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M-
m-
K-
The 3 yrs exclusivity (till Dec 2022) means:
1.) the FDA could not approve any ANDA (independently from other circumstances) till Dec 2022 … for R-IT indication. The exclusivity does not affect MARINE indication.
2.) New ANDAs could be submitted anytime (but not likely before the end of the appeal) as
a.) MARINE patents remain invalid … for MARINE only … FDA can approve ANDA when ready
b.) MARINE patents remain invalid … for MARINE and R-IT … Amarin will file a complaint (due to R-IT) and 30-months stay will be triggered … FDA can approve ANDA after the 30-months / trial (if patents will be invalidated*) and when ready
c.) MARINE patents will be valid … for R-IT only … Amarin will file a complaint and 30-months stay will be triggered … FDA can approve ANDA after the 30-months / trial (if patents will be invalidated*) and when ready
* MARINE patents are important … just imagine a patent trial (about R-IT patents) as obvious MARINE patents + JELIS as a prior art …
Best,
G
p-
e-
p-
You did not get it: a "non-alien" does not see Kurabayashi as teaching prior art ever.
Best,
G
L-
K-
M-
Thx.
To avoid any doubt: I see the sentence / statement as false, wrong … I was devil advocate: why / how could Judge Du see it (misunderstood) … meanwhile something other was written (e.g. forget the knowledge about study statistic, science, etc … about everything … just see / interpret the written words with the as wide as possible meaning.)
Best,
G
e-
m-
Thx.
Best,
G
e-
Thx. I accept it as a "first sight" but take it with grain of salt (due to your view about Mori / Kurabayashi … the focus of the appeal) … will make my own DD (keep in mind your opinion).
Best,
G
m-
K-
K-
e-
T-
"Funny" … see my recent post to e-. (#266676)
Best,
G
M-
No question, the conclusion is wrong … I would like to find the "reason" * why it happened. What is your thought about this part:
"statistically-significant differential effects": it is true … "EPA" arm vas SS, placebo was not (it was NS) … these effects (statistically) were different.
Best,
G
* ps.: to make it clear / avoid any doubt
Meanwhile I expected an ANCHOR approval in Oct 2013, I accepted / saw the reason - shortly after the decision - behind the FDA decision (SPA) … a lot of posters called me a moron … some of them is still way-off.
In this case - especially in light of Hamoa finding about Kurabayashi - I still could not see the reason behind the decsion … other than it was an error
e-
H-
I do not want to release Judge Du … or be a fun of the generics (furthermore I am an ESL) … but:
m-
A new day ... a lot of new posts (views), so I will not reply - directly - to this post (top of my previous reply).
Best,
G
ps.: If you think see my upcoming posts
a-
m-
M-
I could say (think) it is enough to reestablish / determine "unexpected benefit".
Best,
G
W-
It is a factual. I think anybody from the 7 billion (including infants) could see the error.
Best,
G
ps.: procedural - if any - is separate topic
n-
JL-
I did not want to correct the days (I was sure you mean weeks … just a typo).
b-
a- (and all-)
The credit goes to Hamoa only …
Best,
G
m-
I do not reach my final conclusion but …
Thx to Hamoa, I have (most likely) a final conclusion regarding "unexpected benefit".
I think the Claims 8 of the ’677 patent is the most important, since it is the only one that contains "compared to placebo control".
M-
I sent both posts (Hamoa's and mine) to Elisabeth.
Best,
G
N-
n-
Yep .. but could you find an example when the hearing (not the rehearing) was en banc sua sponte ?
Best,
G
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M-
h-
H-
M-
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