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That's always a possibility but who knows what they are thinking.
If this legal process plays out a certain way, that is within the range of outcomes where the legal process drives the business results.
Sleven, Amarin could theoretically amend their complaint to force a showdown with all of them. Or they could fully develop this case, and then use it as a precedent to hammer the others in subsequent lawsuits.
It's a shame it has to go this route, but the generics brought this on themselves through their chicanery.
JRoon, your point is likewise well-taken. Which is why I mentioned that Amarin should engage in an aggressive litigation strategy and attack all of them for infringing on the CVD label. Even if they do not voluntarily exit, use the law and the courts to force them to exit.
Drop the gauntlet, take them to task, and call them out. Used the same blitzkrieg tactics that Hans Guderian's Panzers used to conquer France: Concentrate Amarin's full strength at the enemys' weakest point, namely their infringing labels, and blow a hole in their lines to rout them. Make the sale of generic Vascepa too costly for them to continue.
And as an added benefit, this could constitute a complete defense to the antitrust lawsuits due to the generics' unclean hands as the infringers.
How doctors interpret the label might be a fact question for now, but that could actually turn into a question of law in Amarin's favor moving forward. If that label does not clearly and unequivocally indicate an exclusive use for trigs, and instead, leaves open the potential for being prescribed for CVD, a court can determine that the doctor's interpretation is irrelevant, and that label infringes as a matter of law. Putting aside what's best for Amarin, its embattled shareholders, and CVD patients in general, I find these issues to be intellectually fascinating as a lawyer.
JRoon, these will be heavily litigated legal issues, the outcome of which is to be determined. I am looking at it deeper than legal. Let's say a given generic gets together with counsel to craft a label which doesn't infringe. That does not end the question. Then the actuaries and bean counters come in to determine whether crafting the label in that fashion adversely affects income/profits.
So the generics could be caught in a Catch-22 where yes, the label conforms, but now the math does not work. Or maybe the math still works, and your theory is proven correct where this ruling against Hikma does not affect other generics.
But my gut tells me that the generic business model is based upon swooping in the CVDs and nobody ever holding them holding accountable, because the insurance, pharmacist, and physician actors naturally default towards the generic. Take away the CVD, and all of a sudden, the math might no longer work for them. It will be fascinating to see how this plays out in the real world moving forward.
nuke, they arguably could be liable but I honestly cannot definitively say so, as that issue involves complex questions of fact and law delving not only into patent law, but also insurance law. And if there is liability under some legal theory, Amarin has to make the business judgment whether suing the insurance companies is practical where the benefits justify the costs.
sleven, the entire case survives the pleading stage. Questions of fact cannot be dismissed at the pleadings stage. As a matter of law, dismissal at the pleadings stage is appropriate only where there are clear issues of law, and there are no set of facts under which the plaintiff can prove its case.
Kiwi, the liability for the other generics is the same, unless they can somehow distinguish what they are doing from what Hikma is doing. But with this case as precedent, any generic selling generic Vascepa while infringing upon the CVD indication, does so at their own peril.
TC1, that's exactly right. That's exactly how I see it. The entire generic business model, at least when it comes to Vascepa is based upon chicanery, because as a practical matter, the insurance payors who favor generics by default, many of the physicians, pharmacists, etc., are not going to sit there and differentiate whether the Vascepa prescription is for Trigs or CVD. This is a major reason why the stock price collapsed on Du Day.
Moving forward, with this decision in hand, and especially with a successful verdict, Amarin can potentially embark upon an aggressive litigation strategy of seeking injunctions against any generic who is infringing upon the CVD indication. The elements of an injunction are: (1) the likelihood that the plaintiff will prevail on the merits; (2) the extent to which the plaintiff is suffering irreparable harm due to the conduct complained of; (3) the extent to which the defendant will suffer irreparable harm if the preliminary injunction is issued; and (4) public policy.
For the reasons set forth in the decision, Amarin has a likelihood to succeed on the merits. The sale of generic Vascepa while infringing constitutes irreparable harm (Yes there are monetary damages available, but this about mitigation of future damages). When there is a likelihood of success on the merits and irreparable harm, public policy almost always favors the injunction. Finally, the generics cannot claim irreparable harm because they are the ones infringing.
Hence through this strategy, Amarin can potentially eliminate the generics from the marketplace. The challenge for the generics is to sell generic Vascepa without infringing upon Amarin's CVD indication. The dirty little secret is that to date, putting aside the legalities, their business model is centered upon that very dubious premise. Let their numbers crunchers and actuaries come up with a generic Vascepa sales model which is profitable without infringing. Game on.
These two parties, Amarin and Hikma appear to be sworn enemies, diminishing the otherwise normal chances of settlement. I am not sure if I would settle if I was Amarin, as this appears to be a golden opportunity to vanquish their mortal enemy.
I don't study patent cases enough to know the answer, but courts have wide discretion in fashioning an equitable remedy.
What we do know is that the generics' business model is premised upon cheating, namely infringement upon the CVD indication. If they are legally prevented from doing so and held to account, the incentive to produce and sell generic Vascepa dissipates.
Logically if the Generics can't sell generic Vascepa without infringing, then this could mean the end of generic Vascepa unless they cut some sort of deal.
Best case is the end of generic Vascepa because they can't sell it profitably without infringing.
Realistic is they go to trial, Amarin proves infringement, gets treble damages, and then perhaps gets an injunction to halt generic Vascepa.
There are countless scenarios in between with varying degrees of positivity and negativity. Congress could chime in as could SCOTUS. Overall Amarinians should be cautiously optimistic with no guarantees as of yet.
Correct. At least. The amount of documents exchanged could be voluminous. Plus Amarin is going to want all internal and strategic deliberations to establish bad faith and intent. Hikma will defend by saying that their deliberations are protected trade secrets.
Plenty of motion practice between two arch enemies. Realistically, I wouldn't expect a trial date until 2026.
The Federal Circuit issues its Mandate, reminding the case back to the District Court for further proceedings. The Magistrate will schedule a Conference to set up a discovery schedule.
Parallel to these proceedings, Hikma has 10 days to move for rehearing or rehearing en banc, and 30 days to petition SCOTUS for Certiorari, which is tolled if they pursue the en banc process.
Thanks to Anilkhera I was just informed of this glorious victory. This is the biggest post-Du win for the company and its shareholders, and the best piece of news since the pre-Du label expansion at the close of 2019. It's amazing how the courts can actually mete out justice and make the right calls when the judges are not Du, Dyk, and Reyna.
There's not a heck of a lot of legal analysis necessary. This is just a huge validation and smackdown of the Generics. They could try moving en banc or for certiorari to the SCOTUS, but those are longshots. Everyone should enjoy the win.
The outpouring of respect, admiration, and compassion for Jason has been tremendous. Below is a very timely message from his widow, Heidi Ritzenhaler. I provide her full name because she likewise has glowing tribute to Jason with pictures on Facebook that is publicly accessible if anyone wants to read or comment.
"Jason was incredibly passionate about Vascepa’s benefits and deeply upset about how it all played out. I know he would want everyone to continue the fight. What I want ask though, is that the group makes sure it doesn’t overtake your real, everyday life with the people you love and that love you. That is what is left at the end of the day.
Here is a link to Jason’s obituary - https://www.farberfuneralhome.com/obituary/Jason-Williams#tributewall. Feel free to share it with those who would want to know."
Take Care,
Heidi
The legal effort that we undertook would not have even gotten off the ground but-for Jason's energy and enthusiasm. He will be missed.
His ex-wife reached out to me directly, because she knew that Jason and I were in frequent communication.
Most tragically, he took his own life. Below is the link to the funeral home.
https://www.farberfuneralhome.com/obituary/Jason-Williams?utm_source=obit-share&utm_medium=referral&utm_campaign=relationship-bar&utm_content=copy-link
It is with a heavy heart that I report that one of the true legends of this Board, Jason Williams, known to all as "Biobillionaire", tragically passed away last week. Jason was the key person who literally "put the band together" when we mounted our challenge to the outrageous judicially endorsed fraud perpetrated upon Amarin and its shareholders, something from which neither the company nor its stock price nor its shareholders have ever recovered.
I got to know Jason really well as we worked on the effort and beyond. Jason was a passionate believer in Vascepa, passionately cared about the shareholders, and was fearless in calling out management. An overall great human being who died much too young, and leaves behind his ex-wife and two teenage children.
He was a one-of-a-kind character who will never be duplicated, and will truly be missed.
It is jargon within the Clerk's Office for setting filing and hearing deadlines.
Putting aside the legal distinctions between parent and subsidiary, the answer is essentially, Yes.
Well that's a great point. Business realities sometimes supersede potential litigation gains.
Sleven, that is very plausible, especially because Hikma may be the primary target of the lawsuit. By getting HealthNet out of the way, Amarin was able to appeal as of right with all issues being final as to all parties.
Could they pull in another insurance company? Yes. Will they? Likely not, as I think with the delay and the tone of the oral argument, they want to zero in on their arch-enemy, Hikma.
Institutional failure. I can't perpetually dwell on it without being dumbfounded and angered, but we all deserved better. Hopefully for the shareholders, this current court process eventually yields justice along with corresponding share appreciation from the current $1.00 levels.
BBI, Judge Du is absolutely deserving of complete blame for her disgraceful Opinion ducking the issue when we presented her Mistake and the Fraud upon the Court to her in crystal clear fashion. There are no words too strong to condemn the lawlessness and abdication of judicial duty on the part of Judges Du, Reyna, and especially Judge Dyk in the way that they turned a blind eye to what was "obviously" presented to them.
When that occurs, and the courts themselves abdicate their judicial duties, the Rule of Law dissipates, and lawlessness ensues. This is not ego or sour grapes. It is fact. And a lot of good people were hurt along the way.
No problem, JRPac. It is my pleasure to discuss the law with all of the good people here who have royally been screwed by the lawlessness that has plagued Amarin related court proceedings from the Du decision to date.
cloudera, an injunction is premature at this time. All the CAFC is saying is that Amarin is entitled to try to make its case through discovery, overcome an SJ motion, and try the case before a jury. Who knows, if discovery goes well, Amarin might be able to move for SJ. Once Amarin either wins a jury verdict, or has enough material to win summary judgment, they will be in position to seek an injunction.
lizzy, there is no time limit.
A lot depends upon the language in the Remand. We should all very much look forward to seeing the Opinion when it comes down.
I wish cbb. But too much time has passed, and too many courts have passed on the opportunity to remedy that problem. Amarin doesn't want to pursue, and even if they did, it is no longer ripe to pursue. The courts wrongfully denied us standing, so we cannot pursue. If we had a Panel like today's Panel, I believe we would have prevailed. It's very frustrating that justice is largely dependent upon who is meting it out.
And that's just the thing. Their business model is dependent upon the Generic being prescribed for the CVD indication. An injunction which formally stops that, could cripple generic Vascepa.
If the substance, tone, and tenor of the oral argument is any indication, the Panel emphatically agrees that the Motion to Dismiss stage was too early to throw out this case, and the decision doing so should be reversed and remanded for the parties to commence discovery.
Yes sleven. The Pandora's Box will be open. It just makes sense. As we have all raged on this Board since the lawless Du decision, and the further lawlessness failing to remedy the Du decision, including our own case, the entire process of Generic Vascepa has been a judicially endorsed scam. Lawlessness.
Everyone knows including the Generics that their business model is directly dependent upon nobody in the sales/distribution chain caring that about the infringement. Well through this lawsuit, the scabs will be picked off that scam. The Generics are in a real quandary. Their optimized profit margins are dependent upon an unfair playing field. If the Rule of Law finally prevails over the previous lawlessness, and the playing field is finally slevened, then the math might no longer work for the Generics, leading to Amarin recapturing the U.S. market.
That was a huge advantage as an Appellant, because the Appellant could point to the Judge who already saw the case their way.
Zip, I wish there was a procedural mechanism to right that wrong, but unfortunately that ship has sailed. But rejoice in the fact that the favorable decision likely emerging from today's argument could finally turn the tide the way it should have always been flowing.
Ani, see my comments and those of others below. Amarin stands in the best position it has stood in since the day of that dreadful Judge Du decision. This case could completely upend the lawless dynamic which has since transpired.
It could drag, but imagine the upside. Generics could be backed into a corner: As long as they are allowed to infringe the business model makes sense. If not allowed to infringe, then the business model fails. If I am running Amarin, I am going for the jugular. Drive them from the market. Legally. By the Generics own choice, because they can only profit from generic Vascepa through unsavory infringement.