Litigation

Merck Sharp & Dohme Corp. v. Sandoz Inc.

settled

1:19-cv-00312-RGA

Filed
2019-02-13

Patents at issue (1)

7326708

Defendants (1)

Summary

Action asserting the '708 patent; resolved by settlement/consent judgment.

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 before drafting. Let me run several searches in parallel.

Good foundation. Now let me verify the Sandoz-specific docket events, the settlement/consent judgment, and market context.

Key legal developments & outcome

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

I'll research the key legal developments in this litigation, building on the prior sections.

Let me dig into the Sandoz-specific docket events, the consent judgment, and the PTAB/ Federal Circuit outcomes.

I hit the tool-call limit mid-research, so I'll present what is well-sourced and flag the gaps explicitly. Note two important framing points before the chronology: (1) the Sandoz action was never tried and never separately construed — it was folded into MDL No. 2902 before Judge Andrews, and it ended in a negotiated consent judgment, so the "outcome" is a settlement, with the substantive validity fight against other ANDA filers (chiefly Mylan) supplying the merits rulings that shaped the '708 patent's fate; and (2) I was able to verify the MDL-wide events and PTAB/Federal Circuit events with primary documents, but not every Sandoz-specific docket entry (I ran out of searches before pulling the full 19-cv-312 docket).

Key legal developments and outcome — Merck Sharp & Dohme Corp. v. Sandoz Inc., No. 1:19-cv-00312-RGA

1. Pre-suit posture and filing (Feb. 2019)

The action is one of a wave of 14 Hatch-Waxman suits Merck filed on 2019-02-13 after generic manufacturers submitted 26 ANDAs seeking approval of sitagliptin phosphate generics (Januvia®, Janumet®, Janumet XR®). Merck asserted the '708 patent (dihydrogenphosphate salt of sitagliptin; expiry 2026-11-24, with pediatric exclusivity to 2027-05-24) against 23 defendants in 13 Delaware actions plus one N.D. W. Va. action, and the '921 patent against three of those groups. (JPML MDL-2902 transfer order; IPR2020-00040 Petition, D.I. 6–7; OB listing at thefdalawblog.com.)

  • 2019-02-13 — Complaint filed, 35 U.S.C. § 271(e)(2), D. Del., assigned to Judge Richard G. Andrews. Sandoz answered on the merits — no motion to dismiss or transfer was filed by Sandoz; the case proceeded straight to MDL coordination.

2. Pleadings and appearances (Feb.–Apr. 2019)

Date Docket event (19-cv-312) Significance
2019-02-14 Service on Sandoz; D.I. 7 declaration of mailing (filed 2019-02-25) Triggered the § 355(j)(5)(B)(iii) 30-month stay
2019-02-28 D.I. 8 Notice of Appearance (Dominick T. Gattuso); D.I. 9 stipulation extending answer to 2019-04-10 Local counsel enters
2019-03-07/03-08 Merck pro hac vice admissions (Jingyuan Luo; Anthony H. Sheh) Williams & Connolly team enters
2019-04-10 D.I. 10 Answer, Defenses, and Counterclaims; D.I. 11 Rule 7.1 disclosure (parent: Novartis AG) Sandoz counterclaimed non-infringement and invalidity of the '708 patent
2019-04-10/11/12 D.I. 12 PHV motion (Zullow, Rapalino, Jefferson, Larochelle), granted 2019-04-11, notices 2019-04-12 Goodwin Procter team of record

(Source: Justia docket 1:2019cv00312/67785; CourtListener docket 14640212.)

3. MDL centralization (Aug. 2019)

  • 2019-08-08 — JPML Transfer Order created In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 2902, transferring the N.D. W. Va. action to D. Del. and consolidating pretrial proceedings before Judge Andrews (master docket 1:19-md-02902-RGA). The order expressly justified centralization to "prevent inconsistent rulings (particularly with respect to claim construction and issues of patent validity)." 19-cv-312 was one of the constituent actions. (JPML, MDL-2902-Initial_Transfer-07-19.pdf.)

This is the single most important procedural fact for the Sandoz case: after August 2019 the Sandoz action advanced as one track within the MDL, sharing Markman, discovery, and (for some defendants) expert practice with the other generics.

4. Parallel PTAB proceeding on the '708 patent (Oct. 2019 – May 2021

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 plaintiff in this case using multiple searches.

Let me pull the docket details and verify the plaintiff's counsel firms.

Plaintiff's Counsel of Record — Merck Sharp & Dohme Corp. v. Sandoz Inc., No. 1:19-cv-00312-RGA (D. Del.)

Plaintiff Merck Sharp & Dohme Corp. was represented by a two-firm team: McCarter & English, LLP (Wilmington, DE) as Delaware/local counsel and Williams & Connolly LLP (Washington, DC) as lead trial counsel appearing pro hac vice. This case was filed as one of the related "Sitagliptin Phosphate ('708 & '921) Patent Litigation" actions consolidated before Judge Andrews as In re Sitagliptin Phosphate Patent Litigation, 19-md-2902-RGA, and the same Merck team appeared across those related complaints. (CourtListener docket 14640212; MDL caption reflected in the Torrent consent judgment, No. 19-320-RGA, D.I. 45.)

Caveat up front: the case was resolved by settlement/consent judgment and terminated September 27, 2021 (FJC IDB record for 1:19-cv-00312). Filings themselves are public (there was no sealing of the appearances), but I was not able to pull every individual docket entry directly from PACER, so entry numbers below are drawn from RECAP/CourtListener and third-party docket mirrors and should be verified against the live docket.

Delaware / Local Counsel — McCarter & English, LLP (Renaissance Centre, 405 N. King St., 8th Floor, Wilmington, DE 19801)

These three attorneys signed the complaint, the Rule 7.1 disclosure, and the ANDA supplemental-information form, and are of record as Merck's Delaware counsel.

Attorney Role Notes
Daniel M. Silver (Del. Bar #4758) Delaware counsel of record / local counsel; primary signer on Merck's filings (complaint, disclosures, stipulations) McCarter Wilmington partner; Chambers-ranked Delaware IP litigator; extensive Hatch-Waxman/ANDA and life-sciences patent litigation (e.g., Genentech v. Amgen, D. Del.; Novartis in the Entresto MDL, 20-md-2930-RGA).
Michael P. Kelly (Del. Bar #2295) Delaware counsel of record / local counsel (senior Delaware partner; listed "lead attorney" on related McCarter dockets) Longtime head of McCarter's Delaware IP practice; frequently counsel to brand pharma in Delaware ANDA cases (including BMS v. Merck PD-1 litigation and Koninklijke Philips); publicly describes McCarter as refusing to represent the generic side.
Alexandra M. Joyce (Del. Bar #6423) Delaware counsel of record (now partner, elevated April 1, 2025) Chambers-ranked in Intellectual Property–Delaware; focuses on Hatch-Waxman/ANDA and complex commercial litigation for pharma/life-sciences clients; represented Merck across numerous Delaware ANDA suits.

Out-of-State / Lead Counsel (pro hac vice) — Williams & Connolly LLP (725 Twelfth St. NW, Washington, DC 20005)

Merck moved for pro hac vice admission of these six Williams & Connolly attorneys early in the case (motion at D.I. 7, granted by Judge Andrews); they are the substantive/lead counsel of record. The same Williams & Connolly team served as Merck's counsel in the parallel PTAB proceedings on the '708 patent.

Attorney Role Notes
Bruce R. Genderson Lead trial counsel (pro hac vice) Williams & Connolly partner and leading patent/appellate advocate; frequent Federal Circuit and Supreme Court patent litigator for brand pharma.
Jessamyn S. Berniker Lead/backup counsel (pro hac vice) Williams & Connolly partner; known for PTAB/IPR and patent litigation work; designated Merck backup counsel in the '708 IPRs.
Stanley E. Fisher Counsel (pro hac vice) Williams & Connolly partner; designated Merck's lead counsel in the parallel PTAB IPRs on the '708 patent (Reg. No. 55,820); veteran Hatch-Waxman/patent litigator.
Shaun P. Mahaffy Counsel (pro hac vice) Williams & Connolly; designated Merck backup counsel in the '708 IPRs.
Anthony H. Sheh Counsel (pro hac vice) Williams & Connolly (Reg. No. 70,576); designated Merck backup counsel in the '708 IPRs.
Jingyuan Luo Counsel (pro hac vice; admitted for electronic noticing March 7, 2019) Williams & Connolly associate/counsel on the Merck team.

Additional later appearance: Vanessa O. Omoroghomwan (Williams & Connolly) was added as a pro hac vice attorney for Merck on the docket at a later stage per third-party docket mirrors — I could not independently confirm the date or the specific filing, so treat this as lower-confidence.

Notes on sourcing / limitations

  • The names, roles, and firm affiliations above are well grounded in the complaint caption and Rule 7.1 disclosure (both McCarter and the case documents reproduced at paragraphfour.com and Docket Alarm), the Docket Alarm/CourtListener docket entries for the pro hac vice motions, and the Williams & Connolly mandatory-notice filings in the related '708 patent IPRs (PTAB petitions 1537262 / 1537482), which list Fisher, Berniker, Genderson, Zolan, Baumgarten, Mahaffy, and Sheh as Merck's counsel.
  • I was not able to verify individual docket entry numbers for every appearance from PACER directly; the pro hac vice motion is at approximately D.I. 7, and the pro hac vice admissions were docketed March 7–8, 2019. Confirm against the live PACER docket before citing specific entry numbers.
  • I did not find any indication that Merck used in-house counsel of record under Rule 83.5 in this particular case (in-house Merck attorneys such as Paul D. Matukaitis and Edward W. Murray appear as "of counsel" on some other Merck complaints, but I could not confirm their appearance here).
  • Because the case settled, no trial-team lineup or fee/lead-counsel designation from a pretrial order was located; the "lead vs. local" labels above reflect the conventional division of labor on the docket and in the MDL rather than an express court designation.

Defendant representatives

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

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

Let me dig into the specific firms and attorneys.

Bottom line

Sandoz's defense team in Merck Sharp & Dohme Corp. v. Sandoz Inc., No. 1:19-cv-00312-RGA (D. Del.) was a Goodwin Procter LLP national team working with Wilmington local counsel Dominick T. Gattuso. The case ran 2/13/2019 – 9/27/2021 and was resolved by consent judgment (D.I. 187), not by trial, so the roster below is the roster that appeared on the docket and litigated through the pretrial stage (including in the consolidated MDL 19-md-02902-RGA).

One important sourcing caveat up front: the docket entries below are verified from CourtListener/RECAP, Justia and UniCourt captures of the PACER docket; the firm affiliations for two of the pro hac vice attorneys (Jefferson, Larochelle) and for Zhu/Fischer are not stated in the docket text I could retrieve and are flagged as unconfirmed. No counsel names here are inferred beyond what appears in docket entries.

Counsel of record for Sandoz Inc.

Attorney Role Firm / office Basis (docket) Note on experience
Dominick T. Gattuso Local (Delaware) counsel; functionally lead Delaware counsel — signed the answer, counterclaims, stipulations and all filing-side papers Heyman Enerio Gattuso & Hirzel LLP, Wilmington, DE D.I. 8, Notice of Appearance (2/28/2019); D.I. 9 (stipulation to extend); D.I. 10 (Answer, Defenses & Counterclaims, 4/10/2019); D.I. 12 (PHV motion) Long-time Delaware ANDA/patent local counsel (Super Lawyers IP litigation; Best Lawyers; AV-rated); routinely Delaware counsel to national firms in Hatch-Waxman cases (e.g., Dr. Reddy's and other generic-defendant dockets). Vice-chair, ABA IP Section Chemical & Life Sciences Patent Committee.
Keith A. Zullow Lead trial counsel (pro hac vice); filed the PHV motion and was the principal Goodwin attorney for Sandoz Goodwin Procter LLP, New York (NYT Building, 620 Eighth Ave.) — since 2024, Gemini Law LLP D.I. 12, Mot. for PHV Appearance of Zullow, Rapalino, Jefferson & Larochelle (4/10/2019); granted 4/11/2019; PHV notice entered 4/12/2019 ~30 years of pharma/biotech IP litigation; registered patent attorney (Reg. No. 37,975); 20-year Goodwin partner in Life Sciences Disputes. Trial/lead counsel for Roxane, West-Ward and Teva in ANDA litigations and IPRs (e.g., Novartis compound-patent case; CELEBREX®; VIAGRA®; PULMICORT RESPULES®); Best Lawyers "Litigation – Patent" 2021–2024.
Emily L. Rapalino Pro hac vice counsel; Goodwin IP Litigation partner / Life Sciences Disputes Goodwin Procter LLP, Boston (100 Northern Ave.) D.I. 12 (PHV motion, granted 4/11/2019); PHV notice 4/12/2019 Brings advanced biology degrees to small-molecule and biologics disputes; key role in Cephalon/Treanda® trial win and in Sandoz's Esbriet® (pirfenidone) district-court and Federal Circuit wins (Genentech v. Sandoz, 55 F.4th 1368 (Fed. Cir. 2022)); Sandoz-side counsel in the Federal Circuit Latisse®/bimatoprost appeal; 2026 BTI Client Service All-Star.
Julius Jefferson Pro hac vice counsel (appearance allowed 4/2019) Firm affiliation not confirmed from the retrieved docket text — the PHV motion (D.I. 12) groups him with the Goodwin team, and contemporaneous Goodwin/MDL 19-2902 filings show the Sandoz side staffed by Goodwin Procter, so Goodwin Procter is the strong inference, but I could not verify it against a primary source D.I. 12; PHV "added for electronic noticing" 4/12/2019 Verify independently before relying on this entry; I did not retrieve a firm bio or a signature block for him in this case.
Christie Larochelle Pro hac vice counsel (appearance allowed 4/2019) Firm affiliation not confirmed — same caveat as Jefferson (grouped with the Goodwin team on D.I. 12) D.I. 12; PHV notice 4/12/2019 Verify independently; no firm bio or case signature block retrieved.
Shaobo Zhu Pro hac vice counsel, added February 2020 Firm not confirmed from retrieved sources D.I. 46 (2/10/2020), Motion for PHV Appearance of Attorneys Shaobo Zhu and Sarah J. Fischer, filed in 19-cv-312 and companion cases 19-cv-317/318 and 19-md-2902; granted by Judge Andrews 2/10/2020; PHV notices entered for Sandoz Docket text lists the motion as filed by Teva/Watson/Sandoz jointly (these were coordinated '708 / ANDA matters), so read the Sandoz-specific scope of appearance with care.
Sarah J. Fischer Pro hac vice counsel, added February 2020 Firm not confirmed from retrieved sources Same D.I. 46 / 2/10/2020 PHV order and notice Same caveat as Zhu.

In-house counsel: no Sandoz (Novartis) in-house attorney appears of record in the retrieved docket entries; Sandoz's Rule 7.1 disclosure identified Novartis AG as its corporate parent (D.I. 11, 4/10/2019).

What I could not verify / possible false leads

  • "K. Dorsney" and "J. Phillips" as Sandoz counsel. A third-party aggregator (Patexia) lists "K. Dorsney, J. Phillips, D. Gattuso" against this case name. Kennth L. Dorsney (Morris James) practices Delaware patent local counsel work, but I found no PACER-derived entry putting Dorsney or any "J. Phillips" on the Sandoz side of 19-cv-312. That listing is most likely an artifact of the consolidated/associated-case grouping (Judge Andrews' related Merck '708 dockets, 19-cv-310 through 19-cv-321, and 19-md-2902-RGA). Do not treat it as a counsel-of-record entry without pulling the docket.
  • Sealed material. Several pretrial filings were sealed (e.g., D.I. 186, [SEALED] Amended Exhibit to Proposed Pretrial Order, 9/24/2021, with a minute entry noting no redacted version was filed). Sealing affected expert reports/exhibits, not the appearance docket — counsel identities are public. The only genuinely missing firm-level data are the plaintiffs'-side-vs-defendant-side signature blocks