The detailed information for PTAB case with proceeding number IPR2022-00215 filed by Hikma Pharmaceuticals USA Inc. et al. against Amarin Pharmaceuticals Ireland Limited on Nov 30, 2021. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2022-00215
Filing Date
Nov 30, 2021
Petitioner
Hikma Pharmaceuticals USA Inc. et al.
Respondent
Amarin Pharmaceuticals Ireland Limited
Status
Terminated-Settled
Respondent Application Number
13768906
Respondent Tech Center
1600
Respondent Patent Number
8642077
Termination Date
Mar 14, 2022

Proceeding Documents

The table below shows documents filed in the case, listing each document name, filing date, document type, and filing party. Tracking these filings indicates the activity of the parties involved in the case, and the types of documents filed can provide insights into the legal strategies being employed.


Document NameFiling DateCategoryFiling Party

Alert me when new update on this case

Notice: refund approved

Mar 22, 2022PAPERBOARD

Petitioners' Request For Refund Of Post-Institution Fees

Mar 15, 2022PAPERPETITIONER

Termination Decision: Settlement Prior to Institution of Trial

Mar 14, 2022PAPERBOARD

Joint Request That Agreement Be Treated As Business Confidential Information And Kept Separate Under 35 U.S.C. �� 317(b)

Mar 10, 2022PAPERPETITIONER

EXPUNGED

Mar 10, 2022EXHIBITPETITIONER

Joint Motion To Terminate

Mar 10, 2022PAPERPETITIONER

Ex. 1050-Settlement Agreement (Business Confidential)

Mar 10, 2022EXHIBITPETITIONER

Patent Owner's Mandatory Notices

Mar 8, 2022PAPERPATENT OWNER

Patent Owner's Power of Attorney

Mar 8, 2022PAPERPATENT OWNER

Notice: Notice filing date accorded

Dec 14, 2021PAPERBOARD

Ex. 1001 - U.S. Patent No. 8,642,077 B2 to Manku et al.

Nov 30, 2021EXHIBITPETITIONER

Ex. 1003 - WO 2007/142118 to Yokoyama et al. (2007) (certified English translation)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1004 - 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 Nutri. 1085

Nov 30, 2021EXHIBITPETITIONER

Ex. 1005 - 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 (2007)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1006 - Satoh et al., Purified Eicosapentaenoic Acid Reduces Small Dense LDL, Remnant Lipoprotein Particles, and C-Reactive Protein in Metabolic Syndrome, 30:1 Diabetes Care 144 (2007)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1007 - 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 (1997)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1008 -Third Report of the National Cholesterol Education Program (N CEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel 111) Final Report (Sept. 2002) Part 1

Nov 30, 2021EXHIBITPETITIONER

Ex. 1008 -Third Report of the National Cholesterol Education Program (N CEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel 111) Final Report (Sept. 2002) Part 2

Nov 30, 2021EXHIBITPETITIONER

Ex. 1008 - Third Report of the National Cholesterol Education Program (N CEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel 111) Final Report (Sept. 2002) Part 3

Nov 30, 2021EXHIBITPETITIONER

Ex. 1009 - Plaintiffs' Corrected Post-Trial Proposed Findings of Fact and Conclusions of Law (Feb. 27, 2020) from Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 16-2525, D.I. 377, 510 (D. Nev.)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1010 - Day 2 (Jan. 14, 2020) Trial Transcript from Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 16-2525 (D. Nev.) (Testimony of Dr. Budoff)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1011 -Vital and Health Statistics, Serum Lipids of Adults 20-74 Years: United States, 1976-80, 11:242, Nat'l Health Survey, U.S. Dept. Health & Human Servs. (Mar. 1993)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1012 - Schmidt et al., Lipid evaluation in HIV-1-positive patients treated with protease inhibitors, 4 Antiviral Ther. 163-170 (1999)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1014 - Lovaza, Physicians' Desk Reference 2699 (62d ed. 2007)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1015 - Nozaki et al., Effects of Purified Eicosapentaenoic Acid Ethyl Ester on Plasma Lipoproteins in Primary Hypercholesterolemia, 62 Int'l J. Vitamin & Nutr. Res. 256- 60 (1992)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1016 - 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)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1017 - Joint Stipulations of Fact from Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 16-2525 (D. Nev.)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1018 - Day 7 (Jan. 28, 2020) Trial Transcript from Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 16-2525 (D. Nev.) (Testimony of Dr. Toth)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1020 -Plaintiffs' Infringement Contentions from Amarin Pharma, Inc. et al. vs. Hikma Pharms. USA Inc. et al., C.A. No. 20-1630 (D. Del.)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1019 -Plaintiffs' Validity Contentions from Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 16-2525 (D. Nev.) Part 1

Nov 30, 2021EXHIBITPETITIONER

Ex. 1019 -Plaintiffs' Validity Contentions from Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 16-2525 (D. Nev.) Part 2

Nov 30, 2021EXHIBITPETITIONER

Ex. 1019 -Plaintiffs' Validity Contentions from Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 16-2525 (D. Nev.) Part 3

Nov 30, 2021EXHIBITPETITIONER

Ex. 1019 -Plaintiffs' Validity Contentions from Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 16-2525 (D. Nev.) Part 4

Nov 30, 2021EXHIBITPETITIONER

Ex. 1021 - Plaintiffs' Opposition to Motion to Dismiss from Amarin Pharma, Inc. et al. vs. Hikma Pharms. USA Inc. et al., C.A. No. 20-1630 (D. Del.)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1022 - Plaintiffs' First Amended Complaint from Amarin Pharma, Inc. et al. vs. Hikma Pharms. USA Inc. et al., C.A. No. 20-1630 (D. Del.) (D.I.17)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1023 - Exhibit U to Plaintiffs' First Amended Complaint,Ballantyne et al., Efficacy and Safety of Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Statin-Treated Patients with Persistent High Triglycerides

Nov 30, 2021EXHIBITPETITIONER

Ex. 1024 - Exhibit V to Plaintiffs' First Amended Complaint, Bhatt et al., Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia, 380:1 N. Engl. J. Med. 11-22 (2018)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1025 -Amarin Response to U.S. Patent Office re U.S. Patent Application No. 17/768,906 (Aug. 26, 2013)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1026 - Davidson et al., Efficacy and Tolerability of Adding Prescription Omega-3 Fatty Acids 4 g/d to Simvastatin 40 mg/d in Hypertriglyceridemic Patients

Nov 30, 2021EXHIBITPETITIONER

Ex. 1027 - Saito et al., Effects of EPA on Coronary Artery Disease in Hypercholesterolemic Patients with Multiple Risk Factors: Sub-Analysis of Primary Prevention Cases from the Japan EPA Lipid Intervention Study (JELIS)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1028 - Notice of Allowability from U.S. Patent Office re U.S. Patent Application No. 13/768,906 (Sept. 30, 2013)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1029 - FDA Briefing Document, Endocrinologic and Metabolic Drugs, Advisory Committee Meeting regarding ANCHOR trial (Oct. 16, 2013)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1030 -U.S. Patent Office Interview Summary re U.S. Patent Application No. 13/614,111 (Dec. 12, 2012)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1031 - Amarin Supplemental Response to U.S. Patent Office re U.S. Patent Application No. 13/614,111 (Jan. 11, 2013)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1032 - Notice of Allowability from U.S. Patent Office re U.S. Patent Application No. 13/614,111 (Feb. 11, 2013)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1033 - Vascepa Label (12/2019)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1034 - World Health Organization Memorandum, Classification of Hyperlipoproteinemias, 43:891, 501-508 (1972)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1035 - Declaration of C. Rosebraugh from Amarin Pharma, Inc. et al. v. U.S. F.D.A. et al., No. 15-3588 (S.D.N.Y.)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1036 - Scheduling Order from Amarin Pharma, Inc. et al. vs. Hikma Pharms. USA Inc. et al., C.A. No. 20-1630 (D. Del.)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1037 - Hikma's Motion to Dismiss from Amarin Pharma, Inc. et al. vs. Hikma Pharms. USA Inc. et al., C.A. No. 20-1630 (D. Del.)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1038 - Office Action from U.S. Patent Office re U.S. Patent Application No. 13/768,906 (May 24, 2013)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1039 -Original Japanese version of WO 2007/142118 to Yokoyama et al.

Nov 30, 2021EXHIBITPETITIONER

Ex. 1040 - U.S. Patent No. 6,384,077 to Peet et al.

Nov 30, 2021EXHIBITPETITIONER

Ex. 1041 - U.S. Patent No. 6,479,544 to Horrobin

Nov 30, 2021EXHIBITPETITIONER

Ex. 1042 - U.S. Patent No. 7,119,118 to Peet et al.

Nov 30, 2021EXHIBITPETITIONER

Ex. 1043 - Amarin Reports Fourth Quarter and Full Year 2004 Results Report

Nov 30, 2021EXHIBITPETITIONER

Ex. 1044 - U.S. Patent Application Publication No. 2007/0021504 A1 to Yokoyama et al.

Nov 30, 2021EXHIBITPETITIONER

Ex. 1045 - 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

Nov 30, 2021EXHIBITPETITIONER

Ex. 1046 - Joint Claim Construction Chart from Amarin Pharma, Inc. et al. vs. Hikma Pharms. USA Inc. et al., C.A. No. 20-1630 (D. Del.)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1047 - Curriculum vitae of Edward A. Fisher

Nov 30, 2021EXHIBITPETITIONER

Ex. 1048 -Lipitor (atorvastatin calcium) Label (09/2007)

Nov 30, 2021EXHIBITPETITIONER

Ex. 1049 - Crestor (rosuvastatin calcium) Label (11/2007)

Nov 30, 2021EXHIBITPETITIONER

Petitioner's HIKMA Power of Attorney

Nov 30, 2021PAPERPETITIONER

Ex. 1002 - Expert Declaration of Edward A. Fisher, M.D., Ph.D., M.P.H.

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 1

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 2

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 3

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 4

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 5

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 6

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 7

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 8

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 9

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 10

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 11

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 12

Nov 30, 2021EXHIBITPETITIONER

Ex. 1013 - Expert Declaration of Sylvia Hall-Ellis, Ph.D. Part 13

Nov 30, 2021EXHIBITPETITIONER

IPR Petition '077

Nov 30, 2021PAPERPETITIONER