MINUTES OF PROCEEDINGS - Bench Trial
January 13, 2020 (Day 1)
Proceedings begin at 8:35 AM. Also present for Amarin: Joseph Kennedy as corporate representative, Barbara Kurys as patent counsel and Litigation Support Technician David Brooks. Also present for Defendants: Neema Kumar as corporate representative for Hikma, Andrew Allen and Deeph Jain as corporate representatives for DR and Litigation Support Technician Stephen Gros.
The Court asks counsel to refer to the paragraph number of any stipulated facts and to mention whether exhibits have been admitted as stipulated exhibits. The Court directs counsel to use abbreviations for the levels of triglyceridemia.
Mr. Sipes addresses the Court with regard to portions of exhibits that are confidential. The Court discusses the process for sealed testimony with counsel. Mr. Sipes advises the Court that the parties will provide a thumb drive of all the designated portions of depositions each party will be submitting for the Court’s review. The depositions will contain hyperlinks to the exhibits.
Ms. Whitt advises the Court that Defendants have added to their exhibit list. The Court will address this issue later in the day.
Mr. Sipes and Mr. Klein present opening statements.
Steve Ketchum is sworn to testify. Ms. Kean examines the witness. Plaintiff’s exhibit 1186 is marked and admitted. Stipulated exhibit 940 is admitted.
Recess: 10:18 AM – 10:39 AM.
Direct examination of Steve Ketchum resumes. Plaintiff’s exhibits 482, 807, 289, 298, 297, 762, 942, 990, and 994 are marked and admitted.
Recess: 12:34 PM – 1:08 PM.
Direct examination of Steve Ketchum resumes. Plaintiff’s exhibits 439, 1189, 272 and 1185 are marked and admitted. Defendants’ exhibit 2247 is marked. Mr. Klein conducts cross examination.
Recess: 3:05 PM – 3:23 PM.
Cross examination of Steve Ketchum resumes. At the conclusion of cross examination, the following Defendants’ exhibits are admitted: 1558, 1800, 1809, 1814, 1816, 1829, 1836, 1837, 1838, 2104, 2226, 2235, 2241, 2247, 2248, 2250, 2252, 2255, and 2267, without objection by Plaintiff. Plaintiff objects to Defendants’ exhibits 2250 and 2299. The Court allows Mr. Klein to ask Dr. Ketchum about 2250. Mr. Klein conducts cross examination. Ms. Keane withdraws Plaintiff’s objection to 2250. Defendants’ exhibit 2250 is admitted. The Court will defer its ruling on Defendants’ exhibit 2259 to allow Plaintiff an opportunity to review the demonstrative exhibit and verify its accuracy. Defendant’s demonstrative slides may be attached to the minutes of this hearing. Counsel will report back to the Court.
Ms. Keane conducts redirect examination of Steve Ketchum. The witness is excused.
Ms. Whitt addresses the Court with regard to new exhibits Defendants have added to their exhibit list. Plaintiffs do not object to the addition of Defendants’ exhibits 2266 and 2267. Mr. Rounds responds. The Court directs Defendants to identify the witness for which they plan to use the additional documents by 1/14/2020.
The Court directs Defendants to seek admission of exhibits at the time they are introduced, rather than waiting to the end of the examination.
Ms. Whitt offers a flash drive containing Matthew Budoff’s slides, Plaintiff’s demonstrative slides that will be used in the examination of Matthew Budoff and final deposition designations. The following exhibits are admitted in the depositions: 291, 292, 307, 294, 308, 273, 185, 186, 198, 196, 273, 193, 192, 195, 187, 188, 194, 274, 189, 190, 821, 814, 817, 818, 816, 813, 819, 814, 820, 812, 219, 21, 226, 227, 210, 216, 217, 219, 228, 208, 206, 207, 203, 479, 935, 753, 755, 757, 754, 479, 480, 474, 475, 472, 476, 469 and 470 are admitted.
Mr. Sipes asks the Court about whether counsel can speak to witnesses who are on the witness stand during breaks.
The bench trial is continued to January 14, 2020 at 8:30 AM.
Recess: 5:20 PM.
January 14, 2020 (Day 2)
Proceedings begin at 8:33 AM. Also present for Amarin: Joseph Kennedy as corporate representative, Barbara Kurys as patent counsel and Litigation Support Technician David Brooks. Also present for Defendants: Neema Kumar as corporate representative for Hikma, Andrew Allen and Deeph Jain as corporate representatives for DR and Litigation Support Technician Stephen Gros.
Ms. Keane advises that there is an error in Defendant’s demonstrative slides used in cross examination of Steve Ketchum. Mr. Sipes suggests that Defense counsel could prepare a chart citing the specific “DDX” numbers. The court will address the concern later in the day. The Court encourages counsel to meet and conferment o reach a resolution.
Matthew Budoff is sworn to testify. Mr. Kennedy examines the witness. Plaintiff’s exhibit 1186 is marked and admitted. Stipulated exhibit 940 is admitted.
Recess: 10:18 AM – 10:39 AM.
Direct examination of Steve Ketchum resumes. Plaintiff’s exhibit 1161 is marked and admitted. The witness is qualified as an expert in the areas of clinical treatment of lipidemia, including TG, and cardiology. Plaintiff’s exhibits 989 and 269 are marked and admitted.
Recess: 9:12 AM – 9:38 AM (to resolve a technical issue.)
Direct examination of Matthew Budoff resumes. Plaintiff’s exhibits 566, 1203, 1209, 288, 289, 277 and 285 are marked and admitted.
Recess: 10:55 AM – 11:21 AM.
Direct examination of Matthew Budoff resumes. Plaintiff’s exhibits 26, 25, 22, 30, and 31 are marked and admitted.
Recess: 12:24 PM – 1:04 PM
Ms. Klein conducts cross examination of Matthew Budoff. Defendant’s exhibits 1982, 1632, and 1578 are marked and admitted. . Defendant’s exhibit 1554 is marked.
Recess: 2:55 PM – 3:16 PM.
Cross examination of Matthew Budoff resumes. Defendant’s exhibits 203 and 2247 are marked and admitted. Mr. Kennedy conducts redirect examination. The witness is excused.
Mr. Sipes advises that Plaintiff closes their case.
Ms. Fundakowski presents Defendants’ Rule 52(c) motion. Mr. Sipes responds. The Court reserves its ruling.
Jonathan Scheinberg is sworn to testify. Mr. Reig examines the witness. Defendants’ exhibit 2226 is marked and admitted. The witness is qualified as an expert in cardiology. Defendant’s exhibits 1953, 1957, 2266,.1984 and 1679 are marked and admitted. Defendant’s exhibit 1960 is marked. The witness steps down.
The Court advises counsel that it will issue an oral ruling on Defendants’ Rule 52(c) motion. For the reasons the Court has placed on the record, Defendants’ Rule 52(c) motion is denied.
The Court has reviewed the 25 exhibits Defendants added to their exhibit list. The court encourages counsel to resolve the evidentiary issues. The Court will not exclude the late disclosed exhibits. Plaintiff’s oral motion to exclude the late disclosed exhibits is denied.
Counsel agree to file the chart referencing the exhibits, page numbers and “DDX” numbers Mr. Klein utilized in cross examination of Steve Ketchum in CM/ECF. The Courtroom Administrator will file the minutes of proceedings for January 13, 2020.
The bench trial is continued to January 15, 2020 at 8:30 AM.
Recess: 5:32 PM.
January 15, 2020 (Day 3)
Proceedings begin at 8:33 AM. Also present for Amarin: Joseph Kennedy as corporate representative, Barbara Kurys as patent counsel and Litigation Support Technician David Brooks. Also present for Defendants: Neema Kumar as corporate representative for Hikma, Andrew Allen and Deeph Jain as corporate representatives for DR and Litigation Support Technician Stephen Gros.
Mr. Reig resumes direct examination of Jonathan Scheinberg. Defendant’s exhibit 1986 is marked and admitted. Ms. Keane conducts cross examination. Defendant’s exhibit 1697 is marked. The witness is excused.
Recess: 10:28 AM – 10:48 AM.
Ms. Heydorn addresses the Court to present the thumb drive containing deposition designations. The following exhibits used in the depositions are admitted: 1733, 1734, 1735, 1736, 1737, 1738, 1739, 1740, 1741, 1742, 1743, 1745, 1747, 1750, 1793, 1797, 1853, 1854, 1855, 1856, 1857, 1859, 1860, 1861, 1862, 1881, 1882, 1883, 1884, 1885, 1886, 1887, 1888, 1889 and 1890.
Mr. Reig advises the Court that Defendants will now proceed with the obviousness portion of the case.
Jay Walter Heineke is sworn to testify. Mr. Reig examines the witness. Defendants’ exhibit 2222 is marked and admitted. The witness is qualified as an expert in the area of lipoprotein metabolism and lipid disorders. Defendants’ exhibit 1546, 1524, 1588 and 1589 are marked and admitted.
Recess: 12:32 PM – 1:23 PM.
Direct examination of Jay Heineke resumes. Defendants’ exhibits 1605, 1587, 1581, 1641, and 2001 are marked and admitted.
Recess: 2:35 PM – 2:54 PM.
Mr. Sipes conducts cross examination of Jay Heineke. Defendants’ exhibit 1604 is marked and admitted. Mr. Reig conducts redirect examination. The witness is excused.
The Court and counsel discuss the schedule. Ms. Huttner announces the names of the witnesses who will testify on Friday.
The bench trial is continued to Friday, January 17, 2020 at 8:30 AM.
Recess: 5:00 PM.
January 17, 2020 (Day 4)
Proceedings begin at 8:33 AM. Also present for Amarin: Joseph Kennedy as corporate representative, Barbara Kurys as patent counsel and Litigation Support Technician David Brooks. Also present for Defendants: Neema Kumar as corporate representative for Hikma, Andrew Allen and Deeph Jain as corporate representatives for DR and Litigation Support Technician Stephen Gros.
Mr. Reig moves Defendants’ Exhibit 1960 into evidence. Defendants’ exhibit 1960 is admitted.
Edward A. Fisher is sworn to testify. Ms. Huttner examines the witness. Defendants’ exhibit 2295 is marked and admitted. The witness is qualified as an expert in preventative cardiology, investigation about lipid disorders and atherosclerosis in diabetics and other patients. Defendants’ exhibits 2124, 1624, and 2106 are marked and admitted.
Recess: 10:29 AM – 10:47 AM.
Direct examination of Edward Fisher resumes. Defendants’ exhibits 2139, 2140, 2126 and 2145 are marked and admitted. Plaintiff’s exhibit 271 is marked and admitted, subject to redaction by Plaintiff.
Recess: 12:29 PM – 1:10 PM.
Direct examination of Edward Fisher resumes. Defendants’ exhibits 2143, 2144 and 2146 are marked and admitted. Mr. Sipes conducts cross examination. Defendants’ exhibit 1574 is marked. Plaintiff’s exhibit 373 is marked and admitted.
Recess: 2:55 PM – 3:13 PM.
The Court has reviewed the portion of the deposition of Edward Fisher that led to Ms. Huttner’s objections to Mr. Sipes’s examination. The Court issues an evidentiary ruling.
Cross examination of Edward Fisher resumes. Plaintiff’s exhibits 1219 and 162 are marked and admitted. Plaintiff’s exhibits 492, 956 and 949 are marked.
Recess: 4:08 PM – 4:20 PM.
Ms. Huttner and Mr. Sipes conduct further examination of Edward Fisher. The witness is excused.
Ms. Huttner and Mr. Sipes discuss scheduling with the Court.
The Court makes observations regarding confidential documents and sealing of documents.
The bench trial is continued to Tuesday, January 21, 2020 at 8:30 AM.
Recess: 4:52 PM.
January 21, 2020 (Day 5)
Proceedings begin at 8:31 AM. Also present for Amarin: Joseph Kennedy as corporate representative, Barbara Kurys as patent counsel and Litigation Support Technician David Brooks. Also present for Defendants: Neema Kumar as corporate representative for Hikma, Andrew Allen and Deeph Jain as corporate representatives for DRL and Litigation Support Technician Stephen Gros.
Ivan T. Hofmann is sworn to testify. Mr. Barabas examines the witness. Defendants’ exhibit 2223 is marked and admitted. The witness is qualified as an expert in pharmaceutical economics. Plaintiff’s exhibits 590 and 391 are marked and admitted, subject to redaction. Defendants’ exhibits 2061, 2065, 2066, 2054, 2067, 1607, 2039, 2057, 1762, 1773, 1772, 2050, 2079, 1776, 2088, 2085 and 2299 are marked and admitted, some subject to redaction. Demonstrative exhibits DDX 8.7, DDX 8.8, DDX 8.9, DDX 8.10, DDX 8.12, DDX 8.13, DDX 8.14, DDX 8.15, DDX 8.16, DDX 8.17, DDX 8.18, DDX 8.19, DDX 8.20, DDX 8.21, and DDX 8.22 are admitted as summary demonstrative exhibits under FRE 1006.
Recess: 10:18 AM – 10:38 AM.
Mr. Kennedy conducts cross examination of Ivan T. Hoffmann. Defendants’ 1606 is marked. Plaintiff’s exhibit 1218 is marked and admitted. The witness is excused.
Mr. Barabas announces that Defendants rest their case in chief on invalidity, subject to deposition designations, and reserving the right to present rebuttal to Plaintiff’s rebuttal.
Carl Peck is sworn to testify. Mr. Kennedy examines the witness. Plaintiff’s exhibit 1109 is marked and admitted. The witness is qualified as an expert in FDA regulation and new and generic drugs, including drug labels. Plaintiff’s exhibits 573, 776, and 572 are marked and admitted.
Recess: 12:03 PM – 12:37 AM.
Mr. Klein conducts cross examination of Carl Peck. Plaintiff’s exhibit 763 is marked and admitted. Mr. Kennedy conducts redirect examination. The witness is excused.
Sean Nicholson is sworn to testify. Mr. Kennedy examines the witness. Plaintiff’s exhibit 1098 is marked and admitted. The witness is qualified is an expert in the economics of the pharmaceutical industry. PDX 5.5, PDX 5.6, PDX 5.7, PDX 5.9, PDX 5.10, and PDX 5.13 are admitted as summary demonstrative exhibits under FRE 1006. Plaintiff’s exhibits 590, 632, 644, 659, 589, 746, 602, 600, 590, 657, 658, 661, 663 and 711 are marked and admitted, many subject to redaction.
Recess: 2:55 PM – 3:17 PM.
Direct examination of Sean Nicholson resumes. PDX 5-14, PDX 5-15, PDX 15-16, PDX 5-20, PDX 5-21, PDX 5-22, PDX 5-23, and PDX 524 are admitted as demonstrative exhibits under FRE 1006. Plaintiff’s exhibits 752, 637, 658, 724, 607, 612, 642, 647, 643, 645, 580, 581, 577, 719, 644, 655, 659, 669, 628, 629, 630, 631, 633, 634, 635, 636, 664, 645, 641, 646, and 662 are marked and admitted, subject to redaction. Mr. Rounds conducts cross examination. Defendants’ exhibit 1684 is marked. Exhibit 2 of Defendants’ exhibit 1684 is marked and admitted as 1684-A. Plaintiff’s exhibit 576 is marked and admitted. The witness is excused.
The Court and counsel discuss the schedule. The Courtroom Administrator advises the Court and counsel as to how much time each side has used.
The bench trial is continued to Monday, January 27, 2020 at 8:30 AM in Reno Courtroom 5 before Chief Judge Miranda M. Du.
Recess: 5:24 PM.
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