Merck Sharp & Dohme Corp. v. Macleods Pharmaceuticals Ltd. et al.

I'll research this case to provide an accurate overview.

Let me get the specific docket history for the Macleods case itself.

Let me verify the Macleods case outcome and patent details.

Case Overview and Background

Parties. This is a conventional Hatch-Waxman brand-versus-generic action — not an NPE/PAE or university assertion. Plaintiff Merck Sharp & Dohme Corp. is the operating subsidiary of Merck & Co., Inc. (Kenilworth, NJ) and the owner/assignee of the patent-in-suit, U.S. Pat. No. 7,326,708 ("the '708 patent"); no publicly held corporation owns 10% or more of its stock (Merck mandatory notices, IPR2020-01060). Defendants Macleods Pharmaceuticals Ltd., an Indian generic manufacturer based in Mumbai, and its U.S. affiliate Macleods Pharma USA, Inc., are ANDA filers. Merck is the innovator/operating company enforcing a product (drug-substance) patent against a would-be generic competitor.

Accused product and asserted patent. Macleods submitted an ANDA seeking FDA approval to market a generic version of Merck's sitagliptin phosphate franchise — Januvia (sitagliptin phosphate), and/or the combination products Janumet / Janumet XR (sitagliptin + metformin HCl). Merck received Macleods' paragraph IV notice on Nov. 20, 2018, and filed suit on Feb. 13, 2019; the complaint identifies the '708 patent, expiration listed as Nov. 24, 2026 (Justia docket, 1:19-cv-00316). Technically, the '708 patent claims the dihydrogenphosphate salt of sitagliptin ("1:1 sitagliptin DHP") — a DPP-4 inhibitor used to treat Type 2 diabetes — and, in dependent claims, crystalline monohydrate forms of that salt, plus a process for preparing the monohydrate and pharmaceutical compositions (Markman opinion, In re Sitagliptin Phosphate ('708 & '921) Patent Litig., MDL 19-2902-RGA, 11/17/2020). The caption here asserts only the '708 patent; the companion U.S. Pat. No. 8,414,921 (sitagliptin/metformin formulations) was asserted against some, but not all, defendants in the broader campaign.

Procedural posture, venue, and significance. Filed in the U.S. District Court for the District of Delaware before Judge Richard G. Andrews (Case No. 1:19-cv-00316-RGA), the case was one of roughly 14 parallel Merck suits filed in February 2019 against sitagliptin ANDA filers; in August 2019 the JPML centralized them as MDL No. 2902 before Judge Andrews, expressly citing his experience with complex patent litigation and noting that 13 of the 14 actions were already in Delaware (JPML Transfer Order, MDL-2902). Delaware mattered because it is a preferred Hatch-Waxman forum and the natural venue for ANDA actions under 35 U.S.C. § 271(e)(2). A common scheduling order set a Markman hearing for Aug. 18, 2020 and a 3-day bench trial for Oct. 4, 2021, with fact discovery closing Nov. 20, 2020 (Unified Patents litigation portal, 1:19-cv-00316). Judge Andrews issued a single global claim-construction opinion on Nov. 17, 2020 covering the '708 and '921 patents, holding (among other things) that the "crystalline monohydrate" term means a repeating unit cell with a 1:1 water-to-salt ratio and that certain XRPD "absorption bands" claim language was indefinite.

The case is notable less for its own docket than for its place in Merck's multi-front effort to extend Januvia/Janumet exclusivity beyond the 2023 expiry of the basic sitagliptin compound patent, using the later-expiring salt/polymorph '708 patent as the pivotal secondary protection. That patent was tested in four parallel IPRs — Mylan's IPR2020-00040 (FWD May 7, 2021, affirmed by the Federal Circuit in Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp., Oct. 2022, with Judges Lourie, Reyna, and Stoll), plus IPR2020-01045 (Teva/Watson), IPR2020-01060 (Dr. Reddy's), and IPR2020-01072 (Sun) — and survived on non-obviousness/inherency grounds (Patent Docs summary; National Law Review). The Macleods case did not reach trial; it resolved by settlement, and Merck ultimately settled with more than two dozen generic manufacturers to permit U.S. generic sitagliptin entry in May 2026 (Janumet XR in July 2026) — roughly seven months ahead of the patent's nominal November 2026 expiry (Close Concerns/Endpoint summary, Mar. 2023; DrugPatentWatch). The economic stakes were large: Januvia/Janumet were a ~$6 billion-per-year franchise at peak.

Sourcing caveat: The specific dismissal/consent-judgment entry and settlement terms for the Macleods action itself are not well documented in the public sources retrieved; the case's "settled" status and the fact that Macleods was among the ANDA filers covered by Merck's 2022–2023 settlement wave allowing 2026 entry are supported, but I could not locate a dated Macleods-specific stipulation of dismissal or a first-filer/exclusivity determination for Macleods. Those specific points should be confirmed against the MDL 19-2902 docket before being relied upon.

I'll research this case systematically across the docket, PTAB, and legal news sources.

I have strong leads. Let me dig into the PTAB proceedings and the consent judgment details.

Now let me pin down the Macleods-specific resolution, the MDL claim construction, and the joinder IPRs.

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

Let me verify the specific attorneys and their firms.

Plaintiff's Counsel of Record — Merck Sharp & Dohme Corp. v. Macleods Pharmaceuticals Ltd., No. 1:19-cv-00316-RGA (D. Del.)

Case context (for grounding): This is a Hatch‑Waxman/ANDA action asserting U.S. Patent No. 7,326,708 ("Phosphoric acid salt of a dipeptidyl peptidase‑IV inhibitor" — the sitagliptin dihydrogenphosphate salt/monohydrate patent listed in the Orange Book for JANUVIA/JANUMET). It is one of a group of parallel Merck actions filed 2019‑02‑13 and consolidated into In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, No. 1:19-md-02902-RGA (D. Del.) before Judge Richard G. Andrews. The case terminated by consent judgment (a proposed consent judgment was filed on the docket); consistent with the metadata, the matter is treated as settled.

Merck's representation followed a consistent two‑firm structure across the sitagliptin cases: lead national/first‑chair counsel from Williams & Connolly LLP (Washington, D.C.), with McCarter & English, LLP (Wilmington, Delaware) serving as Delaware/local counsel under D. Del. Local Rule 83.5.

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Delaware / local counsel — McCarter & English, LLP, Renaissance Centre, 405 N. King St., 8th Floor, Wilmington, DE 19801

Pro hac vice / national counsel — Williams & Connolly LLP, 680 Maine Ave. SW, Washington, D.C. 20024

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Sourcing and caveats

• Docket‑based identifiers: The District of Delaware docket (UniCourt and Dockets.Justia mirrors of the CM/ECF docket, plus the Unified Patents litigation portal entry for 1:19‑cv‑00316) lists Merck's plaintiff‑side attorneys as Anthony H. Sheh, Michael P. Kelly, Daniel M. Silver, Alexandra M. Joyce, and Jingyuan Luo, with pro hac vice entries for Sheh (Mar. 8, 2019) and Luo (Mar. 7, 2019). The MDL docket sheet (1:19-md-02902-RGA) separately lists Michael P. Kelly as "LEAD ATTORNEY" and Daniel M. Silver as "ATTORNEY TO BE NOTICED," both at McCarter & English, Wilmington.
• Pro hac vice roster: The broader six‑attorney roster (Genderson, Berniker, Fisher, Mahaffy, Sheh, Luo) comes from a Form‑6‑style PHV motion docketed in the parallel sitagliptin actions (e.g., Merck v. Wockhardt Bio AG, No. 1:19‑cv‑00321‑RGA; Merck v. Sandoz Inc.). Merck filed materially identical motions across the group, and the individuals named there are almost certainly the same team, but I could not retrieve the corresponding 316‑case motion document itself to confirm each name is on this docket. Names taken from docket text are also subject to OCR/transcription error in the aggregator sources.
• Firm attributions for Genderson, Fisher, Berniker, and Mahaffy are inferred from their appearance together on Merck's PHV motions; I did not obtain an independent firm website or opinion citation tying each to Williams & Connolly in this matter. Do not treat those four firm attributions as verified. Sheh's Williams & Connolly affiliation is verified (his own PTAB declaration and the W&C attorney bio).
• In‑house Merck counsel: I found no entry reflecting appearance or notice of Merck in‑house attorneys in this docket. If Merck in‑house counsel (e.g., its IP litigation group, which handles the sitagliptin portfolio) were served with notice, that does not appear in the public docket entries retrieved.
• Sealed material: No substantive filings in this case appear sealed in a way that would hide counsel of record; appearances are public. The limitation is not sealing but rather that my retrieval relied on third‑party docket mirrors rather than a PACER pull of the full docket sheet, which is the reason for the caveats above.
• Related proceedings worth noting: The '708 patent was challenged in IPR2020‑00040 (Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.), in which Sheh was designated backup counsel for Merck — useful corroboration that the Williams & Connolly team handled both the district court and PTAB aspects of this patent family. Claim construction in the MDL was decided by Judge Andrews (see Merck Sharp & Dohme Corp. v. Anchen Pharmaceuticals, Inc., D. Del. — the '708/'921 Markman ruling addressing "crystalline monohydrate" and the '921 "surfactant" terms).

Bottom line: If you need the single authoritative answer — Michael P. Kelly (lead) and Daniel M. Silver, both of McCarter & English's Wilmington office, are the Delaware counsel of record for Merck; Anthony H. Sheh and Jingyuan Luo (Williams & Connolly, Washington, D.C.) appeared pro hac vice for Merck in this case, with the wider Williams & Connolly team (Genderson, Fisher, Berniker, Mahaffy) appearing across the consolidated sitagliptin litigation.

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

Let me confirm the firm affiliations and roles.

Let me check the CourtListener docket and confirm local counsel and any additional appearances.

Defense Counsel of Record — Merck Sharp & Dohme Corp. v. Macleods Pharmaceuticals Ltd. et al., 1:19-cv-00316-RGA (D. Del.)

Summary

Macleods was represented by a two-firm team: a Delaware local counsel firm handling all CM/ECF filings (per D. Del. Local Rule 83.5(d)) and a Washington, DC–based Hatch-Waxman firm appearing pro hac vice as lead substantive counsel. The same team appeared for Macleods across the related Merck ANDA actions in this district (including 1:19-cv-00320-RGA, consolidated into MDL No. 1:19-md-02902-RGA before Judge Andrews).

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1. A. Neal Seth — Lead counsel (pro hac vice)

• Firm / office: Wiley Rein LLP (now "Wiley"), 2050 M Street NW, Washington, DC.
• Role: Lead trial/appellate counsel; registered patent attorney (USPTO Reg. No. 67,075) and chair of the firm's Intellectual Property practice. Admitted pro hac vice on defendants' motion, D.I. 10 (filed Mar. 19, 2019; granted same day).
• Experience note: Deep ANDA/Hatch-Waxman defense practice — firm bio and press materials credit him with leading defense teams in the aripiprazole (Abilify), bendamustine (Treanda), fesoterodine (Toviaz), and roflumilast (Daliresp) matters; joined Wiley in 2014 from BakerHostetler; GW Law J.D., Cornell B.S. (chemical engineering). He is also the Wiley IP practice chair who has represented Macleods in related proceedings, including the later In re Entresto (Sacubitril/Valsartan) Patent Litigation, 1:20-md-02930 (D. Del.) (Wiley press release).

2. Laura R. Braden — Counsel (pro hac vice)

• Firm / office: Wiley Rein LLP, Washington, DC.
• Role: Pro hac vice counsel, appearing jointly with Mr. Seth under the same D.I. 10 motion (certification attached as Attachment #2); CM/ECF noticing added Mar. 22, 2019.
• Experience note: Part of the Wiley team representing generic manufacturers in ANDA litigation; contemporaneously appeared with Mr. Seth for Macleods co-defendants in Merck Sharp & Dohme Corp. v. Torrent Pharmaceuticals Ltd. et al., 1:19-cv-00872-RGA (D. Del.) (same D.I. 12 PHV motion format). (Her individual career history beyond firm-level litigation work is not well documented in public sources I could verify; treat the bio detail as firm-level rather than personal.)

3. John M. Seaman — Delaware/local counsel of record

• Firm / office: Abrams & Bayliss LLP, 20 Montchanin Road, Suite 200, Wilmington, DE 19807 (Delaware Bar).
• Role: Delaware counsel of record — filed the PHV motion (D.I. 10), the Answer and Counterclaims (D.I. 11, Apr. 8, 2019), the Answer to the First Amended Complaint with counterclaims (Feb. 2020), the stipulation to amend the scheduling order (Mar. 2020), and all discovery/service notices on behalf of Macleods. As local counsel he is the registered CM/ECF filer for the defense.
• Experience note: Wilmington commercial/IP litigator (Penn J.D. 1999); prior firms include Potter Anderson & Corroon and Bouchard Margules & Friedlander; has represented ANDA defendants such as Hetero USA in Pfizer v. Sandoz/Hetero D. Del. actions and has been recognized in Best Lawyers for Commercial Litigation since 2017. Wiley's own press materials confirm he and Abrams & Bayliss partner April M. Ferraro served as co-counsel to Wiley in representing Macleods in the related Entresto MDL.

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Caveats and verification notes

• Docket coverage is partial. The public docket summaries I could reach (Justia dockets) were last refreshed April 8, 2019, so I cannot independently confirm every appearance entry after that date. Later entries (Feb.–Apr. 2020) are corroborated through the Unified Patents litigation portal and the filing text of related cases. A PACER pull of the full docket sheet would be needed to confirm whether any additional attorneys appeared, withdrew, or substituted after mid-2019.
• April M. Ferraro (Abrams & Bayliss) is documented as Macleods' co-counsel alongside Mr. Seaman and the Wiley team in the Entresto MDL; I found no verified appearance by her on this docket (1:19-cv-00316). Do not treat her as counsel of record here without confirming on PACER.
• No in-house counsel appeared on the docket for Macleods in this action based on the available records.
• No sealed-appearance issue identified — the appearances here were ordinary PHV motions and notices, not sealed filings.
• The case resolved by consent judgment signed by Judge Andrews on April 28, 2020 (entered on a proposed consent judgment filed by plaintiff), consistent with the "settled" status in the case metadata.

Sources: D. Del. docket 1:19-cv-00316 (Justia Dockets, docket/67789; UniCourt case page), Unified Patents litigation portal entry for 1:19-cv-00316 (docket text through the Apr. 28, 2020 consent judgment), Wiley Rein press release ("Wiley Wins High-Profile Drug Patent Case on Behalf of Generic Manufacturer"), Wiley Rein partner biographies and 2014/2016 firm press releases, USPTO PTAB Paper No. 4 documents listing A. Neal Seth as Reg. No. 67,075, and Abrams & Bayliss / Martindale / Best Lawyers attorney profiles for John M. Seaman.