Merck Sharp & Dohme Corp. v. Watson Laboratories, Inc. et al.

Case Overview and Background

Parties. Merck Sharp & Dohme Corp. (now Merck Sharp & Dohme LLC) is the plaintiff and patent holder — an operating company subsidiary of Merck & Co., Inc., not an NPE or university. It is the owner of U.S. Patent No. 7,326,708 (the "'708 patent") and the holder of the sitagliptin NDAs at issue. The defendants in this action are Watson Laboratories, Inc. and Watson Pharmaceuticals, Inc. (Teva's U.S. generics/legacy-Actavis entities) and Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd. was originally named but was voluntarily removed by stipulation in April 2019 (D.I. 13, signed by Judge Andrews 4/18/2019). All defendants are generic-drug manufacturers. So this is a classic brand-vs-generic Hatch-Waxman (ANDA) case, not a PAE assertion.

Accused product/technology. Merck filed this and a wave of companion suits after generic manufacturers submitted ANDAs seeking FDA approval to market generic sitagliptin phosphate products before the '708 patent expires. Sitagliptin phosphate is the active ingredient in Merck's Januvia (sitagliptin), Janumet (sitagliptin/metformin HCl), Janumet XR (extended-release), Juvisync (sitagliptin/simvastatin), and later Steglujan (ertugliflozin/sitagliptin) (JPML MDL-2902 transfer order; Orange Book listings). This particular docket (1:19-cv-00317) was filed February 13, 2019 and, per the Robins Kaplan Hatch-Waxman bulletin, concerns generic Janumet (sitagliptin phosphate/metformin HCl) products; the parallel Teva-sitagliptin case (1:19-cv-00318) covered Januvia. I could not independently verify the exact ANDA number for the Watson/Teva filing from the sources reviewed.

Patent. The lone asserted patent, U.S. 7,326,708 ("Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor," Cypes et al., issued Feb. 5, 2008, assigned to Merck), is a chemical/salt patent claiming the 1:1 dihydrogenphosphate (DHP) salt of sitagliptin (a DPP-IV inhibitor for Type 2 diabetes) and hydrates thereof, including the crystalline monohydrate of the (S)- and (R)-configurations. One-line sketch: it claims a specific salt form — sitagliptin dihydrogenphosphate, 1:1 stoichiometry — of the known sitagliptin molecule. It is a later, narrower "species" patent layered over Merck's earlier genus patent (U.S. 6,699,871). Orange Book expiration is listed as November 24, 2026, with pediatric exclusivity to May 24, 2027.

Procedural Posture and Venue

Filed in the U.S. District Court for the District of Delaware before Judge Richard G. Andrews (RGA). Delaware was a natural venue for Hatch-Waxman ANDA litigation — the corporate home of many generics, and where thirteen of the fourteen related sitagliptin suits were already pending. The Judicial Panel on Multidistrict Litigation centralized the related actions as In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 2902 (D. Del.), assigned to Judge Andrews (JPML initial transfer order, July 2019). Docket entries show coordinated pretrial activity (e.g., stipulations and orders entered jointly in 19-cv-317 and 19-md-2902), joint claim construction, and a first amended/corrected complaint in the summer of 2020. The case terminated November 9, 2020, consistent with a settlement.

Why It's Notable

Three features stand out. First, it is part of one of the larger consolidated generic challenges to a blockbuster diabetes franchise; Merck sued over 26 ANDAs across numerous defendants, all keyed to the '708 (and, in several cases, '921) patents. Second, the IPR linkage: although this district case settled, Teva/Watson filed IPR2020-01045 (June 10, 2020) on the same '708 claims, substantively identical to Mylan's earlier IPR2020-00040, and moved to join it. The Board instituted and granted joinder on September 1, 2020 (decided by APJs Snedden, Pollock, and Majors). When Merck and Teva settled, the Board terminated IPR2020-01045 on December 8, 2020 and directed Teva/Watson to withdraw from the joined Mylan IPR (Paper 25; joint motion filed Dec. 15, 2020). Third, the underlying merits fight continued well beyond this docket: the Mylan IPR (IPR2020-00040) reached a final written decision upholding the '708 claims, which the Federal Circuit affirmed in Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp. (Fed. Cir. Oct. 2022, Lourie, J.), holding that WO 2003/004498 did not anticipate (expressly or inherently) the 1:1 sitagliptin DHP salt and did not render it obvious. That preserved Merck's sitagliptin salt protection until 2026–2027 — the reason the generic settlements in this MDL matter commercially.

Sourcing note: Party identity, filing date, judge, MDL number, IPR numbers/outcomes, patent title/claims, and the November 2020 termination are well supported by the JPML order, PTAB filings (IPR2020-01045 papers and IPR2020-00040 FWD), the Federal Circuit decision, and the Unified Patents docket. The precise accused ANDA number and the confidential settlement terms for 19-cv-317 are not publicly disclosed and are not stated here; the "generic Janumet" product mapping rests on the Robins Kaplan bulletin rather than a directly reviewed complaint. Where a fact is not sourced above, treat it as unconfirmed.

I'll research this case systematically, starting with the docket and the '708 patent.

Let me pull the specific docket for 1:19-cv-00317 and details on the MDL and settlement.

Now let me get the specific docket entries for the dismissal and any stay motions.

Merck Sharp & Dohme Corp. v. Watson Laboratories, Inc. et al., No. 1:19-cv-00317-RGA (D. Del.)

Bottom line: This case was one of ~14 parallel Hatch‑Waxman actions Merck filed on 2019‑02‑13 over sitagliptin phosphate (Januvia/Janumet/Janumet XR), consolidated before Judge Richard G. Andrews as MDL No. 2902. Watson/Teva never got to trial in the district court — the case was settled and closed in November 2020. But Teva/Watson fought on at the PTAB as a "me‑too" joinder petitioner in Mylan's IPR on the '708 patent, which they then abandoned as part of the same settlement. The '708 patent survived the PTAB and the Federal Circuit.

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1. Filing and initial pleadings

2019‑02‑13 — Complaint (D.I. 1). Merck Sharp & Dohme Corp. filed a Hatch‑Waxman infringement action in D. Del. against Watson Laboratories, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd. Venue was predicated on Teva USA's Delaware incorporation (Compl. ¶¶ venuesections; Ex. 2042 in IPR2020‑01045 reproduces D.I. 1). The complaint asserted two patents: U.S. 7,326,708 ("the '708 patent," the dihydrogenphosphate salt of sitagliptin / its crystalline monohydrate) and U.S. 8,414,921 ("the '921 patent," sitagliptin + metformin fixed‑dose compositions). The accused products were ANDA No. 202327 (generic Januvia) and ANDA No. 202365 (generic Janumet). Merck alleged the notice letters did not contest that the ANDA products infringe '708 claim 1 — i.e., it was a validity/§ 271(e)(2) fight from the start.

• Note the party naming: aggregator dockets list the case initially as Merck Sharp & Dohme Corp. v. Watson Pharmaceuticals, Inc. et al.; the IPR petitions refer to it as Merck v. Watson Pharmaceuticals, Inc. et al., 1:19‑cv‑00317.

2019‑02‑14 — summonses issued. 2019‑02‑15 — waivers of service sent; responses originally due 2019‑04‑16, extended by stipulation to 2019‑04‑30.

2019‑04‑18 — Teva Israel dismissed by stipulation. The parties' "Stipulation and [Proposed] Order To Remove Teva Ltd. as a Party" was so ordered (D.I. 13), terminating Teva Pharmaceutical Industries, Ltd., leaving Watson Laboratories and Teva USA. (SO ORDERED 4/18/2019.)

2019‑04‑30 — Answer and counterclaims (D.I. 16). Watson and Teva USA answered and counterclaimed against Merck — the classic invalidity (anticipation/obviousness) and non‑infringement declaratory counterclaims. Merck replied to the counterclaims shortly after (D.I. 17). A proposed scheduling order followed (2019‑06‑24).

2. MDL consolidation — the decisive structural event

2019‑07‑19 — JPML creates MDL No. 2902. The Judicial Panel on Multidistrict Litigation ordered centralization of In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 2902, in the District of Delaware before Judge Andrews, transferring the N.D. W. Va. Merck v. Mylan action (1:19‑cv‑00101) in and coordinating the 13 Delaware actions. The Panel expressly cited the need to prevent inconsistent claim construction and validity rulings across the generic defendants. The MDL docket (1:19‑md‑02902‑RGA) opened 2019‑08‑08. Case 1:19‑cv‑00317 thereafter proceeded as an MDL member case.

3. Pre‑trial motions of substance

• Motion to stay pending IPR: none appears on the '317 docket. Despite Mylan's IPR2020‑00040 being filed 2019‑10‑30 and instituted 2020‑05‑12, this action pushed forward through fact discovery, expert discovery, and a Markman hearing. The court's claim construction opinion notes that, "due to the pending IPR in connection with the '708 patent, Mylan did not join in any of Defendants' proposed claim constructions" — i.e., the MDL managed the IPR‑vs‑litigation overlap rather than freezing it. If you are looking for a stay ruling for this case, there is no well‑sourced one.
• Amended pleadings (2020). Merck filed a First Amended Complaint (D.I. 70), followed by a sealed stipulation for a Corrected First Amended Complaint (D.I. 85, order at D.I. 86, entered 2020‑08‑07; redacted version 2020‑08‑14). Teva/Watson's time to respond was extended by stipulation to 2020‑08‑10 (D.I. 83).
• Early adversary settlements. Merck began winnowing the MDL almost immediately — e.g., a consent judgment against Torrent entered 2020‑02‑18 (19‑cv‑00320, D.I. 45), enjoining Torrent and dismissing all claims/counterclaims with prejudice and without fees. By the time of the Markman opinion, the court noted Merck had already entered consent judgments with a number of defendants. (Merck later disclosed it ultimately settled with 22 generic companies, permitting Januvia/Janumet entry in May 2026 or earlier under certain circumstances, and Janumet XR in July 2026.)
• No summary judgment, JMOL, or fee motion in this case — it settled before any dispositive practice matured.

4. Claim construction (Markman)

• 2020‑08‑18 — Markman hearing in the MDL on terms spanning both the '708 and '921 patents. A pre‑hearing oral order (2020‑08‑14) directed that "surfactant" and "sitagliptin" be argued first, then the disputed '708 terms.
• 2020‑11‑17 — Claim construction opinion, In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, C.A. No. 19‑md‑2902‑RGA (also filed as D.I. 135 in 19‑cv‑00311‑RGA; 25 pp.; Andrews, J.). The opinion addressed the asserted terms in the '708 and '921 claims. Practical significance: by the date of the opinion the '317 case had already settled, so the constructions mattered chiefly to the surviving MDL/Mylan track. I have not verified the specific constructions adopted for each term, so I won't characterize them.

5. Discovery milestones of strategic significance

Fact discovery on the joint MDL track ran hard through mid‑2020 while the IPR clock ticked:

• 2020‑07‑22 — Notice of service of Watson's discovery responses (MDL D.I. 141).
• 2020‑08‑06 — Merck served responses/objections to defendants' third set of joint document requests (Nos. 118‑157) (MDL D.I. 158); Teva served Rule 30(b)(6) deposition objections (MDL D.I. 170, 2020‑08‑17).
• 2020‑08‑31 / 2020‑09‑09 — Opening discovery letter briefs (several sealed, later redacted), including a brief by Biocon Limited.
• 2020‑09‑04 / 09‑09 — Merck deposition notices (including David DeCicco, noticed for 2020‑10‑30) and notices of service of joint interrogatories (Nos. 11‑13).
• 2020‑09‑08 — Teva/Watson served their Initial Invalidity Contentions (MDL D.I. 110 in 19‑cv‑317). This is strategically telling: invalidity contentions were served after the PTAB had already instituted review of the '708 patent (2020‑05‑12) and after joinder was granted (2020‑09‑01), confirming the defendants intended to litigate validity in both fora.
• 2020‑09‑10 — Discovery conference before Judge Andrews (court reporter Heather Triozzi) — the last substantive case event.

6. Settlement, dismissal, and final disposition of the district court case

• 2020‑11‑09 / 2020‑11‑10 — case terminated. Aggregator dockets report the termination date for 1:19‑cv‑00317 as 2020‑11‑09 (Unified Patents) / closed 11/10/20 (AI‑Lab). The settlement was the

I'll search across multiple angles — case caption, parties, patent number, MDL, settlement, and the related IPR — to find press coverage.

Initial results are mostly primary documents and Merck releases. Let me target trade press and legal-news outlets specifically.

Good — I now have IPR/appellate trade coverage. Let me look specifically for coverage of the Teva/Watson settlement, the MDL, and the IPR joinder.

Press and trade coverage

Bottom line: I found no news article — from Reuters, Bloomberg Law, Law360, Ars Technica, The Verge, or any mainstream outlet — that reports on Merck v. Watson, No. 1:19-cv-00317 itself. Press searches on the caption, the party names, the '708 patent number, and the November 2020 settlement turned up no story covering this docket's consent judgment, Teva/Watson's IPR2020-01045 "me-too" petition and joinder, or the November 2020 dismissal. The only industry publication I located that names this case at all is the Robins Kaplan Generically Speaking Hatch-Waxman bulletin (Spring 2019), whose "New ANDA Cases" table carries a single row: "Janumet (sitagliptin phosphate / metformin HCl) — 7,326,708 — Merck Sharp & Dohme Corp. v. Watson Labs., Inc., 19-0317 (D. Del.), Feb. 13, 2019, Hon. Richard G. Andrews." That is a docket-index entry, not reporting; it contains no account of the dispute, the defense, or the outcome. Coverage of the franchise clustered instead around the Mylan/Viatris track, which is why the notable press record below concerns the '708 patent rather than this defendant.

What trade press did cover — extensively — is the merits fate of the '708 patent after this case settled. IPWatchdog reported on 2022-09-29 that the Federal Circuit affirmed the PTAB, quoting the court's "957 predicted salts … is insufficient to meet the 'at once envisage' standard" and describing Judge Lourie's opinion as the third precedential patent opinion issued that week. Patent Docs published a detailed 2022-10-07 write-up walking through the anticipation, antedation (§ 102(e)/§ 103(c) common-ownership) and obviousness holdings, and observed that the decision "illustrate[s] once again the difficulty parties have in overcoming the presumption of substantial evidence in IPRs." Practitioner-side analysis came from Finnegan attorneys in the National Law Review ("Predictably Part 2: Merck Overcomes Obviousness Challenge at the PTAB"), which framed the takeaway as the continued unpredictability of crystalline salt formation and Merck's tactical use of the pre-AIA § 103(c)(1) common-ownership exception to knock out its own WO '498 reference. None of these pieces mentions Watson or Teva's role as a joinder petitioner — that aspect of the story appears to be entirely uncovered in the press.

Business-press coverage addressed the commercial stakes rather than this docket. FiercePharma reported in early 2023 that Merck and Viatris had agreed to settle the West Virginia case on confidential terms with a licensed entry "on specific dates prior to the expiration of the relevant patents-in-suit," and quantified the franchise at $4.5 billion in 2022 sales for Januvia plus Janumet. pharmaphorum framed the paired PTAB/Federal Circuit and district-court wins as protecting "its third biggest-selling drug for another few years," putting first-half 2022 sales at almost $2.5 billion, and noted that "Viatris eschewed a settlement deal … in the hope of gaining earlier entry." A Spanish-language bulletin, saludyfarmacos.org, summarized Endpoints News reporting (Paul Schloesser, 2023-03-20) that the proposed Viatris judgment would bar Mylan-affiliated sales until after both the '708 and '921 patents expire. Merck's own 2022-09-22 press release is the source most outlets relied on for the settlement-entry dates (May 2026 for Januvia/Janumet, July 2026 for Janumet XR, "or earlier under certain circumstances") and for the '708 expiration dates (Nov. 24, 2026; pediatric exclusivity to May 24, 2027) — company statements rather than independent reporting.

Where accounts diverge or go beyond the record: the count of settling generics is inconsistent across sources — Merck's September 2022 release says only "multiple generic companies," FiercePharma and pharmaphorum both say "more than 20," Merck's FY2024 Form 10-K states a total of 26, and the earlier section of this case summary says 22. No outlet I found reported any damages figure, royalty, or payment term for the Watson/Teva settlement, and none characterized the terms; Merck's releases confirm only that the settlements are confidential and license early entry. Trade trackers supply the downstream market detail that the litigation press did not: Robins Kaplan's Q2 2026 generic-launch chart records Teva launching generic Januvia on 2026-05-28 and Apotex on 2026-06-03, and an Optum Rx new-generic bulletin lists Teva as an AB-rated launcher — i.e., the defendant here ultimately marketed a licensed generic under the settlement regime, a fact reported nowhere as a litigation story. One further discrepancy worth flagging against the earlier sections of this summary: the Robins Kaplan 2019 bulletin lists only the '708 patent for No. 19-0317 (mapping it to Janumet), whereas the "Key legal developments" section above states that the complaint asserted both the '708 and '921 patents and accused both ANDA 202327 (Januvia) and ANDA 202365 (Janumet); the sealed amended complaints in this docket make the pleaded patent set difficult to verify from public sources, so that point should be treated as unconfirmed.

Sources

• As previously disclosed, beginning in 2019, a number of generic drug companies filed ANDAs seeking approval of generic forms of ...
• UNITED STATES PATENT AND TRADEMARK OFFICE
• UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION
• Merck Sharp & Dohme Corp. v. Anchen Pharmaceuticals, Inc. – CourtListener.com - Trial Court Document
• Merck & CIE v
• Merck & Cie v. Watson Labs., Inc. - Merck & Cie v. Watson Labs., Inc.
• Merck Sharp & Dohme Corp
• Authorities for Merck & Cie v. Watson Laboratories Inc., 1:13-cv-00978 - CourtListener.com - Merck & Cie v. Watson Laboratories Inc. (1:13-cv-00978)
• #100 in Merck & Cie v. Watson Laboratories Inc. (D. Del., 1:13-cv-00978) – CourtListener.com - Merck & Cie v. Watson Laboratories Inc.
• In re: Sitagliptin Phosphate ('708 & '921) Patent Litigation
• Worldwide combined sales of Januvia and Janumet, medicines that help lower blood sugar levels in adults with type 2 diabetes, de...
• Patent Expiration Is a Trigger. What You Really Need Is the Opportunity Behind It. - Patent Expiration Is a Trigger. What You Really Need Is the Opportunity Behind It.

I'll research the plaintiff's counsel of record for this docket. Let me run several searches.

Excellent initial data. Let me pin down the specific pro hac vice motions, local counsel firm, and verify a couple of ambiguous names.

Plaintiff's Counsel of Record — Merck Sharp & Dohme Corp. v. Watson Laboratories, Inc., 1:19-cv-00317-RGA

Bottom line

Merck was represented by a two-firm team: McCarter & English, LLP (Wilmington, DE) as Delaware/local counsel, and Williams & Connolly LLP (Washington, DC) as outside merits/trial counsel, appearing pro hac vice. Every pro hac vice motion in this docket was filed by Delaware counsel (Daniel M. Silver), as D. Del. Local Rule 83.5(d) requires. There is no indication of Merck in-house counsel entering an appearance on this docket; Merck's in-house team is not named in any filing I could locate.

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

2. Merck's merits/trial counsel — Williams & Connolly LLP (then 725 Twelfth St. N.W., Washington, DC 20005; now 680 Maine Ave. S.W.)

All admitted pro hac vice in this docket via motions filed by Silver. Order of appearance, with the PHV groupings reflected in the docket:

I'll research the docket and related filings to identify defense counsel in this case.

I have initial leads. Let me drill into the specific attorney names and firms.

Now let me verify the remaining defense attorneys and the pro hac vice teams.

Defense Counsel of Record — Merck Sharp & Dohme Corp. v. Watson Laboratories, Inc. et al., 1:19-cv-00317-RGA

Sourcing caveat up front. The public docket extracts I could reach for this case are incomplete — Justia's copy was last retrieved April 12, 2019; the fuller runs come from Unified Patents' litigation portal, Patexia, UniCourt and PTAB exhibit copies of Delaware docket sheets. Several filings in this docket are sealed (the answer/counterclaims, the amended complaints, discovery letters), and signature blocks for every appearance are not all visible. Below, I mark each identification as confirmed (appears by name in a docket entry or court filing I reviewed) or unverified (name appears on the docket, but I could not independently confirm current firm/office). I did not find any in-house counsel of record on the public docket.

Two-tier defense team

The Teva/Watson defense was staffed the way Delaware ANDA cases usually are: a Wilmington firm as Delaware/local counsel of record (required by D. Del. L.R. 83.5(d) to be the CM/ECF filer), with out-of-state Goodwin Procter LLP attorneys admitted pro hac vice to do the substantive work.

Corroboration and cross-checks

• Goodwin Procter as defense firm. Patexia's law-firm profile independently lists Goodwin Procter LLP as Defendant counsel in case 1:19-cv-00317 (filed Feb. 13, 2019), which corroborates the Goodwin team drawn from the D.I. 12 PHV motion.
• Other defense-side names on the MDL-level docket. A Sept. 10, 2020 discovery-conference minute entry across 19-md-2902 lists "Counsel for Defendant's: D. Gattuso, J. Philips, F. Cottrell, A. Gaza, S. Fineman." Steven J. Fineman (Richards, Layton & Finger) and the others appear in MDL-wide defendant-group roles (e.g., Fineman filed a notice of subpoenas for Anchen/Par, not Teva/Watson) and should not be attributed to this docket as Teva/Watson counsel without further verification.
• Plaintiff side (for contrast only). Merck was represented by Morris, Nichols, Arsht & Tunnell (Daniel M. Silver, Michael P. Kelly, Alexandra M. Joyce) locally, with Williams & Connolly LLP (Genderson, Fisher, Berniker, Mahaffy, Sheh, Luo, Zolan, Baumgarten) as PHV counsel — names appearing in both this docket's PHV motions and the IPR2020-01045 mandatory notices.

Flags / discrepancies to reconcile

1. Party-name discrepancy with the case metadata. The metadata lists defendants as Watson Laboratories, Inc.; Watson Pharmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc. The docket sheets I reviewed show the named defendants as Teva Pharmaceutical Industries, Ltd., Teva Pharmaceuticals USA, Inc., and Watson Laboratories, Inc. — with no Watson Pharmaceuticals, Inc. (though some PTAB papers style the case "Merck v. Watson Pharmaceuticals, Inc., et al."). The earlier case section notes Teva Pharmaceutical Industries, Ltd. was dismissed by stipulation (D.I. 13, signed 4/18/2019) — yet the D.I. 10 appearance (4/11/2019) and D.I. 12 PHV motion both name Teva Israel as a represented party, which is consistent timing-wise but means counsel's appearance formally covered a party later dropped.
2. Counsel rosters changed post-2019. Any "current firm" characterization must be dated: Zullow's move to Gemini Law (2024) postdates the case; Gattuso's firm affiliation is stated as of the litigation (Heyman Enerio Gattuso & Hirzel LLP) and I could not confirm his present firm.
3. Not located. I found no appearance of record by any Teva/Watson in-house attorney in this docket, and I could not verify the firm affiliations of Jefferson, Larochelle, Zhu, Fischer, or Wingfield from primary sources within my search budget. If exactness matters (e.g., for a conflicts check), pull the full PACER docket — specifically D.I. 10, 12, the Feb. 2020 PHV motion, and the Aug. 2020 defense answer/counterclaims signature block — where each attorney's firm and address will be stated.