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c-
Using the patent application claim as a mosaic, the USPTO simply finds all the elements of the claim in one or more pieces of prior art and rigidly declares the mosaic to have been obvious. We know (at least in case of one patent) the USPTO found the patent obvious and granted due to secondary consideration).
I agree, the question(s):
- Did the Judge see everything correctly … made correct factual findings … or not?
- Did she apply Graham correctly … or not (Did she make a procedural error)?
- Was / were the 4th factor (secondary consideration) weak … was i "clear and convincing" evidence?
No final opinion (yet) … more later.
Best,
G
d-
$X for the Co + $Y CVR (depends on the outcome of the appeal).
Best,
G
A lot of things are discussed currently, however I do not understand why the following two topic are part of it …
(I) Label
Generics will have the following one, the MARINE label
An ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
Limitations of Use: The effect of EPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
The fourth ANDA applicant referenced above is Apotex Inc., or Apotex, which sent us a paragraph IV certification notice in September 2016. The notice reflected that Apotex made a paragraph IV notice as to some, but not all, of the patents listed in the Orange Book for Vascepa. Because Apotex did not make a paragraph IV certification as to all listed patents, Apotex cannot market a generic version of Vascepa before the last to expire of the patents for which Apotex did not make a paragraph IV certification, which is in 2030. At a later date, Apotex may elect to amend its ANDA in order to make a paragraph IV certification as to additional listed patents. If and when Apotex does make such an amendment, it would be required to send Amarin an additional paragraph IV certification notice, and Amarin would then have the ability to file a lawsuit against Apotex pursuant to the Hatch-Waxman Amendments.
c-
Can we find one or two trial on epa vs apoB to invalidate Kura?
m-
You might have misinterpreted P of differences in changes over time in the EPA group being statistically significant as "Kurabayashi teaches differently: ss changes in Apo-B exist". What I'm reading from Table 3 of Kurabayashi is that there is NO statistically significant changes in Apo-B between the Control group and the EPA group.
g-
The '728 is not about Apo-B.
The "Patent Office found that a decrease in Apo B was an unexpected benefit" in case of the '727 patent.
Can we assume USPTO Examiner had at least considered Kurabayshi?
The prior art is either silent or teaches that there is no statistically significant change in Apo-B levels when patients with TG levels less than 150 mg/dl or between 150-499 mg/dl are treated with either 96% pure ethyl-EPA or a mixture of ethyl-EPA and DHA
m-
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
Yes, the '728 contains a reference to Kurabayashi … but is not about ApoB reduction.
ApoB is part of the U.S. Patent No. 8,318,715 (“the ‘715 Patent”) Claim 14, U.S. Patent No. 8,357,677 (“the ‘677 Patent”) Claim 8 and U.S. Patent No. 8,518,929 (“the ‘929 Patent”) Claim 5.
'728 is a is a continuation of co-pending U.S. application Ser. No. 12/702,889 ('727 patent). The co-pending U.S. application Ser. No. 12/702,889 ('727 patent) was approved as (see Doc 262)
Applicant was able to overcome the above 103 obviousness rejection by showing: … The prior art is either silent or teaches that there is no statistically significant change in Apo-B levels when patients with TG levels less than 150 mg/dl or between 150-499 mg/dl are treated with either 96% pure ethyl-EPA or a mixture of ethyl-EPA and DHA
g-
Correct … as MARINE result showed affect on Apo-B by 4 grams but not by 2 grams.
But is does not affect prior art.
Best,
G
b-
Just a silly thought
b-
I do not say (because I do not have a definite proof … but more likely) it is a sure thing but the USPTO found "all" patents as obvious based on prior art (Graham - first - 3 factors) … they granted the patents because of secondary considerations (Graham 4th factor).
Best,
G
b-
AMRN should have changed Vascepa chemical composition slightly, for REDUCE-IT indication. Then it would be a "different drug".
C-
do you weight all secondary considerations to determine if The secondary considerations are a Graham Factor? Or does it take only one positive secondary to be included as the 4th Graham Factor?
c-
As of now (but it is not the final) I see it as:
- in case of (at least some) patents Apo-B effect was enough to overcome 103 rule … the relevance of it depends on Kurabayashi … but if I have to vote now: Judge see it correctly
- "teaching" about below / over TG 500 … I have to investigate further
- Secondary Consideration: … I see it as a biggest topic
(i) based on the same facts USPTO and the Judge concluded differently
(ii) looks like the Judge applied a "unique" view / approach … took "all" SC and weighted them …
As I see now (again is not a final view / conclusion): SC are matters (only) … other issues (More, Kuba, LDL-C, Apo-B, etc.) are beyond doubt - for a POSA.
Based on Graham first 3 factors … the patents are obvious … but based on Graham 4 factors the patents are … to be continued.
Best,
G
a-
At least for me: hard to understand your post … what would you like to say … but:
brilliant finding as per your post that Kurcbayashi WAS considered by the POSA as to the Amarin patent application
findings on the Mori trial study
T-
I do not have a firm opinion … as of now. one hand … (i) …. other hand (ii).
One of them* is not true.
Best,
G
* please note: it could be from two different patent
R-
The quote suggest that the examiner did not see / consider Kurabayashi .. in case of 12/702,889 application.
On the other hand: Amarin says … "Kurabayashi was considered by the USPTO during the prosecution of the Asserted Patents. See PX 21 (’728 Patent) at 8."
Best,
G
ps.:
(i) I have to check which patent is belongs to 12/702,889 application
(ii) I go out with the dog everyday between 9:00/:15-11:00/11:30 (CET) … in any circumstances … nothing could "overwrite" it ...
Doggy time ...
c-
The prior art is either silent or teaches that there is no statistically significant change in Apo-B levels when patients with TG levels less than 150 mg/dl or between 150-499 mg/dl
c-
Looks like to me pto did consider Kura trial and concluded it was not stat sig
j-
What I found:
(i) Doc 374: "Kurabayashi was considered by the USPTO during the prosecution of the Asserted Patents. See PX 21 (’728 Patent) at 8."
(ii) Doc 262 (12/702,889 application): "The prior art is either silent or teaches that there is no statistically significant change in Apo-B levels when patients with TG levels less than 150 mg/dl or between 150-499 mg/dl are treated with either 96% pure ethyl-EPA or a mixture of ethyl-EPA and DHA, or when a mixture of ethyl-EPA and DHA was administered to patients with TG levels above 500 mg/dl"
The (i) says it was … the (ii) is interesting if it was … (suggest was not).
Best,
G
r-
it was obvious to zero physicians a decade ago, but 'Judge' Du thinks that it obvious to POSAs? Anyone see the absurd ridiculousness of her ruling?
r-
Imagine if a generic manufacturer comes in and says that they will start selling Humira for something bogus and not patented, like headaches or muscle soreness?
Are we in a really much different situation with Vascepa / generics? The only difference that I see is that there is a Marine label already... but who says that it cannot be pulled, perhaps after several persuasive conversations?
a-
Still working on it. As usual, I would like to double check everything* before I wrote my opinion (my posted view - as noted - was an impression).
* e.g.: Kurabayashi (Apo-B) was or was not considered by the patent examiner?
Best,
G
o-
but aren't there other patents in the MARINE indication?
l-
He did not reply meaningfully … just like a moron … as he is.
Best,
G
z-
I hope this will trigger a block: you are more stupid than looks like. (to avoid any doubt: it is to trigger a block … hopefully I do not see any post / reply from you).
you are a moron ….
"Best",
G
I will not do any favor for you … you do what you want … It will be my pleasure … reduce the stupid noise.
How the hell do you know, BS artist.
N-
From memory …
He should refer to the June 5 letter … and it said (something like): if Amarin decides … if will meet the condition in the XY letter / guidance … they could sell as DS.
It was far away from recommendation of DS route …. and definitely not an OTC route.
Best,
G
j-
You are welcome: 2-16-cv-02525-MMD-NJK - Doc 262
Best,
G
Janet Woodcock who suggested to a few Epadi members we could OTC.
when 3 will be enuf imo
j-
Start with: Case 2:16-cv-02525-MMD-NJK Document 262-3 Filed 09/13/19 Page 1 of 15 ("Exhibit 18 Notice of Allowance for United States Patent Application No. 12/702,889")
Best,
G
s-
already expected....ergo obvious
s-
And if it all was so obvious why did the FDA require AMRN to go through a multi-year multi thousand person trial.
c-
The court then found that, during prosecution, the Examiner did not consider Kurabayashi.
j-
Thx.
Doc 331
Kurabayashi was considered by the United States Patent and Trademark Office during the prosecution of the Asserted Patents
the Patent Office’s examiner did not consider Kurabayashi. (Id. at 246-47.)
The examiner did not cite Kurabayashi, which showed that EPA reduced Apo B.
r-
I count it as a wishful thinking.
Best,
G
ps.: I will detail in my full / "final" analysis, summmary
o-
My view: nope. The ruling is stands.
Best,
G