1366
`
`402 FEDERAL SUPPLEMENT, 3d SERIES
`
`3. The parties shall proceed with dis-
`covery according to this Court’s
`scheduling order. ECF No. 10.
`
`SO ORDERED on August 21, 2019.
`
`,
`
`
`
`
`IN RE: SITAGLIPTIN PHOSPHATE
`(’708 & ’921) PATENT
`LITIGATION
`
`MDL No. 2902
`
`United States Judicial Panel on
`Multidistrict Litigation.
`
`August 8, 2019
`
`Before SARAH S. VANCE, Chair,
`LEWIS A. KAPLAN, R. DAVID
`PROCTOR, CATHERINE D. PERRY,
`KAREN K. CALDWELL, NATHANIEL
`M. GORTON, Judges of the Panel.
`
`TRANSFER ORDER
`
`SARAH S. VANCE, Chair
`
`Before the Panel:* Plaintiff and patent-
`holder Merck Sharp & Dohme Corporation
`
`* Judge Ellen Segal Huvelle did not participate
`in the decision of this matter.
`1. Alvogen Pine Brook LLC f/k/a Alvogen Pine
`Brook, Inc. and Alvogen Malta Operations
`Ltd.; Anchen Pharmaceuticals, Inc. and Par
`Pharmaceutical, Inc.; Sandoz Inc.; Apotex
`Inc. and Apotex Corp.; Zydus Pharmaceuti-
`cals (USA) Inc. and Cadila Healthcare Ltd.;
`Macleods Pharmaceuticals Ltd. and Macleods
`Pharma USA, Inc.; Watson Laboratories, Inc.
`and Teva Pharmaceuticals USA, Inc.; Sun
`Pharma Global FZE and Sun Pharmaceutical
`Industries Ltd.; Torrent Pharmaceuticals Ltd.
`and Torrent Pharma Inc.; Wockhardt Bio AG
`and Wockhardt USA LLC; and Lupin Ltd. and
`Lupin Pharmaceuticals, Inc.
`
`moves under 28 U.S.C. § 1407 to centralize
`pretrial proceedings
`in this patent
`in-
`fringement litigation in the District of De-
`laware. This litigation consists of fourteen
`actions pending in two districts, as listed
`on Schedule A. Mylan Inc. and Mylan
`Pharmaceuticals Inc. (collectively, Mylan),
`which are defendants in the Northern Dis-
`trict of West Virginia action, do not oppose
`the motion. Generic manufacturer defen-
`dants 1 in thirteen District of Delaware
`actions take no position on centralization,
`but if it is ordered, suggest that the Dis-
`trict of Delaware serve as the transferee
`district.
`Merck filed these actions after generic
`drug manufacturers submitted a total of 26
`Abbreviated New Drug Applications (AN-
`DAs) seeking approval by the U.S. Food
`and Drug Administration (FDA) to make
`and sell generic versions of sitagliptin
`phosphate drugs, which are popular diabe-
`tes medications known as dipeptidyl pepti-
`dase-IV (DPP-IV)
`inhibitors. Sitagliptin
`phosphate
`is the active
`ingredient of
`Merck’s Januvia (sitagliptin phosphate),
`Janumet (metformin hydrochloride; sita-
`gliptin phosphate), and Janumet XR (met-
`formin hydrochloride; sitagliptin phosphate
`extended release tablets) drug products.
`The actions on the motion are a series of
`Hatch-Waxman 2 patent infringement law-
`
`2. Under the Drug Price Competition and Pat-
`ent Term Restoration Act of 1984, Pub. L. No.
`98–417, 98 Stat. 1585 (1984) (the ‘‘Hatch-
`Waxman Act’’), Congress established an in-
`centive for companies to bring generic ver-
`sions of branded drugs to market faster than
`they otherwise might by granting the first
`company to file an ANDA an ‘‘exclusivity peri-
`od’’ of 180 days, during which the FDA may
`not approve for sale any competing generic
`version of the drug. See Teva Pharm. USA,
`Inc. v. Sebelius, 595 F.3d 1303, 1304-05 (D.C.
`Cir. 2010). Submitting an ANDA with a
`‘‘paragraph IV certification’’—stating that the
`patents listed in the FDA’s Orange Book as
`covering the previously approved drug are
`invalid or will not be infringed by the generic
`
`Merck Sharp & Dohme Corp. Exhibit 2023
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 1
`
`

`

`IN RE SITAGLIPTIN PHOSPHATE (’708 & ’921) PATENT
`Cite as 402 F.Supp.3d 1366 (U.S.Jud.Pan.Mult.Lit. 2019)
`
`1367
`
`suits, in which Merck alleges that each of
`the defendants has infringed two U.S. Pat-
`ents 3 by filing an ANDA seeking FDA
`approval to market generic sitagliptin
`phosphate in the United States.
`On the basis of the papers filed and
`hearing held, we find that these actions
`involve common questions of fact, and that
`centralization in the District of Delaware
`will serve the convenience of the parties
`and witnesses and promote the just and
`efficient conduct of this litigation. All ac-
`tions involve substantially identical claims
`that defendants infringed the two Merck
`patents. Centralization
`is warranted to
`prevent inconsistent rulings (particularly
`with respect to claim construction and is-
`sues of patent validity) and overlapping
`pretrial obligations, to reduce costs, and to
`create efficiencies for the parties, courts,
`and witnesses.
`Although the cases in this litigation are
`pending in only two districts, we have long
`acknowledged that ‘‘actions involving the
`validity of complex pharmaceutical patents
`and the entry of generic versions of the
`patent holder’s drugs are particularly well-
`suited for transfer under Section 1407.’’ In
`re Alfuzosin Hydrochloride Patent Litig.,
`560 F. Supp. 2d 1372, 1372 (J.P.M.L. 2008).
`Given the complexity of the allegations and
`regulatory framework governing Hatch-
`Waxman cases, as well as the need for
`swift progress in this litigation that in-
`volves the potential entry of generic diabe-
`tes drugs into the market, placing all ac-
`
`tions before a single judge should foster
`the efficient resolution of all the actions.
`
`We select the District of Delaware as
`the appropriate transferee district for
`these actions. Thirteen of the fourteen ac-
`tions are pending in this district. We are
`confident that Judge Richard G. Andrews,
`who is well-versed in complex patent litiga-
`tion, will steer this matter on a prudent
`course.
`
`IT IS THEREFORE ORDERED that
`the action listed on Schedule A and pend-
`ing outside the District of Delaware is
`transferred to the District of Delaware
`and, with the consent of that court, as-
`signed to the Honorable Richard G. An-
`drews for coordinated or consolidated pre-
`trial proceedings.
`
`SCHEDULE A
`
`MDL No. 2902 — IN RE: SITAGLIPTIN
`PHOSPHATE (’708 & ’921) PATENT
`LITIGATION
`
` District of Delaware
`
`MERCK SHARP & DOHME CORP. v.
`ALVOGEN PINE BROOK LLC, ET
`AL., C.A. No. 1:19–00310
`MERCK SHARP & DOHME CORP. v.
`ANCHEN
`PHARMACEUTICALS,
`INC., ET AL., C.A. No. 1:19–00311
`MERCK SHARP & DOHME CORP. v.
`SANDOZ INC., C.A. No. 1:19–00312
`
`drug—constitutes a statutory act of infringe-
`ment that creates subject-matter jurisdiction
`for a district court to resolve any disputes
`regarding patent infringement or validity be-
`fore the generic drug is sold. See 35 U.S.C.
`§ 271(e)(2)(A); Eli Lilly & Co. v. Medtronic,
`Inc., 496 U.S. 661, 676-78, 110 S.Ct. 2683,
`110 L.Ed.2d 605 (1990). If the patent-holder
`initiates an infringement action against the
`ANDA filer within 45 days of receipt of the
`paragraph IV certification, then the FDA may
`not approve the ANDA until the earlier of
`
`either 30 months or the issuance of a decision
`by a court that the patent is invalid or not
`infringed by
`the generic manufacturer’s
`ANDA. See 21 U.S.C. § 355(j)(5)(B)(iii).
`
`3. The patents are U.S. Patent Nos. 7,326,708
`and 8,414,921, which disclose and claim, in-
`ter alia, sitagliptin phosphate and various po-
`lymorphic forms of the molecule, as well as
`formulations combining sitagliptin phosphate
`with metformin, another diabetes drug, re-
`spectively.
`
`Merck Sharp & Dohme Corp. Exhibit 2023
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 2
`
`

`

`1368
`
`402 FEDERAL SUPPLEMENT, 3d SERIES
`
`SCHEDULE A—Continued
`MERCK SHARP & DOHME CORP. v.
`APOTEX INC., ET AL., C.A. No. 1:19–
`00313
`MERCK SHARP & DOHME CORP. v.
`ZYDUS PHARMACEUTICALS (USA)
`INC., ET AL., C.A. No. 1:19–00314
`MERCK SHARP & DOHME CORP. v.
`MACLEODS PHARMACEUTICALS
`LIMITED, ET AL., C.A. No. 1:19–
`00316
`MERCK SHARP & DOHME CORP. v.
`WATSON LABORATORIES, INC., ET
`AL., C.A. No. 1:19–00317
`MERCK SHARP & DOHME CORP. v.
`TEVA PHARMACEUTICALS USA,
`INC., C.A. No. 1:19–00318
`MERCK SHARP & DOHME CORP. v.
`SUN PHARMA GLOBAL FZE, ET
`AL., C.A. No. 1:19–00319
`MERCK SHARP & DOHME CORP. v.
`TORRENT
`PHARMACEUTICALS
`LIMITED, ET AL., C.A. No. 1:19–
`00320
`
`SCHEDULE A—Continued
`MERCK SHARP & DOHME CORP. v.
`WOCKHARDT BIO AG, ET AL., C.A.
`No. 1:19–00321
`MERCK SHARP & DOHME CORP. v.
`LUPIN LIMITED, ET AL., C.A. No.
`1:19–00347
`MERCK SHARP & DOHME CORP. v.
`TORRENT
`PHARMACEUTICALS
`LIMITED, ET AL., C.A. No. 1:19–
`00872
`
` Northern District of West Virginia
`MERCK SHARP & DOHME CORP. v.
`MYLAN PHARMACEUTICALS, INC.,
`ET AL., C.A. No. 1:19–00101
`
`,
`
`
`
`Merck Sharp & Dohme Corp. Exhibit 2023
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 3
`
`