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SMH … It is not new … Google Patents show the date as of today …
08-09-2016: Final Rejection
07-17-2019: Abandoned -- After Examiner's Answer or Board of Appeals Decision
Application Number: 14/477,034
Best,
G
R- (&jomama9231 & NickHous)
B-
Check the (name / history of the)
- NFC champion trophy
- Governor of New York (1995–2006)
- founder of 20th Century Fox & founder of Paramount Pictures
- biggest county in Iowa
… 'Just one more thing' (by Colombo) … maybe you will find "one" more interesting name.
Best,
G
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r- Document 309:
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Please ask Rob Cos (investorvillage) to post Jefferies summary about Day 5 (Jan 21).
The last one was Day 4: Generics Case May be Waning, Discussion of Recent AZN Epanova Failed Study...
TIA,
G
A layman summary of the patent case / Updated (Part 3; See Part 1 here and Part 2 here)
Generics bear the burden of proving patents are obvious.
Generics have to prove with “clear-and-convincing-evidence(s)”* that ALL patents are obvious.
* The evidence presented by a party during the trial must be highly and substantially more probable to be true than not and the trier of fact must have a firm belief or conviction in its factuality. It is a higher level of burden of persuasion than "preponderance of the evidence"
Amarin bear the burden of proving patent infringement.
Amarin has to prove with “burden of proof”** that Generics will induce infringement of (at least) ONE claim.
** The standard is met if the proposition is more likely to be true than not true. The standard is satisfied if there is greater than fifty percent chance that the proposition is true (preponderance of the evidence).
The Patents-In-Suit (Asserted Claims)
6 patents … 10 Claims are the topic.
U.S. Patent No. 8,293,728 (“the ‘728 Patent”), Claim 1 & Claim 16
U.S. Patent No. 8,318,715 (“the ‘715 Patent”), Claim 14
U.S. Patent No. 8,357,677 (“the ‘677 Patent”), Claim 1 & Claim 8
U.S. Patent No. 8,367,652 (“the ‘652 Patent”), Claim 1
U.S. Patent No. 8,431,560 (“the ‘560 Patent”), Claim 4 & Claim 17
U.S. Patent No. 8,518,929 (“the ‘929 Patent”), Claim 1 & Claim 5
(i) 3 Claims (‘728 Patent Claim 1* & 16, ‘715 Patent Claim 14*) are subject of “without concurrent lipid altering therapy” (*and “achieve the lipid effects required”
(ii) 6 Claims (‘677 Patent Claim 1 & 8, ‘652 Patent Claim 1, ‘560 Patent Claim 4 & 17, ‘929 Patent Claim 5) are subject of “achieve the lipid effects required” (without requirement of “without concurrent lipid altering therapy”)
(iii) All Claims are subject of “at least 12 weeks”;
arguments.
(i) “without concurrent lipid altering therapy”
Meanwhile the label (“14. Clinical Study”) contains information about statin usage (“Twenty-five percent of patients were on concomitant statin therapy”) it is silent about other concurrent lipid altering therapies, e.g., fibrates, niacin, and ezetimibe.
The “Clinical Pharmacology” section of the label reports studies on “Drug-Drug Interactions” between EPA and various concurrently administered drugs and states that EPA did not change the
pharmacokinetics or blood levels of “atorvastatin”. GV can safely be coadministered with a concurrent lipid altering therapy (with statin).
The label do not explicitly or implicitly instruct physicians to administer GV to a patient who is not on concurrent lipid altering therapy.
Generics’ labels do not encourage, recommend, or promote administering GV without concurrent lipid altering therapy. … no inducement exist in case of these (i) Claims.
(ii) “without concurrent lipid altering therapy”
It’s a close call …
- The label does not have to encourage all physicians it is sufficient that Generics' labels will encourage some physicians
- Inducement need not be premised on explicit instructions to perform the infringing method, where the proposed label
- “Indications and Usage” & “Dosage and Administration” section [Sections] vs. full label (package insert)
- plausible interpretation of the labelling that suggests the Court could find induced infringement
See more in Part 2 (here) about these (in connection with “12-weeks”)
Generics’ labels could encourage, recommend, or promote administering GV to achieve the lipid effects.
(iii) “at least 12 weeks”
The remaining claim is the ‘929 Patent Claim 1:
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That's the beauty … see who it is.
Best,
G
A layman summary of the patent case (Part 3; See Part 1 here and Part 2 here)
[Mod - who sticked Part 2 - please replace with this]
Generics bear the burden of proving patents are obvious.
Generics have to prove with “clear-and-convincing-evidence(s)”* that ALL patents are obvious.
* The evidence presented by a party during the trial must be highly and substantially more probable to be true than not and the trier of fact must have a firm belief or conviction in its factuality. It is a higher level of burden of persuasion than "preponderance of the evidence"
Amarin bear the burden of proving patent infringement.
Amarin has to prove with “burden of proof”** that Generics will induce infringement of (at least) ONE claim.
** The standard is met if the proposition is more likely to be true than not true. The standard is satisfied if there is greater than fifty percent chance that the proposition is true (preponderance of the evidence).
The Patents-In-Suit (Asserted Claims)
6 patents … 10 Claims are the topic.
U.S. Patent No. 8,293,728 (“the ‘728 Patent”), Claim 1 & Claim 16
U.S. Patent No. 8,318,715 (“the ‘715 Patent”), Claim 14
U.S. Patent No. 8,357,677 (“the ‘677 Patent”), Claim 1 & Claim 8
U.S. Patent No. 8,367,652 (“the ‘652 Patent”), Claim 1
U.S. Patent No. 8,431,560 (“the ‘560 Patent”), Claim 4 & Claim 17
U.S. Patent No. 8,518,929 (“the ‘929 Patent”), Claim 1 & Claim 5
(i) All Claims are subject of “at least 12 weeks”;
(ii) 8 Claims (‘728 Patent Claim 1, ‘715 Patent Claim 14, ‘677 Patent Claim 1 & Claim 8, ‘652 Patent Claim 1, ‘560 Patent Claim 4 & Claim 17, ‘929 Patent Claim 5) are subject of “achieve the lipid effects required”
(iii) 3 Claims (‘728 Patent Claim 1 & Claim 16, ‘715 Patent Claim 14) are subject of “without concurrent lipid altering therapy”
arguments.
For simplicity let’s assume that Amarin could not prove inducement regarding “achieve the lipid effects required” and “without concurrent lipid altering therapy” … Generics’ labels do not encourage, recommend, or promote administering GV to achieve the lipid effects … Generics’ labels do not encourage, recommend, or promote administering GV without concurrent lipid altering therapy.
The remaining claim is the ‘929 Patent Claim 1:
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I expected an offer in Q1 2019 but I revised it (IRCC) in Q2 19 (or sometimes in 2019) as after FDA approval and Order.
Meanwhile a BO is not guaranteed I could not imagine that nobody interested in Vascepa (at least offer will be (was? but low) submitted).
I see Q2 2020 as a reasonable time for it … after the Order. (plus: Amarin will know the list of questions regarding EU submission … or - not likely - the Opinion / recommendation for approval by end of March.)
(i) Amarin win the litigation
(ii) (short) list of questions regarding EU submission … or Opinion
…
Best,
G
c-
O-
v1
Assumption:
- price: $1,600 / year / patient
- licensing revenue (Amarin): 25% ($400 / year / patient)
- cost of a "selling" company: $160 / year / patient … sales commission, marketing, etc.
- COGS: $360 / year / patient
1.) partnership:
Amarin: $400 / year / patient
"selling" company: $680 / year / patient (1,600 - 400 - 360 - 160)
2.) BO:
"selling" company: $1,080 / year / patient (1,600 - 360 - 160)
v2
Assumption:
- price: $2,000 / year / patient
- licensing revenue (Amarin): 25% ($500 / year / patient)
- cost of a "selling" company: $160 / year / patient … sales commission, marketing, etc.
- COGS: $360 / year / patient
1.) partnership:
Amarin: $500 / year / patient
"selling" company: $980 / year / patient (2,000 - 500 - 360 - 160)
2.) BO:
"selling" company: $1,480 / year / patient (2,000 - 360 - 160)
v3
Assumption:
- price: $1,200 / year / patient
- licensing revenue (Amarin): 25% ($300 / year / patient)
- cost of a "selling" company: $160 / year / patient … sales commission, marketing, etc.
- COGS: $360 / year / patient
1.) partnership:
Amarin: $300 / year / patient
"selling" company: $380 / year / patient (1,200 - 300 - 360 - 160)
2.) BO:
"selling" company: $680 / year / patient (1,200 - 360 - 160)
Best,
G
m- (&concapk & MNBioMike)
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(Relevant) Events in 2020:
(Mod's- please replace the previous sticky)
January 27-28; 29(TBC); 30(TBC); 31(TBC): Trial (Amarin Pharma Inc. et al v. West-Ward Pharmaceuticals Corp et al; 2:16-cv-02525)
February: Trial decision (TBC) - scenario, which is not all that infrequent, where after both arguments closed, the judge hints his/her inclination to rule in the favor of the plaintiff or defendant.
February (Week 9 … TBA): Q4 & FY 2019 (10-K and CC)
March / April: Trial decision
March: Day 120 Opinion by EMA (if no question ... target date: March 26)
April: Response to Day 120 list of questions on or before April 24 (TBC) … it is the earliest deadline after March 26 … Amarin will have three to six months to answer the list of questions
May (Week 19 … TBA): Q1 2020 (10-Q and CC)
Q2: Direct to consumer branded advertisement launch in U.S.
June: Commission Decision (based on Day 120 Opinion by EMA on March 26, target date: June 1)
June: Day 180 Opinion by EMA (if no more question ... target date: June 25)
June: Response to Day 180 list of questions on or before June 30 (TBC) *
* Please note: used exceptionally and after agreement with the Rapporteurs when minor issues remain which allow the applicant to respond shortly after the CHMP list of questions and the Rapporteurs to assess the responses within a shortened assessment time.
July: "Special" Day 210 Opinion by EMA (target date: July 23) *
August (Week 32 … TBA): Q2 2020 (10-Q and CC)
August: Response to Day 180 list of questions on or before August 18 (TBC) … it is the earliest deadline after June 25 … Amarin will have one to three months to answer the list of questions.
August: Commission Decision (based on Day 180 Opinion by EMA on Jun 25, target date: August 31)
September: Day 210 Opinion by EMA (target date: September 17)
September: Commission Decision (based on "Special" Day 210 Opinion by EMA on July 23, target date: September 28) *
November (Week 45 … TBA): Q3 2020 (10-Q and CC)
November: Commission Decision (based on Day 210 Opinion by EMA on September 17, target date: November 23)
Q4 (TBC): Chinese MARINE trial result [It was initiated by end of 2017]
Best,
G
c-
JL-
J-
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z- (&Retiredceo &invest2992)
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.
- - - - -
Best,
G
BB- (&Relic)
M-
g-
And the context (btw / fyi: today is with Teva and is not with Sandoz):
LINZESS longest patents expire: 10/30/2031 (they have one till 08/16/2033 but I did not check the relevance of that)
1st settlement: January 16, 2018
Sun Pharmaceutical Industries Ltd.; entry: February 1, 2031
2nd settlement: May 3, 2018
Aurobindo Pharma Ltd; entry: August 5, 2030
3rd settlement: January 2, 2019
Mylan Pharmaceuticals, Inc.; entry: February 5, 2030
4th settlement: January 6, 2020
Sandoz Inc.; entry: February 5, 2030
5th (last / final) settlement: January 22, 2020
Teva Pharmaceuticals, USA; entry: March 1, 2029
Notes:
- They gave up 31 months (March 1, 2029 - October 30,2031)
- EVA was the last one … meanwhile in case of Amarin the first
Best,
G
R- (& Retiredceo #242761)
JL-