Merck Sharp & Dohme Corp. v. Aurobindo Pharma Limited

I'll research this case using web search to verify the details.

Case Overview: Merck Sharp & Dohme Corp. v. Aurobindo Pharma Limited, No. 1:20-cv-00949-RGA (D. Del.)

Parties and posture. This is a conventional Hatch-Waxman ANDA case, not a non-practicing-entity assertion. The plaintiff, Merck Sharp & Dohme Corp. (since renamed Merck Sharp & Dohme LLC, a New Jersey entity and subsidiary of Merck & Co., Inc.), is the brand innovator and Orange Book NDA holder for the sitagliptin franchise — JANUVIA®, JANUMET®, and JANUMET® XR. The defendants, Aurobindo Pharma Limited (Hyderabad, India) and Aurobindo Pharma USA, Inc. (a Delaware corporation), are among the world's largest generic manufacturers. Merck filed the complaint on July 15, 2020, in the District of Delaware, and the case was assigned to Judge Richard G. Andrews (RGA), who was also presiding over the coordinated sitagliptin litigation. Consistent with Merck's status as an operating company, the Stanford NPE Litigation Database classifies the asserter here as an "8 – Product company," i.e., a practicing-entity suit, not a PAE campaign. (Merck 2025 complaint citing No. 20-949-RGA; Stanford NPE Database – '708)

Accused product and asserted patent. The accused conduct is Aurobindo's submission of ANDA No. 212952 for Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg — a generic version of JANUVIA — which FDA received on April 30, 2020. That ANDA carried a paragraph IV certification to U.S. Patent No. 7,326,708 ("the '708 patent"), and Merck sued within the 45-day statutory window, triggering the 30-month stay. FDA's later tentative-approval letter for ANDA 212952 expressly confirms that "[l]itigation was initiated within the statutory 45-day period against Aurobindo for infringement of the '708 patent" in Civil Action No. 20-00949. (FDA ANDA 212952 tentative approval letter) Only one patent is at issue: the '708 patent, "Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor" (issued Feb. 5, 2008; inventors Cypes et al.; assigned to Merck). In one line, the '708 patent claims the dihydrogenphosphate (DHP) salt of sitagliptin — a DPP-IV inhibitor used to treat Type 2 diabetes — including its (R)-configuration, its crystalline monohydrate form, and a process for crystallizing that monohydrate. This is the "salt/polymorph" patent that covers the actual commercial form of sitagliptin phosphate monohydrate used in JANUVIA, JANUMET, and JANUMET XR; it is listed in the Orange Book with a November 24, 2026 expiration plus pediatric exclusivity extending to May 24, 2027. (Orange Book listing; [In re

I'll research this case using web searches against the sources you've specified.

Let me dig into the specific docket and the related MDL and IPRs.

I'll research the counsel of record for Merck in this D. Del. action.

Good progress. Let me confirm the Delaware local counsel and the full pro hac vice roster in the 20-949 docket itself.

Let me verify the specific docket entries and the full attorney roster via CourtListener's RECAP docket.

Counsel of Record for Plaintiff Merck Sharp & Dohme Corp. — No. 1:20-cv-00949-RGA (D. Del.)

Sourcing note. PACER's docket sheet is paywalled, so the roster below is reconstructed from RECAP-derived aggregators (Justia Dockets, Unified Patents litigation portal, Patexia, CourtListener), the D. Del. filings themselves, and PTAB filings in the parallel '708 IPRs that reproduce Merck's district-court service list. Where I could not confirm something, I say so rather than infer.

The '708 case followed the same two-tier staffing model Merck used across the whole JANUVIA/JANUMET sitagliptin program (the In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, No. 19-md-2902-RGA MDL and the related 19-cv-310 et seq. / 20-cv-749, -776, -815, -847, -1099 actions): a Delaware local-counsel firm that signs and files everything, and a Washington, D.C. merits/trial team admitted pro hac vice.

---

1. Merits / lead counsel — Williams & Connolly LLP, Washington, D.C.

By order dated September 28, 2020, Judge Andrews granted Merck's motion under D. Del. LR 83.5 for pro hac vice admission of eight Williams & Connolly attorneys (D.I. 12 in 20-cv-949; docketed in tandem as D.I. 12 in 19-md-2902 and the companion cases, Unified Patents docket). The firm entered PHV notices for Genderson (9/29/2020), Sheh (9/28/2020), and Zolan (10/2/2020) (Justia docket, 20-cv-1099 companion).

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

Let me look at the specific docket for 1:20-cv-00949 and the Aurobindo filings.

Let me dig into the specific appearances for Aurobindo in this docket.

Counsel of Record — Aurobindo Defendants, Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., No. 1:20-cv-00949-RGA (D. Del.)

Important sourcing caveat up front. This case resolved by dismissal/settlement — the docket was terminated September 29, 2021, and FDA's tentative-approval letter for ANDA 212952 confirms "this case was dismissed." Because there was no trial or claim-construction opinion in this docket (the Markman ruling came in the related MDL, In re Sitagliptin Phosphate ('708 & '921) Patent Litig., No. 19-md-2902-RGA), Aurobindo's trial team never surfaced in a published opinion. The attorney/party fields on the free aggregators for this specific docket are incomplete, and I was unable to pull the primary signature blocks (the Aug. 2020 stipulation extending Aurobindo's answer deadline, the answer/counterclaims, or the dismissal stipulation) before exhausting my research budget. What follows is therefore a best-evidence list with confidence levels, not a certified PACER extract.

Identified / likely counsel for Aurobindo

National/lead counsel — unverified for this docket, but Aurobindo's recurring firms

Aurobindo's outside-counsel roster is well documented in other matters, and it is plausible some of these attorneys appeared pro hac vice in 20-949, but I found no primary filing tying any of them to 20-949:

• Sterne, Kessler, Goldstein & Fox — Sasha Rao (lead counsel) is a prominent PTAB/Fed. Cir. patent litigator; appears in Aurobindo D. Del. filings (see CourtListener PDF above).
• **Greenberg Tra