Replies to Post #246673 onAmarin Corp Plc (AMRN)

Replies to #246673 on Amarin Corp Plc (AMRN)

02/16/20 9:46 AM

#246675 RE: Biobillionair #246673

PACER: Highlights fro Amarin
Warning...format is horrible when copied to ihub, but the content should be enough to get the message across.
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XI. DEFENDANTS INDUCE INFRINGEMENT OF ALL TEN ASSERTED CLAIMS ........ 78
A. Infringement Legal Standard ............................................................................................ 80
B. Defendants’ Labels Will Induce Clinicians to Administer Defendants’ ANDA Products to
Severely Hypertriglyceridemic Patients for at Least 12 Weeks ............................................. 83
1. Defendants’ Proposed Labels Encourage Long-Term Use........................................... 84
2. FDA Approved VASCEPA for, and Accordingly Would Approve Defendants’ ANDA
Products for, Long-Term Use ........................................................................................... 90
C. Defendants’ Labels Will Induce Clinicians to Administer Defendants’ ANDA Products to
Severely Hypertriglyceridemic Patients with the Intent to Reduce TGs without Raising LDLC and to Reduce Apo B .......................................................................................................... 92
1. “to effect a reduction in triglycerides without raising LDL-C”.................................... 92
2. “to effect a reduction . . . in apo B” ............................................................................. 98
D. Defendants’ Labels Will Induce Clinicians to Administer Defendants’ ANDA Products to
Severely Hypertriglyceridemic Patients as Monotherapy Without Concurrent Administration
of Other Lipid-Lowering Drugs Like Statins........................................................................ 100
E. Clinicians Prescribing Vascepa or One of Defendants’ ANDA Products to Treat Severely
Hypertriglyceridemic Patients Will Directly Infringe the Asserted Claims......................... 103
F. Defendants Will Induce Infringement of Each of the Asserted Claims.......................... 104
1. Defendants Will Induce Infringement of Claim 1 of the ’728 Patent......................... 104
a) “A method of reducing triglycerides in a subject having a fasting baseline
triglyceride level of 500 mg/dl to about 1500 mg/dl”............................................... 106
b) “administering orally to the subject about 4 g per day of a pharmaceutical
composition”............................................................................................................. 108
Case 2:16-cv-02525-MMD-NJK Document 374 Filed 02/14/20 Page 3 of 299
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c) “compared to a second subject”.......................................................................... 110
2. Defendants Will Induce Infringement of Claim 16 of the ’728 Patent....................... 112
3. Defendants Will Induce Infringement of Claim 1 of the ’652 Patent......................... 113
4. Defendants Will Induce Infringement of Claim 1 of the ’677 Patent......................... 115
5. Defendants Will Induce Infringement of Claim 8 of the ’677 Patent......................... 118
6. Defendants Will Induce Infringement of Claim 14 of the ’715 Patent....................... 120
a) “to effect a statistically significant reduction in triglycerides”........................... 121
b) “to effect a statistically significant reduction . . . in apo[] B” ............................ 122
c) “without effecting a statistically significant increase of LDL-C” ...................... 123
7. Defendants Will Induce Infringement of Claim 4 of the ’560 Patent......................... 125
8. Defendants Will Induce Infringement of Claim 17 of the ’560 Patent....................... 128
9. Defendants Will Induce Infringement of Claim 1 of the ’929 Patent......................... 131
10. Defendants Will Induce Infringement of Claim 5 of the ’929 Patent................. 133
XII. DEFENDANTS HAVE FAILED TO PROVE CLEARLY AND CONVINCINGLY THAT
THE ASSERTED CLAIMS ARE INVALID AS OBVIOUS.................................................... 134
A. Introduction..................................................................................................................... 134
B. Obviousness Legal Standard........................................................................................... 140
1. Obviousness Standard................................................................................................. 140
2. Obvious to Try ............................................................................................................ 141
3. Objective Indicia of Non-Obviousness....................................................................... 141
C. Definition of a Person of Ordinary Skill in the Art ........................................................ 143
D. Priority Date.................................................................................................................... 144
E. Prosecution...................................................................................................................... 146
F. Prior Art .......................................................................................................................... 150
1. Description of Defendants’ “Key” Prior Art .............................................................. 150
a) Lovaza PDR (DX 1535) ..................................................................................... 150
b) Mori 2000 (DX 1538)......................................................................................... 152
c) Hayashi (DX 1532)............................................................................................. 156
d) Kurabayashi (DX 1534)...................................................................................... 161
e) WO ’900 (DX 1525)........................................................................................... 162
Case 2:16-cv-02525-MMD-NJK Document 374 Filed 02/14/20 Page 4 of 299
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2. Prior Art Concerning EPA.......................................................................................... 163
a) Epadel PI 2007 (DX 1528) ................................................................................. 163
b) Rambjør (DX 1961)............................................................................................ 166
c) Mori 1999 (PX 565)............................................................................................ 166
d) Woodman (PX 563)............................................................................................ 167
e) Grimsgaard (DX 1530)....................................................................................... 167
f) von Schacky (DX 1605)...................................................................................... 168
3. Art Purportedly Describing Treatment of Severe Hypertriglyceridemia with EPA... 170
a) Takaku (DX 1550).............................................................................................. 170
b) Saito 1998 (DX 1546)......................................................................................... 171
c) Matsuzawa (DX 1537)........................................................................................ 172
d) Nakamura (DX 1539)......................................................................................... 172
4. JELIS Prior Art ........................................................................................................... 173
a) Yokoyama 2007 (DX 1553) ............................................................................... 173
b) Saito 2008 (DX 1547)......................................................................................... 182
c) WO ’118 (DX 1524)........................................................................................... 183
5. Other Selected Prior Art.............................................................................................. 185
a) Lovaza Statistical Review (PX 939)................................................................... 185
b) Tricor Label (PX 388) ........................................................................................ 187
G. Defendants’ Have Failed to Adduce Clear and Convincing Evidence That a Person of
Ordinary Skill in March 2008 Would Have Been Motivated to Use Purified EPA to Treat
Severe Hypertriglyceridemia ................................................................................................ 189
H. Defendants’ Have Failed to Adduce Clear and Convincing Evidence That a POSA in
March 2008 Would Have Had a Reasonable Expectation of Success That Purified EPA
Would Reduce TGs in SHT Patients without Raising LDL-C ............................................. 201
I. Defendants Have Failed to Adduce Clear and Convincing Evidence That It Was
“Obvious to Try” Purified EPA to Reduce TGs in Severely Hypertriglyceridemic Patients
without Raising LDL-C ........................................................................................................ 207
J. Defendants Have Failed to Adduce Clear and Convincing Evidence That It Was Obvious
to Treat Severe Hypertriglyceridemia with a Combination of Purified EPA and a Statin to
Reduce TGs Without Raising EPA....................................................................................... 209
K. Defendants’ Attempted Eleventh Hour Reliance on the 2007 Lipitor Labeling Is
Procedurally Improper and Factually Unavailing................................................................. 212