Litigation
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc. et al.
dismissed1:19-cv-01489-RGA
Patents at issue (1)
Plaintiffs (1)
Defendants (2)
Summary
Voluntarily dismissed without prejudice by stipulation; parallel action proceeded in N.D. W. Va.
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 drafting the overview.
Let me dig into the procedural history — the MDL, the transfer, and the dismissal.
Key legal developments & outcome
Major rulings, motions, claim construction, settlements, and the present posture or final disposition.
I'll research this case thoroughly using web search across the sources you mentioned.
This is a rich, multi-venue dispute. Let me dig into the specific dockets, the JPML/MDL history, and the parallel PTAB and Federal Circuit proceedings.
In the news
What the press has reported about this case, summarized with links to the source articles.
I'll research press coverage of this litigation, starting with the two known articles and then searching additional angles.
Let me pull the two known articles directly.
Press coverage of Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.
Almost all of the press coverage is of the PTAB/Federal Circuit track, not the Delaware case. The reporting clusters on the Federal Circuit's September 29, 2022 decision in Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp., No. 21-2121, which affirmed the Board's final written decision in IPR2020-00040 upholding claims 1–4, 17, 19 and 21–23 of the '708 patent. IPWatchdog (Eileen McDermott, 2022-09-29) reported that the court "upheld a Patent Trial and Appeal Board (PTAB) decision finding that Mylan Pharmaceuticals, Inc. failed to show that certain claims of Merck Sharp & Dohme Corp.'s patent for a Type 2 Diabetes treatment were anticipated or would have been obvious over the cited prior art," noted that Judge Lourie authored the opinion, and flagged it as the court's "third precedential patent opinion this week." Fed Circuit Blog likewise logged it in its daily "Opinions & Orders" roundup for that date as a precedential PTAB appeal. None of the coverage I found addresses the Delaware docket (1:19-cv-01489) itself, its transfer into MDL 2902, or the stipulated dismissal — consistent with the summary above, that case was a procedural waypoint and the merits fight happened at the Board.
The single most-covered legal point was the "at once envisage" / 957-salts holding. IPWatchdog quoted the opinion directly — "We agree with Merck…that a class of 957 predicted salts that may result from the 33 disclosed compounds and eight preferred acids…is insufficient to meet the 'at once envisage' standard" — and explained that Mylan argued Edmondson (WO 2003/004498 and its equivalent U.S. Patent 6,699,871) disclosed sitagliptin among 33 compounds and phosphoric acid among eight "particularly preferred" acids, while Merck countered that hindsight selection from a large class is not In re Petering anticipation. Finnegan's "At the PTAB" blog ran a detailed practitioner analysis headlined "957 Salts Too Many to 'At Once Envisage'; Mylan's Attacks on Patentability Peter Out," noting the court's statement that "we cannot provide a specific number defining a 'limited class'… It depends on the 'class,'" and that 957 salts "is a far cry from the 20 compounds 'envisaged' by the narrow genus in Petering." PatentDocs (also syndicated on Lexology, 2022-10-05) added the panel composition — Lourie, joined by Reyna and Stoll — and walked through the antedation ruling: Merck reduced the subject matter to practice before Edmondson's publication, making Edmondson a pre-AIA § 102(e) rather than § 102(a) reference, with the § 103(c) common-ownership exception then knocking it out of the obviousness case for claims 1, 2, 17, 19 and 21–23.
How outlets framed significance, and where they went beyond the record. The commercial framing is thin but present: Illinois Lawyer Now noted that the '708 patent is Orange Book–listed for Steglujan, Janumet, Janumet XR, Januvia and Juvisync for Type 2 diabetes — the closest thing to a market-impact statement in the coverage. Life Sciences IP Review covered the same ruling under the headline "MSD prevails in diabetes drug dispute with Mylan," framed around "branded diabetes treatment Janumet XR" and using the ex-US corporate name "MSD" — a labeling difference worth noting, since the U.S. docket and all other coverage use "Merck." I found no reported damages figures, settlement terms, or revenue/market-share estimates in any account of this dispute; the outcome was purely a validity affirmance, so there was nothing to monetize in the press. The most expressly advocative item is not press but a filing: a copy of the certiorari petition in No. 21-2121 posted at fedcircuitblog.com (file path dated November 2022), which argues the panel imposed an extra "direction to select" requirement on list disclosures and thereby "contravened settled precedent" in Perricone, Gleave and Wm. Wrigley — that is Mylan's advocacy, not a report of the holding.
Gaps and unverified items. I could not verify that the second known article, IPWatchdog's "Patent Filings Roundup: End-of-Month Filing Spike; IP Val Sues Smart Thermostat Cos." (Jonathan Stroud, 2022-02-11), actually discusses this litigation; the retrievable text is about IP Valuation Partners/Rosen Technologies thermostat NPE suits in W.D. Tex., and I found no passage tying it to Merck, Mylan, the '708 patent or IPR2020-00040. It may mention the case in a docket-statistics table I could not load, but I will not attribute anything to it without confirmation. Likewise, I found no Reuters, Bloomberg Law, Law360, or mainstream coverage of the Delaware action or its dismissal, and the practitioner commentary that does exist (Finnegan, PatentDocs/MBHB, Illinois Lawyer Now) is IPR-focused and largely post-hoc summary of the Rule 36-adjacent merits reasoning rather than independent reporting. One factual cross-check: Orange Book data reproduced in the FDA Law Blog's Orange Book compilations lists the '708 patent with a November 24, 2026 expiry and May 24, 2027 pediatric exclusivity — the commercial stake the IPR was actually about, and a useful anchor since no outlet reported a dollar figure.
Sources
- Mylan Archives - Posts Tagged: "Mylan"
- Litigation Archives - Posts in Litigation
- Patent Trial and Appeal Board Archives - Posts Tagged: "Patent Trial and Appeal Board"
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
- UNITED STATES PATENT AND TRADEMARK OFFICE
- | SINVASTATIN; STTAGLIPTIN PHOSPHATE - JUVISYNC N 202343 006 6699871 Jul 26, 2022 DS DP U-1188 6699871*PED Jan 26, 2023 7125873 ...
- | ERTUGLIFLOZIN; METEORMIN HYDROCHLORIDE - SEGLUROMET N 209806 002 8080580 Ju1 13, 2030 DS DP U-2214 9308204 Oct 21, 2030 DP ...
- 7326708 Nov 24, 2026 DS DP U-2214
- 7326708 | NPE Litigation Database
- Opinion - Memorandum Opinion – #135 in Merck Sharp & Dohme Corp. v. Anchen Pharmaceuticals, Inc. (D. Del., 1:19-cv-00311) – CourtListener.com - Merck Sharp & Dohme Corp. v. Anchen Pharmaceuticals, Inc.
- Merck Sharp & Dohme Corp. v. Anchen Pharmaceuticals, Inc., et al., No. 1:2019cv00311 - Document 135 (D. Del. 2020) - Merck Sharp & Dohme Corp. v. Anchen Pharmaceuticals, Inc., et al., No. 1:2019cv00311 - Document 135 (D. Del. 2020)
- #56 in IN RE: Sitagliptin Phosphate ('708 & '921) Patent Litigation (J.P.M.L., MDL No. 2902) – CourtListener.com - IN RE: Sitagliptin Phosphate ('708 & '921) Patent Litigation
Plaintiff representatives
Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- McCarter & English
- Michael P. Kelly · lead counsel
- Daniel M. Silver · local counsel
- Alexandra M. Joyce · local counsel
- Williams & Connolly
- Stanley E. Fisher · lead counsel
- Bruce R. Genderson · of counsel
- Jessamyn S. Berniker · backup counsel
- Alexander S. Zolan · counsel
- Anthony H. Sheh · counsel
- Shaun P. Mahaffy · counsel
- Elise M. Baumgarten · counsel
- Jingyuan Luo · counsel
- David M. Krinsky · backup counsel
- Schrader, Byrd & Companion
- James F. Companion · local counsel
- Frank X. Duff · local counsel
- Sandra K. Law · local counsel
I'll research the docket and counsel for this case.
Let me pull the actual docket sheet and appearances.
Let me get the full docket sheet details and verify local counsel.
Counsel of Record — Plaintiff Merck Sharp & Dohme Corp., Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc. et al., No. 1:19-cv-01489-RGA (D. Del.)
Important procedural caveat first. This docket is a transferred case, and appearances are split across three dockets. It was originally filed in the Northern District of West Virginia (as Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc., No. 1:19-cv-00101, N.D. W. Va.), transferred by the JPML, and docketed in Delaware on August 9, 2019 as 1:19-cv-01489-RGA. It was then folded into the consolidated pretrial proceeding In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 19-2902-RGA, and later remanded back to N.D. W. Va. (see the "Jointly Designated Records for MDL Remand re: 1:19-cv-1489" entries on the N.D. W. Va. docket, CourtListener entry for 1:19-cv-00101). Because of that, the fullest counsel listing exists on the MDL docket sheet (1:19-md-02902-RGA), which is reproduced in a PTAB filing for IPR2020-00040, rather than on the member-case docket. Where I could not independently verify a Delaware pro hac vice grant, I say so.
1. Delaware local counsel — McCarter & English, LLP (Wilmington, DE)
| Name | Role | Notes |
|---|---|---|
| Michael P. Kelly | Lead attorney (so designated on the MDL docket) | McCarter & English, Renaissance Centre, 405 N. King St., 8th Fl., Wilmington, DE 19801. Long-time Delaware IP/ANDA litigator and former head of the firm's Delaware office; entered his appearance on the MDL docket (MDL DN 53). |
| Daniel M. Silver | Delaware counsel (local) | McCarter & English, Wilmington; Wilmington office managing/co-managing partner and Executive Committee member. Specializes in Hatch-Waxman/BPCIA plaintiff-side innovator work; IAM Patent 1000 "United States: Delaware" ranking; Chambers USA IP (Delaware). Actively filed in this case (e.g., D.I. 75 Joint Claim Construction Chart; D.I. 76 sealed Notice of Service of Subpoena; MDL DN 52 Notice of Appearance). |
| Alexandra M. Joyce | Delaware counsel (local) | McCarter & English, Wilmington; part of the same Merck sitagliptin ANDA team across the MDL member cases (MDL DN 54 Notice of Appearance). |
Sources: MDL 19-2902 docket sheet excerpt (counsel block listing Kelly as "LEAD ATTORNEY" and Silver/Joyce for Merck), https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1537482](/patent/1537482)/download-documents?artifactId=m-W-HYyUa7LbaRQWIuLG98ETLH0vIOshZqIYVHzdMCuRBmMArckw5l4 ; McCarter & English attorney profiles, https://www.mccarter.com/people/daniel-m-silver/ and https://www.iam-media.com/rankings/patent-1000/profile/person/daniel-m-silver ; Justia docket for 1:19-cv-01489 (D. Del.), https://dockets.justia.com/docket/delaware/dedce/1:2019cv01489/69701 .
2. Lead trial/pharmaceutical counsel — Williams & Connolly LLP (Washington, D.C.)
These attorneys carried the case from its inception in West Virginia (where their pro hac vice motions, D.I. 13–19, were granted on May 13, 2019) into Delaware and into the parallel IPRs.
| Name | Role | Notes |
|---|---|---|
| Stanley E. Fisher (Reg. No. 55,820) | Lead counsel for Merck — designated Merck's lead PTAB counsel in IPR2020-00040 | Williams & Connolly LLP, 725 Twelfth St., N.W., Washington, D.C. 20005, sfisher@wc.com. Merck's longtime Hatch-Waxman/sitagliptin counsel; moved for PHV in the original N.D. W. Va. action (D.I. 14). |
| Bruce R. Genderson | Of counsel / backup (PHV) | W&C Washington. Senior W&C appellate and patent litigator; listed as Merck backup counsel in the IPR2020-00040 mandatory notices. |
| Jessamyn S. Berniker (Reg. No. 72,328) | Backup counsel | W&C Washington; designated Merck's first backup PTAB counsel in IPR2020-00040; PHV motion at D.I. 17 (N.D. W. Va.). |
| Alexander S. Zolan | Counsel (PHV) | W&C Washington; PHV motions in both forums (N.D. W. Va. D.I. 13; D. Del. D.I. 21 granting PHV, May 13, 2019) and appears in the MDL counsel block. Later co-lead on related Merck sitagliptin matters. |
| Anthony H. Sheh (Reg. No. 70,576) | Counsel (PHV) | W&C Washington; PHV granted in N.D. W. Va. (D.I. 26, May 13, 2019); signed the Joint Claim Construction submissions in the MDL. |
| Shaun P. Mahaffy (Reg. No. 75,534) | Counsel | W&C Washington; PHV fee paid in the N.D. W. Va. phase (D.I. 19); briefed claim construction in the MDL. |
| Elise M. Baumgarten | Counsel (PHV) | W&C Washington; listed in the IPR2020-00040 mandatory notices and the MDL counsel block; PHV motion later docketed in the MDL/remand proceedings (MDL DN 84). |
| Jingyuan Luo | Counsel | W&C Washington; PHV granted in N.D. W. Va. (D.I. 23, May 13, 2019); appears in the Justia plaintiff-counsel list for 1:19-cv-01489. |
| David M. Krinsky (Reg. No. 72,339) | Backup counsel | W&C Washington; added as backup in Merck's Fourth Amended Mandatory Notices in IPR2020-00040 (Oct. 29, 2020). |
Sources: Williams & Connolly lawyers' signatures and designations in IPR2020-00040 (Patent Owner's Fourth Amended Mandatory Notices), https://www.docketalarm.com/cases/PTAB/IPR2020-00040/... ; IPR2020-00040 Joint Notice Regarding District Court Claim Construction (identifying Fisher, Genderson, Berniker, Mahaffy and Sheh as "Counsel for ... Merck Sharp & Dohme Corp."), https://www.docketalarm.com/cases/PTAB/IPR2020-00040/... ; Justia docket 1:19-cv-01489 (PHV orders D.I. 21–26; verification of attorney admission re Genderson, Berniker, Fisher, Zolan, Mahaffy, Sheh, Luo at D.I. 8), https://dockets.justia.com/docket/delaware/dedce/1:2019cv01489/69701 .
3. Former local counsel from the originating forum — Schrader, Byrd & Companion PLLC (Wheeling, W. Va.)
These attorneys signed the plaintiff-side papers while the case sat in N.D. W. Va. and appear on the transferred Delaware docket as plaintiff's counsel (their appearances were not necessarily re-filed on the Delaware docket after transfer).
| Name | Role | Notes |
|---|---|---|
| James F. Companion | Local counsel (West Virginia) | Schrader, Byrd & Companion, PLLC, Wheeling, WV. Docketed filer on Merck's Delaware docket entries carried over from W. Va. (e.g., D.I. 39 Notice of Appearance of Sandra K. Law). |
| Frank X. Duff | Local counsel (West Virginia) | Schrader, Byrd & Companion, PLLC, Wheeling, WV; Notice of Appearance docketed in the W. Va. phase (MDL DN 46, per the jointly designated remand records). |
| Sandra K. Law | Local counsel (West Virginia) | Notice of appearance filed June 24, 2019 in the pre-transfer action (D.I. 39, "Notice of Appearance by Sandra K. Law (Companion, James)"). |
Sources: Justia docket 1:19-cv-01489 (D.I. 39), https://dockets.justia.com/docket/delaware/dedce/1:2019cv01489/69701 ; CourtListener, Merck Sharp & Dohme, LLC v. Mylan Pharmaceuticals Inc., 1:19-cv-00101 (N.D. W. Va.) — jointly designated MDL remand records citing "MDL DN 46 – Notice of Appearance for Frank Duff," https://www.courtlistener.com/docket/15043896/merck-sharp-dohme-llc-v-mylan-pharmaceuticals-inc/ .
Caveats and sourcing limits
- Which docket controls. No single docket captures all plaintiff appearances cleanly. The Delaware member docket (1:19-cv-01489) shows the W&C/West Virginia cohort plus Silver's later filings; the MDL docket (1:19-md-02902-RGA) is where the McCarter & English appearances and Kelly's "lead attorney" designation are recorded. I have not independently confirmed a separate pro hac vice order in D. Del. for every W&C attorney following the transfer — the Delaware docket's PHV orders (D.I. 21–26) were entered May 13, 2019, i.e., while the case was still in West Virginia form.
- Sealed/limited material. Some associated filings were sealed (e.g., D.I. 31, 34 in the W. Va. phase), and the case terminated by stipulation of dismissal, so there was no trial-stage appearance list. I found no sealed counsel-appearance entries.
- Not verified. I did not find a Merck in-house attorney appearing of record on this docket; Merck's trial team here was outside counsel. Any in-house counsel involvement is not reflected on the docket and I won't speculate.
- No fabrication. Every name above is tied to a docket entry, a filed signature block, or a firm/ranking profile cited inline. Attorneys whose only connection to this litigation family is the broader MDL (rather than 19-1489 specifically) are identified as such
Defendant representatives
Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
I'll research defense counsel for Mylan across the Delaware docket, the MDL, and the parallel N.D. W. Va. action.
Good leads. Let me dig deeper into the specific defense-side attorneys.