`BAYER INTELLECTUAL PROPERTY
`GMBH, ET AL.,
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`
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`SIGMAPHARM LABORATORIES, LLC,
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`v.
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`Plaintiffs,
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`Defendant.
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`
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`Civil Action No. 1:17-cv-00648-RGA
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 1 of 38 PageID #: 44
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`
`
`
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`DEFENDANT SIGMAPHARM LABORATORIES, LLC’S ANSWER,
`AFFIRMATIVE DEFENSES AND COUNTERCLAIMS
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`Defendant Sigmapharm Laboratories, LLC, by and through its undersigned counsel, and
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`for its Answer responds to the separately-numbered paragraphs of Plaintiffs Bayer Intellectual
`
`Property GmbH, Bayer AG and Janssen Pharmaceuticals, Inc.’s Complaint, as follows:
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`1.
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`Defendant admits that Plaintiffs’ Complaint purports to assert claims of
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`infringement of U.S. Patent No. 9,539,218 (“the ’218 patent”) under the Patent Laws of the
`
`United States and, in particular, 35 U.S.C. § 271(e)(2); however, Defendant denies that there is
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`any factual or legal basis for any of Plaintiffs’ claims against it in this action, and therefore,
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`Defendant denies the allegations in this Paragraph.
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`2.
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`Defendant is without knowledge or information sufficient to form a belief as to
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`the truth of the allegations of Paragraph 2 of Plaintiffs’ Complaint, and therefore, denies the
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`same.
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`3.
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`Defendant is without knowledge or information sufficient to form a belief as to
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`the truth of the allegations of Paragraph 3 of Plaintiffs’ Complaint, and therefore, denies the
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`same.
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`1
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`

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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 2 of 38 PageID #: 45
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`4.
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`Defendant is without knowledge or information sufficient to form a belief as to
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`the truth of the allegations of Paragraph 3 of Plaintiffs’ Complaint, and therefore, denies the
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`same.
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`5.
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`6.
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`Admitted.
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`Defendant admits that it is engaged in the development of unique generic and
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`branded drug products and does so in compliance with the Federal Food, Drug, and Cosmetic
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`Act. Except as so admitted, Defendant denies the allegations of Paragraph 6 of Plaintiffs’
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`Complaint.
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`7.
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`8.
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`Admitted.
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`Defendant admits that it is engaged in the development of unique generic and
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`branded drug products and does so in compliance with the Federal Food, Drug, and Cosmetic
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`Act. Except as so admitted, Defendant denies the allegations of Paragraph 8 of Plaintiffs’
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`Complaint.
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`9.
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`Defendant admits that it is engaged in the development of unique generic and
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`branded drug products and does so in compliance with the Federal Food, Drug, and Cosmetic
`
`Act. Except as so admitted, Defendant denies the allegations of Paragraph 9 of Plaintiffs’
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`Complaint.
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`10.
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`Defendant incorporates each of the preceding paragraphs in their entirety as if
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`each is fully set forth herein.
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`11.
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`Paragraph 11 of Plaintiffs’ Complaint states legal conclusions to which no
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`response is required. To the extent any response is required, Defendant admits that the
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`Complaint purports to assert claims of patent infringement under the Patent Laws of the United
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`2
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 3 of 38 PageID #: 46
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`States, over which this Court has subject matter jurisdiction. Except as so admitted, Defendant
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`denies the allegations of Paragraph 11 of Plaintiffs’ Complaint.
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`12.
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`Paragraph 12 of Plaintiffs’ Complaint states legal conclusions to which no
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`response is required. To the extent any response is required, Defendant admits that the
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`Complaint purports to assert claims of patent infringement under the Patent Laws of the United
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`States, over which this Court has subject matter jurisdiction. Except as so admitted, Defendant
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`denies the allegations of Paragraph 12 of Plaintiffs’ Complaint.
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`13.
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`Defendant admits that it has consented to jurisdiction in this judicial district in
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`Case No. 1:15-cv-00902-RGA; that the claims of patent infringement asserted in Case No. 1:15-
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`cv-00902-RGA arise from the filing of ANDA No. 208546 and that Defendant asserted
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`counterclaims in Case No. 1:15-cv-00902-RGA. Except as so admitted, Defendant denies the
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`allegations of Paragraph 13 of Plaintiffs’ Complaint.
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`14.
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`Defendant admits that it consented venue in this District for the limited purpose of
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`this Action. Except as so admitted, Defendant denies the allegations of Paragraph 14 of
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`Plaintiffs’ Complaint.
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`15.
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`Defendant admits that the information set forth in Paragraph 15 appears in
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`publicly available FDA documents. Except as so admitted, Defendant denies the allegations of
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`Paragraph 15 of Plaintiffs’ Complaint.
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`16.
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`Defendant admits that the information set forth in Paragraph 16 appears in
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`publicly available FDA documents. Except as so admitted, Defendant denies the allegations of
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`Paragraph 16 of Plaintiffs’ Complaint.
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`17.
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`Defendant admits that, based on the face of Exhibit A of the Complaint, the ’218
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`patent it issued on January 10, 2017 and is entitled “Prevention and Treatment of
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`3
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 4 of 38 PageID #: 47
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`
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`Thromboembolic Disorders.” Except as so admitted, Defendant denies the allegations of
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`Paragraph 17 of Plaintiffs’ Complaint.
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`18.
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`Defendant is without knowledge or information sufficient to form a belief as to
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`the truth of the allegations of Paragraph 18 of Plaintiffs’ Complaint, and therefore, denies the
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`same.
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`19.
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`Defendant is without knowledge or information sufficient to form a belief as to
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`the truth of the allegations of Paragraph 19 of Plaintiffs’ Complaint, and therefore, denies the
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`same.
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`20.
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`Defendant is without knowledge or information sufficient to form a belief as to
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`the truth of the allegations of Paragraph 20 of Plaintiffs’ Complaint, and therefore, denies the
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`same.
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`21.
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`Defendant is without knowledge or information sufficient to form a belief as to
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`the truth of the allegations of Paragraph 21 of Plaintiffs’ Complaint, and therefore, denies the
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`same.
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`22.
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`Defendant admits that the ‘218 patent is listed in the FDA’s Approved Drug
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`Products with Therapeutic Equivalence Evaluations (a/k/a the “Orange Book”) in connection
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`with XARELTO. Except as so admitted, Defendant denies the allegations of Paragraph 22 of
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`Plaintiffs’ Complaint.
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`23.
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`Defendant admits that the it served a Notice Letter on April 12, 2017 in
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`accordance with 21 U.S.C. § 355(j)(2)(B) and that said Notice Letter speaks for itself. Except as
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`so admitted, Defendant denies the allegations of Paragraph 23 of Plaintiffs’ Complaint.
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`24.
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`Defendant admits that the April 12, 2017 Notice Letter speaks for itself. Except
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`as so admitted, Defendant denies the allegations of Paragraph 24 of Plaintiffs’ Complaint.
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`4
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 5 of 38 PageID #: 48
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`25.
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`Defendant admits that the April 12, 2017 Notice Letter speaks for itself. Except
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`as so admitted, Defendant denies the allegations of Paragraph 25 of Plaintiffs’ Complaint.
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`26.
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`Defendant admits that the content of ANDA No. 208546 speaks for itself. Except
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`as so admitted, Defendant denies the allegations of Paragraph 26 of Plaintiffs’ Complaint.
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`27.
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`28.
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`Denied.
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`Defendant admits that the April 12, 2017 Notice Letter speaks for itself. Except
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`as so admitted, Defendant denies the allegations of Paragraph 28 of Plaintiffs’ Complaint.
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`29.
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`Defendant admits that the content of ANDA No. 208546 speaks for itself. Except
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`as so admitted, Defendant denies the allegations of Paragraph 29 of Plaintiffs’ Complaint.
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`30.
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`31.
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`Denied.
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`Defendant admits that it has knowledge of the claims of the ‘218 patent. Except
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`as so admitted, Defendant denies the allegations of Paragraph 31 of Plaintiffs’ Complaint.
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`32.
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`33.
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`34.
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`35.
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`Denied.
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`Denied.
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`Denied.
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`Paragraph 35 of Plaintiffs’ Complaint states legal conclusions to which no
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`response is required. To the extent a response is required, Defendant denies the allegations in
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`this Paragraph.
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`36.
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`37.
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`Admitted.
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`Defendant incorporates each of the preceding paragraphs in their entirety as if
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`each is fully set forth herein.
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`38.
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`39.
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`Denied.
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`Denied.
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`5
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 6 of 38 PageID #: 49
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`
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`40.
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`41.
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`42.
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`43.
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`Denied.
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`Denied.
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`Denied.
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`Any allegation in Plaintiffs’ Complaint not expressly admitted by Defendant is
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`hereby denied. Having answered Plaintiffs’ Complaint, Defendant denies that Plaintiffs are
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`entitled to the relief requested in Plaintiffs’ Prayer for Relief or to any relief whatsoever, and
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`Defendant requests that all such relief be denied in toto.
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`AFFIRMATIVE DEFENSES
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`Without prejudice to the denials set forth in their Answer and without admitting any
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`allegations of the Complaint not otherwise admitted, Defendant avers and asserts the following
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`Affirmative Defenses to Plaintiffs’ Complaint:
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`44.
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`45.
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`Plaintiffs’ Complaint fails to state any claim upon which relief may be granted.
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`The manufacture, use, or sale, offer for sale, or importation of the product that is
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`the subject of Defendant’s ANDA No. 208546 has not infringed, does not infringe, and would
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`not, if marketed, manufactured, used, sold, offered for sale, or imported, infringe any valid or
`
`enforceable claim of the ‘218 patent.
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`46.
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`The ‘218 patent has been, and is, invalid and void on the grounds that the
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`purported invention attempted to be patented therein fails to meet one or more of the conditions
`
`of patentability specified in Title 35, United States Code, including without limitation one or
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`more of §§ 102 and/or 103 of said Title.
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`47.
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`The ’218 patent has been, and is, unenforceable and void on the grounds of
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`inequitable conduct as more specifically detailed below in the counterclaim of inequitable
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`conduct, the paragraphs of which are incorporated herein by reference.
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`6
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 7 of 38 PageID #: 50
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`48.
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`All possible affirmative defenses may not have been alleged herein insofar as
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`sufficient facts were not available after reasonable inquiry upon the filing of Defendant’s
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`Answer and, therefore, Defendant reserves the right to amend its Answer to allege additional
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`affirmative defenses if subsequent investigation and/or discovery warrants.
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`COUNTERCLAIMS
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`For its counterclaims against Plaintiffs/Counterclaim Defendants Bayer Intellectual
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`Property GmbH, Bayer Pharma AG and Janssen Pharmaceuticals, Inc. (collectively
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`“Counterclaim Defendants”), Defendant/Counterclaim Plaintiff Sigmapharm Laboratories, LLC
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`(“Sigmapharm”) states as follows:
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`49.
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`Sigmapharm is a limited liability company duly organized and existing under the
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`laws of the Commonwealth of Pennsylvania, having its principal place of business at 3375
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`Progress Drive, Bensalem, PA 19020.
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`50.
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`Upon information and belief, Bayer Intellectual Property GmbH is a German
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`corporation having its principal place of business at Alfred-Nobel-Strasse 10, 40789 Mannheim
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`am Rhein, Germany.
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`51.
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`Upon information and belief, Bayer Pharma AG is a German corporation having a
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`principal place of business at Müllerstrasse 178, 13353 Berlin, Germany.
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`52.
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`Upon information and belief, Janssen Pharmaceuticals, Inc. is a Pennsylvania
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`corporation having a principal place of business at 1125 Trenton-Harbourton Road, Titusville,
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`New Jersey.
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`53.
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`The Court has personal jurisdiction over Counterclaim Defendants because
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`Counterclaim Defendants have availed themselves of the rights and privileges of this forum by
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`suing Sigmapharm in this Judicial District and, upon information and belief, because of
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`7
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`Counterclaim Defendants’ systematic and continuous contacts with this District by virtue of
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`Counterclaim Defendants’ distribution of drugs for sale and use in this judicial district.
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`54.
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`This Court has jurisdiction over the subject matter of these counterclaims
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`pursuant to §§ 1331 and 1338(a) of Title 28 of the United States Code, as they involve claims
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`arising out of the United States Patent Act, 35 U.S.C. § 1, et seq.
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`55.
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`Venue for these Counterclaims is proper in this District in which Counterclaim
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`Defendants’ Complaint is pending.
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`56.
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`As a consequence of Counterclaim Defendants’ Complaint, there is an existing,
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`continuing, actual controversy between Counterclaim Defendants on the one hand and
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`Sigmapharm on the other. Counterclaim Defendants brought such action against Sigmapharm
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`based on its submission of ANDA No. 208546.
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`57.
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`This Court may declare the rights and legal relations for the parties pursuant to 28
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`U.S.C. §§ 2201 and 2202 and 35 U.S.C. § 271(e)(5), because these Counterclaims present an
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`actual controversy within the Court’s jurisdiction.
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`58.
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`The Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., as
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`amended by the Hatch-Waxman Amendments, sets forth the rules that the FDA follows when
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`considering whether to approve both brand-name and generic drugs.
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`59.
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`Under the Hatch-Waxman Amendments, an applicant seeking to market a new
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`brand-name drug must prepare a New Drug Application (“NDA”) for consideration by FDA. See
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`21 U.S.C. § 355. An NDA must include, among other things, the number of any patent that
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`claims the “drug” or a “method of using [the] drug” for which the NDA was submitted and for
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`which a claim of patent infringement could reasonably be asserted against an unauthorized party.
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`See 21 U.S.C. §§ 355(b)(1) and (c)(2); 21 C.F.R. §§ 314.53(b) and (c)(2).
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`8
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 9 of 38 PageID #: 52
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`60.
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`Upon approval of the NDA, the FDA publishes patent information for the
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`approved drug in “Approved Drug Products with Therapeutic Equivalence Evaluations,”
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`commonly known as the “Orange Book.” See 21 U.S.C. § 355(j)(7)(A)(iii).
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`61.
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`Generic drugs are versions of brand-name prescription drugs that typically contain
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`the same active ingredients, but not necessarily the same inactive ingredients as the brand-name
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`original.
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`62.
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`Before 1984, a company that wished to make a generic version of an FDA
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`approved drug had to file an application containing new studies showing the already-approved
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`drug’s safety and effectiveness. Preparing such an application was as time-consuming and costly
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`as the original NDA.
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`63.
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`In 1984, however, Congress enacted the Drug Price Competition and Patent Term
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`Restoration Act, also known as the Hatch-Waxman Amendments. See Pub. L. No. 98-417, 98
`
`Stat. 1585 (1984) (codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156 and 271(e)). Congress
`
`passed the Hatch-Waxman Amendments, which simplified the procedure for obtaining approval
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`of generic drugs, for the purpose of decreasing the cost of pharmaceuticals through increased
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`competition. Under the Hatch-Waxman Amendments, a generic manufacturer submits what is
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`called an Abbreviated New Drug Application (“ANDA”).
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`64.
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`To receive approval of its ANDA, an applicant must show that its generic drug is
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`“bioequivalent” to the listed reference drug. See 21 U.S.C. § 355(j)(4)(F). When filing an
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`ANDA seeking approval of a generic version of a drug listed in the Orange Book, the ANDA
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`applicant must also “certify” that any patent information listed in the Orange Book does not
`
`preclude FDA approval of the ANDA applicant’s generic version of the drug. See 21 U.S.C. §
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`355(j)(2)(A)(vii); 21 C.F.R. § 314.94(a)(12).
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`9
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 10 of 38 PageID #: 53
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`65.
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`A so-called “paragraph IV” certification asserts that the listed patent is invalid,
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`unenforceable, and/or will not be infringed and, on that basis, seeks FDA approval of the generic
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`product prior to patent expiration. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
`
`66.
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`An applicant submitting an ANDA containing a paragraph IV certification must
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`notify both the patent holder and NDA holder of its paragraph IV certification. See 21 U.S.C. §
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`355(j)(2)(B)(i).
`
`67.
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`Upon receiving notice of the paragraph IV certification, the patent holder has 45
`
`days in which to file an infringement suit against the generic manufacturer. See 21 U.S.C. §
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`355(j)(5)(B)(iii); 35 U.S.C. § 271(e)(2)(A).
`
`68.
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`Patent holders have a significant strategic incentive to file suit because doing so,
`
`regardless of merit, prevents the FDA from approving the generic maker’s ANDA for a period of
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`30 months. See 21 U.S.C. § 355(j)(5)(B)(iii).
`
`69.
`
`If the court hearing the infringement action decides the patent is valid,
`
`enforceable, and would be infringed by the product proposed in the ANDA, the FDA will not
`
`approve the ANDA until the patent expires. See 21 U.S.C. § 355(j)(5)(B)(iii). If, however, the
`
`court hearing the infringement action rules before the expiration of the 30-month period that the
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`patent is invalid, unenforceable, and/or not infringed, the FDA may approve the ANDA. Id.
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`70.
`
`On or about January 10, 2017, the USPTO issued the ‘218 patent, entitled
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`“Prevention and Treatment of Thromboembolic Disorders.” Based on the allegations asserted in
`
`the Counterclaim Defendant’s complaint Bayer Intellectual Property GmbH is the assignee of the
`
`‘218 Patent; Bayer AG is an exclusive licensee of the ’218 patent and Janssen is an exclusive
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`sublicensee of the ’218 patent.
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`71.
`
`Upon information and belief, Janssen Pharmaceuticals, Inc. is indicated in the
`
`
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`10
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 11 of 38 PageID #: 54
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`records of the FDA as the holder of New Drug Application No. 022406 for XARELTO
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`rivaroxaban 10 mg, 15 mg and 20 mg tablets, which are sold by Counterclaim Defendants.
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`72.
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`The ‘218 patent is listed in the electronic version of the Orange Book in
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`association with XARELTO.
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`73.
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`Sigmapharm filed an ANDA (No. 208546) with the FDA seeking approval of its
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`generic rivaroxaban 10 mg, 15 mg and 20 mg tablets, prior to the expiration of the ‘218 patent.
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`74.
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`Because Sigmapharm seeks FDA approval of its generic rivaroxaban 10 mg, 15
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`mg and 20 mg tablets before expiration of the ‘218 patent that Counterclaim Defendants listed in
`
`the Orange Book, Sigmapharm’s ANDA includes paragraph IV certifications to these patents.
`
`75.
`
`In accordance with 21 U.S.C. § 355(j)(2)(B), Sigmapharm notified Counterclaim
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`Defendants in writing by the Notice Letter that it had filed ANDA No. 208546 with a
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`certification provided for in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the ‘218 patent is invalid and
`
`thus will not be infringed by the product that is the subject of ANDA No. 208546.
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`76.
`
`In accordance with 21 U.S.C. § 355(j)(2)(B)(iv)(ii), the Notice Letter included a
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`detailed statement of the factual and legal basis for the certification that the ’218 patent will not
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`be infringed by the product that is the subject of ANDA No. 208546, is invalid and is
`
`unenforceable.
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`77.
`
`On May 26, 2017, Counterclaim Defendants sued Sigmapharm alleging
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`infringement of the ‘218 patent.
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`78.
`
`By bringing suit against Sigmapharm, Counterclaim Defendants have taken active
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`steps to block Sigmapharm’s attempt to launch its generic rivaroxaban 10 mg, 15 mg and 20 mg
`
`tablets.
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`79.
`
`The ‘218 patent will not be infringed by the manufacture, use, sale, offer for sale,
`
`
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`11
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 12 of 38 PageID #: 55
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`or importation of Sigmapharm’s proposed generic rivaroxaban 10 mg, 15 mg and 20 mg tablets
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`80.
`
`The ’218 patent is invalid and thus will not be infringed by the manufacture, use,
`
`sale, offer for sale, or importation of Sigmapharm’s proposed generic rivaroxaban 10 mg, 15 mg
`
`and 20 mg tablets.
`
`81.
`
`The ’281 patent is unenforceable due to inequitable conduct and thus will not be
`
`infringed by the manufacture, use, sale, offer for sale, or importation of Sigmapharm’s proposed
`
`generic rivaroxaban 10 mg, 15 mg and 20 mg tablets.
`
`82.
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`Because of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Sigmapharm and Counterclaim Defendants as to liability for
`
`infringement of the ‘218 patent, which is of sufficient immediacy and reality to warrant the
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`issuance of a Declaratory Judgment.
`
`COUNT I
`DECLARATORY JUDGMENT OF
`NON-INFRINGEMENT OF THE ‘218 PATENT
`
`
`
`83.
`
`Sigmapharm hereby realleges as if fully set forth each of the foregoing
`
`paragraphs.
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`84.
`
`Counterclaim Defendants have brought claims against Sigmapharm alleging
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`infringement of the ’218 patent.
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`85.
`
`There is an actual, substantial, and continuing justiciable case or controversy
`
`between Sigmapharm and Counterclaim Defendants having adverse legal interests of sufficient
`
`immediacy and reality to warrant the issuance of declaratory judgment concerning the non-
`
`infringement of the ’218 patent.
`
`86.
`
`The manufacture, use, sale, offer for sale, or importation of the products that are
`
`the subject of Sigmapharm’s ANDA (No. 208546) has not infringed, does not infringe, and
`
`
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`12
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 13 of 38 PageID #: 56
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`would not if manufactured, used, sold, offered for sale, or imported, infringe any valid or
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`enforceable claim of the ’218 patent.
`
`87.
`
`Sigmapharm is entitled to a judicial declaration that the manufacture, use, sale,
`
`offer for sale, or importation of the products that are the subject of Sigmapharm’s ANDA (No.
`
`208546) has not infringed, does not infringe, and would not, if manufactured, used, sold, offered
`
`for sale, or imported, infringe any valid or enforceable claim of the ’218 patent.
`
`COUNT II
`DECLARATORY JUDGMENT OF
`INVALIDITY OF THE ‘218 PATENT
`Sigmapharm hereby realleges as if fully set forth each of the foregoing
`
`88.
`
`paragraphs.
`
`89.
`
`Counterclaim Defendants have brought claims against Sigmapharm alleging
`
`infringement of the ’218 patent.
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`90.
`
`This counterclaim arises under the Patent Laws of the United States, 35 U.S.C. §
`
`100 et seq. and the Declaratory Judgement Act, 28 U.S.C. §§ 2201 and 2202, and seeks a
`
`declaration that claims of the ’218 patent are invalid for failure to comply with the statutory
`
`prerequisites of Title 35 of the United States Code, including without limitation, one or more of
`
`§§ 101, 102, 103, and/or 112, or other
`
`judicially-created bases for
`
`invalidity and
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`unenforceability, such as double patenting.
`
`91.
`
`One or more claims of the ’218 patent are invalid for failure to comply with the
`
`statutory prerequisites of Title 35 of the United States Code, including without limitation, one or
`
`more of §§ 101, 102, 103, and/or 112, or other judicially-created bases for invalidation and
`
`unenforceability, such as double patenting.
`
`92.
`
`A present, genuine, and justiciable controversy exists between Sigmapharm and
`
`
`
`13
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 14 of 38 PageID #: 57
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`Counterclaim Defendants regarding, inter alia, the validity of the claims of the ’218 patent.
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`93.
`
`Sigmapharm is entitled to a declaration that the claims of the ’218 patent are
`
`invalid for failure to comply with the statutory prerequisites of Title 35 United States Code,
`
`including without limitation, one or more of §§ 101, 102, 103, and/or 112, or other judicially-
`
`created bases for invalidation and unenforceability, such as double patenting.
`
`COUNT III
`DECLARATORY JUDGMENT OF
`UNENFORCEABILITY OF THE ‘218 PATENT
`Sigmapharm hereby realleges as if fully set forth each of the foregoing
`
`94.
`
`paragraphs.
`
`95.
`
`The claims of the ’218 patent are unenforceable due to inequitable conduct based
`
`on material omissions made with specific intent to deceive the United States Patent and
`
`Trademark Office (“PTO”).
`
`Background
`
`96.
`
`The ’218 patent issued on January 10, 2017 on U.S. Patent Application No.
`
`11/882,218 (“the ’218 application”) which was
`
`the 371 National Stage Entry of
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`PCT/EP2006/000431 which was filed on June 19, 2006 and received a § 371 (c) date of July 16,
`
`2008. The ’218 application claims foreign priority to European Patent No. EP 05001893, which
`
`was filed on January 31, 2005.
`
`97.
`
`Frank Misselwitz, Dagmar Kubitza (“Inventor Kubitza”), Son-Mi Park and Klaus
`
`Wehling are the named inventors of the ’218 patent (collectively “Named Inventors”).
`
`98.
`
`The ’218 patent is entitled “Prevention and Treatment of Thromboembolic
`
`Disorder.”
`
`99.
`
`Counterclaim Defendants content that the ’218 patent includes claims covering
`
`
`
`14
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`

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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 15 of 38 PageID #: 58
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`
`methods of treating thromboembolic disorders with once daily dosing with rapid release
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`rivaroxaban tablets.
`
`100. The Primary Examiner for the ’218 patent was Sreeni Padmanabhan.
`
`101. William F. Gray (“Gray”) is identified as the attorney of record on the documents
`
`associated with the July 27, 2007 initial filing of the ’218 application. See Exhibit 1, 07/27/2007
`
`Transmittal Letter at 3 and 07/27/2007 Information Disclosure Statement at 1.
`
`102. On information and belief, Gray was employed by Bayer Pharmaceuticals
`
`Corporation, 400 Morgan Lane, West Haven, Connecticut at the time of the filing of the ’218
`
`application. Id. 07/27/2007 Information Disclosure Statement at 1.
`
`103. Christine M. Hansen (“Hansen”) is identified as the prosecution attorney for the
`
`’218 application, and was involved in communicating with the PTO regarding the ’218 patent.
`
`104. On information and belief Hansen was an attorney at Connoly Bove Lodege &
`
`Hutz LLP during the prosecution of the ’218 application. Id. 07/16/2008 Response to
`
`Notification of Missing Requirements at 1.
`
`105. On information and belief Hansen’s work address during the prosecution of the
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`’218 application was 1007 North Orange Street, P.O. Box 2207, Wilmington, Delaware. Id.
`
`106. Pre-AIA 35 U.S.C. § 103 was effective during the prosecution of the ’218 patent
`
`and states:
`
`
`
`
`
`(a) A patent may not be obtained though the invention is not
`identically disclosed or described as set forth in section 102, if the
`differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have
`been obvious at the time the invention was made to a person
`having ordinary skill in the art to which said subject matter
`pertains. Patentability shall not be negatived by the manner in
`which the invention was made.
`
`15
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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 16 of 38 PageID #: 59
`
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`107. Obviousness-type double patenting is a judicially created doctrine that is designed
`
`to prohibit a party from extending the duration of the right to exclude with claims in a later
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`patent that are not patentably distinct from claims in an earlier patent. See, Eli Lilly & Co. v.
`
`Barr Labs., Inc., 251 F.3d 955, 967 (Fed. Cir. 2001).
`
`108. On information and belief, Hansen and Gray were aware of their duty of candor
`
`and good faith in dealing with the PTO imposed by upon them by 37 C.F.R. § 1.56, including the
`
`requirement to disclose to the PTO information known to be material to patentability of the
`
`claims of the ’218 application.
`
`109.
`
`Inventor Kubitza acknowledged his duty of candor and good faith in dealing with
`
`the PTO under C.F.R. § 1.56 in the Declaration which was submitted to the PTO on July 16,
`
`2008, including his duty to disclose to the PTO “information which is material to the
`
`patentability of [the ’218] application.” Id. 07/16/2008 Combined Declaration and Power of
`
`Attorney at 3.
`
`110. On information and belief Gray, Hansen and Kubitza, in breach of their duty of
`
`candor and good faith required by 37 C.R.R. § 1.56 and with specific intent to deceive the
`
`Examiner and/or the Board of Patent Appeals made material omissions and misrepresentations to
`
`the PTO regarding the ’218 patent.
`
`Prosecution of the ’218 Patent and the Material Omissions
`
`111. The ’218 application contained the following 8 claims when it was filed:
`
`1. A method of treating a thromboembolic disorder comprising
`administering a direct factor Xa inhibitor no more than once daily
`for at least five consecutive days in an oral dosage form to a
`patient in need thereof, wherein said inhibitor has a plasma
`concentration half life of 10 hours or less when orally administered
`to a human patient.
`
`
`
`
`
`16
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`

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`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 17 of 38 PageID #: 60
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`2. The method of claim 1, wherein one dosage form is administered.
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`3. The use of an oral dosage form of a direct factor Xa inhibitor for
`the manufacture of a medicament for the treatment of a
`thromboembolic disorder administered once daily for at least five
`consecutive days, wherein said inhibitor has a plasma
`concentration half life of hours or less when orally administered to
`a human patient.
`
`
`4. The method or use as claimed in any of Claims 1 to 3, wherein the
`thromboembolic disorder is ST Segment Elevation Myocardial
`Infarction (STEMI), Non ST Segment Elevation Myocardial
`Infarction (NSTEMI), unstable angina, reocclusion after
`angioplasty or aortocoronary bypass, pulmonary embolisms, deep
`vein thromboses or stroke.
`
`
`5. The method or use as claimed in any of Claims 1 to 4, wherein the
`oral dosage form is a rapid-release tablet.
`
`
`6. The method or use as claimed in any of Claims 1 to 5, wherein the
`direct factor Xa inhibitor is 5-Chloro-N-( { (5S)-2-oxo-3-[4-(3-
`oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl }methyl)-2-
`thiophenecarboxamide.
`
`
`7. A packaged pharmaceutical composition comprising a container
`containing a rapid-release tablet comprising 5-Chloro-N-( { (5S)-2-
`oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-l ,3-oxazolidin-5-yl
`}methyl)-2-thiophenecarboxamide, said container furthermore
`containing instructions for using said rapid-release tablet to treat a
`thromboembolic disorder.
`
`
`8. The packaged pharmaceutical composition of claim 7, comprising
`a container containing a rapid-release tablet comprising 5-Chloro-
`N-( { (5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-l ,3-
`oxazolidin-5-yl} methyl)-2-thiophenecarboxamide, said container
`furthermore containing instructions for administering said rapid-
`release tablet at a frequency of once daily.
`
`
`Id. 07/27/2007 Application at 15.
`
`112. An Information Disclosure Statement (“IDS”) was submitted by Gray on July 27,
`
`2007 that disclosed the following two scientific abstracts authored by Inventor Kubitza:
`
`Kubitza et al. Multiple Dose Escalation Study Investigating the
`Pharmacodynamics, Safety, and Pharmacokinetics of BAY 59-
`
`
`
`17
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`

`

`Case 1:17-cv-00648-RGA Document 11 Filed 06/28/17 Page 18 of 38 PageID #: 61
`
`
`7939 an Oral, Direct Factor Xa Inhibitor in Healthy Male Subjects,
`Blood, Vol. 102:11, 16 Nov. 2003, pg. 811a
`
`
`Kubitza et al., ABSTRACT 3010, Single Dose Escalation Study
`Investigating
`the
`Pharmacodynamics,
`Safety,
`and
`Pharmacokinetics of BAY 59-7939 an Oral, Direct Factor Xa
`Inhibitor in Healthy male Subjects, Blood, Vol. 102:11, 16 Nov.
`2003, pg. 813a, Abstract 3010.
`
`
`
`Id., 07/27/2007 IDS at 2. The Examiner referred to these abstracts as Kubitza et al.1 and Kubitza
`
`et al.2, respectively, during the prosecution of the ’218 application. Id. 03/17/2011 Office Action
`
`at 5-6. This convention will be adopted throughout the remainder of this counterclaim.
`
`113. On information and belief, Inventor Kubitza presented the data summarized in the
`
`Kubitza et al.1 and Kubitza et al.2 at scientific conferences more than one year prior to the
`
`January 31, 2005 foreign priority date claimed by the ’218 patent (“Kubitza Presentations”) and
`
`this information was not included in the July 27, 2007 Information Disclosure Statement in
`
`violation of Inventor Kubitza’s and Gray’s duties under 37 C.F.R. § 1.56.
`
`114. On information and belief, the data disclosed during the Kubitza Presentations
`
`subsequently was published in the journal of Clinical Pharmacology & Therapeutics. See
`
`Exhibit 2, Kubitza et al., Safety, pharmacodynamics, and pharmacokinetics of single doses of
`
`BAY 59-7939, an oral, direct factor Xa inhibitor, Clinical Pharmacology & Therapeutics,
`
`78(4):412-31 (2005) (Kubitza III).
`
`115. On information and belief, the Kubitza Presentations disclosed information that is
`
`consistent with the use of the prior art rapid release rivaroxaban tablets in a once daily