Litigation

Merck Sharp & Dohme Corp. v. MSN Laboratories et al.

settled

Patents at issue (1)

7326708

Summary

Settled by consent judgment; unless authorized by the settlement agreement, MSN is enjoined from infringing the '708 patent, and all claims, counterclaims, affirmative defenses, and demands were dismissed with prejudice.

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 verify the details before writing the overview.

Let me dig deeper into the specific MSN case docket and the '708 patent's IPR history.

Now let me verify the trial outcome against Mylan, the antitrust angle, and MSN-specific details.

Case Overview and Background

Parties. This is a conventional brand-versus-generic Hatch-Waxman action, not an NPE/PAE or university assertion. The plaintiff, Merck Sharp & Dohme Corp., is the operating pharmaceutical subsidiary of Merck & Co., Inc. and the owner/assignee of the patent-in-suit; it is unrelated to the FTC's "assertion entity" category (the Stanford NPE Litigation Database classifies Merck as a "product company" asserter for the '708 patent). Merck's Delaware counsel of record in the sitagliptin matters was McCarter &

Key legal developments & outcome

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

I'll research this case thoroughly across multiple sources.

Key Legal Developments & Outcome — Merck Sharp & Dohme Corp. v. MSN Pharmaceuticals Inc. et al.

Framing note. This case is not a stand-alone lawsuit; it is one tag-along action inside In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 19-2902-RGA (D. Del.), before Judge Richard G. Andrews. The MSN action is C.A. No. 1:21-cv-01172-RGA, and nearly every substantive event in it is a docket entry cross-filed in both the individual case and the MDL. That framing matters: the MDL's claim-construction and IPR activity shaped this case even though MSN itself never litigated a motion.

1. Pre-history: the MDL and the earlier MSN action

Date (YYYY-MM-DD) Event
2019-02-13/14 Merck files the first wave of sitagliptin ANDA suits in D. Del. (C.A. Nos. 19-310 through 19-321) against Alvogen, Anchen/Par, Sandoz, Apotex, Zydus, Teva, Watson, Sun, Torrent, Wockhardt, and others, plus a separate action against Mylan in N.D. W. Va.
2019-07 (transfer order; MDL docket opened 2019-08-08) JPML centralizes pretrial proceedings in D. Del. before Judge Andrews. See J.P.M.L., In re: Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 2902, Transfer Order — https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2902-Initial_Transfer-07-19.pdf

Earlier, separate MSN action (background only — different court): Merck had previously sued MSN over the same product line in Merck Sharp & Dohme Corp. v. MSN Laboratories Private Ltd. and MSN Pharmaceuticals, Inc., No. 3:18-cv-00675 (D.N.J., Judge Peter G. Sheridan), filed 2018. The docket shows pro hac vice admissions for Merck's Irell & Manella team (Bruce M. Wexler, Preston K. Ratliff II, Scott F. Peachman) and a defense appearance by Philip L. Hirschhorn, with a scheduling conference on 2018-06-13. I could not verify the disposition of that D.N.J. action within my search budget — treat its outcome as unsourced.

2. Filing and initial pleadings in the D. Del. action

Date Docket / Event
2021-08-12 Complaint filed, D.I. 1 — Merck Sharp & Dohme Corp. v. MSN Laboratories Private Limited and MSN Pharmaceuticals Inc., 1:21-cv-01172-RGA (D. Del.). ANDA/§ 271(e)(2) action asserting U.S. Patent No. 7,326,708 ('708, the sitagliptin dihydrogenphosphate crystalline monohydrate patent). D.I. 3 (ANDA supplemental information): patentee's paragraph IV notice received no earlier than 2021-06-30; patent expiration 2026-11-24 (2027-05-24 with pediatric exclusivity); 30-month stay deadline no earlier than 2023-12-30. D.I. 4 (Patent/Trademark Report); D.I. 5 (Rule 7.1 disclosure, parent Merck & Co., Inc.).
2021-08-12 Companion case 1:21-cv-01173-RGA filed the same day (a second defendant group); the two were assigned together to Judge Andrews on 2021-08-18.
2021-09-08 Pro hac vice appearance of David M. Krinsky (Merck), granted — cross-entered at MDL D.I. 572.
2021-09-13 Waivers of service sent to both MSN entities.
2021-11-12 Answer deadline (first). D.I. 7 & 8 (waivers returned executed) set answer due 2021-11-12.
2021-11-19 Oral Order: Judge Andrews notes that no answers had been filed by the 11/12 deadline and orders a status letter.
2021-11-23 Stipulation to extend MSN's time to answer/move to 2021-12-13, so ordered (D.I. 10; MDL D.I. 628). Earlier that day the Clerk struck MSN's/ plaintiff's filing at D.I. 10 for failing to reference the MDL caption — a small but real procedural hiccup in MDL housekeeping.
2021-12-15 Oral Order again noting that MSN's answers, due 2021-12-13, had not been filed, and directing Merck to file a status letter within three days.
2021-12-20 Joint Status Report and Stipulation to Extend Time to 2022-01-20, so ordered (D.I. 12; MDL D.I. 643).
2022-01-07 PROPOSED Consent Judgment filed (D.I. 13).

What did not happen: MSN never filed an answer, counterclaims, or affirmative defenses in the D. Del. action. The docket shows repeated extensions and the court's twice-issued oral orders flagging the missing answers — the clear signature of settlement negotiations running in parallel with the pleading deadline. So the "answer/counterclaims" stage of this case is essentially

Plaintiff representatives

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

I'll research the docket and counsel for this case.

Let me pull the full docket and identify all plaintiff-side appearances.

Let me confirm the appearance list and firm affiliations.

Counsel of Record — Plaintiff Merck Sharp & Dohme Corp.

Case: Merck Sharp & Dohme Corp. v. MSN Pharmaceuticals Inc. and MSN Laboratories Private Limited, No. 1:21-cv-01172-RGA (D. Del.), filed Aug. 12, 2021; U.S. Patent No. 7,326,708 ("DHP salt of sitagliptin," Januvia®). Assigned to Judge Richard G. Andrews; docketed as a member case of In re Sitagliptin ('708 & '921) Patent Litig., No. 1:19-md-02902-RGA (D. Del.). Closed by consent judgment, D.I. 13–14 (Jan. 7, 2022). (docket; Patexia docket; UniCourt)

The case was short-lived (complaint → consent judgment in ~5 months), so the public appearance list is short. All counsel below appear on the docket for this case; where a person's connection is only to the parallel proceedings, I flag it.

Delaware / local counsel of record — McCarter & English LLP (Wilmington, DE)

Attorney Role Notes
Daniel M. Silver Counsel of record; filed the lead non-resident appearance motion (D.I. 6, Sept. 8, 2021) McCarter & English LLP, 405 N. King St., 8th Fl., Wilmington, DE. The Delaware IP litigator who together with Alexandra Joyce staffs Merck's Delaware Hatch-Waxman dockets — the same pairing appears as "Attorneys for Plaintiffs" in Merck's later Delaware ANDA suits (e.g., the 2025 Changzhou/Torrent/MSN matter, C.A. No. 1:25-cv-00479-GBW). (D.I. 6 docket text; later Merck Delaware filing)
Alexandra M. Joyce Delaware counsel of record; functionally the day-to-day filer McCarter & English LLP, Wilmington, DE. Signed the waiver-of-service returns (D.I. 7–8, Sept. 17, 2021), the status report/stipulations (D.I. 10, 12), and the proposed consent judgment (D.I. 13). (Patexia docket)
Michael P. Kelly Listed among plaintiff's attorneys of record on the docket for 1:21-cv-01172 McCarter & English LLP, Wilmington, DE. The Justia/UniCourt party-attorney listing identifies him as plaintiff-side counsel alongside Silver and Joyce. Caveat: I was unable to re-verify his individual firm bio page or a specific filing signed by him in this docket before hitting research limits — treat his precise role (lead vs. supervisory) as unconfirmed. (UniCourt)

Non-resident / national counsel — Williams & Connolly LLP (Washington, DC)

Attorney Role Notes
David M. Krinsky Pro hac vice (motion D.I. 6; SO ORDERED by Judge Andrews Sept. 8, 2021) — the only non-Delaware attorney formally admitted in this case Williams & Connolly LLP, 680 Maine Ave. SW, Washington, DC. Krinsky is part of the Williams & Connolly team defending the '708 patent for Merck; he was added as backup counsel for Patent Owner in the PTAB proceeding on the same patent, Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp., IPR2020-00040 (Fourth Amended Mandatory Notices). The PHV motion was filed jointly across the MDL and 14+ member/related '708 cases, including 21-cv-1172. (pro hac vice order; IPR2020-00040 mandatory notices)

Attorneys connected to the same patent/MDL but not confirmed on the 1:21-cv-01172 docket

  • Stanley E. Fisher (Williams & Connolly LLP, Washington, DC) — Merck's named lead counsel for Patent Owner in the final written decision of IPR2020-00040 (May 7, 2021), where the PTAB upheld claims of the '708 patent, and a fixture of the sitagliptin MDL. He is the natural "lead counsel" for the Merck side of this patent family, but I cannot confirm a docket entry for him in 21-cv-01172 specifically. (IPR2020-00040 FWD counsel listing)
  • Jessamyn S. Berniker, Shaun P. Mahaffy, Anthony H. Sheh (Williams & Connolly LLP) — listed with Fisher as Patent Owner's counsel on the IPR2020-00040 final written decision. Do not attribute these to the district court docket on this record.

Explicit gaps / caveats

  1. No Merck in-house attorney is identified on the public docket for 21-cv-01172 — Merck's Rule 7.1 disclosure (D.I. 5) names Merck & Co., Inc. as parent but no corporate counsel. In-house counsel, if any, did not enter an appearance.
  2. No formal "entry of appearance" filings by Williams & Connolly appear in this docket besides the Krinsky pro hac vice motion and certification — typical for a case resolved on a consent judgment before any substantive motion practice.
  3. The docket as publicly mirrored (Justia last retrieved Sept. 17, 2021; UniCourt last updated Oct. 11, 2021; Patexia through Jan. 2022) shows only 15 docket entries. Any PACER-only appearance or sealed filing after those retrieval dates is not reflected here. Given the case closed Jan. 7, 2022, additional appearances are unlikely but I cannot rule them out without a live PACER pull.
  4. Note the firm/docket distinction: McCarter & English is Delaware counsel (admitted in D. Del.); Williams & Connolly is the national/PTAB-side firm. If you need the definitive lead-counsel designation for settlement purposes, the operative document is the consent judgment (D.I. 14) and the signature blocks on D.I. 13, both signed by Alexandra M. Joyce for plaintiff.

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 appearances for the MSN defendants.

Let me pin down the specific docket and defendant counsel appearances.

The docket shows an early consent judgment — let me determine whether defense counsel ever entered an appearance.

Record id: 7326708-merck-sharp-dohme-corp-v-msn-laboratories-msn-pharmaceuticals · edit in Admin