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I’d like to read the transcripts. Can you spot to google drive as others have done with other pacer links ?
Thx
We don’t know that they didn’t raise this point at trial. NO one has read the oral arguments. It coulda been a one liner by an expert. Even still it’s almost the same point we are making on Kurabayashi. Further like markman said -to a judge a within group diff may be enough (for reasonable chance of success and thus obviousness) even tho no scientist phd or doc would ever even look at that. We want between group difference. This is where law and science have frustrating differences.
Raf. I know it’s frustrating but at end of day the judge missed this not Covington (IMO). It’s not even a close point. The judge just didn’t get it on every scientific point made including Kurabayashi which we have discussed at length on this bored.
Mori if it’s read by anyone clearly shows a POSA would prefer DHA over EPA effects. There’s not even a hint that someone reading that study would then use EPA alone. Hikma lawyers spoon fed her excerpts and she copy pasted many of them into her brief and failed to adequately give amrn a fair trial. I think this case was way over her head.
Read Mori. Or take a look at the conclusion of it below that I pasted. It’s ridiculous how we lost this case but I don’t think it was Covington. Luckily all the major issues were raised at trial and we can post a strong appeal. As another poster said , no one realized what she was thinking until her decision came out and it was too late. With the appeal, we will be able to listen to oral arguments and decide early if the judges get it or not (which is great). I’ll be there.
“Despite an increase in LDL cholesterol after DHA supplementation, LDL particle size increased—a finding that may be favorable. Furthermore, EPA but not DHA increased fasting glucose concentrations.
These findings may help clarify which of the n-3 fatty acids is responsible for the protective mechanisms of dietary n-3 fats on cardiovascular disease. They suggest that, despite an increase in LDL cholesterol after DHA supplementation, the increased LDL particle size may represent a shift to less atherogenic particles, in which case the parallel increase in HDL2 cholesterol and decrease in triacylglycerol may represent a more favorable lipid profile than that seen after EPA supplementation.”
Hope so. I’m not saying we can’t win. I think the law errors are out path though.
Bottom line is Bhatts paper changes little. I commend him for doing it but the judges don’t understand statistics and just go by the papers conclusions. I have respect for all the lawyers on the board but this is a highly scientific and statistical issue that was way over Judge Dus head. I think we focus on singers points and the weighing of secondary considerations errors and hope for best. Looking forward to seeing their response brief altho I’m sure it’ll be painful To read.
Would have liked mar or another attorney to weigh in on this point ? Seems to be a possible focal point. Thx for posting.
Covid Vascepa trial - Anyone have a best guess when we can see results from this. It’s only a 14 ya trial and I think open label ? You think within 6weeks?
To your point 2 I am still not at ease. It was turned down but when the patent examiner overcame it they clearly wrote that they only overcame it bc of ApO-B. I went back and read it all. Therefore I don’t know that the point singer makes is a valid point, but I defer to the lawyers or someone more knowledgeable than me. It seems if they turned it down and later accepted it in full it would have more weight but bc they still found it obvious to reduce TG and not raise LDL it’s tough (for me) to get past that point.
Agree with the points but was wondering why singer didn’t state them as such. I independently thought of the same responses as you to these points when reading but singer didn’t write those points in. His other points are great but still. We still have more time and oral arguments but I want to see more from our team.
Very nice write up. Clear and concise. Thanks for taking the time to do it. What are the possible outcomes that can come out of this?
No bc it’s the number of events that was reduced.
The issue for me is this reasonable expectation of success. Legally speaking what is the definition of that and how does that apply to our case. I think that’s the hardest thing to grasp and the crux of the case. Essentially if effects in the Tg<500 group was enough to show a reasonable expectation of success in the TG>500 group then we r shit outa luck for that argument. I don’t think it was bc no one did it for years if it was so obvious and all TG lowering therapies increased LDL in TG>500 populations so clearly it’s not obvious the same wouldn’t have happened in our marine trial.
I think our lawyers argue it well and differentiate Tg<500 from severely elevated but the patent examiner didn’t get it neither did Du so it’s not a lock.
Agree G I was suprised in the approach they took and am glad they did it this way. When you compare their argument to defenders and to the interpretation of Judge Du I am still really not sure which way this specific argument will go. Lawyers and urself can weight in. It really depends which way the judge leans. We can win this case multiple diff ways which is great but one way would be winning the argument of TG< 500 was not proven to be similar to Tg> 500 as it relates to LDL cholesterol. Case would be closed
I just finished the whole thing myself. Was a nice read. I am surprised (yet very happy and bullish) that they stuck with their trial argument that TG<500 is diff then Tg> 500. They saved that argument and I thought it was impossible from being saved. Good to see. It was very persuasive and if you win that argument you win obviousness period.
I also enjoyed his comments about the patent examiner.
Recall the argument by defendants that the patent examiner initially rejected our patent (trying to show its weakness). This seems to hold no weight bc it was overcome and assumed to be valid. Our lawyers go on to say “ almost every patent ever allowed was once rejected by an examiner.” Lol
One argument made by us is
“Obviousness determinations are made by courts without deference to the rulings of the patent examiner.”
Therefore doesn’t matter at all that we were initially rejected. Period.
All the errors around Kurabayashi I sent in and many of you helped formulate were in the brief and strong. Looking forward to seeing the defendants reply brief now.
We have a much stronger argument for reduce it then we do marine. Probly multiple orders of magnitude higher. I agree we have learned no patent is safe. However if we win the appeal on Marine patent it’s safe to say we will win any fight against a generic on reduce it. Plus if we win appeal on marine our road to 2029 and beyond has a fairly good head start bc of exclusivity ,timing for generics to even start a case against reduce it and then obviously supply issues. The big issue with amrn is winning the appeal against generics for marine. I look forward to reading the brief Tuesday and all documents thereafter and will likely go to oral arguments provided out brief on Tuesday gets me motivated.
1st off welcome back.
What’s the significance of this? You think BB were assigned shares?
Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059).
I think we need some more data as it wasn’t stat significant for mortality but will c.
How does settlement help. Just gets the next generic from launching. You would have to settle with all generics. I don’t see how that’s possible.
WRONG. Vascepa had a very small increase in Afib seen. Most of it was related to people who already had a Hx Afib and just went back into it which we see all the time with Afib pts. After you take those people out it was a fraction of an increase in Afib in those without a hx. HCQ and Zithromax temporarily causing an increase in a prolonged QT which is what has been shown so far is very close to being clinically insignificant. Close bc it’s insignificant unless it leads to part 2 which is an arrhythmia. The news keeps talking of possibility of leading to cardiac events but that’s not enough. It has the POTENTIAL to increase the chance of Afib (very very very small chance). We give other meds that prolong the QT all the time for colitis (zofran and cipro together ) and rarely ever see it cause Afib or torsades a far worse deadly arrhythmia. It’s a theoretical risk that can happen and will happen on a freak event but you are talking about extraordinarily rare events. To even consider not giving Vascepa with HCQ and z pack would be mal practice. Vascepa doesn’t prolong the QTC. It’s two diff mechanisms.
how is it legal for them to produce this epa overseas and not an infringement on vascepa.
I never saw this before. Hm. Do we know how then the patent examiner Eventually overcame the unexpected benefit and granted the patent ? What changed.
G. Appreciate all your posts. I like you tried to figure this all out and make sense of it.
However it is clear error. There’s no way to interpret that statement as correct
“statistically-significant differential effects": it is true … "EPA" arm vas SS, placebo was not (it was NS) … these effects (statistically) were different. “
It is not true. EPA arm was SS. Placebo arm was not. These effects were different but were not different with statistical significance. There was SS bw the groups. Therefore, one cannot claim “SS differential effects.” Cannot be argued.
Thx pharma
Can you fill us in how exactly that works ? I prescribe DAW vascepa. You see generic is out there. How do you choose which generic to provide (tevA hikma or amrns own generic)?
Thanks for posting the comparison for all to see.
Qs for the board. Can someone explain the relevance of this "SYNERGY" as I think it may be another fatal error by Judge Du and may help us win the case. I really don't understand how it is relevant and I think the Judge got confused on it and made a conclusion against amrn in her decision based solely on it.
Amrn Findings of Fact Post trial states
"Although Dr. Heinecke opined that the results do not suggest “any interaction or synergy between estriol and EPA,” see Trial Tr. 735:21–24 (Heinecke Direct), a person of ordinary skill would have understood, as Dr. Toth (who was trained in OB/Gyn) explained, that estriol is a “complex molecule” and therefore, Kurabayashi does not tell that person “much of anything about EPA alone.”
Defendants Findings of Fact Post trial brief states
"The results reported in Kurabayashi do not suggest any interaction or synergy between
EPA and estriol. Heinecke Tr. 735:21-736:9. Instead, synergy is usually only seen between drugs that have similar effects, such as two drugs that reduce blood pressure. Id. (Heinecke).
282. In light of the statistically-significant differential effects reported between the EPA and control groups, a person of ordinary skill in the art would have attributed the reduction in Apo B to EPA. Id. at 737:24-738:8 (Heinecke)."
Judge Du Decision essentially copy and pastes the defendants above statements as she write
"The results reported in Kurabayashi do not suggest any interaction or synergy
between EPA and estriol. (ECF No. 367 at 735:21-736:9.) Instead, synergy is usually only seen between drugs that have similar effects, such as two drugs that reduce blood pressure. (Id.)
In light of the statistically-significant differential effects reported between the EPA and control groups, a POSA would have attributed the reduction in Apo B to EPA. (Id. at 737:24-738:8.)"
CAN SOMEONE PLEASE EXPLAIN TO ME/ARGUE HOW SYNERGY AT ALL COMES INTO PLAY HERE TO SHOW THE RESULTS CAN BE CONCLUDED TO BE FROM EPA ALONE. I REALLY CANT GET IT INTO WORDS HOW IRRELEVANT THAT STATEMENT IS AND I MAY SEND MY SECOND WRITE UP TO AMARIN REGARDING THIS POINT AS I THINK IT IS HEAVILY WEIGHTED IN HER BRIEF. THANKS
That point seems to be mixed in federal court. Will depend what’s judges we get. Goal at appeal is to punch as many wholes in the case as possible and get back to the fact that there is not clear and convincing evidence to prove obviousness/invalidate our patents.
Arguments are
-The one above you spoke of in terms of improperly weighing secondary considerations.
-Improperly shifting the burden to amrn when the burden was on the defendants. Judge Du does this in her decision
Then to me the bigger issue is below
-Fact error - Kurabayashi was considered by the patent office despite Judge Du stating the opposite
-Fact error- Kurabayashi showed no stat sig bw groups with Respect to Apo B reduction despite Judge Du stating the opposite
There’s other minor arguments too but I expect the above to be the main stuff in the upcoming appeal brief we can read. Will see.
Yes. Only thing is the three secondary considerations were much much weaker for BMS then amrns claims are (and the judge sorta mentions that if u read thru it). So to reiterate if we get unexpected benefit on our side I can’t see how we lose. To be fair, I couldn’t believe we lost the case to begin with but in a lot of ways I think the decision is wrong so I can’t necessarily admit I was wrong just yet.
I disagree with you ,respectfully. See case law on Bristol Meyers vs Teva. BMS had 3 secondary considerations in their favor and lost at trial on obviousness. Thoughts on that ?
Therefore I agree with G and others in that we need to win on unexpected benefit which is why I have spent a lot of time on Kurabayashi and the fact errors judge Du committed (and have emailed IR/Covington who actually sent me a thank you message surprisingly)
Thanks for the info as usual. Seems to be more than 50 percent which was stated.
Hmmm.... Hopefully we can do better than that. I still am hopeful Monday conf call has something good for us. Our market cap here is so undervalued. No one knows what Europe or even China is worth. US also has a chance to produce some sales or we can get the dream and win on appeal. Let’s see. I’m a holder.
Well what do you make then of how lovaza only lost 50 percent of sales to generics? I don’t think we lose the whole market bc it is hard to produce etc. If we were to maintain any percent of the US market that’s massive bc currently the share price has baked in not one dollar from US sales. Thoughts ?
Why r u happy there’s no Q and A? Thx
If you read all the briefs and some additional case law, you will see how you don’t need overlapping numbers to demonstrate a reasonable chance of success which was all that is needed. We argued this point throughout the case but we failed to convince Judge Du and that was a big loss for our team.
Agreed but those are diff arguments. I can’t write their whole brief just trying to provide some definite errors and stay concise.
The Tg>500 being different then the Tg<500 is an uphill battle for amarin as we lost that argument In round 1 fairly miserably. We can win this suit even without winning on that point.
Thx. I’m adding all this feedback in and will be submitting my final version tmw. Great work by the board.
IR/Covington- Help from the Board before I send this to them. Any edits just reply to this chain. Thanks in advance to everyone.
As a physician who has read all of the data and all of the briefs in this case, please review the below fatal errors in the patent case that may be of assistance to Amarin.
In Judge Du’s Decision page 30 Lines 14-16, she states “In light of the statistically-significant differential effects reported between the EPA and control groups, a POSA would have attributed the reduction in Apo-B to EPA. (Id. at 737:24-738:8.)
Judge Du makes a fact error because the above statement is entirely incorrect. There was no statistically significant difference between the EPA group (defined as EPA +estriol) and the control group (estriol alone). In fact, if you read the Kurabayashi study, APo-B reduction is mentioned no where in the discussion section or the conclusion of the article. It is merely mentioned in one line in the results section (3rd paragraph from the Results section) and states, “The apolipoprotein B level in the eicosapentaenoic acid group was significantly lower at week 48 compared with the baseline level, but there was no significant difference between the groups.” Let me emphasize the second part of that statement, “but there was no significant difference between the groups.” This carries tremendous weight. Furthermore, if you look at Table 3 which Judge Du also has in her decision, there was no statistically significant difference in Apo-B levels between the “EPA group” and the “control group” at every time interval measured. Please see “NS” (Not significant) underneath week 12, week 24, and week 48 of the Table.
Scientifically, you cannot compare a patients baseline numbers to their numbers at week 48 and conclude anything of significance. Comparisons must be done to a control group and this is well known. One citation of a multitude can be seen here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3286439/. titled, “ Comparisons against baseline within randomised groups are often used and can be highly misleading.” The author concludes ,“ Randomised groups should be compared directly by two-sample methods and separate tests against baseline are highly misleading.”
Another error within the Apo-B discussion occurs. The judge points to a reduction in Apo-B with a p value of <0.001 as being ?“highly significant”. However, the flaw here is the within group comparison is a well known misleading conclusion. Please see another example below with the same exact p value quoted by Judge Du (p<0.001), yet concluding there was not even “good evidence” of a between group difference.
“In a randomized trial of morphine vs. placebo for the anaesthesia of mechanically ventilated pre-term babies, it was reported that morphine-treated babies showed a significant reduction in adrenaline concentrations during the first 24 hours (median change -0.4 nmol/L, P < 0.001), which was not seen in the placebo group (median change 0.2 nmol/L, P < 0.79 (sic)) [15]. There is no way to test whether the between group difference is significant. Even though the median changes in this example are in opposite directions, this does not imply that there is good evidence that the treatments are different ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3286439/)
Aside from the fact errors by Judge Du, the Kurabayashi article in and of itself has several limitations which severely impair any results of the article even those accepted as valid by Judge Du. The trial is Japanese only, women only, limited to post menopausal females, small in size, and in a non-peer reviewed nutritional journal. Therefore, any data taken from this article would not make a POSA feel they have a reasonable chance of success in reducing Apo- B, let alone reducing it in a TG>500 population never before studied. The trial was considered by the patent examiner and referenced in the patents (Despite Judge Du incorrectly stating otherwise). It should be clear that Amarin’s own Marine trial failed to reduce Apo-B with its 2 gram dose and only showed this non obvious unexpected benefit with its 4 gram dose. In conclusion, a POSA would conclude exactly what the patent examiner concluded, “
The prior art is either silent or teaches that there is no statistically significant change in Apo-B levels when patients with TG levels less than 150 mg/dl or between 150-499 mg/dl are treated with either 96% pure ethyl-EPA or a mixture of ethyl-EPA and DHA, or when a mixture of ethyl-EPA and DHA was administered to patients with TG levels above 500 mg/dl (see item 25 on page 6 and Table 1 of the Bays’ declaration dated 05/16/2012; see also Table A on page 15 of Applicant’s response dated 01/13/2012). Applicant also presented convincing arguments (see Bays' declaration dated 05/16/2012, items 10 through 24 on pages 2 through 6) against the three references presented by the Examiner (Connor et. al., Fisher et. al. and Park et. al.) regarding the predictability of lowering Apo-B with 96% pure ethyl EPA in patients with TG levels above 500 mg/dl (see non-final rejection dated 03/02/2012, pages 20-23).
This statement is inclusive of Kurabayashi as no pure ethyl-EPA drug showed a reduction in Apo-B. Finally, if the initial patent examiner granted the patent essentially based on “long felt and unmet need” and the “unexpected benefit,” and Amarin now has in its favor those two conditions plus commercial success (granted by Judge Du), there is no clear and convincing evidence of obviousness to invalidate the Amarin patents.
Opinion from the board-
What do you guys think about this ?
“We note that Lovaza, a branded Omega-3 prescription drug maintained 50% of its market value several years post the launch of generics, in part due to the lack of sufficient quantities of generic Omega-3 alternatives.”
Is it possible we can maintain even 50
Percent of sales. We are baked in for making 0
Dollars in the US with generics. I really wonder if we can effectively limit the supply of the generics which would be extraordinarily bullish.
Thx for pulling quotes these are helpful. However our situation is opposite. Judge trying to make an obviousness statement about A when the data is A and B together showing a reduction in Apo B and has no comparison group to B showing any significance. IF A (epa) reduced Apo B, you would expect a diff between the A and A plus B bc B (estriol) would not be working so the diff between the groups would get larger and significant.
This is an excellent point and should be sent to IR and Covington.
Also, there was no ss at any point in the trial except at baseline to 48 weeks. All other time intervals had no significance. Lastly, the reduction in apo B is not mentioned anywhere in the discussion or conclusion of the article. Another error by Judge DU to falsely interpret the data.
Great find
How G? Look at that table. All comparisons even within the epa estriol group are not ss except until you get to 48 weeks. That has to lose a lot of credibility. Also it is no where In discussion or conclusion of article. I don’t think this is hypothesis generating.