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B-
B-
r-
I did not analyzed the outcomes … but see the upcoming schedule: several are [on the briefs] ( Upcoming Oral Arguments )
Best,
G
ps.: I assume
argued = oral argument
on the briefs = no oral argument
a-
Basically … based on the quality of the post (by some) … hopefully yes (the some) …
Best,
G
m-
Plaintiffs-Appellants’ Opening Brief (May 12 / done) … Defendants-Appellees’ Responsive Brief … Plaintiffs-Appellants’ Reply Brief … Oral Arguments (?)
The CAFC could decide / choose to rule based on Briefs (as did in several cases recently).
Best,
G
(Relevant) Events:
Dancing in the dark: If you think, please replace my previous post (sticky) with this one. Thx.
May
- May 19: Amicus curiae… if any
June
- June 22: Defendants-Appellees’ Responsive Brief (40 days from service of opening brief))
July
- July 2 : Plaintiffs-Appellants’ Reply Brief (assuming expedited filing …normal: July 13)
- July 17: Response to Day 120 list of questions (LoQ), March 26 (Please note: all EMA deadlines – below – are based on response by July 17. Amarin has three months to answer the LoQ but the no clock restart in June.)
August
- (Week 32) Q2 2020 (10-Q and CC)
September
- Week 36 (August 31- September 4): Oral argument (FCA) …Meanwhile July / August is technically possible but it is not likely, September is the earliest, realistic time in any scenario but could be later
- September 17: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- Decision about EU approach (partnership or GIA or hybrid)
November
- Week 45: Q3 2020 (10-Q and CC)
- November 23: Commission Decision / formal approval (based on Day 180 Opinion by EMA, September 17)
December
- December 23: Response to Day 180 LoOI, September 17 (Amarin will have three months to answer the LoOI.)
- Chinese MARINE trial completion / result
January
- Order (FCA) (average time is 4 months after oral argument)
- January 28: Day 210 Opinion by EMA / recommendation of approval
February
- Healthcare professional and consumer launch: Delayed until after sales representatives can resume face-to-face meetings and pending successful ANDA appeal
April
- April 5: Commission Decision / formal approval (based on Day 210 Opinion by EMA, January 28)
Note:
a.) dates are (i) all “on or before” (ii) lot of them TBA or TBC
b.) EMA approval calculated by the “longest” (3-months reply) timeframe due to changed communication by the company.
“Our expectation is that VASCEPA will be approved near the end of this year for launch in Europe” vs. “recommendation for approval of VASCEPA by the European Medicines Agency near the end of this year” (latest).
Amarin “speed” (reply) will depends (IMO) on the appeal procedure: expedited or normal
c.) if something will be sometime during the relevant quarter it is listed for the last month of the quarter
Best,
G
ps.:
(i) alternative EMA timetable, calculated by the 2-months reply
- May 22: Response to Day 120 list of questions (LoQ), March 26
- July 23: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- September 28: Commission Decision / formal approval (based on Day 180 Opinion by EMA, July 23)
- September 15: Response to Day 180 LoOI, July 23
- October 15: Day 210 Opinion by EMA / recommendation of approval
- December 21: Commission Decision / formal approval (based on Day 210 Opinion by EMA, October 15)
(ii) appeal: The Life of an Appeal
Is it possible that none of you (none of your identity) disturb me with an OT, useless, non-informative post? … with any post?
Defendants-Appellees’ Responsive Brief due by June 22 (40 days) … unless the Court will order differently … I think: not likely.
Looks like the appeal will be a standard appeal … may self-expedited by the parties (by Amarin only?).
I found it informative, could give answers to a lot of questions: The Life of an Appeal I think the chart is useful for a lot of us.
Best,
G
W-
I read it once only … I will again … and again with unbiased view (I mean do not assume any type of intention on Du’s side … several funny were posted).
At first sight: more or less what I expected … except a HTG vs VHTG part. More precisely (as a first read), they did not arguing that HTG is different than VHTG as a main argument but that Defendant did not prove that HTG is the same as VHTG. Brilliant approach … make it a procedural error instead a factual (which could be deferred).
Best,
G
W-
Too much ado about nothing … all related cases (about 1g or 0,5 g) "should be" closed. Some were consolidated, some none. The Judge in that case "take" the decision from this case … with the consent of the parties.
Did you noticed that the Opening Brief was submitted on Tuesday? It has the same meaning or relevance as N-'s post(s) …
Best,
G
20-1723 Appeal
CalMustang: with courtesy of Mikenac, If you think, sticky this one. Thx.
Appellant: Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (AMRN)
Appellee:
- West-Ward Pharmaceuticals International Limited (n/k/a Hikma Pharmaceuticals International Limited) and Hikma Pharmaceuticals USA Inc. (Hikma)
-Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (Reddy)
Available documents #:
4: DOCKETING STATEMENT (AMRN)
8: UNOPPOSED MOTION TO EXPEDITE BRIEFING AND ORAL ARGUMENT
13: DOCKETING STATEMENT (Hikma)
23: DOCKETING STATEMENT (Reddy)
30: APPELLANTS’ OPENING BRIEF
31: NOTICE OF CORRECTION OF APPELLANTS’ OPENING BRIEF
32: APPELLANTS’ CORRECTED OPENING BRIEF
Thanks to raf- for the Docs.
Best,
G
M-
I believe I wrote "All" … " ".
"All" means all that I have … (When I will have new Doc I will upload it, will update the folder.)
I gave my finger and you would like to get my arm …
Best,
G
C-
20-1723 Appeal
CalMustang: with courtesy of Mikenac, If you think, sticky this one. Thx.
"All" docs: 20-1723
Doc 30: APPELLANTS’ OPENING BRIEF
Thanks to raf- for the Docs.
Best,
G
t-
Expected release date: May 12
Due date: June 21 (60 days from docketing statement … I am not sure, stand corrected)
Best,
G
W-
a-
C-
i- (&MontanaState83 / 272747)
r- (& gozips / 272681 & CaptBeer / 272701)
r-
What does any Court has to do with anything?
A ton of patents and claims (about MARINE indication) are valid acc. to him … SMH
I have no idea about his motivation, why he is trying to misleading the board … or if it is not intentional, it tells everything about his expertise … BS is a BS (independently from its type: positive or negative)
Best,
G
W-
r-
Some poster claimed you are a patent expert …
r-
c-
M- (ps: rosemountbomber / 373560)
c-
M-
g-
IF (and it is an if) Apo-B / “Kurabayashi” will be counted as unexpected benefit", then the chance - that the Claim 8 of 677 would be non-obvious and hence valid - is higher. Furthermore: An unexpected benefit can save the validity of a patent claim even if that benefit is not itself recited in the claim.
Best,
G
JL-
M-
Yep.
Best,
G
m-
To avoid any doubt: I agree with you … when I read Covid / Obama / Trump / basement refurbishment / etc. in a post … I click next.
Sometimes the kindergarten (physical) message board is more informative.
Best,
G
MORE LIKELY GO UP OR DOWN FROM HERE
d-
Thx … but read it with a grain of salt. (I am not a lawyer just a layman.)
Best,
G
W-
Appeal … as I see / think (now):
raf-: If you think, please replace my previous post (sticky) with this one. Thx.
First: few things about the appeal:
- new evidence / fact are not permitted (the District Court (DC) documents could be used)
- meanwhile the Federal Circuit (CAFC) is not obligated to defer to the DC, any factual findings determined by the DC should – technically- be subject to deference by the CAFC and usually they are deferring except clear error (a clear mistake was made, rather than finding that the CAFC disagrees with the finding by the DC).
- legal obviousness / analysis is not equal with FDA approvability or scientific acceptance … the burden is lower: teaching, suggestion on motivation (TSM) is enough … in case of no TSM, “obvious to try” could be enough also.
If something was not published in a peer reviewed medical journal, in a Nutritional journal only does not matter … it is part of the prior art
Second: to treat patients – to reduce TG - having TG above 500 mg/dl with 96% pure ethyl-EPA was prima facie obvious according to the DC and the USPTO … does not worth the effort to challenge it.
Third: few things, which are a narrow escape … a longshot (Could be tried but – maybe – does not worth the effort, the time, as it is an appeal.)
Secondary considerations (prima facie or totality)
Meanwhile it looks like that the DC used prima facie approach
Worth to watch every episodes (at least the first two seasons … I have a backlog since then)