Merck Sharp & Dohme Corp. v. Annora Pharma Private Ltd.

I'll research this case thoroughly. Let me start with the docket and patent details.

Let me dig into the specific docket for this case.

Let me pull the full docket and the settlement terms, plus the MDL context.

Case Overview & Background

Parties. Merck Sharp & Dohme Corp. (since May 2022, Merck Sharp & Dohme LLC, following an internal merger) is the plaintiff — a wholly owned subsidiary of Merck & Co., Inc. and the holder of the New Drug Applications for Januvia® (sitagliptin phosphate), Janumet® (sitagliptin/metformin HCl), and Janumet XR®. This is a classic operating-company/Hatch-Waxman assertion, not an NPE or university suit: Merck sued to protect a branded diabetes franchise, was represented in the MDL by McCarter & English (Daniel M. Silver, Alexandra M. Joyce) and Williams & Connolly (Bruce R. Genderson, Alexander S. Zolan, Jessamyn S. Berniker), per the MDL docket for 1:19-md-02902-RGA. Defendant Annora Pharma Private Ltd. is an Indian generic manufacturer; the docket in this case also names Hetero USA Inc. as a co-defendant and the consent judgment runs to both (19-md-02902, D.I. 653). Annora's filings were made by Kevin Capuzzi (Annora/Hetero's Paragraph 3 initial disclosures, D.I. 645–646), and parallel Merck complaints in this district allege Annora acts as an agent of Hetero, which "made the ultimate decision to file the Annora ANDA" — a relationship Merck has used to establish personal jurisdiction over the foreign manufacturer. Caveat: I could not verify Annora's full lead-trial-counsel lineup from a primary source.

Accused product and patent. The accused technology is Annora's Abbreviated New Drug Application for generic sitagliptin phosphate tablets (25/50/100 mg) referencing Januvia, based on a Paragraph IV certification that the patent-in-suit is invalid, unenforceable, and/or not infringed. The sole patent asserted here is U.S. Patent No. 7,326,708 ("the '708 patent"), which claims the 1:1 dihydrogen phosphate (DHP) salt of sitagliptin — i.e., one phosphate anion paired with one sitagliptin amine cation — as well as its crystalline monohydrate, pharmaceutical compositions, and processes for making it (see the claim constructions in Judge Andrews' Nov. 17, 2020 Markman opinion, 19-md-02902, D.I. 310). In plain terms: the '708 patent is the salt/polymorph patent, not the underlying compound patent. Because the earlier sitagliptin compound patent (6,699,871) has expired, '708 is the last-expiring U.S. patent covering the marketed salt form, listed in

I'll research this case across docket sources, court opinions, and PTAB records.

Bottom line

Merck Sharp & Dohme Corp. v. Annora Pharma Private Ltd., No. 1:21-cv-01006-RGA (D. Del.) was a short-lived, settlement-driven Hatch-Waxman case — not a merits litigation. It was filed 2021-07-09 and terminated roughly seven months later by a consent judgment entered 2022-02-10 that enjoined Annora from infringing U.S. Patent No. 7,326,708 unless the settlement agreement authorized otherwise. The case never reached Markman, summary judgment, or trial. Its real significance is contextual: it was the last wave of Merck's Januvia®/Janumet® (sitagliptin phosphate) ANDA campaign and it closed on the strength of Merck's PTAB win on the same patent.

A sourcing caveat up front: I reconstructed the docket from the Unified Patents Delaware litigation portal (a PACER mirror), Justia's docket index, the PTAB petition/notice filings on PTAB CTS, and Robbins Kaplan's Generically Speaking ANDA-settlement bulletins. I was not able to pull the PACER docket directly, so a few intermediate docket entries (noted below) are dated only to the month/period.

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1. Filing and initial pleadings

Counsel for defendants: Annora was represented by Bayard P.A. (Stephen B. Brauerman, Ronald P. Golden III) and Carlson Caspers (Todd S. Werner, Saukshmya Trichi) in the parallel Annora matters, with Manish K. Mehta and Zaiba Baig admitted pro hac vice in this case (D.I. 11, 12, granted 2021-10-05).

2. Answer and counterclaims — apparently never filed

No answer, affirmative defenses, or counterclaims appear on this docket. The timeline instead shows Merck granting extensions:

• 2021-09-09 — Stipulation (D.I. 9) extending defendants' deadline to answer/move to 2021-10-11, so-ordered by Judge Andrews (cross-filed at D.I. 574 in the MDL).
• 2021-10-05 — Two pro hac vice motions granted.
• 2021-11-29 — The Rule 16(b) scheduling conference set for 2021-11-30 was cancelled — an early signal that the parties were negotiating rather than litigating.
• 2021-12-03 — Correcting entry striking deficient notices of service that omitted the MDL cross-reference.
• Undated in my sources (late 2021/early 2022) — The case was referred to Magistrate Judge Mary Pat Thynge for mediation under the District's standing ADR order.

I could not find a filed answer or counterclaim complaint in any source. If one was filed, it was withdrawn or superseded as part of the settlement, and I don't want to attribute specific invalidity/non-infringement theories to Annora without the document.

3. Pre-trial motions of substance — none

There were no motions to dismiss, no § 1404(a) transfer motion, no motion to stay pending IPR, and no summary judgment practice. The only substantive motions were the two pro hac vice appearances and the agreed extension. The absence of a stay motion is notable: four IPR petitions against the '708 patent were pending or decided during the case's life (see § 6), and the case was resolved rather than stayed.

4. Claim construction (Markman) — never reached

The case terminated before the Rule 16(b) conference, so no claim construction order, no Markman hearing, and no joint claim construction statement. For context, the '708 patent had been construed in the consolidated MDL and in the parallel N.D. W. Va. action, but nothing issued in 21-1006.

5. Discovery milestones — none of strategic significance

No scheduling order issued and no discovery was taken. The only "discovery-adjacent" filings were the notices of service in December 2021 that were struck for failure to cross-reference the MDL.

6. Parallel PTAB proceedings on the '708 patent (highly relevant)

The '708 patent was one of the most heavily attacked patents in the sitagliptin campaign. The relevant IPRs:

The three June 2020 petitions were all styled as "substantially identical" to IPR2020-00040 with express requests for joinder under § 315(c), arguing the § 325(d)/§ 314(a) General Plastic and NHK Spring factors. The Board's 2020-09-01 papers for those three cases are reported by DrugPatentWatch as their decision dates; I could not independently confirm from PTAB CTS whether each was an institution/joinder grant or a denial, so I'm flagging that as unverified.

Effect on the litigation: the 2021-05-07 FWD in IPR2020-00040 was the decisive event. With the '708 claims upheld at the Board and Annora facing the MDL's coordinated schedule, Annora settled rather than litigate.

7. Settlement and final disposition

Publicly available terms (per Robbins Kaplan's Generically Speaking Q1 2022 ANDA-settlement bulletin, listing "Merck Sharp & Dohme Corp. v. Annora Pharma Private Ltd., 21-1006 (D. Del.), Januvia® (sitagliptin phosphate tablets), 7,326,708"): "Unless specifically authorized under the settlement agreement, Annora is enjoined from infringing the patent-in-suit." The consent judgment uses the same template Merck employed across the sitagliptin settlements — a defined "Annora Product" tied to the ANDA, "Licensed Patent" = '708, an Affiliate definition, a covenant enforceable per the settlement agreement, and retained district-court jurisdiction to enforce. The license entry date, royalty terms, and any acceleration provisions are confidential and not public.

No appeal was taken in 21-1006, and there is no present posture — the case is closed

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

Plaintiff's Counsel of Record — Merck Sharp & Dohme Corp. v. Annora Pharma Private Ltd., No. 1:21-cv-01006-RGA (D. Del.)

Important framing / sourcing caveat up front. This case was filed July 9, 2021 and closed only ~7 months later by consent judgment (D.I. 26, signed by Judge Richard G. Andrews on Feb. 10, 2022, per the docket: "CONSENT JUDGMENT between Annora Pharma Private Limited, Hetero USA Inc., and Merck Sharp & Dohme Corp."; "CASE CLOSED per D.I. 26"). It was pleaded as a tag‑along to the sitagliptin MDL, In re: Sitagliptin Phosphate ('708 & '921) Patent Litigation, No. 1:19-md-02902-RGA (D. Del.), before the same judge. See Unified Patents docket for 1:21-cv-01006; MDL docket via PTAB exhibit.

Most filings in this docket are short stipulations/waivers and the consent judgment; the complaint and consent judgment signature blocks were not retrievable in full in my searches. The names below come from (a) the MDL 19‑md‑2902 attorney appearances, (b) the Merck filing signature on the 1:21‑cv‑01006 docket, and (c) the MDL Markman opinion and IPR papers identifying which lawyers actually argued/appeared for Merck. I have not confirmed a formal appearance form bearing each name in the 1:21‑cv‑01006 docket itself, and Merck's in‑house counsel are not identified in any public filing I could find.

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

Note: I could not verify a separate formal "entry of appearance" by any of these three on the 1:21‑cv‑01006 docket sheet itself; their identification rests on the MDL appearance record and the Merck docket signature in this case.

Lead trial counsel (pro hac vice, not Delaware‑admitted) — Williams & Connolly LLP (Washington, DC)

(W&C address for all: 725 Twelfth Street NW, Washington, DC 20005; the MDL team also used a case‑specific service address, MerckSitagliptin@wc.com.)

Counsel listed in

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

Let me get the full docket for 1:21-cv-01006 specifically.

Let me verify Kevin Capuzzi's firm at the relevant time and pull the actual docket entries.

Counsel of Record — Defendants Annora Pharma Private Limited and Hetero USA Inc.

Bottom line: The defense was represented by a two-tier team from Benesch, Friedlander, Coplan & Aronoff LLP — one Delaware-bar-admitted attorney filing locally in Wilmington, plus two Benesch patent attorneys from the firm's Chicago office admitted pro hac vice. This is the same Benesch team that has represented Annora/Hetero across D. Del. ANDA litigation for years. That said, my sourcing on this docket is a third-party docket aggregator (Unified Patents portal reproducing PACER text) rather than a PACER pull I performed myself, so I flag the confidence level per entry below.

1. Kevin M. Capuzzi — Delaware / local counsel of record

• Firm: Benesch, Friedlander, Coplan & Aronoff LLP — Wilmington, Delaware office (1313 N. Market Street, Suite 1201, Wilmington, DE 19801).
• Role: The Delaware-admitted attorney of record for both Annora Pharma Private Limited and Hetero USA Inc. Per the 1:21-cv-01006 docket, he entered the NOTICE of Appearance on behalf of Annora Pharma Private Limited and Hetero USA Inc., filed the MOTIONs for Pro Hac Vice Appearance of the Chicago attorneys (D.I. 11, 12), and signed the ANSWER to the Complaint and COUNTERCLAIMS against Merck Sharp & Dohme Corp. (entered/modified 10/12/2021). Because D. Del. Local Rule 83.5(d) requires local counsel to file all papers, he was the operative CM/ECF filer for the defense.
• Experience note: Capuzzi is Annora/Hetero's long-standing Delaware counsel in Hatch-Waxman matters — he appeared for the same defendants in Boehringer Ingelheim Pharms. Inc. v. Annora Pharma Private Ltd., No. 1:18-cv-01786 (D. Del.) (Notice of Appearance for Hetero USA 12/17/2018; for Annora 1/4/2019, per the Justia docket), and in later cases such as Bayer Consumer Care AG v. Hetero USA Inc., No. 1:23-cv-01221 and Harmony Biosciences, LLC v. AET Pharma US, Inc., No. 1:23-cv-01340 (CourtListener parties pages list him at Benesch's Wilmington office).
• Caveat: CourtListener's party pages in the later Hetero matters show Capuzzi's representation as "TERMINATED" (e.g., 07/30/2026 in 1:23-cv-01221). I did not verify whether that reflects a departure from Benesch, a client change, or a case-specific withdrawal. It does not affect his role in the 2021–22 Merck case, which had already ended by consent judgment.

2. Manish K. Mehta — outside/lead counsel (pro hac vice)

• Firm: Benesch, Friedlander, Coplan & Aronoff LLP — Chicago office (333 West Wacker Drive, Suite 1900, Chicago, IL 60606).
• Role: Outside counsel for Annora and Hetero USA; admitted pro hac vice in this case by order of Judge Richard G. Andrews signed October 5, 2021 (D.I. 11). Most likely the lead substantive/patent attorney on the defense (the pleadings he signed in the parallel Boehringer case list him alongside Baig as "Attorneys for Defendants Annora Pharma Private Ltd and Hetero USA Inc.").
• Experience note: Registered-patent-litigation counsel for Annora/Hetero in multiple ANDA suits in D. Del. and D.N.J. (e.g., the 2018–19 Boehringer empagliflozin cases, C.A. Nos. 18-1786-CFC and 20-277-CFC, and 19-cv-1594 in D.N.J.), typically paired with Baig.

3. Zaiba Baig — outside counsel (pro hac vice)

• Firm: Benesch, Friedlander, Coplan & Aronoff LLP — Chicago office (same address as Mehta).
• Role: Outside counsel for Annora and Hetero USA; admitted pro hac vice by the same October 5, 2021 order (D.I. 12). The docket reflects both Baig's and Mehta's PHV admissions "for Annora Pharma Private Limited and Hetero USA Inc."
• Experience note: Same Annora/Hetero ANDA defense portfolio as Mehta — her name appears as "admitted pro hac vice" on the Annora/Hetero answer and counterclaims in the Boehringer empagliflozin case (D. Del. 18-cv-1786, D.I. 19).

4. Michael S. Weinstein — related Annora/Hetero counsel (not confirmed in this case)

• Firm: Benesch (Chicago), on the same defense teams in Boehringer 18-cv-1786 and Harmony Biosciences 23-cv-01340.
• Role: He was admitted PHV for Annora/Hetero in those cases, but I could not confirm a notice of appearance or PHV admission for him in 1:21-cv-01006 — the aggregated docket text I retrieved lists only Mehta and Baig as the PHV attorneys in this case. Treat his participation here as unverified.

Things I could not verify / caveats

• No in-house counsel identified. I found no record of Annora, Hetero Labs, or Hetero USA in-house attorneys appearing in this docket.
• Docket-entry numbering is partial. I have solid confirmation for the PHV motions (D.I. 11 = Mehta, D.I. 12 = Baig) and the 10/5/2021 PHV order, and for the Answer/Counterclaims and Notice of Appearance by Capuzzi (both recorded around 10/12/2021). I do not have the exact D.I. numbers for the Notice of Appearance or the Answer/Counterclaims from a primary source.
• Later counsel lineup differs. In the current wave of Annora/Hetero Delaware ANDA cases (e.g., Adverio Pharma GmbH v. Annora Pharma Private Ltd., No. 1:25-cv-00479-GBW), the defense is being handled by different firms — Cozen O'Connor (Kaan Ekiner, Wilmington; W. Blake Coblentz, Aaron S. Lukas, Washington D.C.; Keri L. Schaubert, New York; Madison H. McNulty and Anna Pedraza Beck, Philadelphia) and, in some filings, Smith Katzenstein & Jenkins LLP (Neal C. Belgam, Daniel Taylor, Wilmington) with Rimon, P.C. (H. Howard Wang, Princeton, NJ). This post-dates the instant case and should not be attributed to the 2021–22 Merck matter.

Cross-check against prior sections / metadata

• Consistent: The prior section's statement that Annora/Hetero filings here were made by Kevin Capuzzi is confirmed. The presence of Hetero USA Inc. as a co-defendant (again flagged in the prior section) is confirmed by the docket and by the consent judgment naming both defendants.
• Flagged discrepancy (metadata vs. docket): The case metadata lists the defendant as only "Annora Pharma Private Ltd."; the actual docket and the February 10, 2022 consent judgment run against Annora Pharma Private Limited and Hetero USA Inc. As noted previously, the metadata is under-inclusive on this point.
• Naming: The prior section's note that Merck Sharp & Dohme Corp. became Merck Sharp & Dohme LLC (May 2022) is consistent with the later-captioned filings I reviewed; the 2021 complaint and the PHV papers in this case still use "Merck Sharp & Dohme Corp."

Primary sources: Unified Patents litigation portal, Merck Sharp & Dohme LLC v. Annora Pharma Private Ltd. et al., 1:21-cv-01006 (D. Del.) docket text — https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1:21-cv-01006 ; Justia docket, Boehringer Ingelheim Pharms. Inc. v. Annora Pharma Private Ltd., 1:18-cv-01786 (D. Del.) — https://dockets.justia.com/docket/delaware/dedce/1:2018cv01786/66897 ; CourtListener parties pages for 1:23-cv-01221 and 1:23-cv-01340 (Capuzzi/Benesch Wilmington); Annora/Hetero answer and counterclaims in 18-cv-1786 (listing Mehta and Baig, Benesch Chicago, admitted pro hac vice).