Hopewell Pharma Ventures, Inc. v. Ares Trading SA

I'll start by verifying the parties, the IPR, and any parallel district court litigation.

Good — this is an IPR, with a parallel D. Del. ANDA case. Let me dig into the parties, the parallel district court case, and the sibling IPRs.

Case overview: Hopewell Pharma Ventures, Inc. v. Ares Trading SA, IPR2023-00482

A framing correction first, because it drives everything else. The flagged docket is not a district-court infringement action — it is an inter partes review at the PTAB, filed by Hopewell Pharma Ventures, Inc. as Petitioner against Ares Trading S.A. as Patent Owner, challenging claims 1–6, 8–9, 11–12, 14–16, 18–20, 23–27, 30 and 33–34 of U.S. Patent No. 10,849,919 ("the '919 patent"). Petition filed Feb. 10, 2023; terminated-settled Aug. 16, 2023, before institution. The "plaintiff/defendant" roles in the prompt are therefore inverted relative to the PTAB caption, and the real infringement litigation sits one layer underneath: Merck KGaA, Merck Serono S.A. and Ares Trading S.A. v. Hopewell Pharma Ventures, Inc. (and consolidated generics defendants), No. 1:22-cv-01365-GBW-CJB (D. Del., filed Oct. 17, 2022). On the party identities: Merck KGaA (Darmstadt, Germany) is the parent; Merck Serono S.A. (Switzerland) owns the '947 and '903 patents; Ares Trading S.A. (Switzerland) — a Merck KGaA subsidiary and affiliate of Merck Serono — owns the '919 patent. Hopewell is not an NPE/PAE: it is a small U.S. generic-drug developer (U.S. pharma company pursuing lower-cost generics) whose ANDA covers generic cladribine; it is financed by the litigation funder GLS Capital and led by co-founder/CEO Dr. Jonathan Embleton (per Sterne Kessler's Oct. 4, 2024 press release). That funder-backed generic challenger posture — a generic filer outsourcing the validity fight to a funder and an IPR boutique — is the analytically interesting structural feature, not a classic NPE assertion pattern.

Accused product and patents. The accused instrumentality is Hopewell's proposed generic cladribine 10 mg tablets (ANDA No. 215547), a generic version of Merck's MAVENCLAD®, asserted under 35 U.S.C. § 271(e)(2) on the basis of the ANDA submission itself. The three patents in the family all claim oral cladribine dosing regimens for multiple sclerosis built around a four-phase cycle — an "induction period," a cladribine-free period, a "maintenance period," and a second drug-free period: (1) U.S. 7,713,947 ("Cladribine regimen for treating multiple sclerosis"; claims 36, 38, 39, 41–46 asserted) — the original oral-regimen patent, about 2–4 month induction at ~1.7–3.5 mg/kg, 8–10 months off drug, ~2–4 month maintenance at ~1.7 mg/kg; (2) U.S. 8,377,903 (same title; claims 17, 19, 20, 22–27 asserted) — a continuation-style variant expressly limited to relapsing-remitting or early secondary progressive MS with different dose parameters; and (3) U.S. 10,849,919 ("Cladribine regimen for treating progressive forms of multiple sclerosis," Ares Trading; independent claims 1, 14, 24 and 27 asserted) — the newest and narrowest member, directed at primary and secondary progressive MS (a far smaller, high-unmet-need population) with a cumulative ~3.5 mg/kg dose over two years; it claims priority to Nov. 24, 2017 and, on a nominal 20-year term, would expire in the late 2030s. In IPR2023-00482 the prior-art grounds were built on ClinicalTrials.gov records, Schreiber (2011), Montalban (2016), Giovannoni (2010) and Alvarez-Gonzalez (2017) — with the interesting wrinkle that Hopewell, anticipating a public-accessibility fight, submitted a dedicated librarian declaration (Nancy E. Adams, Ed.D., Penn State) authenticating each reference's public availability. Patent Owner's POPR (D.I. 6, May 17, 2023) argued no reasonable likelihood as to the challenged claims and relied on objective indicia of non-obviousness (the "uniformly disappointing" prior failures of cladribine in progressive MS).

Procedural posture, venue, and why it matters. In the PTAB proceeding, Patent Owner was represented by Wilmer Cutler Pickering Hale and Dorr LLP (lead: Emily R. Whelan, Reg. No. 50,391); Petitioner by Sterne, Kessler, Goldstein & Fox PLLC (lead: Eldora L. Ellison, Ph.D.). The docket ran: Petition (Feb. 10, 2023) → POPR (May 17, 2023) → Petitioner's Reply to POPR (June 9, 2023) → Patent Owner's Sur-Reply (June 16, 2023) → Joint Motion to Terminate (Aug. 15, 2023), joint request to file the settlement agreement confidentially under 37 C.F.R. § 42.74 → Termination Decision, pre-institution settlement (Aug. 16, 2023) → Petitioner's refund request (Sept. 6, 2023). Underlying venue is the District of Delaware, before Judge Gregory B. Williams with Magistrate Judge Christopher J. Burke — the single most important ANDA forum in the country, and the residence of the defendant (Hopewell is a Delaware corporation with its principal place of business in Wilmington), which made venue essentially uncontestable. Two things make the docket notable. First, this IPR is the outlier of a three-IPR campaign: Hopewell's sibling petitions IPR2023-00480 ('947) and IPR2023-00481 ('903), filed Jan. 23, 2023 and prosecuted to the end, produced final written decisions invalidating all challenged claims, affirmed by the Federal Circuit on Oct. 30, 2025 (Merck Serono S.A. v. Hopewell Pharma Ventures, Inc., Nos. 2025-25-1210/-1211), rehearing denied Jan. 22, 2026, mandate and D. Del. final judgment Jan. 29, 2026 — with the appellate opinion's real doctrinal contribution being its clarification of the pre-AIA §§ 102(a)/(e) "by another" requirement where the prior-art reference (the 2004 Bodor application, born of the Serono–IVAX joint development) and the challenged patents share overlapping inventors (A&O Shearman IP blog; Sterne Kessler, Jan. 26, 2026). By contrast, the '919 proceeding evaporated early via confidential settlement, which is why the '919 patent drops out of the later D. Del. opinions. Second, the '919 patent was not litigated to judgment against Hopewell but remains live against other filers — it was asserted in Merck KGaA v. Aurobindo Pharma (1:23-cv-00039-GBW) and appears in the consolidated Delaware actions against Accord and Apotex, so the '919 is the only Merck cladribine patent in this family still "currently active" and still generating exposure for the rest of the ANDA field. Market context: MAVENCLAD is described in the trade press (Law360) as a blockbuster MS franchise; its U.S. patent estate has been the subject of parallel attacks (e.g., TWI Pharmaceuticals' IPR2023-00050 against the '903 patent, in addition to Hopewell's), and the Delaware court ultimately imposed a global stay across all defendants' cases, tolling Hopewell's 30-month stay while leaving Apotex's untolled — a Hatch-Waxman stay/competitive-advantage fight litigated through Dec. 4, 2025 (Merck KGaA v. Hopewell Pharma Ventures, Inc., 2025 WL 3485555 (D. Del. Dec. 4, 2025) (Williams, J.)), and an instructive case study in how filing an IPR can cost an ANDA first-filer real exclusivity time.

Sourcing caveats. Docket entries and dates for IPR2023-00482 are drawn from the PTAB/patexia and Docket Alarm document indices (D.I. 1–14; Exhibits 1001–1065) and are consistent across sources; I have not independently pulled the Board's termination decision text, so the precise settlement terms are unknown and are confidential by order. Party identities, ownership structure and the D. Del. docket number are confirmed by the complaint (D.I. 1, 1:22-cv-01365) and Petitioner's Updated Mandatory Notices (IPR2023-00481, D.I. 5, Feb. 22, 2023). Counsel and the firm affiliations are from the PTAB filings and Sterne Kessler press releases. I could not locate a Reuters/Law360 item specifically covering IPR2023-00482 — all trade coverage targets the sibling '480/'481 appeals and the Delaware 30-month-stay ruling — and the inference that a covenant or agreed dismissal

I'll verify the underlying litigation docket and the PTAB/procedural developments before laying out the chronology.

Now let me pull the D. Del. docket chronology and the post-Federal Circuit events.

I'll verify counsel on both sides of the PTAB caption and in the underlying Delaware action.

Let me pull the Delaware docket counsel details and confirm the WilmerHale/Morris Nichols plaintiff-side teams.

Counsel of record — Hopewell Pharma Ventures, Inc. v. Ares Trading S.A., IPR2023-00482

Threshold framing issue, again. The prompt labels Hopewell as "plaintiff" and Ares Trading as "defendant," which matches the case metadata but inverts the PTAB caption. In IPR2023-00482 Hopewell is the Petitioner and Ares Trading the Patent Owner — so the "plaintiff-side" counsel in this proceeding are Hopewell's IPR counsel. Separately, in the actual § 271(e)(2) infringement action sitting underneath the IPR (Merck KGaA, Merck Serono S.A. & Ares Trading S.A. v. Hopewell Pharma Ventures, Inc., No. 1:22-cv-01365-GBW-CJB (D. Del.)), the plaintiffs are the Merck entities, not Hopewell. I give you both, because "plaintiff in this patent infringement case" is ambiguous on these facts.

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A. Petitioner-side counsel (Hopewell = the party the metadata calls "plaintiff")

All from Petitioner's filings in IPR2023-00482 (Petition, Feb. 10, 2023; Updated Mandatory Notices under 37 C.F.R. § 42.8(a)(3), Paper 9, Aug. 7, 2023).

Do not overlook the "steady state" of the record. The Aug. 7, 2023 Updated Mandatory Notices for IPR2023-00482 list four counsel only — Ellison (lead) plus Partington, Vira and Rozendaal. Christina E. Dashe was added to Hopewell's back-up team in the sibling IPR2023-00480 (Updated Mandatory Notices, Jan. 5, 2024) and appears in the D. Del. and Federal Circuit filings, but I found no § 42.8 notice in the '482 record adding her there — and given the '482 petition was filed Feb. 10, 2023 and terminated Aug. 16, 2023, the window for further appearance notices was short. Treat Dashe, Tyler Liu, Pratibha Khanduri, Madeleine Bond and patent agent Sarah Leesman as the broader Sterne Kessler campaign team (per the firm's Oct. 4, 2024 and Jan. 26, 2026 press releases), not necessarily as counsel of record in the '482 docket itself. The Sterne Kessler press releases describe the team at the level of "the IPR proceedings" collectively — IPR2023-00480 and -00481 — and none of them names IPR2023-00482, which is consistent with the '482 settling early.

No local counsel, no in-house counsel. The PTAB does not require local counsel, and I found no in-house Hopewell attorney on the PTAB papers — Hopewell's CEO Dr. Jonathan Embleton speaks for the company in press statements but is not counsel of record.

• Sourcing caveat: the '482 counsel list above is from the Petitioner's own mandatory notices as reproduced in the Docket Alarm document index for IPR2023-00482 (Papers 8/9). I did not pull a signed § 42.8 notice from PTAB's own PTACTS interface for '482, so confirm against the PTAB docket if you need a certified list. GLS Capital, Hopewell's litigation funder, has no counsel of record.

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B. Patent Owner-side counsel (Ares Trading) in IPR2023-00482

Included for completeness because the metadata labels this party "defendant," but in the underlying infringement action this party is a plaintiff:

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C. If you meant the true § 271(e)(2) plaintiff — Merck in D. Del. 1:22-cv-01365-GBW-CJB

From the D. Del. docket (reproduced as Ex. 1045 to the '482 petition; corroborated by Justia, UniCourt, NPE-Stanford and CourtListener docket entries):

Plaintiffs (Merck KGaA, Merck Serono SA, Ares Trading SA):

• Jack B. Blumenfeld — lead counsel, Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE. Delaware's preeminent ANDA defense firm; appears for Merck across the consolidated cladribine cases.
• Jeremy A. Tigan — Morris Nichols, Wilmington, DE. Same team; the firm signature on the D. Del. stipulations and scheduling filings in this case.
• Wenli Gu — WilmerHale (appears on the D. Del. docket for the Merck side per the Ex Parte attorney index); WilmerHale carries the substantive/PTAB and appellate work while Morris Nichols serves as Delaware local counsel.
• Note: DrugPatentWatch lists Morris Nichols as the firm on this docket for plaintiff Merck.

Defendant (Hopewell) — for contrast, since this is where Hopewell's litigation counsel appear:

• Karen Elizabeth Keller — Shaw Keller LLP, Wilmington, DE (Delaware local counsel).
• Nathan Roger Hoeschen — Shaw Keller LLP, Wilmington, DE (local counsel).
• Chandrika Vira, Christina E. Dashe, John C. Rozendaal — Sterne Kessler, admitted pro hac vice in D. Del. for Hopewell (this is the bridge between the IPR team and the district court team).

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What I could not verify

• No separate counsel of record filings in IPR2023-00482 beyond the petition, POA and mandatory notices — the proceeding terminated-settled on Aug. 16, 2023 before institution, so there are no institution-stage or FWD-stage appearances to report, and no deposition/PHV motions.
• I could not confirm a full list of WilmerHale attorneys formally admitted pro hac vice in the '482 IPR specifically (the POA permits them generically); the named individuals (Bassett, Fox, Graber, Million-Perez, Xu, Gu) are documented in the companion '480/'481 appeals and the D. Del. action, and I'm flagging that inference rather than presenting it as a '482 record fact.
• DrugPatentWatch surfaces an attorney listed only as "Christopher B." on the D. Del. plaintiff side; I could not resolve a full name and won't guess. One docket entry (Dec. 31, 2025, D.I. 264) is a notice of withdrawal of co-counsel — I could not retrieve the name from the available index, so the current plaintiff-side roster in D. Del. may have shrunk since the 2024 snapshots quoted above.

I'll research counsel on both sides of the caption, since the metadata's "defendant" label (Ares Trading) is inverted relative to the real infringement action (where Hopewell is the defendant). Let me search.

Let me pull the D. Del. docket's attorney entries and the PTAB counsel lists in more detail.

Let me confirm the PTAB patent-owner counsel roster in this IPR and whether WilmerHale appeared in the D. Del. case.

Counsel of record — a necessary framing note

The case metadata labels Ares Trading SA as the "defendant(s)." In the proceeding actually docketed under IPR2023-00482, Ares Trading is the Patent Owner (the party defending the '919 patent), and Hopewell Pharma Ventures is the Petitioner. Meanwhile, the real infringement action underneath — Merck KGaA, Merck Serono SA & Ares Trading SA v. Hopewell Pharma Ventures, Inc., No. 1:22-cv-01365-GBW-CJB (D. Del.) — has Hopewell as the defendant. So "counsel for the defendant" is answered two ways depending on which case you mean. I give both, flagged. I have not located a Reuters/Law360 piece naming counsel; everything below is grounded in PTAB filings, the D. Del. docket index, and the firm-published sources cited. Where the record is incomplete I say so.

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1. Ares Trading SA — the named "defendant"/Patent Owner in IPR2023-00482

Ares's Power of Attorney under 37 C.F.R. § 42.10 (filed Mar. 1, 2023, D.I. 4) appoints Wilmer Cutler Pickering Hale and Dorr LLP ("WilmerHale") via Customer No. 23483, with the notice address at the firm's Boston office (60 State Street). Counsel of record:

Two caveats: (a) the WilmerHale roster above merges the IPR2023-00482 filings with the firm's service certificates in the closely related IPRs, because the team is designated family-wide and the certificates of service in -00482 itself list only Whelan (lead), Geng, and Kan; (b) the Board's termination (Paper 12, Aug. 16, 2023) ended the case before institution, so there is no later counsel-substitution record to consult.

WilmerHale's district-court role. In the underlying D. Del. action, the plaintiffs' (Merck/Ares) Delaware counsel of record are Morris, Nichols, Arsht & Tunnell LLP — Jack B. Blumenfeld and Jeremy A. Tigan (Wilmington), who filed the complaint (D.I. 1) and appear on the docket. WilmerHale functions as Merck's PTAB/patent-side counsel; I could not confirm a WilmerHale pro hac vice appearance in 1:22-cv-01365 from the sources retrieved, so I state that as an open item rather than assert it.

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2. Hopewell Pharma Ventures — the actual defendant in the D. Del. infringement action

Because the prompt's "defendant" label cuts against the underlying case, here is Hopewell's counsel of record in 1:22-cv-01365-GBW-CJB, drawn from the District of Delaware docket (Docket Alarm/Justia entries; D.I. 8, 9, 10, 14):

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

• Karen Elizabeth Keller — local counsel; filed the extension stipulation (D.I. 8). Shaw Keller name partner; one of the most active D. Del. ANDA/Hatch-Waxman local counsel.
• Nathan Roger Hoeschen — local counsel; filed Hopewell's Answer/affirmative defenses/counterclaims (D.I. 9) and the Rule 7.1 disclosure (D.I. 10). Delaware ANDA litigator.

Lead trial counsel (admitted pro hac vice) — Sterne, Kessler, Goldstein & Fox PLLC (1101 K St. NW, 10th Fl., Washington, DC):

• John Christopher Rozendaal — pro hac vice (D.I. 14, granted Jan. 20, 2023).
• Chandrika Vira — pro hac vice (D.I. 14).
• Christina E. Dashe — pro hac vice (D.I. 14).

Same firm, PTAB side of the caption (Petitioner Hopewell in IPR2023-00482), per Petitioner's Updated Mandatory Notices (D.I. 9, Aug. 7, 2023):

• Eldora L. Ellison, Ph.D. (Reg. No. 39,967) — lead counsel (Sterne Kessler, DC); Ph.D. chemist and Sterne Kessler director; the firm's lead across Hopewell's '480/'481/-00482 campaign.
• Olga A. Partington, Ph.D. (Reg. No. 65,326), Chandrika Vira (Reg. No. 60,607), and John C. Rozendaal (pro hac vice) — back-up counsel.

So Hopewell ran a two-firm structure typical of D. Del. ANDA practice: Sterne Kessler as substantive/PTAB lead and Shaw Keller as Delaware local counsel — and the same Sterne Kessler attorneys (Vira, Rozendaal, plus Dashe) appeared both in the district court and at the PTAB.

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3. Other defendants in the consolidated Delaware litigation (context only)

The '919/'947/'903 patents were also asserted against other ANDA filers in related Delaware actions — Aurobindo (1:23-cv-00039-GBW) and Apotex (and Accord, 1:22-cv-00974-GBW) — which the court consolidated with the Hopewell case. Those defendants' counsel are on their dockets rather than in 1:22-cv-01365, and the metadata's case (this IPR) does not name them as parties. I did not pull their appearances for this response; if you want the full consolidated-defendant roster, say so and I'll run the individual dockets.

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Bottom line

• If "defendant" = the party named in this PTAB case (Ares Trading SA, the Patent Owner), counsel of record is WilmerHale — Emily R. Whelan (lead), with Deric Geng and Cindy Kan as back-up (David Bassett on the family-wide team), plus in-house Prisca von Ballmoos.
• If "defendant" = the infringement defendant on the merits (Hopewell, in 1:22-cv-01365), counsel is Shaw Keller LLP (Karen E. Keller, Nathan R. Hoeschen) as Delaware local counsel and Sterne Kessler (J.C. Rozendaal, Chandrika Vira, Christina E. Dashe) pro hac vice.

Confidence/caveats: The PTAB lead/back-up designations and the Shaw Keller/Sterne Kessler district-court appearances are well sourced (POA, mandatory notices, pro hac vice motion D.I. 14, docket indices). The items I could not fully verify are: whether David Bassett is separately named in the -00482 mandatory notice versus only in the sibling IPRs; the full in-house counsel name beyond von Ballmoos; and any WilmerHale district-court appearance in 1:22-cv-01365. No counsel has been invented, and no filing here appears to have been sealed in a way that hides counsel (the sealed material is the settlement agreement).