Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 1 of 31
`
`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
`
`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
`
`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
`
`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.,
`
`JOINT STIPULATIONS OF FACT
`
`
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`Defendants.
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`IPR2022-00215
`
`Ex. 1017, p. 1 of 31
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 2 of 31
`
`
`
`I.
`
`INTRODUCTION
`
`1.
`
`This is a civil action for patent infringement arising under the patent laws
`
`of the United States, 35 U.S.C. § 100, et seq., including 35 U.S.C. § 271(e)(2), and the
`Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, arising from Defendants’1 filing of
`Abbreviated New Drug Applications (“ANDAs”) under Section 505(j) of the Federal Food,
`
`Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(j), seeking approval from the United States
`Food and Drug Administration (“FDA”) to market generic versions of Plaintiffs’2 VASCEPA®
`product.
`
`II.
`For purposes of this case only, the parties stipulate to the following facts, which require
`
`STIPULATED FACTS
`
`no proof at trial:
`A.
`
`THE PARTIES
`2.
`
`Plaintiff Amarin Pharma, Inc. is a company organized and existing under
`
`the laws of Delaware with its principal place of business at 440 Route 22, Bridgewater, NJ
`
`08807.
`
`3.
`
`Plaintiff Amarin Pharmaceuticals Ireland Limited
`
`is a company
`
`incorporated under the laws of Ireland with registered offices at 88 Harcourt Street, Dublin 2,
`
`Dublin, Ireland.
`4.
`
`Defendant Hikma Pharmaceuticals USA Inc. is a company organized and
`
`existing under the laws of Delaware with its principal place of business at 246 Industrial Way
`
`West, Eatontown, NJ 07724.
`
`
`1 Defendants Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals International
`Limited (collectively, “Hikma”) and Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
`Laboratories, Ltd. (collectively, “DRL”) (Hikma and DRL collectively, “Defendants”).
`2 Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited
`(collectively, “Plaintiffs” or “Amarin”).
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`IPR2022-00215
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`Ex. 1017, p. 2 of 31
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`

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`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 3 of 31
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`
`
`5.
`
`Defendant Hikma Pharmaceuticals International Limited is a company
`
`incorporated under the laws of the United Kingdom with registered offices at 1 New Burlington
`
`Place, London, England W1S 2HR.
`6.
`
`Defendant Dr. Reddy’s Laboratories, Inc. is a company organized and
`
`existing under the laws of New Jersey with its principal place of business at 107 College Road
`
`East, Princeton, NJ 08540.
`7.
`
`Defendant Dr. Reddy’s Laboratories, Ltd. is an Indian public limited
`
`liability company organized and existing under the laws of India and having a principal place of
`
`business at 8-2-337, Road No. 3, Banjara Hills, Hyderabad, Andhra Pradesh 500 034, India.
`B.
`
`THE ASSERTED PATENTS
`8.
`
`Amarin Pharmaceuticals Ireland Limited is the owner of the Asserted
`
`Patents.3
`
`9.
`
`Each of the Asserted Patents is entitled “METHODS OF TREATING
`
`HYPERTRIGLYCERIDEMIA.”
`10.
`
`The U.S. Applications that ultimately issued as the Asserted Patents are
`
`continuations of U.S. Application No. 12/702,889, filed on February 9, 2010, which ultimately
`
`issued as U.S. Patent No. 8,293,727 (“the ’727 Patent”).
`11.
`
`The Asserted Patents further claim priority to U.S. Provisional Application
`
`No. 61/151,291, filed on February 10, 2009, and U.S. Provisional Application No. 61/173,755,
`
`filed on April 29, 2009.
`12. Mehar Manku, Ian Osterloh, Pierre Wicker, Rene Braeckman, and Paresh
`
`Soni are named as inventors of the Asserted Patents.
`
`
`3 U.S. Patent No. 8,293,728 (“the ’728 Patent”), U.S. Patent No. 8,318,715 (“the ’715
`Patent”), U.S. Patent No. 8,357,677 (“the ’677 Patent”), U.S. Patent No. 8,367,652 (“the ’652
`Patent”), U.S. Patent No. 8,431,560 (“the ’560 Patent”), and U.S. Patent No. 8,518,929 (“the
`’929 Patent”)
`
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`IPR2022-00215
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`Ex. 1017, p. 3 of 31
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`

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`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 4 of 31
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`
`
`13.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the Asserted Patents are listed in the
`
`Orange Book—published by FDA and formally known as Approved Drug Products with
`
`Therapeutic Equivalence Evaluations—in connection with New Drug Application (“NDA”) No.
`
`202057.
`1.
`
`The ’728 Patent
`14.
`15.
`
`The PTO issued the ’728 Patent on October 23, 2012.
`
`Amarin Pharmaceuticals Ireland Limited filed U.S. Application No.
`
`13/349,153, which ultimately issued as the ’728 Patent, on January 12, 2012.
`16.
`
`U.S. Application No. 13/349,153 is a continuation of U.S. Application No.
`
`12/702,889, filed on February 9, 2010, now the ’727 Patent.
`2.
`
`The ’715 Patent
`17.
`18.
`
`The PTO issued the ’715 Patent on November 27, 2012.
`
`The PTO issued a Certificate of Correction to the ’715 Patent on August
`
`11, 2015.
`
`2019.
`
`19.
`
`The PTO issued a Certificate of Correction to the ’715 Patent on May 21,
`
`20.
`
`Amarin Pharmaceuticals Ireland Limited filed U.S. Application No.
`
`13/282,145, which ultimately issued as the ’715 Patent, on October 26, 2011.
`21.
`
`U.S. Application No. 13/282,145 is a continuation of U.S. Application No.
`
`12/702,889, filed on February 9, 2010, now the ’727 Patent.
`3.
`
`The ’677 Patent
`22.
`23.
`
`The PTO issued the ’677 Patent on January 22, 2013.
`
`Amarin Pharmaceuticals Ireland Limited filed U.S. Application No.
`
`13/608,775, which ultimately issued as the ’677 Patent, on September 10, 2012.
`24.
`
`U.S. Application No. 13/608,775 is a continuation of U.S. Application No.
`
`13/349,153, filed on January 12, 2012, now the ’728 Patent, which is a continuation of U.S.
`
`Application No. 12/702,889, filed on February 9, 2010, now the ’727 Patent.
`
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`IPR2022-00215
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`Ex. 1017, p. 4 of 31
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`

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`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 5 of 31
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`
`
`4.
`
`The ’652 Patent
`25.
`26.
`
`The PTO issued the ’652 Patent on February 5, 2013.
`
`Amarin Pharmaceuticals Ireland Limited filed U.S. Application No.
`
`13/610,247, which ultimately issued as the ’652 Patent, on September 11, 2012.
`27.
`
`U.S. Application No. 13/610,247 is a continuation of U.S. Application No.
`
`13/349,153, filed on January 12, 2012, now the ’728 Patent, which is a continuation of U.S.
`
`Application No. 12/702,889, filed on February 9, 2010, now the ’727 Patent.
`5.
`
`The ’560 Patent
`28.
`29.
`
`The PTO issued the ’560 Patent on April 30, 2013.
`
`Amarin Pharmaceuticals Ireland Limited filed U.S. Application No.
`
`13/711,329, which ultimately issued as the ’560 Patent, on December 11, 2012.
`30.
`
`U.S. Application No. 13/711,329 is a continuation of U.S. Application No.
`
`13/623,450, filed on September 20, 2012, now the ’920 Patent, which is a continuation of U.S.
`
`Application No. 13/349,153, filed on January 12, 2012, now the ’728 Patent, which is a
`
`continuation of U.S. Application No. 12/702,889, filed on February 9, 2010, now the ’727
`
`Patent.
`
`6.
`
`The ’929 Patent
`31.
`32.
`
`The PTO issued the ’929 Patent on August 27, 2013.
`
`Amarin Pharmaceuticals Ireland Limited filed U.S. Application No.
`
`13/776,242, which ultimately issued as the ’929 Patent, on February 25, 2013.
`33.
`
`U.S. Application No. 13/776,242 is a continuation of U.S. Application No.
`
`13/711,329, filed on December 11, 2012, now the ’560 Patent, which is a continuation of U.S.
`
`Application No. 13/623,450, filed on September 20, 2012, now the ’920 Patent, which is a
`
`continuation of U.S. Application No. 13/349,153, filed on January 12, 2012, now the ’728
`
`Patent, which is a continuation of U.S. Application No. 12/702,889, filed on February 9, 2010,
`
`now the ’727 Patent.
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`IPR2022-00215
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`Ex. 1017, p. 5 of 31
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`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 6 of 31
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`
`
`7.
`
`Prior-Art References
`34.
`
`Epadel Capsules 300, Japan Pharmaceutical Reference 369 (2nd ed. 1991)
`
`(“Epadel JPR”) was published in 1991 and is prior art to the Asserted Patents.
`35. Matsuzawa et al., Effect of Long-Term Administration of Ethyl
`
`Icosapentate (MND-21) in Hyperlipidaemic Patients, 7 J. Clin. Therapeutic & Medicines 1801–
`
`1816 (1991) (“Matsuzawa”) was published in 1991 and is prior art to the Asserted Patents.
`36.
`
`Takaku et al., Study on the Efficacy and Safety of Ethyl Icosapentate
`
`(MND-21) in Treatment of Hyperlipidemia Based on a Long-Term Administration Test, 7 J. Clin.
`
`Therapeutics & Medicine 191–213 (1991) (“Takaku”) was published in 1991 and is prior art to
`
`the Asserted Patents.
`37. Wojenski et al., Eicosapentaenoic Acid Ethyl Ester as an Antithrombotic
`
`Agent: Comparison to an Extract of Fish Oil, Biochim. Biophys. Acta., 1081(1):33–38 (1991)
`
`(“Wojenski”) was published in 1991 and is prior art to the Asserted Patents.
`38.
`
`Nozaki et al., Effects of Purified Eicosapentaenoic Acid Ethyl Ester on
`
`Plasma Lipoproteins in Primary Hypercholesterolemia, 62 Int’l J. Vitamin & Nutrition Res.
`
`256–60 (1992) (“Nozaki”) was published in 1992 and is prior art to the Asserted Patents.
`39.
`
`Hayashi et al., Decreases in Plasma Lipid Content and Thrombotic
`
`Activity by Ethyl Icosapentate Purified from Fish Oils, 56(1) Curr. Therap. Res. 24–31 (1995)
`
`(“Hayashi”) was published in 1995 and is prior art to the Asserted Patents.
`40.
`
`Shinozaki et al., The Long-Term Effect of Eicosapentaenoic Acid on
`
`Serum Levels of Lipoprotein (a) and Lipids in Patients with Vascular Disease, 2(2) J. Atheroscl.
`
`Thromb. 107–09 (1996) (“Shinozaki”) was published in 1995 and is prior art to the Asserted
`
`Patents.
`
`41.
`Grimsgaard et al., Highly Purified Eicosapentaenoic Acid and
`Docosahexaenoic Acid in Humans Have Similar Triacylglycerol- Lowering Effects but Divergent
`
`Effects on Serum Fatty Acids, 66 Am. J. Clin. Nutr. 649–59 (1997) (“Grimsgaard”) was
`
`published in 1997 and is prior art to the Asserted Patents.
`
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`IPR2022-00215
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`Ex. 1017, p. 6 of 31
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`

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`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 7 of 31
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`
`
`42.
`
`Harris
`
`et
`
`al., Safety and Efficacy of Omacor
`
`in Severe
`
`Hypertriglyceridemia, J. Cardiov. Risk, 4:385–391 (1997) (“Harris”) was published in 1997 and
`
`is prior art to the Asserted Patents.
`43.
`
`Saito et al., Results of Clinical Usage of Improved Formulation (MND-
`
`21S) Epadel Capsule 300 with Respect to Hyperlipidemia, 26(12) Jpn. Pharmacol. Ther. 2047–
`
`62 (1998) (“Saito”) was published in 1998 and is prior art to the Asserted Patents.
`44.
`Nakamura et al., Joint Effects of HMG-CoA Reductase Inhibitors and
`Eicosapentaenoic Acids on Serum Lipid Profile and Plasma Fatty Acid Concentrations in
`
`Patients with Hyperlipidemia, 29(1) Int. J. Clin. Lab. Res. 22–25 (1999) (“Nakamura”) was
`
`published in 1999 and is prior art to the Asserted Patents.
`45.
`
`Kurabayashi et al., Eicosapentaenoic Acid Effect on Hyperlipidemia in
`
`Menopausal Japanese Women, Obstet. Gynecol. 96:521–8 (2000) (“Kurabayashi”) was
`
`published in 2000 and is prior art to the Asserted Patents.
`46. Mori et al., Purified Eicosapentaenoic and Docosahexaenoic Acids Have
`Differential Effects on Serum Lipids and Lipoproteins, LDL Particle Size, Glucose, and Insulin
`
`in Mildly Hyperlipidemic Men, 71 Am. J. Clinical Nutrition 1085–94 (2000) (“Mori 2000”) was
`
`published in 2000 and is prior art to the Asserted Patents.
`47.
`
`National Institutes of Health, National Heart, Lung, and Blood Institute,
`
`“Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment
`
`Panel III, Executive Summary,” May 2001) (“ATP III Guidelines”) was published in 2001 and is
`
`prior art to the Asserted Patents.
`48.
`
`Katayama et al., Efficacy and Safety of Ethyl Icosapentate (Epadel®)
`
`Given for a Long Term Against Hyperlipidemia, 21 Prog. Med. 457–467 (2001) (“Katayama”)
`
`was published in 2001 and is prior art to the Asserted Patents.
`49.
`
`Nestel et al., The n-3
`
`fatty acids eicosapentaenoic acid and
`
`docosahexaenoic acid increase systemic arterial compliance in humans, 76 Am. J. Clin. Nutr.
`
`76:326–30 (2002) (“Nestel”) was published in 2002 and is prior art to the Asserted Patents.
`
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`IPR2022-00215
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`Ex. 1017, p. 7 of 31
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`

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`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 8 of 31
`
`
`
`50.
`
`Okumura et al., Eicosapentaenoic Acid Improves Endothelial Function in
`
`Hypertriglyceridemic Subjects Despite Increased Lipid Oxidizability, 324 Am. J. Med. Sci. 247–
`
`53 (2002) (“Okumura”) was published in 2002 and is prior art to the Asserted Patents.
`51.
`
`Park & Harris, Omega-3 Fatty Acid Supplementation Accelerates
`
`Chylomicron Triglyceride Clearance, 44 J. LIPID RES. 44:455-463 (2003) (“Park”) was
`
`published in 2003 and is prior art to the Asserted Patents.
`52.
`Yokoyama et al., Effects of eicosapentaenoic acid on cardiovascular
`events in Japanese patients with hypercholesterolemia: Rationale, design, and baseline
`
`characteristics of the Japan EPA Lipid Intervention Study (JELIS), 146 Am. Heart J. 613–20
`
`(2003) (“Yokoyama 2003”) was published in 2003 and is prior art to the Asserted Patents.
`53.
`
`Omacor® Label (2004) (“Omacor 2004”) was published in 2004 and is
`
`prior art to the Asserted Patents.
`54. Maki et al., Lipid responses to a dietary docosahexaenoic acid supplement
`
`in men and women with below average levels of high density lipoprotein cholesterol, 24 J. Am.
`
`Col. Nutr. 189–99 (2005) (“Maki”) was published in 2005 and is prior art to the Asserted
`
`Patents.
`
`55.
`
`Geppert et al., Microalgal Docosahexaenoic Acid Decreases Plasma
`
`Triacylglycerol in Normolipidaemic Vegetarians: A Randomized Trial, 95 Brit. J. Nutrition 779–
`
`86 (2006) (“Geppert”) was published in 2006 and is prior art to the Asserted Patents.
`56.
`
`Omacor®, Physicians’ Desk Reference 2735 (60d ed. 2006) (“Omacor
`
`PDR”) was published in 2006 and is prior art to the Asserted Patents.
`57.
`
`Lovaza®, Physicians’ Desk Reference 2699 (62d ed. 2007) (“Lovaza
`
`PDR”) was published in 2007 and is prior art to the Asserted Patents.
`58.
`
`Lovaza® Label 2007 (“Lovaza 2007”) was published in 2007 and is prior
`
`art to the Asserted Patents.
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`IPR2022-00215
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`Ex. 1017, p. 8 of 31
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`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 9 of 31
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`
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`59.
`
`Satoh et al., Purified Eicosapentaenoic Acid Reduces Small Dense LDL,
`
`Remnant Lipoprotein Particles, and C-Reactive Protein in Metabolic Syndrome, 30 Diabetes
`
`Care 144–146 (2007) (“Satoh”) was published in 2007 and is prior art to the Asserted Patents.
`60.
`
`Epadel Capsules 300 Package Insert, January 2007 Update (Version 5)
`
`(ICOSAPENT_DFNDTS00008961–969) (“Epadel PI 2007”) was published in 2007 and is prior
`
`art to the Asserted Patents.
`61.
`Yokoyama et al., Effects of Eicosapentaenoic Acid on Major Coronary
`Events in Hypercholesterolaemic Patients (JELIS): a Randomized Open-Label, Blinded Endpoint
`
`Analysis, 369 Lancet 1090–98 (2007) (“Yokoyama 2007”) was published in 2007 and is prior art
`
`to the Asserted Patents.
`62. WO 2007/142118 (“WO ’118”) was published on December 13, 2007 and
`
`is prior art to the Asserted Patents.
`63. WO 2008/004900 (“WO ’900”) was published on January 10, 2008 and is
`
`prior art to the Asserted Patents.
`64.
`Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High
`
`American Heart Association, Third Report of the National Cholesterol
`
`Blood Cholesterol in Adults (Adult Treatment Panel III) Final Report, 106 Circulation 3143
`
`(2002) was published in 2002 and is prior art to the Asserted Patents.
`65.
`
`Agren et al., Fish Diet, Fish Oil and Docosahexaenoic Acid Rich Oil
`
`Lower Fasting and Postprandial Plasma Lipid Levels, 50 European J. Clinical Nutrition 765
`
`(1996) was published in 1996 and is prior art to the Asserted Patents.
`66.
`
`Oh et al., Management of Hypertriglyceridemia, 75 American Family
`
`Physician 1365 (2007) was published in 2007 and is prior art to the Asserted Patents.
`67.
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`Isley et al., Pilot Study of Combined Therapy With ω-3 Fatty Acids and
`
`Niacin in Atherogenic Dyslipidemia, 1 J. Clinical Lipidology 211 (2007) was published in 2007
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`and is prior art to the Asserted Patents.
`
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`IPR2022-00215
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`Ex. 1017, p. 9 of 31
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`

`

`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 10 of 31
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`
`
`68. McLennan et al., The cardiovascular protective role of docosahexaenoic
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`acid, 300 European J. Pharmacology 83 (1996) was published in 1996 and is prior art to the
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`Asserted Patents.
`69.
`
`Bays et al., Prescription Omega-3 Fatty Acids and Their Lipid Effects:
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`Physiologic Mechanisms of Action and Clinical Implications, 6 Expert Reviews Cardiovascular
`
`Therapy 391 (2008) was published in 2008 and is prior art to the Asserted Patents.
`70.
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`Bays, Rationale for Prescription Omega-3-Acid Ethyl Ester Therapy for
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`Hypertriglyceridemia: A Primer for Clinicians, 44 Drugs of Today 205 (2008) was published in
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`2008 and is prior art to the Asserted Patents.
`71. Mori et al., Effect of Eicosapentaenoic Acid and Docosahexaenoic Acid on
`
`Oxidative Stress and Inflammatory Markers in Treated-Hypertensive Type 2 Diabetic Subjects,
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`35 Free Radic. Biol. Med. 772 (2003) was published in 2003 and is prior art to the Asserted
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`72.
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`Rambjor et al., Eicosapentaenoic Acid Is Primarily Responsible for
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`Hypotriglyceridemic Effect of Fish Oil in Humans, 31 Lipids S-45 (1996) was published in 1996
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`and is prior art to the Asserted Patents.
`73.
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`Balk et al., Effects of omega-3 fatty acids on serum markers of
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`cardiovascular disease risk: A systematic review, 189 Atherosclerosis 19 (2006) was published
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`in 2006 and is prior art to the Asserted Patents.
`74. Woodman, et al., Docosahexaenoic acid but not eicosapentaenoic acid
`
`increases LDL particle size in treated hypertensive type 2 diabetic patients, 26 Diabetes Care
`
`253 (2003) was published in 2003 and is prior art to the Asserted Patents.
`75. Woodman, et al., Effects of purified eicosapentaenoic acid and
`
`docosahexaenoic acid on platelet, fibrilolytic and vascular function in Type 2 diabetic patients,
`
`166 Atherosclerosis 85 (2003) was published in 2003 and is prior art to the Asserted Patents.
`
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`IPR2022-00215
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`Ex. 1017, p. 10 of 31
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`

`

`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 11 of 31
`
`
`
`76. Mori et al., Docosahexaenoic Acid but Not Eicosapentaenoic Acid Lowers
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`Ambulatory Blood Pressure and Heart Rate in Humans, 34 Hypertension 253 (1999) was
`
`published in 1999 and is prior art to the Asserted Patents.
`77.
`Nilsen et al., Effects of a High-Dose Concentrate of n-3 Fatty Acids or
`Corn Oil Introduced Early After an Acute Myocardial Infarction on Serum Triacylglycerol and
`
`HDL Cholesterol, 74 Am. J. Clinical Nutrition 50 (2001) was published in 2001 and is prior art
`
`to the Asserted Patents.
`78. Mori et al., Differential Effects of Eicosapentaenoic Acid and
`Docosahexaenoic Acid on Vascular Reactivity of
`the Forearm Microcirculation
`in
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`Hyperlipidemic, Overweight Men, 102 Circulation 1264 (2000) was published in 2000 and is
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`prior art to the Asserted Patents.
`79.
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`Austin et al., Hypertriglyceridemia as a Cardiovascular Risk Factor, 81
`
`Am. J. Cardiology 7B (1998) was published in 1998 and is prior art to the Asserted Patents.
`80.
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`Hooper et al., Risks and Benefits of Omega 3 Fats for Mortality,
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`Cardiovascular Disease, and Cancer: Systematic Review, 332 BMJ 752 (2006) was published in
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`2006 and is prior art to the Asserted Patents.
`81.
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`Rader, Lipid Disorders, in Textbook of Cardiovascular Medicine 55 (Eric
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`J. Topol ed., 3d ed. 2007) was published in 2007 and is prior art to the Asserted Patents.
`82.
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`von Schacky, A review of omega-3 ethyl esters for cardiovascular
`
`prevention and treatment of increased blood triglyceride levels, 2 Vascular Health and Risk
`
`Management 251 (2006) was published in 2006 and is prior art to the Asserted Patents.
`83.
`
`Hamazaki et al., Docosahexaenoic Acid-Rich Fish Oil Does Not Affect
`
`Serum Lipid Concentrations of Normolipidemic Young Adults, 126 The Journal of Nutrition 2784
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`(1996) was published in 1996 and is prior art to the Asserted Patents.
`84.
`al., Supplementation with an Algae Source of
`Docosahexaenoic Acid Increases (n-3) Fatty Acid Status and Alters Selected Risk Factors for
`
`Conquer
`
`et
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`IPR2022-00215
`
`Ex. 1017, p. 11 of 31
`
`

`

`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 12 of 31
`
`
`
`Heart Disease in Vegetarian Subjects, 126 The Journal of Nutrition 3032 (1996) was published
`
`in 1996 and is prior art to the Asserted Patents.
`85. McKenney, Prescription omega-3 fatty acids for the treatment of
`
`hypertriglyceridemia, 64 Am. J. Health-System Pharmacy 595 (2007) was published in 2007 and
`
`is prior art to the Asserted Patents.
`86. McKenney et al., Role of Prescription Omega-3 Fatty Acids in the
`
`Treatment of Hypertriglyceridemia, 27 Pharmacotherapy 715 (2007) was published in 2007 and
`
`is prior art to the Asserted Patents.
`87.
`
`Center for Drug Evaluation and Research, FDA, Application Number 21-
`
`654, Statistical Review(s) (2004) (“Lovaza Statistical Review”) was published in 2004 and is
`
`prior art to the Asserted Patents.
`88.
`
`Center for Drug Evaluation and Research, FDA, Approval Package for
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`Application Number 21-654, Medical Review (2004) ("Lovaza Medical Review") was published
`
`in 2004 and is prior art to the Asserted Patents.
`89.
`
`Buckley et al., Circulating triacylglycerol and apoE levels in response to
`
`EPA and docosahexaenoic acid supplementation in adult human subjects, 92 British J. Nutrition
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`477(2004) was published in 2004 and is prior art to the Asserted Patents.
`90.
`
`Nelson el al., The Effect of Dietary Docosahexaenoic Acid on Plasma
`
`Lipoproteins and Tissue Fatty Acid Composition in Humans, 32 Lipids 1137 (1997) was
`
`published in 1997 and is prior art to the Asserted Patents.
`91. Woodman
`Docosahexaenoic Acids on Glycemic Control, Blood Pressure, and Serum Lipids in Type 2
`
`al., Effects of Purified Eicosapentaenoic and
`
`et
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`Diabetic Patients with Treated Hypertension, 76 Am. J. Clinical Nutrition 1007 (2002) was
`
`published in 2002 and is prior art to the Asserted Patents.
`92.
`
`Grundy et al., Diagnosis and Management of the Metabolic Syndrome: An
`
`American Heart Association/Nat’l Heart, Lung, and Blood Institute Scientific Statement, 21
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`IPR2022-00215
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`Ex. 1017, p. 12 of 31
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`

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`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 13 of 31
`
`
`
`Current Opinion Cardiology 1 (2006) was published in 2006 and is prior art to the Asserted
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`Patents.
`
`93.
`
`Itoi, H. et al., Comparison of the long-term effects of oral estriol with the
`
`effects of conjugated estrogen on serum lipid profile in early menopausal women, 36 Maturitas
`
`217 (2000) was published in 2000 and is prior art to the Asserted Patents.
`94. Weber et al., Docosahexaenoic Acid Selectively Attenuates Induction of
`Vascular Cell Adhesion Molecule-1 and Subsequent Monocytic Cell Adhesion to Human
`
`Endothelial Cells Stimulated by Tumor Necrosis Factor-α, 15 Arteriosclerosis Thrombosis
`
`Carlson et al., On the rise in low density and high density lipoproteins in
`
`Vascular Biology 622 (1995) was published in 1995 and is prior art to the Asserted Patents.
`95.
`the
`
`response
`
`to
`
`treatment of hypertriglyceridaemia
`
`in
`
`type
`
`IV and
`
`type V
`
`hyperlipoproteinaemias, 26 Atherosclerosis 603 (1977) was published in 1977 and is prior art to
`
`the Asserted Patents.
`96. Mahley et al., Drug Therapy for Hypercholesterolemia and Dyslipidemia,
`
`in The Pharmacological Basis of Therapeutics 933 (Goodman Gilman et al. eds., 11th ed. 2005)
`
`was published in 2005 and is prior art to the Asserted Patents.
`97.
`
`Grimsgaard et al., Effects of highly purified eicosapentaenoic acid and
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`docosahexaenoic acid on hemodynamics in humans, 68 Am. J. Clin. Nutr. 52 (1998) was
`
`published in 1998 and is prior art to the Asserted Patents.
`98.
`
`Harris, W., Fish Oils and Plasma Lipid and Lipoprotein Metabolism in
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`Humans: A Critical Review, 30 J. Lipid Research 785 (1989) was published in 1989 and is prior
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`art to the Asserted Patents.
`99. Maitra et al., Comparison of two assays for measuring LDL cholesterol,
`
`43 Clinical Chemistry 1040 (1997) was published in 1997 and is prior art to the Asserted Patents.
`100. Nauck et al., Methods for Measurement of LDL-Cholesterol: A Critical
`
`Assessment of Direct Measurement by Homogeneous Assays versus Calculation, 48 Clinical
`
`Chemistry 236 (2002) was published in 2002 and is prior art to the Asserted Patents.
`
`
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`IPR2022-00215
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`Ex. 1017, p. 13 of 31
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`

`

`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 14 of 31
`
`
`
`101. Rifai et al., Measurement of Low-Density-Lipoprotein Cholesterol in
`
`Serum: a Status Report, 38 Clin. Chem. 150 (1992) was published in 1992 and is prior art to the
`
`Asserted Patents.
`102. Westerveld et al., Effects of Low-Dose EPA-E on Glycemic Control, Lipid
`Profile, Lipoprotein(a), Platelet Aggregation, Viscosity, and Platelet and Vessel Wall Interaction
`
`in NIDDM, 16 Diabetes Care 683 (1993) was published in 1993 and is prior art to the Asserted
`
`Patents.
`
`103.
`
` LOPID®, Physicians’ Desk Reference 1626 (44th ed. 1990) was
`
`published in 1990 and is prior art to the Asserted Patents.
`104. LOPID® Physicians’ Desk Reference 2554 (58th ed. 2004) was published
`
`in 2004 and is prior art to the Asserted Patents.
`105. TRICOR® Label (2004) was published in 2004 and is prior art to the
`
`Asserted Patents.
`106. TRICOR® Physicians’ Desk Reference 527 (61st ed. 2007) was published
`
`in 2007 and is prior art to the Asserted Patents.
`107. EP 0 273 708 A2 was issued on July 6, 1988 and is prior art to the
`
`Asserted Patents.
`108. EP 0 277 747 was issued on August 10, 1988 and is prior art to the
`
`Asserted Patents.
`109. EP 0 347 509 was issued on December 27, 1988 and is prior art to the
`
`Asserted Patents.
`110. U.S. Patent No. 5,215,630 was issued on June 1, 1993 and is prior art to
`
`the Asserted Patents.
`111.
`
` U.S. Patent No. 5,840,944 was issued on November 24, 1998 and is prior
`
`art to the Asserted Patents.
`112. U.S. Patent No. 6,303,330 was issued on November 6, 2001 and is prior
`
`art to the Asserted Patents.
`
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`IPR2022-00215
`
`Ex. 1017, p. 14 of 31
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`

`

`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 15 of 31
`
`
`
`113. U.S. Patent No. 6,384,077 was issued on May 7, 2002 and is prior art to
`
`the Asserted Patents.
`114. U.S. Patent No. 6,846,942 was issued on January 25, 2005 and is prior art
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`to the Asserted Patents.
`115. U.S. Patent Application Publication No. 2003/0104048 was published on
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`June 5, 2003 and is prior art to the Asserted Patents.
`116. U.S. Patent Application Publication No. 2006/0134178 was published on
`
`June 22, 2006 and is prior art to the Asserted Patents.
`117. Ando, Eicosapent Acid Reduces Plasma Levels of Remnant Lipoproteins
`
`and Prevents in Vivo Peroxidation of LDL in Dialysis Patients, 10 J. AM NEPHROL 2177 (1999)
`
`was published in 1999 and is prior art to the Asserted Patents.
`118. Chan et al., Factorial study of the effects of atorvastatin and fish oil on
`
`dyslipidaemia in visceral obesity, 32 EUROPEAN J. OF CLINICAL INVESTIGATION 429-436 (2002)
`
`was published in 2002 and is prior art to the Asserted Patents.
`119. Contacos et al., Effect of Pravastatin and w-3 Fatty Acids on Plasma
`
`Lipids and Lipoproteins in Patients With Combined Hyperlipidemia, 13 ARTERIOR THROMB
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`VASC BIOL. 1755-1762 (1993) was published in 1993 and is prior art to the Asserted Patents.
`120. Kelley et al., Docosahexaenoic Acid Supplementation Improves Fasting
`
`and Postprandial Lipid Profiles in Hpertriglyceridemic Men, 86:2 CLINICAL NUTRITION 324-333
`
`(2007) was published in 2007 and is prior art to the Asserted Patents.
`121. Leigh-Firbank et al, Eicosapentaenoic Acid and Docosahexaenic Acid
`
`from Fish Oils: Differential Associations with Lipid Responses, 87 BRITISH J. OF NUTRITION
`
`435-445 (2002) was published in 2002 and is prior art to the Asserted Patents.
`122. Lovegrove, et al., Moderate Fish-oil Supplementation Reverses Low-
`Platelet, Long-chain n-3 Polyunsaturated Fatty Acid Status and Reduces Plasma Triacylglycerol
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`Concentrations in British Indo-Asians, 79 CLINICAL NUTRITION 974-982 (2004) was published in
`
`2004 and is prior art to the Asserted Patents.
`
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`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1017, p. 15 of 31
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`

`

`Case 2:16-cv-02525-MMD-NJK Document 324 Filed 01/06/20 Page 16 of 31
`
`
`
`123. Mataki, et al., Effect of Eicosapentaenoic Acid in Combination with HMG-
`
`CoA Reductase Inhibitor on Lipid Metabolism, 5:1 INTERNATIONAL MEDICAL J. 35-36 (1998)
`
`124. Pownall, et al., Correlation of Serum Triglyceride and Its Reduction by ꙍ-
`
`was published in 1998 and is prior art to the Asserted Patents.
`
`3 Fatty Acids with Lipid Transfer Activity and the Neutral Lipid Compositions of High-density
`
`and Low-density Lipoproteins, ATHEROSCLROSIS (1998) was published in 1998 and is prior art to
`
`the Asserted Patents.
`125. Theobald, et al., LDL Cholesterol-raising Effect of Low-dose
`
`Docosahexaenoic Acid in Middle-aged Men and Women, 79:4 CLINICAL NUTRITION 558-563
`
`(2004) was published in 2004 and is prior art to the Asserted Patents.
`126. Virani and Nambi, The Role of