Litigation

Merck Sharp & Dohme Corp. v. Lupin Limited et al.

settled

1:20-cv-00776

Patents at issue (1)

7326708

Summary

Second action against Lupin 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.

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Merck Sharp & Dohme Corp. v. Lupin Limited et

Key legal developments & outcome

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

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In the news

What the press has reported about this case, summarized with links to the source articles.

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Press coverage of Merck Sharp & Dohme Corp. v. Lupin Limited, No. 1:20-cv-00776 (D. Del.)

The bottom line: this docket generated essentially no dedicated press coverage. I searched the case caption, the party names, the '708 patent number, the drug names (Januvia, Janumet), the MDL number (19-2902), and the settlement/consent-judgment angle across general web search, and did not find a single article from Reuters, Bloomberg Law, Law360, Ars Technica, The Verge, IPWatchdog, Patently-O, EFF Deeplinks, or any comparable outlet that is about this particular case. What exists is (a) docket and filing aggregators, (b) Merck's own SEC disclosures, (c) law-firm ANDA-settlement bulletins that list the case in a table, and (d) general-market coverage of the broader sitagliptin patent war in which this case was a single, short-lived component. No outlet reported a damages figure, trial outcome, or settlement term for this case, because there was none to report: the action was resolved by a consent judgment before any trial on infringement by Lupin.

What the court record shows, and what the secondary sources confirm about it. The Patexia docket compilation for 1:20-cv-00776 shows the case was filed 2020-06-09 against Lupin Limited and Lupin Pharmaceuticals, Inc. on U.S. Patent No. 7,326,708, was coordinated with MDL No. 19-2902 before Judge Richard G. Andrews, was set for a December 2021 bench trial alongside the Dr. Reddy's and Zydus matters, and terminated when Judge Andrews signed a consent judgment on 2021-01-29 (D.I. 67), followed by an amended consent judgment on 2021-03-11 (D.I. 70). The text of the amended consent judgment — filed to correct "an inadvertent clerical error" — recites that the parties had entered three settlement agreements plus an amendment, enjoins Lupin from infringing the '708 patent as to ANDA Nos. 212546, 214433 and 214399, and dismisses all claims and counterclaims with prejudice and without costs. Notably, the judgment itself contains no financial terms, no royalty rate, and no licensed entry date — the economics are in the (undisclosed) settlement agreements. The same judgment's caption lists both C.A. No. 19-347-RGA and C.A. No. 20-776-RGA, confirming this case was folded into one settlement package with Merck's earlier Lupin action.

Coverage that goes beyond this docket. The strongest available source on the significance of the sitagliptin settlements is a Williams & Connolly case note, Merck Prevails in Patent Trial (Sept. 2022), which frames the picture: Merck "won a major trial victory in Hatch-Waxman patent litigation relating to the company's blockbuster sitagliptin products: Januvia, Janumet, and Janumet XR," and that victory "followed a settlement on the eve of trial of related matters that had been coordinated as an MDL proceeding in the District of Delaware." That pre-trial MDL settlement is the disposition of this case and its sister suits; the firm also notes the Federal Circuit/PTAB win upholding the '708 patent claims in May 2021, which eliminated the invalidity risk that was Lupin's main lever in this action. On the commercial terms, Close Concerns, summarizing Endpoints News reporting on 2023-03-21, wrote that Merck's earlier settlements "allow generic versions of Januvia and Janumet to enter the market in May 2026, or earlier under certain circumstances," well ahead of the patents' May 2027 expiry, and noted the Januvia franchise had recorded over $75 billion in cumulative sales since launch. DrugPatentWatch similarly describes "Merck's settlements with more than two dozen generic manufacturers" licensing U.S. entry in May 2026 (Januvia/Janumet) and July 2026 (Janumet XR) — i.e., the Lupin deal was one of ~26 such settlements, and its value to Lupin (an earlier entry date) is nowhere itemized in the public record.

Where accounts differ, and one caution on sourcing. Merck's own disclosures are the most reliable source on aggregate outcome, and they frame the settlements as uniformly favorable: the company's 10-K states that "the Company has settled with a total [of] 26 generic companies providing that these generic companies can bring their generic versions of Januvia and Janumet to the market in the U.S. in May 2026 or earlier under certain circumstances." Reported entry dates have drifted slightly across outlets and years — Merck's 2022 filings referenced May 2026 while its 2020 filings referenced "November 2026," reflecting subsequent settlements and pediatric exclusivity — so any single press figure should be read against the filing date. Two other cautions: Lawyerly (an Australian legal outlet) reported that "Merck Sharp & Dohme has taken a unit of Indian generic manufacturer Lupin to court for allegedly threatening to infringe the patent for its multibillion-dollar diabetes drugs Januvia and Janumet," with a follow-up, Merck Sharp & Dohme drops lawsuit over Januvia patent — but based on the outlet's jurisdiction and phrasing, these appear to concern the Australian Federal Court proceeding, not the Delaware action at issue here, and I could not verify their content beyond the abstracts. And several contemporaneous 2020 trade-press items about this wave of filings — e.g., CNBC-TV18, BW Businessworld and Express Pharma — cover Merck's June 2020 suits against Dr. Reddy's and Aurobindo, filed in the same window and asserting the same '708 patent, giving useful market context ($5.5 billion in 2019 global Januvia/Janumet revenue, $2.3 billion of that in the U.S.) but never mentioning Lupin or this case number. The Robinson+Kaplan Hatch-Waxman settlement bulletin is the closest thing to a case-specific trade item, but the Lupin entry it lists is a different docket (21-1105), so it should not be used as a source for this case.

Sources

Plaintiff representatives

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

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Defendant representatives

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

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Let me pull the specific docket entries and counsel listings for this case and its related consolidated proceeding.

Now let me get the actual pleadings and docket entries in 1:20-cv-776 to confirm the appearance signature blocks.

Bottom line

In this action (a member case of In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 19-2902-RGA (D. Del.)), Lupin's defense was presented by two firms: Knobbe, Martens, Olson & Bear LLP (Washington, D.C.) as lead/out-of-state counsel, and a Wilmington firm as Delaware counsel — originally Richards, Layton & Finger, P.A. (Frederick L. Cottrell, III and Alexandra M. Ewing). No in-house Lupin attorney appears on the docket.

Counsel of record for Lupin Limited and Lupin Pharmaceuticals, Inc.

Attorney Role Firm / office Note
William R. Zimmerman Lead counsel (of counsel/out-of-state) Knobbe, Martens, Olson & Bear LLP, 1717 Pennsylvania Ave. NW, Ste. 900, Washington, D.C. Knobbe partner and Lupin's lead trial counsel in the sitagliptin ('708) MDL; named in the MDL caption as "Of counsel" for Lupin Ltd. and Lupin Pharmaceuticals, Inc.
Jonathan E. Bachand Lead/arguing counsel Knobbe Martens, Washington, D.C. Appears as arguing counsel for Lupin in the MDL opinion of Nov. 17, 2020 (C.A. No. 19-311-RGA) — "Jonathan Bachand (argued), William Zimmerman, Andrea Cheek, KNOBBE, MARTENS, OLSON & BEAR, LLP … attorneys for Defendant Lupin."
Andrea L. Cheek Lead/back-up counsel Knobbe Martens, Washington, D.C. Knobbe pharma/ANDA litigation partner; also on Lupin's team in the sitagliptin MDL and the later 2022 MDL filings.
Frederick L. Cottrell, III (DE Bar #2555) Delaware / local counsel Richards, Layton & Finger, P.A., 920 N. King St., Wilmington, DE Longtime Delaware Hatch-Waxman counsel; DE counsel for Lupin in the '708 sitagliptin MDL alongside Knobbe.
Alexandra M. Ewing (DE Bar #6407) Delaware / local counsel; filing attorney Richards, Layton & Finger, P.A. (at the time of this case); now Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE Docket entries in this case (e.g., Lupin's Notice of Service of Core Technical Documents) are signed "Ewing, Alexandra." She later moved to Morris Nichols, where she has continued as Lupin's Delaware counsel in ANDA cases (Otsuka v. Lupin, 1:21-cv-00900; Harmony Biosciences v. Lupin, 1:23-cv-01286).

Docket/source basis

  • **MDL caption listing C.A. No