throbber
Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 1 of 20 PageID #: 1365
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
` BAYER INTELLECTUAL PROPERTY GMBH,
` BAYER PHARMA AG, and
` JANSSEN PHARMACEUTICALS, INC.
`
`
`Plaintiffs,
`
`
`
`
`
`
`
`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
`
`through its undersigned counsel, hereby responds to the separately numbered paragraphs of the
`
`Complaint filed by Plaintiffs Bayer Intellectual Property GmbH, Bayer Pharma AG and Janssen
`
`Pharmaceuticals, Inc. (collectively, “Bayer” or “Plaintiffs”) in Civil Action No. 16-628-SLR
`
`against Breckenridge, as follows.
`
`NATURE OF THE ACTION
`
`1. Breckenridge admits that Plaintiffs purport to bring this action under the patent laws
`
`of the United States, and in particular for infringement of one or more of U.S. Patent Nos.
`
`7,157,456 (“the ’456 patent”) and 7,592,339 (“the ’339 patent”), related to, inter alia,
`
`Breckenridge’s Abbreviated New Drug Application seeking approval to engage in the
`
`commercial manufacture, use, offer for sale, sale, and/or importation of a generic version of
`
`rivaroxaban tablets (“Breckenridge’s ANDA Products”). Breckenridge denies the remaining
`
`allegations of paragraph 1.
`
`
`
`1
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 2 of 20 PageID #: 1366
`
`
`
`THE PARTIES
`
`Plaintiffs
`
`2. Breckenridge is without information sufficient to form a belief as to the truth of the
`
`averments in paragraph 2 and therefore denies them.
`
`3. Breckenridge admits that, upon information and belief, Bayer Pharma AG has a place
`
`of business at Müllerstrasse 178, 13353 Berlin, Germany. Breckenridge is without
`
`information sufficient to form a belief as to the truth of the remaining averments in paragraph
`
`3 and therefore denies them.
`
`4. Breckenridge admits that, upon information and belief, Janssen Pharmaceuticals, Inc.
`
`has a place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey.
`
`Breckenridge is without information sufficient to form a belief as to the truth of the remaining
`
`averments in paragraph 4 and therefore denies them.
`
`Breckenridge
`
`5. Breckenridge admits that it is a corporation organized and existing under the laws of
`
`the State of Florida and that it has a principal place of business at 6111 Broken Sound Parkway,
`
`NW, Suite 170, Boca Raton, Florida 33487.
`
`6. Breckenridge admits that it is engaged in, inter alia, the development and marketing
`
`of drug products, and that it has filed Abbreviated New Drug Applications (“ANDAs”) with the
`
`Food and Drug Administration (“FDA”) seeking approval to manufacture, use and sell generic
`
`versions of drug products, and that in one or more instances such ANDAs have included a
`
`certification provided for in 21 U.S.C. § 355(j)(2)(A)(vii)(IV). Except as so admitted,
`
`Breckenridge denies the allegations of paragraph 6.
`
`
`
`2
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 3 of 20 PageID #: 1367
`
`7. Admitted.
`
`8. The allegations of paragraph 8 appear to be directed to whether the Court has personal
`
`jurisdiction over Breckenridge, which is a legal conclusion to which no response is required. To
`
`the extent any response is required, solely for purposes of this lawsuit, Breckenridge does not
`
`contest personal jurisdiction over it by this Court. To the extent further averments in paragraph 8
`
`are not addressed by the foregoing, Breckenridge denies them.
`
`9. The allegations of paragraph 9 appear to be directed to whether the Court has personal
`
`jurisdiction over Breckenridge, which is a legal conclusion to which no response is required. To
`
`the extent any response is required, solely for purposes of this lawsuit, Breckenridge does not
`
`contest personal jurisdiction over it by this Court. To the extent further averments in paragraph 9
`
`are not addressed by the foregoing, Breckenridge denies them.
`
`JURISDICTION
`
`10. Breckenridge incorporates its responses to Paragraphs 1 - 9 as if fully set forth herein.
`
`11. Admitted.
`
`12. Admitted.
`
`13. The allegations of paragraph 13 appear to be directed to whether this Court has
`
`personal jurisdiction over Breckenridge, which is a legal conclusion to which no response is
`
`required. To the extent any response is required, solely for purposes of this lawsuit,
`
`Breckenridge does not contest personal jurisdiction over it by this Court. To the extent further
`
`averments in paragraph 13 are not addressed by the foregoing, Breckenridge denies them.
`
`14. The allegations of paragraph 14 appear to be directed to whether this Court has
`
`personal jurisdiction over Breckenridge, which is a legal conclusion to which no response is
`
`required. To the extent any response is required, solely for purposes of this lawsuit,
`
`
`
`3
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 4 of 20 PageID #: 1368
`
`Breckenridge does not contest personal jurisdiction over it by this Court. To the extent further
`
`averments in paragraph 14 are not addressed by the foregoing, Breckenridge denies them.
`
`15. The allegations of paragraph 15 appear to be directed to whether this Court has
`
`personal jurisdiction over Breckenridge, which is a legal conclusion to which no response is
`
`required. To the extent any response is required, solely for purposes of this lawsuit,
`
`Breckenridge does not contest personal jurisdiction over it by this Court. To the extent further
`
`averments in paragraph 15 are not addressed by the foregoing, Breckenridge denies them.
`
`VENUE
`
`16. The allegations of paragraph 16 appear to be directed to whether venue is proper in
`
`this judicial district, which is a legal conclusion to which no response is required. To the extent
`
`any response is required, solely for purposes of this lawsuit, Breckenridge does not contest
`
`venue. To the extent further averments in paragraph 16 are not addressed by the foregoing,
`
`Breckenridge denies them.
`
`FACTUAL BACKGROUND
`
`17. Breckenridge admits that information publicly available in the records of FDA
`
`indicates that New Drug Application (“NDA”) No. 022406 is for rivaroxaban 10 mg, 15 mg, and
`
`20 mg tablets; that the rivaroxaban tablets that are the subject of said NDA are (i) indicated to
`
`reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation,
`
`(ii) for the treatment of deep vein thrombosis (DVT), and of pulmonary embolism (PE), and for
`
`the reduction in the risk of recurrence of DVT and of PE; and (iii) for the prophylaxis of DVT,
`
`which may lead to PE in patients undergoing knee or hip replacement surgery; and that the trade
`
`name for said tablets is XARELTO®. To the extent that the remaining averments in paragraph 17
`
`are not addressed, Breckenridge denies them.
`
`
`
`4
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 5 of 20 PageID #: 1369
`
`18. Breckenridge admits that information publicly available in the records of FDA
`
`indicates that FDA approved NDA No. 022406 and that the owner of said application is Janssen
`
`Pharmaceuticals, Inc. To the extent that the remaining averments in paragraph 18 are not
`
`addressed, Breckenridge denies them.
`
`The ’456 Patent
`
`19. Breckenridge admits that U.S. Patent No. 7,157,456 (“the ’456 patent”) is entitled
`
`“Substituted Oxazolidinones and Their Use in the Field of Blood Coagulation,” and that the
`
`patent indicates on its face that it was issued on January 2, 2007. Breckenridge admits that what
`
`purports to be a copy of the ’456 patent was attached as Exhibit A to the complaint.
`
`Breckenridge denies that the ’456 patent was duly and legally issued. To the extent that the
`
`remaining averments in paragraph 19 are not addressed, Breckenridge denies them.
`
`20. The allegations of paragraph 20 state legal conclusions to which no answer is
`
`required. To the extent any answer is required, Breckenridge denies the allegations in paragraph
`
`20.
`
`21. Breckenridge is without sufficient information to form a belief as to the truth of the
`
`averments in paragraph 21; however, Breckenridge admits that a search for patent assignment on
`
`the United States Patent and Trademark Office website indicates that the ’456 patent is assigned
`
`to Bayer Intellectual Property GmbH; otherwise, denied.
`
`22. Breckenridge is without sufficient information to form a belief as to the truth of the
`
`averments in paragraph 22 and therefore denies them.
`
`23. Breckenridge is without sufficient information to form a belief as to the truth of the
`
`averments in paragraph 23 and therefore denies them.
`
`
`
`5
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 6 of 20 PageID #: 1370
`
`24. Breckenridge admits that the ’456 patent is listed in the FDA’s Approved Drug
`
`Products with Therapeutic Equivalence Evaluations (the “Orange Book”) in connection with
`
`XARELTO®. Breckenridge is without sufficient information to form a belief as to the truth of
`
`the remaining averments in paragraph 24 and therefore denies them.
`
`The ’339 Patent
`
`25. Breckenridge admits that U.S. Patent No. 7,592,339 (“the ’339 patent”) is entitled
`
`“Substituted Oxazolidinones and Their Use in the Field of Blood Coagulation,” and that the
`
`patent indicates on its face that it was issued on September 22, 2009. Breckenridge admits that
`
`what purports to be a copy of the ’339 patent was attached as Exhibit B to the complaint.
`
`Breckenridge denies that the ’339 patent was duly and legally issued. To the extent that the
`
`remaining averments in paragraph 25 are not addressed, Breckenridge denies them.
`
`26. The allegations of paragraph 26 state legal conclusions to which no answer is
`
`required. To the extent any answer is required, Breckenridge denies the allegations in paragraph
`
`26.
`
`27. Breckenridge is without sufficient information to form a belief as to the truth of the
`
`averments in paragraph 27; however, Breckenridge admits that a search for patent assignment on
`
`the United States Patent and Trademark Office website indicates that the ’339 patent is assigned
`
`to Bayer Intellectual Property GmbH; otherwise, denied.
`
`28. Breckenridge is without sufficient information to form a belief as to the truth of the
`
`averments in paragraph 28 and therefore denies them.
`
`29. Breckenridge is without sufficient information to form a belief as to the truth of the
`
`averments in paragraph 29 and therefore denies them.
`
`
`
`6
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 7 of 20 PageID #: 1371
`
`30. Breckenridge admits that the ’339 patent is listed in the FDA’s Approved Drug
`
`Products with Therapeutic Equivalence Evaluations (the “Orange Book”) in connection with
`
`XARELTO®. Breckenridge is without sufficient information to form a belief as to the truth of the
`
`remaining averments in paragraph 30 and therefore denies them.
`
`Infringement by Breckenridge
`
`31. Breckenridge admits that in a letter dated June 27, 2016, Breckenridge provided
`
`notice that it had filed ANDA No. 208220 for Breckenridge’s ANDA Products, which are
`
`generic versions of XARELTO®. To the extent further averments in paragraph 31 are not
`
`addressed by the foregoing, Breckenridge denies them.
`
`32. Admitted.
`
`33. Breckenridge admits that Breckenridge’s ANDA includes the FDA-required labeling
`
`for Breckenridge’s proposed ANDA Product. That labeling speaks for itself. To the extent
`
`further averments in paragraph 33 are not addressed by the foregoing, Breckenridge denies them.
`
`34. Breckenridge denies the allegations of paragraph 34.
`
`35. Breckenridge admits that, in accordance with 21 U.S.C. § 355(j)(2)(B), the
`
`Breckenridge Notice Letter indicated that Breckenridge had filed ANDA No. 208220 with a
`
`certification provided for in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the ’456 and ’339
`
`patents. To the extent further averments in paragraph 35 are not addressed by the foregoing,
`
`Breckenridge denies them.
`
`36. Breckenridge admits that ANDA No. 208220 seeks FDA approval of its ANDA
`
`product. Breckenridge is without sufficient information to form a belief as to the truth of the
`
`remaining averments in paragraph 36 and therefore denies them.
`
`37. Denied.
`
`
`
`7
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 8 of 20 PageID #: 1372
`
`38. Breckenridge admits that it has knowledge of the claims of the ’456 and ’339 patents.
`
`To the extent further averments in paragraph 38 are not addressed by the foregoing,
`
`Breckenridge denies them.
`
`39. Denied.
`
`40. Denied.
`
`41. Denied.
`
`42. Admitted.
`
`43. On information and belief, Breckenridge admits the allegations of paragraph 43.
`
`COUNT I
`(Infringement of the ’456 Patent)
`
`44. Breckenridge incorporates its responses to paragraphs 1-43 as if fully set forth herein.
`
`45. The allegations of paragraph 45 appear to be directed to whether it is a technical act
`
`of infringement under 35 U.S.C. § 271(e)(2)(A) to submit “an application under Section 505(j)
`
`of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a
`
`drug claimed in a patent or the use of which is claimed in a patent,” which is a legal conclusion
`
`to which no response is required. Breckenridge denies any allegations of substantive
`
`infringement of the ’456 patent. To the extent further averments in paragraph 45 are not
`
`addressed by the foregoing, Breckenridge denies them.
`
`46. Denied.
`
`47. Denied.
`
`48. Denied.
`
`49. Denied.
`
`
`
`
`
`8
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 9 of 20 PageID #: 1373
`
`COUNT II
`(Infringement of the ’339 Patent)
`
`50. Breckenridge incorporates its responses to paragraphs 1-49 as if fully set forth herein.
`
`51. The allegations of paragraph 51 appear to be directed to whether it is a technical act
`
`of infringement under 35 U.S.C. § 271(e)(2)(A) to submit “an application under Section 505(j)
`
`of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a
`
`drug claimed in a patent or the use of which is claimed in a patent,” which is a legal conclusion
`
`to which no response is required. Breckenridge denies any allegations of substantive
`
`infringement of the ’339 patent. To the extent further averments in paragraph 51 are not
`
`addressed by the foregoing, Breckenridge denies them.
`
`52. Denied.
`
`53. Denied.
`
`54. Denied.
`
`55. Denied.
`
`RESPONSE TO PRAYER FOR RELIEF
`
`Breckenridge denies that Plaintiffs are entitled to any of the relief requested by the
`
`Complaint, or any other relief whatsoever.
`
`AFFIRMATIVE DEFENSES
`
`Breckenridge asserts the following defenses without prejudice to the denials in this
`
`Answer and without admitting any allegations of the Complaint not otherwise admitted.
`
`Breckenridge does not assume the burden of proof on any such defenses, except as required by
`
`the applicable law with respect to the particular defense asserted. Breckenridge reserves the right
`
`to assert other defenses and/or to otherwise supplement or amend its Answer and Affirmative
`
`
`
`9
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 10 of 20 PageID #: 1374
`
`Defenses to the Complaint upon discovery of facts or evidence rendering such action
`
`appropriate.
`
`FIRST DEFENSE
`(Non-Infringement of the ’456 Patent)
`
`Plaintiffs have failed to aver any facts that support their allegations of infringement by
`
`the proposed Breckenridge ANDA products. The proposed Breckenridge ANDA Products,
`
`which may be marketed if and when the ANDA obtains approval, would not directly or
`
`indirectly infringe any valid claim of the ’456 patent, either literally or under the doctrine of
`
`equivalents.
`
`SECOND DEFENSE
`(Invalidity of the ’456 Patent Based on Title 35 of the U.S. Code)
`
`One or more claims of the ’456 patent are invalid to a person having ordinary skill in the
`
`art, and for otherwise failing 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.
`
`THIRD DEFENSE
`(Non-Infringement of the ’339 Patent)
`
`Plaintiffs have failed to aver any facts that support their allegations of infringement by
`
`the proposed Breckenridge ANDA products. The proposed Breckenridge ANDA Products,
`
`which may be marketed if and when the ANDA obtains approval, would not directly or
`
`indirectly infringe any valid claim of the ’339 patent, either literally or under the doctrine of
`
`equivalents.
`
`
`
`
`
`10
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 11 of 20 PageID #: 1375
`
`FOURTH DEFENSE
`(Invalidity of the ’339 Patent Based on Title 35 of the U.S. Code)
`
`One or more claims of the ’339 patent are invalid to a person having ordinary skill in the
`
`art, and for otherwise failing 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.
`
`FIFTH DEFENSE
`(Additional Defenses or Counterclaims)
`
`Breckenridge reserves all defenses available under the Federal Rules of Civil Procedure
`
`and the U.S. Patent laws and any additional defenses or counterclaims that discovery may reveal
`
`including that Plaintiffs have failed to aver any facts supporting the conclusion that they have
`
`suffered any irreparable injury or harm under 35 U.S.C. § 283, and that Plaintiffs have failed to
`
`aver any facts supporting that this is an exceptional case and an award of attorney’s fees under
`
`35 U.S.C. § 285.
`
`COUNTERCLAIMS
`
`For its counterclaims against Counterclaim-Defendants Bayer Intellectual Property
`
`GmbH, Bayer Pharma AG and Janssen Pharmaceuticals, Inc. (collectively “Counterclaim
`
`Defendants”), Counterclaim-Plaintiff Breckenridge Pharmaceutical, Inc. (“Breckenridge” or
`
`“Counterclaim Plaintiff”), states as follows:
`
`THE PARTIES
`
`
`
`Counterclaim-Plaintiff Breckenridge Pharmaceutical, Inc. (“Breckenridge”) is a
`
`corporation organized and existing under the laws of Florida with a principal place of business at
`
`6111 Broken Sound Parkway, NW, Suite 170, Boca Raton, Florida 33487.
`
`2.
`
`Counterclaim-Defendant Bayer Intellectual Property GmbH (“BIP”) is a
`
`corporation organized and existing under the laws of the Federal Republic of Germany, with a
`
`
`
`11
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 12 of 20 PageID #: 1376
`
`place of business at Alfred-Nobel-Strasse 10, 40789 Monheim am Rhein, Germany.
`
`3.
`
`Counterclaim-Defendant Bayer Pharma AG (“BPA”) is a corporation organized
`
`and existing under the laws of the Federal Republic of Germany, with a place of business at
`
`Müllerstrasse 178, 13353 Berlin, Germany.
`
`4.
`
`Counterclaim-Defendant Janssen Pharmaceuticals,
`
`Inc.
`
`(“Janssen”)
`
`is a
`
`corporation organized and existing under the laws of the Commonwealth of Pennsylvania, with
`
`a place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey.
`
`JURISDICTION AND VENUE
`
`5.
`
`These counterclaims arise under the Patent Laws of the United States, 35 U.S.C.
`
`§§ 1 et seq. and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`6.
`
`This Court has original jurisdiction over the subject matter of these counterclaims
`
`pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`7.
`
`This Court has personal jurisdiction over Counterclaim-Defendants because
`
`Counterclaim-Defendants have availed themselves of the rights and privileges of this forum by
`
`bringing this civil action in this judicial district and because, upon information and belief,
`
`Counterclaim-Defendants conduct substantial business in, and have regular and systematic
`
`contact with, this judicial district.
`
`8.
`
`Venue for these counterclaims is proper in this judicial district pursuant to 28
`
`U.S.C. §§ 1391(b) and (c) and 1400(b).
`
`PATENTS-IN-SUIT
`
`9.
`
`Janssen has alleged that it holds New Drug Application (“NDA”) No. 022406, by
`
`which the United States Food and Drug Administration (“FDA”) granted approval for the
`
`
`
`12
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 13 of 20 PageID #: 1377
`
`manufacture and sale of rivaroxaban tablets, 10mg, 15mg and 20mg, which it sells in the United
`
`States under the registered trademark XARELTO®.
`
`10.
`
`Upon information and belief, BIP has listed U.S. Patent No. 7,157,456 (“the ’456
`
`patent”) and U.S. Patent No. 7,592,339 (“the ’339 patent”) in the FDA’s publication, Approved
`
`Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”) as covering the
`
`XARELTO® drug product, the compound rivaroxaban, pharmaceutical compositions containing
`
`rivaroxaban, processes for preparing it and methods for using it.
`
`THE ’456 PATENT
`
`
`
`On or about January 2, 2007, the United States Patent and Trademark Office
`
`(“PTO”) issued the ’456 patent, entitled “Substituted Oxazolidinones and Their Use in the Field
`
`of Blood Coagulation.”
`
`
`
`The ’456 patent indicates on its face that it is assigned to Bayer Healthcare AG. A
`
`search for patent assignments on the United States Patent and Trademark Office website
`
`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
`
`sublicensee under the ’456 patent.
`
`
`
`Breckenridge submitted Abbreviated New Drug Application (“ANDA”) No.
`
`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
`
`“ANDA Products”). That ANDA contains a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`
`indicating that the ’456 patent is invalid, unenforceable, and/or will not be infringed by the
`
`manufacture, use, importation, sale or offer for sale of Breckenridge’s ANDA Products.
`
`
`
`13
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 14 of 20 PageID #: 1378
`
`
`
`By letter dated June 27, 2016, Breckenridge provided notice with respect to its
`
`proposed ANDA Products and the ’456 patent under 21 U.S.C. § 355(j)(2)(B)(ii).
`
`
`
`Breckenridge made an Offer of Confidential Access to its ANDA No. 208220
`
`pursuant to 21 U.S.C. § 355(j)(5)(C)(i)(III), in its June 27, 2016 Notice Letter.
`
`
`
`On July 25, 2016, Counterclaim-Defendants initiated civil action, C.A. No. 1:16-
`
`cv-00628, against Counterclaim-Plaintiff in this judicial district alleging infringement of the ’456
`
`patent.
`
`
`
`Counterclaim-Plaintiff seeks a declaratory judgment that the ’456 patent is not
`
`infringed and/or is invalid.
`
`THE ’339 PATENT
`
`
`
`On or about September 22, 2009, the United States Patent and Trademark Office
`
`(“PTO”) issued the ’339 patent, entitled “Substituted Oxazolidinones and Their Use in the Field
`
`of Blood Coagulation.”
`
`
`
`The ’339 patent indicates on its face that it is assigned to Bayer Schering Pharma.
`
`A search for patent assignments on the United States Patent and Trademark Office website
`
`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
`
`sublicensee under the ’339 patent.
`
`
`
`Breckenridge submitted Abbreviated New Drug Application (“ANDA”) No.
`
`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
`
`ANDA contains a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) indicating that the ’339
`
`
`
`14
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 15 of 20 PageID #: 1379
`
`patent is invalid, unenforceable, and/or will not be infringed by the manufacture, use,
`
`importation, sale or offer for sale of Breckenridge’s ANDA Products.
`
`
`
`By letter dated June 27, 2016, Breckenridge provided notice with respect to its
`
`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
`
`pursuant to 21 U.S.C. § 355(j)(5)(C)(i)(III), in its June 27, 2016 Notice Letter.
`
`
`
`On July 25, 2016, Counterclaim-Defendants initiated civil action, C.A. No. 1:16-
`
`cv-00628, against Counterclaim-Plaintiff in this judicial district alleging infringement of the ’339
`
`patent.
`
`
`
`Counterclaim-Plaintiff seeks a declaratory judgment that the ’339 patent is not
`
`infringed and/or is invalid.
`
`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.
`
`
`
`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).
`
`
`
`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 ’456 patent under any provision of 35 U.S.C. § 271.
`
`
`
`15
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 16 of 20 PageID #: 1380
`
`
`
`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.
`
`
`
`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 ’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
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 17 of 20 PageID #: 1381
`
`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.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Counterclaim-Plaintiff respectfully requests that this Court enter a
`
`judgment in its favor and against Counterclaim-Defendants as follows:
`
`(a)
`
`Dismissing
`
`the Complaint with prejudice and entering
`
`judgment
`
`for
`
`Counterclaim-Plaintiff;
`
`(b)
`
`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
`
`product pursuant to ANDA No. 208220;
`
`(c)
`
`(d)
`
`Declaring that the claims of the ’456 patent and ’339 patent are invalid;
`
`Enjoining Counterclaim-Defendants, their officers, agents, servants, employees,
`
`attorneys and any person who acts in concert or participation with Counterclaim-Defendants
`
`from threatening to assert or otherwise attempting to enforce the ’456 patent and ’339 patent
`
`
`
`18
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 19 of 20 PageID #: 1383
`
`against Counterclaim-Plaintiff, its customers, suppliers, or anyone in privity with Counterclaim-
`
`Plaintiff;
`
`(e)
`
`Declaring that this case is exceptional pursuant to 35 U.S.C. § 285 and awarding
`
`Counterclaim-Plaintiff its reasonable attorneys’ fees and costs incurred in this action;
`
`(f)
`
`Awarding Counterclaim-Plaintiff its costs and expenses incurred in this action;
`
`and
`
`(g)
`
`Awarding Counterclaim-Plaintiff such other and further relief as this Court may
`
`deem proper.
`
`
`
`19
`
`
`
`
`
`

`

`Case 1:15-cv-00902-SLR Document 120 Filed 09/26/16 Page 20 of 20 PageID #: 1384
`
`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
`
`
`
`
`
`
`
`
`
`
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket