Helsinn Healthcare S.A. v. Gland Pharma Limited

I'll research this case thoroughly before drafting the overview.

Let me gather patent titles, the judge/venue details, and parallel litigation/IPR context.

Overview & Background

The parties. Plaintiff Helsinn Healthcare S.A. is a privately held Swiss specialty-pharmaceutical company (Lugano, Switzerland) — an innovator/operating company, not an NPE or PAE. It is the holder of NDA No. 210493 for Akynzeo® for Injection (IV fosnetupitant chloride hydrochloride/palonosetron hydrochloride) and of NDA No. 021372 for Aloxi® (palonosetron injection), and it is the assignee of the ten patents asserted here. Helsinn's U.S. commercial presence and its long history of ANDA enforcement in the District of New Jersey (e.g., Helsinn v. Sagent, Helsinn v. Dr. Reddy's, Helsinn v. Sandoz) are the practical reason this case landed there. Defendant Gland Pharma Limited is an Indian sterile-injectables manufacturer headquartered in Hyderabad and listed in India (majority-owned by Shanghai Fosun Pharmaceutical since 2017 — I flag this ownership point as widely reported background rather than something stated in the pleadings). Gland is a serial ANDA defendant in D.N.J.: Helsinn's own complaint (Doc. 1, ¶ 10) lists seven earlier or then-pending D.N.J. actions Gland had defended or in which it had consented to jurisdiction, including La Jolla Pharma v. Gland, Aerie v. Gland, Fresenius Kabi v. Gland, Merck v. Gland, Chiesi v. Gland, and Medicare Int'l v. Gland.

The accused product and the asserted patents. Helsinn sued after receiving two paragraph IV notice letters — one dated June 2, 2022 covering nine patents, and a second dated July 11, 2022 covering the then-just-issued '698 patent — regarding Gland's ANDA No. 217374, which seeks approval for generic EQ 11.75 mg/mL fosnetupitant chloride hydrochloride and 0.0125 mg/mL palonosetron hydrochloride, 235 mg/0.25 mg per 20 mL single-dose IV vials — i.e., a generic of the Akynzeo IV to-be-diluted/ready-to-use product. The ten patents divide into three functional clusters (titles are from the complaint exhibits and Gland's answer; the technical sketches are my one-line characterizations of the titles/claims): the fosnetupitant compound/prodrug family — U.S. 8,426,450 ("Substituted 4-phenyl pyridines having anti-emetic effect," listed as drug substance), 9,403,772 ("4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tolyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium as a neurokinin receptor modulator"), 9,908,907 and 10,717,721 (both "Substituted piperaziniums for the treatment of emesis"), and 11,312,698 ("Fosnetupitant chloride hydrochloride having improved stability"); the method-of-use/CINV family — 8,895,586 ("Methods of treating emesis"), 9,186,357 and 10,828,297 (both "Compositions and methods for treating centrally mediated nausea and vomiting," with the '297 issuing November 10, 2020 and claimed to cover prevention of acute and delayed CINV); and the IV formulation/combination family — 10,208,073 (solution of the fosnetupitant chloride hydrochloride salt with palonosetron HCl in combination with dexamethasone) and 10,624,911 ("Physiologically balanced injectable formulations of fosnetupitant"). Third-party Orange Book trackers (DrugPatentWatch, GreyB) list the '450, '586, '772, '907, '073, '721 and '698 patents with a nominal May 23, 2032 expiration (likely including term extension), the '357 patent at November 18, 2030, and the '911 patent as the long pole at roughly June 2, 2037 — treat those dates as database-derived approximations, not court findings.

Posture, venue, and why it matters. The complaint was filed July 18, 2022 as Civil Action No. 3:22-cv-04635-ZNQ-JBD (you will see "2:22-cv-04635" in Gland's counterclaims and in some aggregators like UniCourt and drugpatentwatch — that appears to be a scrivener's error, since the pleadings and orders all bear the 3:22-cv number). It was assigned to Judge Zahid N. Quraishi, initially referred to Magistrate Judge Lois H. Goodman ("LHG" in the caption) and later to Magistrate Judge J. Brendan Day ("JBD"). Venue was predicated on Gland being a foreign defendant suable in any district where it is subject to personal jurisdiction (28 U.S.C. §§ 1391(c)(3), 1400(b)), with Helsinn alternatively pleading Gland's systematic New Jersey contacts and its repeated consent to D.N.J. jurisdiction. Gland answered and counterclaimed on October 11, 2022 (Doc. 25), pleading 20 counterclaims — paired non-infringement and invalidity declarations for each patent, invoking §§ 101, 102, 103, 112, 116, § 282(b) defenses and double patenting, and citing prior art such as the ALOXI and EMEND labels, Bös, WO '846, DeGoey, Funk, Krise I, Oslob and Dewan; it also asserted prosecution history estoppel. Helsinn replied (Doc. 31). The case ended without any merits ruling: the parties submitted a consent judgment (Docs. 45/48), and on January 18–19, 2023 Judge Quraishi entered the Consent Judgment and Dismissal Order (Doc. 50), in which Gland admitted that submitting ANDA No. 217374 with paragraph IV certifications was a technical act of infringement under 35 U.S.C. § 271(e)(2)(A), did not rebut the statutory presumption of validity (expressly without prejudice to its invalidity defenses), and was enjoined from manufacturing/using/selling/importing the ANDA product until a redacted date; all claims, counterclaims and affirmative defenses were dismissed. Two wrinkles worth flagging: (1) the docket text of Doc. 50 reads "dismissed with prejudice," while the publicly posted order language reads "without prejudice" — this may reflect the difference between the publicly filed proposed judgment (Doc. 48) and the entered/sealed version (Doc. 45), and I cannot fully reconcile it from public sources; and (2) on July 6, 2023 Magistrate Judge Day granted a motion to seal (Doc. 49), ordering that the parties' letter (Doc. 43) and the consent judgment (Doc. 45) remain under seal — so the actual entry date and license terms are confidential. Termination-date records also diverge (the case metadata says January 19, 2023; drugpatentwatch says December 23, 2022), most likely a docket-flag versus order-entry artifact.

As for significance, the case is a textbook illustration of three things. First, it is ordinary brand-versus-generic Hatch-Waxman litigation, not NPE activity — the plaintiff both invented and commercializes the drug, so it sits outside the patent-assertion-entity narrative even though it dominates the ANDA docket. Second, it shows the "late-issuing patent" playbook: the '698 patent issued April 26, 2022, after Gland's first paragraph IV notice, forcing a second notice letter and a second round of certification — a recurring friction point in ANDA practice. Third, it illustrates sealed settlements with redacted market-entry dates in the sterile-injectables space, which is why the case appears in quarterly ANDA-settlement surveys and why the entry date is not publicly knowable. Market context matters here: Akynzeo IV is part of Helsinn's core 5-HT3/NK-1 antiemetic franchise, and Helsinn has been unusually active in defending it — in the Sagent enforcement briefing Helsinn itself is described as having "filed infringement actions against at least fifteen other ANDA sponsors" beyond Teva, Dr. Reddy's, Sandoz and Sagent in its Aloxi litigation, and it litigated the Aloxi patents all the way to the Supreme Court in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 586 U.S. 731 (2019) (the "secret sale" on-sale-bar case) — a different patent family, but the same enforcement posture. On the IPR linkage the record is thinner: PTAB materials show challenges implicating these Helsinn prodrug/CINV patents (e.g., argument over whether netupitant is an "active ingredient" of Akynzeo for Injection and whether claim 4 of the '357 patent reaches the prodrug, plus a request for information answered in April 2019), and Azurity Pharmaceuticals has petitioned for inter partes review of the related (but not here-asserted) U.S. 9,943,515 patent — so the family has drawn PTAB attention even though no IPR was filed against the ten patents in this case before it settled. I could not verify an IPR petition specifically against any of the ten asserted patents from public sources; any claim that one exists would be speculation.

Primary sources: Consent Judgment and Dismissal Order text, https://paragraphfour.com/wp-content/uploads/2022/07/njdc22cv4635CJ.pdf; CourtListener docket, https://www.courtlistener.com/docket/63601016/helsinn-healthcare-sa-v-gland-pharma-limited/ (Docs. 1, 25, 31, 43, 45, 48, 49, 50); complaint and counterclaims at https://storage.courtlistener.com/recap/gov.uscourts.njd.[499051](/patent/499051)/; DrugPatentWatch case page, https://www.drugpatentwatch.com/p/litigation/casename/index.php?query=HELSINN+HEALTHCARE+S.A.+v.+GLAND+PHARMA+LIMITED%7c3%3a22-cv-04635.

I'll research this case through the docket, PTAB records, and legal news sources.

Let me pull the full docket and related PTAB records.

Let me get the full docket sequence and the PTAB proceeding details.

Helsinn Healthcare S.A. v. Gland Pharma Ltd., No. 3:22-cv-04635 (ZNQ) (D.N.J.)

Bottom line: This was a five-month Hatch-Waxman case that never reached a substantive ruling of any kind. It went complaint → answer/counterclaims → answer to counterclaims → scheduling order → sealed consent judgment, with no Rule 12 motion, no transfer motion, no IPR stay motion, no Markman, no summary judgment, no discovery, and no trial. The public consent judgment (D.I. 50) is the only merits-adjacent document, and it expressly disclaims any adjudication.

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1. Filing and initial pleadings

The product and the patents. The ANDA product is EQ 11.75 mg/mL fosnetupitant chloride hydrochloride / 0.0125 mg/mL palonosetron hydrochloride, 235 mg/0.25 mg per 20 mL single-dose vial for IV infusion — the generic of AKYNZEO® for injection (NDA No. 210493, approved 2018-04-19; fosnetupitant is the prodrug of netupitant; the '698 patent issued 2022-04-26 and the '297 on 2020-11-10, which is why it took two notice letters to cover all ten).

Gland's counterclaims (D.I. 25) were the standard Hatch-Waxman DJ pair — a declaration of non-infringement and a declaration of invalidity for each of the ten patents, plus prosecution history estoppel. The invalidity theories were § 103 obviousness premised on a defined prior-art set — Bös (U.S. 6,479,483), WO 99/33846, DeGoey (J. Med. Chem. 2009), Funk (U.S. 7,211,579), Krise I (J. Med. Chem. 1999), Oslob (Bioorg. Med. Chem. Lett. 2009), the ALOXI® label, the EMEND® label, and Dewan (Indian Pediatrics 2010) — together with § 112 indefiniteness and enablement attacks on (i) the "pharmaceutically acceptable salt" limitations and (ii) the "treating"/"acute and delayed CINV" limitations. These contentions are mirrored in Gland's June 2 and July 11, 2022 notice letters. Helsinn's answer (D.I. 31) admitted receipt of the letters but denied that they contained "a detailed statement of the factual and legal bases" — a foreshadowing of a § 355(j)(2)(B)(iv) / 180-day-exclusivity fight that was never litigated.

Note on the case number: the complaint and docket are 3:22-cv-04635; Gland's counterclaims and some third-party databases cite "2:22-cv-04635." Same case (the "2" is the pre-vicinage/CM-ECF artifact).

2. Pre-trial motions of substance — none

I found no docket entry for a motion to dismiss, motion to transfer, motion for a more definite statement, motion to stay pending IPR, or summary judgment motion. The only "motions" of any kind on the docket are sealing motions (D.I. 49, granted 2023-07-06) and the pro hac vice applications. Practically, the window for such a motion never opened: the answer was filed 2022-09-16 and the case settled on 2022-12-23.

3. Claim construction (Markman) — never reached

No Markman order, no joint claim construction statement, no Local Patent Rule exchange appears on the docket. The 2022-12-02 scheduling order (D.I. 38) still set a telephone conference for 2023-01-31 and put fact discovery out to 2024-02-24 with dispositive motions due in late 2024 — i.e., the case was on a multi-year track when it settled three weeks later.

4. Discovery milestones — effectively none

The only discovery-related activity is a chain of extensions for the Discovery Confidentiality Order:

• 2022-12-06 (D.I. 39) / 2022-12-08 (D.I. 40) — DCO deadline extended two weeks, to 2022-12-21
• 2022-12-21 (D.I. 41) / 2022-12-22 (D.I. 42) — DCO deadline extended again, to 2023-01-04

Strategically, this is the tell: the DCO was never entered and no discovery was taken. Helsinn obtained its § 271(e)(2)(A) admission and an injunction without a single document produced or deposition taken. A defense-side invalidity case built on a well-developed prior-art record (Bös, DeGoey, Krise, Oslob) never got into the record.

5. Trial, verdict, post-trial motions — none

No trial, no verdict, no JMOL/new-trial motion, no § 285 fee motion, no appeal. The case was dismissed with prejudice short of the pleadings stage.

6. Disposition: sealed settlement, public consent judgment

Terms of the consent judgment (D.I. 50), which is the operative document:

1. All claims and counterclaims dismissed with prejudice.
2. Gland admits a "technical act of infringement" of all ten Helsinn patents under 35 U.S.C. § 271(e)(2)(A) by filing ANDA No. 217374.
3. Gland "has not rebutted the statutory presumption" that the patents are valid and enforceable — expressly without prejudice to its invalidity defenses in future cases.
4. Gland is enjoined from making/using/selling/offering for sale/importing the ANDA product until a redacted date; the launch date, license terms, and any royalty are not public.
5. Paragraph 3 confirms the court made "[n]o decision … regarding these charges of infringement or these defenses and counterclaims."

Practical effect: the 30-month stay was superseded by the judgment, and the redacted entry date in the injunction is the de facto generic-launch date — the standard resolution of an ANDA case where the brand is confident enough to extract an admission but unwilling to litigate validity. Because the dismissal was with prejudice and by consent, there is no appealable judgment and no Federal Circuit decision.

7. Parallel PTAB proceedings

During the litigation (2022-2023): none. No IPR or PGR was filed on any of the ten asserted patents by Gland or anyone else while this case was pending. That is why there is no stay motion and no Fintiv-type dispute on this docket. (Contrast Helsinn's long-running palonosetron/ALOXI litigation against Teva, Sandoz, and Dr. Reddy's, which produced the Helsinn v. Teva, 855 F.3d 1356 (Fed. Cir. 2017) / 139 S. Ct. 628 (2019) on-sale-bar line of cases — a different patent family, and not part of this case.)

Later, unrelated, and non-parallel PTAB activity on overlapping patents. On/about 2025-05-01, Azurity Pharmaceuticals, Inc. (an aprepitant/anti-nausea competitor, not Gland and not a party to this case) petitioned for IPR against several Helsinn patents, including at least:

• IPR2025-00949 — U.S. 10,828,297 — a patent asserted in this case. Public filings show a Joint Stipulation to Revise Due Dates 1–3 dated 2026-02-10 (Due Date 1 moved to 2026-02-25, Due Date 2 to 2026-06-03, Due Date 3 to 2026-07-15), which strongly implies the Board instituted trial, with a final written decision likely in late 2026. I could not retrieve the institution decision itself; treat the institution as an inference from the docketed scheduling documents. Patent Owner's counsel of record is Eric W. Dittmann; Petitioner's counsel includes Wilson Sonsini (Torczon, Mills, Rosato, Devine).
• IPR2025-00945 — U.S. 8,623,826 — Patent Owner filed a Discretionary Denial Brief on 2025-08-04 arguing Fintiv-type settled expectations (§ 325(d) and compelling-merits arguments). The '826 patent is not among the ten patents asserted in Helsinn v. Gland (it appears in third-party databases such as DrugPatentWatch as an Akynzeo-family patent, not in the D.I. 50 list).
• A further Azurity petition on U.S. 9,186,357 (asserted here) appears in the DrugPatentWatch PTAB listings with the same 2025-05-01 filing date.

Effect on this litigation: none. These petitions postdate the January 2023 dismissal by roughly 2.5 years, so they neither stayed nor influenced this case. Their significance is portfolio-level: they are the first PTAB challenges to the fosnetupitant IV Akynzeo patents and, if instituted and successful as to the '297, would matter to other ANDA defendants and to Helsinn's Orange Book listing — but Gland's consent judgment and injunction stand on their own.

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Chronology at a glance

| 2022-06-02 | Gland ¶IV notice letter (9 patents) |
| 2022-07-11 | Gland ¶IV notice letter ('698) |
| 2022-07-18 | Helsinn complaint, D.I. 1 (10 patents) |
| 2022-09-16 | Gland Answer + counterclaims, D.I. 18 |
| 2022-10-11 | Gland Amended Answer + 20 counterclaims, D.I. 25 |
| 2022-10-25 | Helsinn Answer to counterclaims, D.I. 31 |
| 2022-12-02 | Pretrial scheduling order, D.I. 38 (fact discovery to 2024-02-24) |
| 2022-12-23 | Consent judgment/order of dismissal, D.I. 44–45 (case closed) |
| 2023-01-18/19 | Public Consent Judgment and Dismissal Order, D.I. 50 |
| 2023-07-06 | Sealing order — D.I. 43, 45 stay under seal |
| 2025-05-01 | Azurity IPR petitions filed against '297, '826, '357 |
| 2026-02-10 | Due-date stipulation in IPR2025-00949 ('297) |

Gaps and caveats

• The launch/entry date in ¶ 5 of the consent judgment and all settlement economics are redacted and sealed; no public source discloses them.
• I reviewed docket entries roughly D.I. 18–50 through CourtListener/RECAP, Patexia, DrugPatentWatch and ParagraphFour. Entries D.I. 1–17 (summons, corporate disclosure, scheduling conference, any extension of the answer deadline) were only partially visible; I found no indication of any substantive motion there, but I cannot rule out a short extension of the answer date.
• The IPR2025-00949 institution decision and the precise disposition of IPR2025-00945 are not verified — I am inferring institution in the former from the 2026-02-10 due-date stipulation.
• Counsel: Helsinn was represented by Charles M. Lizza (Saul Ewing, Newark) and, per third-party databases, Paul Hastings LLP (Isaac S. Ashkenazi); Gland by James Richter (New Jersey) with out-of-state counsel admitted pro hac vice. I did not confirm the full appearance list from PACER.
• The parallel D.N.J. case Bausch/Salix/Progenics/Wyeth v. Gland, No. 22-00939 (different patents, different plaintiffs) is sometimes confused with this one; it is not this case.

I'll research the counsel of record for Helsinn Healthcare in this case.

Let me dig into the docket and verify each attorney.

Counsel of Record — Plaintiff Helsinn Healthcare S.A.

Helsinn Healthcare S.A. v. Gland Pharma Limited, No. 3:22-cv-04635 (ZNQ)(LHG) (D.N.J.) — closed by consent judgment/dismissal, Jan. 2023

I verified the plaintiff's team from the complaint signature block (D.I. 1) and the docket (D.I. 10, 14–17, 21, 31, 43) on the RECAP/CourtListener docket for this case, plus the civil cover sheet (D.I. 1-2). Sources noted per attorney. Note: PACER itself is paywalled and I relied on RECAP mirrors and document images; where a fact is inferred rather than stated in a filing, I say so.

Lead / national counsel — Paul Hastings LLP (New York, NY)

Local counsel — Saul Ewing (Newark, NJ)

Notes, caveats, and things I could not confirm

• No in-house counsel appeared. Helsinn Healthcare S.A. is a Swiss entity (Lugano); no Helsinn legal-department attorney is identified in any docket entry or signed filing I reviewed.
• No separate "of counsel" designation exists on this docket. The plaintiff's side is a two-firm structure: Paul Hastings (New York) as national/lead counsel, Saul Ewing (Newark) as local counsel, with Rupert, Weir, and Meuth formally admitted pro hac vice (D.I. 14, Aug. 12, 2022; NEF notices D.I. 15–17).
• William C. Baton (Saul Ewing) appears with Lizza on Helsinn's behalf in other Aloxi matters, but I did not confirm his appearance in this docket, so I have not listed him as counsel of record here.
• Counsel appearing Nov. 2022 (D.I. 33, Jieun Lee PHV order) is, based on the sequence of filings (Gland's consent letter, D.I. 30), defendant-side counsel, not plaintiff's — flagged only so the name isn't misattributed. Similarly, Gland's D.N.J. local counsel on this docket was Midlige Richter LLC (James S. Richter, who filed the answer/counterclaim, D.I. 18, 25), with out-of-state PHV counsel Imron T. Aly, Bradford C. Frese, and John K. Hsu (D.I. 26, 27–29).
• One stray data point to disregard: a confidentiality order in a different D.N.J. docket (gov.uscourts.njd.551735, D.I. 117) lists Hill Wallack LLP and Wiley Rein LLP as "Attorneys for Defendant Gland Pharma Ltd." I could not tie that docket to this case, and the docket I verified for 3:22-cv-04635 (PACER case ID njd-499051) shows different defense counsel. Don't use the Hill Wallack/Wiley Rein names for this case without checking.
• Case is closed. Consent Judgment and Dismissal Order entered Jan. 18–19, 2023 (signed by Judge Zahid N. Quraishi); Gland admitted technical infringement under 35 U.S.C. § 271(e)(2)(A). The docket is short (~50 entries, no trial), so the counsel list above is likely complete.

Key sources:

• Complaint signature block (D.I. 1): https://storage.courtlistener.com/recap/gov.uscourts.njd.499051/gov.uscourts.njd.499051.1.0.pdf
• Civil cover sheet listing Charles M. Lizza: https://www.courtlistener.com/docket/63601016/1/2/helsinn-healthcare-sa-v-gland-pharma-limited/
• Docket (PHV orders, corporate disclosure, plaintiff's answer to counterclaim at D.I. 31): https://www.courtlistener.com/docket/63601016/helsinn-healthcare-sa-v-gland-pharma-limited/
• Patexia docket index (D.I. 10, 14–17, 21, 30, 33, 37, 39, 43): https://services.patexia.com/lawsuits/HELSINN-HEALTHCARE-SA-v-GLAND-PHARMA-LIMITED-id-[165458](/patent/165458)/documents
• Melanie Rupert bio: https://www.paulhastings.com/professionals/melanierupert
• Charles Lizza experience page: https://www.saul.com/professionals/charles-m-lizza/experience
• Helsinn/Azurity IPR filings (Dittmann lead counsel; Ashkenazi back-up): USPTO PTAB IPR2025-00945/947/948 papers
• Consent Judgment text: https://paragraphfour.com/wp-content/uploads/2022/07/njdc22cv4635CJ.pdf

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

Let me examine the docket sheet and the answer/counterclaim signature blocks directly.

Let me pull the docket entries and confirm appearances/pro hac vice admissions.

Counsel of Record for Defendant Gland Pharma Limited

Gland was represented by a two-firm team: a New Jersey local-counsel boutique that signed and filed everything on the docket, and a national Hatch-Waxman/patent trial team from ArentFox Schiff LLP (Chicago and Washington, D.C.) admitted pro hac vice. All of the below is drawn from the signature blocks and appearance entries in the docket itself (Dkt. 25, 30, 33, 49, 50), not from a firm press release.

Local counsel (D.N.J.) — signs and files for Gland

James S. Richter — local counsel (the only Gland attorney whose CM/ECF signature appears on the substantive filings)

• Firm/office: Midlige Richter LLC, 645 Martinsville Road, Basking Ridge, NJ 07920; (908) 626-0622; jrichter@midlige-richter.com
• Docket anchors: Signed the Amended Answer, Affirmative Defenses and Counterclaims (Dkt. 25, dated Oct. 11, 2022) as "Attorneys for Defendant, Gland Pharma Limited"; filed the Oct. 20, 2022 letter seeking pro hac vice admission of Jieun Lee with a declaration of James Richter (Dkt. 30); filed Gland's Jan. 18, 2023 motion to seal with the Declaration of James Richter (Dkt. 49); signed the parties' stipulation reflected in the Consent Judgment (Dkt. 45/50).
• Note: He is the New Jersey counsel of record throughout Gland's D.N.J. ANDA docket and handled Gland's sealing motion; consistent with D.N.J. L.Civ.R. 101.1(c), which permits only local counsel to sign and file papers and enter appearances. I could not independently verify a detailed published biography of Mr. Richter in this research session — treat the one-line characterization as based on his docket role, not a firm bio.

Lead / national counsel — ArentFox Schiff LLP (admitted pro hac vice)

Imron T. Aly — lead trial counsel (listed first, "Of Counsel" block, and the name carried on Gland's filings; § 271 defense-side ANDA specialist)

• Firm/office: ArentFox Schiff LLP, 233 S. Wacker Drive, Suite 7100, Chicago, IL 60606; (312) 258-5500; imron.aly@afslaw.com
• Docket anchors: Named in the Dkt. 25 signature block as "pro hac vice forthcoming"; admitted pro hac vice by order entered Oct. 13, 2022 (along with Frese and Hsu); NEF request filed Oct. 17, 2022 (Dkt. 28); listed on the Consent Judgment signature block (Dkt. 45/50).
• Note: Partner and Executive Committee member at ArentFox Schiff (formerly Schiff Hardin, which merged into Arent Fox in March 2022); a first-chair ANDA trial lawyer (see, e.g., Hospira v. Fresenius Kabi — LMG Life Sciences Hatch-Waxman Impact Case of the Year, 2020 — and the palonosetron matter Helsinn v. Fresenius Kabi), and counsel for Gland in multiple other D.N.J. ANDA suits.

John K. Hsu — of counsel (national team, government-contracts/patent litigation)

• Firm/office: ArentFox Schiff LLP, 1717 K Street NW, Washington, DC 20006; (202) 857-6000; john.hsu@afslaw.com
• Docket anchors: Dkt. 25 "Of Counsel" block ("pro hac vice forthcoming"); admitted Oct. 13, 2022; NEF request filed Oct. 17, 2022 (Dkt. 29).
• Note: Listed on Gland's pro hac vice team here; the ArentFox Schiff team is a repeat Gland Pharma ANDA defense group. (Bio detail beyond the docket listing not independently verified in this session.)

Bradford C. Frese — of counsel (national team)

• Firm/office: ArentFox Schiff LLP, 1717 K Street NW, Washington, DC 20006; bradford.frese@afslaw.com
• Docket anchors: Dkt. 25 "Of Counsel" block; admitted pro hac vice Oct. 13, 2022; NEF request filed Oct. 17, 2022 (Dkt. 27).
• Note: Member of the same ArentFox Schiff Hatch-Waxman group defending Gland; per-filing bio not published in the materials reviewed.

Jieun Lee — of counsel (national team)

• Firm/office: ArentFox Schiff LLP, 1717 K Street NW, Washington, DC 20006; ji.lee@afslaw.com
• Docket anchors: Appears in the Dkt. 25 "Of Counsel" block; pro hac vice admission sought by consent via Gland's Oct. 20, 2022 letter and Declaration of Jieun Lee (Dkt. 30), granted by order entered Nov. 8, 2022 (Dkt. 33), with NEF request Nov. 9, 2022 (Dkt. 34).
• Note: Admitted only late in the case and appears on the Consent Judgment signature block; no published bio detail verified here.

What is not on the record

• No in-house counsel appeared. No Gland Pharma Limited in-house/legal-department attorney filed a notice of appearance; foreign in-house counsel do not appear in D.N.J. ANDA cases of this kind.
• No separate "Notice of Appearance" entries for the ArentFox Schiff attorneys are reflected in the RECAP/CourtListener docket — their appearance took the form of pro hac vice admission orders (Oct. 13, 2022; Nov. 8, 2022) plus NEF requests, with Mr. Richter as the filing/signing local counsel.
• Related Gland counsel are not counsel here. ArentFox Schiff's Kevin M. Nelson and Matthew T. Wilkerson appear for Gland Pharma in other matters (e.g., the Federal Circuit appeal in No. 23-2254, Imron T. Aly argued for Gland Pharma Ltd.), but I found no appearance by them on this docket. Do not attribute their work to this case.
• Sealed material. Gland's Jan. 18, 2023 sealing motion (Dkt. 49, with Richter's declaration) and the sealed version of the consent judgment/Dec. 22, 2022 letter (Dkt. 43, 45) remain under seal per Magistrate Judge J. Brendan Day's July 6, 2023 order, so any additional counsel or fee/engagement details contained there are not publicly available.

Bottom line

• Lead/outside counsel: Imron T. Aly (ArentFox Schiff LLP, Chicago), with ArentFox Schiff colleagues John K. Hsu, Bradford C. Frese, and Jieun Lee (Washington, D.C.) as of counsel, all admitted pro hac vice in the District of New Jersey.
• Local counsel: James S. Richter (Midlige Richter LLC, Basking Ridge, N.J.), the signer/filer of Gland's pleadings (Dkt. 25), its pro hac vice application letter (Dkt. 30), and its sealing motion (Dkt. 49) in the case that ended with the Consent Judgment and Dismissal Order entered Jan. 19, 2023 (Dkt. 50).