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3000 before the adcom. All in under for 25000 directly after. Good luck to us both.
Sleven,
Once again, I don't disagree. I have faith in management or I wouldn't own shares. In my experience (in general and especially with this company) you don't go out on stage if you don't have a song to sing. This could be more substantial then we expect.
Sleven,
Kush, I went and checked on one of our patents that relate to amr-102. It involves using a statin as a shell to hold vascepa. I do not know much about pharmaceutical manufacturing. Do you think we can do what you suggest in a cost effective way?
Awesome, that is the hardest I have laughed in days. Thank you.
Sleven
I agree with everything you just posted. The part of this that I don't quite follow is, if this is ongoing litigation, what can they say? I mean beyond the press release that we all read.
That is a very good question. Different statin dosages would seem to be a problem with a combination therapy. I had never considered that before. I think you are right to point that out as a problem. Not to mention the variety of different statin drugs that people are taking.
Sleven,
Yes. Historical that is exactly what they have done. That was what I expected this time. That said why do this Monday conference. Never done an early quarterly update before. (to my memory) not much reason to talk about the corporate effect of the pandemic. Why do this at all.
Has this company ever offered an update on continuing litigation? Isn't it the company's standard policy to say that they don't comment about ongoing court cases? If they do comment what can they possible say that isn't already known? Any rational thoughts on this would be appreciated.
Sleven,
That's funny.
Yes. I would like some feedback from board lawyers, as I am not one. The reason for a company to have multiple patents is to have multiple different legal defenses. I tried to get clarity from BB on this matter, but he offered none. Just because no one other than BB and now me has presented this idea to the board does not make the idea wrong.
Sleven,
Kiwi, I think that is right. Based on the appeal that relates to this pattent case. If they try to go to market during the appeal process what you say will happen I believe is what will happen.(baring an injunction). I am suggesting that even if we lose this appeal we still have other patents that provide protection. Until they make a product I don't think they are in violation of those patents. The minute they make and try to sell something, that changes. In my mind this would trigger a brand new case. Separate from this appeal. If I am right then they are back were they where in 2016. Six patents down seventy'ish more to go. Again not a lawyer so this view might be completely wrong
Sleven,
Kiwi, that wasn't exactly what I meant. I don't have a vast wealth of patents law knowledge, but it is my understanding that if generic companies actually begin to produce a product they have new legal exposure. If they produce something that is close enough to our drug to get an anda then they are violating aspects of our patents that relate to manufacturing and composition. At that point back to court in a brand new case. If I have this wrong I would love it if someone would correct me.
Don't get me wrong. The drop in share price is very real. It doesn't make me happy. You correctly pointed out that we have no idea what the strategy is going forward. Without knowing that it is hard to say whether or not faster is better.
I understand but only partially agree. Until we actually have generic competition our real value has not been impaired. There is a perception of impairment. If it turns out that our strategy is to keep them in court for the next nine years, slower is better.
Sleven,
Money, I agree with your assessment of the situation. I also think a buy out is unlikely for the reasons you stated. I am certain that amarin has a strategy. We just don't know exactly what it is yet.
I don't think speed is the idea in this legal battle. So long as we remain in court generic competition is theoretical not actual.
Yes! Not drinking good scotch tonight. We need to keep our sense of humour.
Sleven,
My only guess. He thought we would win. That would have put this to rest and prove our parents were impenetrable. He was apparently wrong. I think nothing lost other than leverage. Thank you for discussion.
Thank you, I think if we keep our heads, and wait to see what the real strategy is, we will come out of this ok.
Sleven,
Ham, I take your point. The market would still remain fragmented. We could give Teva the edge by modifying the settlement. Our parents would still be vacated. However If we did this the other generic companies would win nothing by winning. If we go down in this fight they win nothing. This suggest to me they need to come to the table.
Kiwi, thanks for getting back to me. Backing Teva in the US would make sense in the event of losing the appeal. Royalty payments are better than nothing. I would think we could also amend our settlement agreement with Teva to get them to market possible ahead of the generics we are in court with. Winning the court battle in this situation is not the point. ( in my opinion.) Money is the point. Backing Teva would be one more way we could stop the other generic companies from making money. If we can see this then I assume all the lawyers involved can see this. This situation is very different then our FDA battle from year's ago. Amarin and the generic companies both have something to gain by reaching an agreement, and everything to loose by fighting. I have been invested here since before the original adcom. Reading your posts ever since. Nice to actually talk to you.
Sleven.
G50, I am looking at this exactly the same way you are. Unless I am completely wrong a generic court win would turn out to be a financial loss. Without us I don't see how they can expand the market. I do see how this gives them leverage in a negotiation. If we win they lose. If we lose they don't win. Is there a flaw in my logic? Thank you for discussing this.
Forgive my ignorance. Can anyone confirm that amarin did in fact not address these issues at trial.
Kiwi, yes that is exactly my thinking. If they take this to the end and invalidate the patents at issue in this trial. Amarin obviously would not advertise in the US to build the market they need to sell into. Not to mention every other generic company would try to get there share of the existing market like dog's fighting over a scrap of meet. I think it is in there best interest to sit down and work this out. I am not a lawyer, but my understanding is that an appeal is basically an extension of the original case, so a settlement should be able to vacate the decision. Would love to hear a lawyers opinion on this, thanks for replying.
Sleven,
Do you think that the generic companies want to fight the appeal to a conclusion? If they win is that the best outcome for them. Teva settled in this matter for a six month head start. I think the company made a mistake going to judgment in the case, but I still don't see an appeal win as the best outcome for these two generic companies. Do you disagree?
Situational summary as I see it. (1) We win the appeal and this is over. (2) we lose the appeal. If we litigate the appeal and loose I believe that it is a peric victory for generics. They will have the right to enter a market that is unripe. They also can not advertise to build that market. Amarin obviously would not advertise for them. If they try to produce a product that should open them up to another round of lawsuits that are covered by our composition and manufacturing patents. They would probably still be in court until 2030. In my opinion the only solution that benefits both parties is some form of settlement. This is different than our fight with FDA. FDA had nothing to gain or loose. The generic companies do. Not sure if I am correct, but this is how I see it.
Agreed, equivalence is up to the FDA. For once the ultra conservative nature of this bureaucracy may actually work in our favor. To far from our product no anda to close and it's back to court. Thanks for helping me work through this. I am leaning more and more toward a settlement as being the final outcome here.
Thank you for clarifying. It is my understanding that to receive an anda the generics must prove to FDA that composition is identical.(especially in the case where method of action is uncertain.) If this is the case then any alterations to the composition or process to avoid patent infringement would likely trigger FDA to not grant anda status. Am I looking at this incorrect in your opinion?
I want to make sure I understand. Not a lawyer. You are saying that the composition aspect of this patent can be litigated separate from the method of use portion. If that is accurate then we should be able to keep generics in court almost indefinitely. To me that would suggest a settlement of some type is the only way out for generics. Or am I completely wrong?
Thank you. I read over this patent earlier today.i think the problem with using this is beyond composition the patent is tied to a method of use. (Lowering trig's without raising ldl-c). That is the method of use that the judge has called obvious.
I agree with your line of thinking. I have been trying to find a patent that relates to manufacturing or composition that is not directly tied to a method of use. If we have just one I believe that it would represent a production barrier.
Posters on this forum have done a remarkable job of exposing the glaring errors of judge Du's decision. I agree with all of you. I am of the belief that Amarin has legal recourse that extends beyond this Court case to fend off generic intrusion into our market. Do any of you know if we have patents that can be litigated if generics try to produce. If we can keep this in court for another 9 years then the generics have no choice but to settle, or gain no benefit. Someone please tell me why I am wrong.
JL. Please correct me. I thought that once a generic drug was given approval,they were considered as equivalent to the label drug. Indication was not relevant. I have an investor here for more than a decade but just now joined the conversation.
BB, I tried to contact tact you yesterday. Not sure if you received my message. New to message board conversation. I think you are right about our other patents protecting us from generics producing. I have been trying to identify which patents come into play when generics try to produce. Can you please give some guidance.
I agree. I don't know if we can convince FDA to pull the marine indication. Once an indication is given what power do we have with FDA to get them to remove it.
Yes. A generic drug is a generic equivalent. Anything that a brand name drug is approved for is covered by the generic equivalent. Generics do not have specific indications. This is my understanding.
This would require FDA cooperation. I do not know if it is outside the realm of the possible, but the FDA is not the easiest institution to deal with. I see your strategy. I think it would work if FDA would play ball.
Dave, that's funny.
The suite prevented FDA from granting anda to the generics. Now that the judge has rendered a decision FDA is free to proceed. if FDA grants anda, and only if FDA grants anda, are the generics free to enter the market. If FDA grants then it is the appropriate to ask the court for an injunction.
At risk. Is after grant of anda but before end of litigation. Anda required for marketing.