Merck Sharp & Dohme Corp. v. Dr. Reddy's Laboratories Ltd. et al.

I'll research this case thoroughly using web search before writing the overview.

Good foundation. Let me dig deeper on the specific product/ANDA for the '847 case, the MDL, and the IPR outcomes.

Let me pin down the '847 complaint specifics, the Delaware trial outcome, and the DRL settlement launch date.

Case Overview & Background

Parties. Plaintiff Merck Sharp & Dohme Corp. (MSD) is the operating-company subsidiary of Merck & Co., Inc. that holds the New Drug Applications and patents for Merck's sitagliptin franchise; it is not an NPE/PAE or university. Defendants Dr. Reddy's Laboratories, Ltd. (India) and its U.S. affiliate Dr. Reddy's Laboratories, Inc. are generic-drug manufacturers that file ANDAs to sell lower-cost copies of branded medicines. This is a classic Hatch-Waxman (ANDA) case, Nature of Suit 835, in which an innovator asserts a listed Orange Book patent against a would-be generic entrant. Merck's litigation team was Williams & Connolly LLP (Bruce Genderson, Stanley Fisher, Alexander Zolan, Jessamyn Berniker, et al.) with McCarter & English LLP as Delaware counsel (Michael Kelly, Daniel Silver, Alexandra Joyce); Dr. Reddy's was represented by Tedd Van Buskirk and Russell Faegenburg (pro hac vice) with David Ellis Moore as Delaware counsel (dockets.justia.com docket; Unified Patents portal).

Accused product and patent. Merck alleged that Dr. Reddy's infringed U.S. Patent No. 7,326,708 ("the '708 patent"), titled "Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor," issued February 5, 2008, by filing ANDAs seeking pre-expiration approval of generic sitagliptin products. Sitagliptin phosphate is the active ingredient in Merck's Type 2 diabetes drugs JANUVIA® (sitagliptin), JANUMET® (sitagliptin/metformin), and JANUMET XR® (extended-release sitagliptin/metformin). The '708 patent is a salt/polymorph patent — claim 1 covers the 1:1 dihydrogenphosphate salt of sitagliptin (or a hydrate), claims 2–4 cover the (R)- and (S)- configurations and the crystalline monohydrate, and claims 5–7 recite XRPD d-spacing characterizations, with claim 24 a crystallization process. It is listed in the Orange Book for all three products, with a nominal expiry of November 24, 2026 (plus pediatric exclusivity to May 24, 2027) (Orange Book listing; Merck MDL transfer motion). The consent judgment identifies the relevant Dr. Reddy's ANDAs as Nos. 214700, 214685, and 215722, and the companion 21-cv-01033 action was directed to ANDA No. 215722 (Janumet XR) (Consent Judgment, C.A. 20-847 & 21-1033; Unified Patents docket, 21-1033). I could not fully confirm from the retrieved sources which specific product ANDAs (Januvia vs. Janumet) were named in the original '847 complaint versus the 2021 filing, so the allocation of ANDA numbers to each of the two dockets should be treated as an inference.

Procedural posture, venue, and significance. Filed June 24, 2020 in the District of Delaware (Wilmington) and assigned to Judge Richard G. Andrews, the case was folded into MDL No. 19-md-02902-RGA, In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, which centralized 14 Merck actions (13 in Delaware plus a Mylan action transferred from N.D. W. Va.) asserting the '708 and '921 patents against roughly 23 defendants/26 ANDAs (JPML transfer order, MDL 2902). Delaware was chosen as the transferee district because nearly all actions were already there and because the district (and Judge Andrews specifically) handles a heavy Hatch-Waxman docket — a venue that matters both for its experienced bench and for the consolidated claim-construction and trial schedule. Judge Andrews held a joint Markman in the MDL on November 17, 2020, construing the disputed '708 terms (crystalline monohydrate, the XRPD "absorption bands" language, and the crystallization-at-25 °C limitation) (MDL Memorandum Opinion, Nov. 17, 2020). A bench trial was calendared for October 4, 2021, but before it proceeded Merck and Dr. Reddy's settled; on October 5, 2021 Judge Andrews entered a stipulated Consent Judgment resolving both 20-847 and 21-1033 — all claims and counterclaims dismissed with prejudice and Dr. Reddy's enjoined from infringing the '708 patent except as its confidential settlement agreements permit (Consent Judgment).

The case is notable for three reasons. First, it is one battle in a coordinated, multi-front campaign by Merck to extend the sitagliptin franchise beyond the compound patent (U.S. 6,699,871) using the '708 salt/polymorph patent and the '921 formulation patent — a strategy that, as Merck has disclosed, supports U.S. exclusivity for Januvia/Janumet until May 2026 and Janumet XR until July 2026. Second, it illustrates the tight linkage between ANDA litigation and PTAB proceedings: Dr. Reddy's filed its own petition (IPR2020-01060) and then joined Mylan's IPR2020-00040, which went to a May 7, 2021 Final Written Decision upholding the challenged '708 claims, affirmed by the Federal Circuit in Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp., No. 21-2121 (Fed. Cir. Sept. 29, 2022) (the "957 salts"/In re Petering "at once envisage" case) — leaving the patent intact and strengthening Merck's settlement leverage (Fed. Cir. opinion; Finnegan PTAB blog). Third, the market stakes were substantial — sitagliptin was the first FDA-approved DPP-IV inhibitor and a multi-billion-dollar diabetes franchise — making the resulting generic-entry dates (negotiated, not litigated) economically significant even though the specific launch dates remain confidential.

Sourcing note: Facts above are drawn from the public docket (Justia/Unified Patents/Docket Alarm), the JPML transfer order, the MDL claim-construction opinion, the Fed. Cir. Mylan opinion, the filed Consent Judgment, and Merck's SEC disclosures. Where a detail (e.g., which DRL ANDA corresponded to which product in the original '847 complaint, or the confidential settlement entry date) is not confirmed by a retrieved source, I have said so rather than speculate.

I'll research this case systematically. Let me start with the docket and case basics.

This is the sitagliptin (Januvia) '708 patent litigation, part of a larger MDL. Let me dig into the PTAB proceedings and the related MDL.

Let me dig into the IPR joinder/termination for Dr. Reddy's, the '708 certificate of correction, and the ultimate MDL disposition.

Merck Sharp & Dohme Corp. v. Dr. Reddy's Laboratories (D. Del. No. 1:20-cv-00847) — Chronology & Outcome

Bottom line: This was one ANDA case (sitagliptin phosphate / JANUVIA) inside the much larger In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 19-2902-RGA (D. Del.) before Judge Richard G. Andrews. DRL filed its IPR before Merck sued it. Merck won the IPR at the Board and on appeal, and then resolved this case (and all remaining MDL defendants) by consent judgment on the eve of the October 2021 validity bench trial. No trial, no verdict, no JMOL/§ 285 ruling ever issued in this case.

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1. Filing & initial pleadings

I'll search for press coverage of this case from multiple angles.

Let me verify the Moneycontrol article directly and search for additional press coverage angles.

Let me try to locate the Moneycontrol article and search for settlement-specific coverage.

Press coverage of Merck Sharp & Dohme Corp. v. Dr. Reddy's Laboratories (D. Del. 1:20-cv-00847)

The filing drew a single, widely syndicated wire story — and almost nothing else. The only article I could locate that is specifically about this docket is the Moneycontrol piece from 2020-06-26, which is the Press Trust of India wire copy ("Merck Sharp & Dohme Corp sue Dr Reddy's Labs over Januvia, Janumet generics") republished across Indian business media. The same PTI text appeared at CNBC-TV18 ("Merck Sharp & Dohme moves US court against Dr Reddy's on diabetic drugs," bylined PTI, 2020-06-26, 4:44 PM IST), and a Moneycontrol tag index confirms the wording ("Merck has filed the possible patent infringement petition against Dr Reddy's in the United States District Court for the District of Delaware on four counts"). The reporting is transactional and sparse: that Merck pleaded four counts; that Dr. Reddy's had submitted ANDAs to FDA seeking pre-expiration approval of generic Januvia and Janumet; that Merck sought preliminary and permanent injunctions barring manufacture, use, sale, offer for sale, or importation of the ANDA products; and that the '708 patent was the vehicle. For scale, CNBC-TV18 reported that Januvia and Janumet together "clocked over USD 5.5 billion revenues globally including USD 2.3 billion in USA in 2019," while Express Pharma put Janumet alone at "over $2 billion revenues globally including $589 million in the US in 2019."

Later references to this case appear only as background in the parallel Aurobindo coverage. Both Express Pharma and ET HealthWorld (2020-08-25) led with Merck's suit against Aurobindo Pharma over Janumet and mentioned this case only in a single line: "In June, Merck had filed a petition against Dr Reddy's Laboratories in a US court over similar patent issues on Janumet and Januvia." Neither added independent reporting on the DRL docket. Notably, none of the filing-wave stories mentions the PTAB proceeding at all — even though Dr. Reddy's had already filed IPR2020-01060 against the '708 patent — and none discusses the then-pending MDL No. 19-2902 consolidation. The coverage frames the suit as a Dr. Reddy's business-risk item for Indian investors, not as a patent-law or exclusivity story, and the only color is unattributed: "A city-based pharmaceutical company senior official said patent infringement cases are not uncommon for generic drug makers in the USA and the lawsuit will not have any implications on the performance of the company" (CNBC-TV18).

The reporting diverges from the court record in at least two places worth flagging. First, the patent-expiry framing: PTI reported that "[p]atents of Januvia and Janumet will expire in July 2022 for the US with six-month pediatric exclusivity, Merck said in its 2019 annual report" (CNBC-TV18) — but that date relates to earlier-listed protection, not the '708 patent actually asserted here, whose Orange Book expiry is November 24, 2026 (to May 24, 2027 with pediatric exclusivity), as the FDA's own ANDA 214685 approval letter reflects (FDA approval letter, ANDA 214685). Second, the filing date: PTI says the petition was "filed on June 23," whereas the docket records the complaint as filed June 24, 2020. The press also refers generically to "ANDAs," whereas the complaint itself identifies ANDA Nos. 214700 (Januvia) and 214685 (Janumet) (complaint text via Docket Alarm) — which resolves the open question flagged in the earlier overview: 20-847 covers the Januvia and Janumet ANDAs, while 21-1033 covers ANDA 215722 (Janumet XR).

There was no press coverage of the outcome. I found no Reuters, Bloomberg Law, Law360, IPWatchdog, or Patently-O article about the October 5, 2021 consent judgment in this docket, and no outlet reported settlement terms (which remain confidential). The public traces of the resolution are non-journalistic: the filed Consent Judgment, the FDA's statement that "this case was dismissed" in the ANDA 214685 approval letter, and Merck's SEC 10-Q language that, "[a]s a result of settlement agreements with generic drug companies related to the later expiring 2027 salt/polymorph patent directed to the specific

Sources

• IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
• As previously disclosed, beginning in 2019, a number of generic drug companies filed ANDAs seeking approval of generic forms of ...
• Janumet ((\widehat{\Xi})) (sitagliptin phosphate / metformin HCl) 7,326,708 Merck Sharp & Dohme Corp
• UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION
• _also Pl
• Diabetes - Generics, Legal
• Merck moves US court against Aurobindo Pharma on diabetic drug Janumet - - Pharma
• Merck Sharp & Dohme moves US court against Dr Reddy's on diabetic drugs - CNBC TV18 - HomeLegal NewsMerck Sharp & Dohme moves US court against Dr Reddy's on diabetic drugs
• 2013年4月1日，美国默克公司向德里高等法院提起诉讼，指控Glenmark公司的仿制药Zita和Zita-Met侵犯了其西他列汀的专利权
• ANDA Litigation Settlements
• IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
• Defendants' actions in defending this case do not constitute an exceptional case under 35 U

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

Let me dig into the specific attorneys and their firms.

Let me find the actual complaint signature block and confirm the Delaware firm affiliations at the time of filing.

Plaintiff's Counsel of Record — Merck Sharp & Dohme Corp. v. Dr. Reddy's Labs., No. 1:20-cv-00847-RGA (D. Del.)

Merck was represented by a two-firm team: Williams & Connolly LLP (Washington, D.C.) as first-chair/trial counsel on the '708 patent, and McCarter & English, LLP (Wilmington, Del.) as Delaware counsel. The case was a member/associated case of In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 19-md-02902-RGA, before Judge Richard G. Andrews, which is why the same team appears across both dockets.

Delaware counsel — McCarter & English, LLP (Renaissance Centre, 405 N. King St., 8th Fl., Wilmington, DE 19801)

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

Good leads. Let me verify the specific docket entries and firms.

Let me pin down the pro hac vice motions, docket numbers, and confirm which attorneys entered appearances.

Counsel of Record — Defendants Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc.

Merck Sharp & Dohme Corp. v. Dr. Reddy's Laboratories, Ltd. et al., No. 1:20-cv-00847-RGA (D. Del.) (Judge Richard G. Andrews; ANDA/§ 271(e)(2) action on U.S. Pat. No. 7,326,708; terminated Oct. 5, 2021 by consent judgment)

Defendants were represented by a two-firm team: Potter Anderson & Corroon LLP as Delaware counsel of record, and Lerner David Littenberg Krumholz & Mentlik LLP (now branded "Lerner David LLP") as lead/PHV counsel. The same Lerner David team also represented Dr. Reddy's as petitioners in the parallel IPR2020-01060, which is useful corroboration because the IPR mandatory notices list the identical lineup.

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Delaware (local) counsel of record — Potter Anderson & Corroon LLP, Wilmington, DE

Because of D. Del. Local Rule 83.5(d), the Delaware attorneys were the registered CM/ECF filers; the docket notation for the PHV admissions states this expressly.

Lead / merits counsel — Lerner David Littenberg Krumholz & Mentlik LLP, Cranford (formerly Westfield), NJ

In-house counsel

No in-house attorney for Dr. Reddy's appears in the public docket record I could review. DRL's filings were signed by outside counsel only.

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Caveats and sourcing notes

• Docket-source quality. The live PACER docket for 20-cv-847 is not directly searchable here; the entries above are drawn from docket-aggregator mirrors of the PACER record — Unified Patents' litigation portal (portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1:20-cv-00847), Patexia, UniCourt, and Docket Alarm's OCR docket (which shows filing 6/24/2020, termination Oct. 5, 2021, Judge Andrews). Docket numbers cited (D.I. 8, 9, 10) are consistent across those mirrors; the exact D.I. number for the Gurule PHV motion and for the consent judgment I could not verify item-by-item, so I have not assigned numbers to those.
• Do not confuse with DRL's other Merck matters. Dr. Reddy's used different Delaware counsel in related and follow-on litigations. For example, in Merck Sharp & Dohme Corp. v. Dr. Reddy's Labs., C.A. No. 21-1033-RGA (JANUMET XR® / ANDA 215722), DRL's answer was filed by Neal C. Belgam and Eve H. Ormerod (Smith, Katzenstein & Jenkins LLP) with Windels Marx Lane & Mittendorf LLP as co-counsel. Those names are not counsel of record in 20-cv-847 and should not be attributed to this docket.
• Other apparent DRL counsel teams found in searches were for unrelated matters: Amgen v. Sandoz / biosimilar matters (Marguerite M. Sullivan, Latham & Watkins), the E.D. Pa. matter (Carlos Ortiz / Kayley B. Sullivan, Baker & Hostetler), the N.J. MDL matter where Devan V. Padmanabhan and Sri K. Sankaran (Padmanabhan & Dawson) appeared with Lerner David, and a D.D.C. matter where Kendall Gurule appears with a Polsinelli email address. None of these reflect appearances in 20-cv-847 (the Polsinelli/Gurule email indicates she later moved firms — the 20-cv-847 appearance was while she was at Lerner David).
• Sealed material. The docket contains sealed filings (e.g., [SEALED] expert reports and pretrial exhibits, and a "[SEALED] AMENDED Exhibit 4P"), so any attorney whose only connection to the case appears in sealed papers would not surface. I found no indication that any DRL appearance is sealed.
• No fabrication flag. Attorneys not listed above should not be assumed to have appeared. If you need a line-by-line verification, the definitive check is PACER for D. Del. 1:20-cv-00847 (the "attorneys" tab and each PHV order), since the aggregator mirrors capture only part of the docket.