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I believe it is Marksman. Came out the next day...
We can yet all Attorney's have said the Judges will NOT re-review the Case examples such as Mori or the other study.
I am hoping during the appeal Amarin can speak of those study failures to the Judges with hopes of reinforcing the lack of weight Du could have given either of them! In short giving a HIGHER weight to the Secondary considerations!
YET UNDERSTAND: She decided based on the real world use of the Marine Patent ONLY as she should was asked to do by Amarin - <500 Trigs for Pancreatitis! Even Amarin HATED that we were locked into >500 just as everyone on this board! No one cared or cares about >500 Trigs vs <500 where our larger target market really is.
Now, if we were allowed to say: "Hey, 5 years later we also invented R-It! Can you validate Marine because we need to protect R-It?"
She said several times we are fighting the "useless Marine patent only" and wanting to stop the Generics from selling Pure EPA for Pancreatitis.
She said the Secondary Considerations relative to the "Who cares about the Marine Patent" as they really don't amount to enough to cancel her (flawed medical) opinion of studies - Mori and the other one.
We can only hope the Appellant Judges see that the much bigger negative effect approving the Generics for Marine will have on Vascepa!
Just my opinion!
18% awarded appeal. 67% of those win on appeal.
He dummied it down to 50/50 because even though he feels we have a 67% case, only 50% of the Appellant Judges we could get utilize the 2nd Confederations as a Scale-Tipper!
BOTH Attorneys say its not our merited case yet the Judges! Seem sickening to believe yet true!
Du is NOT one who subscribes to the "Secondary Considerations" concept!
Exactly!
Google: "Settlement before Appeal"... You'll see our options... They discuss vacating the Trial decision in lieu of a Settlement if agreed by all parties...
Understood yet the Appealant Judges are using different ways of deciding. Some appreciate 2nd Considerations while other Judges are not looking at it that way. Right, wrong, or indifferent - both articles are saying: Hope to get the 3 Judges (or at least 2) that will enforce the 2nd Consideration format... Its not a Law that they follow it yet a path they should use. Not all Appellant Judges follow it. If we lose to those that don't follow it, do you Appeal further?!?
Short answer: Google "Settlement Pending Appeal". You'll see they discuss vacating Trial Decisions...
I have to go back and dig it up...
I heard the Harvard Attorney on the call and saw the 2nd article challenging his view. I emailed the Harvard Attorney (Jacob) asking for his opinion on the 2nd article.
He surprisingly replied saying his position he made on the call is a 100% solid argument that won't change YET he repeated that he believes our success of an Appeal wholly depends on the 3 Judges we get... He said the 2nd article basically says the very same. He said there is a 50/50 split amongst the Judges on how they will decide this case. Some in our favor and others staying with Du's decision.
I sent this to Elisabeth last week when it was first on-line...
I read of a similar case last week where the Plaintiffs lost, were granted an Appeal, yet prior to the formal Court Appeal Review, they settled. The Court then vacated the original Trial Decision and allowed the Settlement to stand. WE CAN ONLY HOPE! I assume the fact that the Appeal was allowed that it motivated the Defendants to work out a Settlement! Let's hope JT can be a bit smarter if given this 2nd chance!
Raf: I bet you are right. When you control the largest drug of its kind, you gain more friends than enemies!
You just don't fall over and accept failure.
You turn lemons into lemonade!
She allowed it yet said it will not effect her decision. She told the defendants the same when they tried to have it kept out of the trial.
Like every other sale they made - mostly FREE stock options paying their lifestyles at our expense!
That is where the rub is...
Our money as investors going to all of the stock options they awarded themselves over and over and over and then executed them (and our investment along the way)...
Not according to the Judge... She did not want R-IT introduced in the case...
They sold half of what they acquired which could likely be for tax purposes... If they sold ALL that would be a mess...
What I do not understand is how they have the 13.58 sale price for a Transaction that occurred on March 31st - the day after the plummet...
HAMOA: Would love to hear your opinion on this new Article from earlier today:
https://www.markmanadvisors.com/blog/2020/4/2/amarin-did-the-court-commit-a-procedural-error-when-invalidating-the-vascepa-patents
Jomama9231: R-IT was left out because the Generics are trying ONLY to use the >500 Trig Marine (weak) Patent to gain entry into the Vascepa R-IT market. The Judge said the R-IT Patent is not what is being challenged here and did not want any of it's success in to sway her decision.
The Generics are acting like they ONLY want to enter the "Lowering Trigs that are above 500 to help people with Pancreatitis" game...
The "Success" of Vascepa is on the R-IT patents - not the Marine patent.
We want to see the Company and (1) product as a singular entity encompassing all of the Patents as one yet as the generics did here, they challenges one Patent, won, and can now sell a Generic version of Vascepa...
I will say it again: I hope I am wrong!
Hamoa: Question - Could Judge Du have been considering the weight of the "Secondary Considerations" on the Marine >500 Trig use (ONLY) and NOT the Cardiovascular benefits of R-IT? Amarin really did not see the >500 Tri Marine approval as anything special meaning "it was only good for Pancreatitis".
If you recall she was initially not a fan (so to speak) of allowing anything in relative to R-It even noting that she did not believe it would or should have any bearing on the case.
If we keep thinking the "Secondary Considerations" should cover the OUTSTANDING effects of R-IT, wouldn't she be judging the case in it's entirety on R-It and not just the "not so impressive Marine patent?"
Another way of asking this is: Would we still be saying she erred if we ONLY had Marine and this whole case was about Marine (as though R-IT never existed) and she was weighing the Secondary Considerations to tip the scale of an approval (Marine) that really did not mean much to anyone let alone Amarin? (Meaning the Secondary Considerations really did not mean that much in the Marine case...)
I am hoping we are not all saying that the "Secondary Considerations" MUST take into consideration that overwhelming success of the R-IT patent (which she clearly said would not and should not let it become part of her decision...)
Personally I hope I am completely wrong...
You will make money yet you might not make money... It is not for sure yet you are not going to make money. Yet you may...
Just want to cover all bases so I am not wrong...
Do you have to really post self-serving comments at a time like this?
Truly not necessary and 150% self-serving...
18% Chance of getting by the Initial Review to allow it to go to Appeal...
Appears as though we have enough to get it to Appeal...
Then 64% of the Patent Holders win once allowed to go to Appeal...
He dummied the 64% down to "a little over 50%" when you combine" the following:
1. Getting a Good Team of (3) of the (12) Judges
2. Strength of the Appeal Material
Of the (12) Judges he said (6) are Procedurally and Patent Strong meaning that is good... They will be willing to find her error and reverse it.
The other (6) are Procedurally Weak YET Patent Strong...
Part I do not understand:
The Harvard Patent Professor they utilized is using "existing case statistics" and not necessarily the "HUGE GLARING MISTAKE" as a base because he said he never saw an error this large nor did he want to get anyone's hopes up...
The moderator tried to get him to "raise our chances of a win" by asking this similar question yet he said he preferred siding with available case statistics...
JUDGE DU'S FIRST PATENT BENCH TRIAL THAT SHE EVER HANDLED WAS OURS (Per the Attorney Professor on the Jefferies Conference call...)
Absolutely Stunning...
https://centurylink.cwebcast.com/ses/1rvwqrkLXyk6VlfZ0WkY5w~~?ek=c2228d41-3637-4d41-96f5-bf0fc7bf0379
JL: As a Physician - How do you feel a Cardiologist will feel writing a Heart Medication Script "off-label" to use for something as serious as a Heart Attack (no pun intended) for a Drug that is technically not approved for the condition that he/she writes it for? Do Cardiologists really care about the "Cost Savings" the patient will incur by picking picking an unapproved, off-label product?
I just seem to think they will stay with the approved product in a Life or Death situation. This is not a skin condition or sinus issue. We are talking about someone who has serious Cardiovascular issues...
And even still - if some do, to what degree will it effect our overall sales of the drug... Maybe not enough to tip the scales!?!
Your thoughts?
Appeals (Excellent Perspective): Let's not forget the excellent write up by Hamoa during the Trial providing great insight into the issue the Judge used to quash our case! Reflecting back on this certainly adds fuel to Amarin's ability to get a reversal!
"OBVIOUSNESS
In today's call, Silbersher focused primarily on the Mori prior art when discussing the obviousness issue. In my view, Silbersher failed to fully grasp the effectiveness of Amarin's dismissal of Mori as a basis for proving obviousness. Mori was a 59-person study that compared the effect of 4 grams per day of EPA to the effect of 4 grams per day of DHA on subjects with median triglyceride levels of 166 mg/dL and 199 mg/dL, respectively. Mori was a study that in no way studied the effects of EPA and DHA on subjects with triglyceride levels anywhere near 500 mg/dL. That's very significant, for, as stated by Dr. Toth, "We've already established that patients with very high triglycerides have a very different LDL response." Additionally, defendants' expert, Dr. Heineke, on cross-examination, acknowledged that a POSA would have understood patients with hypertriglyceridemia to be "entirely different" from patients with mixed dyslipidemia.
The generics argue that because EPA raised LDL levels less than DHA, a POSA would have found it obvious to eliminate EPA from any EPA/DHA therapy in order to more effectively treat severe hypertriglyceridemia without raising LDL levels. Amarin correctly argued a POSA would not have found this obvious for the following reasons:
- both EPA and DHA raised LDL levels in the study, with HDL raising LDL levels by 8%, and EPA raising LDL levels 3.5%
- the lower LDL raise in the EPA group can likely be attributed to the difference in baseline triglyceride levels between the two groups (DHA median level being 11% higher than EPA group triglyceride levels)
- the study included NO subjects with triglyceride levels over 500 mg/dL
- Severely hypertriglyceridemic patients (>500 mg/dL) had been shown to respond dramatically differently to triglyceride lowering therapies versus a <500 mg/dL population
Furthermore, Mori, rather than teaching that EPA offered any advantages over DHA, in fact taught that EPA was, by multiple measures, INFERIOR to DHA with respect to beneficial effects on subjects. Those measures include:
- inferior triglyceride lowering effects
- inferior ability to raise HDL
- inferior ability to increase LDL particle size
- inferior ability to not raise fasting glucose
For all of the above reasons, a POSA would clearly have not found it obvious to eliminate DHA from an EPA/DHA therapy in order to more effectively treat severe hypertriglyceridemia.
Note that the burden of proof for non-obviousness is on the generics, and that burden is a daunting one. They must prove that the USPTO clearly erred in issuing the Vascepa patents. To the extent they're relying on Mori to make that case, they fall far short of providing "clear and convincing" evidence that the examiner failed to grasp ways in which Mori demonstrated that Amarin's claims are obvious."
Appeal: Once the case is Appealed, the WIN is put on the back burner until it is overturned or enforced - in effect it is temporarily vacated. I am hoping that during the time it is on the back burner, both sides can work out a Settlement. I has happened before...
It is certainly NOT going to help the Generics if Amarin packs their bags and heads back to Ireland flipping off the US all the way home!
Let Amarin practice that strategy out loud over the next 24 months as they appeal, do not push US Sales at all, and if they do not settle or lose the Appeal, go back to Ireland, F-the US, and build-up Europe!
I am sure that will thrill any intelligent Judge who would have sided with Amarin that is by not allowing this half-assed 56 person un-monitored test to tip the scale!
WE HAD TO GO THRU A (6) YEAR 8000 PERSON TEST TO PROVE OUR CASE!!!
She reserved the right to ignore it, find it faulty, and allow Amarin to move on!
So does the Appeals Judge!
MORI STUDY ATTACHED: https://www.ncbi.nlm.nih.gov/pubmed/10799369
GOTTA LOVE #7...
From Steve on the Yahoo Boards:
"What I think I think.... just another temporary setback in a long list of setbacks....
1. If unchallenged, generics will have to file an aNDA to sell in the US which could take anywhere from 1 - 3 years to get approval.
2. If challenged, (and it will be challenged)it could take twice as long if even successful
3. We could we awarded an injunction to prohibit the generics from selling in the US while the appeal process winds it's way through the appeals courts. Will take years to resolve.
4. If generics make it through all that, they can't infringe on any patents related to REDUCE-IT study findings and new indication.
5. This finding is only applicable to the US. We've only been selling in the US (Saudi and Australia can't be contributing much) for the most part since 2012ish and for the indication of lowering Trigs greater than 500. So we are barely scratching the surface with new indication scripts which will be the big ramp.
6. Generics will be locked out of the EU, China, and Canada for a long time.
7. All this talk about off label scripts for generics if they ever succeed in an aNDA...... ask yourself, how liable would doctors be for prescribing a generic for CV risk and the patient dies of a heart attack or stroke?
8. Amarin said that if after they've exhausted all legal remedies and if an aNDA was approved, they would provide an update as to how they would adjust certain promotional activities for VACSCEPA in the US. We have years to plan for this.
9. We are in Q2 now which is when we expected to get approval for new promotional commercials.
10. Think how aggressive we are going to be now at promoting V.
11. Expected EU approval in Q4.
12. Ongoing trials of V.... will they bear fruit.
13. BO is far from off the table."
Excellent Post from "Steve" on the Yahoo Boards:
What I think I think.... just another temporary setback in a long list of setbacks....
1. If unchallenged, generics will have to file an aNDA to sell in the US which could take anywhere from 1 - 3 years to get approval.
2. If challenged, (and it will be challenged)it could take twice as long if even successful
3. We could we awarded an injunction to prohibit the generics from selling in the US while the appeal process winds it's way through the appeals courts. Will take years to resolve.
4. If generics make it through all that, they can't infringe on any patents related to REDUCE-IT study findings and new indication.
5. This finding is only applicable to the US. We've only been selling in the US (Saudi and Australia can't be contributing much) for the most part since 2012ish and for the indication of lowering Trigs greater than 500. So we are barely scratching the surface with new indication scripts which will be the big ramp.
6. Generics will be locked out of the EU, China, and Canada for a long time.
7. All this talk about off label scripts for generics if they ever succeed in an aNDA...... ask yourself, how liable would doctors be for prescribing a generic for CV risk and the patient dies of a heart attack or stroke?
8. Amarin said that if after they've exhausted all legal remedies and if an aNDA was approved, they would provide an update as to how they would adjust certain promotional activities for VACSCEPA in the US. We have years to plan for this.
9. We are in Q2 now which is when we expected to get approval for new promotional commercials.
10. Think how aggressive we are going to be now at promoting V.
11. Expected EU approval in Q4.
12. Ongoing trials of V.... will they bear fruit.
13. BO is far from off the table.
Judges Ruling Link:
https://www.scribd.com/document/454018521/Amarin-Pharma-Inc
"Amarin Corp. lost a court ruling in its bid to prevent generic-drug makers from selling a low cost version of its fish-oil treatment Vascepa until 2030. Six patents on the drug, which all expire in 2030, are invalid, said District Court Judge Miranda Du in Las Vegas."
Patent Office Over-ruling District Court Case:
Just sent to Michael Yee of Jeffries and Elisabeth of Amarin Investor Relations...
Notes as:
"Please pass on to Amarin Mangement - we can use all the help we can find right now!"
100% Same Sentiment... Been in since 2012. Never sold a share and bought more to average down in the after hours this evening...
Had a 200k investment make it down to 10k and back up to 350k.
This product is huge and not lost to Generics because of a Carve-out for Pancreatitis...
The parts and pieces like you will not make me millions yet I am confident I will get my initial investment back and then some (once again!)
Funny - Your posting, Louie's, and one or two others post drop share this sentiment.
Everyone else is "doom and gloom" with nothing to back it up...
The roller coaster ride is getting to them.
All part of a successful Company!
Cheers!
A Decent Article Covering All (most) of the Bases:
https://seekingalpha.com/article/4335110-amarins-patent-defeat-current-options
Judge Du Cases reversed: According to a 2016 article, Judge Du had (4) cases of (44) at the time reversed:
"U.S. District Judge Miranda Du of Reno started in 2012, and has only handled 44 cases. The four that were reversed, or 9.1 percent, seem skewed because of the low number of cases."
https://www.reviewjournal.com/news/news-columns/jane-ann-morrison/some-judges-reversed-more-than-others/
Never give up Hope:
Trial Results Challenged on Obviousness, Decision Reversed, Slate Cleared when Both Parties Settled:
https://www.ipwatchdog.com/2019/12/14/federal-circuit-reverses-ptabs-invalidity-decision-regarding-wireless-communications-patent/id=117034/
Amarin has loads of Patents - this did not invalidate ALL of their Patents...
BIO: Looking for your thoughts...
1. Would Generics really want to set up a Company to sell a Generic version of Vascepa for Pancreatitis alone? Are there any other conditions this Judgment allows them to sell for? Reduction in Triglycerides or just this for Pancreatitis?
2. I wonder if Amarin would want to work out a deal with them to keep them away - your thoughts...
Not saying "needed info" yet more along the line of "they are obviously not going to call the Attorney's in to hear the verdict. Not saying they cannot schedule a conference call to read the verdict yet wouldn't you consider her commitment to the end of March a "deadline" in essence?
Trial: I am sure someone must have already posted this yet this notice is on the US District Court (Hon. Miranda M DU - Chief Judge) of Nevada Home Page:
Court Operations Under Exigent Circumstances created by COVID-19: All civil and criminal trials, including any associated deadlines, are continued until April 10, 2020 pending further order of the Court; All non-case related events scheduled to be held in the District’s courthouses,including the Inn of Court and Project Real, are postponed pending further order of the Court; As to criminal matters, the time period of continuances be excluded under the Speedy Trial Act. See General Order 2020-03 for additional information.
JL said when asked during the Trial in an interview if Amarin will "fight" or "settle", he clearly said "Fight" and he apparently meant it...
In my opinion:
He want to fight to quash as many future attempts from other generics now (and hopefully forever!)...
JEFFERIES TRIAL CLOSING SUMMARY:
Jefferies-Trial Proceedings Complete, Decision by March 31 per Judge
Trial Proceedings Complete, Decision by March 31 per Judge
Date January 28, 2020
Key Takeaway
In court proceedings for the AMRN vs. Hikma/Reddy's case have ended, following 7 days of expert witness testimony. The judge did not provide a preliminary ruling or hint at which way she is ruling, but she did state the written ruling will be made by March 31. We continue to think AMRN has made a compelling argument for induced infringement and nonobviousness and see the stock up +10-20% on a positive ruling.
RATING
BUY
TICKER
AMRN
PRICE
$20.26^
MARKET CAP
$8.4B
PRICE TARGET (PT)
$30.00
^Prior trading day's closing price unless otherwise noted.
Insights
Big Picture: AMRN stock has been relatively range bound the last month despite positive news on the competitive front with two key competitor trials having failed. We attribute this stock action to investor focus on the uncertainty associated with the AMRN trial and the potential risk for Hikma/DRL to present some "bombshell" evidence. With in court proceedings for the trial now completed, and Hikma/DRL having presented their best case, we are now more confident that AMRN is likely to prevail, removing the chief overhang on the stock.
Summary and timing of Judge Du's written decision: Day 7 included cross-examination of AMRN's expert witness Dr. Peter Toth, followed by redirect and recross. The day ended early with the Judge setting a March 31st deadline for her written ruling. We get the sense the decision will likely be more of a late March event, as the prosecution/defense have to submit their post findings of facts by Feb 14th and post trial briefs by Feb 28th and the Judge noting "I'll have a month" to write the ruling.
We think it will be hard to not rule in favor of AMRN. As a reminder, the key claims in dispute are: 1)Induced Infringement: AMRN had to show that a doc prescribing Hikma/DRL generic Vascepa would be more than likely (~51%) to infringe on AMRN's patents covering 12+ weeks of dosing. On this front, AMRN was able to clearly show that most docs, including Hikma/DRL's expert witnesses, would prescribe generic Vascepa for more than 12 weeks - infringing on AMRN's patent. 2) Obviousness: Hikma/DRL had to show that there was a high likelihood (~75%) that AMRN's patents were obvious and someone skilled in the art would have easily developed Vascepa based on the prior art (e.g., studies, publications, etc). While Hikma/DRL did present some interesting evidence in support of obviousness, we thought constant citation of AMRN documents by their expert witnesses was a glaring hole in their case.