Case 1:18-cv-00202-IMK Document 40 Filed 02/04/19 Page 1 of 5 PageID #: 1325
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
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`Civil Action No. 18-202-IMK
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`ANACOR PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
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`MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.,
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`Defendants.
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`REPLY IN SUPPORT OF ANACOR’S MOTION TO STAY CASE
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`The parties agree that a stay is appropriate while the PTAB addresses Mylan’s challenge
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`to the validity of the patents-in-suit. The parties also agree that a stay should terminate if the
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`PTAB concludes that any claims are patentable. The parties’ principal disagreement is whether,
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`in the event that the PTAB determines that all of the claims of all of the patents-in-suit are
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`unpatentable, the proposed stay should continue until after any appeal of that decision has run its
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`course. Mylan’s position—that a stay should terminate before completion of such an appeal—is
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`wrong for two reasons.
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`First, Mylan would not be prejudiced by a stay through appeal. Anacor vigorously
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`disputes that the patents-in-suit are invalid. But even assuming for the sake of argument that
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`they are, Mylan has only two ways to trigger an early termination of the FDA’s 30-month stay of
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`approval: (1) prevail before the PTAB and on any appeal of the PTAB’s decision; or (2) litigate
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`this case to judgment and persuade this Court that the patents-in-suit are invalid on the basis of
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`“clear and convincing evidence,” a higher evidentiary burden than the one it must meet before
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`the PTAB. The PTAB is expected to issue its final written decision in a few months, and there is
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`no reason to believe that litigating this case all the way to judgment (under a different standard of
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`Case 1:18-cv-00202-IMK Document 40 Filed 02/04/19 Page 2 of 5 PageID #: 1326
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`proof, and undoubtedly with different evidence than was presented to the PTO) would be any
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`faster than completing an appeal of the PTAB’s decision. If Mylan or the other challenger in the
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`PTAB proceedings were to win the hypothetical appeal, the 30-month stay would end; if the
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`hypothetical appeal was lost, then Mylan would be largely estopped from relitigating
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`obviousness in this forum. Either way, the appeal would either resolve this matter completely or
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`significantly impact its scope. Simultaneously litigating this case to judgment while a dispositive
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`appeal of the PTAB’s decision runs its course would waste the resources of the parties and the
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`Court for no apparent reason.
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`In an effort to sidestep that conclusion, Mylan engages in speculative hand-waving by
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`suggesting that it might raise defenses in this Court that are not available before the PTAB,
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`“including, inter alia, non-infringement and non-prior art based invalidity.” D.I. 39 at 4. In its
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`September 17, 2018 notice letter to Anacor, Mylan had a statutory obligation to provide “a
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`detailed statement of the factual and legal basis of [its] opinion that the [patents-in-suit are]
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`invalid or will not be infringed.” 21 U.S.C. § 355(j)(2)(B)(iv)(II). The only factual and legal
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`bases Mylan identified in that letter were obviousness and issue preclusion on the basis of a
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`previous finding of obviousness involving a different patent.1 The patents-in-suit issued over 18
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`months before Mylan sent its notice letter. Mylan has had ample opportunity to assess whether it
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`has any defenses of non-infringement or non-prior art based invalidity, and it has not identified
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`any. Mylan’s speculation that it might yet conjure up such a defense is not a justification to
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`waste resources in parallel litigation in this Court.
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`1 Anacor did not include Mylan’s notice letter as an exhibit to this reply because Mylan marked
`it “CONFIDENTIAL.”
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`Case 1:18-cv-00202-IMK Document 40 Filed 02/04/19 Page 3 of 5 PageID #: 1327
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`Second, Mylan turns the Hatch-Waxman Act on its head when it accuses Anacor of
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`improperly seeking to “postpon[e] generic competition for Anacor’s brand product” and obtain
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`“an artificial extension of Anacor’s monopoly,” merely by asserting its patent rights. D.I. 39 at
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`1, 5. In the Hatch-Waxman Act, Congress struck a balance between innovator pharmaceutical
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`companies such as Anacor and generic copyists like Mylan by including provisions to encourage
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`the prompt and fair resolution of patent disputes. Because Anacor sued Mylan within the 45-day
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`time period prescribed by the Hatch-Waxman Act, a 30-month regulatory stay of approval on
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`Mylan’s ANDA is required by the Act, which stay can terminate early only under certain specific
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`circumstances. Anacor is merely following the statutorily-proscribed process here.
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`Anacor agrees with Mylan that if this Court enters a stay pending a decision by the
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`PTAB, then there will be no need for a stay pending resolution of Anacor’s JPML motion to
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`transfer. See D.I. 39 at 5. But in the event this Court does not stay this case for the PTAB’s
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`decision, then Anacor stands by its in-the-alternative request for a stay until its JPML motion is
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`decided. Mylan speculates that such a stay could result in “[a]n indefinite stay going beyond”
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`the PTAB’s resolution of the pending IPRs, but according to the JPML’s own data, that is very
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`unlikely to occur. See, e.g., John G. Heyburn II, A View from the Panel: Part of the Solution, 82
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`Tulane L. Rev. 2225, 2242 (2008) (stating that “the average time between filing and decisions” is
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`“about thirteen weeks” with a range of “between ten and seventeen weeks”). And it is Mylan,
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`not Anacor, who has engaged in “manipulative forum shopping.” D.I. 39 at 6. Fourteen ANDAs
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`have been filed, and of those fourteen filers, Mylan is the only filer who has objected to venue in
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`Delaware. It makes absolutely no sense for this case to proceed on its own in the Northern
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`District of West Virginia, particularly when a transfer to Delaware would not affect Mylan’s
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`ability to continue to challenge the validity of the patents in its chosen forum: the PTAB.
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`3
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`Case 1:18-cv-00202-IMK Document 40 Filed 02/04/19 Page 4 of 5 PageID #: 1328
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`Anacor’s motion to transfer is simply intended to avoid a needless waste of resources by the
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`parties and the judicial system—precisely what MDLs were designed to do.2 See, e.g., In re
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`Rosuvastatin Calcium Patent Litig., 560 F. Supp. 2d 1381, 1382 (J.P.M.L. 2008) (transferring
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`Hatch-Waxman cases to the District of Delaware and observing that “[a]ctions involving the
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`validity of complex pharmaceutical patents and the entry of generic versions of the
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`patentholder’s drugs are particularly well-suited for transfer under” the MDL statute).
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`CONCLUSION
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`For the foregoing reasons and for those set forth in Anacor’s opening memorandum,
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`Anacor respectfully requests that this Court grant Anacor’s motion and enter a stay according to
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`the terms Anacor has proposed.
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`Dated: February 4, 2019
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`OF COUNSEL:
`Aaron P. Maurer
`David I. Berl
`David M. Horniak
`Anthony Sheh
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`(202) 434-5029 (Facsimile)
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` Respectfully submitted,
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`SCHRADER COMPANION DUFF & LAW, PLLC
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`/s/ James F. Companion
`James F. Companion
`401 Main Street
`Wheeling, WV 26003
`(304) 233-3390
`jfc@schraderlaw.com
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`Attorneys for Plaintiff Anacor
`Pharmaceuticals, Inc.
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`2 Mylan suggests that Anacor somehow acted improperly by filing suit against Mylan in the
`District of Delaware less than two weeks after one district judge, in an unrelated patent
`infringement case, found that Mylan is not subject to venue in Delaware for the purpose of that
`litigation. See D.I. 39 at 6. Obviously, Anacor is not bound by that court’s decision and is not
`obligated to assume that the same facts would apply in this case.
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`4
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`Case 1:18-cv-00202-IMK Document 40 Filed 02/04/19 Page 5 of 5 PageID #: 1329
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`CERTIFICATE OF SERVICE
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` I
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` hereby certify that on February 4, 2019, I caused a true and correct copy of the foregoing
`REPLY IN SUPPORT OF ANACOR’S MOTION TO STAY CASE to be electronically filed
`with the Clerk of the Court using the CM/ECF system, which will send notification of such filing
`to all counsel of record as follows:
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`Gordon H. Copland, Esq.
`Gordon.Copland@steptoe-johnson.com
`William J. O’ Brien, Esq.
`William.Obrien@steptoe-johnson.com
`Steptoe & Johnson PLLC
`400 White Oaks Blvd.
`Bridgeport, WV 26330
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`T.O. Kong
`Wendy L. Devine
`Kristina M. Hanson
`Anjali Deskmukh
`Wilson Sonsini Goodrich & Rosati
`One Market Plaza
`Spear Tower, Suite 3300
`San Francisco, CA 94105
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`Counsel for Defendants Mylan Pharmaceuticals Inc. and Mylan Inc.
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`/s/ James F. Companion
`James F. Companion, Esq. (#790)
`Schrader Companion Duff & Law, PLLC
`401 Main Street
`Wheeling, WV 26003
`Phone: (304) 233-3390
`Fax: (304) 233-2769
`jfc@schraderlaw.com
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`OF COUNSEL:
`Aaron P. Maurer
`David I. Berl
`David M. Horniak
`Anthony Sheh
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`(202) 434-5029 (Facsimile)
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