Litigation

Merck Sharp & Dohme Corp. v. Wockhardt Bio AG et al.

settled

1:19-cv-00321-RGA

Filed
2019-02-13

Patents at issue (1)

7326708

Summary

Action asserting the '708 patent; settled.

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 to build an accurate overview.

I have strong initial data. Let me verify additional details about the Wockhardt entities, the MDL, and the IPR linkage.

Let me verify the Wockhardt-specific consent judgment terms and settlement entry dates.

Key legal developments & outcome

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

I'll research this case systematically across the docket, PTAB, and legal press.

Let me dig into the Wockhardt-specific docket and the MDL structure.

Let me pull the Wockhardt-specific docket and the consent judgment.

Merck Sharp & Dohme Corp. v. Wockhardt Bio AG, No. 1:19-cv-00321-RGA (D. Del.)

Bottom line up front

Wockhardt was one of ~14 generic defendants Merck sued in early 2019 on U.S. Patent No. 7,326,708 (the sitagliptin dihydrogenphosphate "salt" patent underlying Januvia®/Janumet®). The Wockhardt case never reached Markman, summary judgment, or trial. It was resolved by a consent judgment entered 2020-05-28, roughly nine weeks after the case was folded into MDL No. 2902 and about two weeks after the PTAB instituted the lead IPR on the '708 patent. Everything that happened later (Markman, the Delaware validity trial, the Mylan trial in N.D. W. Va., the Federal Circuit IPR appeal) occurred in the other MDL member cases or in the Mylan litigation — not as to Wockhardt.

I should flag at the outset: Wockhardt's own docket is thin (it was dismissed very early), so several classic "developments" you asked about simply do not exist in this case. I note those gaps explicitly below rather than backfilling from the MDL.

1. Filing and initial pleadings

2019-02-13 — Complaint filed (D.I. 1). Hatch-Waxman ANDA action against Wockhardt Bio AG and Wockhardt USA LLC alleging infringement of U.S. Pat. No. 7,326,708. Merck's Rule 7.1 disclosure (D.I. 5) identifies Merck & Co., Inc. as parent. The ANDA "supplemental information" form (D.I. 3) lists the patent's expiration as 2026-11-24 and a paragraph IV notice date of 2019-01-21 — though the docket entry as recorded reads "1/21/2014," which appears to be a clerical error on the form; I would not rely on that date without checking the paper itself.

2019-02-14 — Summonses issued and the Wockhardt entities served (D.I. 7–8).

2019-02-21/22 — Case assigned to Judge Richard G. Andrews; Merck moved pro hac vice for Bruce R. Genderson, Jessamyn S. Berniker, Stanley E. Fisher, Shaun P. Mahaffy, Anthony H. Sheh, and Jingyuan Luo (Williams & Connolly), granted 2019-02-22 (D.I. 6). Delaware counsel: Daniel M. Silver, Alexandra M. Joyce, and Michael P. Kelly (McCarter & English).

2019-03-07 — Wockhardt's Answer, defenses, and Counterclaim (D.I. 9), together with its Rule 7.1 disclosure identifying Wockhardt Ltd. as corporate parent (D.I. 10). The counterclaim is the customary ANDA declaratory-judgment package (non-infringement and invalidity of the '708 patent). Wockhardt's pro hac vice counsel — David H. Silverstein, Aziz Burgy, and Christopher M. Gallo (Axinn, Veltrop & Harkrider) — were admitted 2019-03-12 (D.I. 11); Kelly E. Farnan (Richards, Layton & Finger) served as Delaware counsel.

2019-03-28 — Merck's Answer to the Counterclaim (D.I. 12).

No motion to dismiss, transfer, or stay was filed in the Wockhardt case. Wockhardt did not move to transfer venue; when Merck moved the JPML to centralize on 2019-05-15, Wockhardt (with the other Delaware defendants) took no position on centralization while suggesting Delaware as transferee

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 Merck Sharp & Dohme Corp. in this case.

Let me dig into the docket entries and individual attorney affiliations.

Let me verify the specific complaint signature block and pro hac vice motion (D.I. 6) for this case.

Plaintiff's Counsel of Record — Merck Sharp & Dohme Corp. v. Wockhardt Bio AG, No. 1:19-cv-00321-RGA (D. Del.)

Context note first: This case is one of ~14 companion Hatch-Waxman/ANDA actions Merck filed on Feb. 13, 2019 over U.S. Pat. No. 7,326,708 (sitagliptin phosphate — Januvia/Janumet/Januvet XR). They were centralized as In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 2902, C.A. No. 1:19-md-02902-RGA (D. Del.) (JPML transfer order, 402 F. Supp. 3d 1366 (J.P.M.L. 2019)). Merck staffed all of the sitagliptin cases with the same two-firm team, so the roster below is consistent across the MDL. This action settled via Consent Judgment, D.I. 115 (May 28, 2020) (proposed at D.I. 114), so no merits briefing on counsel's arguments ever issued here. Nothing about the appearance roster is sealed — counsel information is on the public docket; the sealed items in the MDL relate to the Teva/Alvogen amended complaints, not appearances.

1. Lead / merits counsel — Williams & Connolly LLP (Washington, DC)

Merck's national Hatch-Waxman counsel of record, admitted pro hac vice in Delaware. Per the docket, D.I. 6 was the motion for pro hac vice appearance (so-ordered by Judge Andrews on Feb. 22, 2019), and the docket reflects pro hac vice notices for Anthony H. Sheh (added Mar. 8, 2019) and Jingyuan Luo (added Mar. 7, 2019). The same W&C signature block appears on Merck's ANDA supplemental-information filings in the companion cases (e.g., C.A. No. 1:19-cv-00311).

Name Role Firm / Office Notes
Bruce R. Genderson Lead merits counsel (pro hac vice) Williams & Connolly LLP, 725 Twelfth St. N.W., Washington, DC Co-head of W&C's IP practice; one of the country's best-known Hatch-Waxman/§ 271(e) defense-and-enforcement litigators; long-time Merck outside counsel and frequent Federal Circuit advocate.
Stanley E. Fisher Merits counsel (pro hac vice); Merck's designated lead counsel in the parallel PTAB proceedings Williams & Connolly LLP, Washington, DC Named lead counsel for Patent Owner Merck in Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp., IPR2020-00040 (Reg. No. 55,820); also backup lead in the Teva IPR2020-01045 petition filings. Deep chemical/pharma patent bench.
Jessamyn S. Berniker Merits counsel (pro hac vice) Williams & Connolly LLP, Washington, DC Registered patent attorney on Merck's '708 IPR team (Reg. No. 72,328); pharmaceutical salts/polymorph and formulation litigation.
Shaun P. Mahaffy Merits counsel (pro hac vice) Williams & Connolly LLP, Washington, DC Reg. No. 75,534; part of the '708 district-court and IPR team.
Anthony H. Sheh Merits counsel (pro hac vice; entered Mar. 8, 2019) Williams & Connolly LLP, Washington, DC Reg. No. 70,576; listed on Merck's joint notice regarding district-court claim construction in IPR2020-00040.
Jingyuan Luo Merits counsel (pro hac vice; entered Mar. 7, 2019) Then Williams & Connolly LLP, Washington, DC; now Orrick, Herrington & Sutcliffe LLP, Silicon Valley office Biochemistry/stem-cell background; former law clerk to Judge Raymond T. Chen (Fed. Cir.); small-molecule salt/polymorph ANDA and BPCIA work.

Caveat: I could not independently confirm from free sources the full caption list of D.I. 6 (PACER paywall); the W&C group above is drawn from the Delaware docket's pro hac vice notices in this case plus the identical signature block/PHV motion used in the companion sitagliptin cases. Alexander S. Zolan (W&C) appears on the PHV motion in the related C.A. No. 1:19-cv-00872-RGA but I have not verified a Zolan appearance in 19-cv-321 — treat as unconfirmed for this case.

2. Local counsel of record — Young Conaway Stargatt & Taylor LLP (Wilmington, DE)

Under D. Del. Local Rule 83.5(d), Delaware counsel must be the CM/ECF-registered filers; Young Conaway signed and filed all papers here (e.g., D.I. 7, D.I. 8 summons returns and D.I. 12, Merck's answer to Wockhardt's counterclaim, filed by "Silver, Daniel"; the MDL consent judgment at D.I. 114/115 likewise filed by Silver).

Name Role Firm / Office Notes
Michael P. Kelly Lead local counsel of record (docket/CM-ECF lists him as LEAD ATTORNEY for Merck) Young Conaway Stargatt & Taylor LLP, Rodney Square, 1000 N. King St., Wilmington, DE Long-time Delaware local counsel for branded pharma in ANDA cases; a fixture on Judge Andrews' Hatch-Waxman docket.
Daniel M. Silver Local counsel (active filer) Young Conaway Stargatt & Taylor LLP, Wilmington, DE Helmed the day-to-day Delaware filings in this case and across the MDL (summons, answer/counterclaim, notices of service, consent judgments); also Delaware counsel for Genentech in Genentech v. Amgen.
Alexandra M. Joyce Local counsel Young Conaway Stargatt & Taylor LLP, Wilmington, DE Appears in the case's counsel listing; she filed a notice of appearance in the related Delaware Genentech matter the same spring (Mar. 29, 2019). Her appearance in 19-cv-321 specifically is not reflected in the truncated docket snapshots I could retrieve (docket last free-updated around Mar./Apr. 2019) — treat as probable but unconfirmed for this individual docket.

3. In-house counsel

No Merck in-house attorney is identified in the complaint signature block, notice of appearance, or PHV papers in this action. Merck's public filings were made through Williams & Connolly and Young Conaway. I found no source naming a Merck legal-department lawyer of record in 19-cv-321; do not assume one exists on the docket.

4. Parallel PTAB counsel (for cross-reference — not district-court counsel of record here)

In the IPRs against the '708 patent (Mylan v. Merck, IPR2020-00040; Teva/Watson v. Merck, IPR2020-01045), Merck's Patent Owner team included the Williams & Connolly attorneys above, plus Keith A. Zullow and Sarah J. Fischer of Goodwin Procter LLP (New York) as lead/backup counsel in the Teva-filed petition's service block. Note the distinction: Goodwin appears in the IPR paper as petitioner-side counsel of record in that filing's certificate, and the '708 IPR filings are dense enough that I'd flag this as a point to confirm directly from the PTAB record before attributing a role.

Summary of the plaintiff-side roster: lead merits counsel Williams & Connolly LLP (Washington, DC) — Bruce R. Genderson (lead), Stanley E. Fisher (also Merck's IPR lead), Jessamyn S. Berniker, Shaun P. Mahaffy, Anthony H. Sheh, Jingyuan Luo; local counsel Young Conaway Stargatt & Taylor LLP (Wilmington, DE) — Michael P. Kelly (lead), Daniel M. Silver (primary filer), and likely Alexandra M. Joyce.

Defendant representatives

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

I'll research the docket and counsel of record for the Wockhardt defendants.

Let me verify the specific firms and roles for each defense attorney.

Let me pull the actual docket entries and the Answer signature block.

Counsel of Record — Defendants Wockhardt Bio AG and Wockhardt USA LLC

Analyst note on sourcing: PACER is paywalled, so this is built from the Justia/Docket Alarm docket snapshot (last retrieved 3/28/2019), the UniCourt docket aggregation, the CourtListener/RECAP MDL No. 2902 record, USPTO PTAB filings, and firm/Chambers/IAM/World IP Review profiles. Everything below traces to a docket entry or a published filing. I flag the two items I could not independently confirm.

Defense team

# Attorney Role Firm / Office Notes
1 Kelly E. Farnan Delaware counsel of record (local/lead in-court) — signed the Answer and the PHV motion; the only Delaware-bar attorney on the team, and under D. Del. L.R. 83.5(d) the filer of all papers Richards, Layton & Finger, P.A., One Rodney Square, 920 N. King St., Wilmington, DE 19801 Director and head of RLF's Intellectual Property Group; Chambers USA Band 1 (Delaware IP), IAM Patent 1000 "Gold," named to MIP's Top 250 Women in IP. Deep ANDA track record in D. Del., e.g., Allergan USA v. Sun Pharm. Indus., C.A. No. 19-2317-RGA (for Sun) and Intel Corp. v. Fortress Inv. Grp.
2 David H. Silverstein Lead trial / merits counsel (appeared pro hac vice) — first-named movant on the PHV motion and the principal defense signatory on the MDL papers; Reg. No. 61,948 Axinn, Veltrop & Harkrider LLP, New York (114 W. 47th St., New York, NY) at the relevant time Joined Axinn as a partner in its IP Group in Dec. 2015 from in-house at Par Pharmaceutical, where he managed all patent, antitrust, unfair-competition and trade-secret litigation; led Par's IPR2017-01767 ('278 patent) as lead counsel. A senior Hatch-Waxman/ANDA litigator.
3 Aziz Burgy Backup/co-trial counsel (appeared pro hac vice); Reg. No. 51,514 Axinn, Veltrop & Harkrider LLP, Washington, DC (950 F. St. N.W. / 1901 L St. N.W.) Partner, IP Group; joined Axinn Dec. 2015 from Arent Fox. 30+ pharmaceutical and medical-device patent cases plus extensive PTAB practice; WIPR "Leaders" honoree. Later secured a six-patent consent judgment for Cosette Pharmaceuticals in the Firvanq litigation (D. Del.).
4 Christopher M. Gallo Backup counsel (appeared pro hac vice); Reg. No. 70,291 Axinn, Veltrop & Harkrider LLP, Washington, DC (950 F. St. N.W.) Axinn associate/attorney on the same IP team; appears alongside Silverstein and Burgy as backup counsel in Axinn's PTAB mandatory notices (e.g., IPR2017-01767).

In-house counsel: none appears on the docket. No Wockhardt in-house attorney entered an appearance of record.

Docket support

  • D.I. 9 (filed Mar. 7, 2019) — Answer to Complaint, Defenses, and Counterclaim by Wockhardt USA LLC and Wockhardt Bio AG, signed by Kelly E. Farnan. This is the operative appearance establishing Farnan as Delaware counsel of record.
  • D.I. 10 (Mar. 7, 2019) — Rule 7.1 Disclosure Statement identifying Wockhardt Ltd. as corporate parent of both defendants.
  • D.I. 11 (Mar. 11, 2019) — Motion for Pro Hac Vice Appearance of Attorney David H. Silverstein, Aziz Burgy, and Christopher M. Gallo, filed by Farnan.
  • Mar. 12, 2019 — motion SO ORDERED by Judge Richard G. Andrews.
  • Mar. 13, 2019 — the three PHV attorneys "added for electronic noticing," with the docket's standard L.R. 83.5(d) notation that Delaware counsel must be the CM/ECF filers.
  • D.I. 12 (Mar. 28, 2019) — Merck's Answer to the counterclaim (plaintiff's team: Daniel M. Silver and Alexandra M. Joyce, McCarter & English; Michael P. Kelly, Anthony H. Sheh and Jingyuan Luo, pro hac vice).

Post-2019: the action was folded into In re: Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 2902. In that consolidated proceeding, Silverstein filed a Notice of Waiver of Oral Argument (MDL Dkt. 49), styled on behalf of "Defendants Anchen Pharmaceuticals, Inc., Par Pharmaceuticals, Inc., Wockhardt Bio AG, Wockhardt USA LLC" — confirming Axinn as the continuing merits counsel for Wockhardt. This case was closed 05/28/2020 on settlement, consistent with the case status in the metadata.

Caveats and things I could not verify

  1. Silverstein's current firm affiliation. His Axinn partnership (NY) is documented as of the 2018–2019 filings and PTAB notices. Recent directory/ranking coverage (e.g., Benchmark Litigation's Axinn profile) names Aziz Burgy in DC but does not re-list Silverstein, and I found no withdrawal notice on the docket snapshot I could access. Treat his Axinn/NY affiliation as accurate as of the case's pendency, not necessarily today.
  2. Docket coverage is incomplete. The Justia snapshot was last retrieved 3/28/2019 and the UniCourt snapshot 4/14/2019, so any late-2019/2020 appearances, substitutions, or a formal stipulation of dismissal naming additional counsel could not be captured. If you need the complete appearance list (including any attorney who appeared only for the MDL phase or the IPR), a direct PACER pull of the 1:19-cv-00321-RGA docket and MDL No. 2902 docket is required.
  3. No sealed-filing issue: the docket entries I relied on (D.I. 9, 10, 11, 12) are public; I found no indication that counsel identification was placed under seal.
  4. I did not find any separate Delaware local counsel beyond Farnan/RLF during the 2019 window, and no evidence that Wockhardt Bio AG and Wockhardt USA LLC were represented by different firms in this action — a single Axinn/RLF team acted for both.

Bottom line: four attorneys of record for the Wockhardt defendants — Kelly E. Farnan (Richards, Layton & Finger, Wilmington — Delaware/local lead); and David H. Silverstein, Aziz Burgy, and Christopher M. Gallo (Axinn, Veltrop & Harkrider — New York and Washington, DC, admitted pro hac vice, per D.I. 11). No in-house counsel of record.