Merck KGaA et al. v. Aurobindo Pharma USA, Inc. et al.

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

Good foundation. Let me dig into the consolidated case, IPRs, and the drug/market context.

Let me pin down the '919 patent's fate, the other IPRs, and the Aurobindo-specific posture.

I'll research this case thoroughly. Let me start with several searches.

Let me dig deeper into the consolidated case, PTAB proceedings, and final disposition.

Let me get more docket specifics on the Aurobindo case and the answer/counterclaims.

Key Legal Developments & Outcome — Merck KGaA v. Aurobindo Pharma USA, Inc., No. 1:23-cv-00039-GBW-CJB (D. Del.)

Important framing note: This action was a "tag-along" ANDA case that was *consolidated into the lead cladribine action, Merck KGaA v. Hopewell Pharma Ventures, Inc., No. 1:22-cv-01365-GBW-CJB (D. Del.)* (filed 2022-10-17). See Docket Alarm docket excerpt for 1:23-cv-00039; CourtListener / RECAP docket for 1:22-cv-01365. As a result, most substantive merits events (claim construction, stay, appellate resolution) happened in the consolidated lead case and were made applicable to Aurobindo. The Aurobindo-specific docket is comparatively thin. Facts below are sourced; I flag where I could not confirm a detail.

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1. Pre-suit and filing

2. Initial pleadings — answer & counterclaims

Caveat: The docket records retrieved show an Answer with affirmative defenses; I could not confirm whether Aurobindo pleaded separate declaratory-judgment counterclaims (invalidity/non-infringement). In ANDA practice these are common, but the retrieved entries do not show a counterclaim filing. Treat as unconfirmed.

3. Consolidation and early case management (late 2023)

• 2023-05-02 to 05-18 (D.I. 12–14): proposed orders, notice of service, and a stipulation to extend time — routine scheduling.
• 2023-10-24: Oral order (Judge Burke) asking the parties in 22-974, 22-1365, and 23-00039 to meet and confer on consenting to Magistrate Judge Burke's jurisdiction to conduct all proceedings, signaling the court's intent to move the consolidated matter toward a final post-trial decision. (CourtListener minute entry)
• The three Merck cladribine actions were consolidated; the Aurobindo and Apotex actions were folded into the Hopewell lead case. The '919 patent, while originally asserted, was dropped from the case as consolidated.

4. Claim construction (Markman) — 2023–2024

5. Discovery milestones of strategic significance

• Priority-date / conception fight. Defendants Aurobindo and Apotex filed a Motion to Strike (D.I. 130) targeting Plaintiffs' belated supplemental interrogatory responses (Nos. 1, 2) and validity contentions that asserted an earlier conception-based priority date, and to preclude Merck from relying on conception. This went directly to whether the Bodor Iv

I'll research the counsel of record for the plaintiffs in this consolidated D. Del. case. Let me start with several searches.

Good progress. The complaint signature block gives me the core team. Now let me verify the consolidation into 22-1365 and check for any additional/updated counsel.

Let me pin down the pro hac vice roster and the WilmerHale team, plus check for any later substitutions.

Counsel of Record — Plaintiffs (Merck KGaA, Merck Serono SA, Ares Trading SA)

Important framing note: No. 1:23-cv-00039 was consolidated into No. 1:22-cv-01365-GBW-CJB "for all purposes, including trial" by the July 10, 2023 scheduling order in the lead case (D.I. 29 in 22-1365). Both the 22-1365 and 23-39 dockets carry the identical plaintiff-side roster: Morris, Nichols, Arsht & Tunnell LLP as Delaware counsel and Wilmer Cutler Pickering Hale and Dorr LLP as outside/of counsel. The two complaints' caption blocks are the same team with one minor variation (noted below). Both cases were globally stayed in January 2025 pending the IPR appeals, so no new party counsel has appeared since.

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Delaware counsel — Morris, Nichols, Arsht & Tunnell LLP (1201 N. Market St., Wilmington, DE 19899)

Both are designated as "Attorneys for Plaintiffs" on the signature blocks of the 23-39 Complaint (filed Jan. 13, 2023) and the Oct. 17, 2022 complaint in 22-1365.

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Of counsel / outside counsel — Wilmer Cutler Pickering Hale and Dorr LLP

These attorneys appear in the "OF COUNSEL" block of the complaints and were admitted pro hac vice in D. Del. by order of Judge Williams dated Dec. 21, 2022 (D.I. 12 in 22-1365: "MOTION for Pro Hac Vice Appearance of Attorney David B. Bassett, Gillian T. Farrell, Vinita Ferrera, Emily R. Whelan, Deric X. Geng and David Mlaver").

Note on IPR-only counsel: WilmerHale attorneys Cindy Kan (New York), Asher S. McGuffin, Mary Pheng, and appellate partners Mark C. Fleming and James M. Lyons (Boston) appear in the PTAB/Federal Circuit filings and service lists for the same patents, but I found no entry of appearance for them on the D. Del. docket in 22-1365 or 23-39. They should not be listed as district-court counsel of record.

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Gaps and caveats

• No in-house counsel appears in the CM/ECF "attorney to be noticed" listings for the plaintiffs; the docket shows only the Morris Nichols and WilmerHale entries. If Merck legal-department personnel are involved, they have not entered an appearance.
• No party-counsel substitution motions were found for plaintiffs after the Jan. 2025 global stay. The last plaintiff-side activity in the consolidated docket is ministerial (e.g., notices of service).
• The list above is drawn from the complaint signature blocks and the Dec. 21, 2022 PHV order as reproduced in the docket sheets and on CourtListener/UniCourt. I could not independently re-verify each name against a live PACER attorney report within this session; where a name appeared in only one of the two complaints (Serena Li, David Mlaver), I've flagged it as uncertain.
• Substance context for the reader: the asserted patents ('947 and '903) were invalidated by the PTAB in IPR2023-00480/-00481 (Sept. 18, 2024) and the Federal Circuit affirmed on Oct. 30, 2025; the '919 patent was asserted in the original 23-39 complaint but dropped. This explains the prolonged stay and the absence of recent counsel activity.

I'll research the counsel of record for the defendants in this case. Let me start with several searches.

I have solid data on defendants' counsel in the 1:23-cv-00039 docket and useful leads on the consolidated case (22-1365). Let me dig deeper into counsel changes, firms, and individual backgrounds.

Below is what the public record shows for defense counsel in Merck KGaA v. Aurobindo Pharma USA, Inc., No. 1:23-cv-00039-GBW (D. Del.). Note the case was consolidated into 1:22-cv-01365-GBW-CJB, so appearances span both dockets, and the defendants are the two Aurobindo entities (Aurobindo Pharma USA, Inc. and Aurobindo Pharma Limited), who are jointly represented.

Defendants' counsel of record

Docket anchors (public): D.I. 9 — Motion for Pro Hac Vice Appearance of Attorneys Dmitry V. Shelhoff, Kenneth S. Canfield, Edward D. Pergament and Julia S. Kim (filed 1/31/2023; SO ORDERED 2/1/2023); D.I. 10 — Answer with affirmative defenses signed by Schladweiler; D.I. 11 — Rule 7.1 disclosure. The pro hac vice grants were docketed 2/2/2023.

Important qualifications

• Consolidation and counsel drift. Because 23-cv-00039 was consolidated into 22-1365, the operative defense team is the Greenberg Traurig (Delaware) + Pergament & Cepeda (PHV) pairing. The 22-1365 docket shows Greenberg Traurig attorneys (Schladweiler, Delcollo) filing on Aurobindo's behalf; a notice to remove Phillip Takhar as co-counsel appears on that docket (Takhar's firm is not confirmed from the sources retrieved).
• Do not confuse with other Aurobindo matters. Different counsel appear for Aurobindo in the Merck Sharp & Dohme sugammadex case and the Acadia/NUPLAZID cases (e.g., Williams & Connolly, Kratz & Barry, Kelley Drye). Those are separate matters and are not counsel here.
• Firm office location for Pergament & Cepeda is not confirmed by the sources retrieved — the docket lists only the pergamentcepeda.com email addresses, no street address. I did not verify a specific office city, so I am flagging that rather than guessing. I also could not confirm a formal "lead counsel" designation on this docket beyond the pro hac vice grouping.
• No sealed-counsel issue: the appearances here are public; nothing suggests counsel is undisclosed. If you need the current, post-stay roster (the case was stayed 8/6/2024 and later shown as terminated), pull the live PACER docket for 1:22-cv-01365-GBW-CJB, since RECAP/CourtListener snapshots used above may lag.