Nicholas J. Santoro (Nev. Bar No. 532)
`SANTORO WHITMIRE, LTD.
`10100 W. Charleston Blvd., Suite 250
`Las Vegas, Nevada 89135
`Telephone: (702) 948-8771
`Facsimile: (702) 948-8773
`E-mail: nsantoro@santoronevada.com
`
`Christopher N. Sipes (admitted pro hac vice)
`Einar Stole (admitted pro hac vice)
`Michael N. Kennedy (admitted pro hac vice)
`Megan P. Keane (admitted pro hac vice)
`COVINGTON & BURLING LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`Telephone: (202) 662-6000
`Facsimile: (202) 662-6291
`E-mail: csipes@cov.com, estole@cov.com,
`mkennedy@cov.com, mkeane@cov.com
`
`Attorneys for Plaintiffs Amarin Pharma, Inc. and
`Amarin Pharmaceuticals Ireland Limited
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEVADA
`
`AMARIN PHARMA, INC. et al.,
`
`Plaintiffs,
`
`v.
`
`WEST-WARD PHARMACEUTICALS CORP.,
`et al
`
`Defendants.
`
`Case No.: 2:16-cv-02525-MMD-NJK
`
`(Consolidated with 2:16-cv-02562-MMD-NJK
`and 2:16-cv-02658-MMD-NJK)
`
`PLAINTIFFS’ PRELIMINARY VALIDITY
`CONTENTIONS PURSUANT TO
`LPR 1-10
`
`CONFIDENTIAL
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`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1019, p. 1 of 2444
`
`

`

`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`
`INTRODUCTION ............................................................................................................ 10
`
`PERSON OF ORDINARY SKILL IN THE ART AND INVENTION DATE ............... 16
`
`A.
`
`B.
`
`Person of Ordinary Skill in the Art ....................................................................... 16
`
`Priority Date of the Asserted Claims .................................................................... 16
`
`III.
`
`STATE OF THE ART ...................................................................................................... 17
`
`A.
`
`B.
`
`Introduction ........................................................................................................... 17
`
`Key Concepts in Lipid Science ............................................................................. 20
`
`1.
`
`2.
`
`3.
`
`Lipids ........................................................................................................ 21
`
`Lipoproteins .............................................................................................. 22
`
`Dyslipidemia ............................................................................................. 27
`
`C.
`
`In Treating Hypertriglyceridemia, the Very High TG Group Was
`Considered Substantially Different than Other Groups ........................................ 32
`
`1.
`
`2.
`
`3.
`
`4.
`
`ATP-III and Practicing Physicians Recognized Different Primary
`Risks and Treatment Goals for Very-high TG Patients ............................ 33
`
`It Was Well Understood that Very-high TG Patients Reacted to
`TG-Lowering Medications Differently than Other TG Groups ................ 35
`
`The FDA Followed the ATP-III Classifications in Reviewing TG
`Lowering Drugs ........................................................................................ 35
`
`Very-High TG Patients Often Presented with Visible Symptoms ............ 36
`
`D.
`
`Drugs Approved to Treat High TG Patients Prior to VASCEPA ......................... 36
`
`1.
`
`2.
`
`Niacin ........................................................................................................ 36
`
`Fibrates and Prescription Omega-3s ......................................................... 37
`
`E.
`
`A Person of Ordinary Skill Did Not Differentiate Between EPA and
`DHA’s TG-Lowering Mechanism or LDL-C impact ........................................... 43
`
`1.
`
`A Person of Ordinary Skill Understood EPA and DHA had the
`Same TG-Lowering Mechanism ............................................................... 44
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`1 2 3 4 5 6 7 8 9
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`CONFIDENTIAL
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`2
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`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1019, p. 2 of 2444
`
`

`

`
`
`2.
`
`A Person of Ordinary Skill in the Art Did Not Differentiate
`Between EPA and DHA When Discussing the LDL-C Impact of
`Prescription Omega-3 Fatty Acids in Patients with Very-High TG
`Levels ........................................................................................................ 47
`
`F.
`
`Studies Were Inconclusive Regarding Differential Effects of EPA and
`DHA ...................................................................................................................... 49
`
`IV.
`
`DESCRIPTION OF REFERENCES ................................................................................ 51
`
`A.
`
`General Overview ................................................................................................. 51
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Defendants Fail to Provide Studies Directed to the Very-High TG
`Patient Population ..................................................................................... 51
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`Studies That Were Not Placebo Controlled .............................................. 54
`
`Japanese Studies........................................................................................ 55
`
`Studies That Administered EPA and DHA in Varying
`Concentrations .......................................................................................... 55
`
`Studies which administered only EPA or only DHA ................................ 57
`
`B.
`
`Summary of Prior Art References ......................................................................... 57
`
`1.
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`2.
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`3.
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`4.
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`5.
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`6.
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`7.
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`8.
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`9.
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`10.
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`11.
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`12.
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`WO ‘118.................................................................................................... 57
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`WO ‘900.................................................................................................... 58
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`Agren......................................................................................................... 60
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`Ando .......................................................................................................... 61
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`Calabresi ................................................................................................... 62
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`Chan 2002 II ............................................................................................. 64
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`Chan 2003 ................................................................................................. 65
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`Childs ........................................................................................................ 67
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`Conquer 1996 ............................................................................................ 68
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`Contacos .................................................................................................... 69
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`Geppert ...................................................................................................... 70
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`Grimsgaard ................................................................................................ 71
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`CONFIDENTIAL
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`3
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`Hikma Pharmaceuticals
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`IPR2022-00215
`
`Ex. 1019, p. 3 of 2444
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`

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`13.
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`14.
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`15.
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`16.
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`17.
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`18.
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`19.
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`20.
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`21.
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`Hamazaki .................................................................................................. 72
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`Hayashi ..................................................................................................... 73
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`Katayama .................................................................................................. 75
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`Kelley ........................................................................................................ 76
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`Kris-Etherton............................................................................................. 79
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`Kurabayashi .............................................................................................. 79
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`Leigh-Firbank ........................................................................................... 80
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`Lovaza PDR .............................................................................................. 82
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`Lovegrove ................................................................................................. 83
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`22. Maki .......................................................................................................... 84
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`23. Mataki ....................................................................................................... 85
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`24. Matsuzawa ................................................................................................ 86
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`25. Mori 2000.................................................................................................. 89
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`26. Mori 2006.................................................................................................. 90
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`27.
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`28.
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`29.
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`30.
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`31.
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`32.
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`33.
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`34.
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`35.
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`36.
`
`37.
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`Nakamura .................................................................................................. 93
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`Nelson ....................................................................................................... 94
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`Nestel ........................................................................................................ 95
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`Nozaki ....................................................................................................... 96
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`Okumura ................................................................................................... 97
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`Omacor PDR ............................................................................................. 98
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`Park ........................................................................................................... 99
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`Rambjor................................................................................................... 101
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`Saito ........................................................................................................ 102
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`Sanders .................................................................................................... 105
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`Satoh ....................................................................................................... 105
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`CONFIDENTIAL
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`4
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`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1019, p. 4 of 2444
`
`

`

`
`
`38.
`
`39.
`
`40.
`
`41.
`
`Shinozaki................................................................................................. 106
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`Takaku..................................................................................................... 107
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`Theobald ................................................................................................. 110
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`Virani ...................................................................................................... 111
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`42. Wojenski ................................................................................................. 112
`
`43. Woodman ................................................................................................ 112
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`44.
`
`45.
`
`Yokoyama 2007 ...................................................................................... 113
`
`Zalewski .................................................................................................. 115
`
`V.
`
`Responses to Defendants’ Joint Invalidity Contentions ................................................. 115
`
`A.
`
`The ’728 Patent ................................................................................................... 117
`
`1.
`
`2.
`
`3.
`
`4.
`
`The ’728 Patent Claims Eligible Subject Matter Under § 101 ............... 117
`
`The Asserted Claims of the ‘728 Patent Are Not Anticipated by
`WO ‘118.................................................................................................. 121
`
`The Claims of the ‘728 Patent Would Not Have Been Obvious In
`Light of the Asserted References ............................................................ 138
`
`The ’728 Patent is Not Invalid Under § 112 ........................................... 293
`
`B.
`
`The ‘715 Patent ................................................................................................... 303
`
`1.
`
`2.
`
`3.
`
`4.
`
`The ’715 Patent Claims Eligible Subject Matter Under § 101 ............... 303
`
`The Asserted Claims of the ‘715 Patent Are Not Anticipated by
`WO ‘118.................................................................................................. 307
`
`The Claims of the ‘715 Patent Would Not Have Been Obvious In
`Light of the Asserted References ............................................................ 324
`
`The ’715 Patent is Not Invalid Under § 112 ........................................... 466
`
`C.
`
`The ‘335 Patent ................................................................................................... 477
`
`1.
`
`2.
`
`The ’335 Patent Claims Eligible Subject Matter Under § 101 ............... 477
`
`The Asserted Claims of the ‘335 Patent Are Not Anticipated by
`WO ‘118.................................................................................................. 481
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`CONFIDENTIAL
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`5
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`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1019, p. 5 of 2444
`
`

`

`3.
`
`4.
`
`The Claims of the ‘335 Patent Would Not Have Been Obvious In
`Light of the Asserted References ............................................................ 498
`
`The ’335 Patent is Not Invalid Under § 112 ........................................... 643
`
`D.
`
`The ‘399 Patent ................................................................................................... 652
`
`1.
`
`2.
`
`3.
`
`4.
`
`The ’399 Patent Claims Eligible Subject Matter Under § 101 ............... 652
`
`The Asserted Claims of the ‘399 Patent Are Not Anticipated by
`WO ‘118.................................................................................................. 656
`
`The Claims of the ‘399 Patent Would Not Have Been Obvious In
`Light of the Asserted References ............................................................ 672
`
`The ‘399 Patent is Not Invalid Under § 112 ........................................... 810
`
`E.
`
`The ‘677 Patent ................................................................................................... 820
`
`1.
`
`2.
`
`3.
`
`4.
`
`The ’677 Patent Claims Eligible Subject Matter Under § 101 ............... 820
`
`The Asserted Claims of the ‘677 Patent Are Not Anticipated by
`WO ‘118.................................................................................................. 824
`
`The Claims of the ‘677 Patent Would Not Have Been Obvious In
`Light of the Asserted References ............................................................ 839
`
`The ‘677 Patent is Not Invalid Under § 112 ........................................... 972
`
`F.
`
`The ‘446 Patent ................................................................................................... 980
`
`1.
`
`2.
`
`3.
`
`4.
`
`The ’446 Patent Claims Eligible Subject Matter Under § 101 ............... 980
`
`The Asserted Claims of the ‘446 Patent Are Not Anticipated by
`WO ‘118.................................................................................................. 984
`
`The Claims of the ‘446 Patent Would Not Have Been Obvious In
`Light of the Asserted References ............................................................ 999
`
`The ’446 Patent is Not Invalid Under § 112 ......................................... 1130
`
`G.
`
`The ‘652 Patent ................................................................................................. 1139
`
`1.
`
`2.
`
`The ’652 Patent Claims Eligible Subject Matter Under § 101 ............. 1139
`
`The Asserted Claims of the ‘652 Patent Are Not Anticipated by
`WO ‘118................................................................................................ 1143
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`CONFIDENTIAL
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`6
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`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1019, p. 6 of 2444
`
`

`

`3.
`
`4.
`
`The Claims of the ‘652 Patent Would Not Have Been Obvious In
`Light of the Asserted References .......................................................... 1158
`
`The ’652 Patent is Not Invalid Under § 112 ......................................... 1293
`
`H.
`
`The ‘920 Patent ................................................................................................. 1302
`
`1.
`
`2.
`
`3.
`
`4.
`
`The ’920 Patent Claims Eligible Subject Matter Under § 101 ............. 1302
`
`The Asserted Claims of the ‘920 Patent Are Not Anticipated by
`WO ‘118................................................................................................ 1306
`
`The Claims of the ‘920 Patent Would Not Have Been Obvious In
`Light of the Asserted References .......................................................... 1321
`
`The ’920 Patent is Not Invalid Under § 112 ......................................... 1444
`
`I.
`
`The ‘560 Patent ................................................................................................. 1452
`
`1.
`
`2.
`
`3.
`
`4.
`
`The ’560 Patent Claims Eligible Subject Matter Under § 101 ............. 1452
`
`The Asserted Claims of the ‘560 Patent Are Not Anticipated by
`WO ‘118................................................................................................ 1456
`
`The Claims of the ‘560 Patent Would Not Have Been Obvious In
`Light of the Asserted References .......................................................... 1472
`
`The ’560 Patent is Not Invalid Under § 112 ......................................... 1603
`
`J.
`
`The ‘650 Patent ................................................................................................. 1612
`
`1.
`
`2.
`
`3.
`
`4.
`
`The ’650 Patent Claims Eligible Subject Matter Under § 101 ............. 1612
`
`The Asserted Claims of the ‘650 Patent Are Not Anticipated by
`WO ‘118................................................................................................ 1616
`
`The Claims of the ‘650 Patent Would Not Have Been Obvious In
`Light of the Asserted References .......................................................... 1631
`
`The ’650 Patent is Not Invalid Under § 112 ......................................... 1760
`
`K.
`
`The ‘929 Patent ................................................................................................. 1769
`
`1.
`
`2.
`
`The ’929 Patent Claims Eligible Subject Matter Under § 101 ............. 1769
`
`The Asserted Claims of the ‘929 Patent Are Not Anticipated by
`WO ‘118................................................................................................ 1773
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`CONFIDENTIAL
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`7
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`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1019, p. 7 of 2444
`
`

`

`3.
`
`4.
`
`The Claims of the ‘929 Patent Would Not Have Been Obvious In
`Light of the Asserted References .......................................................... 1788
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`The ‘929 Patent is Not Invalid Under § 112 ......................................... 1921
`
`L.
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`The ‘698 Patent ................................................................................................. 1929
`
`1.
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`2.
`
`3.
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`4.
`
`The ’698 Patent Claims Eligible Subject Matter Under § 101 ............. 1929
`
`The Asserted Claims of the ‘698 Patent Are Not Anticipated by
`WO ‘118................................................................................................ 1933
`
`The Claims of the ‘698 Patent Would Not Have Been Obvious In
`Light of the Asserted References .......................................................... 1948
`
`The ’698 Patent is Not Invalid Under § 112 ......................................... 2069
`
`M.
`
`The ‘372 Patent ................................................................................................. 2078
`
`1.
`
`2.
`
`3.
`
`4.
`
`The ’372 Patent Claims Eligible Subject Matter Under § 101 ............. 2078
`
`The Asserted Claims of the ‘372 Patent Are Not Anticipated by
`WO ‘118................................................................................................ 2082
`
`The Claims of the ‘372 Patent Would Not Have Been Obvious In
`Light of the Asserted References .......................................................... 2097
`
`The ’372 Patent is Not Invalid Under § 112 ......................................... 2228
`
`N.
`
`The ‘594 Patent ................................................................................................. 2237
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`The ’594 Patent Claims Eligible Subject Matter Under § 101 ............. 2237
`
`The Asserted Claims of the ‘594 Patent Are Not Anticipated by
`WO ‘118................................................................................................ 2241
`
`The Claims of the ‘594 Patent Would Not Have Been Obvious In
`Light of the Asserted References .......................................................... 2256
`
`The ’594 Patent is Not Invalid Under § 112 ......................................... 2387
`
`The ’594 Patent is Not Invalid for Obviousness-Type Double
`Patenting ............................................................................................... 2395
`
`O.
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`Objective Indicia of Non-Obviousness ............................................................. 2397
`
`1.
`
`2.
`
`Unexpected Results ............................................................................... 2397
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`Long-Felt Need and Failure of Others .................................................. 2424
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`8
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`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1019, p. 8 of 2444
`
`

`

`3.
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`4.
`
`5.
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`6.
`
`Skepticism ............................................................................................. 2434
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`Industry Praise ...................................................................................... 2436
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`Copying ................................................................................................. 2439
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`Commercial Success ............................................................................. 2439
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`CONFIDENTIAL
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`9
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`Hikma Pharmaceuticals
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`IPR2022-00215
`
`Ex. 1019, p. 9 of 2444
`
`

`

`
`
`I.
`
`INTRODUCTION
`
`On June 9, 2017, Defendants Dr. Reddy’s Laboratories, Inc., Dr. Reddy’s Laboratories,
`
`Ltd., Teva Pharmaceuticals USA, Inc., Andrx Labs, LLC, West-Ward Pharmaceutical Corp., and
`
`West-Ward Pharmaceuticals International Ltd. (collectively, “Defendants”) served Plaintiffs
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`Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Ltd. (collectively, “Amarin” or
`
`“Plaintiffs”) with Joint Preliminary Invalidity Contentions (“Defendants’ Joint Invalidity
`
`Contentions”) for the asserted claims of U.S. Patent Nos. 8,293,728 (“the ’728 patent”),
`
`8,318,715 (“the ’715 patent”), 8,357,677 (“the ’677 patent”), 8,367,652 (“the ’652 patent”),
`
`8,377,920 (“the ’920 patent”), 8,399,446 (“the ’446 patent”), 8,415,335 (“the ’335 patent”),
`
`8,426,399 (“the ’399 patent”), 8,431,560 (“the ’560 patent”), 8,440,650 (“the ’650 patent”),
`
`8,518,929 (“the ’929 patent”), 8,524,698 (“the ’698 patent”), 8,546,372 (“the ’372 patent”), and
`
`8,617,594 (“the ’594 patent”) (collectively, the “asserted patents” or the “patents-in-suit”).1
`
`Pursuant to Local Patent Rule 1-10, Plaintiffs hereby provide to Defendants the following
`
`Responses to Defendants’ Joint Invalidity Contentions.
`
`The Asserted Claims of the ‘728 patent are Claims 1-19; the Asserted Claims of the ‘715
`
`patent are Claims 1-19; the Asserted Claims of the ‘677 patent are Claims 1-9; the Asserted
`
`Claims of the ‘652 patent are Claims 1-18; the Asserted Claims of the ‘920 patent are Claims 1-
`
`10; the Asserted Claims of the ‘446 patent are Claims 1-11; the Asserted Claims of the ‘335
`
`patent are Claims 1-29; the Asserted Claims of the ‘399 patent are Claims 1-9; the Asserted
`
`Claims of the ‘560 patent are Claims 1-20; the Asserted Claims of the ‘650 patent are Claims 1-
`
`14; the Asserted Claims of the ‘929 patent are Claims 1-9; the Asserted Claims of the ‘698 patent
`
`
`1 The asserted claims of the Patents-in-Suit were identified in Plaintiffs’ Preliminary Infringement Contentions,
`served by Amarin on April 7, 2017.
`
`CONFIDENTIAL
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`23
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`24
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`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1019, p. 10 of 2444
`
`

`

`
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`are Claims 1-8; the Asserted Claims of the ‘372 patent are Claims 1-25; and the Asserted Claims
`
`of the ‘594 patent are Claims 1-7 and 10-26.
`
`Plaintiffs reserve the right to amend or supplement these contentions as discovery
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`proceeds in this case, as the Court construes the claims, and as permitted by the Court and the
`
`Nevada Local Patent Rules. In particular, fact discovery has just begun, no depositions have
`
`taken place, nor has any expert discovery commenced. Further, claim construction proceedings
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`have not yet begun and the Court has not construed the claims of the Asserted Patents.2
`
`Plaintiffs also reserve their right to amend or supplement these contentions in the event that
`
`Defendants amend their contentions to set forth additional combinations of references that it
`
`alleges render obvious any of the asserted claims, or in the event that any Defendant later
`
`produces references and/or amends its contentions to provide more specific information
`
`regarding any references. Furthermore, with respect to objective indicia of non-obviousness,
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`Plaintiffs reserve the right to amend or supplement these contentions as discovery proceeds in
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`this case. Plaintiffs further reserve their rights to amend or modify these contentions in the event
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`that the Court adopts particular claim constructions.
`
`Defendants’ Invalidity Contentions do not comply with Nevada Local Patent Rule (Local
`
`Pat. R.) 1-8, which requires Defendants to (1) indicate whether “each item of prior art”
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`anticipates or renders obvious each asserted claim, and if obviousness is alleged, (2) explain why
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`the alleged prior art renders the asserted claims obvious, and (3) identify “any combinations of
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`prior art showing obviousness.” Defendants have submitted over 650 alleged prior art references
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`in their contentions and failed to (1) indicate whether each item of alleged prior art anticipates or
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`2 Accordingly, these contentions should not be interpreted as a statement of Plaintiff’s position with respect to the
`construction of any claim terms.
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`CONFIDENTIAL
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`IPR2022-00215
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`Ex. 1019, p. 11 of 2444
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`renders obvious each asserted claim, (2) explain why the alleged prior art renders the asserted
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`claims obvious, and (3) identify “any combinations of prior art showing obviousness.”
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`In Exhibit O to Defendants’ Joint Invalidity Contentions, Defendants improperly list over
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`650 alleged prior art references. Defendants provide no specificity and do not even indicate
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`whether a particular reference is relied upon for anticipation or obviousness. Defendants do not
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`formulate a specific theory of alleged prima facie obviousness of any claim of the asserted
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`patents and fail to articulate their alleged invalidity challenge with the required specificity. For
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`example, the Defendants do not: (1) identify which of these 650 references, or which portion of
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`the reference, is being relied upon; (2) indicate whether any of the 650 references are relied upon
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`alone or in some identified combination; or (3) identify which specific claims are allegedly
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`obvious over a specific reference or combination. Instead of crystallizing one or more theories
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`of either anticipation or obviousness as the Local Rules require, Defendants broadly reserve the
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`right to rely on any of the over 650 references and provide the specificity and detail required by
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`the Local Rules at some future date. Such wholesale importation of prior art does not comply
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`with the specific requirements of Local Pat. R. 1-8. Defendants’ generalized, purportedly non-
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`limiting contentions do not comply with the Local Rules and do not allow Plaintiffs an
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`opportunity to fairly respond to Exhibit O given the absence of any explanation defining how
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`each alleged prior art reference is being relied upon for anticipation or obviousness.
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`Defendants’ Joint Invalidity Contentions are separately inadequate and do not comply
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`with Nevada’s Local Patent Rules because they do not formulate a specific theory of alleged
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`prima facie obviousness of any claim of the asserted patents and fail to focus their alleged
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`invalidity challenge. For example, on pgs. 13-23 of Defendants’ Joint Invalidity Contentions,
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`Defendants list 77 alleged prior art references from the 650 alleged prior art references listed in
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`Hikma Pharmaceuticals
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`IPR2022-00215
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`Ex. 1019, p. 12 of 2444
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`Exhibit O. Although Defendants provide summaries of these 77 alleged prior art references in
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`pgs. 26-155 of their Contentions, Defendants again fail to: (1) provide any indication of whether
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`a reference is being relied upon for anticipation or obviousness; (2) explain how each alleged
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`prior art reference relied upon for obviousness renders the asserted claims obvious; or (3)
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`identify the specific combinations of alleged prior art relied on to allegedly establish obviousness
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`of any specific claim.
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`For example, with respect to anticipation, Defendants specifically identify only one
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`alleged prior art reference, WO 2007/142118, as anticipatory. Although Local Pat. R. 1-8(c)
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`makes clear that a simple declaration that alleged prior art renders asserted claims obvious is
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`insufficient, Defendants rely on exactly such an assertion—that each of the 77 alleged prior art
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`references either anticipates or renders obvious each asserted claim. Nevada’s Local Patent
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`Rules require Defendants set forth an explanation or theory of why the alleged prior art renders
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`the asserted claims obvious, and identify “any combinations of prior art showing obviousness.”
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`Defendants’ attempt to rely on any or all of the 77 alleged prior art references, without providing
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`anything more than generalized and conclusory statements, deprives Plaintiffs of the “parity,”
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`“focus,” and notice contemplated by the Local Patent Rules.
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`Similarly, Defendants’ disclosure with respect to the prior art products Epadel and
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`Lovaza/Omacor is inadequate and does not comply with Nevada’s Local Patent Rules.
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`Defendants make the unsupported assertion that these products “anticipate and/or render obvious
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`on or more of the Asserted Claims, alone or in combination with the prior art listed above.”3
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`Defendants, however offer no explanation as to how or why these products would render the
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`asserted claims anticipated or obvious, nor do they identify “any combinations of prior art
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`3 Defendants’ Joint Invalidity Contentions at 24.
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`IPR2022-00215
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`Ex. 1019, p. 13 of 2444
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`showing obviousness.” Accordingly, Defendants have not properly disclosed any invalidity
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`contention with respect to these products. Plaintiffs reserve the right to move to strike any
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`attempt by Defendants to belatedly offer invalidity arguments relying on these products.
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`Defendants also characterize their Joint Contentions as “non-limiting, illustrative,”4 and
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`apparently reserve the right to add additional references, combinations and theories. Plaintiffs
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`clearly cannot respond to unstated invalidity theories or compilations of broad assertions without
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`any grounding in specific asserted claims or combinations of alleged prior art references.5
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`For all the reasons stated above, Plaintiffs reserve the right to oppose Defendants’
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`attempts to amend their contentions, under Local Patent Rule 1-12, to add additional invalidity
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`theories, prior art, prior art combinations, or other disclosures not fairly presented in Defendants’
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`Joint Invalidity Contentions, served on June 10, 2017. Plaintiffs also reserve the right to strike
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`any subsequent submissions, briefing or attempts to belatedly disclose new invalidity positions,
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`including but not limited to expert reports or testimonies articulating a theory or prior art
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`combination not fairly presented in Defendants’ Joint I