Litigation
Merck KGaA et al. v. Accord Healthcare, Inc.
stayed1:22-cv-00974-GBW
- Court
- D. Del.
- Filed
- 2022-07-25
Patents at issue (3)
Plaintiffs (3)
Defendants (1)
Summary
First Amended Complaint (ANDA No. 216813) asserted the '947, '903, and '919 patents. The case was stayed within the same global stay; there was no separate '919 outcome.
Case overview & background
Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.
I'll research this case across multiple sources before drafting.
Good material. Now let me pin down the IPR outcomes, the related D. Del. cases, and the market/regulatory context.
Key legal developments & outcome
Major rulings, motions, claim construction, settlements, and the present posture or final disposition.
I'll research this case systematically, starting with the docket and case metadata.
Let me dig into the stay, the parallel IPRs, and the Federal Circuit outcome.
Now let me trace the Accord docket entries for the stay, and check for any '919 patent IPR and 2026 developments.
Bottom line
This is a Hatch-Waxman (ANDA) case about generic Mavenclad® (cladribine) 10 mg tablets, ANDA No. 216813. It never reached claim construction, summary judgment, or trial: it was stayed by stipulation in December 2022, and it was later swept into the global stay Judge Williams imposed in the lead Mavenclad case (Merck KGaA v. Hopewell Pharma Ventures, No. 22-cv-1365-GBW-CJB), pending appeals of the PTAB decisions that invalidated the asserted claims of the '947 and '903 patents. That global stay is the operative posture; as of today the Accord action remains stayed with no merits ruling on the '919 patent.
1. Filing and initial pleadings (2022)
| Date | Event |
|---|---|
| 2022-06-13/14 | Accord's Paragraph IV notice letter to Merck re ANDA No. 216813 (cladribine 10 mg tablets), certifying as to the '947 and '903 patents. The D.I. 4 ANDA disclosure form lists the notice date as 2022-06-14; Accord's Answer pleads the letter as dated 2022-06-13. |
| 2022-07-25 | Complaint filed (D.I. 1) against Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd., asserting the '947 and '903 patents. Filed within the 45-day window. (Suit is § 271(e)(2) infringement plus DJ/§ 271(a)-(c) counts.) |
| 2022-07-27 | Initial assignment to Delaware's Vacant Judgeship (VAC) (D.I. 8); pro hac vice motions for Merck's WilmerHale team (Bassett, Ferrera, Whelan, Geng, et al.). |
| 2022-08-02 | Waivers of service; answers due 2022-10-03. |
| 2022-09-07 | Case reassigned to Judge Gregory B. Williams (initials GBW added). |
| 2022-09-22 | Stipulation of dismissal of Intas without prejudice (D.I. 14), so-ordered 2022-09-26 — caption amended to Accord alone. Accompanying it: First Amended Complaint (D.I. 15) adding Ares Trading SA as a plaintiff and adding the '919 patent as Count III (asserted claims 1, 14, 24, 27). |
| 2022-10-06 | Accord's Answer and Affirmative Defenses (D.I. 19). |
Two points of strategic significance in the pleadings:
- The '919 patent was added after the fact. It issued/listed on the Orange Book only after Accord's notice letter, so Accord made no Paragraph IV certification on it. Accord's Answer pleads that "Accord has not sent a new Notice Letter to Merck since the '919 patent was listed on the Orange Book," and
Plaintiff representatives
Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
I'll research the counsel of record for the plaintiffs in this case. Let me start with several targeted searches.
I have good initial data. Let me dig deeper into the specific attorneys and their firms, plus check for any later docket activity.
Counsel of Record — Plaintiffs (Merck KGaA, Merck Serono SA, Ares Trading SA)
Sourcing note: PACER itself was not directly reachable; the below is reconstructed from the docket mirrors (Bloomberg Law docket, DocketAlarm, Justia Dockets, UniCourt), the D.I. 7 and D.I. 13 pro hac vice motions, the PTAB mandatory notices/filings in the parallel IPRs, and WilmerHale/Morris Nichols firm pages. Docket entries are cited where I could identify them. Because the case is stayed, this reflects the appearance roster as of the last substantive docket activity — no new appearances should be expected while the stay is in place.
A. Delaware local counsel — Morris, Nichols, Arsht & Tunnell LLP (Wilmington, DE)
| Name | Role | Firm / Office | Note |
|---|---|---|---|
| Jack B. Blumenfeld | Delaware local counsel / lead Delaware attorney (Del. Bar #1014) | Morris, Nichols, Arsht & Tunnell LLP, 1201 N. Market St., Wilmington, DE | Band 1 Chambers USA; IAM Patent 1000 "gold" Delaware practitioner; long-time Merck/Allergan/Galderma ANDA counsel in D. Del.; signed the Complaint/Amended Complaint papers. |
| Jeremy A. Tigan | Delaware local counsel (Del. Bar #5239) | Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE | Chambers/IP Stars–rated Delaware IP litigator; appears as local counsel for Merck across the related MAVENCLAD ANDA suits (e.g., the related Aurobindo and Hopewell actions); signed the D.I. 17 Patent Office report. |
Caveat: One docket snippet shows a "NOTICE of Withdrawal of Counsel by Merck KGaA, Merck Serono SA (Tigan, Jeremy)" appearing on the docket track that includes this case number. I could not confirm from the mirrors which docket entry number it carries in 1:22-cv-00974-GBW or whether it relates to this file versus a consolidated companion case, so I flag it rather than state it as a conclusion. Blumenfeld and Tigan are the two Delaware attorneys identified as plaintiffs' counsel of record by UniCourt and DocketAlarm for this docket.
B. Lead / merits counsel — Wilmer Cutler Pickering Hale and Dorr LLP (WilmerHale)
These attorneys were admitted pro hac vice by D.I. 7 (granted by Judge Colm F. Connolly, 7/27/2022), and D.I. 13 / D.I. 13 SO ORDERED (Judge Williams, 9/21/2022).
| Name | Role | Firm / Office | Note |
|---|---|---|---|
| David B. Bassett | Lead trial counsel / merits lead | WilmerHale — 7 World Trade Center, 250 Greenwich St., New York, NY (also Boston) | 35+ year IP litigator, former chair of the firm's IP Litigation Practice; lead trial counsel in a dozen-plus patent trials. Lead counsel for Bristol-Myers Squibb/Pfizer in the Eliquis® Hatch-Waxman litigation and for Gilead in the Sovaldi®/Harvoni® IPRs; Fed. Cir. wins for Braintree and Millennium/Takeda. Declared he represents Merck in Accord (IPR2023-00050, Ex. 2001). WilmerHale's site now lists him as "Retired Partner." |
| Vinita Ferrera | Lead/merits (WilmerHale) | WilmerHale — Boston, MA | Long-time Merck Hatch-Waxman counsel (e.g., Forest Labs/Merck v. Accord, C.A. No. 15-272 (D. Del.), 2017 service list); appeared in Merck's IPR2023-00049/-00050 and co-counsel in the MAVENCLAD appeals. |
| Emily R. Whelan | Merits counsel; designated PTAB lead counsel for Merck in the parallel IPRs | WilmerHale — Boston, MA | Registered patent attorney; lead counsel of record in Merck Serono's TWi/Hopewell IPRs (IPR2023-00049/-00050, -00480/-00481) and on the resulting Federal Circuit appeals (Merck Serono S.A. v. Hopewell Pharma Ventures, Nos. 25-1210, 25-1463/-1464). |
| Deric X. Geng, Ph.D. | Merits counsel | WilmerHale — Boston, MA | Ph.D.-credentialed life-sciences litigator; on the Merck service lists for the prior Forest/Merck v. Accord matter and this case. |
| Yang Li | Merits counsel | WilmerHale — Boston, MA | Life-sciences/patent litigation associate; appeared via the D.I. 7 PHV motion. |
| Stephanie Neely | Former merits counsel (withdrawn) | WilmerHale | Admitted pro hac vice via D.I. 7 (7/27/2022) but removed as co-counsel by NOTICE at D.I. 12 (filed 9/13/2022) — "No longer with firm." |
| Gillian T. Farrell | Merits counsel (associate/counsel) | WilmerHale — New York, NY | Admitted pro hac vice by D.I. 13, SO ORDERED 9/21/2022. IP litigation focus; clerked for Judge Sanket J. Bulsara (E.D.N.Y.); worked the MAVENCLAD IPRs and related consolidated D. Del. litigation. |
C. In-house counsel
No in-house (Merck KGaA / Merck Serono / Ares Trading) attorney is identified in the docket entries I could retrieve. Corporate disclosure statements (D.I. 5, D.I. 16) name only the corporate parents, not individual in-house counsel. If in-house counsel appears on the docket, it would be via the corporate disclosure/notices, which the mirrors do not reproduce with attorney names — treat this as not confirmed rather than as absent.
D. Practical summary
- Merits/trial team: WilmerHale (Boston and New York), led by David B. Bassett, with Vinita Ferrera, Emily R. Whelan, Deric X. Geng, Yang Li, and Gillian T. Farrell.
- Delaware local counsel: Morris, Nichols, Arsht & Tunnell LLP — Jack B. Blumenfeld and Jeremy A. Tigan.
- No longer on the team: Stephanie Neely (withdrawn, D.I. 12).
Confidence: High for the WilmerHale/Morris Nichols roster and the D.I. 7/12/13 pro hac vice entries (corroborated across multiple mirrors and the PTAB reciprocity filings). Medium on any post-2022 changes, since I could not pull the live PACER docket — the flagged Tigan withdrawal notice and any case-specific stay filings should be verified directly on PACER if precision is required.
Defendant representatives
Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
I'll research Accord Healthcare's counsel in this case systematically.
Good initial hits. Now let me verify the defense-side attorneys and their firms.
Counsel of Record — Defendant Accord Healthcare, Inc.
Sourcing note. PACER was not directly reachable; the roster below is reconstructed from the D. Del. docket sheet as reproduced in the PTAB exhibit sets (the Accord docket was filed as an exhibit in the TWi/Hopewell IPRs — e.g., EX1032/EX1046), the Bloomberg Law docket, DocketAlarm, UniCourt, CourtListener party reports, and the firms' own attorney pages. Docket entries are cited where identifiable. Because this action has been stayed since December 2022, the roster is frozen at that point — verify on PACER before relying on it for a current appearance.
This dovetails with the plaintiffs' side already covered: Merck is represented by WilmerHale (merits) + Morris, Nichols, Arsht & Tunnell (Delaware). Accord runs the mirror-image structure: a Delaware local-counsel firm plus a Chicago-based Hatch-Waxman boutique as merits/PHV counsel.
A. Delaware local counsel — Greenberg Traurig, LLP (Wilmington, DE)
| Name | Role | Firm / Office | Note |
|---|---|---|---|
| Benjamin J. Schladweiler | Delaware local counsel / lead Delaware attorney; principal signer on the defense filings | Greenberg Traurig, LLP — 222 Delaware Ave., Suite 1600, Wilmington, DE 19801 (firm profile now lists The Nemours Building, 1007 N. Orange St., Suite 1200) | 20+ year IP litigator; Chambers USA Band 3 (Intellectual Property – Delaware), IAM Patent 1000 (2024–2026), Patexia ANDA Litigation Intelligence Top 100 (2024) and ranked 34th among most active Delaware local counsel for defendants in ANDA litigation (2022). Filed Accord's Answer and Affirmative Defenses, D.I. 19 (10/06/2022) and the PHV motion at D.I. 18. Long-time Accord/generics counsel in D. Del. (e.g., Purdue Pharma v. Accord (OxyContin); Ingenus v. Accord, C.A. No. 23-377-CFC). |
| Renee Mosley Delcollo | Delaware local counsel (associate/counsel) | Greenberg Traurig, LLP / Greenberg Traurig, P.A. — Wilmington, DE | IP-litigation and complex-commercial associate; filed Accord's Rule 7.1 Disclosure Statement, D.I. 20 (10/06/2022) identifying Intas Pharmaceuticals Limited as Accord's corporate parent. Recognized by Patexia, Delaware Today, Best Lawyers, and named to the 2025 Delaware Super Lawyers "Rising Stars" list; listed as lead attorney for Accord on the later Ingenus Pharmaceuticals v. Accord docket. |
B. Merits / lead trial counsel — McAndrews, Held & Malloy, Ltd. (Chicago, IL)
All four were admitted pro hac vice by D.I. 18, filed by Accord (signed by Schladweiler) and SO ORDERED by Judge Williams on 9/28/2022; the clerk added them for electronic noticing on 9/29/2022. Firm address of record: McAndrews, Held & Malloy, Ltd., 500 W. Madison St., 34th Floor, Chicago, IL 60661.
| Name | Role | Firm / Office | Note |
|---|---|---|---|
| Alejandro Menchaca | Merits / PHV counsel (Accord's lead non-Delaware attorney on the related Accord files) | McAndrews, Held & Malloy, Ltd. — Chicago, IL | Hatch-Waxman/ANDA defense and PTAB practitioner. Counsel for Accord in Purdue Pharma L.P. v. Accord Healthcare, Inc. (D. Del. and Fed. Cir. No. 2023-1953, the abuse-deterrent/Low-ABUK OxyContin appeal) and in Ingenus v. Accord; also works Intas/Accord-side IPR and PGR proceedings (e.g., IPR2025-00799 / PGR2025-00043). Docket caveat: the CM/ECF noticing entry spells his name "Alejandro Nemchaca" — a clerical typo; the PHV motion and certifications (and his other D. Del. appearances) read Menchaca. |
| Ben J. Mahon | Merits / PHV counsel | McAndrews, Held & Malloy, Ltd. — Chicago, IL | Generic-pharma litigator with an active PTAB docket on behalf of Accord/Intas; named Accord counsel across the OxyContin and Ingenus matters; recent IPR/PGR work for Intas (IPR2025-00799, PGR2025-00043). |
| Bradley P. Loren | Merits / PHV counsel | McAndrews, Held & Malloy, Ltd. — Chicago, IL | Registered patent attorney; listed among Accord's counsel in the Fed. Cir. Purdue v. Accord appeal (No. 2023-1953) and the Ingenus action; independently indexed as an attorney on D. Del. 1:22-cv-00974 (this case). |
| Aaron F. Barkoff | PHV counsel — subsequently WITHDRAWN | McAndrews, Held & Malloy, Ltd. — Chicago, IL | Named first on the D.I. 18 PHV motion and admitted 9/28/2022, but removed as co-counsel by NOTICE at D.I. 21 (filed 10/10/2022). He is a McAndrews shareholder and frequent Accord/Intas PHV counsel in D. Del. (e.g., Novartis v. Accord/Intas, C.A. No. 22-744). He is no longer counsel of record in this case. |
C. In-house counsel
None identified. Accord's only corporate filing in this case is the Rule 7.1 disclosure statement (D.I. 20, filed by Delcollo), which identifies the parent Intas Pharmaceuticals Limited but names no individual in-house attorney. There is no notice of appearance by in-house counsel of record on the docket as reconstructed. Treat this as not confirmed, not as an affirmative absence — docket mirrors do not always surface in-house appearances.
D. Practical summary
- Merits/trial team: McAndrews, Held & Malloy, Ltd. (Chicago) — Alejandro Menchaca, Ben J. Mahon, and Bradley P. Loren are the three PHV attorneys currently of record. Aaron F. Barkoff was admitted but withdrew in October 2022 (D.I. 21).
- Delaware local counsel: Greenberg Traurig, LLP (Wilmington) — Benjamin J. Schladweiler (shareholder; primary filer) and Renee Mosley Delcollo (associate). Local Rule 83.5(d) requires Delaware counsel to be the CM/ECF filers, so Schladweiler is the practical "lead" of record for filing purposes.
- Related-file overlap worth noting: McAndrews (Menchaca, Mahon, Loren, Barkoff) and Greenberg Traurig (Schladweiler, Delcollo) are the same defense team that appears for Accord across its other D. Del. ANDA litigations. Rajendra A. Chiplunkar (McAndrews) appears as Accord counsel in the related Ingenus v. Accord matter but does not appear on this case's docket — do not attribute him here without verification.
Cross-reference / consistency checks against the earlier sections:
- The earlier "Key legal developments" section states the case was stayed by stipulation in December 2022, and the docket confirms the mechanism: a "STIPULATION and Proposed Order Staying Litigation with Respect to Accord Healthcare Inc.," filed by Accord (D.I. 24) and SO ORDERED by Judge Williams on 12/15/2022. That is the last substantive defense-side filing and effectively the last attorney appearance-related activity — consistent with the existing summary that no merits ruling on the '919 patent ever issued.
- One minor internal discrepancy already flagged in the earlier section (the notice-letter date, 2022-06-13 vs. 2022-06-14) is unrelated to counsel and does not affect this roster.
Confidence: High for the Greenberg Traurig / McAndrews split, the four PHV admissions at D.I. 18, the Barkoff withdrawal at D.I. 21, and the Schladweiler (D.I. 19) / Delcollo (D.I. 20) filings — corroborated across the PTAB exhibit docket copies, Bloomberg Law, DocketAlarm/CourtListener, and firm pages. Medium on any post-December-2022 changes (e.g., whether McAndrews or Greenberg Traurig substituted counsel during the long stay), since the live PACER docket could not be pulled; verify directly on PACER if precision is required.