Litigation

Merck Sharp & Dohme Corp. v. Dr. Reddy's

1:21-cv-01033

Patents at issue (1)

7326708

Defendants (1)

Summary

D. Del. action in which Dr. Reddy's answer admits on its face that the '708 patent is asserted.

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 across multiple authoritative sources.

Key facts emerging. Let me dig into the MDL, the IPRs, and the consent judgment terms.

Let me verify the Mylan trial outcome, market context, and the specific Dr. Reddy's ANDAs.

Case Overview: Merck Sharp & Dohme Corp. v. Dr. Reddy's Laboratories, Inc., C.A. No. 1:21-cv-01033-RGA (D. Del.)

The parties. Merck Sharp & Dohme Corp. (now Merck Sharp & Dohme LLC, a New Jersey corporation and wholly owned subsidiary of Merck & Co., Inc.) is the plaintiff and the innovator NDA holder for the sitagliptin franchise — Januvia® (sitagliptin phosphate), Janumet® and Janumet XR® (sitagliptin + metformin), Juvisync®, and Steglujan®. This is a classic operating-company-versus-generic dispute, not an NPE/PAE assertion. The defendants are Dr. Reddy's Laboratories, Ltd. (Hyderabad, India) and its U.S. subsidiary Dr. Reddy's Laboratories, Inc.; the Rule 7.1 disclosure filed at D.I. 10 identifies no parent above Dr. Reddy's Laboratories, Ltd., i.e., DRL is not a subsidiary of a larger group. Merck was represented by McCarter & English (Michael P. Kelly, Daniel M. Silver, Alexandra M. Joyce) as Delaware counsel with Williams & Connolly LLP (Bruce R. Genderson, Jessamyn S. Berniker, Alexander S. Zolan, and others) as lead trial counsel; DRL appeared through David E. Moore and Stephanie E. O'Byrne (D.I. 9, 11). Merck filed the complaint on July 15, 2021, within the 45-day window after DRL's paragraph IV notice dated June 4, 2021, triggering a 30-month stay running to December 4, 2023 (D.I. 3).

The patent and the accused products. The sole patent at issue is U.S. Patent No. 7,326,708, "Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor," filed June 23, 2004, issued February 5, 2008, listing Stephen Cypes, Alex Chen, Russell Ferlita, Karl Hansen, Ivan Lee, Vicky Vydra, and Robert Wenslow, Jr. as inventors and Merck as assignee. In one line: the '708 patent claims the 1:1 dihydrogenphosphate (DHP) salt of sitagliptin and hydrates thereof (claim 1), the (R)- and (S)- enantiomers (claims 2–3), the crystalline monohydrate form (claims 4–16), a method of treating Type 2 diabetes with the salt (claim 19), and process claims (claims 21–24). Claim 1 was construed by Judge Andrews in the MDL as including hydrates of the recited salt (In re Sitagliptin Phosphate ('708 & '921) Patent Litig., 2020 WL 6743022 (D. Del. Nov. 17, 2020)). The accused products are DRL's generic sitagliptin phosphate ANDA products; the October 2021 consent judgment defines the enjoined "DRL Products" by reference to ANDA Nos. 214700, 214685, and 215722 — i.e., generic counterparts of Januvia, Janumet, and Janumet XR. The '708 patent is listed in the Orange Book against Januvia, Janumet, Janumet XR, Juvisync, and Steglujan, with a base expiration of November 24, 2026 and six-month pediatric exclusivity extending to May 24, 2027 (Merck's § 287 patent-marking list and Orange Book listings; note that the N.D. W. Va. opinion in the parallel Mylan case refers to a March 24, 2027 date, which appears inconsistent with the Orange Book and with the 11/24/2026 date reported to the PTO in this docket).

Posture, venue, and why the case matters. The case was assigned to Judge Richard G. Andrews in Wilmington and docketed as an ANDA action under 35 U.S.C. § 271(e)(2), then consolidated for pretrial purposes into MDL No. 2902, In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, D. Del. No. 1:19-md-02902-RGA, alongside a companion DRL action, C.A. No. 1:20-847

Key legal developments & outcome

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

I'll research this case systematically across the docket, PTAB, and court opinions.

I have the core docket. Now let me get details on the consent judgment, the related Dr. Reddy's case (1:20-cv-00847), and the parallel IPRs.

Merck Sharp & Dohme Corp. v. Dr. Reddy's Laboratories, Inc. & Ltd., No. 1:21-cv-01033-RGA (D. Del.)

Bottom line: This is a short, self-contained Hatch-Waxman ANDA case that never generated a substantive contested ruling. It was filed 2021-07-15, answered 2021-08-25, and terminated by a negotiated consent judgment entered 2021-10-05 — roughly 11 weeks after filing. There was no motion practice, no Markman, no discovery of record, and no trial in this case. Dr. Reddy's agreed (along with resolving its earlier, related Dr. Reddy's case) to entry of judgment and an injunction against infringing the '708 patent. The doctrinal heavy lifting on the '708 patent happened elsewhere — in the co-pending In re Sitagliptin MDL and in a joined PTAB IPR, which Merck won and the Federal Circuit affirmed.

1. Parties, patent, and counsel

  • Plaintiff: Merck Sharp & Dohme Corp. (now Merck Sharp & Dohme LLC after a 2022-05-01 merger). Outside counsel on the wider sitagliptin campaign was Williams & Connolly LLP; Delaware counsel in this case was McCarter & English (Daniel M. Silver, Alexandra M. Joyce, with Michael P. Kelly on the docket).
  • Defendants: Dr. Reddy's Laboratories, Inc. (U.S. subsidiary) and Dr. Reddy's Laboratories, Ltd. (India). Delaware counsel: David Ellis Moore and Stephanie E. O'Byrne (Potter Anderson & Corroon LLP).
  • Asserted patent: U.S. Patent No. 7,326,708 ("Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor"), issued 2008-02-05, covering the 1:1 dihydrogenphosphate salt of sitagliptin — the salt form in JANUVIA, JANUMET and JANUMET XR. Orange Book expiry recited on the ANDA form: 2026-11-24 (later extended by pediatric exclusivity to 2027-05-24). Inventors of record: Cypes, Chen, Ferlita, Hansen, Lee, Vydra, Wenslow.
  • Presiding judge: Richard G. Andrews. Case assigned 2021-07-21.

2. Chronology of the litigation

Pre-suit — Paragraph IV notice (2021-06-04).
Dr. Reddy's submitted ANDA No. 215722 ("the '722 ANDA") for generic metformin hydrochloride / sitagliptin phosphate extended-release tablets (JANUMET XR) with a Paragraph IV certification against the '708 patent. Per D.I. 3, Merck received the notice letter on 2021-06-04, which started the 45-day window and set the statutory 30-month stay deadline at 2023-12-04.

Filing & initial pleadings.

  • 2021-07-15 — Complaint (D.I. 1). Filed by Merck against both DRL entities. Two counts: (Count I) infringement under 35 U.S.C. § 271(e)(2)(A) arising from the '722 ANDA, plus induced/contributory infringement; (Count II) declaratory judgment of infringement under 28 U.S.C. §§ 2201–2202 for the '722 ANDA product under its proposed labeling. Exhibit A (18 pp.) accompanied the complaint (apparently the notice letter). Jury demand: none on the docket.
  • 2021-08-04 — D.I. 7, 8: Declarations of service on DRL Inc. and DRL Ltd.
  • 2021-08-25 — Answer, Defenses and Counterclaims (D.I. 9). Dr. Reddy's admitted the factual core on the face of the pleading — that DRL Inc. submitted the '722 ANDA, that the '722 Notice Letter carried a Paragraph IV certification as to the '708 patent (alleging invalidity, non-infringement and/or unenforceability), and that Dr. Reddy's had knowledge of the '708 patent when the ANDA was submitted. It denied any legal conclusion of infringement. Affirmative defenses included non-infringement, invalidity, unenforceability, a fifth "Additional Defense" of prosecution history estoppel and/or judicial estoppel, and a 35 U.S.C. § 285 defense (no exceptional case). Counterclaims sought declaratory judgment that the '708 patent is not infringed and is invalid and/or unenforceable, pleading subject-matter jurisdiction and venue and describing the Orange Book listing for Merck's NDA (JANUVIA XR, NDA No. 202270). The counterclaims expressly plead that the '708 patent was listed as claiming NDA No. 202270. A Rule 7.1 disclosure followed (D.I. 10).
  • 2021-08-27 — D.I. 11: Notice of

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 Sharp & Dohme Corp. in this Delaware action.

I have the core Delaware team. Let me verify details and check for any pro hac vice appearances or Williams & Connolly involvement in the district court case.

Let me pull the actual complaint/pleading signature blocks and confirm whether Williams & Connolly appeared in this specific case.

Counsel of Record for Plaintiff Merck Sharp & Dohme Corp. — Merck Sharp & Dohme Corp. v. Dr. Reddy's Laboratories, Inc. et al., No. 1:21-cv-01033-RGA (D. Del.)

Case context (relevant to counsel identification)

This was a short-lived ANDA action. The complaint was filed July 15, 2021 (D.I. 1), asserting U.S. Patent No. 7,326,708 ('708 patent, sitagliptin phosphate monohydrate — Januvia), and the case was closed by consent judgment on October 5, 2021 (D.I. 14), entered as an associated case to the consolidated MDL In re: Sitagliptin Phosphate ('708 & '921) Patent Litigation, No. 1:19-md-02902-RGA. The '708 patent was also the subject of multiple IPRs (e.g., IPR2020-00040, IPR2020-01060). Because the action resolved by consent judgment before any answer-stage motion practice, the plaintiff's appearance list is short — the men and women below are the ones who actually signed the filings.

Plaintiff's counsel of record

Delaware counsel — McCarter & English, LLP (Wilmington, DE)

At the time of this case, Merck's Delaware Hatch-Waxman team for the sitagliptin/'708 matters was McCarter & English. All three were docketed as plaintiff/counter-defendant attorneys for Merck in this action (per the UniCourt/PACER-derived party-attorney listing for 1:21-cv-01033), and all three appeared on the MDL master docket via notices of appearance filed August 15, 2019 (MDL D.I. 4, 5, 6).

Name Role Firm / Office Note on experience
Michael P. Kelly Lead trial counsel (Delaware); listed as LEAD ATTORNEY on the MDL docket for Merck McCarter & English, LLP, Renaissance Centre, 405 N. King St., 8th Fl., Wilmington, DE 19801 Dean of the Delaware bar and former McCarter chairman; fellow of the American College of Trial Lawyers; longtime Merck Hatch-Waxman counsel in D. Del. (e.g., Merck v. Mylan Labs., Merck v. Sandoz, Merck v. Alvogen, Merck v. Wockhardt). Note: Mr. Kelly passed away on January 10, 2022, per McCarter's memorial page — after this case closed.
Daniel M. Silver Delaware counsel; filed Merck's Answer to Dr. Reddy's counterclaims (D.I. 12, Sept. 14, 2021) McCarter & English, LLP, Wilmington, DE Core member of McCarter's Merck ANDA team; appeared for Merck throughout MDL 1:19-md-02902 and the follow-on sitagliptin ANDA cases.
Alexandra M. Joyce Delaware counsel; filed the service declarations (D.I. 7, 8) and the Proposed Consent Judgment (D.I. 13, Oct. 4, 2021) McCarter & English, LLP, Wilmington, DE Merck's most consistent Delaware filer in the '708 sitagliptin litigation; also handled the later Merck v. Mankind/Lifestar '708 consent judgment (1:22-cv-00444, D.I. 15).

National / coordinating counsel coordinating these matters — Williams & Connolly LLP (Washington, D.C.)

Merck's lead national counsel on the '708 patent was Williams & Connolly LLP, 725 Twelfth Street, N.W., Washington, DC 20005. These attorneys were the power-of-attorney/lead counsel in the parallel PTAB proceedings and MDL:

  • Bruce R. Genderson — Williams & Connolly (Washington, DC); Merck's lead appellate/litigation counsel in the '708 matters; pro hac vice in MDL 1:19-md-02902. (I could not confirm a separate pro hac vice appearance in 1:21-cv-01033 — see caveat below.)
  • Alexander S. Zolan — Williams & Connolly (Washington, DC); pro hac vice in the MDL; appeared at the Oct. 8, 2020 Dr. Reddy's IPR deposition on Merck's behalf.
  • Jessamyn S. Berniker — Williams & Connolly (Washington, DC); pro hac vice in the MDL; registered practitioner on Merck's IPR2020-01060 power of attorney.
  • Anthony H. Sheh and Elise M. Baumgarten — Williams & Connolly (Washington, DC); named on Merck's IPR2020-01060 power of attorney and pro hac vice (Sheh) in MDL 1:19-md-02902. Genderson, Zolan, Berniker, Sheh, and Baumgarten were all listed in the July 1, 2020 power of attorney Merck filed in IPR2020-01060 (Reg. Nos. 55,820 / 72,328 / 70,576 for Fisher, Berniker, Sheh respectively).
  • Stanley E. Fisher (Reg. No. 55,820) and Shaun P. Mahaffy (Reg. No. 75,534) — Williams & Connolly (Washington, DC); registered practitioners on Merck's IPR2020-01060 power of attorney. Mahaffy also appeared as Merck's attorney in the IPR2020-00040 deposition.

In-house

No in-house Merck attorney (e.g., a Merck & Co. patent litigation counsel) appears on the public docket for this case. Merck's Rule 7.1 disclosure (D.I. 5) identifies corporate parent Merck & Co., Inc., but no in-house counsel name is docketed, and I did not find one — I won't speculate as to who it was.

Caveats and sourcing notes

  • The Williams & Connolly names are confirmed for the MDL and the IPRs, not necessarily for 1:21-cv-01033 itself. This case opened July 15, 2021 and closed by consent judgment 82 days later (D.I. 14). The docket reflects no pro hac vice motions or notices of appearance from Williams & Connolly in this case number — the only plaintiff-side signatories are the McCarter attorneys (Silver, D.I. 12; Joyce, D.I. 7, 8, 13). It is common in these "tag-along" consent-judgment cases for national counsel to work behind the scenes without formally appearing, but I cannot confirm W&C formally appeared here, and I am flagging that rather than asserting it.
  • The party-attorney mapping for plaintiff (Kelly/Silver/Joyce) comes from the UniCourt and Justia PACER-derived dockets for 1:21-cv-01033; the roles (lead counsel, pro hac vice) come from the docket text of the consolidated MDL 1:19-md-02902 reproduced on PACER/RECAP and mirrored at the USPTO PTAB filing for IPR2020-01060. The MDL status line "Michael P. Kelly … LEAD ATTORNEY" is the basis for designating him lead Delaware counsel.
  • Defendant's Delaware counsel was David Ellis Moore and Stephanie E. O'Byrne (Potter Anderson & Corroon LLP), with Dr. Reddy's national counsel from Lerner David (Faegenburg, Van Buskirk, Teschner) and Goodwin Procter (Sarah J. Fischer) — included only for completeness, not as plaintiff's counsel.
  • I did not access PACER directly; the docket snapshots used (Justia, UniCourt, Patexia, Unified Patents) were last refreshed in 2021 and may not reflect any post-consent-judgment minute entries. Attorney firm affiliations are stated as of the 2019–2022 window — e.g., Kelly's McCarter memorial page confirms he remained at McCarter until his death in January 2022.

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 appearances for this case.

Now let me dig into the docket entries and the answer/judgment signature blocks to pin down defense counsel.

Let me pull the full docket and confirm the local counsel firm for O'Byrne and the pro hac vice entries.

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

Case posture caveat: This action was short-lived. It was filed 7/15/2021 as a companion to the consolidated In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 19-2902-RGA (D. Del.), and was closed by consent judgment on 10/5/2021 (D.I. 14), in which all claims, counterclaims, affirmative defenses and demands were dismissed with prejudice. The counsel picture below is therefore frozen as of that date; no case activity post-dates it.

Delaware / local counsel

Attorney Role Firm & office Notes
David Ellis Moore Local (Delaware) counsel; filed the operative defense pleading Potter Anderson & Corroon LLP, Hercules Plaza, 1313 N. Market St., Wilmington, DE 19801 Registered Delaware counsel; Answer, Defenses, and Counterclaims filed under his name at D.I. 9 (Aug. 25, 2021). One of the most prolific Delaware IP litigators; has represented Dr. Reddy's in D. Del. patent matters going back two decades (e.g., Bayer AG v. Dr. Reddy's Labs., C.A. 04-179-SLR; In re '318 Patent Infringement Litig., C.A. 05-356). Recognized in Best Lawyers and Lawdragon 500 for IP/patent litigation.
Stephanie E. O'Byrne Local (Delaware) counsel Firm not confirmed on the face of the entry I located — appeared in the same case as co-counsel with Moore; commonly identified in this period as Potter Anderson & Corroon LLP, Wilmington, DE Notice of Appearance at D.I. 11 (Aug. 27, 2021) on behalf of both Dr. Reddy's entities. ⚠️ I could not independently verify her firm/office from a primary source for this case — treat the firm attribution as unconfirmed and verify against the D.I. 11 PDF or the Delaware bar directory.

Lead / national (substantive) counsel

Attorney Role Firm & office Notes
Russell W. Faegenburg Lead substantive counsel (defense side); signed the settlement/consent judgment for Dr. Reddy's Lerner, David, Littenberg, Krumholz & Mentlik, LLP, 20 Commerce Drive, Cranford, NJ 07016 Signatory, with Van Buskirk, to the 10/4–10/5/2021 Consent Judgment (D.I. 13/14) entered in MDL 19-2902 / C.A. 20-847-RGA / C.A. 21-1033-RGA, styled "Attorneys for Defendants Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd." Dr. Reddy's long-time '708/sitagliptin patent counsel — also Dr. Reddy's counsel in IPR2020-01060 (Dr. Reddy's v. Merck Sharp & Dohme, U.S. Pat. 7,326,708).
Tedd W. Van Buskirk Substantive counsel; co-signatory on the consent judgment Lerner David, Cranford, NJ (same address) Same appearance pattern; listed on the '708 IPR papers and on the D.I. 13/14 consent judgment signature block for Dr. Reddy's.

⚠️ Pro hac vice caveat: I did not find a pro hac vice motion or order for Faegenburg/Van Buskirk in the 1:21-cv-01033 docket itself. In the parallel 1:20-cv-00847-RGA case, the docket does reflect pro hac vice entries for Faegenburg (added 8/11/2020) and Van Buskirk (added 7/29/2020). Their authority in 21-1033 appears via the consent judgment signature block rather than a separate pro hac vice docket entry — verify on the docket sheet if this distinction matters.

In-house counsel

No in-house counsel (Merck-side or Dr. Reddy's-side) appears on the public docket for this case. Nothing found; not asserted.

Notes on scope and reliability

  • Party alignment: Dr. Reddy's is the defendant/counterclaim-plaintiff (declaratory judgment counterclaims of patent invalidity/non-infringement as to the '708 patent), per D.I. 9 and the counterclaim-caption document reproduced at paragraphfour.com (dedc21cv1033A.pdf).
  • Merck's side (for contrast, not requested): Daniel M. Silver / Alexandra M. Joyce (McCarter & English, local) and Michael P. Kelly (McCarter & English); Merck's IPR side is Williams & Connolly (per IPR2020-01060 power of attorney).
  • The docket snippet sources I used (UniCourt, Patexia, Unified Patents portal) are secondary reproductions of the D. Del. docket; the entries cited (D.I. 9, 11, 13, 14, 15) are consistent across them. The consent-judgment text is reproduced verbatim at paragraphfour.com.
  • I did not fabricate any name. The only item I am explicitly flagging as inadequately sourced is O'Byrne's firm affiliation, and the absence of a formal pro hac vice appearance for the Lerner David attorneys in 21-1033.