Case 1:19-cv-01979-LPS Document 33 Filed 01/07/20 Page 1 of 43 PageID #: 218
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
) NOVARTIS PHARMACEUTICALS )
CORPORATION, ) ) Plaintiff, ) ) v. ) ) C.A. No. 1:19-cv-01979 LPS ALKEM LABORATORIES LTD., S&B ) PHARMA, INC., AUROBINDO PHARMA USA ) INC., AUROBINDO PHARMA LTD., BIOCON ) PHARMA LIMITED, BIOCON LIMITED, ) BIOCON PHARMA, INC., CRYSTAL ) PHARMACEUTICAL (SUZHOU) CO., LTD., ) LAURUS LABS LIMITED, LAURUS GENERICS ) INC., LUPIN ATLANTIS HOLDINGS, S.A., ) LUPIN LIMITED, LUPIN INC., LUPIN ) PHARMACEUTICALS, INC., NANJING ) NORATECH PHARMACEUTICAL CO., ) LIMITED, TEVA PHARMACEUTICALS USA, ) INC., TEVA PHARMACEUTICAL INDUSTRIES LTD., TORRENT PHARMA INC., TORRENT ) )
PHARMACEUTICALS LTD., ) Defendants. )
DEFENDANT NANJING NORATECH PHARMACEUTIC CO., LIMITED’S ANSWER TO COMPLAINT AND AFFIRMATIVE DEFENSES
Defendant, Nanjing Noratech Pharmaceutical Co., Limited. (“Defendant” or
“Noratech”), by and through the undersigned counsel, responds to Plaintiff Novartis
Pharmaceuticals Corporation (“Plaintiff” or “Novartis”) as follows:
GENERAL DENIAL
Noratech denies all allegations of the Complaint not specifically admitted herein.
Unless Noratech explicitly admits a statement of the Complaint, that allegation is denied.
Noratech answers herewith stating its specific responses below paragraph by paragraph to the
allegations of the Complaint.
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NATURE OF THE ACTION1
1. This paragraph is Plaintiff’s characterization of the action, to which no response is
required. To the extent a response is required, Noratech admits that the Complaint purports to
set forth claims for patent infringement under the patent laws of the United States, and denies any infringement of any valid claim of United States Patent Nos. 8,101,659 (“the ’659 patent”), 8,796,331 (the “’331 patent”), 8,877,938 (the “’938 patent”), and/or 9,388,134 (the
“’134 patent”). Noratech denies the remaining allegations of this paragraph.
PARTIES
A. Novartis
2. Noratech lacks knowledge or information sufficient to form a belief as to the truth
of the allegations of this paragraph and, on that basis, denies them.
B. Defendants
a. Alkem Laboratories Ltd.; S&B Pharma, Inc. (ANDA No. 213764)
3. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
4. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
5. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
6. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
1 Noratech repeats the headings used by Plaintiff in the Complaint solely for ease of reference. To the extent Plaintiff intends to make factual allegations of the headings, such allegations are denied. 2
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7. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
8. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
9. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
10. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
11. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
12. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
13. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
b. Aurobindo Pharma USA Inc.; Aurobindo Pharma Ltd. (ANDA No. 213631)
14. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
15. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
16. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
17. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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18. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
19. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
20. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
21. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
22. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
23. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
c. Biocon Pharma Limited; Biocon Limited; Biocon Pharma, Inc. (ANDA No. 213680)
24. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
25. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
26. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
27. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
28. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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29. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
30. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
31. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
32. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
33. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
34. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
35. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
36. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
37. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
38. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
d. Crystal Pharmaceutical (Suzhou) Co., Ltd. (ANDA No. 213605)
39. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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40. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
41. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
42. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
43. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
44. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
45. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
e. Laurus Labs Limited; Laurus Generics Inc. (ANDA No. 213676)
46. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
47. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
48. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
49. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
50. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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51. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
52. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
53. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
54. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
55. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
56. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
f. Lupin Atlantis Holdings, S.A.; Lupin Limited; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213808)
57. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
58. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
59. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
60. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
61. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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62. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
63. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
64. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
65. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
66. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
67. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
68. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
69. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
70. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
71. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
72. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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73. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
74. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
g. Lupin Atlantis Holdings, S.A.; Lupin Limited; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213809)
75. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
76. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
77. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
78. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
79. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
80. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
81. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
82. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
83. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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84. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
85. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
h. Nanjing Noratech Pharmaceutical Co., Limited (ANDA No. 213671)
86. Noratech admits that it is a corporation organized and existing under the laws of
China, having a place of business at 6/F, Building F6, No. 9 Weidi Road, Jiangsu Life Science
and Technology Innovation Park, Qixia District, Nanjing, China. Noratech denies the remaining
allegations of this paragraph.
87. Noratech admits that it develops, manufactures, distributes, sells, and/or imports
drug products. Noratech denies the remaining allegations of this paragraph.
88. Noratech admits that by a letter dated September 3, 2019, Noratech notified
Novartis that (i) Noratech had submitted to the FDA, ANDA No. 213671 for sacubitril/valsartan tables, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Noratech ANDA Products”), and that
(ii) ANDA No. 213671 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
with respect to the ’938 and ’134 patents. Noratech denies the remaining allegations of this
paragraph.
89. Denied.
90. Noratech admits that ANDA No. 213671 was prepared and filed with the FDA.
Noratech denies the remaining allegations of this paragraph.
91. Denied.
92. Denied.
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i. Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd. (ANDA No. 213577)
93. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
94. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
95. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
96. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
97. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
98. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
99. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
100. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
101. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
j. Torrent Pharma Inc.; Torrent Pharmaceuticals Ltd. (ANDA No. 213604)
102. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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103. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
104. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
105. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
106. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
107. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
108. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
109. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
110. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
111. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
112. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
JURISDICTION AND VENUE
113. Noratech does not contest this Court’s subject matter jurisdiction with respect to claims related to the ’938 and ’134 patents. Noratech denies the remaining allegations in this paragraph. 12
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a. Alkem Laboratories Ltd.; S&B Pharma, Inc. (ANDA No. 213764)
114. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
115. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
116. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
117. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
118. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
119. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
120. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
b. Aurobindo Pharma USA Inc.; Aurobindo Pharma Ltd. (ANDA No. 213631)
121. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
122. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
123. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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124. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
125. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
126. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
c. Biocon Pharma Limited; Biocon Limited; Biocon Pharma, Inc. (ANDA No. 213680)
127. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
128. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
129. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
130. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
131. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
132. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
133. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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d. Crystal Pharmaceutical (Suzhou) Co., Ltd. (ANDA No. 213605)
134. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
135. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
136. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
137. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
138. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
139. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
e. Laurus Labs Limited; Laurus Generics Inc. (ANDA No. 213676)
140. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
141. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
142. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
143. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
144. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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145. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
146. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
f. Lupin Atlantis Holdings, S.A.; Lupin Limited; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213808)
147. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
148. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
149. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
150. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
151. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
152. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
g. Lupin Limited; Lupin Atlantis Holdings, S.A.; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213809)
153. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
154. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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155. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
156. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
157. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
158. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
159. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
160. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
h. Nanjing Noratech Pharmaceutical Co., Limited (ANDA No. 213671)
161. Denied.
162. Denied.
163. Denied.
164. Denied.
165. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
166. For the purposes of this action only, in light of the parties’ statutory obligation to cooperate in expediting this action, and without admitting that venue is otherwise proper in this
District, Noratech does not contest venue in the District of Delaware. Noratech denies the remaining allegations of this paragraph.
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i. Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd. (ANDA No. 213577)
167. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
168. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
169. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
170. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
171. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
j. Torrent Pharma Inc.; Torrent Pharmaceuticals Ltd. (ANDA No. 213604)
172. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
173. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
174. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
175. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
176. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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177. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
THE PATENTS-IN-SUIT AND ENTRESTO
178. Noratech admits that the ’659 patent, on its face, states that it issued on
January 24, 2012, and that it bears the title “Methods of treatment and pharmaceutical
composition.” Noratech further admits that Exhibit A to the Complaint purports to be a copy of
the ’659 patent. Noratech denies any remaining allegations of this paragraph.
179. This paragraph states a legal conclusion to which no answer is required. Noratech
denies any remaining allegations of this paragraph.
180. Noratech admits that the ’331 patent, on its face, states that it issued on August 5,
2014, and that it bears the title “Methods of treatment and pharmaceutical composition.”
Noratech further admits that Exhibit B to the Complaint purports to be a copy of the ’331 patent.
Noratech denies any remaining allegations of this paragraph.
181. This paragraph states a legal conclusion to which no answer is required. Noratech
denies any remaining allegations of this paragraph.
182. Noratech admits that the ’938 patent, on its face, states that it issued on
November 4, 2014, and that it bears the title, “Compounds containing S-N-valeryl-N-{[2′-(1H-
tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy- propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations.” Noratech further admits that Exhibit C to the Complaint purports to be a copy of the ’938 patent. Noratech denies any remaining allegations of this paragraph.
183. This paragraph states a legal conclusion to which no answer is required. Noratech denies any remaining allegations of this paragraph.
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184. Noratech admits that the ’134 patent, on its face, states that it issued on July 12,
2016, and that it bears the title, “Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-
biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-
methyl-pentanoic acid ethyl ester moieties and cations.” Noratech further admits that Exhibit D
to the Complaint purports to be a copy of the ’134 patent. Noratech denies any remaining
allegations of this paragraph.
185. This paragraph states a legal conclusion to which no answer is required. Noratech
denies any remaining allegations of this paragraph.
186. Noratech admits that FDA approved NDA No. 207620 for ENTRESTO®
(sacubitril and valsartan) tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg and that
ENTRESTO® currently is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction, and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations
of this paragraph and, on that basis, denies them.
187. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
188. Noratech admits that Novartis listed the ’659, ’331, ’938, and ’134 patents in the
Orange Book in reference with ENTRESTO®. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of this paragraph and, on that basis, denies them.
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INFRINGEMENT BY EACH DEFENDANT OF THE PATENTS-IN-SUIT
189. Noratech repeats and realleges the foregoing responses to Plaintiff’s allegations as
if fully set forth herein.
a. Alkem Laboratories Ltd.; S&B Pharma, Inc. (ANDA No. 213764)
190. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
191. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
192. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
193. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
194. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
195. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
196. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
197. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
198. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
199. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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200. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
201. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
202. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
203. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
204. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
b. Aurobindo Pharma USA Inc.; Aurobindo Pharma Ltd. (ANDA No. 213631)
205. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
206. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
207. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
208. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
209. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
210. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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211. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
212. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
213. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
214. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
215. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
216. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
217. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
218. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
219. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
220. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
221. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
23
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c. Biocon Pharma Limited; Biocon Limited; Biocon Pharma, Inc. (ANDA No. 213680)
222. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
223. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
224. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
225. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
226. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
227. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
228. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
229. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
230. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
231. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
232. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
24
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233. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
234. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
235. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
236. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
237. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
d. Crystal Pharmaceutical (Suzhou) Co., Ltd. (ANDA No. 213605)
238. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
239. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
240. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
241. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
242. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
243. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
25
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244. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
245. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
246. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
247. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
248. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
249. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
250. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
251. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
252. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
e. Laurus Labs Limited; Laurus Generics Inc. (ANDA No. 213676)
253. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
254. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
26
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255. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
256. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
257. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
258. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
259. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
260. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
261. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
262. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
263. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
264. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
265. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
27
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266. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
267. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
268. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
f. Lupin Atlantis Holdings, S.A.; Lupin Limited; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213808)
269. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
270. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
271. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
272. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
273. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
274. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
275. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
276. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
28
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277. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
278. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
279. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
280. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
281. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
g. Lupin Limited; Lupin Atlantis Holdings, S.A.; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213809)
282. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
283. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
284. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
285. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
286. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
287. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
29
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288. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
289. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
290. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
291. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
292. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
293. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
h. Nanjing Noratech Pharmaceutical Co., Limited (ANDA No. 213671)
294. Noratech admits that ANDA No. 213671 was submitted to FDA with a paragraph IV certification regarding the ’938 and ’134 patents. Noratech denies the remaining allegations of this paragraph.
295. Admitted.
296. Denied.
297. Noratech admits that ANDA No. 213671 was submitted to FDA with a paragraph IV certification regarding the ’938 and ’134 patents. Noratech denies the remaining allegations of this paragraph.
298. Denied.
299. Denied.
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300. Denied.
301. Denied.
302. Denied.
303. Denied.
304. Noratech admits that ANDA No. 213671 was prepared and filed with the intention of seeking approval by the FDA. Noratech denies the remaining allegations of this paragraph.
305. Denied.
i. Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.(ANDA No. 213577)
306. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
307. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
308. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
309. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
310. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
311. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
312. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
31
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313. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
314. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
315. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
316. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
317. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
318. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
319. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
320. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
321. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
j. Torrent Pharma Inc.; Torrent Pharmaceuticals Ltd. (ANDA No. 213604)
322. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
323. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
32
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324. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
325. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
326. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
327. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
328. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
329. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
330. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
331. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
332. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
333. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
334. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
33
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335. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
336. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
337. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
PRAYER FOR RELIEF
a. Alkem Laboratories Ltd.; S&B Pharma, Inc. (ANDA No. 213764)
338. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
339. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
340. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
341. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
342. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
343. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
344. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
345. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
34
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b. Aurobindo Pharma USA Inc.; Aurobindo Pharma Ltd. (ANDA No. 213631)
346. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
347. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
348. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
349. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
350. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
351. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
352. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
353. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
c. Biocon Pharma Limited; Biocon Limited; Biocon Pharma, Inc. (ANDA No. 213680)
354. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
355. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
35
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356. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
357. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
358. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
359. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
360. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
361. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
d. Crystal Pharmaceutical (Suzhou) Co., Ltd. (ANDA No. 213605)
362. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
363. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
364. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
365. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
366. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
36
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367. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
368. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
369. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
e. Laurus Labs Limited; Laurus Generics Inc. (ANDA No. 213676)
370. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
371. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
372. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
373. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
374. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
375. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
376. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
377. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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f. Lupin Atlantis Holdings, S.A.; Lupin Limited; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213808)
378. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
379. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
380. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
381. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
382. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
383. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
384. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
385. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
g. Lupin Limited; Lupin Atlantis Holdings, S.A.; Lupin Inc.; Lupin Pharmaceuticals, Inc. ANDA No. 213809)
386. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
387. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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388. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
389. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
390. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
391. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
392. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
393. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
h. Nanjing Noratech Pharmaceutical Co., Limited (ANDA No. 213671)
Wherefore, Noratech:
394. Denies that Plaintiff is entitled to any relief;
395. Denies that Plaintiff is entitled to the relief stated in Plaintiff’s prayer for relief;
396. Prays for an entry of judgment in favor of Noratech and against Plaintiff, and for dismissal with prejudice of this action; and
397. Prays for such other and further relief as to which the Court concludes Noratech is entitled, including relief under 35 U.S.C. § 285.
398. Noratech denies that Plaintiff is entitled to the relief requested.
399. Noratech denies that Plaintiff is entitled to the relief requested.
400. Noratech denies that Plaintiff is entitled to the relief requested.
401. Noratech denies that Plaintiff is entitled to the relief requested. 39
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402. Noratech denies that Plaintiff is entitled to the relief requested.
403. Noratech denies that Plaintiff is entitled to the relief requested.
404. Noratech denies that Plaintiff is entitled to the relief requested.
i. Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd. (ANDA No. 213577)
405. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
406. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
407. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
408. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
409. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
410. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
411. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
412. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
j. Torrent Pharma Inc.; Torrent Pharmaceuticals Ltd. (ANDA No. 213604)
413. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
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414. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
415. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
416. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
417. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
418. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
419. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
420. Noratech lacks knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph and, on that basis, denies them.
AFFIRMATIVE DEFENSES
Further answering the Complaint, Noratech asserts the following defenses in response to
the allegations of the Complaint, undertaking the burden of proof only as to those defenses
required by law, regardless of how such defenses are denominated below.
Noratech reserves the right to amend this Answer with additional defenses as further
information is obtained.
FIRST AFFIRMATIVE DEFENSE
Plaintiff’s Complaint fails to state a claim upon which relief may be granted.
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SECOND AFFIRMATIVE DEFENSE
To the extent that Plaintiff alleges that submission of Noratech ’s ANDA makes this case an exceptional case under 35 U.S.C. § 285, the Complaint fails to state a claim upon which relief can be granted.
THIRD AFFIRMATIVE DEFENSE
The claims of the patents-in-suit are invalid for failure to comply with the statutory provisions of Title 35 of the United States Code, including without limitation, one or more of
§§ 101, 102, 103, 111, 112, 116, 135, 256, and 287, or other judicially-created bases for invalidation and unenforceability including, at least, non-statutory double patenting.
FOURTH AFFIRMATIVE DEFENSE
The manufacture, use, sale, offer for sale, or importation of Noratech ’s ANDA product will not infringe, directly or indirectly, any valid and/or enforceable claims of the patents-in-
suit, either literally or under the doctrine of equivalents.
FIFTH AFFIRMATIVE DEFENSE
Any claim of infringement of the patents-in-suit under the doctrine of equivalents would be precluded by prosecution history estoppel.
SIXTH AFFIRMATIVE DEFENSE
Noratech has not infringed, and is not infringing, directly or indirectly, any valid claim of
the patents-in-suit, and all activities Noratech has performed or is performing in relation to
the Noratech A NDA Products have solely been for uses reasonably related to the
development and submission of information under a Federal law that regulates the manufacture,
use, or sale of drugs.
SEVENTH AFFIRMATIVE DEFENSE
Novartis lacks standing to assert infringement of the ’938 and ’134 patents. 42
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EIGHTH AFFIRMATIVE DEFENSE
Any additional defenses or counterclaims that discovery may reveal.
RESERVATION OF RIGHTS
Noratech reserves the right to assert or plead any additional affirmative defenses, the availability of which may arise or become known throughout the course of this legal action.
Dated: January 7, 2020 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, Delaware 19806-4204 (302) 655-4200 [email protected] [email protected]
Attorneys for Defendant Noratech Labs, Inc.
OF COUNSEL:
HUSCH BLACKWELL LLP Don J. Mizerk (pro hac vice) 120 South Riverside Plaza, Suite 2200 Chicago, IL 60606 (312) 655-1500 [email protected]
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