Case 1:18-cv-00202-IMK Document 26 Filed 01/14/19 Page 1 of 12 PageID #: 1273
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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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`)))))))))))
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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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`MEMORANDUM IN SUPPORT OF ANACOR’S MOTION TO STAY CASE
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`Plaintiff Anacor Pharmaceuticals, Inc. (“Anacor”) hereby moves to stay this case until the
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`Patent Trial and Appeal Board (“PTAB”) issues final written decisions in inter partes review
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`(“IPR”) Nos. 2018-00168, 2018-00169, 2018-00170, and 2018-00171. If the PTAB finds that all
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`of the claims of the patents are unpatentable, Anacor further moves to continue the stay until the
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`time for appeal of the PTAB’s decisions has expired or any appeals have terminated. In the
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`alternative, Anacor respectfully requests that the Court enter a stay until Anacor’s motion to
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`transfer this case to the District of Delaware, currently pending before the Judicial Panel on
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`Multidistrict Litigation (“JPML”), has been decided.
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`BACKGROUND
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`A.
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`The Inter Partes Review Petitions Filed by Mylan and FlatWing.
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`In November 2017, FlatWing Pharmaceuticals, LLC (“FlatWing”) petitioned the PTAB
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`for inter partes review of all of the claims of U.S. Patent Nos. 9,459,938 (“the ’938 patent”),
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`9,566,289 (“the ’289 patent”), 9,566,290 (“the ’290 patent”), and 9,572,823 (“the ’823
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`patent”)—the same four patents that are at issue in this case. FlatWing’s petitions alleged that
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`those patents (collectively, “the patents-in-suit”) are unpatentable as obvious over the prior art.
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`See 35 U.S.C. § 103. In July 2018, Mylan Pharmaceuticals, Inc., filed petitions with the PTAB
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`seeking to invalidate the same patents on identical grounds. The PTAB instituted trial on
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`FlatWing’s and Mylan’s petitions and has consolidated them into the following four IPRs: IPR
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`No. 2018-00168; IPR No. 2018-00169; IPR No. 2018-00170; and IPR No. 2018-00171.
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`The IPRs are at an advanced stage. Oral argument is scheduled to take place on March 1,
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`2019, and the PTAB is expected to issue its final written decisions in June 2019.
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`B.
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`The Kerydin® ANDA Civil Actions Filed by Anacor.
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`Between September 5 and September 18, 2018—after the PTAB had already instituted
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`trial on all of the patents-in-suit—Anacor received notice letters informing it that, in total,
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`fourteen Abbreviated New Drug Applications (“ANDAs”) have been filed with the FDA seeking
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`approval to manufacture and sell generic versions of Anacor’s Kerydin® (TAVABOROLE)
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`TOPICAL SOLUTION, 5% (“Kerydin”), prior to the expiration of the patents-in-suit. Anacor’s
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`receipt of these notice letters triggered its forty-five day period to sue for infringement of the
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`patents-in-suit under the Hatch-Waxman Act. See 21 U.S.C. § 355(j)(5)(B)(III).
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`In response to these notice letters, Anacor filed four patent infringement actions in
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`October 2018. Three of the four actions were filed in the United States District Court for the
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`District of Delaware.1 In total, Anacor sued twenty-two defendants—including Mylan
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`1 The Delaware actions are captioned as follows: Anacor Pharm., Inc. v. Lupin Ltd., Lupin
`Pharm., Inc., Encube Ethicals Pvt. Ltd., Glasshouse Pharm. Ltd. Canada, & FlatWing Pharma.,
`LLC, No. 1:18-cv-001606-RGA (D. Del.); Anacor Pharm., Inc. v. Ascent Pharm., Inc., Zydus
`Pharm. (USA) Inc., Cadila Healthcare Ltd., Apotex Inc., Apotex Corp., Amneal Pharm. LLC,
`Perrigo Pharma Int’l DAC, Perrigo Co. plc, Aleor Dermaceuticals Ltd., Cipla Ltd., Cipla USA,
`Inc., Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., Taro Pharm. U.S.A., Inc., & Taro
`Pharm. Indus., Ltd., No. 1:18-cv-001673-RGA (D. Del.); and Anacor Pharm., Inc. v. Mylan
`Pharm. Inc. & Mylan Inc., No. 1:18-cv-01699-RGA (D. Del.).
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`2
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`Pharmaceuticals Inc. and Mylan Inc. (collectively, “Mylan”)—in Delaware.2 However, because
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`Mylan objected to venue in the District of Delaware, Anacor also filed a fourth, substantively
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`identical lawsuit against Mylan in this district (the present action).
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`The three Delaware cases are currently pending before Judge Richard G. Andrews, and
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`are at essentially the same procedural stage as this case: most defendants have responded to
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`Anacor’s complaints, but no conferences have been held, no discovery has taken place, and no
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`schedules have been set.3 On November 26, 2018, FlatWing moved to stay the Delaware case in
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`which it is a defendant until the PTAB issues a final written decision in the pending IPRs. See
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`Anacor Pharm., Inc. v. Lupin Ltd., et al., No. 18-cv-1606-RGA, D.I. 23–25 (D. Del. Nov. 26,
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`2018). In response, on December 10, 2018, Anacor filed a cross-motion to stay all three
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`Delaware cases until the PTAB issues final written decisions in the pending IPRs and, if the
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`PTAB finds that all of the claims of all of the patents-in-suit are unpatentable, until the time for
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`appeal of the PTAB’s decisions has expired or any appeals have terminated. See id., D.I. 34 (D.
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`Del. Dec. 10, 2018); Anacor Pharm., Inc. v. Ascent Pharm., Inc., No. 18-1673-RGA, D.I. 46 (D.
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`Del. Dec. 10, 2018); Anacor Pharm., Inc. v. Mylan Pharm. Inc., No. 18-1699-RGA, D.I. 10 (D.
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`Del. Dec. 10, 2018). Both FlatWing’s motion and Anacor’s cross-motion remain pending.
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`Separately, on January 7, 2019, Anacor filed a motion with the JPML seeking to transfer
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`this case to Judge Andrews in the District of Delaware for coordinated and consolidated pretrial
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`proceedings with the cases already pending in that district. See In re: Kerydin (Tavaborole
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`2 There is no dispute that the twenty non-Mylan defendants are subject to jurisdiction and venue
`in the District of Delaware.
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` 3
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` Mylan has moved to dismiss Anacor’s Delaware complaint on the basis of allegedly improper
`venue, but the parties have not yet completed briefing on that motion.
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`3
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`Topical Solution 5% Patent Litig., MDL No. 2884, D.I. 1 (J.P.M.L. Jan. 7, 2019). Anacor’s
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`transfer motion is currently pending.
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`On January 9, 2019, Mylan filed in Delaware a response to FlatWing’s stay motion and
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`Anacor’s cross-motion, stating that “[a] stay of [the Delaware] litigation is appropriate so long as
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`the stay: (i) expires upon issuance of the IPR final written decisions[;] (ii) does not serve as a
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`basis for extension of the regulatory stay of approval of [Mylan Pharmaceuticals Inc.]’s ANDA
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`product; and (iii) does not delay resolution of” Mylan’s motion to dismiss the Delaware case.
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`Anacor Pharm., Inc. v. Mylan Pharm. Inc., No. 18-1699-RGA, D.I. 22 (D. Del. Jan. 9, 2019).
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`Counsel for Mylan has represented that Mylan’s position on the present motion is the same one it
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`articulated in its Delaware response.
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`Mylan’s second and third conditions are met here, as Anacor has agreed not to argue that
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`a stay should serve as the basis for an extension of the regulatory stay of approval of Mylan’s
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`ANDA Product, and unlike in Delaware, Mylan has not moved to dismiss the present action.
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`But Mylan and Anacor disagree as to the appropriate length of the proposed stay if the PTAB
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`determines that all of the claims of the patents are unpatentable. Mylan proposes that the stay
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`terminate after the IPRs conclude, regardless of the result. Anacor proposes that the stay
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`terminate upon either confirmation of the patentability of at least one of the claims at issue in the
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`IPRs, or, if all claims are determined by the PTAB to be unpatentable, after conclusion of any
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`appeal or the expiration of time to appeal (if no appeal is taken).
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`ARGUMENT
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`I.
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`This Court Should Stay this Case and Await Decisions in the Pending IPRs.
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`Courts, including district courts in this circuit, typically consider three factors when
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`deciding whether to stay a case pending PTAB review of a patent-in-suit: (1) whether a stay will
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`simplify the issues in question and trial of the case; (2) whether discovery is complete and
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`4
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`whether a trial date has been set; and (3) whether a stay would unduly prejudice or present a
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`clear tactical disadvantage to the nonmoving party. E.g., Cobalt Boats, LLC v. Sea Ray Boats,
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`Inc., No. 2:15cv21, 2015 WL 7272199, at *2 (E.D. Va. Nov. 16, 2015); Univ. of Va. Patent
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`Found. v. Hamilton Co., No. 3:13-cv-00033, 2014 WL 4792941, at *2 (W.D. Va. Sept. 25,
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`2014); Softview LLC v. Apple Inc., Nos. 12-989-LPS & 10-389-LPS, 2013 WL 4757831, at *1
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`(D. Del. Sept. 4, 2013). District courts applying these factors routinely issue stays pending the
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`outcome of IPR proceedings before the PTAB. See, e.g., Cobalt Boats, 2015 WL 7272199;
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`Univ. of Va. Patent Found., 2014 WL 4792941; Softview, 2013 WL 4757831. All of the above
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`factors weigh in favor of staying this case.
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`A.
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`Anacor’s Proposed Stay Will Simplify the Issues and Trial of the Case.
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`There is no reasonable dispute that the PTAB’s decisions in the pending IPRs will
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`simplify the issues in question and trial of the case. Mylan has petitioned the PTAB to review—
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`and the PTAB has agreed to review—the patentability of all of the claims of the patents-in-suit
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`on the ground that “the differences between the claimed invention and the prior art are such that
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`the claimed invention as a whole would have been obvious . . . to a person having ordinary skill
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`in the art.” 35 U.S.C. § 103(a). Under these circumstances, the PTAB’s decisions will
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`substantially narrow the issues in dispute for at least two reasons.
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`First, the PTAB’s decisions will estop Mylan from relitigating in this proceeding the
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`obviousness of any claims that survive the PTAB’s review. See 35 U.S.C. § 315(e)(2) (“The
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`petitioner in an inter partes review . . . may not assert . . . in a civil action arising in whole or in
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`part under section 1338 of title 28 . . . that the claim is invalid on any ground that the petitioner
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`raised or reasonably could have raised during that inter partes review.”). In its notice letter
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`informing Anacor that it had submitted an ANDA seeking FDA approval to manufacture and sell
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`a generic version of Kerydin®, Mylan asserted principally that the patents-in-suit are invalid as
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`5
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`obvious over the prior art. Thus, the PTAB’s decision will eliminate what appears to be the most
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`significant invalidity dispute between Anacor and Mylan.
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` Second, in the event the PTAB determines that all of the claims of the patents-in-suit are
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`unpatentable, then the patents-in-suit will be subject to cancellation unless the Federal Circuit
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`reverses the PTAB’s decision. See 35 U.S.C. § 318(b) (“If the [PTAB] issues a final written
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`decision . . . and the time for appeal has expired or any appeal has terminated, the Director shall
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`issue and publish a certificate canceling any claim of the patent finally determined to be
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`unpatentable . . . .”). In that scenario, if this case simply remains stayed until “the time for
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`appeal [of the PTAB’s decisions] has expired or any appeal has terminated,” id., it is very likely
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`that the number of issues in this case will, at the very least, be substantially reduced.
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`The Federal Circuit has observed that when the PTAB grants a petition to review all of
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`the claims of a patent—as it has done here—the PTAB’s decision has the potential to simplify
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`the issues for trial and therefore weighs “heavily” in favor of a stay. VirtualAgility Inc. v.
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`Salesforce.com, Inc., 759 F.3d 1307, 1312–14 (Fed. Cir. 2014). Numerous district courts have
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`reached a similar conclusion, particularly where, as here, the PTAB’s decision will estop
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`defendants in the district court proceeding. See, e.g., 454 Life Sciences Corp. v. Ion Torrent Sys.,
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`Inc., No. 15-595-LPS, 2016 WL 6594083, at *3 (D. Del. Nov. 7, 2016) (“Even if the IPR
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`proceedings result in all of the Asserted Claims remaining valid, the fact that Defendants will be
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`estopped—from asserting in this litigation any ground for invalidity that they ‘raised or
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`reasonably could have raised’ during the IPR proceedings . . . will simplify the issues left to be
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`litigated in this case.”); Cobalt Boats, 2015 WL 7272199, at *3 (finding issue simplification
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`“weighs strongly in favor of granting a stay” because IPR “has the possibility of disposing with
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`the entire case”); Softview, 2013 WL 4757831, at *1 (“Should all of the asserted claims be found
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`6
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`invalid, this litigation would be ‘simplified’ because it would be concluded. . . . Another
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`possibility is that some or all of the claims are found not invalid, yet even in that scenario,
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`litigation should be somewhat simplified due to the estoppel effect on [the defendant].”).
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`B.
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`Discovery Has Not Yet Begun and No Trial Date Has Been Set.
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`The fact that this case is at a very early stage also weighs in favor of a stay. No discovery
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`has taken place, no scheduling order has been entered, and the scheduling conference is not set to
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`take place until February 14, 2019. Accordingly, the parties and the Court have yet to expend
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`significant resources on the matter. Courts consistently find that such an early procedural stage
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`counsels in favor of a stay. See, e.g., Neste Oil OYJ v. Dynamic Fuels, LLC, No. 12-1744-GMS,
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`2013 WL 3353984, at *5 (concluding that status of litigation “weighs strongly in favor of
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`granting a stay” where “[t]here has been no scheduling conference, no trial date has been set, and
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`no discovery has taken place”); see also 454 Life Sciences Corp., 2016 WL 6594083, at *4
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`(observing that “[g]ranting a stay relatively early in a case can be said to advance judicial
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`efficiency and ‘maximize the likelihood that neither the Court[]nor the parties expend their assets
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`addressing invalid claims”).
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`C.
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`A Stay Will Not Unduly Prejudice or Tactically Disadvantage Mylan.
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`The stay Anacor has proposed will not unduly prejudice or tactically disadvantage Mylan
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`in any way. As explained above, Mylan chose to petition the PTAB to review the patents-in-suit.
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`Thus, a stay would simply allow the parties to continue to litigate the validity of the patents-in-
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`suit in a forum that Mylan chose, without incurring the unnecessary burden and expense of
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`simultaneously litigating the validity of the same patents in this Court. Moreover, the PTAB is
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`expected to issue a decision on Mylan’s petitions in roughly six months, long before this case
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`would be ready for trial in the absence of a stay. If any claims of the patents-in-suit survive the
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`PTAB’s review, then the parties will still have ample time—roughly two years—to litigate this
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`case before Mylan’s ANDA becomes eligible for FDA approval.4 See 35 U.S.C.
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`§ 355(j)(5)(B)(iii). And in the event that the PTAB determines that all of the patents-in-suit are
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`unpatentable, then it would only make sense for this case to remain stayed while the appeals
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`process is concluded, so as to conserve the resources of the parties and the Court.
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`Anacor anticipates that Mylan will argue that allowing a stay to remain in place through
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`appeal of the PTAB’s decisions would unfairly prejudice Mylan because Mylan’s ANDA is
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`subject to a 30-month regulatory stay of approval, and the only way that Mylan can receive
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`regulatory approval before expiration of that 30-month period is to obtain a judgment from a
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`federal district court that the patents-in-suit are invalid or will not be infringed by Mylan’s
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`ANDA Product. But the PTAB’s patentability determination is made under a “preponderance of
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`the evidence” standard—not the “clear and convincing evidence” standard applied in this
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`forum—and therefore Mylan will not be able to avail itself of summary invalidity proceedings in
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`this Court solely on the basis of the PTAB’s decision. See, e.g., Novartis AG v. Noven Pharma.
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`Inc., 853 F.3d 1289, 1294 (Fed. Cir. 2017). Rather, it is the cancellation of a patent by the
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`United States Patent and Trademark Office, which cannot occur until after the time for appeal of
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`the PTAB’s decision has expired or any appeal has terminated, 35 U.S.C. § 318(b), that could
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`serve as the basis for a judgment in this Court. Thus, if the PTAB concludes that patents-in-suit
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`are unpatentable in their entirety, it makes sense to allow any appeal of that decision to run its
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`course.
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`II.
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`In the Alternative, the Court Should Stay this Case until the JPML Decides
`Anacor’s Motion to Transfer.
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`If this Court is not inclined to stay this case for Mylan’s IPRs, then, at a minimum, the
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`Court should stay this case until the JPML decides Anacor’s motion to transfer this case to the
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`4 Mylan’s ANDA will be eligible for FDA approval on March 2021.
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`District of Delaware. Although the filing of a motion to transfer with the JPML does not trigger
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`an automatic stay, “[c]ourts often stay proceedings pending action by the JPML to preserve
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`judicial resources and to ensure consistency in disposition of like matters.” City of New Castle v.
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`Purdue Pharma L.P., No. 18-1472, 2018 WL 3438841, at *3 (E.D. Pa. July 16, 2018) (quotation
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`marks and citation omitted); Packer v. Power Balance, LLC, No. 11-802 (WJM), 2011 WL
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`109901, at *2 (D.N.J. Mar. 22, 2011) (“Stays of civil actions are common when the issue of
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`transfer is before the JPML.”); see also, e.g., Young v. Bristol-Myers Squibb Co., No. 17-609-
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`LPS, 2017 WL 2774735, at *3 (D. Del. June 27, 2017) (staying case); Pa. Ex rel. Kane v.
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`McGraw-Hill Cos., No. 1:13-cv-605, 2013 WL 1397434, at *4 (M.D. Pa. Apr. 5, 2013) (same);
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`W. Va. ex rel. McGraw v. Countrywide Fin. Corp., No. 3:08-1093, 2008 WL 11430010, at *1–*2
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`(S.D. W. Va. Nov. 5, 2008) (same).
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`The decision whether to stay a case while a motion to transfer is pending before the
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`JPML “requires ‘an exercise of judgment, which must weigh competing considerations and
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`maintain an even balance.’” Packer, 2011 WL 1099001 at *1 (quoting Landis v. N. Am. Co., 299
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`U.S 248, 255–56 (1936)). In deciding whether to enter such a stay, courts consider factors
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`similar to the factors they consider when deciding whether to stay a case for a decision by the
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`PTAB. See, e.g., Meyers v. Bayer AG, 143 F. Supp. 2d 1044, 1049 (E.D. Wis. 2001) (“[T]he
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`factors to be considered include (1) the interests of judicial economy; (2) hardship and inequity
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`to the moving party if the action is not stayed; and (3) potential prejudice to the non-moving
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`party.”); Young, 2017 WL 2774735, at *3 (staying case because it “will simplify, or eliminate,
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`the pretrial issues before this court; will allow for the possibility of efficient resolution of pretrial
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`issues before the MDL court, should the cases be transferred; will not affect discovery or any
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`other deadlines, as none have been set; and will not unduly prejudice Plaintiffs, who remain free
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`to raise arguments before the JPML and, if there is a transfer, to fully and fairly litigate their
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`cases before the MDL court.”).
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`These factors weigh in favor of a stay until the JPML decides Anacor’s motion to
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`transfer. Right now, this case and the cases pending in Delaware are at essentially the same
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`procedural stage, but the Delaware cases are unlikely to progress further until after FlatWing’s
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`and Anacor’s motions to stay are decided. Under these circumstances, undertaking the effort to
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`set a schedule and advance this case risks wasting the resources of the parties and the Court. For
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`example, any scheduling and case-management efforts undertaken in this venue will be moot if
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`Anacor prevails on its transfer motion. Moreover, in the absence of a stay, this case could
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`become “out-of-sync” with the Delaware cases, which could undermine some of the benefits of
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`transfer and consolidation. And a short stay of this case until the JPML issues its decision will
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`not prejudice any party. See, e.g., Am. Seafood, Inc. v. Magnolia Processing, Inc., Nos. 93-1030
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`& 92-1086, 1992 WL 102762, at *1 (E.D. Pa. May 7, 1992) (observing that stay will not cause
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`prejudice because it “will only be in effect until the JPML issues its decision” and “there will be
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`no extended delay in the commencement of discovery”); W. Va. ex rel. McGraw, 2008 WL
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`11430010, at *2 (“[A]ny prejudice Plaintiff may suffer from a short stay in this case is greatly
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`outweighed by the interests of efficiency, economy, uniformity, and predictability served by
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`issuing the stay . . . pending transfer to the MDL court”); Pa. ex rel. Kane, 2013 WL 1397434, at
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`*5 (observing that stay “will be relatively short” because “[t]he JPML is typically prompt in
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`determining whether to transfer a matter” (citing David F. Herr, Multidistrict Litigation Manual
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`§ 4:27 (2012 ed.)).
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`CONCLUSION
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` For the foregoing reasons, Anacor respectfully requests that this Court enter a stay on
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`the following terms:
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`1.
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`This case should be stayed in its entirety until the PTAB enters final written
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`decisions in each of IPR Nos. 2018-00168, 2018-00169, 2018-00170, and 2018-00171;
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`2.
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`In the event that the PTAB finds that one or more claims of any of the patents-in-
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`suit are patentable, then the stay should immediately terminate so that the parties can “reasonably
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`cooperate in expediting” this case as required by 21 U.S.C. § 355(j)(5)(B); and
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`3.
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`In the event that the PTAB finds that all of the claims of all of the patents-in-suit
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`are unpatentable, then the stay should continue until the time for appeal of the PTAB’s decisions
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`has expired or any appeals have terminated.
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`In the alternative, Anacor respectfully requests that the Court stay this case until Anacor’s
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`pending motion to transfer this case to the District of Delaware is decided by the JPML.
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`Dated: January 14, 2019
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`
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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
`
`Attorneys for Plaintiff Anacor
`Pharmaceuticals, Inc.
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`CERTIFICATE OF SERVICE
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` I
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` hereby certify that on January 14, 2019, I caused a true and correct copy of the foregoing
`MEMORANDUM IN SUPPORT OF ANACOR’S MOTION TO STAY 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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