`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`
` BAYER INTELLECTUAL PROPERTY GMBH,
` BAYER PHARMA AG, and
` JANSSEN PHARMACEUTICALS, INC.
`
`
`Plaintiffs,
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`
`
`
`
`
`
`AUROBINDO PHARMA LIMITED., et al.
`
`v.
`
`
`
`
`
`Civ. A. No. 15-902 (SLR)
`(Consolidated)
`
`
`
`
`
` Defendants.
`
`DEFENDANT BRECKENRIDGE PHARMACEUTICAL, INC.’S ANSWER,
`AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS TO
`COMPLAINT FILED IN C.A. NO. 16-628
`
`Defendant Breckenridge Pharmaceutical, Inc. (“Breckenridge” or “Defendant”), by and
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`through its undersigned counsel, hereby responds to the separately numbered paragraphs of the
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`Complaint filed by Plaintiffs Bayer Intellectual Property GmbH, Bayer Pharma AG and Janssen
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`Pharmaceuticals, Inc. (collectively, “Bayer” or “Plaintiffs”) in Civil Action No. 16-628-SLR
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`against Breckenridge, as follows.
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`NATURE OF THE ACTION
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`1. Breckenridge admits that Plaintiffs purport to bring this action under the patent laws
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`of the United States, and in particular for infringement of one or more of U.S. Patent Nos.
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`7,157,456 (“the ’456 patent”) and 7,592,339 (“the ’339 patent”), related to, inter alia,
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`Breckenridge’s Abbreviated New Drug Application seeking approval to engage in the
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`commercial manufacture, use, offer for sale, sale, and/or importation of a generic version of
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`rivaroxaban tablets (“Breckenridge’s ANDA Products”). Breckenridge denies the remaining
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`allegations of paragraph 1.
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`1
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 2 of 20 PageID #: 1366
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`
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`THE PARTIES
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`Plaintiffs
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`2. Breckenridge is without information sufficient to form a belief as to the truth of the
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`averments in paragraph 2 and therefore denies them.
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`3. Breckenridge admits that, upon information and belief, Bayer Pharma AG has a place
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`of business at Müllerstrasse 178, 13353 Berlin, Germany. Breckenridge is without
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`information sufficient to form a belief as to the truth of the remaining averments in paragraph
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`3 and therefore denies them.
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`4. Breckenridge admits that, upon information and belief, Janssen Pharmaceuticals, Inc.
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`has a place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey.
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`Breckenridge is without information sufficient to form a belief as to the truth of the remaining
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`averments in paragraph 4 and therefore denies them.
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`Breckenridge
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`5. Breckenridge admits that it is a corporation organized and existing under the laws of
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`the State of Florida and that it has a principal place of business at 6111 Broken Sound Parkway,
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`NW, Suite 170, Boca Raton, Florida 33487.
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`6. Breckenridge admits that it is engaged in, inter alia, the development and marketing
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`of drug products, and that it has filed Abbreviated New Drug Applications (“ANDAs”) with the
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`Food and Drug Administration (“FDA”) seeking approval to manufacture, use and sell generic
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`versions of drug products, and that in one or more instances such ANDAs have included a
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`certification provided for in 21 U.S.C. § 355(j)(2)(A)(vii)(IV). Except as so admitted,
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`Breckenridge denies the allegations of paragraph 6.
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`2
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 3 of 20 PageID #: 1367
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`7. Admitted.
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`8. The allegations of paragraph 8 appear to be directed to whether the Court has personal
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`jurisdiction over Breckenridge, which is a legal conclusion to which no response is required. To
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`the extent any response is required, solely for purposes of this lawsuit, Breckenridge does not
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`contest personal jurisdiction over it by this Court. To the extent further averments in paragraph 8
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`are not addressed by the foregoing, Breckenridge denies them.
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`9. The allegations of paragraph 9 appear to be directed to whether the Court has personal
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`jurisdiction over Breckenridge, which is a legal conclusion to which no response is required. To
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`the extent any response is required, solely for purposes of this lawsuit, Breckenridge does not
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`contest personal jurisdiction over it by this Court. To the extent further averments in paragraph 9
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`are not addressed by the foregoing, Breckenridge denies them.
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`JURISDICTION
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`10. Breckenridge incorporates its responses to Paragraphs 1 - 9 as if fully set forth herein.
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`11. Admitted.
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`12. Admitted.
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`13. The allegations of paragraph 13 appear to be directed to whether this Court has
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`personal jurisdiction over Breckenridge, which is a legal conclusion to which no response is
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`required. To the extent any response is required, solely for purposes of this lawsuit,
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`Breckenridge does not contest personal jurisdiction over it by this Court. To the extent further
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`averments in paragraph 13 are not addressed by the foregoing, Breckenridge denies them.
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`14. The allegations of paragraph 14 appear to be directed to whether this Court has
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`personal jurisdiction over Breckenridge, which is a legal conclusion to which no response is
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`required. To the extent any response is required, solely for purposes of this lawsuit,
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`
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`3
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`Breckenridge does not contest personal jurisdiction over it by this Court. To the extent further
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`averments in paragraph 14 are not addressed by the foregoing, Breckenridge denies them.
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`15. The allegations of paragraph 15 appear to be directed to whether this Court has
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`personal jurisdiction over Breckenridge, which is a legal conclusion to which no response is
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`required. To the extent any response is required, solely for purposes of this lawsuit,
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`Breckenridge does not contest personal jurisdiction over it by this Court. To the extent further
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`averments in paragraph 15 are not addressed by the foregoing, Breckenridge denies them.
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`VENUE
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`16. The allegations of paragraph 16 appear to be directed to whether venue is proper in
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`this judicial district, which is a legal conclusion to which no response is required. To the extent
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`any response is required, solely for purposes of this lawsuit, Breckenridge does not contest
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`venue. To the extent further averments in paragraph 16 are not addressed by the foregoing,
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`Breckenridge denies them.
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`FACTUAL BACKGROUND
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`17. Breckenridge admits that information publicly available in the records of FDA
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`indicates that New Drug Application (“NDA”) No. 022406 is for rivaroxaban 10 mg, 15 mg, and
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`20 mg tablets; that the rivaroxaban tablets that are the subject of said NDA are (i) indicated to
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`reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation,
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`(ii) for the treatment of deep vein thrombosis (DVT), and of pulmonary embolism (PE), and for
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`the reduction in the risk of recurrence of DVT and of PE; and (iii) for the prophylaxis of DVT,
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`which may lead to PE in patients undergoing knee or hip replacement surgery; and that the trade
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`name for said tablets is XARELTO®. To the extent that the remaining averments in paragraph 17
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`are not addressed, Breckenridge denies them.
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`4
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 5 of 20 PageID #: 1369
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`18. Breckenridge admits that information publicly available in the records of FDA
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`indicates that FDA approved NDA No. 022406 and that the owner of said application is Janssen
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`Pharmaceuticals, Inc. To the extent that the remaining averments in paragraph 18 are not
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`addressed, Breckenridge denies them.
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`The ’456 Patent
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`19. Breckenridge admits that U.S. Patent No. 7,157,456 (“the ’456 patent”) is entitled
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`“Substituted Oxazolidinones and Their Use in the Field of Blood Coagulation,” and that the
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`patent indicates on its face that it was issued on January 2, 2007. Breckenridge admits that what
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`purports to be a copy of the ’456 patent was attached as Exhibit A to the complaint.
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`Breckenridge denies that the ’456 patent was duly and legally issued. To the extent that the
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`remaining averments in paragraph 19 are not addressed, Breckenridge denies them.
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`20. The allegations of paragraph 20 state legal conclusions to which no answer is
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`required. To the extent any answer is required, Breckenridge denies the allegations in paragraph
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`20.
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`21. Breckenridge is without sufficient information to form a belief as to the truth of the
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`averments in paragraph 21; however, Breckenridge admits that a search for patent assignment on
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`the United States Patent and Trademark Office website indicates that the ’456 patent is assigned
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`to Bayer Intellectual Property GmbH; otherwise, denied.
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`22. Breckenridge is without sufficient information to form a belief as to the truth of the
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`averments in paragraph 22 and therefore denies them.
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`23. Breckenridge is without sufficient information to form a belief as to the truth of the
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`averments in paragraph 23 and therefore denies them.
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`5
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 6 of 20 PageID #: 1370
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`24. Breckenridge admits that the ’456 patent is listed in the FDA’s Approved Drug
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`Products with Therapeutic Equivalence Evaluations (the “Orange Book”) in connection with
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`XARELTO®. Breckenridge is without sufficient information to form a belief as to the truth of
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`the remaining averments in paragraph 24 and therefore denies them.
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`The ’339 Patent
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`25. Breckenridge admits that U.S. Patent No. 7,592,339 (“the ’339 patent”) is entitled
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`“Substituted Oxazolidinones and Their Use in the Field of Blood Coagulation,” and that the
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`patent indicates on its face that it was issued on September 22, 2009. Breckenridge admits that
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`what purports to be a copy of the ’339 patent was attached as Exhibit B to the complaint.
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`Breckenridge denies that the ’339 patent was duly and legally issued. To the extent that the
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`remaining averments in paragraph 25 are not addressed, Breckenridge denies them.
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`26. The allegations of paragraph 26 state legal conclusions to which no answer is
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`required. To the extent any answer is required, Breckenridge denies the allegations in paragraph
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`26.
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`27. Breckenridge is without sufficient information to form a belief as to the truth of the
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`averments in paragraph 27; however, Breckenridge admits that a search for patent assignment on
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`the United States Patent and Trademark Office website indicates that the ’339 patent is assigned
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`to Bayer Intellectual Property GmbH; otherwise, denied.
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`28. Breckenridge is without sufficient information to form a belief as to the truth of the
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`averments in paragraph 28 and therefore denies them.
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`29. Breckenridge is without sufficient information to form a belief as to the truth of the
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`averments in paragraph 29 and therefore denies them.
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`6
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 7 of 20 PageID #: 1371
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`30. Breckenridge admits that the ’339 patent is listed in the FDA’s Approved Drug
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`Products with Therapeutic Equivalence Evaluations (the “Orange Book”) in connection with
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`XARELTO®. Breckenridge is without sufficient information to form a belief as to the truth of the
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`remaining averments in paragraph 30 and therefore denies them.
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`Infringement by Breckenridge
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`31. Breckenridge admits that in a letter dated June 27, 2016, Breckenridge provided
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`notice that it had filed ANDA No. 208220 for Breckenridge’s ANDA Products, which are
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`generic versions of XARELTO®. To the extent further averments in paragraph 31 are not
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`addressed by the foregoing, Breckenridge denies them.
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`32. Admitted.
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`33. Breckenridge admits that Breckenridge’s ANDA includes the FDA-required labeling
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`for Breckenridge’s proposed ANDA Product. That labeling speaks for itself. To the extent
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`further averments in paragraph 33 are not addressed by the foregoing, Breckenridge denies them.
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`34. Breckenridge denies the allegations of paragraph 34.
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`35. Breckenridge admits that, in accordance with 21 U.S.C. § 355(j)(2)(B), the
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`Breckenridge Notice Letter indicated that Breckenridge had filed ANDA No. 208220 with a
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`certification provided for in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the ’456 and ’339
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`patents. To the extent further averments in paragraph 35 are not addressed by the foregoing,
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`Breckenridge denies them.
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`36. Breckenridge admits that ANDA No. 208220 seeks FDA approval of its ANDA
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`product. Breckenridge is without sufficient information to form a belief as to the truth of the
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`remaining averments in paragraph 36 and therefore denies them.
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`37. Denied.
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`7
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 8 of 20 PageID #: 1372
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`38. Breckenridge admits that it has knowledge of the claims of the ’456 and ’339 patents.
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`To the extent further averments in paragraph 38 are not addressed by the foregoing,
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`Breckenridge denies them.
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`39. Denied.
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`40. Denied.
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`41. Denied.
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`42. Admitted.
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`43. On information and belief, Breckenridge admits the allegations of paragraph 43.
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`COUNT I
`(Infringement of the ’456 Patent)
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`44. Breckenridge incorporates its responses to paragraphs 1-43 as if fully set forth herein.
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`45. The allegations of paragraph 45 appear to be directed to whether it is a technical act
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`of infringement under 35 U.S.C. § 271(e)(2)(A) to submit “an application under Section 505(j)
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`of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a
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`drug claimed in a patent or the use of which is claimed in a patent,” which is a legal conclusion
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`to which no response is required. Breckenridge denies any allegations of substantive
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`infringement of the ’456 patent. To the extent further averments in paragraph 45 are not
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`addressed by the foregoing, Breckenridge denies them.
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`46. Denied.
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`47. Denied.
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`48. Denied.
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`49. Denied.
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`8
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 9 of 20 PageID #: 1373
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`COUNT II
`(Infringement of the ’339 Patent)
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`50. Breckenridge incorporates its responses to paragraphs 1-49 as if fully set forth herein.
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`51. The allegations of paragraph 51 appear to be directed to whether it is a technical act
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`of infringement under 35 U.S.C. § 271(e)(2)(A) to submit “an application under Section 505(j)
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`of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a
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`drug claimed in a patent or the use of which is claimed in a patent,” which is a legal conclusion
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`to which no response is required. Breckenridge denies any allegations of substantive
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`infringement of the ’339 patent. To the extent further averments in paragraph 51 are not
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`addressed by the foregoing, Breckenridge denies them.
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`52. Denied.
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`53. Denied.
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`54. Denied.
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`55. Denied.
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`RESPONSE TO PRAYER FOR RELIEF
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`Breckenridge denies that Plaintiffs are entitled to any of the relief requested by the
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`Complaint, or any other relief whatsoever.
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`AFFIRMATIVE DEFENSES
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`Breckenridge asserts the following defenses without prejudice to the denials in this
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`Answer and without admitting any allegations of the Complaint not otherwise admitted.
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`Breckenridge does not assume the burden of proof on any such defenses, except as required by
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`the applicable law with respect to the particular defense asserted. Breckenridge reserves the right
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`to assert other defenses and/or to otherwise supplement or amend its Answer and Affirmative
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`9
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 10 of 20 PageID #: 1374
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`Defenses to the Complaint upon discovery of facts or evidence rendering such action
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`appropriate.
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`FIRST DEFENSE
`(Non-Infringement of the ’456 Patent)
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`Plaintiffs have failed to aver any facts that support their allegations of infringement by
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`the proposed Breckenridge ANDA products. The proposed Breckenridge ANDA Products,
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`which may be marketed if and when the ANDA obtains approval, would not directly or
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`indirectly infringe any valid claim of the ’456 patent, either literally or under the doctrine of
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`equivalents.
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`SECOND DEFENSE
`(Invalidity of the ’456 Patent Based on Title 35 of the U.S. Code)
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`One or more claims of the ’456 patent are invalid to a person having ordinary skill in the
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`art, and for otherwise failing to comply with one or more of the requirements for patentability set
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`forth in Title 35 of the U.S. Code, including §§ 102, 103 and/or 112.
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`THIRD DEFENSE
`(Non-Infringement of the ’339 Patent)
`
`Plaintiffs have failed to aver any facts that support their allegations of infringement by
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`the proposed Breckenridge ANDA products. The proposed Breckenridge ANDA Products,
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`which may be marketed if and when the ANDA obtains approval, would not directly or
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`indirectly infringe any valid claim of the ’339 patent, either literally or under the doctrine of
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`equivalents.
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`10
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 11 of 20 PageID #: 1375
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`FOURTH DEFENSE
`(Invalidity of the ’339 Patent Based on Title 35 of the U.S. Code)
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`One or more claims of the ’339 patent are invalid to a person having ordinary skill in the
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`art, and for otherwise failing to comply with one or more of the requirements for patentability set
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`forth in Title 35 of the U.S. Code, including §§ 102, 103 and/or 112.
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`FIFTH DEFENSE
`(Additional Defenses or Counterclaims)
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`Breckenridge reserves all defenses available under the Federal Rules of Civil Procedure
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`and the U.S. Patent laws and any additional defenses or counterclaims that discovery may reveal
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`including that Plaintiffs have failed to aver any facts supporting the conclusion that they have
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`suffered any irreparable injury or harm under 35 U.S.C. § 283, and that Plaintiffs have failed to
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`aver any facts supporting that this is an exceptional case and an award of attorney’s fees under
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`35 U.S.C. § 285.
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`COUNTERCLAIMS
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`For its counterclaims against Counterclaim-Defendants Bayer Intellectual Property
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`GmbH, Bayer Pharma AG and Janssen Pharmaceuticals, Inc. (collectively “Counterclaim
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`Defendants”), Counterclaim-Plaintiff Breckenridge Pharmaceutical, Inc. (“Breckenridge” or
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`“Counterclaim Plaintiff”), states as follows:
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`THE PARTIES
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`
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`Counterclaim-Plaintiff Breckenridge Pharmaceutical, Inc. (“Breckenridge”) is a
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`corporation organized and existing under the laws of Florida with a principal place of business at
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`6111 Broken Sound Parkway, NW, Suite 170, Boca Raton, Florida 33487.
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`2.
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`Counterclaim-Defendant Bayer Intellectual Property GmbH (“BIP”) 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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`11
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 12 of 20 PageID #: 1376
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`place of business at Alfred-Nobel-Strasse 10, 40789 Monheim am Rhein, Germany.
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`3.
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`Counterclaim-Defendant Bayer Pharma AG (“BPA”) is a corporation organized
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`and existing under the laws of the Federal Republic of Germany, with a place of business at
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`Müllerstrasse 178, 13353 Berlin, Germany.
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`4.
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`Counterclaim-Defendant Janssen Pharmaceuticals,
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`Inc.
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`(“Janssen”)
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`is a
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`corporation organized and existing under the laws of the Commonwealth of Pennsylvania, with
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`a place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey.
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`JURISDICTION AND VENUE
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`5.
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`These counterclaims arise under the Patent Laws of the United States, 35 U.S.C.
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`§§ 1 et seq. and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
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`6.
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`This Court has original jurisdiction over the subject matter of these counterclaims
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`pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`7.
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`This 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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`bringing this civil action in this judicial district and because, upon information and belief,
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`Counterclaim-Defendants conduct substantial business in, and have regular and systematic
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`contact with, this judicial district.
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`8.
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`Venue for these counterclaims is proper in this judicial district pursuant to 28
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`U.S.C. §§ 1391(b) and (c) and 1400(b).
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`PATENTS-IN-SUIT
`
`9.
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`Janssen has alleged that it holds New Drug Application (“NDA”) No. 022406, by
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`which the United States Food and Drug Administration (“FDA”) granted approval for the
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`12
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 13 of 20 PageID #: 1377
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`manufacture and sale of rivaroxaban tablets, 10mg, 15mg and 20mg, which it sells in the United
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`States under the registered trademark XARELTO®.
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`10.
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`Upon information and belief, BIP has listed U.S. Patent No. 7,157,456 (“the ’456
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`patent”) and U.S. Patent No. 7,592,339 (“the ’339 patent”) in the FDA’s publication, Approved
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`Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”) as covering the
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`XARELTO® drug product, the compound rivaroxaban, pharmaceutical compositions containing
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`rivaroxaban, processes for preparing it and methods for using it.
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`THE ’456 PATENT
`
`
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`On or about January 2, 2007, the United States Patent and Trademark Office
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`(“PTO”) issued the ’456 patent, entitled “Substituted Oxazolidinones and Their Use in the Field
`
`of Blood Coagulation.”
`
`
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`The ’456 patent indicates on its face that it is assigned to Bayer Healthcare AG. A
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`search for patent assignments on the United States Patent and Trademark Office website
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`indicates the most recent assignment was to BIP, recorded on August 1, 2012. On information
`
`and belief, BPA is an exclusive licensee under the ’456 patent and Janssen is an exclusive
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`sublicensee under the ’456 patent.
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`
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`Breckenridge submitted Abbreviated New Drug Application (“ANDA”) No.
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`208220 to the FDA, under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
`
`§ 355(j)), seeking approval to market 10 mg, 15 mg, and 20 mg rivaroxaban tablets, oral (the
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`“ANDA Products”). That ANDA contains a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`indicating that the ’456 patent is invalid, unenforceable, and/or will not be infringed by the
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`manufacture, use, importation, sale or offer for sale of Breckenridge’s ANDA Products.
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`
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`13
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 14 of 20 PageID #: 1378
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`
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`By letter dated June 27, 2016, Breckenridge provided notice with respect to its
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`proposed ANDA Products and the ’456 patent under 21 U.S.C. § 355(j)(2)(B)(ii).
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`
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`Breckenridge made an Offer of Confidential Access to its ANDA No. 208220
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`pursuant to 21 U.S.C. § 355(j)(5)(C)(i)(III), in its June 27, 2016 Notice Letter.
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`
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`On July 25, 2016, Counterclaim-Defendants initiated civil action, C.A. No. 1:16-
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`cv-00628, against Counterclaim-Plaintiff in this judicial district alleging infringement of the ’456
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`patent.
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`
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`Counterclaim-Plaintiff seeks a declaratory judgment that the ’456 patent is not
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`infringed and/or is invalid.
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`THE ’339 PATENT
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`
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`On or about September 22, 2009, the United States Patent and Trademark Office
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`(“PTO”) issued the ’339 patent, entitled “Substituted Oxazolidinones and Their Use in the Field
`
`of Blood Coagulation.”
`
`
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`The ’339 patent indicates on its face that it is assigned to Bayer Schering Pharma.
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`A search for patent assignments on the United States Patent and Trademark Office website
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`indicates the most recent assignment was to BIP, recorded on August 1, 2012. On information
`
`and belief, BPA is an exclusive licensee under the ’339 patent and Janssen is an exclusive
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`sublicensee under the ’339 patent.
`
`
`
`Breckenridge submitted Abbreviated New Drug Application (“ANDA”) No.
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`208220 to the FDA, under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
`
`§ 355(j)), seeking approval to market 10 mg, 15 mg, and 20 mg rivaroxaban tablets, oral. That
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`ANDA contains a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) indicating that the ’339
`
`
`
`14
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 15 of 20 PageID #: 1379
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`patent is invalid, unenforceable, and/or will not be infringed by the manufacture, use,
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`importation, sale or offer for sale of Breckenridge’s ANDA Products.
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`
`
`By letter dated June 27, 2016, Breckenridge provided notice with respect to its
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`proposed ANDA Products and the ’339 patent under 21 U.S.C. § 355(j)(2)(B)(ii).
`
`
`
`Breckenridge made an Offer of Confidential Access to its ANDA No. 208220
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`pursuant to 21 U.S.C. § 355(j)(5)(C)(i)(III), in its June 27, 2016 Notice Letter.
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`
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`On July 25, 2016, Counterclaim-Defendants initiated civil action, C.A. No. 1:16-
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`cv-00628, against Counterclaim-Plaintiff in this judicial district alleging infringement of the ’339
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`patent.
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`
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`Counterclaim-Plaintiff seeks a declaratory judgment that the ’339 patent is not
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`infringed and/or is invalid.
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`COUNT I
`(Declaratory Judgment of Non-Infringement of the ’456 Patent)
`
`
`
`Counterclaim-Plaintiff restates and re-alleges each of the foregoing paragraphs 1-
`
`24 of the counterclaims as if fully set forth herein.
`
`
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`Counterclaim-Defendants have alleged that Breckenridge’s filing of ANDA No.
`
`208220 infringes the ’456 patent.
`
`
`
`As evidenced by Counterclaim-Defendants’ Complaint and Counterclaim-
`
`Plaintiff’s Answer in this action, there is an actual, substantial, and continuing justiciable case or
`
`controversy between Counterclaim-Plaintiff and Counterclaim-Defendants regarding
`
`the
`
`infringement of the ’456 patent under 21 U.S.C. § 355(j)(5)(C)(ii).
`
`
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`The manufacture, use, sale, offer for sale, and/or importation by Breckenridge of
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`its proposed product pursuant to ANDA No. 208220 will not infringe, directly or indirectly, any
`
`valid claim of the ’456 patent under any provision of 35 U.S.C. § 271.
`
`
`
`15
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`
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 16 of 20 PageID #: 1380
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`
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`The proposed ANDA Products, which may be marketed upon approval of ANDA
`
`No. 208220, would not infringe any valid claim of the ’456 patent, either literally or under the
`
`doctrine of equivalents.
`
`
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`Counterclaim-Plaintiff is entitled to a judicial determination that the proposed
`
`product which is the subject of ANDA No. 208220 has not infringed, does not infringe, and
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`would not, if marketed, infringe any valid claim of the ’456 patent.
`
`COUNT II
`(Declaratory Judgment of Invalidity of the ’456 Patent)
`
`
`
`Counterclaim-Plaintiff restates and re-alleges each of the foregoing paragraphs 1-
`
`30 of the counterclaims as if fully set forth herein.
`
`
`
`As evidenced by Counterclaim-Defendants’ Complaint and Counterclaim-
`
`Plaintiff’s Answer in this action, there is an actual, substantial, and continuing justiciable case or
`
`controversy between Counterclaim-Plaintiff and Counterclaim-Defendants regarding the validity
`
`of the claims of the ’456 patent under 21 U.S.C. § 355(j)(5)(C)(ii).
`
`
`
`Based at least upon the facts and the reasons set forth in the detailed statement
`
`accompanying the letter June 27, 2016, the claims of the ’456 patent are invalid for failure to
`
`comply with one or more of the requirements for patentability set forth in Title 35 of the U.S.
`
`Code, including §§ 102, 103, and/or 112.
`
`
`
`Counterclaim-Plaintiff is entitled to a judicial determination that the claims of the
`
`’456 patent are invalid for failure to comply with one or more of the requirements for
`
`patentability set forth in Title 35 of the U.S. Code, including §§ 102, 103 and/or 112.
`
`
`
`16
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`
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 17 of 20 PageID #: 1381
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`COUNT III
`(Declaratory Judgment of Non-Infringement of the ’339 Patent)
`
`
`
`Counterclaim-Plaintiff restates and re-alleges each of the foregoing paragraphs 1-
`
`34 of the counterclaims as if fully set forth herein.
`
`
`
`Counterclaim-Defendants have alleged that Breckenridge’s filing of ANDA No.
`
`208220 infringes the ’339 patent.
`
`
`
`As evidenced by Counterclaim-Defendants’ Complaint and Counterclaim-
`
`Plaintiff’s Answer in this action, there is an actual, substantial, and continuing justiciable case or
`
`controversy between Counterclaim-Plaintiff and Counterclaim-Defendants regarding
`
`the
`
`infringement of the ’339 patent under 21 U.S.C. § 355(j)(5)(C)(ii).
`
`
`
`The manufacture, use, sale, offer for sale, and/or importation by Breckenridge of
`
`its proposed product pursuant to ANDA No. 208220 will not infringe, directly or indirectly, any
`
`valid claim of the ’339 patent under any provision of 35 U.S.C. § 271.
`
`
`
`The proposed ANDA Products, which may be marketed upon approval of ANDA
`
`No. 208220, would not infringe any valid claim of the ’339 patent, either literally or under the
`
`doctrine of equivalents.
`
`
`
`Counterclaim-Plaintiff is entitled to a judicial determination that the proposed
`
`product which is the subject of ANDA No. 208220 has not infringed, does not infringe, and
`
`would not, if marketed, infringe any valid claim of the ’339 patent.
`
`COUNT IV
`(Declaratory Judgment of Invalidity of the ’339 Patent)
`
`
`
`Counterclaim-Plaintiff restates and re-alleges each of the foregoing paragraphs 1-
`
`40 of the counterclaims as if fully set forth herein.
`
`
`
`17
`
`
`
`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 18 of 20 PageID #: 1382
`
`
`
`As evidenced by Counterclaim-Defendants’ Complaint and Counterclaim-
`
`Plaintiff’s Answer in this action, there is an actual, substantial, and continuing justiciable case or
`
`controversy between Counterclaim-Plaintiff and Counterclaim-Defendants regarding the validity
`
`of the claims of the ’339 patent under 21 U.S.C. § 355(j)(5)(C)(ii).
`
`
`
`Based at least upon the facts and the reasons set forth in the detailed statement
`
`accompanying the letter dated June 27, 2016, the claims of the ’339 patent are invalid for failure
`
`to comply with one or more of the requirements for patentability set forth in Title 35 of the U.S.
`
`Code, including §§ 102, 103, and/or 112.
`
`
`
`Counterclaim-Plaintiff is entitled to a judicial determination that the claims of the
`
`’339 patent are invalid for failure to comply with one or more of the requirements for
`
`patentability set forth in Title 35 of the U.S. Code, including §§ 102, 103, and/or 112.
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`PRAYER FOR RELIEF
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`WHEREFORE, Counterclaim-Plaintiff respectfully requests that this Court enter a
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`judgment in its favor and against Counterclaim-Defendants as follows:
`
`(a)
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`Dismissing
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`the Complaint with prejudice and entering
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`judgment
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`for
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`Counterclaim-Plaintiff;
`
`(b)
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`Declaring that no valid claim of the ’456 patent or ’339 patent would be infringed
`
`by the manufacture, use, sale, offer for sale, and/or importation of Breckenridge’s proposed
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`product pursuant to ANDA No. 208220;
`
`(c)
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`(d)
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`Declaring that the claims of the ’456 patent and ’339 patent are invalid;
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`Enjoining Counterclaim-Defendants, their officers, agents, servants, employees,
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`attorneys and any person who acts in concert or participation with Counterclaim-Defendants
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`from threatening to assert or otherwise attempting to enforce the ’456 patent and ’339 patent
`
`
`
`18
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`
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 19 of 20 PageID #: 1383
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`against Counterclaim-Plaintiff, its customers, suppliers, or anyone in privity with Counterclaim-
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`Plaintiff;
`
`(e)
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`Declaring that this case is exceptional pursuant to 35 U.S.C. § 285 and awarding
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`Counterclaim-Plaintiff its reasonable attorneys’ fees and costs incurred in this action;
`
`(f)
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`Awarding Counterclaim-Plaintiff its costs and expenses incurred in this action;
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`and
`
`(g)
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`Awarding Counterclaim-Plaintiff such other and further relief as this Court may
`
`deem proper.
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`
`
`19
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`
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`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 20 of 20 PageID #: 1384
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`PHILLIPS, GOLDMAN, MCLAUGHLIN &
`HALL, P.A.
`
`
`
`/s/ John C. Phillips, Jr.
`John C. Phillips, Jr. (#110)
`Megan C. Haney (#5016)
`1200 North Broom Street
`Wilmington, DE 19806
`(302) 655-4200
`jcp@pgmhlaw.com
`mch@pgmhlaw.com
`
`Bruce D. DeRenzi
`Robert F. Vroom
`Breckenridge Pharmaceutical, Inc.
`60 East 42nd Street
`
`Suite 5210 New York, NY 10165
`(646) 448-1308
`(646) 448-1309
`
`B. Jefferson Boggs
`Matthew L. Fedowitz
`MERCHANT & GOULD PC
`1701 Duke Street, Suite 310
`Alexandria, VA 22314
`(703) 684-2500
`
`Christopher J. Sorenson
`MERCHANT & GOULD PC
`3200 IDS Center
`80 S. Eighth Street
`Minneapolis, MN 55402
`(612) 332-5300
`
`Attorneys for Defendant Breckenridge
`Pharmaceutical, Inc.
`
`20
`
`Dated: September 26, 2016
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`