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Have you seen that somewhere ? If you did , find that and post bc that’s material info and can reverse this whole case.
Yes. She missed it gentlemen. it was referenced.
Tasty agree with you. At least I agree on the point that Kurabayashi should be irrelevant. I think it’s harder to prove to overturn her terrible decision to exclude reduce it. It’s actually a really easy argument but bc she lists 5 independent reasons to exclude I am sure our team doesn’t want to waste the appeal arguing those points bc you are better off focusing time elsewhere.
Mori was cited
“Kurabayashi was considered by the PTO. The examiner signed off on it and its printed on the cover of the patents as having been considered.”
From another poster on seeking alpha. Not sure if that’s true though. Look forward to your thoughts G
Qs for you. If pharmacy doesn’t clarify which pts are on label or off label, how does amrn know the exact percent that is prescribed off label? Thanks.
I’m still not sure either. It wasn’t cited. He cited three other articles. How can we know if maybe he just looked at it and discarded it bc it’s not relevant.
I’m happy to listen to your argument if you want to provide one. Otherwise this sounds completely nonsensical.
You have lost so much credibility. To me you were such a great resource pre reduce it. Since then, I am not sure if you just lost it or you are frustrated. I can understand the frustration but what you are saying now is completely ridiculous.
I find this very striking as well. She even says amrn can’t have it both ways. We didn’t even get it one way. Either give us reduce it or strike Mori and all the other studies that are irrelevant
Agreed. She takes it out of context. Just bc we may expect you to reduce your TG > 500 as you may with a starting value <500, we may not expect the other lipid markers to be as favorable. She leaves out important testimony showing therapies that reduce TG but your LDL increases as you treat higher and higher TG levels. Therefore it would not be obvious to a POSA that all parameters would be effected similarly in a severely elevated TG population.
hey raf. here's how she differs from the way me and you think. She is grossly mistaken but this is what we are dealing with.
"Moreover, Plaintiffs’ arguments also depend on another factual premise that lacks evidentiary support—that patients with TG levels above 500 mg/dL respond differently to TG-lowering therapy than patients with TG levels below 500 mg/dL. (ECF No. 379 at 23- 24.) But even if Mori and other studies on patients with lower TGs did not provide “conclusive proof” of EPA’s effects, they were enough to form “a reasonable expectation of success.” Hoffmann-La Roche, 748 F.3d at 1331. Indeed, Dr. Toth conceded that POSAs could rely on data in patients with triglycerides below 500 mg/dL to make reasonable predictions about how patients above that threshold would respond. As he admitted, “a skilled artisan would know that a drug that reduces triglycerides in a patient at 400, is very likely to also reduce triglycerides in a patient at 600.” (ECF No. 371 at 1860:8-11.) Thus, the Court finds that a POSA “would have reasonably expected purified EPA to reduce triglyceride levels above 500,” even without data confirming that result. (Id. at 1860:12-15.)"
I mean I like that she gave us 2 but I would have liked if we also kept the unexpected benefit of reduction of apo B bc to me that’s why we were ultimately granted the patent. I think our lawyers need to focus the appeal on that. However like
Hamoa and others have said we can win even with just the two secondary considerations in our favor.
After diving deeper. It seems the examiner brought up 3 articles regarding apo B but didn’t cite this specific one Kurabayashi. It’s a totally worthless article scientifically but the fact that the Judge didn’t see it as worthless is unfortunate. It also sucks it wasn’t cited bc that could have helped us.
What’s your opinion on us removing our NDA for the marine label and us prescribing Vascepa based on reduce it label and off label for marine label. We don’t need the marine label anymore. Would that interfere with generics? Can we do something like that if we get desperate?
It’s a dead issue. Listen I see your point. I was in that camp. It’s frustrating but
we aren’t going to win with that argument. If you read the judges full decision you’ll see what she does. Plus the original patent examiner screws us in his wording.
So in amrn facts and order page 145. It is stated “ Thus, in the Reasons for Allowance the Examiner maintained his view that, even if there was no prior art teaching administration of purified EPA to a patient population of 500 mg/dl or greater, prior art teaching administration of purified EPA to a patient population with “[e]ven a slight overlap in range” established prima facie obviousness.”
Therefore these ridiculous trials with even 1 pt or a hypothetical pt over 500 is what’s killing us. She’s connecting all pts of 300 400 500 600 as having the same essential physiology and that’s backed up by experts. Further experts agree that the cut off of 500 is arbitrary. She concludes that Tg>500 cut point is not very significant. I don’t have her exact argument in front of me.
The level doesn’t matter raf. Something I learned as well. If it was obvious at 150-500 the court is accepting that as reasonably suggesting obviousness in Tg> 500. Therefore we can’t use that argument. The argument to dismiss Kurabayashi is that it was Japanese only, women , no legitimate control group as in a true placebo, 1.8g, and the fact that our marine trial showed the reduction in Apo B only in the 4 G dose and not the 2 G thereby adding to the non obviousness of the finding
Thanks G. So essentially Kurayabashi was not cited as reviewed by the examiner here. Three other articles were used and all easily argued by amrn and examiner agreed. Interestingly, here's what the examiner says in regards to accepting the patent. The dose mattered. This adds further evidence of non obviousness to our unexpected benefit argument and was not mentioned by Judge Du. The 4 g dose and not the 2 g dose showed the benefit in reduction of Apo B.
"The Marine Trial shows the criticality of the 4 g per day dose, as opposed to the 2 g per day dose wherein no Apo-B effect was observed, and based on the importance of lowering Apo-B in these patients, it is concluded that Applicant has effectively shown unexpected results for his invention."
IF the appeal court can re instate the unexpected benefit as being non obvious, we win the appeal period. Judge Du falsely accepted Kurayabashi as evidence (which it clearly is not) and arrived at a false conclusion regarding APo B reduction being obvious.
Can you explain more specifically what you mean ?
Yeah. It’s sealed. We need that lol
That is a lawyers opinion of the case. We still don’t know what the actual truth is. I’m trying to get the original patent examiners comments and how he weighed the Apo B issue bc that to me is the big deal.
Agree this is not mentally healthy. I’m glued to it and it’s really not healthy. I’m just so disgusted in this decision. It’s one thing to lose bc our DD was bad but I felt like myself and this board got this right yet we still lost. I don’t think I can really ever get over this decision. It’s just mind boggling.
Ur confusing law with science. I’ve now learned the two are very different. The reduce it trial has nothing to do with our law suit from a law perspective but is very heavily connected from a scientific standpoint.
Major break through if someone can get his response here :
8. In case this Appeal fails, could Amarin divest itself of its MARINE TG greater than 500mg/dl NDA, (relying in future on off label physician usage for this indication). By swallowing a poison pill as it were to force the generic companies to start a new NDA app of their own for this indication rather than piggy back an ANDA on Amarin’s Vascepa MARINE indication patent - they could tie the generics down for quite a while getting a new indication and an NDA of their own.?
(Mr Silbersher's response to this question from a TPT member is currently exclusive to the TPT community. His response, which has interesting implications in Amarin's legal struggle, may be made public at a later date - Dr. Ashok Dutta.)
Doc 331 filed 1/6/2020.
I agree you can attack both and amrn will. However, it will be harder to overcome the first point bc both PTO office and Judge Du agreed and both got it wrong.
Much easier to overcome the secondary consideration of unexpected benefit bc the original PTO office got that right and to my knowledge and to amrn fact and order brief the Kurayabashi trial was in front of the PTO office so nothing new has changed (this trial didn’t come out of no where to my knowledge).
Agreed and well said.
They are weighed as a whole against the primary. However if our original patent was granted on
-unexpected benefit of Apo B
Plus unmet need
Then you would think if the same two issues stood we should win by clear and convincing evidence. Judge Du took away our unexpected benefit but sides with us on commercial praise. That may still be enough to win but it wasn’t to her. I think if we can get unexpected benefit back in it’s a slam dunk bc then nothing has changed.
Bc the original PTO office got it wrong, the obviousness point you refer to is a harder uphill battle. I agree the evidence is so weak it’s mind boggling and makes me lose all respect for the system. However, we need to focus on the reduction of Apo-B (the unexpected benefit). That’s our pathway imo to win on appeal.
Eight. Appreciate your posts. Crux of case to me is how Judge Du dismisses the unexpected benefit of Apo B. This secondary consideration (in addition to the unmet need) was the major reason we were granted the patent. In Judge Du decision, we were only favored on unmet need and commercial praise. I think another secondary consideration would have been key and/or the original one of unexpected benefit. Do you have access to the original patent comments. I’d love to know what the patent examiner said about Apo B back then.
'Kurabayashi was considered by the United States Patent and Trademark Office during the prosecution of the Asserted Patents.
“
Line 24-25 page 157 of facts and order.
Qs is whose telling the truth ? Amrn says it was considered. Other side said it wasn’t.
Any idea ? I think this is a big point.
With all due respect, this response is irrelevant to my post. I am aware the reduce it patent is not in qs. That doesn’t mean the data from reduce it is excluded.
Any lawyers want to help comment on the below. The main question is the final paragraph but the beginning is the background.
So in amrn facts and order page 145. It is stated “ Thus, in the Reasons for Allowance the Examiner maintained his view that, even if there was no prior art teaching administration of purified EPA to a patient population of 500 mg/dl or greater, prior art teaching administration of purified EPA to a patient population with “[e]ven a slight overlap in range” established prima facie obviousness.”
Therefore, it seems that the primary considerations were obvious after looking at the trials of TG<500 and were applied to the patent of TG>500 bc of the slight overlap in range which was acceptable. However, we were granted the patent bc of the secondary considerations.
““ Instead, the Examiner found the pending claims patentable because “Applicant was able to overcome the above 103 obviousness rejection by showing: 1 - Unexpected results, and 2 - Long felt unmet medical need.” See, e.g., PX 380 at 000010, Notice of Allowance at AMRN03059936. The Examiner then spent more than three pages specifically discussing the evidence of objective indicia supporting the Examiner's ultimate conclusion that the claims were patentable. See, e.g., id at 000010–13. “
Judge Du argues that our unexpected benefit of reduction of Apo-B was obvious after looking at Kurabayashi. A trial of Japanese women with no legitimate control group that doesn’t even have that statement in their conclusion. Regardless, because she disagrees with the unexpected benefit, ultimately she rules the marine patent was obvious.
What we need to do is get unexpected benefit back into the picture or add another secondary consideration. Obviously I would love to know what the original patent office thought of Kurabayashi because why is she all of a sudden bringing that into play with a different opinion than the original patent office.
-Does anyone have that information or can post?
More importantly, I would like to know HOW REDUCE IT WAS KEPT OUT of secondary consideration. If we rely on the wording of the original patent office that all the primary consideration trials were < 500 but can still be applied bc “[e]ven a slight overlap in range” established prima facie obviousness,” then why cant REDUCE IT be relevant in talking of TG>500 when the focus of the trial is <500 (just a slight overlap in range but close enough). Why are the defendents getting it both ways. We have to find a way to get REDUCE IT INCLUDED because that unexpected benefit will give us the win.
Explain how then in amrn facts and order it says that they did. I can post it later or if you have it just do a search function but it’s there. That’s where I’m confused.
The unexpected benefit was reduction of Apo B. Judge Du however (incorrectly) states this reduction was also obvious bc of the Kurabayashi study. See my other posts today on that.
The issue I’m having is it’s stated this wasn’t in front of the PTO office but Amrn facts and order says it was. I think the truth of this point is important because if this was already looked at and thrown aside I don’t see how it can arise here as new evidence.
I did listen. Good points. I just can’t comment on that. I mean the qs is if you were the generic would you do that. They got this 1/100000 win. They may not settle bc even if they lose on appeal they can just wait until our patents are up and make a generic then. I wish I understood what happened pre trial in settlement negotiations. That’s the real key here. How far is amrn willing to go on this. I have a feeling JT doesn’t want to settle and still believes he will win and won’t sell a dime of the company. We may have to ride this thru the appeal.
Well she adds an irrelevant study that the PTO office didn’t look at. With the additional study she uses she Makes her conclusion. A study of only women with no real control group and TG of ~150 which is not relevant to our patent. Unreal.
You make a good point. It can still stand. However, the way she arrived at her conclusion was flawed. Her conclusions on Mori are also flawed and her use of an irrelevant study Kurabayashi to support Mori was ridiculous. That was a study of EpA and estriol vs estriol alone in menopausal women with TG levels around 150. No true control and no men. Not relevant to our qs of pts with Tg>500. I think the federal court needs to realize these flaws and a few of them together get us a win on appeal. It can’t just be the procedural error she made (unless the fed court rules that when they weigh the evidence in the secondary considerations against primary it was enough to rule in our favor)
Agree JL. A very tough day. I read the opinion in full. She relied on a “hypothetical patient” in Mori with Tg> 500 to conclude that Epa was shown to reduce TG and not raise LDL in pts. She states Mori had pts in the Tg> 500 group (even if it was one) and that’s enough to say it was obvious and that the results would not be limited to just the Tg< 500 group. You and I both know a three arm trial of 20 pts each with maybe 1 having TG>500 is not scientific evidence. I can’t put into words how I feel after reading this brief. I hate to say it but I can’t conclude anything else other than she was paid off. I’m long guys. Painful hit today.
Morgues r full is a real thing. We have that issue. Also some funeral homes not accepting bodies unless their cremated.
ER volume is down (thankfully) but of the volume we r getting it’s probably now 90 percent covid pts. Hard to imagine what peak will be in 2 weeks bc there’s no where to put people. However we will get through it and make it to the downside of the curve.
Nothing in pacer that’s relevant.