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Invest, I think you have great intentions but in my opinion we should leave this to amarin and not interfere in they efforts building the appeal. Particularly because the case is in the best possible hands.
Sorry for my ignorance HDG, but can you remind me when those shares were issued originally (and why). Also if they can convert at any time, what is the advantage to maintain them as preference share to begin with.
Thanks
Thank you!
My comments in red
There was one question on the call that JT did not fully answered. Someone asked when we will know if expedited proceeding was accepted and schedule. For our legal experts, can you weight in on whether we would know this before or after the opening briefs? thanks
Exactly. What is so difficult to understand. Thanks JL
What is this based on? Can you provide any basis for this other than just being your own opinion? Amarin has regulatory and patent protection in Europe. The situation in USA is not likely in my view to negatively affect pricing
A couple of comments below
I agree with that Raf...I don't understand why they didn't there was so much at stage..
Do you have any thoughts on when we will hear about:
-FC accepts/reject expedited
-When the oral arguments will be scheduled (now or after Amarin files opening briefs?)
Raf (of others) at what stage we will know about the day oral arguments are scheduled?
Not a lawyer, but in my personal opinion what led the judge to misinterpret K is irrelevant, including whether generics cropped or not the table to try to misguide her.
I believe that the lawyers will keep it to the facts. And there are many instances in the documents supporting those facts (a) the paper indicate that there are no differences between the groups, (b) both Amarin and generics' experts agree that there are no difference between the groups, (c) despite that judge wrote that there were....All of those put together=clear factual error.
Even if I agree with you, I think the obvious error on K. is likely to be brought up as it speaks to a secondary factor that was improperly weighted against amarin. Should that error had not occurred the case may have gone the other weight even with the incorrect procedure followed. All together (procedural errors+factual errors, which are also mentioned in the docket) makes the case in appeal even stronger
best
I am not sure new generics can enter as they will be facing reduce-it patents.
I believe the reason why H &R are not affected by reduce it is because they filed an ANDA in 2016 when the only indication for EPA was pancreatitis. This is why they only need to prevail over marine patents.
Others can weirht in if this is incorrect.
Thanks so much marjac
Thanks so much Raf
Anyone who can help. Is there anything here that can speak to normal vs expedited timelines?
best
makes sense. Thanks so much marjac
thank you so much marjac, that was very helpful.
My understanding from that link thought is that the timelines described there is for non-expedited cases. Do expedited cases follow the same timeline? or alternatively, are decisions accelerated on expedited cases?
thanks sts66, very clear post. I fully agree with this
question for those with legal background on the board.
If Amarin manages to have a hearing in Summer, when should we approximately expect the ruling from the FC? Should we expect to hear it within 3-months? or earlier given that this would be an expedited case?
Thanks
In my opinion it is not unrealistic, but having a CVR for a significant amount of Billions of dollars I believe does not give great optics to the BP acquiring Amarin. So I would imagine that if Amarin can secure an expedited ruling and expect resolution within 3-4 months after summer, it is more plausible that a BO waits for clarity. However if the resolution is expected next year, the European market needs work to get it started, so I don't think that they would wait and a CVR then would be more likely.
Not sure I follow....the results from the federal court are expected relatively soon, therefore it would be simpler and would make more sense to me something like:
EU (12B), ROW (6B), USA (2B this accounts for USA residual value on the worse case scenario...patents no valid) + CVR (additional 10B if patents are re-established). That would be equal to 20B cash now + 10B on a CVR that should be expected to be paid within the next 6-12months
thanks for sharing....your record looks exactly like mine. I am still holding. What is the downside?
-Current situation....worse case scenario give a value of zero to USA. We still have Europe+ROW. I don't think the value of Amarin would be less than $30 dollars on a BO (I believe I am being conservative).
-Upper case...patent validity is restored...then I would say 50-60 dollars would be conservative.
It doesn't matter how you cut it, it looks like keeping/investing in Amarin today is a good decision. We will also know how those scenarios play out within 6-12 months. Happy to be challenged on the views expressed on this message.
the same for Anchor, you (we) were not wrong....the FDA was wrong to give the SPA in the first place.
Thanks JL,
I understand that, I see the appeal as an opportunity for 3 new judges to see all the record. Unclear what their final decision will be, but before we got into this nightmare, most people was giving Amarin the upper hand. Therefore once errors are considered and using all the records, we should have a new "fair" shot to a ruling. We will see if that ruling comes in our favor or not, but I believe it will be fair and not as controversial as the one from the district Court.
We as a message board community has an history of expending hours debating things (just one example, mineral oil issue and whether the FDA there to get us after the 2012 debacle in 2019....). Look JL, I would say that I did not like what occurred to us in 2012, I did not expect it and it was an error from the FDA to give us the SPA in the first place. That error was corrected too late and caused Amarin and investors a lot of harm. I believe we are in a similar situation now. Nobody expected a ruling on our patent as "obvious" ( I have doubts myself about infringement). We have a district court ruling that used erroneously Kurabayashi (and weight of secondaries) in a way that we don't think was correct. I don't think that there was ill-intend or political bias or anything behind this. I truly believe they were errors by a human being on a very complex case. Because of that, we will get a new chance at the federal court to look at the full case again by 3 PEOPLE, if they see it the same way that Judge Du (despite the issues we have uncover), then the patents are obvious. If differently, they see the issues the same way that we do, they will use the appropriate standards (weight of proof on the generics) and using the record there is a good chance that they see that the patents are not obvious as the USPTO officer did, and as the commercial success that took place after that review further supports.
DKNY1,
I don't think anyone is saying here that turning a case around in the federal court is easy. IT IS NOT. However we are all here trying to figure out whether amarin has substantial arguments, or not, to do so. The answer is that yes it has. Again, am I saying that Amarin will win. No absolutely not, but what I am saying is that you use statistics to measure things for which you don't have information. For instance before we read the ruling and everything else, statistics inform me about how difficult ( in general terms) is to reverse a ruling. Now that we have done a lot of research on this particular case, we have learned that there are clear errors that can be used to make build a strong appeal case. This again does not give us confidence of a win. But builds our confidence that the chances of a reversal may be better than the historical record. One more last time....Does that mean that we will win....absolutely not...but it tells us Amarin has good arguments to put up a robust fight.
Not sure I follow this. The record CLEARLY shows an error. How and why the judge got to that error is irrelevant. This is an error that amarin can use in their appeal. I don’t mean disrespect as I am not a lawyer, but all this sounds to me like a lot of unnecessary dancing.
Nobody is sure about the outcome (we don’t have crystal balls) but one thing is clear this is an error and amarin will use it to the maximum of their abilities to make the case that the patents are valid.
Some selected portions from my previous post:
OK, this is the reason the examiner gave. I got this from one of the documents that HDG provided on the folder that contains all the info he knows, so big thank you to him and on a personal note, missing him on the message board. I hope he can be back as soon as possible
This is the document for those that want to read it:
2-16-cv-02525-MMD-NJK - Doc 262.pdf
(under exihibit-18 page 42-53)
Eight,
My understanding is that the district court claims are all prima facie obvios but she does not claim that she find in this case that there is a strong showing of obviousness . She gives this reference saying that even in cases of strong obvioness (although I don't see her claiming that this is one of those), secondary may not be enough and give the reference of ZUP. I am not a lawyer, so would love to hear your thoughts on whether I am interpreting this correctly.
E
But the strong point of obviousness is made by district court which is a matter of law based in part by an incorrect understanding of the USPTO decision (who issued the patent just based on secondary therefore did not find it strongly obvious), correct?
The USPTO office and DU do not agree on this in fact.
The USPTO saw all the evidence (including K despite what district court said) and still issued the patent.
So based only on obviousness (and supported bu the district court misunderstanding on K) a decision was made that is not clear to me pass the burden of clear and overwhelming bar that defendants are suppose to meet.
I believe Defendants would have a very hard time but looking at the kind of statements that they made, they will likely would say that the patent covers a "placebo control" and the study did not use.a placebo as control but an arm without EPA...I don't think what else they can argue
:
Claims 8 of the ’677 patent
Quote:
The method of claim 1, comprising administering to the subject about 4 g of the pharmaceutical composition daily for the period of at least about 12 weeks to effect a reduction in apolipoprotein B compared to placebo control.
Best,
G
Excellent find, thanks Hamoa
that is helpful, thanks
I have a question about a potential BO. If one offer was announced today and provided it is accepted, what is the expectation of the acquisition timeline. Would it take 3, 6 or 9 month to finalize?
I assume that it would require an investor vote (may take 1-month or more to organize) and then FTC approval...may take also a few months I assume
yes I was surprised about that one....that means that a Q4 ruling may not be impossible (3-4 months after oral arguments