Case 1:18-cv-00202-IMK Document 45 Filed 03/14/19 Page 1 of 10 PageID #: 1351
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
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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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`Civil Action No. 18-202-IMK
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`JOINT REPORT OF RULE 26(f) MEETING AND PROPOSED DISCOVERY PLAN
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`Pursuant to Federal Rules of Civil Procedure 16 and 26(f), Local Civil Rules 16.01(b)
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`and (c), and the Court’s December 4, 2018 Order (D.I. 20), the parties, by and through their
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`undersigned counsel, jointly submit this Report and Proposed Discovery Plan. Counsel for the
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`parties participated in a telephone conference pursuant to Order, and as required by Rule 26(f),
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`on January 17, 2019 to discuss a proposal for proceeding, and the parties exchanged various
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`email communications as to the planning report and an exchange of proposals. The participants
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`in the initial conference were:
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` James F. Companion on behalf of Plaintiff Anacor Pharmaceuticals, Inc. (“Anacor”);
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`and
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` William J. O’Brien on behalf of Mylan Pharmaceuticals Inc. (“MPI”) and Mylan Inc.
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`(collectively, “the Mylan Defendants”).
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`The parties discussed matters under Federal Rules 16 and 26(f) and Local Rule 16.01(b).
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`Case 1:18-cv-00202-IMK Document 45 Filed 03/14/19 Page 2 of 10 PageID #: 1352
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`I.
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`CASE BACKGROUND
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`A.
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`Overview
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`This is a Hatch-Waxman action arising out of MPI’s filing of an Abbreviated New Drug
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`Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval
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`to manufacture and sell a generic version of Anacor’s Kerydin® (TAVABOROLE) TOPICAL
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`SOLUTION, 5% (“Kerydin”), prior to the expiration of U.S. Patent Nos. 9,459,938; 9,566,289;
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`9,566,290; and 9,572,823 (collectively, “the patents-in-suit”). MPI’s ANDA is one of fourteen
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`ANDAs that have been filed with regard to Kerydin.
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`Anacor sued all fourteen ANDA filers—including the Mylan Defendants—in the United
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`States District Court for the Delaware in October 2018.1 Anacor also filed a fourth,
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`substantively identical lawsuit against the Mylan Defendants in this district (the present action).
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`The Mylan Defendants filed a Motion to Dismiss the Delaware action. Anacor Pharm., Inc. v.
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`Mylan Pharm. Inc. & Mylan Inc., No. 1:18-cv-01699-RGA (D. Del.), D.I. 14. Anacor
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`voluntarily dismissed the action against the Mylan Defendants in Delaware on March 1, 2019.
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`See Anacor Pharm., Inc. v. Mylan Pharm. Inc. & Mylan Inc., No. 1:18-cv-01699-RGA (D. Del.),
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`D.I. 28. The remaining Delaware cases (against all ANDA filers other than the Mylan
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`Defendants) are currently before Judge Richard G. Andrews and are at an early procedural stage:
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`most defendants have responded to Anacor’s complaints, but no conferences have been
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`scheduled or held, no discovery has taken place, and no schedules have been set.
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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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`B.
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`The Inter Partes Review Petitions
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`Separately, in November 2017, FlatWing Pharmaceuticals, LLC (“FlatWing”) petitioned
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`the Patent Trial and Appeal Board (“PTAB”) for inter partes review (“IPR”) of all of the claims
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`of the patents-in-suit. In July 2018, MPI filed similar petitions with the PTAB seeking to
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`invalidate the same patents. The PTAB has instituted trial on all of FlatWing’s and MPI’s
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`petitions and has consolidated them into the following four IPRs: IPR No. 2018-00168; IPR No.
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`2018-00169; IPR No. 2018-00170; and IPR No. 2018-00171. The PTAB heard oral argument on
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`March 1, 2019. Anacor and MPI anticipate that the PTAB will issue its final written decisions in
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`June 2019.
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`C. Motion to Transfer
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`On January 7, 2019, Anacor filed a motion with the Judicial Panel on Multidistrict
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`Litigation (“JPML”) seeking to transfer the present action to Judge Andrews in the District of
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`Delaware for coordinated and consolidated pretrial proceedings with the cases already pending in
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`that district. See In re: Kerydin (Tavaborole Topical Solution 5% Patent Litig., MDL No. 2884,
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`D.I. 1 (J.P.M.L. Jan. 7, 2019). Anacor’s transfer motion is fully briefed and is scheduled for oral
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`argument on March 28, 2019.
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`D. Motions to Stay
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`On November 26, 2018, FlatWing moved to stay the Delaware case in which it is a
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`defendant until the PTAB issues a final written decision in the pending IPRs. In response, on
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`December 10, 2018, Anacor filed a cross-motion to stay all three Delaware cases. The Delaware
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`court denied both motions in an oral order on March 1, 2019. See Anacor Pharm., Inc. v. Lupin
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`Ltd., No. 18-cv-1606-RGA, D.I. 55 (D. Del. Mar. 1, 2019); Anacor Pharm., Inc. v. Ascent
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`Pharm., Inc., No. 18-1673-RGA, D.I. 90 (D. Del. Mar. 1, 2019); Anacor Pharm., Inc. v. Mylan
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`Pharm. Inc., No. 18-1699-RGA, D.I. 27 (D. Del. Mar. 1, 2019).
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`3
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`Case 1:18-cv-00202-IMK Document 45 Filed 03/14/19 Page 4 of 10 PageID #: 1354
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`In the present action, on January 14, 2019, Anacor moved to stay this case until the
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`PTAB issues final written decisions in the pending IPRs, and if the PTAB finds that all of the
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`claims of the patents are unpatentable, to continue the stay until the time for appeal of the
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`PTAB’s decisions has expired or any appeals have terminated. D.I. 25. In the alternative,
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`Anacor moved for a stay until Anacor’s motion to transfer has been decided by the JPML. Id.
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`Anacor’s stay motion remains pending.
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`II.
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`DISCOVERY PLAN
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`The parties jointly propose the following discovery plan.
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`A.
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`Initial Disclosures
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`Pursuant to the Court’s December 4, 2018 Order (D.I. 20), the parties exchanged initial
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`disclosures on February 22, 2019.
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`B.
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`Subjects of Discovery, Completion of Discovery, and Whether Discovery
`Should Be Conducted in Phases
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`Discovery will be needed on the following subjects:
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`1. Infringement of the patents-in-suit.
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`2. Validity of the patents-in-suit, including objective indicia of nonobviousness.
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`3. Claims and/or defenses asserted in Anacor’s Complaint (D.I. 1), the Mylan
`Defendants’ Answer and Counterclaims (D.I. 21), and Anacor’s Answer to the
`Mylan Defendants’ Counterclaims (D.I. 23).
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`Anacor submits that it is premature to set a case schedule while Anacor’s motion to stay
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`and motion to transfer are pending before this Court and the JPML. The Mylan Defendants
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`submit that preparing a case schedule can do no harm and will be more efficient if the Court
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`denies Anacor’s Motion to Stay. If the Court prefers to set a schedule now, the parties’
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`respective proposals, including proposed dates for the completion of discovery and fact and
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`expert discovery phases, are set forth in attached Exhibit A.
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`4
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`Case 1:18-cv-00202-IMK Document 45 Filed 03/14/19 Page 5 of 10 PageID #: 1355
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`C.
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`Issues about Disclosure, Discovery, and Preservation of Electronically Stored
`Information
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`The parties will negotiate an appropriate Protective Order for submission to the Court.
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`Pending entry of a protective order, discovery and disclosures deemed confidential by a party
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`shall be produced to the adverse party on an “Outside Counsel Eyes Only” basis.
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`The parties anticipate exchanging electronically stored information (“ESI”), and will
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`jointly prepare for this Court’s consideration a proposed stipulated ESI agreement addressing the
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`form or forms in which ESI should be produced.
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`D.
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`Limitations on Discovery
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`The parties agree that discovery should be conducted in accordance with the Federal
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`Rules of Civil Procedure and the Local Rules of this Court. The parties agree to be reasonable
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`and cooperative with respect to the number and timing of document requests and requests for
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`admissions as further clarified below.
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`1.
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`Informal Coordination
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`The parties agree that, in the event the JPML declines to transfer this matter to the
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`District of Delaware for coordinated pretrial proceedings, this matter should be informally
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`coordinated with the Delaware actions so as to minimize the burden and expense of discovery on
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`the parties and the Court. If Anacor’s motion to transfer is denied, the parties will confer and
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`make a joint proposal to the Court regarding appropriate informal coordination.
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`2. Written and Document Discovery
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`a.
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`Interrogatories
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`Anacor shall be entitled to serve a maximum of fifteen (15) interrogatories, including
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`contention interrogatories and sub-parts, on Defendants. Defendants collectively shall be
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`5
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`Case 1:18-cv-00202-IMK Document 45 Filed 03/14/19 Page 6 of 10 PageID #: 1356
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`entitled to serve a maximum of fifteen (15) interrogatories, including contention interrogatories
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`and sub-parts, on Anacor.
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`b.
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`Requests for Admission
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`Anacor shall be entitled to serve a maximum of fifteen (15) requests for admission on
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`Defendants. Defendants collectively shall be entitled to serve a maximum of fifteen (15)
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`requests for admission on Anacor. The limits referred to in this paragraph shall not apply to
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`requests for admission related solely to authentication.
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`3.
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`Fact Depositions
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`Anacor’s Position
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`Anacor is permitted a maximum of fifty (50) hours of depositions of Defendants
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`(excluding experts). Defendants collectively are permitted a maximum fifty (50) hours of
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`depositions of Anacor (excluding experts). These limits include Rule 30(b)(6) depositions.
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`Defendants will endeavor, if possible, to coordinate their deposition requests with requests made
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`by the defendants in the Delaware actions, so as to minimize the burden and expense of
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`duplicative depositions on the affected individuals and parties.
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`The Mylan Defendants’ Position
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`In addition to a notice of deposition pursuant to Fed. R. Civ. P. 30(b)(6) and deposition
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`notices/subpoenas to the ten named inventors on the patents-in-suit, the parties agree that each of
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`Plaintiffs and the Mylan Defendants shall take a maximum of 5 depositions of fact witnesses,
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`unless these limits are increased by agreement of the parties or by order of the Court. Each
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`deposition shall be limited to a maximum of 7 hours on the record unless the maximum is
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`increased by agreement of the parties or by order of the Court. Defendants will endeavor, if
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`possible, to coordinate their deposition requests with requests made by the defendants in the
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`6
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`Case 1:18-cv-00202-IMK Document 45 Filed 03/14/19 Page 7 of 10 PageID #: 1357
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`Delaware actions, so as to minimize the burden and expense of duplicative depositions on the
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`affected individuals and parties.
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`4.
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`Expert Discovery
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`The proposed schedule in attached Exhibit A includes dates for expert discovery pursuant
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`to Federal Rule 26(a)(2) and Federal Rules of Evidence 702 and 703. For avoidance of doubt, as
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`set forth in Exhibit A, any objective indicia of nonobviousness will be addressed in the second
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`round of expert reports, to which the Mylan Defendants may reply in a third round limited to that
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`topic.
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`III. OTHER ITEMS
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`A.
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`Time to Join Other Parties, Amend Pleadings, Complete Discovery, and File
`Motions
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`The parties’ proposals for deadlines to join other parties, amend the pleadings, complete
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`discovery, and file motions are included in attached Exhibit A.
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`B.
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`Dispositive Motions
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`Anacor’s Position
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`The issues in this bench trial are not conducive to dispositive motions. Should any party
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`wish to file a dispositive motion, that party should request a status conference with the Court to
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`discuss the nature of the proposed motion and, if allowed, a briefing schedule.
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`Mylan Defendants’ Position
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` The Mylan Defendants believe this case may be resolved through dispositive motions.
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`The Mylan Defendants have included dates on which to file dispositive motions believing this
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`will alleviate potential subsequent delay in the proposed schedule.
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`C.
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`Trial
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`The parties propose a five (5) day bench trial.
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`7
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`Case 1:18-cv-00202-IMK Document 45 Filed 03/14/19 Page 8 of 10 PageID #: 1358
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`D.
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`Service of Documents
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`The parties agree to service by email.
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`E.
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`Additional Local Rule 16.01 Disclosures
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`1.
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`Complex-Case Designation
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`The parties agree that at this time this case should not be designated as complex pursuant
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`to Civil Local Rule 16.01(b)(1). The parties also agree that at this time, there is no need to
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`monitor this case in an individualized and case-specific manner through one or more case-
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`management conferences.
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`2.
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`Disputed Facts
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`The parties will continue to discuss whether they can agree upon the disputed facts that
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`have been alleged in the pleadings.
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`3.
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`Trial by Magistrate Judge
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`The parties do not consent to trial by a magistrate judge.
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`4.
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`Alternative Dispute Resolution
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`The parties do not consider this matter to be appropriate for an alternative dispute
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`resolution process at this time.
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`5.
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`Discovery of ESI
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`The parties will meet and confer on discovery of electronically stored information
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`pursuant to Local Civil Rule 26.06.
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`6.
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`Agenda for Scheduling Conference
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`In addition to the matters set forth herein, the parties will be prepared to discuss Anacor’s
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`Motion to Stay (D.I. 25) at the scheduling conference.
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`8
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`Case 1:18-cv-00202-IMK Document 45 Filed 03/14/19 Page 9 of 10 PageID #: 1359
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`Dated: March 14, 2019
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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 (WV Bar # 790)
`401 Main Street
`Wheeling, WV 26003
`(304) 233-3390
`jfc@schraderlaw.com
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`
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`OF COUNSEL:
`Aaron P. Maurer (admitted PHV)
`David I. Berl (admitted PHV)
`David M. Horniak (admitted PHV)
`Anthony Sheh (admitted PHV)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
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`Attorneys for Plaintiff Anacor
`Pharmaceuticals, Inc.
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`
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`STEPTOE & JOHNSON PLLC
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` /s/ Gordon H. Copland
`Gordon H. Copland (WV Bar # 829)
`William J. O’Brien (WV Bar # 10549)
`400 White Oaks Boulevard
`Bridgeport, WV 26330
`(304) 933-8000
`gordon.copland@steptoe-johnson.com
`william.obrien@steptoe -johnson.com
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`OF COUNSEL:
`T.O. Kong (admitted PHV)
`Wendy L. Devine (admitted PHV)
`Kristina M. Hanson (admitted PHV)
`Anjali Deshmukh (admitted PHV)
`WILSON SONSINI GOODRICH & ROSATI
`One Market Plaza
`Spear Tower, Suite 3300
`San Francisco, CA 94105
`(415) 947-2000
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`Attorneys for Defendants Mylan
`Pharmaceuticals Inc. and Mylan Inc.
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`9
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`Case 1:18-cv-00202-IMK Document 45 Filed 03/14/19 Page 10 of 10 PageID #: 1360
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`CERTIFICATE OF SERVICE
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`I hereby certify that on the 14th day of March, 2019, I filed the “Joint Report of
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`Rule 26(F) Meeting And Proposed Discovery Plan” with the Clerk of the Court using the
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`CM/ECF system, which will send electronic notification of the same to the following counsel of
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`record:
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`Aaron P. Maurer (pro hac vice)
`amaurer@wc.com
`Anthony Sheh (pro hac vice)
`asheh@wc.com
`David I. Berl (pro hac vice)
`dberl@wc.com
`David M. Horniak (pro hac vice)
`dhorniak@wc.com
`WILLIAMS & CONNOLLY LLP
`725 12th Street, NW,
`Washington, DC 20005
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`
`
`
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`James F. Companion
`jfc@schraderlaw.com
`SCHRADER, COMPANION, DUFF
` & LAW, PLLC
`401 Main Street
`Wheeling, WV 26003
`
`
`
`
`
` /s/ Gordon H. Copland
`Gordon H. Copland, Esquire (WV Bar # 828)
`gordon.copland@steptoe-johnson.com
`William J. O’Brien, Esquire (WV Bar # 10549)
`william.obrien@steptoe-johnson.com
`Steptoe & Johnson PLLC
`400 White Oaks Blvd.
`Bridgeport, WV 26330
`Tel: (304) 933-8000
`Attorneys for Defendants
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