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Marjac, what is the cite for your appeal so that I may find it on PACER?
Conventional wisdom is that it is DHA that helps the brain. I hope he responds that it's Vascepa that he uses.
Thank you
When was the brief filed?
Medical Research Collab is suggesting hikma or another generic company could do Marine like trials and apply to EMA for a marketing license for the hyperlipidemia indication and not violate the 10 year marketing exclusivity granted to Vascepa as a new active substance for the Reduce-It indication. When I look at the rules, I don't see that as possible. Your thoughts?
Good point. Thank you.
What is Amarin's pioneer patent? Does Amarin have patents that will stand on their own without the Marine patents? Does the Jelis trial make the Reduce-it patents obvious?
Glad to hear the good news.
Thank you, Raf!
Raf, any luck finding the script numbers?
Or will the complaint be consolidated with the complaints against Hikma and Dr Ready at the appellate level for the old issues of obviousness and infringement and then remanded to the trial court if the appellate court rules against Amarin for the new claims?
If there are new infringement claims, wouldn't there need to be findings of fact regarding the new infringement claims at the trial court level before the appellate court can weigh in on the claim?
I agree. It is good to keep everyone guessing. Expecting the unexpected will keep them honest. If he didn't say they were not going forward with DTC, could it have been that he said they were putting it on hold? For some reason I got the impression from something JT said that DTC was going to be put on hold due to the loss.
Marjac, It wasn't long ago that JT said AMRN wasn't going forward with the DTC campaign due to the patent trial loss. AMRN shortly after started DTC advertising. Could it be they started the DTC is spite of the trial loss based on a strategy to tie Hikma and Dr Ready up in litigation for years with this new filing by delaying the current appeal until after adjudication of the new infringement claims?
Thank you, Eightisenough.
Whoops, I see Moore is one of the four you favor. Stoll ruled favorably in a couple of cases cited in Amarin's brief, so did Dyk.
What about Moore? She ruled favorably in a couple of cases cited in Amarin's appellate brief. For that matter, so did Taranto. What decisions did you find that you didn't like about Taranto?
JL,
What do you make of this study on Covid19 blood vessel inflammation and Vascepa potential to treat? https://idw-online.de/de/news744978
That is not how mortgage interest works. If you refinance and keep the years and amount of the loan the same as the remaining years and amount on the old mortgage, with a lower rate you pay less interest from the get go.
The standard of review to overturn a judge's finding of fact is clear error. The standard of review for a finding of law is de novo. The Supreme Court and the Appeals Court for the Federal Circuit have ruled that obviousness is a question of law, not a question of fact. No deference is given to the trial judge's finding of obviousness. Under the de novo standard, the appellate panel will make a decision as if the case is being heard for the first time. Amarin has a slightly better than 50% chance of prevailing, maybe more.
Thanks Tuc
Korean religious sect responsible for more than 1/2 of CV infections didn't cooperate with authorities. https://www.google.com/amp/s/www.bbc.com/news/amp/world-asia-51695649
Compliance might not be any better than here.
Thanks Tuc
Thanks HD
Thanks HG
The best attorney in the courtroom is the one who is the most reasonable. Arrogance doesn't get you there.
Never mind. I hadn't had my coffee when I read your post. You were not using the word "intention" as a state of mind. As your cited quote indicates you have to prove culpable conduct which is different than proving intent. Culpable conduct occurs if the label induces doctors to prescribe in ways that will infringe upon the patent.
Isn't a question of whether the label will induce doctors to prescribe for for than 12 weeks? There is no requirement to prove what the intent of the defendants was when they applied for the anda, right?
They are not joined at the hip. One could settle and not the other. One could appeal and not the other.
It does not need to be intentional. Intention is not an element.
Do I understand correctly that with approval in Europe, Vascepa will be obtain an exclusive marketing right in Europe for 10 years, regardless of patent life?
Hey Hamoa, thank you for your post. I seek out your posts because they add greatly to the discussion and my knowledge. I have a small issue in the following statement:
"Defendants are asking Judge Du to:
1) rule that both the USPTO and FDA "clearly and convincingly" erred in judging the non-obviousness of Amarin's inventions, "
I believe the patent office has sole responsibility in determining whether a patent should be issued. Regardless, the defendants are not asking the judge to rule that both the USPTO and the FDA "clearly and convincingly" erred.
Rather, the defendants have the burden of proof to prove the patent is not valid due to obviousness which means the PTO erred in issuing the patent. The burden in substantial. Most civil suits are decided based on the preponderance of the evidence, which means the trier of fact weighs the evidence to determine whether more than 50% of the evidence supports the plaintiff's claim.
Clear and convincing evidence requires much more. I do not believe the courts have ever quantified what percent the evidence must be to be clear and convincing. In law school classes we debate whether it is 75% or more or whether it could be something less. What ever it equates to as a percentage, it is a very difficult burden to meet unless the evidence is there and the attorneys are good enough to make a stronger case than the opposing counsel.
I agree the judge doesn't make decisions solely on facts. Public policy also plays a role when policy is at issue. A weak patent system is contrary to public policy. To rule in favor of the defendants based on some small potential use for less than 12 weeks when the drug is intended to treat chronic conditions in my opinion, would be contrary to the intent of the law and violate public policy.
Agreed. Thank you for the analysis. I find your analysis to be spot on, but I am only a humble 2L.
I believe it is 12 to 36 grams
http://www.endmemo.com/chem/massvolume.php?q=Paraffin
It is my understanding details of SPA were reaffirmed with FDA in 2016.
Thank you for your post. What is your take regarding the defendants’ motion for summary judgment?
The statisticians that designed the trial would not have designed the trial and selected p values such that failure at the 60% or 80% interim analyses would reduce the odds of subsequent success.
Failure to halt early would put an upper bound on RRR except for the fact that certain secondary endpoints must be met as well for an early stop.
Management would have serious liability issues for their guidance that they believe the trial will continue to completion if it were true there is less chance of success if the trial is not halted early or the trial results will not be as strong as they would be if halted early.
Thanks JL. That puts it into perspective for me.
To what extent does the timing of patient enrollment in this trial have upon RRR at the 80% IA and the odds of the trial going full term?
That isn't in question.