Case MDL No. 2902 Document 1-1 Filed 05/15/19 Page 1 of 9
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`IN RE: Sitagliptin Patent Litigation
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`MDL No. _________________
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`MEMORANDUM IN SUPPORT OF MOTION
`TO TRANSFER ACTION TO THE DISTRICT OF DELAWARE
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`Pursuant to 28 U.S.C. § 1407 and Rule 6.2 of the Rules of Procedure of the Judicial Panel
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`on Multidistrict Litigation, Merck Sharp & Dohme Corp. (“Merck”) hereby moves to transfer
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`Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc., and Mylan Inc., Case No. 1:19-cv-
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`00101-IMK, pending in the U.S. District Court for the Northern District of West Virginia, to
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`Judge Andrews in the U.S. District Court for the District of Delaware for coordinated and con-
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`solidated pretrial proceedings with thirteen actions already pending before Judge Andrews in the
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`District of Delaware.
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`BACKGROUND
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`Sitagliptin phosphate was the first dipeptidyl peptidase-IV (“DPP-IV”) inhibitor ap-
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`proved by the U.S. Food & Drug Administration (“FDA”) for the treatment of type 2 diabetes
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`and is the active ingredient of Merck’s JANUVIA® (sitagliptin phosphate), JANUMET® (metformin
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`hydrochloride; sitagliptin phosphate), and JANUMET XR® (metformin hydrochloride; sitagliptin
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`phosphate extended release tablets) drug products. Merck owns U.S. Patent No. 7,326,708 (“the
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`’708 patent”) and U.S. Patent No. 8,414,921 (“the ’921 patent”), which disclose and claim, inter
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`alia, sitagliptin phosphate and various polymorphic forms of the molecule, as well as formula-
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`tions combining sitagliptin phosphate with metformin, another diabetes drug, respectively.
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`Merck has listed the ’708 patent in the FDA’s Approved Drug Products with Therapeutic Equiv-
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`alence Evaluations (the “Orange Book”) for JANUVIA®, JANUMET®, and JANUMET XR®, and has
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`listed the ’921 patent for JANUMET®.
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`1
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`Merck Sharp & Dohme Corp. Exhibit 2022
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 1
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`Case MDL No. 2902 Document 1-1 Filed 05/15/19 Page 2 of 9
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`To date, Merck has received notice of at least twenty-six Abbreviated New Drug Appli-
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`cations (“ANDAs”), filed by various generic pharmaceutical drug companies, seeking FDA ap-
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`proval to market generic versions of JANUVIA®, JANUMET®, and JANUMET XR® prior to the expi-
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`ration of Merck’s patents. According to these notice letters, the ANDAs contain certifications
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`under the Hatch-Waxman Act, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), that the ’708 and ’921 patents
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`are invalid, unenforceable, and/or will not be infringed by the manufacture, use, offer for sale,
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`sale, and/or importation of the respective generic products. In response, Merck filed fourteen
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`separate actions in the U.S. District Court for the District of Delaware alleging that submission
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`of the these ANDAs constituted infringement of the ’708 and ’921 patents (collectively, the “pa-
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`tents-in-suit”). See note 1, infra.
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`On March 21, 2019, Mylan Pharmaceuticals Inc. and Mylan Inc. (collectively, “Mylan”)
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`moved to dismiss Merck’s action against Mylan in Delaware for improper venue. See Case No.
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`1:19-cv-00315-RGA, D.I. 10 (D. Del. Mar. 21, 2019). Seeking to obviate the need for venue
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`discovery, expedite pretrial matters, and preserve judicial resources and the resources of the par-
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`ties, Merck refiled its complaint against Mylan in the U.S. District Court for the Northern Dis-
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`trict of West Virginia, where Mylan concedes that venue is proper. Case No. 1:19-cv-00101-
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`IMK, D.I. 1 (N.D. W. Va. May 2, 2019). Merck and Mylan subsequently entered into a stipula-
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`tion voluntarily dismissing Merck’s Delaware action without prejudice. See Case No. 1:19-cv-
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`00315-RGA, D.I. 21, 22 (D. Del. May 10, 2019).
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`As of the filing of this motion, there are thirteen actions pending in Delaware (the “Dela-
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`ware Actions”) and one action pending in West Virginia (the “West Virginia Action”). In these
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`actions, Merck has asserted the ’708 patent against 23 defendants (organized into 13 defendant
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`groups based on corporate affiliation), and has further asserted the ’921 patent against 3 of those
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`2
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`Merck Sharp & Dohme Corp. Exhibit 2022
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 2
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`Case MDL No. 2902 Document 1-1 Filed 05/15/19 Page 3 of 9
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`defendant groups, including Mylan. All fourteen actions are at an early stage, and one defendant
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`has yet to answer Merck’s complaint. No conferences have been held with any of the courts, no
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`discovery has taken place, and no substantive orders have been issued.
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`ARGUMENT
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`The Panel may centralize actions pursuant to 28 U.S.C. § 1407 if the movant establishes:
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`(1) that there are “common questions of fact” between the actions; (2) that centralization will “be
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`for the convenience of [the] parties and witnesses”; and (3) that centralization “will promote the
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`just and efficient conduct of [the] actions.” Transferring the West Virginia Action to Judge An-
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`drews in the District of Delaware satisfies all three statutory criteria, and centralization is war-
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`ranted under the Panel’s previous decisions in Hatch-Waxman cases. See note 1, infra.
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`I.
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`There Are Common Questions of Fact
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`The fourteen pending actions are parallel Hatch-Waxman patent cases that, by their very
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`nature, will inevitably raise common questions of fact. As the Panel has recognized on numer-
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`ous occasions, patent infringement actions asserting the same or closely related patents will nec-
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`essarily “share common factual and legal questions concerning such matters as the technology
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`underlying the patents, prior art, claim construction and issues of infringement involving the pa-
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`tents.” In re PharmaStem Therapeutics, Inc., Patent Litig., 360 F. Supp. 2d 1362, 1364
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`(J.P.M.L. 2005). The common questions that will likely arise in the pending actions can be
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`grouped roughly into the following four categories.
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`First, based on their notice letters, all defendants intend to litigate the validity of at least
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`claim 1 of the ’708 patent on the grounds of obviousness under 35 U.S.C. § 103. Obviousness is
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`thus a legal issue common to all fourteen cases that, under controlling case law, will require the
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`resolution of numerous common factual issues. These issues include, without limitation, the lev-
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`el of ordinary skill in the art, the scope and content of prior art, whether the person of ordinary
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`3
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`Merck Sharp & Dohme Corp. Exhibit 2022
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 3
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`Case MDL No. 2902 Document 1-1 Filed 05/15/19 Page 4 of 9
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`skill (“POSA”) would have been motivated to the combine prior art references, whether the
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`POSA would have had a reasonable expectation of success in achieving the claimed invention,
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`and the consideration of any objective indicia of nonobviousness. See, e.g., Intercontinental
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`Great Brands LLC v. Kellogg N. Am. Co., 869 F.3d 1336, 1343 (Fed. Cir. 2017) (setting forth the
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`factual determinations underlying the obviousness inquiry).
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`Second, each of the ANDA filers has submitted an application to the FDA for approval to
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`market generic versions of JANUVIA®, JANUMET®, and/or JANUMET XR® using a product label
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`mirroring Merck’s. Accordingly, common questions will be presented as to whether these regu-
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`latory submissions constitute infringement of the patents-in-suit under 35 U.S.C. § 271(e)(2),
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`including at least claim 1 of the ’708 patent, and whether the proposed ANDA products will di-
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`rectly or indirectly infringe Merck’s patents under other provisions of 35 U.S.C. § 271. See Fer-
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`ring B.V. v. Watson Labs., Inc.-Fla., 764 F.3d 1382, 1387–88 (Fed. Cir. 2014); Glaxo, Inc. v.
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`Novopharm, Ltd., 110 F.3d 1562, 1570 (Fed. Cir. 1997).
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`Third, both validity and infringement may require the predicate, pretrial resolution of
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`claim construction disputes. Claim construction is a question of law that may require the district
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`court to resolve subsidiary factual questions. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.
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`Ct. 831, 841 (2015). Moreover, the Panel has repeatedly observed that centralization is neces-
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`sary to prevent inconsistent pretrial rulings “particularly on claim construction issues.” See, e.g.,
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`In re RAH Color Techs. LLC Patent Litig., 347 F. Supp. 3d 1359, 1360 (J.P.M.L. 2018); In re
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`Nebivolol (’040) Patent Litig., 867 F. Supp. 2d 1354, 1355 (J.P.M.L. 2012).
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`Fourth, in addition to requesting a reset of the approval date of each ANDA to the expiry
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`of the ’708 and/or ’921 patents, Merck is seeking permanent injunctive relief to preclude the
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`ANDA filers from marketing their infringing products prior to the expiration of the patents-in-
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`4
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`Merck Sharp & Dohme Corp. Exhibit 2022
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 4
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`Case MDL No. 2902 Document 1-1 Filed 05/15/19 Page 5 of 9
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`suit. Whether Merck is entitled to permanent injunctive relief will turn on common questions of
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`fact. See eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391–92 (2006) (observing that to
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`obtain a permanent injunction, “[a] plaintiff must demonstrate: (1) that it has suffered an irrepa-
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`rable injury; (2) that remedies available at law, such as monetary damages, are inadequate to
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`compensate for that injury; (3) that, considering the balance of hardships between the plaintiff
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`and defendant, a remedy in equity is warranted; and (4) that the public interest would not be dis-
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`served by a permanent injunction”). Additionally, in the event that any defendants attempt to
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`market their ANDA products before these cases are decided, Merck may seek preliminary in-
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`junctive relief, the availability of which will also turn on common questions of fact. See, e.g.,
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`Metalcraft of Mayville, Inc. v. Toro Co., 848 F.3d 1358, 1363–64 (Fed. Cir. 2017).
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`II.
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`Transfer Will Serve the Convenience of the Parties and Witnesses
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`Centralization of the actions before Judge Andrews will serve the convenience of the par-
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`ties and witnesses by ensuring a common pretrial schedule, common fact and expert discovery,
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`and a “streamlined” and consistent approach to scheduling, motions practice, claim construction,
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`and summary judgment. In re Fenofibrate Patent Litig., 787 F. Supp. 2d 1352, 1354 (J.P.M.L.
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`2011). It will also obviate the need for witnesses to appear and participate in more than one pro-
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`ceeding. See PharmaStem, 360 F. Supp. 2d at 1364 (“[T]ransfer under Section 1407 has the
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`benefit of placing all actions . . . before a single judge who can structure pretrial proceedings to
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`consider all parties’ legitimate discovery needs while ensuring that common parties and witness-
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`es are not subjected to discovery demands which duplicate activity that has already occurred or is
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`occurring in other actions.”).
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`Centralization in the District of Delaware will maximize these benefits, as thirteen of the
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`fourteen actions have been assigned to Judge Andrews in that District. Other than Mylan, no De-
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`fendant has contested the propriety of Delaware as a venue to litigate this action. All of the par-
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`5
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`Merck Sharp & Dohme Corp. Exhibit 2022
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 5
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`Case MDL No. 2902 Document 1-1 Filed 05/15/19 Page 6 of 9
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`ties—including Mylan—are repeat litigants in Delaware and/or have previously consented to
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`personal jurisdiction or venue in Delaware. Moreover, Judge Andrews has substantial experi-
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`ence handling Hatch-Waxman cases involving multiple ANDA filers. See, e.g., Novartis Pharm.
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`Corp. v. Breckenridge Pharm., Inc., 248 F. Supp. 3d 578, 582 (D. Del. 2017); Sanofi v. Glen-
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`mark Pharm. Inc., USA, 204 F. Supp. 3d 665, 670 (D. Del. 2016); Endo Pharm Inc. v. Amneal
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`Pharm., LLC, 224 F. Supp. 3d 368 (D. Del. 2016); Reckitt Benckiser Pharm. Inc. v. Watson
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`Labs., Inc., 2016 WL 3186659 (D. Del. June 3, 2016).
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`III. Transfer Will Promote the Just and Efficient Conduct of the Actions
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`Centralization of Hatch-Waxman cases pending in multiple districts was expressly con-
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`templated by the drafters of the Hatch-Waxman Act:
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`In the event of multiple ANDA’s certifying patent invalidity or
`non-infringement, the courts should employ the existing rules for
`multidistrict litigation, when appropriate, to avoid hardship on the
`parties and witnesses and to promote the just and efficient conduct
`of the patent infringement actions.
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`See H.R. Rep. No. 98-857, p.t 1, at 28 & n.14 (1984). The Panel has also recognized on numer-
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`ous occasions that centralization in Hatch-Waxman cases promotes their “just and efficient”
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`conduct as “actions involving the validity of complex pharmaceutical patents and the entry of
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`generic versions of the patent holder’s drugs are particularly well-suited for transfer under Sec-
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`tion 1407.” In re Nebivolol (’040) Patent Litig., 867 F. Supp. 2d 1354, 1355 (J.P.M.L. 2012)
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`(quoting In re Alfuozosin Hydrochloride Patent Litig., 560 F. Supp. 2d 1372, 1372 (J.P.M.L.
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`2008)). In keeping with these legislative and judicial pronouncements, the Panel has granted
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`centralization over a dozen times in Hatch-Waxman cases, while denying centralization only
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`once where the actions at issue were filed two years apart—which is not true here.1 The Panel,
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`1 The undersigned counsel is aware of sixteen motions to transfer in Hatch-Waxman cases that
`were granted by the Panel. See In re Kerydin (Tavaborole) Topical Solution 5% Patent Litig.,
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`6
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`Merck Sharp & Dohme Corp. Exhibit 2022
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 6
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`Case MDL No. 2902 Document 1-1 Filed 05/15/19 Page 7 of 9
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`moreover, has “frequently centralized litigation comprised of only two Hatch-Waxman Act cas-
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`es.” Id. at 1355 & n.4 (emphasis added) (citing In re Armodafinil Patent Litig., 755 F. Supp. 2d
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`1359 (J.P.M.L. 2010); In re Brimonidine Patent Litig., 507 F. Supp. 2d 1381 (J.P.M.L. 2007); In
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`re Metoprolol Succinate Patent Litig., 329 F. Supp. 2d 1368 (J.P.M.L. 2004)). Merck’s fourteen
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`actions asserting the ’708 and ’921 patents present the same canonical scenario and should be
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`centralized in keeping with the Panel’s decisions in these prior cases.
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`CONCLUSION
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`For the foregoing reasons, Merck respectfully requests that the Panel transfer Merck
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`Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc., and Mylan Inc., Case No. 1:19-cv-00101-
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`IMK, pending in the U.S. District Court for the Northern District of West Virginia to Judge An-
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`366 F. Supp. 3d 1370 (J.P.M.L. 2019) (MDL No. 2884) (transferring a Hatch-Waxman case in
`West Virginia against Mylan to Judge Andrews in the District of Delaware because cases against
`thirteen of the fourteen ANDA filers were pending in Delaware); see also In re Nebivolol (’040)
`Patent Litig., 867 F. Supp. 2d 1354 (J.P.M.L. 2012) (MDL No. 2364); In re Fenofibrate Patent
`Litig., 757 F. Supp. 2d 1352 (J.P.M.L. 2011) (MDL No. 2241); In re Armodafinil Patent Litig.,
`755 F. Supp. 2d 1359 (J.P.M.L. 2010) (MDL No. 2200); In re Tramadol Hydrochloride Extend-
`ed-Release Capsule Patent Litig., 672 F. Supp. 2d 1377 (J.P.M.L. 2010) (MDL No. 2126); In re
`Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 657 F. Supp. 2d 1375
`(J.P.M.L. 2009) (MDL No. 2118); In re Rosuvastatin Calcium Patent Litig., 560 F. Supp. 2d
`1381 (J.P.M.L. 2008) (MDL No. 1949); In re Alfuzosin Hydrochloride Patent Litig., 560 F.
`Supp. 2d 1372 (J.P.M.L. 2008) (MDL No. 1941); In re Brimonidine Patent Litig., 507 F. Supp.
`2d 1381 (J.P.M.L. 2007) (MDL No. 1866); In re Desloratadine Patent Litig., 502 F. Supp. 2d
`1354 (J.P.M.L. 2007) (MDL No. 1851); In re Rivastigmine Patent Litig., 360 F. Supp. 2d 1361
`(J.P.M.L. 2005) (MDL No. 1661); In re Metoprolol Succinate Patent Litig., 329 F. Supp. 2d
`1368 (J.P.M.L. 2004) (MDL No. 1620); In re Mirtazapine Patent Litig., 199 F. Supp. 2d 1380
`(J.P.M.L. 2002) (MDL No. 1445); In re Gabapentin Patent Litig., 2001 WL 34834423 (J.P.M.L.
`Feb. 5, 2001) (MDL No. 1384); In re Omeprazole Patent Litig., 1999 U.S. Dist. LEXIS 12589
`(J.P.M.L. Aug. 12, 1999) (MDL No. 1291); In re Nabumetone Patent Litig., 1998 U.S. Dist
`LEXIS 13735 (J.P.M.L. Sept. 2, 1998) (MDL No. 1238).
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`The sole Hatch-Waxman case in which the Panel refused centralization, In re Sumatriptan Suc-
`cinate Patent Litig., 381 F. Supp. 2d 1378, 1379 (J.P.M.L. 2005) (MDL No. 1701), involved ac-
`tions that were filed two years apart and on “opposite ends of the discovery process.” MDL No.
`1701, D.I. 8 at 1 (J.P.M.L. June 8, 2005). In contrast, all fourteen of the cases filed by Merck are
`in their earliest stages and involve numerous complex common questions of fact.
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`7
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`Merck Sharp & Dohme Corp. Exhibit 2022
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 7
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`Case MDL No. 2902 Document 1-1 Filed 05/15/19 Page 8 of 9
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`drews in the U.S. District Court for the District of Delaware for coordinated and consolidated
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`pretrial proceedings.
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`Dated: May 15, 2019
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` Respectfully submitted,
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`/s/ Anthony H. Sheh
`Bruce R. Genderson
`Jessamyn S. Berniker
`Stanley E. Fisher
`Alexander Zolan
`Shaun P. Mahaffy
`Anthony H. Sheh
`Jingyuan Luo*
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`bgenderson@wc.com
`jberniker@wc.com
`sfisher@wc.com
`azolan@wc.com
`smahaffy@wc.com
`asheh@wc.com
`jluo@wc.com
`
`Michael P. Kelly
`Daniel M. Silver
`Alexandra M. Joyce
`MCCARTER & ENGLISH, LLP
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`T: (302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`James F. Companion
`SCHRADER COMPANION DUFF & LAW, PLLC
`401 Main Street
`Wheeling, WV 26003
`(304) 233-3390
`jfc@schraderlaw.com
`
`8
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`Merck Sharp & Dohme Corp. Exhibit 2022
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 8
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`Case MDL No. 2902 Document 1-1 Filed 05/15/19 Page 9 of 9
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`Attorneys for Plaintiff
`Merck Sharp & Dohme Corp.
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`*Admitted only in California. Practice supervised by D.C. Bar mem-
`bers pursuant to D.C. Court of Appeals Rule 49(c)(8).
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`9
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`Merck Sharp & Dohme Corp. Exhibit 2022
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 9
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