Case 1:18-cv-00202-IMK Document 23 Filed 01/04/19 Page 1 of 10 PageID #: 1059
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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.,
`
`
`Defendants.
`
`
`
`ANSWER TO COUNTERCLAIMS
`OF MYLAN PHARMACEUTICALS INC.
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`Plaintiff and Counterclaim Defendant Anacor Pharmaceuticals, Inc. (“Anacor”), by its
`
`attorneys, hereby answers the counterclaims of Defendant and Counterclaim Plaintiff Mylan
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`Pharmaceuticals Inc. (“Mylan”), see D.I. 21, using the paragraph numbers of Mylan’s
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`Counterclaims, as follows:
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`COUNTERCLAIMS
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`In response to the unnumbered paragraph under the heading “COUNTERCLAIMS” on
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`page 17 of Mylan’s Answer to Plaintiff’s Complaint and Counterclaims, Anacor admits that
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`Mylan purports to assert counterclaims seeking a declaratory judgment that the claims of U.S.
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`Patent Nos. 9,459,938 (“the ’938 patent”), 9,566,289 (“the ’289 patent”), 9,566,290 (“the ’290
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`patent”), and 9,572,823 (“the ’823 patent”) (collectively, “the patents-in-suit”) are invalid, but
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`denies that Mylan is entitled to a declaratory judgment of invalidity, or to any other relief
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`whatsoever.
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
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`
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`
`
`
`Civil Action No. 18-202-IMK
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`)))))))))))
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`ANACOR PHARMACEUTICALS, INC.,
`
`
`Plaintiff,
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`
`
`v.
`
`
`MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.,
`
`
`Defendants.
`
`
`
`ANSWER TO COUNTERCLAIMS
`OF MYLAN PHARMACEUTICALS INC.
`
`Plaintiff and Counterclaim Defendant Anacor Pharmaceuticals, Inc. (“Anacor”), by its
`
`attorneys, hereby answers the counterclaims of Defendant and Counterclaim Plaintiff Mylan
`
`Pharmaceuticals Inc. (“Mylan”), see D.I. 21, using the paragraph numbers of Mylan’s
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`Counterclaims, as follows:
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`COUNTERCLAIMS
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`In response to the unnumbered paragraph under the heading “COUNTERCLAIMS” on
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`page 17 of Mylan’s Answer to Plaintiff’s Complaint and Counterclaims, Anacor admits that
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`Mylan purports to assert counterclaims seeking a declaratory judgment that the claims of U.S.
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`Patent Nos. 9,459,938 (“the ’938 patent”), 9,566,289 (“the ’289 patent”), 9,566,290 (“the ’290
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`patent”), and 9,572,823 (“the ’823 patent”) (collectively, “the patents-in-suit”) are invalid, but
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`denies that Mylan is entitled to a declaratory judgment of invalidity, or to any other relief
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`whatsoever.
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`Case 1:18-cv-00202-IMK Document 23 Filed 01/04/19 Page 2 of 10 PageID #: 1060
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`PARTIES
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`1.
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`In its Complaint, Anacor pleaded the allegations recited in Paragraph 1 based on
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`information and belief. Mylan admitted the truth of those allegations in its Answer to Anacor’s
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`Complaint. Anacor therefore admits the allegations of Paragraph 1.
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`2.
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`Anacor admits the allegations of Paragraph 2.
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`NATURE OF THE ACTION
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`3.
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`Anacor admits that Mylan purports to seek declaratory judgments that the claims
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`of the patents-in-suit are invalid, but denies that Mylan is entitled to a declaratory judgment of
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`invalidity, or to any other relief whatsoever.
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`JURISDICTION AND VENUE
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`4.
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`The allegations of Paragraph 4 set forth legal conclusions to which no response is
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`required.
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`5.
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`The allegations of Paragraph 5 set forth legal conclusions to which no response is
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`required.
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`6.
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`The allegations of Paragraph 6 set forth legal conclusions to which no response is
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`required.
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`7.
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`The allegations of Paragraph 7 set forth legal conclusions to which no response is
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`required.
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`BACKGROUND
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`8.
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`9.
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`Anacor admits the allegations of Paragraph 8.
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`Anacor admits the allegations of Paragraph 9.
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`10.
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`Anacor admits the allegations of Paragraph 10.
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`2
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`Case 1:18-cv-00202-IMK Document 23 Filed 01/04/19 Page 3 of 10 PageID #: 1061
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`11.
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`Anacor admits that Mylan notified Anacor by letter dated September 17, 2018
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`(“Mylan’s Notice Letter”) that Mylan had submitted to the FDA ANDA No. 212065 (“Mylan’s
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`ANDA”), which purportedly seeks approval to engage in the commercial manufacture, use
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`and/or sale of Mylan’s generic tavaborole topical solution (“Mylan’s ANDA Product”). Anacor
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`lacks knowledge or information sufficient to form a belief about the truth of the remaining
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`allegations of Paragraph 11.
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`12.
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`Anacor admits that Mylan’s Notice Letter informed Anacor, in writing, that
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`Mylan’s ANDA had been submitted to the FDA with certifications alleging that the patents-in-
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`suit are invalid, unenforceable, and/or will not be infringed by Mylan’s ANDA Product. The
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`remaining allegations of Paragraph 12 set forth legal conclusions to which no response is
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`required. To the extent a response is required, Anacor denies those allegations.
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`13.
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`Anacor admits that Mylan’s Notice Letter included a statement of the purported
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`factual and legal bases for Mylan’s alleged certification that the patents-in-suit are invalid,
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`unenforceable, and/or will not be infringed by Mylan’s ANDA Product. The remaining
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`allegations of Paragraph 13 set forth legal conclusions to which no response is required. To the
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`extent a response is required, Anacor denies those allegations.
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`14.
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`Anacor admits the allegations of Paragraph 14.
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`COUNT 1
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`Declaratory Judgment of Patent Invalidity of U.S. Patent No. 9,459,938
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`15.
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`Anacor incorporates each of the preceding paragraphs 1–14 as if fully set forth
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`herein.
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`16.
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`Anacor admits the allegations of Paragraph 16.
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`3
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`Case 1:18-cv-00202-IMK Document 23 Filed 01/04/19 Page 4 of 10 PageID #: 1062
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`17.
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`Anacor admits that Paragraph 17 purports to state Mylan’s contentions with
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`regard to the ’938 patent, but denies those contentions and denies that Mylan is entitled to a
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`judgment of noninfringement or invalidity of the ’938 patent, or to any other relief whatsoever.
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`18.
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`Anacor admits that it asserts that Mylan’s ANDA Product will infringe the claims
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`of the ’938 patent, and that it is seeking a judgment that would prohibit Mylan from
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`manufacturing, using, offering for sale, and selling Mylan’s ANDA Product until after the
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`expiration of the ’938 patent. Anacor denies that by doing so, it is “interfer[ing]” with any
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`legitimate business objective of Mylan. The remaining allegations of Paragraph 18 purport to
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`state Mylan’s subjective belief as to what will happen in the future “[u]nless Counterclaim
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`Defendant is enjoined.” Anacor lacks knowledge or information sufficient to form a belief about
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`the truth of the remaining allegations of Paragraph 18.
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`19.
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`20.
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`Anacor denies the allegations of Paragraph 19.
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`The allegations of Paragraph 20 state legal conclusions to which no response is
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`required. To the extent a response is required, Anacor denies that the ’938 patent is invalid and
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`denies that Mylan is entitled to a declaratory judgment of invalidity, or to any other relief
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`whatsoever.
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`21.
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`Anacor denies the allegations of Paragraph 21.
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`COUNT 2
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`Declaratory Judgment of Patent Invalidity of U.S. Patent No. 9,566,289
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`22.
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`Anacor incorporates each of the preceding paragraphs 1–21 as if fully set forth
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`herein.
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`23.
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`Anacor admits the allegations of Paragraph 23.
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`4
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`Case 1:18-cv-00202-IMK Document 23 Filed 01/04/19 Page 5 of 10 PageID #: 1063
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`24.
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`Anacor admits that Paragraph 24 purports to state Mylan’s contentions with
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`regard to the ’289 patent, but denies those contentions and denies that Mylan is entitled to a
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`judgment of noninfringement or invalidity of the ’289 patent, or to any other relief whatsoever.
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`25.
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`Anacor admits that it asserts that Mylan’s ANDA Product will infringe the claims
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`of the ’289 patent, and that it is seeking a judgment that would prohibit Mylan from
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`manufacturing, using, offering for sale, and selling Mylan’s ANDA Product until after the
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`expiration of the ’289 patent. Anacor denies that by doing so, it is “interfer[ing]” with any
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`legitimate business objective of Mylan. The remaining allegations of Paragraph 25 purport to
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`state Mylan’s subjective belief as to what will happen in the future “[u]nless Counterclaim
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`Defendant is enjoined.” Anacor lacks knowledge or information sufficient to form a belief about
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`the truth of the remaining allegations of Paragraph 25.
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`26.
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`27.
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`Anacor denies the allegations of Paragraph 26.
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`The allegations of Paragraph 27 state legal conclusions to which no response is
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`required. To the extent a response is required, Anacor denies that the ’289 patent is invalid and
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`denies that Mylan is entitled to a declaratory judgment of invalidity, or to any other relief
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`whatsoever.
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`28.
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`Anacor denies the allegations of Paragraph 28.
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`COUNT 3
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`Declaratory Judgment of Patent Invalidity of U.S. Patent No. 9,566,290
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`29.
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`Anacor incorporates each of the preceding paragraphs 1–29 as if fully set forth
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`herein.
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`30.
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`Anacor admits the allegations of Paragraph 30.
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`5
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`Case 1:18-cv-00202-IMK Document 23 Filed 01/04/19 Page 6 of 10 PageID #: 1064
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`31.
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`Anacor admits that Paragraph 31 purports to state Mylan’s contentions with
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`regard to the ’290 patent, but denies those allegations and denies that Mylan is entitled to a
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`judgment of noninfringement or invalidity of the ’290 patent, or to any other relief whatsoever.
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`32.
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`Anacor admits that it asserts that Mylan’s ANDA Product will infringe the claims
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`of the ’290 patent, and that it is seeking a judgment that would prohibit Mylan from
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`manufacturing, using, offering for sale, and selling Mylan’s ANDA Product until after the
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`expiration of the ’290 patent. Anacor denies that by doing so, it is “interfer[ing]” with any
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`legitimate business objective of Mylan. The remaining allegations of Paragraph 32 purport to
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`state Mylan’s subjective belief as to what will happen in the future “[u]nless Counterclaim
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`Defendant is enjoined.” Anacor lacks knowledge or information sufficient to form a belief about
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`the truth of the remaining allegations of Paragraph 32.
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`33.
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`34.
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`Anacor denies the allegations of Paragraph 33.
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`The allegations of Paragraph 34 state legal conclusions to which no response is
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`required. To the extent a response is required, Anacor denies that the ’290 patent is invalid and
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`denies that Mylan is entitled to a declaratory judgment of invalidity, or to any other relief
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`whatsoever.
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`35.
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`Anacor denies the allegations of Paragraph 35.
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`COUNT 4
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`Declaratory Judgment of Patent Invalidity of U.S. Patent No. 9,572,823
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`36.
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`Anacor incorporates each of the preceding paragraphs 1–35 as if fully set forth
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`herein.
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`37.
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`Anacor admits the allegations of Paragraph 37.
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`6
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`Case 1:18-cv-00202-IMK Document 23 Filed 01/04/19 Page 7 of 10 PageID #: 1065
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`38.
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`Anacor admits that Paragraph 38 purports to state Mylan’s contentions with
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`regard to the ’823 patent, but denies those allegations and denies that Mylan is entitled to a
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`judgment of noninfringement or invalidity of the ’823 patent, or to any other relief whatsoever.
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`39.
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`Anacor admits that it asserts that Mylan’s ANDA Product will infringe the claims
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`of the ’823 patent, and that it is seeking a judgment that would prohibit Mylan from
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`manufacturing, using, offering for sale, and selling Mylan’s ANDA Product until after the
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`expiration of the ’823 patent. Anacor denies that by doing so, it is “interfer[ing]” with any
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`legitimate business objective of Mylan. The remaining allegations of Paragraph 39 purport to
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`state Mylan’s subjective belief as to what will happen in the future “[u]nless Counterclaim
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`Defendant is enjoined.” Anacor lacks knowledge or information sufficient to form a belief about
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`the truth of the remaining allegations of Paragraph 39.
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`40.
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`41.
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`Anacor denies the allegations of Paragraph 40.
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`The allegations of Paragraph 41 state legal conclusions to which no response is
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`required. To the extent a response is required, Anacor denies that the ’823 patent is invalid and
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`denies that Mylan is entitled to a declaratory judgment of invalidity, or to any other relief
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`whatsoever.
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`42.
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`Anacor denies the allegations of Paragraph 42.
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`AFFIRMATIVE DEFENSES
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`Mylan’s Counterclaims fail to allege facts sufficient to state a cause of action and fail to
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`state a claim on which relief may be granted.
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`PRAYER FOR RELIEF
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`The “Wherefore” paragraphs following Paragraph 42, under the heading “PRAYER FOR
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`RELIEF,” state the remainder of Mylan’s request for relief, to which no response is required. To
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`7
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`Case 1:18-cv-00202-IMK Document 23 Filed 01/04/19 Page 8 of 10 PageID #: 1066
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`the extent a response is required, Anacor denies the allegations of the “Wherefore” paragraphs
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`following Paragraph 42 and denies that Mylan is entitled to any of the relief requested therein, or
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`to any relief whatsoever.
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`WHEREFORE, Anacor requests the following relief:
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`(a)
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`An order dismissing each of Mylan’s Counterclaims, with prejudice, and
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`denying all relief sought by Mylan;
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`(b)
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`A judgment that each of the patents-in-suit has been infringed under 35
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`U.S.C. § 271(e)(2) by Mylan’s submission to the FDA of Mylan’s ANDA;
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`(c)
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`A judgment ordering that the effective date of any FDA approval of
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`commercial manufacture, use, or sale of Mylan’s ANDA Product, or any other drug product that
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`infringes or the use of which infringes one or more of the patents-in-suit, be not earlier than the
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`latest of the expiration dates of said patents, inclusive of any extension(s) and additional period(s)
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`of exclusivity;
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`(d)
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`A preliminary and permanent injunction enjoining Mylan, and all persons
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`acting in concert with Mylan, from the commercial manufacture, use, sale, offer for sale, or
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`importation into the United States of Mylan’s ANDA Product, or any other drug product covered
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`by or whose use is covered by one or more of the patents-in-suit, prior to the expiration of said
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`patents, inclusive of any extension(s) and additional period(s) of exclusivity;
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`(e)
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`A judgment declaring that the commercial manufacture, use, sale, offer for
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`sale or importation of Mylan’s ANDA Product, or any other drug product which is covered by or
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`whose use is covered by one-or-more of the patents-in-suit, prior to the expiration of said patents,
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`will infringe, induce the infringement of, and contribute to the infringement by others of, said
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`patents;
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`8
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`Case 1:18-cv-00202-IMK Document 23 Filed 01/04/19 Page 9 of 10 PageID #: 1067
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`(f)
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`A declaration that this is an exceptional case and an award of attorneys’ fees
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`pursuant to 35 U.S.C. § 285;
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`(g)
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`(h)
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`Costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
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`Dated: January 4, 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
`
`
`/s/ James F. Companion
`James F. Companion (#790)
`401 Main Street
`Wheeling, WV 26003
`(304) 233-3390
`jfc@schraderlaw.com
`
`Attorneys for Plaintiff Anacor
`Pharmaceuticals, Inc.
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`9
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`Case 1:18-cv-00202-IMK Document 23 Filed 01/04/19 Page 10 of 10 PageID #: 1068
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`CERTIFICATE OF SERVICE
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` I
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` hereby certify that on January 4, 2019, I caused a true and correct copy of the foregoing
`ANSWER TO COUNTERCLAIMS OF MYLAN PHARMACEUTICALS INC. 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
`
`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/
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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
`
`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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`10
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