Litigation

Novartis Pharmaceuticals Corp. v. Teva Pharmaceuticals USA, Inc.

Settled

1:18-cv-01039

Patents at issue (1)

Summary

ANDA suit against Teva (ANDA No. 208008) asserting the '405 patent; filed around 2018-07-16 and settled.

Case overview & background

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

Case Overview & Background

Parties, accused product, and patent. This is a Hatch-Waxman ANDA suit between two branded/generic pharmaceutical players. Plaintiff Novartis Pharmaceuticals Corporation — a Delaware corporation headquartered in East Hanover, New Jersey and the U.S. arm of Swiss innovator Novartis AG (D.I. 5) — markets Gilenya® (fingolimod), an oral S1P-receptor modulator for relapsing-remitting multiple sclerosis (RRMS). Defendants Teva Pharmaceuticals USA, Inc. and Actavis Elizabeth LLC (both Delaware corporations; Actavis Elizabeth is a Teva affiliate, with ultimate parent Teva Pharmaceutical Industries Ltd. of Israel) are generic-drug manufacturers. Novartis alleged that Teva's Abbreviated New Drug Application No. 208008 for generic fingolimod 0.5 mg capsules — a copy of Gilenya — infringed U.S. Patent No. 9,187,405 under 35 U.S.C. § 271(e)(2) (D.I. 1, D.I. 3; ANDA notice received 11/28/2016). The '405 patent, titled "S1P Receptor Modulators for Treating Relapsing-Remitting Multiple Sclerosis" (issued Nov. 17, 2015; priority June 27, 2006; expiration June 25, 2027), is a method-of-treatment/dosing-regimen patent. Its six claims (independent claims 1, 3, 5 and salt-form dependents 2, 4, 6) cover orally administering 0.5 mg/day of fingolimod (free form or HCl salt) to reduce, prevent, or alleviate RRMS relapses or slow progression "absent an immediately preceding loading dose regimen" — the "no-loading-dose" negative limitation being the technical heart of the case (Compl. ¶27; IPR2017-00854 FWD, Paper 109).

Procedural posture and venue. Filed July 13, 2018 in the District of Delaware (1:18-cv-01039) and assigned to Judge Leonard P. Stark (LPS), the case was one of four coordinated ANDA actions Novartis filed the same day — 18-cv-1038 (Apotex), 18-cv-1039 (Teva/Actavis), 18-cv-1040 (Sun), and 18-cv-1043 (Accord/HEC) — which Judge Stark consolidated for pretrial purposes on October 25, 2018 with 18-cv-1043 as lead (D.I. 38; CourtListener docket 7433584). Venue was premised on both defendants being Delaware corporations deemed to reside in the district under 28 U.S.C. § 1400(b) — the standard basis for Delaware's role as the nation's de facto ANDA litigation hub (D.I. 1). Teva answered on August 8, 2018 with non-infringement and invalidity defenses (§§ 101, 102, 103, 112, double patenting) and declaratory-judgment counterclaims (D.I. 9; answer available via paragraphfour.com). The case never reached trial: after discovery skirmishes and extensions of Teva's document-production deadlines, the parties filed a sealed proposed consent judgment and order of injunction on March 15, 2019 (D.I. 47, redacted version D.I. 48), and the case terminated March 19, 2019 — i.e., settled, with the specific terms sealed.

Why the case is notable. The suit was strategically timed: it came two days after the PTAB's July 11, 2018 Final Written Decision in Apotex Inc. v. Novartis AG, IPR2017-00854, which upheld claims 1–6 of the '405 patent on all three grounds (obviousness over Kovarik+Thomson and Chiba+Kappos 2005+Budde; anticipation by Kappos 2010), rejecting the generics' attack on the 0.5 mg no-loading-dose regimen (Paper 109; Jones Day PTAB Litigation Blog). Teva itself had petitioned for IPR on February 3, 2017, and the various generic petitioners were joined into IPR2017-00854 — making this litigation a direct downstream consequence of the IPR outcome and part of a broader patent-thicket battle over Gilenya, then a ~$3 billion/year blockbuster costing patients nearly $100,000 annually (Argentum cert. petition; RPX/Unified Patent dockets). Notably, Novartis had previously lost IPR challenges to Gilenya's composition claims, so the '405 method claims became the key exclusivity linchpin — prompting Novartis to sue every generic filer. The related lead case (18-cv-1043) ultimately produced the landmark Federal Circuit negative-limitation written-description rulings: a bench trial before Judge Kent A. Jordan (sitting by designation) found the claims valid and infringed (Sept. 11, 2020 final judgment), the Federal Circuit initially affirmed on January 3, 2022 (Novartis Pharms. Corp. v. Accord Healthcare, 21 F.4th 1362), and then on rare panel rehearing reversed on June 21, 2022 (2022 WL 2204163), holding that "silence is generally not disclosure" — the specification's failure to mention loading doses could not support the added "absent an immediately preceding loading dose" limitation. Teva, however, settled this case in March 2019, years before that appellate drama, and its settlement terms were never made public.

Key legal developments & outcome

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

Key Legal Developments — Novartis Pharmaceuticals Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01039-LPS (D. Del.)

Patent at issue: U.S. Patent No. 9,187,405 ("S1P Receptor Modulators for Treating Relapsing-Remitting Multiple Sclerosis") — method claims covering Gilenya® (fingolimod) 0.5 mg/day dosing "absent an immediately preceding loading dose regimen." Presiding judge: Leonard P. Stark. Disposition: Settled/terminated 2019-03-19 (FJC IDB; CourtListener docket 7433584). No trial, no Markman order, no merits opinion.


1. Filing & Initial Pleadings

  • 2016-11-28: Teva/Actavis sent its ANDA No. 208008 Paragraph IV notice letter to Novartis (per the court's ANDA supplemental information; Unified Patents docket).
  • 2017-02-03: Teva and others had already petitioned for IPR of the '405 patent (IPR2017-00854, filed by Apotex; Teva joined later — see §7).
  • 2018-07-13: Novartis filed the complaint (D.I. 1) under 35 U.S.C. § 271(e)(2), asserting infringement of the '405 patent based on Teva's and Actavis Elizabeth LLC's ANDA No. 208008 for generic fingolimod (Gilenya). Strategic note: the suit was filed just two days after the PTAB's Final Written Decision (2018-07-11) upholding claims 1–6 — the complaint expressly relies on that PTAB win. Venue was premised on defendants being Delaware corporations (Ex Parte complaint analysis).
  • 2018-07-18: Case assigned to Judge Stark (associated with related cases 1:18-cv-01038-LPS [Apotex], 1:18-cv-01040-LPS, 1:18-cv-01043-LPS [Accord/HEC]); summonses returned executed on both defendants (answer due 2018-08-08).
  • 2018-08-08: Teva and Actavis Elizabeth LLC filed Answer and Counterclaim (D.I. 9) — asserting non-infringement and invalidity of the '405 patent, plus Rule 7.1 disclosures.
  • 2018-08-29: Novartis answered the counterclaims (D.I. 13).
  • 2018-09-05: Teva pro hac vice counsel appeared (K. Keller, A. Hollis, J. Lefkowitz, G. Springsted, S. Tsou; later J. McConnell).

2. Pre-Trial Motions of Substance

  • No motions to dismiss, transfer, or stay pending IPR appear on the docket. There is no summary-judgment motion either. The docket reflects only scheduling, discovery-dispute letters, and stipulations (CourtListener docket 7433584; Patexia document list).
  • 2018-10-11/12: The parties filed competing discovery/scheduling dispute letters (D.I. 27–30) re: proposed scheduling order, ESI order, and protective order.
  • 2018-10-16: Discovery/scheduling teleconference before Judge Stark.
  • 2018-10-25/26: Case formally associated with lead case 1:18-cv-01043-LPS (Accord/HEC), which later became the test case on the '405 patent's written-description validity.
  • 2018-12-13: Defendants served consolidated invalidity contentions re: the '405 patent (filed by HEC Pharm entities, reflecting the consolidated generic-defense strategy).

3. Claim Construction (Markman)

  • None. The case settled during discovery, before any Markman briefing or hearing. (The PTAB's broadest reasonable interpretation constructions in IPR2017-00854 — e.g., "daily dosage of 0.5 mg" = per-day amount over a multi-day course; preambles limiting — are the only claim-construction rulings on this patent, and they favored Novartis.)

4. Discovery Milestones with Strategic Significance

  • 2018-08-31 / 09-04: Novartis served initial disclosures, accused-product/asserted-patent disclosures, file history, and its First Set of Common RFPs and Interrogatories.
  • 2018-09-17: Defendants served First Joint Interrogatories (Nos. 1–13) and First Joint RFPs (Nos. 1–59); Rule 26(a) and D. Del. Default Standard disclosures.
  • 2018-10-17: Novartis served objections/responses to defendants' first joint discovery.
  • 2019-02-04: Teva stipulated to extend its document-production deadline to 2019-02-28 (D.I. 40); a sealed joint stipulation was filed the same day (D.I. 41, redacted version filed 2019-02-11) — the first public signal of settlement negotiations.
  • 2019-02-06: Judge Stark so-ordered the extension (D.I. 41).
  • 2019-02-28: Second extension for Teva to substantially complete production, to 2019-03-15.
  • 2019-03-04: Teva/Actavis served responses to Novartis's Second Set of Common Interrogatories — the last substantive discovery event before resolution.

5. Trial / Verdict / Post-Trial Motions

  • None. No trial, verdict, JMOL, new-trial motion, or fee motion. The case settled mid-discovery, before trial.

6. Settlement, Dismissal, Judgment — Final Disposition

  • 2019-03-15: Parties filed a [SEALED] Proposed Consent Judgment and Order of Injunction (D.I. 47) — the operative settlement instrument, under which Teva/Actavis presumably agreed to entry of judgment of infringement and an injunction barring launch of ANDA No. 208008 until the '405 patent's expiry (2027-06-25 per the court's ANDA notice) or a future validity ruling, with a license/royalty structure kept confidential.
  • 2019-03-19: Case terminated — disposition "Settled" (FJC IDB; DrugPatentWatch).
  • 2019-03-21: Redacted version of the Proposed Consent Judgment filed.
  • No appeal from the district court in this case. The settlement tracks Novartis's disclosed strategy — it later told analysts that generic competition would begin in 2024 "under settlements reached with other generic makers" (BioPharma Dive).
  • Related-case note: The parallel Accord/HEC case (1:18-cv-01043-LPS) went to trial and judgment for Novartis, was affirmed by a divided Federal Circuit panel on 2022-01-03, then reversed on panel rehearing on 2022-06-21 (Novartis Pharm. Corp. v. Accord Healthcare, Inc.), holding the '405 patent's "absent a loading dose" negative limitation lacked written description. The Supreme Court stayed the mandate (2022). That decision came after this Teva case settled and does not alter this docket's final judgment.

7. Parallel PTAB IPR Proceedings and Their Effect

  • IPR2017-00854 (Apotex Inc./Apotex Corp., filed 2017-02-03) — lead proceeding challenging claims 1–6 of the '405 patent on three grounds (two §103 combinations: Kovarik+Thomson; Chiba+Kappos 2005+Budde; and §102 anticipation by Kappos 2010).
  • IPR2017-01550 (Argentum, filed 2017-06-09), IPR2017-01946 (Actavis Elizabeth/Teva, filed 2017-08-15), and IPR2017-01929 (Sun Pharma, filed 2017-08-16) filed substantively identical petitions with motions for joinder, all granted and joined into IPR2017-00854 with Apotex as lead petitioner. Teva/Actavis were active petitioners in the joined IPR.
  • 2018-07-11 — Final Written Decision, Paper 109: PTAB (APJs Kaiser, Pollock, Sawert) held claims 1–6 not shown unpatentable on all three grounds — the 0.5 mg no-loading-dose regimen was not disclosed or suggested, and the art taught away from low-dose efficacy. This FWD is the direct catalyst for the 2018-07-13 complaint.
  • Federal Circuit appeals from the IPR: Apotex (18-2209), Sun (18-2230), Teva & Actavis (18-2260), Argentum (18-2273). Per the Federal Circuit's decision in Argentum Pharm. LLC v. Novartis Pharm. Corp.: "18-2260 (Teva and Actavis) and 18-2230 (Sun) were dismissed" (Teva's dismissal following this district-court settlement); Apotex settled after argument and its appeal was dismissed; Argentum's appeal was dismissed for lack of Article III standing.
  • Effect on litigation: The PTAB's validity win in July 2018 put Novartis in a strong negotiating posture and prompted the immediate wave of ANDA suits; Teva's post-settlement dismissal of its IPR appeal (18-2260) confirms that the district-court settlement resolved the validity fight for Teva without further merits review.

Bottom Line

This was a short-lived (8-month) ANDA case that never reached claim construction, summary judgment, or trial. Novartis filed suit immediately after the PTAB upheld the '405 patent (FWD 2018-07-11; complaint 2018-07-13); Teva answered with invalidity/non-infringement counterclaims; the parties litigated through initial discovery and consolidated invalidity contentions, then settled — filing a sealed proposed consent judgment and injunction on 2019-03-15 and terminating the case as settled on 2019-03-19. The settlement was part of Novartis's industry-wide resolution of Gilenya ANDA challenges; it mooted Teva's IPR appeal (18-2260), and the '405 patent's ultimate fate was instead decided (adversely to Novartis) years later in the separate Accord/HEC case (1:18-cv-01043-LPS), which Teva's settlement predated.

Sources: CourtListener docket 7433584 (D. Del. PACER/RECAP); FJC IDB; Unified Patents portal; Ex Parte complaint analysis; PTAB IPR2017-00854 Final Written Decision (Paper 109, entered 2018-07-11); Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp. (Fed. Cir.); Jones Day PTAB Litigation Blog (2018-07-30); IPWatchdog (2022-06-21); BioPharma Dive (2022). Caveat: the settlement's financial terms and the final consent judgment are under seal; no docket entry confirms a formal motion-to-dismiss or transfer, and no such motion was found in the public docket.

In the news

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

Plaintiff representatives

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

Counsel of Record for Plaintiff Novartis Pharmaceuticals Corp. — Novartis Pharms. Corp. v. Teva Pharms. USA, Inc., No. 1:18-cv-01039-LPS (D. Del.)

Novartis was represented by a two-tier team standard for Delaware ANDA litigation: Gibson, Dunn & Crutcher LLP as national lead/pro hac vice counsel and McCarter & English, LLP as Delaware local counsel. This is confirmed by the docket (pro hac vice motion D.I. 6, filed 7/23/2018 and so-ordered by Judge Stark on 7/24/2018; CourtListener docket 7433584), the UniCourt party-attorney listing, and the signature blocks on parallel-case filings in the coordinated Gilenya actions (e.g., 18-cv-1040, Sun Pharma; paragraphfour.com PDF), which show the identical team.

National lead counsel — Gibson, Dunn & Crutcher LLP (pro hac vice, admitted 7/24/2018)

  • Jane M. Love, Ph.D. — Lead counsel / first-chair. Partner and Chair of Gibson Dunn's Life Sciences and IP Litigation practices, New York office (200 Park Avenue). She was Novartis's lead counsel in the Gilenya® ANDA campaign against multiple generic filers and lead counsel in the PTAB IPR defending the '405 patent (IPR2017-00854, which Novartis won); the National Law Journal named her a 2020 Health Care/Life Science Trailblazer specifically for the Gilenya work, and Law360 named her a Life Sciences MVP (2017, 2019, 2021). She was formerly Co-Vice Chair of the IP Department at WilmerHale, where she first handled Novartis's Gilenya matters (2015 PTAB filings list her at WilmerHale).
  • Robert W. Trenchard — Co-lead counsel. Partner, Gibson Dunn New York. Per his firm bio, he "co-led the team with partner Dr. Jane Love" in the successful PTAB trial on the dosing method-of-use patent and the ensuing Delaware litigation "against 23 ANDA filers" (including the preliminary injunction against launch-at-risk generics).
  • Paul E. Torchia — Partner, Gibson Dunn New York; appears in the same pro hac vice motion (D.I. 6) and on all Novartis signature blocks in the coordinated cases (e.g., 18-cv-1040 filings); Hatch-Waxman/IP litigator.
  • Andrew P. Blythe — Partner, Gibson Dunn Los Angeles (333 South Grand Avenue); admitted pro hac vice in the same order; appears on the Novartis signature blocks throughout the Gilenya cases.

Delaware local counsel — McCarter & English, LLP (405 N. King St., 8th Floor, Wilmington, DE)

  • Daniel M. Silver (Bar No. 4758) — Principal local counsel and the CM/ECF filing attorney for Novartis; signed the complaint, the pro hac vice motion, all discovery notices, and the joint letters to Judge Stark (D.I. 12, 27, 29, 33, 36, etc.). He is a partner and Wilmington office Co-Managing Partner at McCarter & English, specializing in Hatch-Waxman/BPCIA litigation for innovator plaintiffs (IAM Patent 1000-ranked). The Ex Parte complaint analysis lists "Plaintiff's Counsel: McCarter & English, LLP," consistent with his role.
  • Michael P. Kelly — Partner, McCarter & English, Wilmington; listed as plaintiff's counsel on the UniCourt docket for this case; the same Kelly/Silver/Smyth trio appeared for Novartis in the earlier Gilenya ANDA case Novartis AG v. Ezra Ventures, LLC, No. 15-150-LPS (D. Del.).
  • Benjamin A. Smyth — Partner, McCarter & English, Wilmington; listed as plaintiff's counsel on the UniCourt docket for this case.

Notes and caveats

  • In-house counsel: No Novartis in-house attorney appears as counsel of record on the public docket for this case; the litigation was run entirely by outside counsel.
  • No subsequent substitutions: Because the case settled in March 2019 (consent judgment, D.I. 47–48; terminated 3/19/2019), this team remained counsel of record through termination; no withdrawal or substitution entries appear on the docket.
  • Teva's side (for completeness): Defendants Teva/Actavis were represented by Karen E. Keller and Nathan Hoeschen (Young Conaway Stargatt & Taylor, Wilmington) as local counsel, with pro hac vice appearances by Amanda Hollis, Jay P. Lefkowitz, Gregory Springsted, Sarah K. Tsou (Kirkland & Ellis), and James H. McConnell.

Sources: CourtListener docket 7433584 (D.I. 6 pro hac vice motion; filings signed by Silver); UniCourt case page (pc-db1-807449) listing Smyth, Silver, Kelly, Blythe, Love for plaintiff; Patexia document list (doc. 6, 7/23/2018, pro hac vice for Love, Trenchard, Torchia, Blythe); Gibson Dunn attorney bios (Love, Trenchard); paragraphfour.com ANDA filing for 18-cv-1040 (signature block with Love, Trenchard, Torchia, Blythe, Gibson Dunn); casemine opinion in Novartis AG v. Ezra Ventures, No. 15-150-LPS (Kelly, Silver, Smyth of McCarter & English as Delaware counsel). Note: the pro hac vice order (D.I. 6, so-ordered 7/24/2018) does not distinguish "lead" vs. "of counsel" roles, so role labels reflect the firms' own billing of the engagement (Love/Trenchard as co-leads) and the docket's filing patterns rather than a court designation.

Defendant representatives

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

Counsel of Record for Defendants Teva Pharmaceuticals USA, Inc. and Actavis Elizabeth LLC

Source basis: Docket entries in 1:18-cv-01039-LPS (D. Del.), CourtListener docket 7433584 / UniCourt / Unified Patents portal; PHV motions D.I. 16, 17, 32; Answer & Counterclaim D.I. 9; Rule 26(a) notice of service (D.I. 20, filed by Hoeschen); Shaw Keller LLP signatures on parallel Teva filings (e.g., Novartis v. Teva, 1:17-cv-00393-RGA D.I. 13; Novartis v. Teva Dev., Inc., D. Del. filings); Ex Parte attorney profile for Sarah K. Tsou; Shaw Keller LLP firm bio.

The defendants' docket appearances were split between Delaware local counsel (Shaw Keller LLP) and out-of-state pro hac vice counsel (Kirkland & Ellis LLP) — the standard Delaware ANDA-litigation structure.

Delaware local counsel — Shaw Keller LLP (I.M. Pei Building, 1105 N. Market St., 12th Fl., Wilmington, DE)

Attorney Role Experience note
Karen E. Keller (Bar No. 4489) Lead Delaware counsel for Teva/Actavis; signed the Answer & Counterclaim (D.I. 9, 8/8/2018) and filed the defendants' PHV motions (D.I. 16, 17, 32) Co-founder/Managing Partner of Shaw Keller LLP; former Young Conaway litigator; registered patent attorney (B.S. biochemistry); Chambers/IAM Patent 1000-ranked Delaware IP trial lawyer with an extensive Teva ANDA docket (e.g., Bayer v. Teva, 1:16-cv-01221-LPS; Vanda v. Teva, 1:18-cv-00651)
Nathan R. Hoeschen (Bar No. 6232) Delaware counsel; served defendants' Rule 26(a) and Default Standard disclosures (notice filed by Hoeschen); added for electronic noticing Shaw Keller LLP partner/associate; regular Teva Delaware local counsel across Hatch-Waxman matters

Note: John W. Shaw (No. 3362) and David M. Fry (No. 5486) of Shaw Keller were co-counsel on Teva's Delaware filings in contemporaneous cases (e.g., the Feb. 2018 stipulation in 1:17-cv-00393 lists Shaw, Keller, Fry, and Hoeschen for Teva). The signature block of D.I. 9 in this case is not publicly reproduced in the docket snippets I retrieved, so I cannot independently confirm whether Shaw/Fry also signed the Answer — but they were part of the firm's standing Teva team.

Pro hac vice counsel — Kirkland & Ellis LLP (admitted under D.I. 16, 17, 32)

Attorney Role Firm / office (at the time) Experience note
Jay P. Lefkowitz PHV counsel for Teva/Actavis (D.I. 16, granted 9/5/2018) Kirkland & Ellis LLP — New York Kirkland appellate/IP partner and former White House official; led Teva/Actavis's '405 patent IPR challenges and Hatch-Waxman defense; also known for high-profile appellate and constitutional litigation
Amanda Hollis PHV counsel for Teva/Actavis (D.I. 16) Kirkland & Ellis LLP Kirkland IP litigator on the Teva/Actavis IPR and ANDA team
Gregory Springsted PHV counsel for Teva/Actavis (D.I. 16) Kirkland & Ellis LLP Kirkland IP litigator, part of the Teva/Actavis fingolimod defense team
Sarah K. Tsou PHV counsel for Teva/Actavis (D.I. 17, corrected 9/5/2018) Kirkland & Ellis LLP (confirmed by Ex Parte profile listing her on this case) Kirkland patent litigator; also active in PTAB/IPR work for Teva
James H. McConnell PHV counsel for Teva/Actavis (D.I. 32, granted 10/18/2018; added for electronic noticing 10/22/2018) Kirkland & Ellis LLP — New York Senior Kirkland IP partner with a long record of ANDA/Hatch-Waxman and PTAB litigation

Firm-affiliation caveat: The PHV motions (D.I. 16/17/32) as reproduced in the public docket snippets do not display the movants' firm letterhead; I have attributed the out-of-state counsel to Kirkland & Ellis based on (a) Sarah K. Tsou's Ex Parte attorney profile (which lists Kirkland & Ellis LLP in connection with this case), and (b) the well-documented fact that Lefkowitz, Hollis, Springsted, and McConnell were Kirkland & Ellis partners/associates during 2018–2019 and represented Actavis Elizabeth/Teva in the parallel IPR proceedings (IPR2017-01946). If you need formal verification of the firm letterhead, D.I. 16/17/32 attachments on PACER/RECAP would confirm.

Other attorneys appearing on this docket (consolidated-cases context — not Teva's counsel)

  • John C. Phillips, Jr. — Phillips, Goldman, McLaughlin & Hall, P.A. (Wilmington) — filed the consolidated "Defendants' Response to Plaintiff's Opening Discovery Dispute Letter" docketed in this case (D.I. 28, 30). Because the four Gilenya ANDA actions (18-cv-1038/1039/1040/1043) were consolidated for pretrial purposes with 18-cv-1043 as lead, these letters were filed across all four dockets; Phillips was the Delaware counsel for the Accord/HEC defendants in the lead case (18-cv-1043), not for Teva/Actavis. I could not confirm any Teva-specific appearance by Phillips, so he should not be treated as Teva's counsel of record.
  • Stamatios Stamoulis — Stamoulis & Weinstein LLP (Wilmington) — filed the notice of service of the "Defendants' Consolidated Invalidity Contentions" (D.I. 39, 12/13/2018), but the notice identifies the HEC Pharm entities (lead case defendants) as the serving parties, again reflecting the consolidated structure rather than a Teva appearance.

In-house counsel

No Teva or Actavis in-house attorney appears of record on the public docket for this case (the case settled during discovery, before any filings that would surface in-house counsel). If Teva in-house counsel (e.g., in Teva's Parsippany/North Wales legal department) participated in settlement negotiations, that involvement is not reflected in the court record.

Bottom line

Teva Pharmaceuticals USA, Inc. and Actavis Elizabeth LLC were represented by Shaw Keller LLP (Wilmington) — Karen E. Keller (lead Delaware counsel) and Nathan R. Hoeschen — plus Kirkland & Ellis LLP pro hac vice counsel Jay P. Lefkowitz, Amanda Hollis, Gregory Springsted, Sarah K. Tsou, and James H. McConnell. The case settled (consent judgment, D.I. 47, 3/15/2019; terminated 3/19/2019) before any trial or Markman proceedings, and the defendants' post-settlement dismissal of their IPR appeal (Fed. Cir. No. 18-2260) confirms the Kirkland team's role in resolving the parallel PTAB fight. No filings in this case are sealed in a way that would hide additional counsel of record — the only sealed items are the settlement stipulation/consent judgment (D.I. 41, 47), which would not typically contain counsel lists beyond those already on the docket.