Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 1 of 303
`
`Adam Hosmer-Henner (Nev. Bar No. 12779)
`Chelsea Latino (Nev. Bar No. 14227)
`MCDONALD CARANO LLP
`100 W. Liberty Street, Tenth Floor
`Reno, NV 89501
`Tel.: (775) 788-2000 / Fax: (775) 788-2020
`E-mail: ahosmerhenner@mcdonaldcarano.com;
`clatino@mcdonaldcarano.com
`Christopher N. Sipes (admitted pro hac vice)
`Jeffrey B. Elikan (admitted pro hac vice)
`Einar Stole (admitted pro hac vice)
`Michael N. Kennedy (admitted pro hac vice)
`Megan P. Keane (admitted pro hac vice)
`Eric R. Sonnenschein (admitted pro hac vice)
`Alaina M. Whitt (admitted pro hac vice)
`Han Park (admitted pro hac vice)
`Jordan L. Moran (admitted pro hac vice)
`Daniel J. Farnoly (admitted pro hac vice)
`COVINGTON & BURLING LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`Tel: (202) 662-6000 / Fax: (202) 662-6291
`E-mail: csipes@cov.com, jelikan@cov.com,
`estole@cov.com, mkennedy@cov.com,
`mkeane@cov.com, esonnenschein@cov.com,
`awhitt@cov.com, hpark@cov.com,
`jmoran@cov.com, dfarnoly@cov.com
`Attorneys for Plaintiffs Amarin Pharma, Inc.
`and Amarin Pharmaceuticals Ireland Limited
`
`Nicholas J. Santoro (Nev. Bar No. 532)
`Jason D. Smith (Nev. Bar No. 9691)
`SANTORO WHITMIRE, LTD.
`10100 W. Charleston Blvd., Suite 250
`Las Vegas, NV 89135
`Tel: (702) 948-8771 / Fax: (702) 948-8773
`E-mail: nsantoro@santoronevada.com,
`jsmith@santoronevada.com
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEVADA
`
`AMARIN PHARMA, INC. and AMARIN
`PHARMACEUTICALS IRELAND LIMITED,
`
`Plaintiffs,
`
`v.
`
`CASE NO.: 2:16-cv-02525-MMD-NJK
`
`(Consolidated with
`2:16-cv-02562-MMD-NJK)
`
`HIKMA PHARMACEUTICALS USA INC.,
`et al.,
`
`Defendants.
`
`PLAINTIFFS’ NOTICE OF CORRECTED
`FILING (ECF No. 374)
`
`Plaintiffs Amarin Pharma Inc. and Amarin Pharmaceuticals Ireland Limited (collectively,
`“Plaintiffs”) hereby notify this Court that Plaintiffs recently discovered errors in the Table of
`
`- 1 -
`
`Appx103028
`
`1 2 3 4 5 6 7 8 9
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`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 1 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 2 of 303
`
`Authorities in Plaintiffs’ Post-Trial Proposed Findings of Fact and Conclusions of Law (ECF No.
`374). A corrected version of Plaintiffs’ Post-Trial Proposed Findings of Fact and Conclusions of
`Law, which solely corrects the Table of Authorities, is attached to this Notice as Exhibit A.
`Plaintiffs have contacted Defendants regarding this issue, and Defendants do not object to this
`corrected filing. Plaintiffs therefore ask this Court to accept this Notice of Corrected Filing and the
`attached Plaintiffs’ Corrected Post-Trial Proposed Findings of Fact and Conclusions of Law.
`DATED: February 27, 2020
`
`McDONALD CARANO LLP
`
`
`
`/s/ Adam Hosmer-Henner
`Adam Hosmer-Henner (Nev. Bar No. 12779)
`Chelsea Latino (Nev, Bar No. 14227)
`100 W. Liberty Street, Tenth Floor
`Reno, NV 89501
`Tel.: (775) 788-2000 / Fax: (775) 788-2020
`E-mail: ahosmerhenner@mcdonaldcarano.com;
`clatino@mcdonaldcarano.com
`Christopher N. Sipes (admitted pro hac vice)
`Jeffrey B. Elikan (admitted pro hac vice)
`Einar Stole (admitted pro hac vice)
`Michael N. Kennedy (admitted pro hac vice)
`Megan P. Keane (admitted pro hac vice)
`Eric R. Sonnenschein (admitted pro hac vice)
`Alaina M. Whitt (admitted pro hac vice)
`Han Park (admitted pro hac vice)
`Jordan L. Moran (admitted pro hac vice)
`Daniel J. Farnoly (admitted pro hac vice)
`COVINGTON & BURLING LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`Tel: (202) 662-6000 / Fax: (202) 662-6291
`Email: csipes@cov.com, jelikan@cov.com,
`estole@cov.com, mkennedy@cov.com,
`mkeane@cov.com, esonnenschein@cov.com,
`awhitt@cov.com, hpark@cov.com,
`jmoran@cov.com, dfarnoly@cov.com
`Nicholas J. Santoro (Nev. Bar No. 532)
`Jason D. Smith (Nev. Bar No. 9691)
`SANTORO WHITMIRE, LTD.
`10100 W. Charleston Blvd., Suite 250
`Las Vegas, NV 89135
`Tel: (702) 948-8771 / Fax: (702) 948-8773
`Email: nsantoro@santoronevada.com,
`jsmith@santoronevada.com
`Attorneys for Plaintiffs Amarin Pharma, Inc.
`and Amarin Pharmaceuticals Ireland Limited
`
`- 2 -
`
`Appx103029
`
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`20
`21
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`23
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`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 2 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 3 of 303
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that I am an employee of McDonald Carano LLP and that on February 27,
`2020, I electronically filed the foregoing PLAINTIFFS’ NOTICE OF CORRECTED FILING
`(ECF No. 374) with the Clerk of the Court using the Court’s CM/ECF system, which electronically
`served the attorneys of record set forth below.
`
`Michael D. Rounds, Esq.
`Ryan James Cudnik, Esq.
`BROWNSTEIN HYATT FARBER
`SCHRECK, LLP
`mrounds@bhfs.com
`rcudnik@bhfs.com
`
`Constance S. Huttner, Esq.
`Frank D. Rodriguez, Esq.
`Caroline Sun, Esq.
`Beth Finkelstein, Esq.
`James Barabas, Esq.
`WINDELS MARX LANE &
`MITTENDORF, LLP
`chuttner@windelsmarx.com,
`frodriguez@windelsmarx.com,
`csun@windelsmarx.com,
`bfinkelstein@windelsmarx.com,
`jbarabas@windelsmarx.com
`
`Attorneys for Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories,
`Ltd.
`
`W. West Allen, Esq.
`HOWARD & HOWARD
`ATTORNEYS, PLLC
`wwa@h2law.com
`
`George C. Lombardi, Esq.
`Charles B. Klein, Esq.
`Claire A. Fundakowski, Esq.
`Eimeric Reig-Plessis, Esq.
`Alison M. Heydorn, Esq.
`WINSTON & STRAWN LLP
`glombardi@winston.com,
`cklein@winston.com,
`cfundakowski@winston.com,
`ereigplessis@winston.com
`aheydorn@winston.com
`
`Attorneys for Defendants Hikma Pharmaceuticals USA, Inc. and Hikma Pharmaceuticals
`International Limited
`
`DATED this 27th day of February, 2020.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` /s/ Brian Grubb
`
`
`
`
`An Employee of McDonald Carano LLP
`
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`Appx103030
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 3 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 4 of 303
`
`Exhibit A
`
`Appx103031
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 4 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 5 of 303
`
`Adam Hosmer-Henner (Nev. Bar No. 12779)
`Chelsea Latino (Nev. Bar No. 14227)
`MCDONALD CARANO LLP
`100 W. Liberty Street, Tenth Floor
`Reno, NV 89501
`Tel.: (775) 788-2000 / Fax: (775) 788-2020
`E-mail: ahosmerhenner@mcdonaldcarano.com,
`clatino@mcdonaldcarano.com
`
`Christopher N. Sipes (admitted pro hac vice)
`Jeffrey B. Elikan (admitted pro hac vice)
`Einar Stole (admitted pro hac vice)
`Michael N. Kennedy (admitted pro hac vice)
`Megan P. Keane (admitted pro hac vice)
`Eric R. Sonnenschein (admitted pro hac vice)
`Alaina M. Whitt (admitted pro hac vice)
`Han Park (admitted pro hac vice)
`Jordan L. Moran (admitted pro hac vice)
`Daniel J. Farnoly (admitted pro hac vice)
`COVINGTON & BURLING LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`Tel: (202) 662-6000 / Fax: (202) 662-6291
`E-mail: csipes@cov.com, jelikan@cov.com,
`estole@cov.com, mkennedy@cov.com,
`mkeane@cov.com, esonnenschein@cov.com,
`awhitt@cov.com, hpark@cov.com,
`jmoran@cov.com, dfarnoly@cov.com
`
`Attorneys for Plaintiffs Amarin Pharma, Inc.
`and Amarin Pharmaceuticals Ireland Limited
`
`Nicholas J. Santoro (Nev. Bar No. 532)
`Jason D. Smith (Nev. Bar No. 9691)
`SANTORO WHITMIRE, LTD.
`10100 W. Charleston Blvd., Suite 250
`Las Vegas, NV 89135
`Tel: (702) 948-8771 / Fax: (702) 948-8773
`nsantoro@santoronevada.com,
`jsmith@santoronevada.com
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEVADA
`AMARIN PHARMA, INC. and AMARIN
`PHARMACEUTICALS IRELAND LIMITED,
`
`CASE NO.: 2:16-cv-02525-MMD-NJK
`
`Plaintiffs,
`
`v.
`
`(Consolidated with
`2:16-cv-02562-MMD-NJK)
`
`HIKMA PHARMACEUTICALS USA INC.,
`et al.,
`
`Defendants.
`
`PLAINTIFFS’ CORRECTED POST-
`TRIAL PROPOSED FINDINGS OF FACT
`AND CONCLUSIONS OF LAW
`
`Appx103032
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`28
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`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 5 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 6 of 303
`
`TABLE OF CONTENTS
`
`INTRODUCTION .................................................................................................................. 1
`I.
`II. BACKGROUND OF THE INVENTION .............................................................................. 3
`A. Lipids and Lipid Disorders ................................................................................................. 4
`B. Severe Hypertriglyceridemia .............................................................................................. 7
`1. Causes of Severe Hypertriglyceridemia.......................................................................... 7
`2. Clinical Consequences of Severe Hypertriglyceridemia ................................................ 9
`C. Treatment of Severe Hypertriglyceridemia ...................................................................... 10
`1. Goals of Therapy........................................................................................................... 10
`2. The Available Treatments for Severe Hypertriglyceridemia Prior to VASCEPA ....... 12
`3. A Perceived “General Phenomenon”: LDL-C Increases When TGs Are Reduced In
`Severely Hypertriglyceridemic Patients ........................................................................... 13
`D. Statins Were Not Approved for Treating Severely Hypertriglyceridemic Patients, and
`Were Not Reliably Effective in Reducing TGs ...................................................................... 19
`III. DEVELOPMENT OF THE CLAIMED METHODS OF TREATMENT ........................... 21
`A. Conception of the Claimed Methods ................................................................................ 21
`B. Clinical Development of the Claimed Methods of Treatment .......................................... 24
`IV. VASCEPA ............................................................................................................................ 28
`A. VASCEPA’s FDA Approval ............................................................................................ 28
`B. VASCEPA’s Approved Prescribing Information ............................................................. 31
`V. THE MARINE PATENTS ................................................................................................... 31
`A. Prosecution of the MARINE Patents ................................................................................ 31
`B. Disclosure of the MARINE Patents .................................................................................. 35
`C. Ownership of the MARINE Patents ................................................................................. 35
`D. Asserted Claims ................................................................................................................ 36
`VI. FURTHER CLINICAL DEVELOPMENT OF VASCEPA ................................................. 39
`A. The Need to Address Residual Cardiovascular Risk ........................................................ 39
`B. Failed Cardiovascular Outcome Trials Involving TG-Lowering Agents ......................... 41
`C. ANCHOR .......................................................................................................................... 48
`D. REDUCE-IT ..................................................................................................................... 50
`
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`- ii -
`
`Appx103033
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 6 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 7 of 303
`
`VII. VASCEPA’S APPROVED PRESCRIBING INFORMATION AFTER REDUCE-IT ....... 55
`VIII. DEFENDANTS’ PROPOSED GENERIC DRUGS ............................................................. 60
`A. Abbreviated New Drug Applications................................................................................ 60
`B. Hikma’s ANDA No. 209457 ............................................................................................ 61
`C. DRL’s ANDA No. 209499 ............................................................................................... 63
`D. Defendants’ ANDA Products ........................................................................................... 65
`IX. TRIAL ................................................................................................................................... 66
`A. Live Testimony ................................................................................................................. 66
`B. Deposition Testimony ....................................................................................................... 76
`JURISDICTION AND VENUE ........................................................................................... 78
`X.
`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 LDL-
`C 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
`
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`- iii -
`
`Appx103034
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 7 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 8 of 303
`
`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
`
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`- iv -
`
`Appx103035
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 8 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 9 of 303
`
`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
`
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`- v -
`
`Appx103036
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 9 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 10 of 303
`
`L. Amarin’s Internal Documents and Investor Presentations Are Not Relevant to the Issue of
`Obviousness .......................................................................................................................... 215
`M. The Specification of the Asserted Patents Is Not Relevant to Whether There Was a
`Reasonable Expectation of Success ...................................................................................... 219
`N. The Objective Indicia of Non-Obviousness .................................................................... 222
`1. Unexpected Benefits ................................................................................................... 222
`2. Satisfaction of Long-Felt Need ................................................................................... 231
`3. Skepticism ................................................................................................................... 238
`4. Praise ........................................................................................................................... 239
`5. Commercial Success ................................................................................................... 241
`O. Claim 1 of the ’728 Patent Was Not Obvious ................................................................. 247
`1. A Person of Ordinary Skill in March 2008 Would Not Have Reasonably Expected That
`High Purity EPA Would Avoid Substantial LDL-C Increases in Patients with Very High
`TGs .................................................................................................................................. 248
`a) .... Nothing in Defendants’ “key prior art” would have altered the strong expectation
`that highly purified EPA would produce large LDL-C increases in patients with very
`high TGs.................................................................................................................... 251
`b) ..... The Epadel Prescribing Information 2007 would not have provided a reasonable
`expectation of avoiding large LDL-C increases in patients with very high TGs. ..... 252
`c) .. Other prior art on purified EPA would not have provided a reasonable expectation
`of avoiding substantial increases in LDL-C.............................................................. 253
`d) . Documents Reflecting Amarin’s Views of the Prior Art Would Not Have Provided
`a Person of Ordinary Skill in the Art with a Reasonable Expectation of Success in
`Avoiding LDL-C Increases in Patients with Severe Hypertriglyceridemia .............. 253
`2. A POSA Would Not Have Been Motivated to Eliminate the DHA from Lovaza so as to
`Arrive a High Purity EPA Formulation for Treatment of Severe Hypertriglyceridemia 255
`3. It Was Not “Obvious to Try” 4 g High Purity EPA with Substantially No DHA in
`Patients with TGs of at Least 500 mg/dL ....................................................................... 256
`4. Objective Indicia Further Supports the Non-Obviousness of Claim 1 of the ’728 Patent
` 258
`P. Claim 16 of the ’728 Patent Was Not Obvious............................................................... 259
`Q. Claim 14 of the ’715 Patent Was Not Obvious............................................................... 260
`R. Claim 1 of the ’677 Patent Was Not Obvious ................................................................. 262
`S. Claim 8 of the ’677 Patent Was Not Obvious ................................................................. 265
`
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`- vi -
`
`Appx103037
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 10 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 11 of 303
`
`T. Claim 1 of the ’652 Patent Was Not Obvious ................................................................. 266
`U. Claim 4 of the ’560 Patent Was Not Obvious ................................................................. 267
`V. Claim 17 of the ’560 Patent Was Not Obvious............................................................... 268
`W. Claim 1 of the ’929 Patent Was Not Obvious ................................................................. 269
`X. Claim 5 of the ’929 Patent Was Not Obvious ................................................................. 270
`XIII. REMEDIES......................................................................................................................... 270
`A. Defendants Should Be Enjoined From Marketing Their Approved Products Until
`Expiration of the Asserted Patents ........................................................................................ 270
`B. Under 35 U.S.C. § 271(e)(4), Approval of Defendants’ ANDAs Should Not Be Made
`Effective Until Expiration of the Asserted Patents ............................................................... 271
`XIV. CONCLUSION ............................................................................................................... 271
`
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`20
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`- vii -
`
`Appx103038
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 11 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 12 of 303
`
`TABLE OF AUTHORITIES
`
`CASES
`Abbott Labs. v. TorPharm., Inc.,
`300 F.3d 1367 (Fed. Cir. 2002)................................................................................................81
`
`Page(s)
`
`Alcon Research, Ltd. v. Apotex Inc.,
`687 F.3d 1362 (Fed. Cir. 2012)......................................................................................220, 221
`
`Allergan, Inc. v. Sandoz,
`796 F.3d 1293 (Fed Cir. 2015)...............................................................................................220
`
`Amarin Pharm. Inc. v. Dr. Reddy’s Labs. Inc.,
`Case No. 2:16-cv-02562 (D. Nev. 2016) .................................................................................64
`
`Amarin Pharm. Inc. v. Dr. Reddy’s Labs. Inc.,
`Case No. 2:18-cv-01596 (D. Nev. 2018) .................................................................................65
`
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 ........................................................................................................................239
`
`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010)................................................................................................80
`
`Bayer Schering Pharma AG v. Lupin, Ltd.,
`676 F.3d 1316 (Fed. Cir. 2012)..............................................................................80, 81, 82, 97
`
`Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.,
`769 F.3d 1339 (Fed. Cir. 2014)..............................................................................................142
`
`Cont’l Can Co. USA v. Monsanto Co.,
`948 F.2d 1264 (Fed. Cir. 1991)..............................................................................................244
`
`Corning Glass Works v. Sumitomo Elec. U.S.A., Inc.,
`868 F.2d 1251 (Fed. Cir. 1989)................................................................................................80
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`676 F.3d 1063 (Fed. Cir. 2012)......................................................................136, 141, 142, 222
`
`Eaton Corp. v. Appliance Valves Corp.,
`790 F.2d 874 (Fed. Cir. 1986)................................................................................................212
`
`Eisai Co. v. Dr. Reddy’s Labs. Ltd.,
`533 F.3d 1353 (Fed. Cir. 2008)......................................................................................141, 207
`
`Eli Lilly & Co. v. Teva Parenteral Meds., Inc.,
`845 F.3d 1357 (Fed. Cir. 2017)....................................................................................79, 82, 84
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`- viii -
`
`Appx103039
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1009, p. 12 of 303
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 377 Filed 02/27/20 Page 13 of 303
`
`Envtl. Designs, Ltd. v. Union Oil Co. of California,
`713 F.2d 693 (Fed. Cir. 1983)................................................................................................143
`
`Frazer v. Schlegel,
`498 F.3d 1283 (Fed. Cir. 2007)..............................................................................................146
`
`Glaxo, Inc. v. Novopharm, Ltd.,
`110 F.3d 1562 (Fed. Cir. 2002)................................................................................................81
`
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966) ...................................................................................................140, 141, 142
`
`Grunenthal GmbH v. Alkem Labs. Ltd.,
`919 F.3d 1333 (Fed. Cir. 2019)..........................................................................................81, 82
`
`Hoffmann-La Roche Inc. v. Apotex Inc.,
`748 F.3d 1326 (Fed. Cir. 2014)......................................................................................220, 221
`
`Hyatt v. Boone,
`146 F.3d 1348 (Fed. Cir. 1998)..............................................................................................146
`
`In re Huai-Hung Kao,
`639 F.3d 1057 (Fed. Cir. 2011)......................................................................................143, 233
`
`Interconnect Planning Corp. v. Feil,
`774 F.2d 1132 (Fed. Cir. 1985)..............................................................................216, 217, 254
`
`In re Khelghatian,
`53 C.C.P.A. 1441, 364 F.2d 870 (1966) ................................................................................142
`
`Knoll Pharm. Co. v. Teva Phar