throbber
Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 1 of 19 PageID #: 90
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 17-648 (RGA)
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`BAYER INTELLECTUAL PROPERTY
`GMBH, BAYER AG, and JANSSEN
`PHARMACEUTICALS, INC.,
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`SIGMAPHARM LABORATORIES, LLC,
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`Plaintiffs,
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`v.
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`Defendant.
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`PLAINTIFFS’ ANSWER TO COUNTERCLAIMS
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`Plaintiffs Bayer Intellectual Property GmbH (“BIP”), Bayer AG (Bayer AG and BIP are
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`collectively referred to herein as “Bayer”), and Janssen Pharmaceuticals, Inc. (“Janssen”) (Bayer
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`and Janssen are collectively referred to herein as “Plaintiffs” or “Counterclaim Defendants”), by
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`their attorneys, hereby answer the counterclaims of Defendant and Counterclaim Plaintiff
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`Sigmapharm Laboratories, LLC (“Sigmapharm”), using the paragraph numbers of Sigmapharm’s
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`Answer, Affirmative Defenses and Counterclaims, D.I. 11, as follows:
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`Plaintiffs reassert as if fully set forth each of the paragraphs of Plaintiffs’ Complaint.
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`49.
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`On information and belief, admitted that Sigmapharm is a limited liability
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`company organized and existing under the laws of the Commonwealth of Pennsylvania, with a
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`place of business at 3375 Progress Drive, Bensalem, Pennsylvania 19020.
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`50.
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`Admitted that Bayer Intellectual Property GmbH is a corporation organized and
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`existing under the laws of the Federal Republic of Germany, with a place of business at Alfred-
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`Nobel-Strasse 10, 40789 Monheim am Rhein, Germany.
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`

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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 2 of 19 PageID #: 91
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`51.
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`Admitted that Bayer Pharma AG—which is not a party to this case—is a
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`corporation organized and existing under the laws of the Federal Republic of Germany, with a
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`place of business at Müllerstrasse 178, 13353 Berlin, Germany.
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`52.
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`Admitted that Janssen Pharmaceuticals, Inc. is a corporation organized and
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`existing under the laws of Pennsylvania, with a place of business at 1125 Trenton-Harbourton
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`Road, Titusville, New Jersey.
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`53.
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`The allegations in paragraph 53 are legal conclusions to which no response is
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`required. To the extent a response is required, Plaintiffs do not contest personal jurisdiction for
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`purposes of this action.
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`54.
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`The allegations in paragraph 54 are legal conclusions to which no response is
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`required. To the extent a response is required, Plaintiffs do not contest subject matter
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`jurisdiction.
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`55.
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`The allegations in paragraph 55 are legal conclusions to which no response is
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`required. To the extent a response is required, Plaintiffs do not contest venue for purposes of this
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`action.
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`56.
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`The allegations in the first sentence of paragraph 56 are legal conclusions to
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`which no response is required. To the extent a response is required, admitted that there is an
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`actual case or controversy between Sigmapharm and Plaintiffs with respect to liability for
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`infringement of U.S. Patent No. 9,539,218 (“the ’218 patent”), but denied that Sigmapharm is
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`entitled to any of the relief that it seeks. Admitted that Plaintiffs filed this action against
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`Sigmapharm on the basis of Sigmapharm’s submission of ANDA No. 208546.
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`57.
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`The allegations in paragraph 57 are legal conclusions to which no response is
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`required. To the extent a response is required, admitted that there is an actual case or
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`2
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`

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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 3 of 19 PageID #: 92
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`controversy between Sigmapharm and Plaintiffs with respect to liability for infringement of the
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`’218 patent, but denied that Sigmapharm is entitled to any of the relief that it seeks. Further
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`denied that Sigmapharm has stated a claim under 35 U.S.C. § 271(e)(5).
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`58.
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`The allegations in paragraph 58 characterize federal statutes, which speak for
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`themselves.
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`59.
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`The allegations in paragraph 59 characterize federal statutes and regulations,
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`which speak for themselves.
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`60.
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`The allegations in paragraph 60 characterize a federal statute, which speaks for
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`itself.
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`61.
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`62.
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`Denied.
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`Admitted that the Drug Price Competition and Patent Term Restoration Act of
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`1984 affected a change in the law regarding FDA procedures. Otherwise, denied.
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`63.
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`Admitted that the Drug Price Competition and Patent Restoration Act of 1984 was
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`enacted in 1984. The second and third sentences of paragraph 63 characterize federal statutes,
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`which speak for themselves.
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`64.
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`The allegations in paragraph 64 characterize federal statutes and regulations,
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`which speak for themselves.
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`65.
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`The allegations in paragraph 65 characterize a federal statute, which speaks for
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`itself.
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`itself.
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`66.
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`The allegations in paragraph 66 characterize a federal statute, which speaks for
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`67.
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`The allegations in paragraph 67 characterize federal statutes, which speak for
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`themselves.
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`3
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`

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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 4 of 19 PageID #: 93
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`68.
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`The allegations in paragraph 68 characterize a federal statute, which speaks for
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`itself. Admitted that Plaintiffs have properly filed an action against Sigmapharm in this District
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`for infringement of the ’218 patent, and that Plaintiffs’ Complaint speaks for itself. Denied that
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`Plaintiffs’ action against Sigmapharm lacks merit.
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`69.
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`The allegations in paragraph 69 characterize a federal statute, which speaks for
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`itself.
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`70.
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`Admitted that the ’218 patent issued on January 10, 2017 and that the ’218 patent
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`is entitled “Prevention and Treatment of Thromboembolic Disorders.” Admitted that Bayer
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`Intellectual Property GmbH owns and is the assignee of the ’218 patent. Admitted that Bayer
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`AG is an exclusive licensee under the ’218 patent. Admitted that Janssen is an exclusive
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`sublicensee under the ’218 patent.
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`71.
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`Admitted that Janssen Pharmaceuticals, Inc. is the holder of New Drug
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`Application No. 022406 for XARELTO® rivaroxaban 10 mg, 15 mg and 20 mg tablets.
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`Admitted that Janssen sells XARELTO® rivaroxaban 10 mg, 15 mg and 20 mg tablets in the
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`United States.
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`72.
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`73.
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`74.
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`Admitted.
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`Upon information and belief, admitted.
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`Admitted that the ’218 patent is properly listed in the Orange Book for
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`XARELTO®. Further admitted, on information and belief, that Sigmapharm’s ANDA for
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`generic versions of XARELTO® contained or was updated to contain a paragraph IV
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`certification with respect to the ’218 patent. Denied that the ’218 patent is invalid or
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`unenforceable. Denied that the use of Sigmapharm’s proposed generic version of XARELTO®
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`in accordance with its proposed labeling would not infringe the ’218 patent.
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`4
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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 5 of 19 PageID #: 94
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`75.
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`Admitted that Sigmapharm sent a Notice Letter, which speaks for itself. Denied
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`that the ’218 patent is invalid or unenforceable. Denied that the use of Sigmapharm’s proposed
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`generic version of XARELTO® in accordance with its proposed labeling would not infringe the
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`’218 patent. Plaintiffs deny the remaining allegations in paragraph 75.
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`76.
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`Admitted that Sigmapharm sent a Notice Letter, which speaks for itself. Denied
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`that the ’218 patent is invalid or unenforceable. Denied that the use of Sigmapharm’s proposed
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`generic version of XARELTO® in accordance with its proposed labeling would not infringe the
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`’218 patent. Plaintiffs deny the remaining allegations in paragraph 76.
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`77.
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`Admitted that on May 26, 2017, Bayer and Janssen sued Sigmapharm for
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`infringement of the ’218 patent.
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`78.
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`The allegations in paragraph 78 are legal conclusions to which no response is
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`required. To the extent a response is required, Plaintiffs admit that they have properly filed a
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`Complaint to enforce their patent rights in accordance with the provisions of the Drug Price
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`Competition and Patent Term Restoration Act of 1984 and associated regulations. Plaintiffs
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`deny the remaining allegations in paragraph 78.
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`79.
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`80.
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`81.
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`82.
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`Denied.
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`Denied.
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`Denied.
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`Admitted that there is an actual case or controversy between Sigmapharm and
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`Plaintiffs with respect to liability for infringement of the ’218 patent, and that it is of sufficient
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`immediacy and reality to warrant the issuance of a Declaratory Judgment in favor of Plaintiffs,
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`but denied that Sigmapharm is entitled to any of the relief that it seeks.
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`5
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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 6 of 19 PageID #: 95
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`COUNT I
`DECLARATORY JUDGMENT OF
`NON-INFRINGEMENT OF THE ’218 PATENT
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`83.
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`Plaintiffs reassert as if fully set forth each of their responses to the foregoing
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`paragraphs.
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`84.
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`Admitted that Plaintiffs have properly filed an action against Sigmapharm in this
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`District for infringement of the ’218 patent, and that Plaintiffs’ Complaint speaks for itself.
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`85.
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`The allegations in paragraph 85 are legal conclusions to which no response is
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`required. To the extent a response is required, admitted that there is an actual case or
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`controversy between Sigmapharm and Plaintiffs with respect to liability for infringement of the
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`’218 patent. Denied that Sigmapharm’s proposed generic versions of XARELTO® and/or the
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`use thereof in accordance with their proposed labeling do not infringe the ’218 patent, and
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`further denied that Sigmapharm is entitled to any of the relief that it seeks.
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`86.
`
`87.
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`Denied.
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`Denied.
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`COUNT II
`DECLARATORY JUDGMENT OF
`INVALIDITY OF THE ’218 PATENT
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`88.
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`Plaintiffs reassert as if fully set forth each of their responses to the foregoing
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`paragraphs.
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`89.
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`Admitted that Plaintiffs have properly filed an action against Sigmapharm in this
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`District for infringement of the ’218 patent, and that Plaintiffs’ Complaint speaks for itself.
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`90.
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`The allegations of paragraph 90 purport
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`to characterize Sigmapharm’s
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`counterclaims, which speak for themselves. Denied that the ’218 patent is invalid or
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`unenforceable and further denied that Sigmapharm is entitled to any of the relief that it seeks.
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`6
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`

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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 7 of 19 PageID #: 96
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`91.
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`92.
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`Denied.
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`Admitted that there is an actual case or controversy between Sigmapharm and
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`Plaintiffs with respect to liability for infringement of the ’218 patent. Denied that the ’218 patent
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`is invalid, and further denied that Sigmapharm is entitled to any of the relief that it seeks.
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`93.
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`Denied.
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`COUNT III
`DECLARATORY JUDGMENT OF
`UNENFORCEABILITY OF THE ’218 PATENT
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`94.
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`Plaintiffs reassert as if fully set forth each of their responses to the foregoing
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`paragraphs.
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`95.
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`96.
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`Denied.
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`Admitted that the ’218 patent issued on January 10, 2017. Denied that the ’218
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`patent issued from U. S. Patent Application No. 11/882,218. Admitted that the ’218 patent
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`issued from U.S. Patent Application No. 11/883,218 (“the ’218 application”). Admitted that the
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`’218 application was the § 371 National Stage Entry of PCT/EP2006/000431. Denied that
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`PCT/EP2006/000431 was filed on June 19, 2006. Admitted that the face of the ’218 patent lists
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`a § 371(c)(1)(2)(4) date of July 16, 2008 for PCT/EP2006/000431. Admitted that the ’218 patent
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`claims priority to European Patent Application No. EP 05001893.6. Admitted that EP
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`05001893.6 was filed on January 31, 2005.
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`97.
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`98.
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`Admitted.
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`Admitted that the ’218 patent is entitled “Prevention and Treatment of
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`Thromboembolic Disorders.”
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`99.
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`The allegations in paragraph 99 are legal conclusions to which no response is
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`required, and attempt to characterize Plaintiffs’ Complaint, which speaks for itself. To the extent
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`7
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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 8 of 19 PageID #: 97
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`a response is required, Plaintiffs admit that claim 1 of the ’218 patent recites “[a] method of
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`treating a thromboembolic disorder comprising administering a direct factor Xa inhibitor that is
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`5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-
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`thiophenecarboxamide no more than once daily for at least five consecutive days in a rapid-
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`release tablet to a patient in need thereof, wherein the thromboembolic disorder is selected from
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`the group consisting of pulmonary embolisms, deep vein thromboses, and stroke.”
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`100. Admitted that the ’218 patent lists Sreeni Padmanabhan as the “Primary
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`Examiner.”
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`101. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Admitted that the ’218 application file history contains a
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`document purporting to be a July 27, 2007 transmittal letter and bearing the signature of
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`William F. Gray (“Gray”) and a July 27, 2007 Information Disclosure Statement signed by Gray.
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`102. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Admitted that Gray was employed by a Bayer entity at the time of
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`filing of the ’218 application.
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`103. Admitted that Christine M. Hansen participated in the prosecution of the ’218
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`application and communicated with the PTO regarding prosecution of the ’218 application.
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`104. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
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`Defenses, and Counterclaims. Admitted that Christine M. Hansen (“Hansen”) was an attorney at
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`Connolly Bove Lodge & Hutz LLP during the prosecution of the ’218 application at the time of
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`the July 16, 2008 Response to Notification of Missing Requirements. Denied that Christine M.
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`Hansen was an attorney at Connolly Bove Lodge & Hutz LLP during the entirety of the
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`prosecution of the ’218 application.
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`8
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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 9 of 19 PageID #: 98
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`105. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
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`Defenses, and Counterclaims. Admitted that Hansen’s work address at the time of the July 16,
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`2008 Response to Notification of Missing Requirements was 1007 North Orange Street,
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`P.O. Box 2207, Wilmington, Delaware. Denied that Hansen’s work address was 1007 North
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`Orange Street, P.O. Box 2207, Wilmington, Delaware during the entirety of the prosecution of
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`the ’218 application.
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`106. The allegations of paragraph 106 contain legal conclusions to which no response
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`is required. Paragraph 106 further purports to quote a federal statute, which speaks for itself.
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`107. The allegations of paragraph 107 contain legal conclusions to which no response
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`is required.
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`108. The allegations of paragraph 108 contain legal conclusions to which no response
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`is required. Paragraph 108 further purports to characterize a federal regulation, which speaks for
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`itself. To the extent a response is required, admitted.
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`109. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
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`Defenses, and Counterclaims. The allegations of paragraph 109 contain legal conclusions to
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`which no response is required. Paragraph 109 further purports to characterize a federal
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`regulation, which speaks for itself. To the extent a response is required, Plaintiffs admit that the
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`’218 application file history contains a document purporting to be a Declaration and Power of
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`Attorney stamped received on July 16, 2008 and signed by Dagmar Kubitza, which speaks for
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`itself.
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`110. Denied.
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`9
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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 10 of 19 PageID #: 99
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`111. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
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`Defenses, and Counterclaims. Paragraph 111 purports to characterize and quote from the ’218
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`application filed on July 27, 2017, which speaks for itself.
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`112. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
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`Defenses, and Counterclaims. Admitted that the ’218 application file history contains a
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`document purporting to be a July 27, 2007 Information Disclosure Statement signed by Gray.
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`Admitted that the ’218 application file history contains a document purporting to be a March 17,
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`2011 Office Action. Paragraph 112 purports to characterize the July 27, 2007 Information
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`Disclosure Statement and March 17, 2011 Office Action, which speak for themselves.
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`113. Admitted that Kubitza et al.1 and Kubitza et al.2 refer to “Poster Board[s],” which
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`speak for themselves. The remainder of paragraph 113 calls for a legal conclusion, to which no
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`response is required. To the extent a response is required, Plaintiffs admit that the ’218
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`application file history contains a document purporting to be a July 27, 2007 Information
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`Disclosure Statement, which speaks for itself. Paragraph 113 is otherwise denied.
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`114. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
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`Defenses, and Counterclaims. Admitted that Kubitza et al.1 and Kubitza et al.2 refer to “Poster
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`Board[s],” which speak for themselves. Admitted that there exists a publication “Kubitza et al.,
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`Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral,
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`direct factor Xa inhibitor, Clinical Pharmacology & Therapeutics, 78(4):412-21 (2005),” which
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`speaks for itself. Paragraph 114 is otherwise denied.
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`115. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Paragraph 115 calls for a legal conclusion to which no response is
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`10
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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 11 of 19 PageID #: 100
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`required. To the extent a response is required, admitted that Kubitza et al.1 and Kubitza et al.2
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`refer to “Poster Board[s],” which speak for themselves. Paragraph 115 is otherwise denied.
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`116. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Paragraph 116 calls for a legal conclusion to which no response is
`
`required. To the extent a response is required, Admitted that Kubitza et al.1 and Kubitza et al.2
`
`refer to “Poster Board[s],” which speak for themselves. Paragraph 116 is otherwise denied.
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`117. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Paragraph 117 calls for a legal conclusion to which no response is
`
`required. Admitted that Kubitza et al.1 and Kubitza et al.2 refer to “Poster Board[s],” which
`
`speak for themselves. Paragraph 117 is otherwise denied.
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`118. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Admitted that the Information Disclosure Statements submitted
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`during the prosecution of the ’218 application speak for themselves.
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`119. Admitted that inventor Kubitza is listed as an author of Kubitza et al.1 and Kubitza
`
`et al.2 Paragraph 119 is otherwise denied.
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`120. Admitted that Gray was employed by a Bayer entity at the time of his
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`involvement in the prosecution of the ’218 application. Paragraph 120 is otherwise denied.
`
`121. Admitted that Hansen participated in the prosecution of the ’218 application on
`
`behalf of a Bayer entity. Paragraph 121 is otherwise denied.
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`122. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Admitted that the ’218 application file history contains a
`
`document purporting to be a November 10, 2010 Office Action. Paragraph 122 purports to
`
`characterize and quote from the November 10, 2010 Office Action, which speaks for itself.
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`11
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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 12 of 19 PageID #: 101
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`123. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
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`Defenses, and Counterclaims. Admitted that the ’218 application file history contains a
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`document purporting to be a December 10, 2010 Response to Restriction Requirement.
`
`Paragraph 123 purports to characterize and quote from the December 10, 2010 Response to
`
`Restriction Requirement, which speaks for itself.
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`124. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Denied that the ’218 application file history contains a March 3,
`
`2017 Office Action. Admitted that the ’218 application file history contains a document
`
`purporting to be a March 17, 2011 Office Action. Paragraph 124 purports to characterize the
`
`March 17, 2011 Office Action, which speaks for itself.
`
`125. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Denied that the ’218 application file history contains a March 3,
`
`2017 Office Action. Admitted that the ’218 file history contains a document purporting to be a
`
`March 17, 2011 Office Action. Paragraph 125 purports to characterize and quote from the
`
`March 17, 2011 Office Action, which speaks for itself.
`
`126. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Denied that the ’218 application file history contains a March 3,
`
`2017 Office Action. Admitted that the ’218 application file history contains a document
`
`purporting to be a March 17, 2011 Office Action. Paragraph 126 purports to characterize and
`
`quote from the March 17, 2011 Office Action, which speaks for itself.
`
`127. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Admitted that the ’218 application file history contains a
`
`document purporting to be a June 17, 2011 Response to Non Final Office Action signed by
`
`12
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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 13 of 19 PageID #: 102
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`Hansen. Paragraph 127 purports to characterize and quote from the June 17, 2011 Response to
`
`Non Final Office Action, which speaks for itself.
`
`128. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Denied that the ’218 application file history contains a June 17,
`
`2008 Response to Non Final Office Action. Admitted that the ’218 application file history
`
`contains a document purporting to be a June 17, 2011 Response to Non Final Office Action.
`
`Paragraph 128 purports to characterize and quote from the June 17, 2011 Response to Non Final
`
`Office Action, which speaks for itself.
`
`127. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Denied that the ’218 application file history contains a document
`
`purporting to be a June 17, 2008 Response to Non Final Office Action. Admitted that the ’218
`
`application file history contains a document purporting to be a June 17, 2011 Response to Non
`
`Final Office Action. Paragraph 127 purports to characterize and quote from the June 17, 2011
`
`Response to Non Final Office Action, which speaks for itself.
`
`128. Denied.
`
`129. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Admitted that the ’218 application file history contains a
`
`document purporting to be an Office Action dated September 21, 2011. Paragraph 129 purports
`
`to characterize and quote from the September 21, 2011 Office Action, which speaks for itself.
`
`130. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Paragraph 130 purports to characterize the September 21, 2011
`
`Office Action, which speaks for itself.
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`13
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`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 14 of 19 PageID #: 103
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`131. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
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`Defenses, and Counterclaims. Paragraph 131 purports to characterize the September 21, 2011
`
`Office Action, which speaks for itself.
`
`132. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Paragraph 132 purports to characterize the September 21, 2011
`
`Office Action, which speaks for itself.
`
`133. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Admitted that the ’218 application file history contains a
`
`document purporting to be a January 30, 2012 Response to Final Office Action signed by
`
`Hansen. Paragraph 133 purports to characterize and quote from the January 30, 2012 Response
`
`to Final Office Action, which speaks for itself.
`
`134. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Paragraph 134 purports to characterize and quote from the
`
`January 30, 2012 Response to Final Office Action, which speaks for itself.
`
`135. Denied.
`
`136. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Admitted that the ’218 application file history contains a
`
`document purporting to be a Notice of Appeal dated February 21, 2012 and signed by Hansen.
`
`Admitted that the ’218 application file history contains a document purporting to be an Appeal
`
`Brief dated April 20, 2012 and signed by Hansen.
`
`137. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Paragraph 137 purports to characterize and quote from the
`
`April 20, 2012 Appeal Brief, which speaks for itself.
`
`14
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`

`

`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 15 of 19 PageID #: 104
`
`138. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Admitted that the ’218 application file history contains a
`
`document purporting to be a June 3, 2016 Board of Patent Appeals decision. Paragraph 138
`
`purports to characterize and quote from the June 3, 2016 Board of Patent Appeals decision,
`
`which speaks for itself.
`
`139. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Paragraph 139 is denied.
`
`140. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Admitted that the ’218 application file history contains a
`
`document purporting to be an August 29, 2016 Notice of Allowability. Paragraph 140 purports
`
`to characterize the August 29, 2016 Notice of Allowability, which speaks for itself.
`
`141. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Paragraph 141 purports to characterize the August 29, 2016
`
`Notice of Allowability, which speaks for itself.
`
`142. Plaintiffs note that no Exhibit is attached to Sigmapharm’s Answer, Affirmative
`
`Defenses, and Counterclaims. Paragraph 142 purports to characterize the August 29, 2016
`
`Notice of Allowability, which speaks for itself.
`
`143. Denied.
`
`144. Denied.
`
`The allegations contained in the section headings for Count 3 of Sigmapharm’s
`
`counterclaims are hereby denied.
`
`15
`
`

`

`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 16 of 19 PageID #: 105
`
`DEFENDANT’S PRAYER FOR RELIEF
`
`The “WHEREFORE” paragraphs following paragraph 144 state Sigmapharm’s Prayer
`
`for Relief, to which no response is required. To the extent a response is required, Plaintiffs deny
`
`that Sigmapharm is entitled to any of the relief in the prayer for relief, or to any relief
`
`whatsoever.
`
`*
`
`*
`
`*
`
`Any allegation in the Counterclaims not expressly admitted herein is hereby denied.
`
`AFFIRMATIVE DEFENSES TO COUNTERCLAIMS
`
`Plaintiffs affirmatively state the following defenses, undertaking the burden of proof only
`
`to the extent required by law:
`
`FIRST AFFIRMATIVE DEFENSE
`
`Each of Sigmapharm’s Counterclaims has failed to state a claim upon which relief can be
`
`granted. For example, Sigmapharm has alleged no facts that, if true, would show that the ’218
`
`patent is invalid for any reason.
`
`SECOND AFFIRMATIVE DEFENSE
`
`Sigmapharm’s Counterclaims have failed to state a claim upon which relief for
`
`exceptional cases under 35 U.S.C. § 285 can be granted.
`
`THIRD AFFIRMATIVE DEFENSE
`
`Sigmapharm’s Counterclaims have failed to state a claim for inequitable conduct. For
`
`instance, Sigmapharm has failed to allege facts that, if true, would show materiality or intent to
`
`deceive as required to establish inequitable conduct.
`
`16
`
`

`

`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 17 of 19 PageID #: 106
`
`FOURTH AFFIRMATIVE DEFENSE
`
`Plaintiffs reserve the right to supplement and/or amend these affirmative defenses as may
`
`become available or apparent during discovery proceedings.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`(a)
`
`An order dismissing each of Sigmapharm’s counterclaims, with prejudice, and
`
`denying all relief sought by Sigmapharm;
`
`(b)
`
`(c)
`
`A judgment that Sigmapharm has infringed the ’218 patent;
`
`A judgment ordering that the effective date of any FDA approval for Sigmapharm
`
`to make, use, offer for sale, sell, market, distribute, or import Sigmapharm ANDA Products, or
`
`any product or compound which infringes or the use of which infringes the ’218 patent, be no
`
`earlier than the expiration date of the ’218 patent, inclusive of any extension(s) and additional
`
`period(s) of exclusivity;
`
`(d)
`
`A preliminary and permanent injunction enjoining Sigmapharm, and all persons
`
`acting in concert with Sigmapharm, from making, using, selling, offering for sale, marketing,
`
`distributing, or importing Sigmapharm’s ANDA Products, or any product or compound that
`
`infringes or the use of which infringes the ’218 patent, or the inducement of or the contribution
`
`to any of the foregoing, prior to the expiration date of the ’218 patent, inclusive of any
`
`extension(s) and additional period(s) of exclusivity;
`
`(e)
`
`A declaration that this is an exceptional case and an award of attorneys’ fees
`
`pursuant to 35 U.S.C. § 285;
`
`(f)
`
`(g)
`
`An award of Plaintiffs’ costs and expenses in this action; and
`
`Such further and other relief as this Court may deem just and proper.
`
`17
`
`

`

`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 18 of 19 PageID #: 107
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`OF COUNSEL:
`
`Bruce R. Genderson
`Adam L. Perlman
`Dov P. Grossman
`Alexander S. Zolan
`Martha C. Kidd
`Kathryn S. Kayali
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street NW
`Washington, DC 20005
`(202) 434-5000
`Attorneys for Plaintiffs Bayer Intellectual
`Property GmbH and Bayer AG
`
`David T. Pritikin
`Lisa A. Schneider
`SIDLEY AUSTIN LLP
`One South Dearborn
`Chicago, IL 60603
`(312) 853-7000
`
`Bindu Donovan
`S. Isaac Olson
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`(212) 839-5300
`Attorneys for Plaintiff Janssen
`Pharmaceuticals, Inc.
`
`August 2, 2017
`11217887
`
`
`
`
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Derek J. Fahnestock
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Rodger D. Smith (#3778)
`Derek J. Fahnestock (#4705)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`rsmith@mnat.com
`dfahnestock@mnat.com
`
`Attorneys for Plaintiffs Bayer Intellectual
`Property GmbH, Bayer AG, and Janssen
`Pharmaceuticals, Inc.
`
`18
`
`

`

`Case 1:17-cv-00648-RGA Document 15 Filed 08/02/17 Page 19 of 19 PageID #: 108
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on August 2, 2017, I caused the foregoing to be electronically
`
`
`
`
`
`filed with the Clerk of the Court using CM/ECF, which will send notification of such filing to all
`
`registered participants.
`
`
`
`
`
`I further certify that I caused copies of the foregoing document to be served on
`
`August 2, 2017, upon the following in the manner indicated:
`
`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
`
`/s/ Derek J. Fahnestock
`_________________________________________
`Derek J. Fahnestock (#4705)
`
`R Touhey Myer, Esquire
`CAESAR RIVISE, PC
`800 North King Street, Suite 304
`Wilmington, DE 19801
`Attorneys for Defendant Sigmapharm
`Laboratories, LLC
`
`Robert S. Silver, Esquire
`Lynn Terrebonne, Esquire
`CAESAR RIVISE, PC
`1635 Market Street
`Seven Penn Center, 12th Floor
`Philadelphia, PA 19103
`Attorneys for Defendant Sigmapharm
`Laboratories, LLC
`
`
`
`
`11217887
`
`
`
`

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