Teva Pharmaceuticals USA, Inc. et al. v. Merck Sharp & Dohme Corp.

I'll research this case thoroughly using web search.

Let me dig deeper into the patent, the underlying drug, and the related proceedings.

Let me verify market context, the settlement terms, and the related district court posture.

Case Overview and Background

Note on posture first: despite the metadata's "final written decision" status, IPR2020-01045 itself did not reach a final written decision. It was instituted, then terminated by settlement under 35 U.S.C. § 317 before the merits were decided (Paper 25, Dec. 8, 2020). The substantive validity ruling that aggregators may be echoing came from the lead proceeding into which Teva was joined, IPR2020-00040, which did produce an FWD (Mylan Pharms., Inc. v. Merck Sharp & Dohme Corp., IPR2020-00040, 2021 WL 1833325 (P.T.A.B. May 7, 2021)) — and that FWD went in the patent owner's favor.

The parties and the technology. The petitioners are Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. (its U.S. generics arm), with Teva Pharmaceutical Industries, Ltd. named as a real party in interest (Petitioners' Updated Mandatory Notices, IPR2020-01045). Teva is the world's largest generic manufacturer; it filed ANDAs seeking approval to market generic versions of Merck's sitagliptin products. The patent owner is Merck Sharp & Dohme Corp. ("MSD"), a wholly owned subsidiary of Merck & Co., Inc. — an originator/brand pharmaceutical company — and the assignee of the asserted patent (Patent Owner Mandatory Notices, IPR2020-01045). The "accused" products are Teva/Watson's proposed generic JANUVIA (sitagliptin phosphate) and JANUMET (sitagliptin + metformin) tablets, whose ANDA filings were the predicate for Merck's parallel Hatch-Waxman infringement suits (e.g., Merck Sharp & Dohme Corp. v. Watson Labs., Inc. & Teva Pharms. USA, Inc., No. 1:19-cv-00317-RGA (D. Del.); Merck v. Teva Pharms. USA, Inc., No. 1:19-cv-00318-RGA (D. Del.)).

The patent at issue. U.S. Patent No. 7,326,708 ("Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor"), filed June 23, 2004 and issued Feb. 5, 2008 to inventors Cypes, Chen, Ferlita, Hansen, Lee, Vydra, and Wenslow, is the salt-form (and hydrate) patent for sitagliptin dihydrogenphosphate ("sitagliptin DHP") — the active ingredient in JANUVIA, JANUMET, and JANUMET XR. In one line: it claims a 1:1 dihydrogenphosphate salt of sitagliptin (claim 1), its hydrates and enantiomeric forms (claims 2–3), the crystalline monohydrate and a process for making it (claims 4–16, 24), pharmaceutical compositions (claim 17), and a method of treating Type 2 diabetes (claim 19). A companion patent, U.S. 8,414,921 (the "'921 patent," Janumet metformin compositions), was asserted in the district court MDL but is not at issue in this IPR.

Procedural posture, venue, and why it matters. This is a PTAB inter partes review, not a district court case, so "venue" here means forum strategy: IPR2020-01045 was filed June 10, 2020 and was substantively identical to Mylan's earlier petition in IPR2020-00040 (filed Oct. 30, 2019; instituted May 12, 2020), accompanied by a motion for joinder under 35 U.S.C. § 315(c). The Board instituted Teva's petition and granted joinder on Sept. 1, 2020 (Paper 21), the same day it joined similar "me-too" petitions by Dr. Reddy's (IPR2020-01060) and Sun (IPR2020-01072), with Mylan as lead petitioner and the joinder petitioners agreeing to a "silent understudy" role (Petitioners' Joint Reply in Support of Motions for Joinder). Merck and Teva then settled, filing a joint motion to terminate on Nov. 24, 2020 (Paper 22) with the settlement agreement filed as confidential Ex. 1023; the Board terminated the proceeding on Dec. 8, 2020 without an FWD (Paper 25), and Teva withdrew from IPR2020-00040 on Dec. 15, 2020. The case is notable on several counts: (1) it illustrates the parallel Hatch-Waxman + follow-on IPR/joinder "me-too" pattern, where later ANDA filers ride the first filer's petition to cap costs; (2) the real battleground was IPR2020-00040, where the Board upheld all challenged claims (May 7, 2021) and the Federal Circuit affirmed (Mylan Pharms., Inc. v. Merck Sharp & Dohme Corp., No. 21-2121, 2022 WL 4541687 (Fed. Cir. Sept. 29, 2022)), reinforcing the "at once envisage" limits of In re Petering for genus/list-disclosure anticipation; and (3) the underlying dispute is part of the In re Sitagliptin Phosphate ('708 & '921) MDL No. 2902 before Judge Richard G. Andrews (D. Del.), with a parallel bench trial win for Merck in N.D. W. Va. (Merck v. Mylan, Sept. 2022) finding both patents valid and infringed. Merck's settlements permit generic JANUVIA/JANUMET entry in May 2026 and JANUMET XR in July 2026, with the '708 patent running to Nov. 24, 2026 plus pediatric exclusivity to May 24, 2027 (Merck press release, Sept. 22, 2022) — so sitagliptin's multi-billion-dollar franchise protection turned heavily on defending this one salt patent.

Counsel and panel. Petitioners Teva/Watson were represented by Goodwin Procter LLP (Keith A. Zullow, lead; Sarah J. Fischer; Emily L. Rapalino, pro hac vice). Patent Owner Merck was represented by Williams & Connolly LLP (Stanley E. Fisher, Bruce R. Genderson, Jessamyn S. Berniker, Alexander S. Zolan, Elise M. Baumgarten, Shaun P. Mahaffy, Anthony H. Sheh). The panel was Administrative Patent Judges Sheridan K. Snedden, Robert A. Pollock, and Timothy G. Majors — the same panel that decided IPR2020-00040.

Sourcing caveats. The docket facts above are drawn from PTAB filings via Docket Alarm/PTACTS and the Board's Paper 25 termination decision; the party, patent, and MDL facts are corroborated by the J.P.M.L. transfer order (MDL No. 2902, Aug. 8, 2019), Judge Andrews's Nov. 17, 2020 claim-construction opinion, and the Fed. Cir. opinion. I did not independently verify a precise JANUVIA/JANUMET revenue figure from a primary source, so I have described the franchise qualitatively as multi-billion-dollar; anyone needing an exact sales number should confirm against Merck's 10-K/10-Q. As for the metadata discrepancy: the case was terminated-settled, and no final written decision issued in IPR2020-01045.

I'll research this case across PTAB, district court, and Federal Circuit sources.

Let me dig into the underlying district court litigation and related PTAB proceedings.

Good progress. Now let me pin down the district court litigation outcomes, settlements, and the Teva/Watson disposition.

Framework note before the chronology

The case you've given me — IPR2020-01045 — is not itself a district court infringement suit. It is a PTAB inter partes review filed by Teva/Watson against Merck's U.S. Patent No. 7,326,708 (sitagliptin dihydrogenphosphate, the Januvia®/Janumet® salt patent). The "patent infringement litigation" it belongs to is the Hatch-Waxman campaign In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 2902, C.A. No. 1:19-md-02902-RGA (D. Del.), plus the parallel N.D. W. Va. case against Mylan that actually went to trial. I'll cover the IPR and the litigation it was a defensive/offensive coordinate of.

One correction to the case metadata: aggregators list IPR2020-01045 as "final written decision," and the summary you have says the FWD "echoed IPR2020-00040." The IPR2020-01045 docket shows the proceeding was terminated as settled on 2020-12-08, not decided on the merits. (Docket Alarm docket; IPVerse case page). The only merits FWD on the '708 patent was in the lead IPR, IPR2020-00040 (Mylan), to which Teva/Watson sought joinder. Treat "FWD" in the aggregator data as referring to the joined/lead proceeding.

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Chronology

2019 — The underlying infringement suits

• 2019-02: Merck Sharp & Dohme filed a wave of Hatch-Waxman paragraph IV suits against generics in D. Del. (assigned to Judge Richard G. Andrews) — Alvogen (19-310), Anchen/Par (19-311), Sandoz (19-312), Apotex (19-313), Zydus (19-314), Macleods (19-316), Watson (19-317), Teva (19-318), Sun (19-319), Torrent (19-320), Wockhardt (19-321), Lupin (19-347), among others.
• 2019-05-02: Merck sued Mylan in the N.D. W. Va. (1:19-cv-00101-IMK, Judge Irene M. Keeley), asserting claim 3 of the '708 patent and claim 1 of U.S. Patent No. 8,414,921 (the '921 patent), with Mylan countering for invalidity. (Bench trial opinion, Dkt. 204)
• 2019-08-08: The D. Del. cases were consolidated into MDL No. 2902 for pretrial proceedings before Judge Andrews. The MDL docket lists Teva Pharmaceutical Industries Ltd. among the named defendants. (MDL docket)

2019-10-30 / 2020 — The lead IPR and the joinder cascade

• 2019-10-30: Mylan filed IPR2020-00040 challenging claims 1–4, 17, 19, 21–23 of the '708 patent (anticipation by Merck's own WO 2003/004498 / U.S. 6,699,871 ("Edmondson"), and obviousness over Edmondson + Brittain + Bastin).
• 2020-05-12: Board institutes IPR2020-00040 on all grounds (Paper 21); the panel is APJs Snedden, Pollock, and Majors.

2020-06-10 — IPR2020-01045 filed (your case)

• Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. filed a substantially identical petition against the '708 patent along with a motion for joinder to Mylan's IPR2020-00040 under 35 U.S.C. § 315(c). RPIs identified: Teva Pharmaceutical Industries, Ltd., Teva Pharmaceuticals USA, Inc., and Watson Laboratories, Inc. (Petitioners' Updated Mandatory Notices, Paper 18). Parallel joinder petitions were filed by Dr. Reddy's (IPR2020-01060) and Sun (IPR2020-01072).
• 2020-07-01: Merck's mandatory notices list the full MDL web and the three pending IPRs. (Paper 7)
• 2020-07-09: Merck opposes joinder (Paper, with exhibits EX2027–EX2042), arguing inter alia that joinder would let petitioners avoid discovery into conflicting data from foreign proceedings (the Israeli opposition to the '708 counterpart, Application 172563).
• 2020-07-29: Petitioners' joint reply in support of joinder; the parties had reached agreement on the "silent understudy" role — Teva/Watson would be bound by Mylan's filings, drop their own expert, take no discovery, and not argue at hearing.
• 2020-09-01: Board issues Decision Granting Institution of Inter Partes Review and Granting Motion for Joinder (Paper 21). The Board accepted the

I'll research the counsel of record for the petitioners in this IPR.

Let me dig into the specific filings to enumerate all counsel of record.

Let me pin down the full counsel roster, including any additional back-up or in-house counsel.

Scope note first

Two things need flagging before the roster:

1. This is not a district-court infringement case. IPR2020-01045 is a PTAB inter partes review. There is no PACER docket sheet; the "docket" is PTAB E2E / Paper numbering, and the parties are styled Petitioner(s) and Patent Owner, not plaintiff/defendant. The "plaintiff side" here = Petitioners Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. (RPIs: Teva Pharmaceutical Industries, Ltd., Teva Pharmaceuticals USA, Inc., Watson Laboratories, Inc. — Paper 18, Petitioners' Updated Mandatory Notices).
2. "Counsel of record" in an IPR means the practitioners designated in the power(s) of attorney and mandatory notices under 37 C.F.R. §§ 42.8(b)(3) and 42.10(b), not an appearance filed in court. The roster below is drawn from those filings and the papers served in the proceeding.

The proceeding was terminated as settled on Dec. 8, 2020 (Paper 25), so this is the complete counsel roster as it existed at termination — nothing was sealed on the counsel-identification side.

Petitioner (plaintiff-side) counsel of record

In-house counsel: none identified. No Teva/Watson in-house attorney appears in the petition, the powers of attorney, the mandatory notices, or the papers served. If Teva used in-house counsel in this matter, it is not reflected in the public filings I could retrieve.

One open item: paper 20 (Watson's updated POA) is structured as "Lead Counsel / Back-Up Counsel / Additional Back-Up Counsel." The accessible text captured Zullow and Fischer; the name(s) under "Additional Back-Up Counsel" were not legible in the retrieved copy, and I was unable to open Teva's companion updated POA (Paper 19) in full text. So there may be one or more additional registered practitioners listed who are not captioned here. I am not naming anyone I could not read — the aggregator AI-Verse entry (which lists only "Keith Zullow" for petitioners) is a simplification, not authority.

Sourcing

• IPR2020-01045 docket/timeline: https://www.docketalarm.com/cases/PTAB/IPR2020-01045/Teva_Pharmaceuticals_USA_Inc._v._Merck_Sharp_%26_Dohme_Corp/
• Watson Laboratories, Inc.'s Updated Power of Attorney, Paper 20 (Aug. 20, 2020): https://www.docketalarm.com/cases/PTAB/IPR2020-01045/Inter_Partes_Review_of_U.S._Pat._7326708/08-20-2020-Petitioner/Power_of_Attorney-20-Watson_Laboratories,_Incs_Updated_Power_of_Attorney/
• Petitioners' Motion for Pro Hac Vice Admission of Emily L. Rapalino, Paper 11 (July 27, 2020): https://www.docketalarm.com/cases/PTAB/IPR2020-01045/Inter_Partes_Review_of_U.S._Pat._7326708/07-27-2020-Petitioner/Motion-11-Petitioners_Motion_for_Pro_Hac_Vice_Admission_of_Emily_L_Rapalino_Under_37_CFR_s_4210c/
• Order Granting PHV Admission of Emily L. Rapalino, Paper 15 (Aug. 7, 2020): https://gaeflexstaging-dot-docketupdate.appspot.com/cases/PTAB/IPR2020-01045/Inter_Partes_Review_of_U.S._Pat._7326708/08-07-2020-Board/Order-15-Granting_Petitioners_Motion_for_Pro_Hac_Vice_Admission_of_Emily_L_Rapalino/
• Rapalino PHV declaration, Ex. 1018: https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1537262](/patent/1537262)/download-documents?artifactId=tEg0BkBMKdM0oKZ4oeJb3VsNmJ7Z8LyFX_M0wo-K3K9EG_Zhdxbrc

I'll research the counsel of record for the patent owner (Merck) in this IPR proceeding.

I have the core counsel data. Let me verify attorney bios and roles, and check for any additional counsel appearances.

Let me verify the remaining Williams & Connolly attorneys and check for any other appearances or in-house counsel.

Counsel of Record — Defendant/Patent Owner Side

One important framing correction up front. This docket is an IPR at the PTAB, not a district court infringement action, so the "defendant" label maps onto the Patent Owner, Merck Sharp & Dohme Corp. (respondent in Board parlance). The parties' roles invert from the underlying Hatch-Waxman suits (e.g., Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., No. 1:19-cv-00318 (D. Del.), consolidated in In re Sitagliptin Phosphate ('708 & '921) Patent Litig., MDL No. 19-md-2902-RGA (D. Del.)), where Merck was plaintiff and Teva was defendant. I address the Merck/Patent Owner team below and flag the petitioner side briefly for completeness.

Second correction to the prior summary: the record does not contain a final written decision in IPR2020-01045. The Board instituted on Sept. 1, 2020 and granted joinder to the Mylan IPR (Paper 21), then terminated the proceeding on Dec. 8, 2020 after settlement (Paper 25), expressly noting "a final written decision has not been entered." Any aggregator "FWD" tag for this docket number is a data artifact; the merits FWD and Federal Circuit affirmance belong to the parent Mylan IPR2020-00040 (Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp., 50 F.4th 147 (Fed. Cir. Sept. 29, 2022)).

Merck's PTAB counsel — Williams & Connolly LLP (Washington, DC)

Source: Patent Owner's Power of Attorney, IPR2020-01045 Paper 8 (July 1, 2020); Patent Owner's Mandatory Notices, Paper 7; Termination Decision, Paper 25 (Dec. 8, 2020).

Notes / caveats

• All Williams & Connolly attorneys above are at the firm's Washington, DC office (725 Twelfth Street NW at the time of this proceeding). The Mylan-side and DRL/Sun-side petitioners were represented by other firms — Goodwin Procter (Keith A. Zullow lead, Sarah J. Fischer, Emily L. Rapalino, Michael H. Teschner) for Teva/Watson; Katten Muchin Rosenman for Mylan; Lerner David for DRL; Winston & Strawn for Sun — none of whom represent the defendant/patent owner.
• The settlement agreement (Ex. 1023) and the joint motion to keep it confidential were filed under seal-effective treatment (Paper 23; Paper 25 ¶ 1), but the counsel identities themselves are public via the POA and the Board's Termination Decision. Nothing about the Merck side's representation is sealed.
• I was unable to independently verify professional bios for Zolan and Sheh before hitting my research limit; their names, registration numbers, and firm are confirmed directly from the Board filings, but I would not state their experience specifics without further sourcing.
• Merck's PTAB lead here (Fisher) is the same counsel who argued the parallel Mylan IPR — consistent with the prior summary's observation that this petition was a "me-too"/joinder petition whose substantive defense ran through IPR2020-00040.