Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Disagree
Even if they were signing today they would continue with the Go alone strategy at least until regulatory approval. You never know if the deal could be blocked
I meant on a BO. Not on the announcement
How much value would you put in China assuming a reduce it label? My understanding is that amarin get high teen digit royalties. How that be 10 dollars? more?
Couldbebetter,
I think you had a friend who suggested amarin was open to be sold. Have you heard anything else?
Message from Rafunrafun:
Hindu, please see post #308547
He is out of posts today
Do we have en banc news?
I am confused some people saying in stock teeets we do.
yes, you are correct....still reading. This ruling is better than I originally thought for us. I am not sure if it 100% applies to us, but for sure that generics are going to do a lot of thinking before scaling up sales
My understanding is that the FDA asked TEVA to change the label. In our case that would be equivalent of having the FDA to ask generics to change the label to cover cardiovascular disease. Unless that occurs, I don't think this ruling applies to us (see text below from today's ruling)
In 2011 the FDA required Teva to amend its carvedilol
label to be “identical in content to the approved [GSK
Coreg®] labeling (including the package insert and any
patient package insert and/or Medication Guide that may
be required).” Dist. Ct. Op. at 587. Teva amended its label
to include the indication for treatment of heart failure, as
required by the FDA. Dist. Ct. Op. at 587.
thanks cardio
Cardio,
I think you talk frequently with Vascepa sales rep. If so, what are they saying about the situation?
:) well deserved.
I don't think those messages are inconsistent with what I reasonable strategy would be. Any big Pharma acquiring Amarin will sell Vascepa as a generic in the USA. Until such time an acquisition happens, JT needs to move as he would be a stand alone company. That means he needs to work towards credibly launching a generics effort. It is possible that we will now sometimes in Q4 that Europe is in the bag 100% Until such time, I would not expect big Pharma signing the papers. And again until papers are signed (and beyond, until regulatory approval for the deal) JZ needs to work on a stand alone company including a generic effort.
Marjac,
If we don't hear in 30 days and we go the precedential route, are the odds for reversal greater? or alternatively not much can be read into it?
What would be the timelines if the case is sent back to nevada?
The judge did not actually pity evidences against each other. So the interpretation of the court of appeal is the same that I got to after reading the full case
Very very different to what you can find on our ruling
Rafun
Was the joint appendix filed yesterday?
So 6-weeks from July1st is the shortest possible period to oral arguments?
Does “argued” means that a decision was made without oral arguments?
Could you please post the entire document if you have access. Thanks.
Thanks!
Did we get Scripts today?
:) yes sorry I thought it was Friday today. My bad
Where scripts posted today?
That is strange. CVS caremark charged me only 9 dollars when I refilled at the end of April.
Thanks Marjac
Really appreciate all your work
Thanks so much.
Can I ask you. Once oral arguments occur under an expedited process, how long should it take for the result to be known. 3-4 months or should we expect less (again provided we are under expedited schedule)
Thanks.
My understanding is within 3-4 months for regular non-expedited cases.
I have tried to get info on whether we should expect an accelerated result for expedited cases. I assume that is the case but I don’t have confirmation. If someone knows please educate the board.
While HDG is correct, it seems to me that JT has a good level of confidence on the acceptance of the expedited schedule:
This is from the last earning transcript. See answer to Chen's question:
In my view the same. There were clear errors on the DC court so I am approaching this as 3 new judges having a fresh look at the case with the benefit of the opening briefs pointing out to the errors for them.
Thanks for. posting this. Nice article and very informative. I also read the federal cases associated with it.
Overall, I continue to believe that the federal cases mentioned in the article came to a ruling that is sound to me regardless of the precedure used to weight the Graham factors [so that should be a good sign of what to expect on Amarin's case]. There is an exception thought where I am not sure what to think:
The INTERCONTINENTAL GREAT BRANDS V. KELLOGG.
Majority determined that invention was so obvious that despite overwhelming secondary considerations they ruled (agreeing with DC) that invention was obvious. I read also the dissenting opinion by Judge Reyna. I believe that Reyna makes excellent points. However my intuition (I know not a legal standard) indicate to me that the invention was just so exceedingly obvious so I am not sure that any secondary (as the majority of judges agreed, and Reyna dissented) would be sufficient to change that fact. [Thus far this is the only FC ruling that is casting in my mind some doubts about a potential negative outcome for amarin....albeit I think that amarin case is stronger]
here is the case:
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-2082.Opinion.9-5-2017.1.PDF
thanks HDG nice analysis.
Another way to put it. :
a) DC found erroneously that patent office did not see some of the evidence (K. paper). In other words she assumes that if they did, they would have found the patent to be obvious. FACTUAL ERROR
b) DC looks at SC (with the mind of someone that has already seen the prima facie to be weaken by what is believed to be an oversight of the USPTO). Finds that THE SC ARE NOW EVEN STRONGER THAN THOSE THAT THE USPTO SAW (as we have now commercial success on the bag), but she decides that it does not matter because USTPO did not see all the evidence (FACTUAL ERROR) and some of SC weight against others (PROCEDURAL ERROR)
So What I expect the case for amarin to be build upon is:
-Point out the SC error on K. paper. That should then be seeing by the FC as that USPTO did their job correctly and that should put back the burden of proving invalidity by clear and convicing evidence back to generics
-Correcting the error also indicates that weight of secondaries as saw by USPTO were sufficient at the time....now they are even stronger with comercial success.
In my mind Amarin has a very solid case. I know that we use reference from other trials where things go in one or other way, but as of now, I have not found a ruling from the FC that did not make sense to me once you read the reasoning behind it.
Bottomline, I am not a lawyer but just a layman who after reading all the evidence believe that the chances of amarin to succeed is larger than the 50-50 that some lawyers give. I am not even convinced that this is so dependent on the judges assigned as many believe. That would be the case on a true 50-50 case when the case is very dependent on opinion. In this case there are so many issues, that I believe that regardless of whether you are a judge that likes to follow procedure or not, the issues related to the DC court as so numerous that they may reach a similar conclusion regardless of their style judging.
Exactly my sentiment. I come here to learn about amarin....., those are also keywords for me to push next
HDG,
OK I see. your point now, and it is a fair point. However, there are so many issues with the current ruling that I am hopeful that is reversed in the USA. With respect to other countries, I see how this could encourage generics to try to invalidate the patents in other countries but I continue to believe that if the proper standard is applied, the chances in other countries to invalidate the patents are similar to what we thought before March-30th....that would be very low.
Therefore my thoughts with respect to your question ( the chances being lower, equal, or higher) I would say that it would be fully independent of what happened in the USA, and therefore if the generics feel encouraged to try, their chances of success would be low (as we thought before the ruling here in the USA)
Ok this is new to me. So if the patents do not hold in USA we also lose patent protection in China?
Does not patent need to be filed in each country? If so patents in China are secured as far as we can tell.
Or they could just sell directly the rights of Europe giving the acquirer a first right refusal to buy the rest of the company. that would not require making 2 companies
They must be using an average WAC for the whole period of the model....I guess
Thanks north. But the ITC case was not expedited, right? My question is about expedited cases. Are ruling expected sooner or the standard 3-4 months still are a good rule of thumb.
Thanks for sharing your experience. Is ruling expected in 3-4 months after oral arguments or when expedited it is more frequent to hear earlier than that?
Thanks.