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Generics are more like someone who is firing a gun randomly towards a crowd. Sure, they didn’t aim at one specific person, but if someone is hit there is liability.
It could be murder...it could be manslaughter.
It could be direct infringement...it could be indirect.
Can Amarin require insurance companies to ensure any rx they cover for gV is for treatment of hyper trigs (via prior authorization) or else hint at infringement liability given GSK vs TEVA outcome?
Seems like there is some case here...would at least put up some red tape for a generic launch. Yes not completely foolproof but to get around it would require insurance fraud.
Unfortunately, I believe Amarin has burned through a lot of its “goodwill”. The generic case could be completely overturned and the market will still price this at a discount.
Amarin needs to execute and prove it can do so consistently before the market will price this as it should again.
The beauty with the way the founding fathers set up the US government shined through on Friday.
Checks and balances...
What the majority of naysayers are failing to realize here is it is the court’s job to keep lawmakers in check. Congress can make any law they desire (ahem...Hatch Waxman act), but if the courts find the law unconstitutional or full of loopholes, the courts have full power to end it or interpret it how they see fit.
Prost’s rebuttal in this case was scathing and reading through it definitely brings up some uncertainties on how strong this case’s precedent will be.
But guess what...Congress has no power to reverse the court. For the moment, this case is now the interpretation of the law and until it’s appealed and reversed (if it is), this is the new normal.
US market back in play.
Not a lawyer,but that is my take as well. Unfortunately we’d have to wait for generics to enter mkt and sell before a lawsuit could be brought...which may lead to uncertainty and a depressed stock price for awhile, but things are at least looking up from where they were yesterday
Even further support of implied infringement then
I'd urge everyone to read this passage from the GSK/TEVA decision. Pg 14
Smoking...f'ing...gun.
insert-text-here
Just read through most of the GSK opinion. To me, this seems like a slam dunk (or the unexpected event we have all been hoping for)...if the law is applied evenly to all that participate in the system.
The only thing that trips us up here is if the court invalidated the reduce it patents. We get 3 years exclusivity for that indication right? And then there is roughly 3-4 years of lawsuits and trial times for a reduce-it case to be heard and appealed (worst case).
So effectively that puts us into 2026-2027 before generics can deem a launch not ‘at risk’? Wow...so undervalued.
Well I think AMRN has significant proof that reduce it was non obvious...the FDA basically said this is non obvious and forced then to finish the reduce it trial for this indication.
This is actually brilliant.
Agreed that’s not my point. No problem with that. However, saying there is an unmet need but then discounting that because people did not praise the invention is the issue. Lack of one secondary condition should not cancel another out. There is no case law to support that.
How is the weighing of SC against each other not precedent setting?
One other point on the call that I found extremely odd. When the generics were done with their overview they asked for questions from the panel and almost immediately Dyk said there are no questions let’s move on. Almost without giving the other two a chance to even start talking. It seemed like Dyk was completely in control. How to interpret this...
Did the others already have minds made up and Dyk knew this?
The call today seemed completely one sided, but if it were so one sided why even have the arguments at all and just affirm on briefs similar to a lot of other cases.
There is a tact in the business world, where at meetings, one individual is appointed the “devils advocate” and completely disagrees with the group think opinion no matter what. Could Dyk have been acting in this capacity today?
Absolutely agree...that in my opinion wasn’t the cases strong point. The secondary condition weighing against each other is the topic here. Dyk, from my opinion, didn’t show his cards here. If the court affirms, this will create new case law which will basically place much more burden on patent holders to prove secondary conditions exist. Any weak secondary conditions (ie praise) could completely mute strong ones. Could be a very dangerous thing...
I just listened as well. While I’m no expert, I wouldn’t consider Dyk’s questions “grilling”. He was asking questions to get details around the heart of the case...secondary conditions. I think he pressed Singer into saying the prima facie determination first wasn’t an error, but I don’t think Singer ever gave in to the weighing of secondary conditions error and I don’t think the court clearly had its mind made up about that.. conditions
I believe all of the attorneys on this board said that the attorney they grill the most...they usually side with. They said expect FUD on hearing date.
Devil’s advocate type thing...
I believe some rewards vest on 8/31....so yes prepare yourselves for them next week.
Encouraging numbers the last two weeks...begins to show what can happen with a media blitz. Let’s get this generic lawsuit victory then completely saturate the market with the Vascepa message.
If people are still not going to their doctors, they cannot “ask their doctors about Vascepa”.
Anybody recall what the all time high TRx was?
Tomorrow we see the start of DTC ad impact on scripts...correct?
Are we absolutely certain there will be oral arguments at this point? Or could it still be based off briefs?
Given recent update here:
http://www.cafc.uscourts.gov/argument/upcoming-oral-arguments
Looks like we are going to oral arguments
Panel F: Wednesday, September 2, 2020, 10:00 A.M., Courtroom 402
19-1506 DCT Free Stream Media Corp. v. Alphonso Inc. [argued]
19-2137 PATO Uniloc 2017 LLC v. Google LLC [argued]
19-2277 PATO Uniloc 2017 LLC v. Google LLC [argued]
20-1723 DCT Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA [argued]
20-1536 CAVC Brown v. Wilkie [on the briefs]
Would assume so
After rereading, the price used for the analysis was $3577. Reducing that by 43% is $2038 which comes out to $170 a mo.
What is the typcial US price that AMRN would sell to wholesalers in US?
This company can't catch a break...
These are all of their comp rewards that were just approved during the annual meeting. No one received any shares yet.
They received options that vest in a year (Ie they can turn into shares at this time in 2021).
The “shares” (RSUs) they receive vest at a rate of 1/3 over the next three years. So at this time in 2021, 2022, 2023 each person will get about 9000 shares that they can sell.
Now if there is a buyout everything vests immediately...at which point this will all be over and we can move on anyway.
What’s crazy about this is the strike price on the options is 6.62. In no way do I think the board should have rewarded themselves for the sharp decline in share price like this. If the share price goes back to where it was pre trial loss, they could make 300% on their options alone for doing nothing (or fixing what they shouldn’t have broken in the first place). Completely bogus...
Looks like dr reddy’s is combining the appeal with hikma case. Maybe crossing t’s and dotting i’s before the action.
Or the 10 times are various world governments’ intercepts of communications...
How do you strategize against a judge that twists facts to fit her agenda?
Probably...you've all read the court docs and various prior art studies. There was literally no case here for the generics. All it took was one dumb judge to flip everything upside down. BP has the same risk...
We’ll see what DTC ads do when they start. Tough market with covid and shut downs to make any extrapolations to disappointing sales at this point.
If this gets overturned, this is exactly what Amarin needed to solidify its IP going forward and most likely open doors for any potential buyouts.
The IP went through the wringer here and it will have been completely derisked.
So yes it has been awful but the damage has not been irreparable. In fact, given COVID as well, this could all turn out to be the “best” thing that could have happened for a buyout. Gave mgmt an excuse to pump breaks on cash burn while solidifying IP and also bought time waiting for EMA approval.
1523 pages
Appendix has been filed
Strange...we should be scheduled by now if this logic follows. I wonder if someone looks through the initial brief to determine if there is enough “grey” to schedule an oral hearing vs not.
Obviously I’m super biased in favor of Amarin...but trying to be neutral just reading through the three briefing documents that the judges would read would convincingly persuade me to reverse this.
I don’t think this goes to oral arguments. This gets decided quicker than anticipated.
Too much wrong or grey here for the clear and convincing hurdle to have been overcome.
And new precedent for weighing Secondary Conditions...not a can of worms the courts will want to okay. As soon as the panel reads through this, they act quick to shut this down.
I’m just trying to figure out when the judges will actually start reading through the briefs...
Hypothetically what’s the earliest this case could be decided assuming oral arguments aren’t necessary?
After July 1 appendix...when do the judges get “assigned”?
Nope
“Wake me up before you go go”
Reverse 70
Affirm 25
Remand 5
Settle 0