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Anyone have a subscription to JCI (The Journal of Clinical Investigation)?
If someone does, please post this article published today...
Triglyceride lowering by omega-3 fatty acids: a mechanism mediated by N-acyl taurines
https://www.jci.org/articles/view/147558
CardioMD - Great to hear, thank you so much for the update.
North - I like TDA as well, but strictly on the desktop computer. A good mobile app to use for options is Tastyworks.
CardioMD - On a separate note, did you ever hear back from the RA patient who you recommended Vascepa to? I apologize if I missed any of your earlier posts on this.
eight - "weak evidence of the existence of secondary considerations"
Do you believe that Judge Du used this same logic on the entire secondary considerations in her ruling as the USPTO used just for unexpected benefits (from the non-final rejection of the parent application that resulted in patent '677)?
Is this something that can be applied to unexpected benefits for ApoB in this case as well?
Hamoa - Devil's advocate for you...
"expect Amarin to argue that Vascepa is a life-saving medication"
1) This case is about severe hypertriglyceridemia, not cardiovascular disease. There are many different therapies on the market right now that are FDA-approved to treat severe hypertriglyceridemia, patients can be prescribed any of them.
2) Vascepa is available on the market and doctors can write scripts for it. An expedited appeal will not change that.
3) Vascepa has been FDA-approved to treat severe hypertriglyceridemia since 2012, and doctors are very aware of this in addition to other treatment options. An expedited appeal will not affect that.
"the stripping of their market exclusivity by the district court is hampering it’s roll-out"
This case is about severe hypertriglyceridemia, not cardiovascular disease. An expedited appeal would not affect Amarin's marketing of the CVD benefit of Vascepa, nor would it affect a doctor's ability to write a script for it.
Also, Amarin spent hundreds of millions of $$ for REDUCE-IT and burned 6-7 years knowing the entire time that there was a risk of losing their patents, why should they be worried about an additional $25MM to market it?
"in the midst of a national health crisis"
...which has nothing to do with severe hypertriglyceridemia. It's not considered by the CDC nor FDA as an established underlying issue to be concerned with for COVID-19. This is a chronic condition, not an immediate condition, and treatment can be performed via online visits with physicians in order to comply with social distancing guidelines.
Amarin has to focus on their business condition and the reality of how this decision will affect them.
1) Amarin is a one-drug company, they live or die by sales of Vascepa alone.
2) The majority of sales for Vascepa over the past 2-3 years were really off-label scripts to treat cardiovascular disease. The market for severe hypertriglyceridemia is limited.
3) If a generic of Vascepa can be sold to treat severe hypertriglyceridemia, in reality it will carve out treatment of cardivascular disease and consume a majority of those sales. Many states require pharmacies to automatically swap out scripts for a brand name drug to the cheapest bioequivalent version available, which is usually a generic.
4) Loss of sales to a generic icosapent ethyl will have disastrous effects on Amarin's US business, including the decimation of their sales force and other people involved with SG&A. Adding another 1000+ people to the current levels of unemployment at the current state of the economy would severely affect the ability for those people to support themselves and their families.
5) **My assumption** Amarin is in the process of ramping up R&D of icosapent ethyl by investigating other uses (pointing out the BRAVE study for Alzheimer's Disease, any COVID-19 studies, and other potential indications such as DES). This decision will cause Amarin to drastically cut R&D in the US, with a potential "significant negative impact on public welfare" by affecting these other patient groups.
Freifaller - I personally appreciate DMiller’s realistic and rational POV and opinion when it comes to Amarin. He promotes good-faith debate on the board without skewing nor manipulating facts to fit his opinions.
BB - Could blood thinning be another reason Vascepa would be effective?
All of this is a bit over my head, but it’s worth exploring considering that one of the AEs of Vascepa is bleeding...
Front-line providers need to consider anti-coagulating their rapidly deteriorating COVID-19 patients. Could it be that severe endothelial dysfunction, resulting in microvascular thrombosis, is playing a major role in the rapid deterioration that we see in days 7-10?
— Kashif Pirzada, MD (@KashPrime) April 7, 2020
1/
High incidence of symptomatic thrombotic complications in COVID-19 patients at ICU? YES! We found 31% cumulative incidence despite routine thromboprophylaxis. Published today in @ThrombosisRese1: https://t.co/HMjdBLjiAs. #COVIDー19 #COVID19 @ErasmusMC @AmphiaZKHuis @LUMC_Leiden
— Erik Klok (@Erik_Klok_MD) April 10, 2020
G - Do you feel the same with a potential AMR103, IPE & bempedoic acid?
CardioMD - From your experience, do you believe that Amarin could have a strong shot of increasing overall icosapent ethyl scripts in the US if the reps were pushing it alongside another drug, let’s say something like Nexletol (bempedoic acid)?
Pharmacydude - "Was judge Du’s finding on stat sig difference in ApoB made to prove obviousness of the original patent"
Yes
"like Mori, it’s meaningless since you don’t have to have definitive proof to show obviousness."
A judge does need definitive proof. Which is why her ruling contained a clear error of fact.
"was this used to counter the secondary consideration of unexpected results?"
Yes
AnotherInvestor, Hamky - This market feels like where it was towards the end of January and first week of Feburary. We saw how the virus was killing people in China, how the CCP was reacting to it (entire shutdowns of cities, welding people inside of apartment buildings, tracking every single person with a mobile app), and didn't believe the official numbers (the real numbers were most likely much higher). But yet the market was not pricing in how the US would react once it spread over here. And it wasn't "if" it would hit here, it was "once" it hit here.
Right now, we are looking at a market that is not pricing in a potential economic depression. The hints are there (news articles stating that 1/3 of renters have not yet paid their rent for April, that ~3% of govt back mortgages went into forebarance with a lump sum due in July, record number of 10mm people unemployed within the past two weeks with no end in sight, etc.), but markets keep moving up the past week.
The Amarin share price is not insulated from any of this, as it usually has tracked along with the larger indices. Neither is any potential buy out. Unless there is a bidding war that starts and cannot be stopped, BP most likely will want to wait until the smoke clears until they commit on pulling the trigger.
Vascepa sales are also not insulated from this. People that are laid off have to switch their insurance providers. I don't know exactly how many of these people take Vascepa, but the number won't be zero. We may consider Vascepa a life-saving medication that one should not stop taking, but many people look at a medication that is not providing day-to-day immediate benefits as something that can be rationed or temporarily stopped in favor of paying other bills, debts, etc.
anfla - From Document 331, Plaintiffs' Pretrial Proposed Findings of Fact and Conclusions of Law...
North - Do typos matter when they are in a judge’s decision?
Pages 68-69...
“v. Praise
The Court found, as a factual matter supra in Section III.G.4(c), that Plaintiffs’ proffered evidence of praise for Vascepa was more qualified and equivocal than Plaintiffs argued, and this finds that the praise secondary consideration does not weigh in favor of finding the Asserted Claims nonobvious.”
Hamoa - "She wasn’t trying to set precedent. She was committing a procedural error."
I did not go through law school, so please excuse my ignorance on this topic. But is there an actual "defined procedure" that determines how secondary considerations are weighed for an obviousness defense? "Procedural error" strikes me as something more akin to court rules or codified language. If that is the case, this would be easy to strike down or affirm.
EDIT: I just read Ortakoy's post mentioning a procedural error brought up in the Jefferies call earlier today. I will have to look furhter into that.
My assumption is that the logic that Judge Du used is not strictly defined anywhere, and that case law would typically be looked at to define the logic used with regard to weighing secondary considerations. But if zero case law exists with regard to her logic, Judge Du is effectively setting precedent.
Additionally, it is my assumption that the majority of the judges in the 9th circuit would agree with Judge Du's logic as one of an activist looking to close a loophole in the law that would typically benefit big business...unless case law exists where this logic was ruled as improper.
Please correct my thinking above if it is incorrect.
Hamoa - "a different and flawed interpretation of how secondary considerations should be factored into a judgment of obviousness"
This stood out to me as well while reading the decision on Monday. I am not a lawyer, though, so I am not aware of the intricacies of IP law and am not able to determine if this logic is proper.
Correct me if I'm wrong...you're effectively saying that Judge Du is attempting to set precedent regarding secondary considerations in determining obviousness.
The logic used by Judge Du seems relatively intuitive enough to assume that case law exists where it was used previously by another judge and either overturned or affirmed on an appeal. In fact, I'd be shocked if this logic has never ever been used in a case regarding secondary considerations with an obviousness defense of intellectual property in the history of the US. That said, it wouldn't be the first time I've been surprised this week...the decision in this case took care of that.
Venus - Right now, the market is saying that there is a < 1% chance that this will be overturned on appeal.
Exgermanowner - Reduce-it patents don't matter in US anymore.
Once this verdict is upheld in appeals, generic icosapent ethyl is free on the market. Generics may even start selling it "at-risk" before the appeals process finishes.
Weblink to Investor Call... https://www.webcaster4.com/Webcast/ListenPage?companyId=2037&webcastId=33498
zman - Amarin didn't lose on both counts.
Generics would have infringed.
But all of Amarin's patents were judged to be obvious.
I didn't see any expert state that Amarin would win. They believed that Amarin had a more probable chance of winning, but not that they would actually win.
Relic - "Why tell anyone anything if you have no intentions on upholding them?"
It is my belief that the court is taking this approach...a reasonable person would understand that a district's chief judge could delay a self-imposed and unenforceable target date in the face of an unprecedented comprehensive response to a worldwide epidemic.
MontanaState - "11:59 pm on 3/31/20"...Pacific time
OT PSA...Forgivable Small Business Loans in US (up to $10MM)
Please forward this to anyone you know that either owns a small business with employees, is an independent contractor, or is a sole proprietor in a business.
The US federal government is offering to forgive all or parts of small business loans that are taken out after 15 Feb 2020 in order to cover payroll expenses.
Take advantage of this offer ASAP as there is only a limited amount of money that is available.
Please read the below information to find out more details...
https://eig.org/news/understanding-the-paycheck-protection-program
Quick update...nothing released today. Doubtful anyone is working in the court today. Doesn’t mean that Judge Du will not release her decision this weekend, though.
Sharinky - The “stimulus checks” are really an advanced payment on a new tax credit for the 2020 federal taxes. So, in reality, it’s no different than accepting money for each child dependent, or “energy credits” for installing renewable energy features on your home or if you purchase a battery-electric vehicle.
BigHen - The release feed only goes back to 2pm local yesterday.
My assumption is that filings can happen over the weekend.
Also, Judge Du’s first filing yesterday was 7am local yesterday.
Let’s see if anything starts to get released over the next few hours.
BigHen - FWIW the last document released by a Nevada district clerk was at 10:11 PM local time last night.
Tal10 - It doesn't appear that there was a date given for a decision in this particular case. The decision seemed like a fairly straight-forward one, so this may have been something that they were able to clear off their plate pretty quickly.
Here is info from Pacer Monitor regarding this case...
Wednesday, March 18, 2020
120 REPLY to Response to 112 Motion for Summary Judgment, by Defendant Silver Terrace II Landscape Maintenance Association. (Cwik, Marc)
119 REPLY to Response to109 Motion for Partial Summary Judgment, by Plaintiff Bank of America, N.A.. (Walker, Holly)
Friday, March 13, 2020
118 ORDER granting ECF No.117 Stipulation as follows: - Bank of America's Reply to the Motion for Partial Summary Judgment (ECF No. 109 ) is due by March 18, 2020 - Silver Terrace's Reply to the Motion for Summary Judgment (ECF No. 112 ) is due by March 18, 2020 Signed by Chief Judge Miranda M. Du on 3/13/2020. (Copies have been distributed pursuant to the NEF - AB)
Wednesday, March 11, 2020
117 STIPULATION FOR EXTENSION OF TIME (First Request) for Filing Reply Briefs re112 Motion for Summary Judgment,109 Motion for Partial Summary Judgment, by Defendant Silver Terrace II Landscape Maintenance Association. (Cwik, Marc)
Wednesday, March 04, 2020
116 NOTICE of Appearance by attorney Darren T Brenner on behalf of Plaintiff Bank of America, N.A.. (Brenner, Darren)
Wednesday, February 26, 2020
115 RESPONSE to109 Motion for Partial Summary Judgment, by Defendant Ravenstar Investments, LLC. Replies due by 3/11/2020. (Aman, Nathan)
114 RESPONSE to112 Motion for Summary Judgment, by Plaintiff Bank of America, N.A.. Replies due by 3/11/2020. (Walker, Holly)
113 RESPONSE to109 Motion for Partial Summary Judgment, by Defendant Silver Terrace II Landscape Maintenance Association. Replies due by 3/11/2020. (Cwik, Marc)
Wednesday, February 05, 2020
112 MOTION for Summary Judgment re1 Complaint,,,, by Defendant Silver Terrace II Landscape Maintenance Association. Responses due by 2/26/2020. (Cwik, Marc)
PACER update (for another case)...
Judge Du released a judgment for another case at 10:44AM Eastern this morning...
https://www.pacermonitor.com/case/20095664/Bank_of_America,_NA_v_Silver_Terrace_II_Landscape_Maintenance_Association_et_al
Judgment: https://ecf.nvd.uscourts.gov/doc1/11518277909?caseid=119063
Order: https://ecf.nvd.uscourts.gov/doc1/11518277904?caseid=119063
Her court is open and working today.
Also, the filings from the court overall are starting to pick up the pace, compared to an hour or two before.
Postes - No, not leaks. Leaks are possible before the judgment is communicated, but if Amarin receives word that a phone conference is set up with the attorneys involved to receive the official judgement, my assumption is that they will halt trading of the stock if the market is open, and keep it halted until after they send out a PR about it.
Dmiller - You’re assuming that the judgement is released publicly on PACER before the court communicates the judgement to the attorneys. That may not happen...it’s entirely possible for counsel to get invited to a last minute phone conference, find out the judgement, and report it back to company management before the document is released on PACER.
Your post had good timing...I just happened to be looking into this when I saw it.
If anyone wants access to the Nevada court's live feed, you can plug this link into an RSS feed reader to receive an alert for all documents posted to all cases...
https://ecf.nvd.uscourts.gov/cgi-bin/rss_outside.pl
Or, you can get real-time alerts if you sign up for a free 14-day trial to Pacer Alerts...
https://www.pacermonitor.com/public/case/19726810/Amarin_Pharma_Inc_et_al_v_Hikma_Pharmaceuticals_USA_Inc_et_al
marjac - Judge Du's court is still working.
A judgement on another case was filed yesterday...
https://www.pacermonitor.com/public/case/30210983/Iden_v_Seventh_Judicial_District_Court
Tonight is the third consecutive night that I’ve seen a Jardiance commercial that says I can lower my chance of a heart attack if I’m diabetic. With a list of side effects that I wouldn’t prefer but would stomach to not die. And there was no understanding of how effective the drug is. But the “jump on it” tune catches my attention.
Still waiting to see a Vascepa commercial. Or even a True to Your Heart commercial.
The crappy competition is out-hustling Amarin.
PACER UPDATE........
Change of address for Hikma’s counsel Charles B. Klein and Claire A. Fundakowski at Winston & Strawn, LLP
Biopa - The CCP just admitted that they did not list approx 43,000 people on the “confirmed cases” tally even though they tested positive since those people were asymptomatic and were either quarantined or isolated...
And now this from China - "Citing classified data, the SCMP reports more than 43,000 people in China had tested positive for Covid-19 by the end of Feb but were asymptomatic. They were placed in quarantine and monitored but not included in the official tally of confirmed cases"
— Jonesy (@HedgeyeDJ) March 23, 2020
JL - Would be curious to know if Tom Hanks has been taking Vascepa, as he has seemed to be relatively unscathed by COVID so far (especially as a person with T2DM).
shadoland - "[W]hat happens during a viral flu season? Does anyone try to flatten the curve?"
Yes, by getting a flu shot. Depending on how well the flu spreads, hospitals can have a large number of patients with issues.
That said, COVID is not the flu. COVID is SARS, or Severe Acute Respiratory Syndrome, which specifically attacks the lungs. It is also more contagious than the normal flu. This causes two issues...a shortage of PPE, or personal protection equipment, such as masks. Second, a shortage of ventilators that support people with respiratory issues. These types of shortages do not normally happen at hospitals with the flu.