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DAR, The case I posted looks like it might be Canadian. If so, it doesn't represent a precedent we can use.
CAFC has already ruled on the appeal.
Sleven,
JRoon, I will find and post the actual ruling later. This infringement case is almost identical to the situation that Amarin is in. The generic companies have a mono therapy label. Our label involves combination therapy. Ths is the same situation as the case I posted. Apotex was found guilty of inducing infringement because the majority of patients being treated were given combination therapy.
Sleven,
Nuke, Yes.
Sleven,
Chrome, "Agromento rinviato" v "parere espresso" I think those are decisions.
Sleven,
Skipper, Thanks.
Sleven,
Tke, Thanks. I don't have access to the ST board any longer.
Sleven,
Looks like the reimbursement decision has been postponed.
Sleven,
https://www.aifa.gov.it/ricerca-aifa
New vazkepa documents on AIFA web site. I don't read Italian.
Sleven,
RMB, It wouldn't surprise me to see a request for injunctive relief in the Hikma suit.
Sleven,
DAR, You read it correctly.
Sleven,
Zip, Market cap is not a factor, of damage calculation, in a patent infringement suite. It's about lost earnings. If the infringement is determined to be willfully, punitive damages are applied. (In the US) Three times the calculated damages. Hikma claimed that Vascepa sales were approaching a billion dollars a year when they entered the market. I would think Amarin could produce experts to testify that annual revenue would have grown without generic interference. How much money lost annually? For how many years? Multiply that number by three.
Sleven,
Captain, It looks like our legal counsel may have found the solution to our generic problem. Section 8 cases are usually bench trials, where the judge has the authority to make decisions about the facts. By suing under 35 USC, and making a jury demand, the judge no longer has that authority. The ruling makes that clear. This should pave the way for label only lawsuits. The lawyer representing Hikma understood this. That's why he said this would kill section 8.
Sleven,
RMB, Are you surprised?
Sleven,
Nuke, I understand. The primary topic of discussion for this board is Amarin. When conversation starts to swing in a different direction, I need to say something.
Sleven,
Put an end to the political discussion.
Sleven,
JRoon, You should probably contact Amarin and their legal representation. You can explain why pursuing this litigation against Hikma is simply a waste of time and capital resources. Clearly you have a better understanding of the situation than they do.
Sleven,
JRoon, Nothing has changed? Do you think Teva never stopped selling that product?
Sleven,
JRoon, Doesn't have CVD listed as a limitation of use. Only pancreatitis. That is the primary issue with every generic label. The absence of that language tells a doctor that gv is appropriate for the R-IT indication. It was argued in the appeal.
Sleven,
Marzan, Sorry. Yes.
Sleven,
Marzan, Hikma filled an amended complaint. Yesterday Amarin filled a response to it. Beyond that I don't have access.
Sleven,
Laurent,
https://www.aifa.gov.it/ricerca-aifa
Did a vazkepa search. Got two documents from July 12th that I can't open.
Sleven,
Laurent, Thanks. Any word on the outcome?
Sleven,
Zip, The easiest way to fix the problem with the "skinny label" section of the HW act would be requiring a PA for all section 8 drugs. That would limit them to the indication they were approved for. It's not going to happen until pressure from court rulings force Congress to act. Even if Congress takes action, I have no doubt that they will fuck it up. I know a few doctors. Most don't have time to read medical journals.
Sleven,
Nuke, No one is going to go after doctors or patients for direct infringement. If Amarin has found a way to force the generic product out of the US market doctors can't prescribe it. Generic producers, PBM's, and insurance providers are the three primary targets. It looks like Amarin has chosen to target the source.
Sleven,
Lizzy, Got it.
Sleven,
Lizzy, What application?
Sleven,
Nuke, That is a legal definition. It explains the difference between a matter of law and a matter of fact. In order to understand the ruling from the appeals court, this is an important distinction. They ruled that the information on the label and the advertising materials were both matters of fact. They went on to say that this distinction made it improper for the judge to dismiss. This definition in conjunction with the ruling would suggest that a complaint against other generic companies, based only on the label, would survive the pleading phase. The definition also states that matters of fact need to be decided by the jury, in a jury trial. I don't have enough knowledge to know what that means for the summary judgment stage.
Sleven,