Litigation

Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc.

settled

1:19-cv-00318-RGA

Filed
2019-02-13

Patents at issue (1)

7326708

Summary

Action asserting the '708 patent; settled. Teva/Watson separately petitioned for IPR.

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 thoroughly before drafting the overview.

Excellent — I now have the core facts. Let me verify additional details on the IPR outcomes, settlement, and market context.

Let me pin down the Teva-specific docket events, settlement terms, and market context.

Key legal developments & outcome

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

I'll research this case across the docket, PTAB, and legal press.

Let me dig into the docket, MDL proceedings, and settlement specifics.

Let me research the Teva-specific outcome, the IPRs, and appeals.

In the news

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

I'll search for press coverage across several angles.

Press coverage of Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:19-cv-00318-RGA

Bottom line: there is essentially no article-level press coverage of this specific docket. It was one of fourteen complaints Merck filed on the same day (Feb. 13, 2019) in the sitagliptin ANDA wave, it was folded into MDL No. 2902, and it resolved by confidential settlement before any Teva-specific merits ruling. The coverage that exists is (a) trade/bulletin listings that record the filing, (b) adjacent reporting on the same '708 patent in the Mylan/Viatris action, and (c) market reporting on the sitagliptin settlement wave as a whole. The one article the news index surfaced for this case, Business Insider's 2019-06-26 Supreme Court term roundup, does not discuss this case at all — it is a keyword false positive. Its Teva-related entry is Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the on-sale-bar/AIA § 102 case, which involves a different patent, different product, and no overlap with the '708 litigation. I flag this explicitly because the index implied a connection that the article's text does not support.

Filing coverage (trade bulletins). The two places the docket itself is recorded in the trade press are the Hatch-Waxman case trackers. Robins Kaplan, in its Spring 2019 Generically Speaking new-ANDA bulletin, lists "Merck Sharp & Dohme Corp. v. Teva Pharm. USA, Inc., 19-0318 (D. Del.)," filed Feb. 13, 2019 before Hon. Richard G. Andrews, as part of the sitagliptin phosphate group of filings — the same table that lists the companion 19-0310 through 19-0321 cases. A JD Supra "New ANDA Cases" compilation carries the same entry, also dated Feb. 13, 2019 and assigned to Judge Andrews. Two caveats: these trackers are machine-formatted tables and their product/patent columns are misaligned in the rendered text I could retrieve (the Robins Kaplan table associates the '708 and '921 patents with the sitagliptin products generally, and the JD Supra rendering pairs the 19-0318 line with Juvisync®), so the product-to-docket mapping in the bulletins should not be treated as authoritative over the complaint itself. Neither bulletin does more than list the case; there is no analysis.

Why the case drew no standalone coverage. The substantive '708 story was litigated in the Mylan line, not against Teva. Teva's PTAB challenge was a self-described "me-too" petition — IPR2020-01045, filed June 10, 2020, expressly "filed within one month of the Board's May 12, 2020 Order instituting trial on the petition of Mylan" and raising "no issues which are not raised in Mylan's petition" — and it was joined into Mylan's IPR2020-00040 on Sept. 1, 2020. It never reached a final written decision: the Board terminated it as settled on Dec. 8, 2020 under 35 U.S.C. § 317, ordering the settlement agreement (Ex. 1023) kept confidential under 37 C.F.R. § 42.74(c), and Teva/Watson were withdrawn from IPR2020-00040 on Dec. 16, 2020. Because there was no Teva merits ruling, there was no verdict story. The reported merits win on this patent belongs to the Mylan/Viatris case: Merck's own September 22, 2022 release announced the N.D. W. Va. judgment that both the '708 and '921 patents were valid and infringed, and the Federal Circuit's affirmance of the Mylan IPR outcome was summarized by Illinois Lawyer Now. A specialist blog, Pharma IP Circle, tabulated IPR2020-01045 as "Terminated-Settled" alongside the Mylan, Sun and DRL petitions — the closest thing to a contemporaneous write-up of Teva's challenge, and it is a one-line table entry, not reporting.

Reported numbers and where reporting outruns the record. No outlet has reported the Teva settlement's terms, and that is consistent with the record: the agreement was filed under seal and granted confidential treatment by the PTAB. The only public numbers come from the aggregate settlement wave and from Merck's SEC disclosures. FiercePharma reported that Januvia and Janumet generated $4.5 billion in 2022 — a 15% decline from 2021, which it attributed to Merck's explanation of European and Asian generic pressure plus lower U.S. demand and prices — and that the Viatris settlement gave Viatris a license to launch "on specific dates prior to the expiration of the relevant patents-in-suit," with terms confidential. Close Concerns reported (Mar. 21, 2023) that the settlements permit generic Januvia/Janumet entry in May 2026 and Janumet XR in July 2026, against patent expirations of May 24, 2027 and July 21, 2029 respectively, and noted the Januvia franchise has recorded over $75 billion in cumulative sales since launch. Merck's own Form 10-Q states the company "has settled with over two dozen generic companies" on those same May 2026 / July 2026 dates. Teva is not named in any of these sources in connection with the May 2026 date; attributing a specific entry date to Teva from the public record would be inference, not reporting. Similarly, no article I located reports a damages demand, a royalty, or a payment from Teva — and the $4.5 billion / $75 billion figures are franchise-level, not case-specific, so they should not be presented as a measure of this case's exposure.

Sourcing note: the Business Insider article, the two ANDA bulletins, the Merck release, the FiercePharma piece, the Close Concerns note, and the Illinois Lawyer Now summary were all retrieved and read via search. I did not find any Reuters, Bloomberg Law, Law360, Ars Technica, The Verge, IPWatchdog, Patently-O, or EFF piece addressing No. 1:19-cv-00318 specifically; if such coverage exists it did not surface, and I have not cited any article I could not open.

Sources

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 Merck in this docket.

Good leads. Let me verify the specific appearances and firms.

Counsel of Record for Plaintiff Merck Sharp & Dohme Corp.

Counsel for Merck in No. 1:19-cv-00318-RGA was a two-tier structure typical of Delaware Hatch-Waxman practice: a Wilmington firm as local counsel and a Washington, D.C. trial firm as merits/lead counsel. Both are well documented; a few peripheral names are not, and I flag those.

1. Local counsel — McCarter & English, LLP (Wilmington, DE)

These three attorneys signed the original complaint (D.I. 1, filed Feb. 13, 2019), the Rule 7.1 disclosure, and the ANDA supplemental-information filing, all bearing the same signature block. This is the most solidly verified set of appearances in the docket.

Attorney Role Firm / office Note
Michael P. Kelly (Del. Bar #2295) Local counsel; first-listed on the complaint McCarter & English LLP, Renaissance Centre, 405 N. King St., 8th Fl., Wilmington, DE 19801 Longtime Delaware IP litigator; ranked in IAM Patent 1000 for Delaware; has represented Merck in other Delaware patent matters (e.g., BMS v. Merck, D. Del.).
Daniel M. Silver (Del. Bar #4758 — see numbering note) Local counsel; Wilmington office managing partner McCarter & English LLP, Wilmington, DE IAM Patent 1000 (Bronze, Delaware): "an experienced lead and local counsel who makes light work of complex life sciences disputes"; represents innovator pharma plaintiffs across Hatch-Waxman and BPCIA cases.
Alexandra M. Joyce (Del. Bar #6423) Local counsel McCarter & English LLP, Wilmington, DE Chambers USA "Up and Coming," Intellectual Property–Delaware: "routinely called upon to assist in issues concerning claims of patent infringement… notable experience advising clients from the pharmaceutical sector."

The signature block reads verbatim: "MCCARTER & ENGLISH, LLP /s/ Daniel M. Silver — Michael P. Kelly (#2295), Daniel M. Silver (#4758), Alexandra M. Joyce (#6423), Renaissance Centre, 405 N. King Street, 8th Floor, Wilmington, Delaware 19801… Attorneys for Plaintiff Merck Sharpe & Dohme Corp." (reproduced in the complaint text captured at IPR2020-01045, Ex. 2039, and in the D. Del. ANDA supplemental-information filing).

Numbering discrepancy to flag: the 2019 filings show Silver as #4758; his McCarter signature blocks in recent Delaware matters (2024–2025) show #4578. The two digits appear transposed in one set of documents. I have not resolved which is correct; treat the bar number as secondary to the name.

2. Lead / merits counsel — Williams & Connolly LLP (Washington, D.C.)

Williams & Connolly acted as Merck's substantive counsel on the '708 patent, including in the parallel PTAB proceedings, and its attorneys are reflected in the district court docket as well. In the Patent Owner's Mandatory Notices filed July 1, 2020 in the joined IPR (IPR2020-01045, Paper 7), Merck — expressly identifying this docket, "Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc., Case No. 1:19-cv-00318-RGA (D. Del.)" — designated:

  • Stanley E. Fisher (Reg. No. 55,820) — lead counsel, Williams & Connolly LLP, 725 Twelfth St. N.W., Washington, DC 20005.
  • Jessamyn S. Berniker (Reg. No. 72,328) — first backup counsel.
  • Bruce R. Genderson — backup counsel (admission pro hac vice motion noted as to be submitted).
  • Alexander S. Zolan — backup counsel (same).
  • Elise M. Baumgarten — backup counsel. Her pro hac vice appearance in the D. Del. proceedings is corroborated by docket text: "05/18/2020 — Pro Hac Vice Attorney Elise M. Baumgarten for Merck Sharp & Dohme Corp. added for electronic noticing… Associated Cases: 1:19-cv-00318-RGA, 1:19-md-02902-RGA."
  • Shaun P. Mahaffy (Reg. No. 75,534) — backup counsel.
  • Anthony H. Sheh (Reg. No. 70,576) — backup counsel.

The same Williams & Connolly lineup appears as "FOR PATENT OWNER" on the face of the Board's Sept. 1, 2020 institution/joinder decision (IPR2020-01045, Paper 21), confirming the firm's role as Merck's appellate-grade PTAB and district court team on this patent.

Note on sourcing for this block: the firm, office, and Merck-representation facts are directly documented. What is not independently confirmed for every name is a separately docketed notice of appearance in 1:19-cv-00318 itself — the district court docket text I could retrieve directly confirms Baumgarten's pro hac vice entry, and the remainder of the W&C team is documented through the IPR mandatory notices that expressly tie their representation to this docket. Treat Fisher, Berniker, Mahaffy and Sheh as highly likely to have appeared in the district case (Sheh does appear on the docket aggregator's plaintiff-attorney list — see below), but I cannot point to a discrete D.I. number for each.

3. Additional names on the docket aggregator — one verified, one not

UniCourt's docket-derived "Plaintiff Attorneys" list for 1:19-cv-00318 (snapshot updated April 14, 2019) names five attorneys: Alexandra M. Joyce, Daniel M. Silver, Michael P. Kelly, Anthony H. Sheh, and Jingyuan Luo. The first three are the McCarter local team above; Sheh is the Williams & Connolly patent attorney above.

  • Jingyuan Luo — listed as a plaintiff-side attorney on that aggregator but I could not independently verify her firm, office, or role from any primary filing. Do not attribute her to a firm without confirming; she is plausibly a McCarter or Williams & Connolly associate, but that is inference, not a sourced fact.

4. In-house counsel

I found no named in-house Merck attorney in the public record for this docket. Merck's Rule 7.1 disclosure (signed by McCarter) states only that Merck Sharp & Dohme Corp. "is a wholly owned subsidiary of Merck & Co., Inc.," which "has no parent corporation." I will not guess at in-house names.

5. Structural context

This case was folded into In re Sitagliptin Phosphate ('708 & '921) Patent Litig., No. 1:19-md-2902-RGA (D. Del.) (per the IPR2020-01045 institution decision and the docket's "Associated Cases" notations), and the docket reflects coordinated filings across 19-cv-317/318 and 19-md-2902 — e.g., D.I. 132 (sealed order on the stipulation regarding the first amended complaint) and D.I. 133 (sealed second amended complaint), both filed July 17, 2020. Practically, the same McCarter local team and the Williams & Connolly merits team carried Merck across the MDL and this member case. The action and the parallel Teva/Watson IPR both terminated in settlement in late 2020 (IPR2020-01045 terminated Dec. 8, 2020), consistent with the case status of "settled."

Bottom line: Lead/merits counsel was Williams & Connolly LLP (Stanley E. Fisher lead; Berniker, Genderson, Zolan, Baumgarten, Mahaffy, Sheh), with McCarter & English LLP's Wilmington office (Kelly, Silver, Joyce) as Delaware local counsel of record and signatories on the complaint. One aggregator-listed name, Jingyuan Luo, is unverified, and no in-house counsel is identified in the public record.

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 for the defendant in this D. Del. action.

Good initial data. Let me verify the specific defendant-side attorneys and their firms.

Defendant-side counsel of record — Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:19-cv-00318-RGA (D. Del.)

Posture note first, because it shapes the answer. The only defendant is Teva Pharmaceuticals USA, Inc. ("Teva USA"). Teva Pharmaceutical Industries Ltd. was named originally but was terminated as a party by stipulation and order entered April 18, 2019 (D.I. 12, 13), so several early appearances were filed "on behalf of Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA, Inc." and are Teva USA counsel for our purposes. The case was then consolidated for pretrial purposes into In re Sitagliptin Phosphate ('708 & '921) Patent Litig., No. 1:19-md-2902-RGA, which means many docket entries on 19-cv-318 are MDL-wide joint filings — the names on those entries include counsel for Anchen, Par, Sandoz, Sun, Biocon, etc., not Teva. I have filtered for attorneys whose appearances are attributable to Teva. It also settled by consent judgment (D.I. 185–186, Nov. 10, 2020), so the universe of attorney appearances is closed.

1. Delaware local / counsel of record

Attorney Role Firm / office Notes
Dominick T. Gattuso Delaware counsel of record; the attorney who signed essentially every Teva filing on ECF (e.g., D.I. 17 Answer & Counterclaims; D.I. 111, 146, 152, 163) Heyman Enerio Gattuso & Hirzel LLP, Wilmington, DE (222 Delaware Ave., Ste. 900 / 300 Delaware Ave., Ste. 200) Delaware litigator (Del. bar No. 3630) who serves as local counsel in Hatch-Waxman/ANDA matters; Vice-Chair, ABA Section of IP Law, Chemical & Life Sciences Patent Committee (2024–27). His Notice of Appearance was filed April 12, 2019 (D.I. 9).

2. Lead trial counsel — Goodwin Procter LLP

The core Teva trial team was Goodwin Procter LLP (New York and Boston), admitted pro hac vice under D. Del. L.R. 83.5. Per D.I. 11 (motion filed Apr. 12, 2019, so ordered Apr. 12, 2019), the following four were admitted:

  • Keith A. Zullow — lead trial counsel. Goodwin Procter LLP, The New York Times Building, 620 Eighth Ave., New York, NY (now Of Counsel at Gemini Law LLP, per his 2025 firm bio). Registered patent attorney (Reg. No. 37,975); ~30 years of pharma/chemical IP litigation. He was lead counsel of record for Teva USA and Watson in the parallel IPR2020-01045 against the '708 patent (Petitioners' Power of Attorney, Aug. 20, 2020; Paper 11). Prior Teva work includes the CELEBREX®, VIAGRA®, and PULMICORT RESPULES® ANDA litigations.
  • Emily L. Rapalino — trial counsel. Goodwin Procter LLP, 100 Northern Ave., Boston, MA. Partner, Life Sciences Disputes; ~18 years' patent litigation experience in the chemical