Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
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Transcript of Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
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Charles M. Lizza
William C. BatonSAUL EWING LLP
One Riverfront Plaza, Suite 1520
Newark, NJ 07102-5426
(973) 286-6700
Attorneys for Plaintiffs
Auxilium Pharmaceuticals, Inc. and
FCB I LLC
Of Counsel:
Joseph M. O'Malley, Jr.
Melanie R. Rupert
Isaac S. Ashkenazi
PAUL HASTINGS LLP75 East 55th Street
New York, NY 10022(212) 318-6000
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
AUXILIUM PHARMACEUTICALS, INC. and
FCB I LLC,
Plaintiffs,
v.
WATSON LABORATORIES, INC. (NV),
WATSON PHARMACEUTICALS, INC., andWATSON PHARMA, INC.,
Defendants.
Civil Action No.__________
COMPLAINT FOR PATENT
INFRINGEMENT
(Filed Electronically)
COMPLAINT
Plaintiffs Auxilium Pharmaceuticals, Inc. and FCB I LLC (collectively,
"Plaintiffs") for their Complaint against Defendants Watson Laboratories, Inc. (NV), Watson
Pharmaceuticals, Inc., and Watson Pharma, Inc. (collectively, "Watson" or "Defendants") hereby
allege as follows:
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PARTIES
1. Plaintiff Auxilium Pharmaceuticals, Inc. ("Auxilium") is a corporationorganized and existing under the laws of the State of Delaware, having a principal place of
business at 40 Valley Stream Parkway, Malvern, Pennsylvania 19355.
2. Plaintiff FCB I LLC ("FCB") is a limited liability company organized andexisting under the laws of the State of Delaware, having a principal place of business at 1105
North Market Street, Suite 1300, Wilmington, Delaware 19801.
3. Upon information and belief, Defendant Watson Laboratories, Inc. (NV)("Watson Labs") is a corporation organized and existing under the laws of the State of Nevada,
having a place of business at Morris Corporate Center III, 400 Interpace Parkway, Parsippany,
New Jersey 07054.
4. Upon information and belief, Defendant Watson Pharmaceuticals, Inc.("Watson Pharmaceuticals") is a corporation organized and existing under the laws of the State
of Nevada, having a principal place of business at Morris Corporate Center III, 400 Interpace
Parkway, Parsippany, New Jersey 07054.
5. Upon information and belief, Defendant Watson Pharma, Inc. ("WatsonPharma") is a corporation organized and existing under the laws of the State of Delaware, having
a principal place of business at Morris Corporate Center III, 400 Interpace Parkway, Parsippany,
New Jersey 07054.
6. Upon information and belief, Watson Labs and Watson Pharma arewholly-owned subsidiaries of Watson Pharmaceuticals.
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NATURE OF THE ACTION
7. This is a civil action for infringement of U.S. Patent Nos. 7,320,968("the '968 patent"); 7,608,605 ("the '605 patent"); 7,608,606 ("the '606 patent"); 7,608,607
("the '607 patent"); 7,608,608 ("the '608 patent"); 7,608,609 ("the '609 patent"); 7,608,610
("the '610 patent"); 7,935,690 ("the '690 patent"); 8,063,029 ("the '029 patent"); and 8,178,518
("the '518 patent"). This action arises under the Patent Laws of the United States, 35 U.S.C.
100 et seq.
JURISDICTION AND VENUE
8. This Court has jurisdiction over the subject matter of this action pursuantto 28 U.S.C. 1331 and 1338(a).
9. This Court has personal jurisdiction over Watson Labs because, inter alia,it has a place of business within New Jersey and conducts business in New Jersey. In addition,
Watson Labs has engaged in substantial and continuing contacts with New Jersey. Upon
information and belief, Watson Labs, in concert with Watson Pharmaceuticals and Watson
Pharma, researches, develops, manufactures and distributes numerous generic drugs for sale and
use throughout the United States, including in this judicial district. Watson Labs has also
previously availed itself of this Court by asserting counterclaims arising under the Patent Laws
of the United States in other civil actions initiated in this jurisdiction. See, e.g.,AstraZeneca LP
v. Watson Labs., Inc., et al., Civil Action No. 11-3626 (RMB)(AMD); Teva Neuroscience Inc. v.
Watson Pharma, Inc., et al., Civil Action No. 10-5078 (CCC)(JAD);Hoffmann-La Roche Inc. v.
Watson Labs., Inc., et al., Civil Action No. 10-6206 (SRC)(MAS).
10. This Court has personal jurisdiction over Watson Pharmaceuticalsbecause, inter alia, it has its principal place of business within New Jersey, conducts business in
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New Jersey, and maintains a registered agent for the receipt of process in New Jersey. In
addition, Watson Pharmaceuticals has engaged in substantial and continuing contacts with New
Jersey. Upon information and belief, Watson Pharmaceuticals, in concert with Watson Labs and
Watson Pharma, researches, develops, manufactures and distributes numerous generic drugs for
sale and use throughout the United States, including in this judicial district.
11. This Court has personal jurisdiction over Watson Pharma because, interalia, it has its principal place of business within New Jersey and conducts business in New
Jersey. In addition, Watson Pharma has engaged in substantial and continuing contacts with
New Jersey. Upon information and belief, Watson Pharma, in concert with Watson Labs and
Watson Pharmaceuticals, researches, develops, manufactures and distributes numerous generic
drugs for sale and use throughout the United States, including in this judicial district.
12. Upon information and belief, Watson Pharmaceuticals organizes itsoperations by segments Global Generics, Global Brands, and Distribution. Upon information
and belief, the Global Generics segment, which is responsible for developing and submitting
Abbreviated New Drug Applications ("ANDAs"), as well as manufacturing and marketing
generic pharmaceuticals, relies on contributions from Watson Labs, Watson Pharmaceuticals and
Watson Pharma, each of which works in concert with the others to further the aims of the Global
Generics segment. Upon information and belief, Watson Labs submits ANDAs and
manufactures Global Generics segment products. Upon information and belief, these Global
Generics segment products for which Watson Labs is the named ANDA applicant or
manufacturer are marketed and sold by Watson Pharma throughout the United States, including
in New Jersey.
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13. In its 10-K Annual Report dated February 16, 2012, WatsonPharmaceuticals states that its Global Generics segment has more than 130 ANDAs on file in the
United States, including over 30 new ANDAs filed in the United States in 2011, and explains
that "[w]e sell our generic prescription products primarily under the 'Watson Laboratories' and
'Watson Pharma' labels . . . ." Upon information and belief, the majority of these ANDAs are in
the name of Watson Labs or another subsidiary, Watson Laboratories, Inc. Florida.
14. Upon information and belief, Watson Labs also manufactures at leastsome of the drugs for which it is the named ANDA applicant.
15.
Upon information and belief, Watson Pharma is the distributor of drug
products for which Watson Labs is the named applicant in the United States Food and Drug
Administration's ("FDA") publication titledApproved Drug Products with Therapeutic
Equivalence Evaluations ("Orange Book"). Upon information and belief, Watson Pharma,
acting as the agent of Watson Labs and Watson Pharmaceuticals, markets and sells many, if not
all, of these drug products in New Jersey. Upon information and belief, Watson Labs and
Watson Pharma are parties to one or more contractual agreements for distributing drug products
made under ANDAs held by Watson Labs.
16. Upon information and belief, Watson Pharma is licensed to do business inNew Jersey and has sales personnel assigned to New Jersey for the purpose of marketing and
selling Global Generics segment products of Watson Pharmaceuticals, including Watson Labs
products.
17. Upon information and belief, Watson Labs, Watson Pharmaceuticals andWatson Pharma share at least some employees, officers and directors in common. Upon
information and belief, at least some of the employees, officers and directors shared in common
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among Watson Labs, Watson Pharmaceuticals and Watson Pharma are located at Watson's place
of business in Parsippany, New Jersey. Upon information and belief, these employees, officers
and directors conduct business in Parsippany, New Jersey on behalf of each of Watson Labs,
Watson Pharmaceuticals and Watson Pharma.
18. This Court has personal jurisdiction over Defendants Watson Labs,Watson Pharmaceuticals and Watson Pharma because, inter alia, they (either directly, through
each other as agents, or through other agents) regularly conduct or solicit business in New
Jersey, engage in other persistent courses of conduct in New Jersey, and/or derive substantial
revenue from services or goods used or consumed in New Jersey. These activities further
demonstrate that Watson Labs, Watson Pharmaceuticals and Watson Pharma have continuous
and systematic contacts in New Jersey.
19. Venue is proper in this judicial district pursuant to 28 U.S.C. 1391 and1400(b).
THE PATENTS-IN-SUIT
20. FCB is the lawful owner of the '968 patent, titled "PharmaceuticalComposition," which was duly and legally issued by the United States Patent and Trademark
Office ("USPTO") on January 22, 2008. Auxilium is the exclusive licensee of the '968 patent. A
copy of the '968 patent is attached as Exhibit A.
21. FCB is the lawful owner of the '605 patent, titled "PharmaceuticalComposition," which was duly and legally issued by the USPTO on October 27, 2009. Auxilium
is the exclusive licensee of the '605 patent. A copy of the '605 patent is attached as Exhibit B.
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22. FCB is the lawful owner of the '606 patent, titled "PharmaceuticalComposition," which was duly and legally issued by the USPTO on October 27, 2009. Auxilium
is the exclusive licensee of the '606 patent. A copy of the '606 patent is attached as Exhibit C.
23. FCB is the lawful owner of the '607 patent, titled "PharmaceuticalComposition," which was duly and legally issued by the USPTO on October 27, 2009. Auxilium
is the exclusive licensee of the '607 patent. A copy of the '607 patent is attached as Exhibit D.
24. FCB is the lawful owner of the '608 patent, titled "PharmaceuticalComposition," which was duly and legally issued by the USPTO on October 27, 2009. Auxilium
is the exclusive licensee of the '608 patent. A copy of the '608 patent is attached as Exhibit E.
25. FCB is the lawful owner of the '609 patent, titled "PharmaceuticalComposition," which was duly and legally issued by the USPTO on October 27, 2009. Auxilium
is the exclusive licensee of the '609 patent. A copy of the '609 patent is attached as Exhibit F.
26. FCB is the lawful owner of the '610 patent, titled "PharmaceuticalComposition," which was duly and legally issued by the USPTO on October 27, 2009. Auxilium
is the exclusive licensee of the '610 patent. A copy of the '610 patent is attached as Exhibit G.
27. FCB is the lawful owner of the '690 patent, titled "PharmaceuticalComposition," which was duly and legally issued by the USPTO on May 3, 2011. Auxilium is
the exclusive licensee of the '690 patent. A copy of the '690 patent is attached as Exhibit H.
28. FCB is the lawful owner of the '029 patent, titled "PharmaceuticalComposition," which was duly and legally issued by the USPTO on November 22, 2011.
Auxilium is the exclusive licensee of the '029 patent. A copy of the '029 patent is attached as
Exhibit I.
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29. FCB is the lawful owner of the '518 patent, titled "PharmaceuticalComposition," which was duly and legally issued by the USPTO on May 15, 2012. Auxilium is
the exclusive licensee of the '518 patent. A copy of the '518 patent is attached as Exhibit J.
30. Auxilium holds New Drug Application ("NDA") No. 21-454 on Testimbrand 1% testosterone gel ("Testim") and is the exclusive distributor of Testim in the United
States.
31. Pursuant to 21 U.S.C. 355(b)(1), the '968 patent, the '605 patent, the '606patent, the '607 patent, the '608 patent, the '609 patent, the '610 patent, the '690 patent, the '029
patent, and the '518 patent are listed in the Orange Book as covering Testim
.
ACTS GIVING RISE TO THIS ACTION
Count I Infringement of the '968 Patent
32. Plaintiffs restate all of the preceding paragraphs as if fully set forth herein.33. Upon information and belief, Watson Labs submitted ANDA No. 09-1073
to the FDA under 505(j) of the Federal Food, Drug and Cosmetic Act ("FFDCA"), 21 U.S.C.
355(j). Upon information and belief, ANDA No. 09-1073 seeks FDA approval for the
commercial manufacture, use and sale of generic 1% testosterone gel for topical administration
("the Generic Product").
34. Upon information and belief, pursuant to 505(j)(2)(A)(vii)(IV) of theFFDCA, Watson Labs certified in ANDA No. 09-1073 that claims of the '968 patent are invalid
and/or will not be infringed by the commercial manufacture, use, sale, or offer for sale of the
Generic Product. Upon information and belief, ANDA No. 09-1073 specifically seeks FDA
approval to market the Generic Product prior to the expiration of the '968 patent.
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35. Plaintiffs received written notice of Watson Labs' ANDA No. 09-1073 andits accompanying 505(j)(2)(A)(vii)(IV) certification regarding the '968 patent via Watson's
letter dated April 12, 2012 and sent via Federal Express ("Notice Letter"). In its Notice Letter,
Watson alleged that Claims 1-4 of the '968 patent are invalid as obvious. Watson did not allege
noninfringement of Claims 1-4 of the '968 patent, separate and apart from its assertions that
those claims are invalid as obvious.
36. Upon information and belief, Watson Labs' submission of ANDA No.09-1073 to the FDA, including its 505(j)(2)(A)(vii)(IV) certification concerning the '968
patent, constituted infringement under 35 U.S.C. 271(e)(2)(A).
37. Moreover, if Watson commercially manufactures, uses, offers to sell, sells,or imports any of the Generic Product, or induces or contributes to any such conduct, it would
further infringe the '968 patent under 35 U.S.C. 271(a), (b) and/or (c).
38. Upon information and belief, Watson Labs was aware of the existence ofthe '968 patent prior to filing ANDA No. 09-1073.
39. Watson Pharmaceuticals and Watson Pharma are jointly and severallyliable for any infringement of the '968 patent. Upon information and belief, Watson
Pharmaceuticals and Watson Pharma participated in, contributed to, aided and abetted and/or
induced the submission of ANDA No. 09-1073 and its accompanying 505(j)(2)(A)(vii)(IV)
certification to the FDA.
40. Plaintiffs will be irreparably harmed by Watson's infringing activitiesunless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
law.
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Count II Infringement of the '605 Patent
41. Plaintiffs restate all of the preceding paragraphs as if fully set forth herein.42. Upon information and belief, pursuant to 505(j)(2)(A)(vii)(IV) of the
FFDCA, Watson Labs certified in ANDA No. 09-1073 that the claims of the '605 patent are
invalid and/or will not be infringed by the commercial manufacture, use, sale, or offer for sale of
the Generic Product. Upon information and belief, ANDA No. 09-1073 specifically seeks FDA
approval to market the Generic Product prior to the expiration of the '605 patent.
43. Plaintiffs received written notice of Watson Labs' ANDA No. 09-1073 andits accompanying 505(j)(2)(A)(vii)(IV) certification regarding the '605 patent via Notice Letter
dated April 12, 2012. In its Notice Letter, Watson alleged that Claims 1-3 of the '605 patent are
invalid as obvious. Watson did not allege noninfringement of Claims 1-3 of the '605 patent,
separate and apart from its assertions that those claims are invalid as obvious.
44. Upon information and belief, Watson Labs' submission of ANDA No.09-1073 to the FDA, including its 505(j)(2)(A)(vii)(IV) certification concerning the '605
patent, constituted infringement under 35 U.S.C. 271(e)(2)(A).
45. Moreover, if Watson commercially manufactures, uses, offers to sell, sells,or imports any of the Generic Product, or induces or contributes to any such conduct, it would
further infringe the '605 patent under 35 U.S.C. 271(a), (b) and/or (c).
46. Upon information and belief, Watson Labs was aware of the existence ofthe '605 patent prior to filing ANDA No. 09-1073.
47. Watson Pharmaceuticals and Watson Pharma are jointly and severallyliable for any infringement of the '605 patent. Upon information and belief, Watson
Pharmaceuticals and Watson Pharma participated in, contributed to, aided and abetted and/or
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induced the submission of ANDA No. 09-1073 and its accompanying 505(j)(2)(A)(vii)(IV)
certification to the FDA.
48. Plaintiffs will be irreparably harmed by Watson's infringing activitiesunless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
law.
Count III Infringement of the '606 Patent
49. Plaintiffs restate all of the preceding paragraphs as if fully set forth herein.50. Upon information and belief, pursuant to 505(j)(2)(A)(vii)(IV) of the
FFDCA, Watson Labs certified in ANDA No. 09-1073 that the claims of the '606 patent are
invalid and/or will not be infringed by the commercial manufacture, use, sale, or offer for sale of
the Generic Product. Upon information and belief, ANDA No. 09-1073 specifically seeks FDA
approval to market the Generic Product prior to the expiration of the '606 patent.
51. Plaintiffs received written notice of Watson Labs' ANDA No. 09-1073 andits accompanying 505(j)(2)(A)(vii)(IV) certification regarding the '606 patent via Notice Letter
dated April 12, 2012. In its Notice Letter, Watson alleged that Claims 1-8 of the '606 patent are
invalid as obvious. Watson did not allege noninfringement of Claims 1-8 of the '606 patent,
separate and apart from its assertions that those claims are invalid as obvious.
52. Upon information and belief, Watson Labs' submission of ANDA No.09-1073 to the FDA, including its 505(j)(2)(A)(vii)(IV) certification concerning the '606
patent, constituted infringement under 35 U.S.C. 271(e)(2)(A).
53. Moreover, if Watson commercially manufactures, uses, offers to sell, sells,or imports any of the Generic Product, or induces or contributes to any such conduct, it would
further infringe the '606 patent under 35 U.S.C. 271(a), (b) and/or (c).
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54. Upon information and belief, Watson Labs was aware of the existence ofthe '606 patent prior to filing ANDA No. 09-1073.
55. Watson Pharmaceuticals and Watson Pharma are jointly and severallyliable for any infringement of the '606 patent. Upon information and belief, Watson
Pharmaceuticals and Watson Pharma participated in, contributed to, aided and abetted and/or
induced the submission of ANDA No. 09-1073 and its accompanying 505(j)(2)(A)(vii)(IV)
certification to the FDA.
56. Plaintiffs will be irreparably harmed by Watson's infringing activitiesunless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
law.
Count IV Infringement of the '607 Patent
57. Plaintiffs restate all of the preceding paragraphs as if fully set forth herein.58. Upon information and belief, pursuant to 505(j)(2)(A)(vii)(IV) of the
FFDCA, Watson Labs certified in ANDA No. 09-1073 that the claims of the '607 patent are
invalid and/or will not be infringed by the commercial manufacture, use, sale, or offer for sale of
the Generic Product. Upon information and belief, ANDA No. 09-1073 specifically seeks FDA
approval to market the Generic Product prior to the expiration of the '607 patent.
59. Plaintiffs received written notice of Watson Labs' ANDA No. 09-1073 andits accompanying 505(j)(2)(A)(vii)(IV) certification regarding the '607 patent via Notice Letter
dated April 12, 2012. In its Notice Letter, Watson alleged that Claims 1-15 of the '607 patent are
invalid as obvious. Watson did not allege noninfringement of Claims 1-15 of the '607 patent,
separate and apart from its assertions that those claims are invalid as obvious.
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60. Upon information and belief, Watson Labs' submission of ANDA No.09-1073 to the FDA, including its 505(j)(2)(A)(vii)(IV) certification concerning the '607
patent, constituted infringement under 35 U.S.C. 271(e)(2)(A).
61. Moreover, if Watson commercially manufactures, uses, offers to sell, sells,or imports any of the Generic Product, or induces or contributes to any such conduct, it would
further infringe the '607 patent under 35 U.S.C. 271(a), (b) and/or (c).
62. Upon information and belief, Watson Labs was aware of the existence ofthe '607 patent prior to filing ANDA No. 09-1073.
63.
Watson Pharmaceuticals and Watson Pharma are jointly and severally
liable for any infringement of the '607 patent. Upon information and belief, Watson
Pharmaceuticals and Watson Pharma participated in, contributed to, aided and abetted and/or
induced the submission of ANDA No. 09-1073 and its accompanying 505(j)(2)(A)(vii)(IV)
certification to the FDA.
64. Plaintiffs will be irreparably harmed by Watson's infringing activitiesunless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
law.
Count V Infringement of the '608 Patent
65. Plaintiffs restate all of the preceding paragraphs as if fully set forth herein.66. Upon information and belief, pursuant to 505(j)(2)(A)(vii)(IV) of the
FFDCA, Watson Labs certified in ANDA No. 09-1073 that the claims of the '608 patent are
invalid and/or will not be infringed by the commercial manufacture, use, sale, or offer for sale of
the Generic Product. Upon information and belief, ANDA No. 09-1073 specifically seeks FDA
approval to market the Generic Product prior to the expiration of the '608 patent.
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67. Plaintiffs received written notice of Watson Labs' ANDA No. 09-1073 andits accompanying 505(j)(2)(A)(vii)(IV) certification regarding the '608 patent via Notice Letter
dated April 12, 2012. In its Notice Letter, Watson alleged that that Claims 1-8 of the '608 patent
are invalid as obvious. Watson did not allege noninfringement of Claims 1-3 and 8 of the '608
patent, separate and apart from its assertions that those claims are invalid as obvious.
68. Upon information and belief, Watson Labs' submission of ANDA No.09-1073 to the FDA, including its 505(j)(2)(A)(vii)(IV) certification concerning the '608
patent, constituted infringement under 35 U.S.C. 271(e)(2)(A).
69.
Moreover, if Watson commercially manufactures, uses, offers to sell, sells,
or imports any of the Generic Product, or induces or contributes to any such conduct, it would
further infringe the '608 patent under 35 U.S.C. 271(a), (b) and/or (c).
70. Upon information and belief, Watson Labs was aware of the existence ofthe '608 patent prior to filing ANDA No. 09-1073.
71. Watson Pharmaceuticals and Watson Pharma are jointly and severallyliable for any infringement of the '608 patent. Upon information and belief, Watson
Pharmaceuticals and Watson Pharma participated in, contributed to, aided and abetted and/or
induced the submission of ANDA No. 09-1073 and its accompanying 505(j)(2)(A)(vii)(IV)
certification to the FDA.
72. Plaintiffs will be irreparably harmed by Watson's infringing activitiesunless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
law.
Count VI Infringement of the '609 Patent
73. Plaintiffs restate all of the preceding paragraphs as if fully set forth herein.
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74. Upon information and belief, pursuant to 505(j)(2)(A)(vii)(IV) of theFFDCA, Watson Labs certified in ANDA No. 09-1073 that the claims of the '609 patent are
invalid and/or will not be infringed by the commercial manufacture, use, sale, or offer for sale of
the Generic Product. Upon information and belief, ANDA No. 09-1073 specifically seeks FDA
approval to market the Generic Product prior to the expiration of the '609 patent.
75. Plaintiffs received written notice of Watson Labs' ANDA No. 09-1073 andits accompanying 505(j)(2)(A)(vii)(IV) certification regarding the '609 patent via Notice Letter
dated April 12, 2012. In its Notice Letter, Watson alleged that Claims 1-12 of the '609 patent are
invalid as obvious. Watson did not allege noninfringement of Claims 1-12 of the '609 patent,
separate and apart from its assertions that those claims are invalid as obvious.
76. Upon information and belief, Watson Labs' submission of ANDA No.09-1073 to the FDA, including its 505(j)(2)(A)(vii)(IV) certification concerning the '609
patent, constituted infringement under 35 U.S.C. 271(e)(2)(A).
77. Moreover, if Watson commercially manufactures, uses, offers to sell, sells,or imports any of the Generic Product, or induces or contributes to any such conduct, it would
further infringe the '609 patent under 35 U.S.C. 271(a), (b) and/or (c).
78. Upon information and belief, Watson Labs was aware of the existence ofthe '609 patent prior to filing ANDA No. 09-1073.
79. Watson Pharmaceuticals and Watson Pharma are jointly and severallyliable for any infringement of the '609 patent. Upon information and belief, Watson
Pharmaceuticals and Watson Pharma participated in, contributed to, aided and abetted and/or
induced the submission of ANDA No. 09-1073 and its accompanying 505(j)(2)(A)(vii)(IV)
certification to the FDA.
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80. Plaintiffs will be irreparably harmed by Watson's infringing activitiesunless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
law.
Count VII Infringement of the '610 Patent
81. Plaintiffs restate all of the preceding paragraphs as if fully set forth herein.82. Upon information and belief, pursuant to 505(j)(2)(A)(vii)(IV) of the
FFDCA, Watson Labs certified in ANDA No. 09-1073 that the claims of the '610 patent are
invalid and/or will not be infringed by the commercial manufacture, use, sale, or offer for sale of
the Generic Product. Upon information and belief, ANDA No. 09-1073 specifically seeks FDA
approval to market the Generic Product prior to the expiration of the '610 patent.
83. Plaintiffs received written notice of Watson Labs' ANDA No. 09-1073 andits accompanying 505(j)(2)(A)(vii)(IV) certification regarding the '610 patent via Notice Letter
dated April 12, 2012. In its Notice Letter, Watson alleged that that Claims 1-17 of the '610
patent are invalid as obvious. Watson did not allege noninfringement of Claims 1-12 and 17 of
the '610 patent, separate and apart from its assertions that those claims are invalid as obvious.
84. Upon information and belief, Watson Labs' submission of ANDA No.09-1073 to the FDA, including its 505(j)(2)(A)(vii)(IV) certification concerning the '610
patent, constituted infringement under 35 U.S.C. 271(e)(2)(A).
85. Moreover, if Watson commercially manufactures, uses, offers to sell, sells,or imports any of the Generic Product, or induces or contributes to any such conduct, it would
further infringe the '610 patent under 35 U.S.C. 271(a), (b) and/or (c).
86. Upon information and belief, Watson Labs was aware of the existence ofthe '610 patent prior to filing ANDA No. 09-1073.
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87. Watson Pharmaceuticals and Watson Pharma are jointly and severallyliable for any infringement of the '610 patent. Upon information and belief, Watson
Pharmaceuticals and Watson Pharma participated in, contributed to, aided and abetted and/or
induced the submission of ANDA No. 09-1073 and its accompanying 505(j)(2)(A)(vii)(IV)
certification to the FDA.
88. Plaintiffs will be irreparably harmed by Watson's infringing activitiesunless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
law.
Count VIII Infringement of the '690 Patent
89. Plaintiffs restate all of the preceding paragraphs as if fully set forth herein.90. Upon information and belief, pursuant to 505(j)(2)(A)(vii)(IV) of the
FFDCA, Watson Labs certified in ANDA No. 09-1073 that the claims of the '690 patent are
invalid and/or will not be infringed by the commercial manufacture, use, sale, or offer for sale of
the Generic Product. Upon information and belief, ANDA No. 09-1073 specifically seeks FDA
approval to market the Generic Product prior to the expiration of the '690 patent.
91. Plaintiffs received written notice of Watson Labs' ANDA No. 09-1073 andits accompanying 505(j)(2)(A)(vii)(IV) certification regarding the '690 patent via Notice Letter
dated April 12, 2012. In its Notice Letter, Watson alleged that that Claims 1-16 of the '690
patent are invalid as obvious. Watson did not allege noninfringement of Claims 1-12 of the '690
patent, separate and apart from its assertions that those claims are invalid as obvious.
92. Upon information and belief, Watson Labs' submission of ANDA No.09-1073 to the FDA, including its 505(j)(2)(A)(vii)(IV) certification concerning the '690
patent, constituted infringement under 35 U.S.C. 271(e)(2)(A).
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93. Moreover, if Watson commercially manufactures, uses, offers to sell, sells,or imports any of the Generic Product, or induces or contributes to any such conduct, it would
further infringe the '690 patent under 35 U.S.C. 271(a), (b) and/or (c).
94. Upon information and belief, Watson Labs was aware of the existence ofthe '690 patent prior to filing ANDA No. 09-1073.
95. Watson Pharmaceuticals and Watson Pharma are jointly and severallyliable for any infringement of the '690 patent. Upon information and belief, Watson
Pharmaceuticals and Watson Pharma participated in, contributed to, aided and abetted and/or
induced the submission of ANDA No. 09-1073 and its accompanying 505(j)(2)(A)(vii)(IV)
certification to the FDA.
96. Plaintiffs will be irreparably harmed by Watson's infringing activitiesunless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
law.
Count IX Infringement of the '029 Patent
97. Plaintiffs restate all of the preceding paragraphs as if fully set forth herein.98. Upon information and belief, pursuant to 505(j)(2)(A)(vii)(IV) of the
FFDCA, Watson Labs certified in ANDA No. 09-1073 that the claims of the '029 patent are
invalid and/or will not be infringed by the commercial manufacture, use, sale, or offer for sale of
the Generic Product. Upon information and belief, ANDA No. 09-1073 specifically seeks FDA
approval to market the Generic Product prior to the expiration of the '029 patent.
99. Plaintiffs received written notice of Watson Labs' ANDA No. 09-1073 andits accompanying 505(j)(2)(A)(vii)(IV) certification regarding the '029 patent via Notice Letter
dated April 12, 2012. In its Notice Letter, Watson alleged that Claims 1-10 of the '029 patent are
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invalid as obvious. Watson did not allege noninfringement of Claims 1-10 of the '029 patent,
separate and apart from its assertions that those claims are invalid as obvious.
100. Upon information and belief, Watson Labs' submission of ANDA No.09-1073 to the FDA, including its 505(j)(2)(A)(vii)(IV) certification concerning the '029
patent, constituted infringement under 35 U.S.C. 271(e)(2)(A).
101. Moreover, if Watson commercially manufactures, uses, offers to sell, sells,or imports any of the Generic Product, or induces or contributes to any such conduct, it would
further infringe the '029 patent under 35 U.S.C. 271(a), (b) and/or (c).
102.
Upon information and belief, Watson Labs was aware of the existence of
the '029 patent prior to filing ANDA No. 09-1073.
103. Watson Pharmaceuticals and Watson Pharma are jointly and severallyliable for any infringement of the '029 patent. Upon information and belief, Watson
Pharmaceuticals and Watson Pharma participated in, contributed to, aided and abetted and/or
induced the submission of ANDA No. 09-1073 and its accompanying 505(j)(2)(A)(vii)(IV)
certification to the FDA.
104. Plaintiffs will be irreparably harmed by Watson's infringing activitiesunless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
law.
Count X Infringement of the '518 Patent
105. Plaintiffs restate all of the preceding paragraphs as if fully set forth herein.106. Upon information and belief, ANDA No. 09-1073 seeks FDA approval to
market the Generic Product prior to the expiration of the '518 patent.
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107. Upon information and belief, Watson Labs' submission of ANDA No.09-1073 to the FDA constitutes infringement of the '518 patent under 35 U.S.C. 271(e)(2)(A).
108. Moreover, if Watson commercially manufactures, uses, offers to sell, sells,or imports any of the Generic Product, or induces or contributes to any such conduct, it would
further infringe the '518 patent under 35 U.S.C. 271(a), (b) and/or (c).
109. Watson Pharmaceuticals and Watson Pharma are jointly and severallyliable for any infringement of the '518 patent. Upon information and belief, Watson
Pharmaceuticals and Watson Pharma participated in, contributed to, aided and abetted and/or
induced the submissionof ANDA No. 09-1073 to the FDA.
110. Plaintiffs will be irreparably harmed by Watson's infringing activitiesunless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
law.
PRAYER FOR RELIEF
WHEREFORE, Plaintiffs pray for judgment as follows:
A. That Watson Labs has infringed one or more claims of the '968 patent,
the '605 patent, the '606 patent, the '607 patent, the '608 patent, the '609 patent, the '610 patent,
the '690 patent, the '029 patent, and the '518 patent;
B. That Watson Pharmaceuticals has infringed one or more claims of the '968
patent, the '605 patent, the '606 patent, the '607 patent, the '608 patent, the '609 patent, the '610
patent, the '690 patent, the '029 patent, and the '518 patent;
C. That Watson Pharma has infringed one or more claims of the '968 patent,
the '605 patent, the '606 patent, the '607 patent, the '608 patent, the '609 patent, the '610 patent,
the '690 patent, the '029 patent, and the '518 patent;
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D. That, pursuant to 35 U.S.C. 271(e)(4)(A), the effective date of any
approval of ANDA No. 09-1073 shall not be earlier than the expiration dates of the '968 patent,
the '605 patent, the '606 patent, the '607 patent, the '608 patent, the '609 patent, the '610 patent,
the '690 patent, the '029 patent, and the '518 patent, including any applicable exclusivities or
extensions;
E. That Watson Labs, its officers, agents, servants and employees, and those
persons in active concert or participation with any of them, be preliminarily and permanently
enjoined from commercially manufacturing, using, offering to sell, selling or importing any
Generic Product, prior to the expiration of the '968 patent, the '605 patent, the '606 patent,
the '607 patent, the '608 patent, the '609 patent, the '610 patent, the '690 patent, the '029 patent,
and the '518 patent, including any applicable exclusivities or extensions;
F. That Watson Pharmaceuticals, its officers, agents, servants and employees,
and those persons in active concert or participation with any of them, be preliminarily and
permanently enjoined from commercially manufacturing, using, offering to sell, selling or
importing any Generic Product, prior to the expiration of the '968 patent, the '605 patent, the '606
patent, the '607 patent, the '608 patent, the '609 patent, the '610 patent, the '690 patent, the '029
patent, and the '518 patent, including any applicable exclusivities or extensions;
G. That Watson Pharma, its officers, agents, servants and employees, and
those persons in active concert or participation with any of them, be preliminarily and
permanently enjoined from commercially manufacturing, using, offering to sell, selling or
importing any Generic Product, prior to the expiration of the '968 patent, the '605 patent, the '606
patent, the '607 patent, the '608 patent, the '609 patent, the '610 patent, the '690 patent, the '029
patent, and the '518 patent, including any applicable exclusivities or extensions;
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H. That Plaintiffs be awarded the attorneys' fees, costs and expenses that they
incur prosecuting this action; and
I. That Plaintiffs be awarded such other and further relief as this Court
deems just and proper.
Dated: May 23, 2012
Of Counsel:
Joseph M. O'Malley, Jr.
Melanie R. RupertIsaac S. Ashkenazi
PAUL HASTINGS LLP
75 East 55th StreetNew York, NY 10022
(212) 318-6000
[email protected]@paulhastings.com
Respectfully submitted,
By: s/ Charles M. Lizza
Charles M. LizzaWilliam C. Baton
SAUL EWING LLPOne Riverfront Plaza, Suite 1520Newark, NJ 07102-5426
(973) 286-6700
[email protected]@saul.com
Attorneys for Plaintiffs
Auxilium Pharmaceuticals, Inc. and
FCB I LLC
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CERTIFICATION PURSUANT TO LOCAL CIVIL RULES 11.2 & 40.1
I hereby certify that, to the best of my knowledge, the matter in controversy is not the
subject of any other action pending in any court, or of any pending arbitration or administrative
proceeding.
Dated: May 23, 2012
Of Counsel:
Joseph M. O'Malley, Jr.
Melanie R. RupertIsaac S. Ashkenazi
PAUL HASTINGS LLP
75 East 55th StreetNew York, NY 10022
(212) 318-6000
[email protected]@paulhastings.com
By: s/ Charles M. Lizza
Charles M. Lizza
William C. BatonSAUL EWING LLP
One Riverfront Plaza, Suite 1520
Newark, NJ 07102-5426(973) 286-6700
Attorneys for Plaintiffs
Auxilium Pharmaceuticals, Inc. and
FCB I LLC
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Exhibit A
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Exhibit B
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Exhibit C
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Exhibit D
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Exhibit E
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105/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 105 of 200 PageID: 295720
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106/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 106 of 200 PageID: 295721
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107/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 107 of 200 PageID: 295722
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Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 108 of 200 PageID: 295723
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109/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 109 of 200 PageID: 295724
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110/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 110 of 200 PageID: 295725
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111/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 111 of 200 PageID: 295726
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112/200
Exhibit F
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 112 of 200 PageID: 295727
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
113/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 113 of 200 PageID: 295728
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
114/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 114 of 200 PageID: 295729
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
115/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 115 of 200 PageID: 295730
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
116/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 116 of 200 PageID: 295731
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117/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 117 of 200 PageID: 295732
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118/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 118 of 200 PageID: 295733
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119/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 119 of 200 PageID: 295734
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120/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 120 of 200 PageID: 295735
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121/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 121 of 200 PageID: 295736
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
122/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 122 of 200 PageID: 295737
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
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Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 123 of 200 PageID: 295738
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Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 124 of 200 PageID: 295739
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Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 125 of 200 PageID: 295740
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Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 126 of 200 PageID: 295741
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
127/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 127 of 200 PageID: 295742
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
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Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 128 of 200 PageID: 295743
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
129/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 129 of 200 PageID: 295744
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
130/200
Exhibit G
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 130 of 200 PageID: 295745
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
131/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 131 of 200 PageID: 295746
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
132/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 132 of 200 PageID: 295747
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
133/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 133 of 200 PageID: 295748
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
134/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 134 of 200 PageID: 295749
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
135/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 135 of 200 PageID: 295750
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
136/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 136 of 200 PageID: 295751
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
137/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 137 of 200 PageID: 295752
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
138/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 138 of 200 PageID: 295753
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
139/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 139 of 200 PageID: 295754
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
140/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 140 of 200 PageID: 295755
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
141/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 141 of 200 PageID: 295756
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
142/200
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
143/200
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
144/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 144 of 200 PageID: 295759
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
145/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 145 of 200 PageID: 295760
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
146/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 146 of 200 PageID: 295761
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
147/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 147 of 200 PageID: 295762
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
148/200
Exhibit H
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 148 of 200 PageID: 295763
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
149/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 149 of 200 PageID: 295764
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
150/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 150 of 200 PageID: 295765
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
151/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 151 of 200 PageID: 295766
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
152/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 152 of 200 PageID: 295767
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
153/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 153 of 200 PageID: 295768
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
154/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 154 of 200 PageID: 295769
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
155/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 155 of 200 PageID: 295770
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
156/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 156 of 200 PageID: 295771
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
157/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 157 of 200 PageID: 295772
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
158/200
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
159/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 159 of 200 PageID: 295774
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
160/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 160 of 200 PageID: 295775
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
161/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 161 of 200 PageID: 295776
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
162/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 162 of 200 PageID: 295777
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
163/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 163 of 200 PageID: 295778
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
164/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 164 of 200 PageID: 295779
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
165/200
Exhibit I
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 165 of 200 PageID: 295780
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
166/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 166 of 200 PageID: 295781
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
167/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 167 of 200 PageID: 295782
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
168/200
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
169/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 169 of 200 PageID: 295784
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
170/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 170 of 200 PageID: 295785
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
171/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 171 of 200 PageID: 295786
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
172/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 172 of 200 PageID: 295787
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
173/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 173 of 200 PageID: 295788
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
174/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 174 of 200 PageID: 295789
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
175/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 175 of 200 PageID: 295790
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
176/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 176 of 200 PageID: 295791
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
177/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 177 of 200 PageID: 295792
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
178/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 178 of 200 PageID: 295793
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
179/200
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
180/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 180 of 200 PageID: 295795
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
181/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 181 of 200 PageID: 295796
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
182/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 182 of 200 PageID: 295797
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
183/200
Exhibit J
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 183 of 200 PageID: 295798
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
184/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 184 of 200 PageID: 295799
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
185/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 185 of 200 PageID: 295800
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
186/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 186 of 200 PageID: 295801
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
187/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 187 of 200 PageID: 295802
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
188/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 188 of 200 PageID: 295803
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
189/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 189 of 200 PageID: 295804
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
190/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 190 of 200 PageID: 295805
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
191/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 191 of 200 PageID: 295806
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
192/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 192 of 200 PageID: 295807
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
193/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 193 of 200 PageID: 295808
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
194/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 194 of 200 PageID: 295809
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195/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 195 of 200 PageID: 295810
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196/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 196 of 200 PageID: 295811
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197/200
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
198/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 198 of 200 PageID: 295813
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199/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 199 of 200 PageID: 295814
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7/31/2019 Auxilium Pharmaceuticals et. al. v. Watson Laboratories et. al.
200/200
Case 2:33-av-00001 Document 14998 Filed 05/23/12 Page 200 of 200 PageID: 295815