, Paper 10, May 2017)
• Firm/Location: Gibson, Dunn & Crutcher LLP, 200 Park Avenue, 47th Floor, New York, NY 10166
• Experience: Gibson Dunn litigation partner with extensive first-chair life-sciences patent experience; per his firm bio, he represented Novartis as Patent Owner across the Gilenya® IPRs and the related Delaware ANDA litigation against 23 filers, co-leading with Jane Love.

Andrew Blythe

• Role: Gibson Dunn attorney who appeared for Novartis at the June 4, 2018 oral hearing in the joined lead proceeding IPR2017-00854 ("I'm Jane Love, and with me is — Robert Trenchard and Andrew Blythe. We are from Gibson, Dunn & Crutcher representing Novartis."). He is confirmed as part of the arguing team in the joined trial; I did not find a separate designation filing naming him as additional back-up counsel in IPR2017-01946's own docket, so his formal "of record" status in this specific case number is not independently confirmed.
• Firm/Location: Gibson, Dunn & Crutcher LLP (New York office)

In-house counsel (Novartis) — appeared at the joined proceeding's hearing

Peter Wybell — U.S. Head of Patent Litigation at Novartis; identified at the June 4, 2018 hearing as attending with Gibson Dunn. In-house, not counsel of record on the PTAB designation.

Drew Holmes — Novartis U.S. in-house litigator; also identified at the June 4, 2018 hearing. In-house, not separately designated as PTAB counsel of record.

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Key sources

• Patent Owner's Mandatory Notices, IPR2017-01946, Paper 5 (filed Sept. 5, 2017) — names Jane M. Love, Ph.D. (lead) and Robert W. Trenchard (back-up), both Gibson Dunn (PTACTS/USPTO document).
• Email from Jane M. Love to the PTAB (Sept. 5, 2017) re: joinder non-objection, signed as "Lead Counsel for Patent Owner" (PTACTS).
• Hearing Transcript (June 4, 2018), IPR2017-00854 (the case IPR2017-01946 was joined into) — identifies Gibson Dunn's Love, Trenchard, and Blythe plus Novartis in-house counsel Wybell and Holmes.
• Gibson Dunn attorney bios for Jane M. Love and Robert W. Trenchard (confirming their Novartis/Gilenya '405 patent representation).
• Docket entries via Patexia/Unified Patents: Paper 8 (PO Power of Attorney, Sept. 5, 2017); Paper 9 (Decision Instituting IPR and Granting Motion for Joinder, Sept. 11, 2017); Paper 12 (Final Written Decision in the joined case, Aug. 7, 2018).

Caveats: The proceeding was joined into IPR2017-00854 (Apotex et al. v. Novartis) and no Patent Owner Preliminary Response was filed (Novartis expressly waived it). If you intended the district-court ANDA litigation (e.g., Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., D. Del. 1:18-cv-01043), Gibson Dunn and McCarter & English appear as plaintiff's counsel there — say the word and I can pull that docket's specific appearances.