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I have now read the full thing. I have to say say again first that I am not a lawyer, but it really felt as the judge was placing excessive burden of proof to Amarin vs generics.
IN particular I find very troublesome that she finds 2 of the secondary considerations favoring Amarin and still invalidated the patents.
I simply do not see clearly that defendant has proven that the patent are obvious when everything (including secondary considerations) are evaluated together. I look forward to HDGabor analysis who I have a great respect for, but my own analysis is that Amarin has a significant chance of success on the appeal
I found the judge ruling. The first paragraph of the discussion seems to me that is shifting the burden of proof for the secondary to plaintiffs.
I know others have said it is not that clear case, but I find it problematic:
23 2. Discussion
24 The Court first discusses Defendants’ prima facie obviousness case, which the
25 Court finds Defendants supported with clear and convincing evidence of obviousness at
26 Trial, and then discusses each of Plaintiffs’ proffered objective indicia of nonobviousness.
27 The Court will go on to explain why the Court does not find that Plaintiffs’ proffered
28 evidence of secondary considerations saves the Asserted Claims.
See the bolded area, I would have found more appropriate to describe how the defendant have proved beyond doubts that the secondary considerations are invalid instead.
Here is another recent case that is ongoing:
Markman blog on a NVS patent
This part is interesting:
"To that end, numerous generics filed petitions for inter partes review (IPR) with the PTAB that each challenged the validity of the ’405 patent. Those IPRs were consolidated into one, and in July 2018, the PTAB issued a Final Written Decision upholding the validity of the ‘405 patent."
So It seems that one potential path forward is for Amarin to ask revalidation of their patents to the USPTO
Can someone with legal background confirm if I am understanding this correctly based on my reading of this blog on a different case?
The paragraph below is taken from the Markman advisor blog. What t I don't understand what is the convincing evidence is that was found that was so convincing to alter the patent office examiner. The finding that 4g reduces Apo B and not 2g is novel and surprising. So obviously EPA is not the same than previous treatment, nor it was obvious that that would happen and particularly at that dose (and not to lower doses)
"Instead, the Examiner allowed the claims after concluding that it was “unexpected” that administering 4 g/day of EPA to patients with high TGs would decrease Apo-B levels. In particular, the Examiner concluded that the prior art showed no change in Apo-B levels from administering EPA to patients with TG levels below 500 mg/dl. In addition, Amarin’s MARINE study showed that this result was shown for 4 g/day, but not for 2 g/day, which evidenced certain criticality of the 4 g dose. The Examiner also concluded that there was a long-felt need for a drug for patients with high TG levels that did not also increase LDL-C levels, which is associated with cardiovascular disease, especially given that the two prior drugs approved for treatment of high TGs (Lovasa® and Triplix®) appeared to raise LDL-C levels"
Thanks so much for your contributions to the board and thank you for forwarding that analysis to IR
Mitra,
Was this sent to IR in case it is helpful to the case?
In a way it is saying that the Mori publication cannot be taken as a final word. As such it cannot be found (at least as 2000) as obvious that t EPA does not raise LDL.
I know that Amarin is aware of that but that link shows a very good data-driven discussion on why it is the case.
I have a question for the board regarding Contingent Value Rights or CVR and stock-options
Before I ask the question, I would like to tell you why I am interested in learning about this. I am thinking about he possibility that BP buys Amarin now (let's say 20 dollars) with a CVR depending on the outcome of the appeal (let's say another 30 dollars if positive). If you holds shares, it is clear, if the appeal becomes successful you would get 50dollars/stock
Now what happens if you have LEAPS ( for 2022). Do you have to exercise at the time of company formalizing acquisition (perhaps when investors have only received 20 dollars) or can you wait to exercise later when you will be able to exercise for 50 dollars (sh+CVRs)
Thanks all for your help
Thank you. I understand it the same way. Interesting.
Honest question in that scenario what would prevent other generic companies filing an ANDA?
Thank you!
Sorry if it has been posted (on the go today, so did not look at all messages today). Any update from the court? It should have started already. Not sure if there is someone there keeping us informed.
Thank you!
Can you please post.
Thanks so much.
Thank you very much HD
Thanks HD, very helpful
Do we know what this refers to?
"but the lawyer noted recent developments with one party cut against the possibility of settling"
thanks so much Pharmacydude, this is very helpful and fully understand the concern you raised now.
I am wondering though whether with the new extended label, Insurance companies would put EPA as a different category than omega-3 all together, So regardless of what the indication is (hyperT. or CVD) if a doctor writes Vascepa, the patient gets EPA and nothing else. IS that even possible at this stage?
M
With the approval of CV indication and demonstration that EPA is (likely) different than omega3 oil mixes. Wouldn’t EPA now appear as a new drug in pharmacy formularies as clearly different than omega3?
If so when doctors prescribe EPA there should not be substitution available. In order words the current discussion would only apply for doctors that wrote omega3 (which likely are treating hyper triglycerides)
Thanks for your thought on this.
thanks so much for the kind response. I am guessing we know it was not settle as there was not subsequent announcement but it is still possible that a settlement occurs before Jan-13th, correct?
About generic case. I know this has been thoroughly discussed but I am getting confused.
I think there was a TC earlier on the month for an attempt to settle. Can someone please clarify if that TC happened? Any public information related to it? As I am understanding from those that are posting and following the case closely, It seems that a settlement announcement could come any day before Jan-13th or else we will find out where we are on the case once the judge rules at the end of Q1? Did I get it right?
Thanks so much. Really appreciate your opinion
VuBRU,
I don't fully understand the data on table 3 from today's presentation (https://www.acc.org/~/media/Clinical/PDF-Files/Approved-PDFs/2019/11/11/AHA19/Nov18-Mon/9am-EVAPORATE-aha-2019.pdf)
However, it seems to me that low attenuation plaque is just a small fraction of the total plaque, so variability overthrew (due to the low relative volume) may explain that the p value is high.
Now when you look at total plaque, obviously the numbers are much higher....and potentially more reliable for the mechanism?
I would appreciate your thoughts on the numbers on table-3....thanks so much for all your great contributions
Is the fda likely to wait to the end of Dec for approval? How soon could they approve?
Thanks for sharing. Great results congratulations.
Something I also found interesting is the amount of variability shown on LDL levels for one single patient (n=1).
Cannot help but to be puzzled by the big amount of disproportionate noise that was made for a small change on the LDL levels in reduce-it (absolute number=5) on the placebo and the ridiculous MO saga.
I believe he has a point. Not necessarily because of the size of the capsule but just simply because of sticking to take the capsules every day is hard for a significant amount of people.
He provided a good example. Statins are easier to take and compliance is not great.
Despite that, the market population is so huge, that even if compliance is not great I don’t see how BP would not want to take this out of amarin’s hands for a healthy premium.
Thanks all for your insights.
I am catching up with messages. Earlier today someone was contacting IR for clarification. Was any reply posted?
Can someone confirm if holdings by baker brothers changed?
I saw a reduction but someone mentioned here earlier that they actually have 2 accounts so total holdings may have not changed.
Sorry if this has been posted before as I may have missed it.
JL, I would appreciate your comments as well. Thanks.
Thank you. Always enjoy your insight.
What are your thoughts about the following.
In the trial all patients are treated for LDL-C goal. So if mineral oil reduced absorption in same patients as soon as doctors saw LDL-C rising then they should have increased their statin dose canceling out any mineral oil effect.
Additionally, At the end even if LDL- C went up in the placebo a few points all patients in the placebo arm on average remained below the optimal level of LDL-C (100 mg/dl) so I just cannot see how mineral oil could explain the 25% reduction regardless of how you cut this pie.
What was said about Europe?
Could not call this morning.
I don’t see why a priority review would interfere with organizing an AC. See page 16. Even if we have an AC we should get it reviewed within 6 months.
https://www.fda.gov/downloads/aboutfda/centersoffices/cder/manualofpoliciesprocedures/ucm218757.pdf
Do not have access. Please post key takeaway if you do
https://www.streetinsider.com/dr/news.php?id=14998577
Thanks
Agree with you. But IF the trial hits that p value at interim, I think it is likely it will be stopped.
Others have argued before that it would run to completion anyways and the point I was trying to make is that I don’t see why in this case.
Some argue that this trial needs to be run to completion. Why?
I understand an outcome trial makes sense to run it all the way as with time arms separate more. The more the arms separate the more vascepa will be valued.
Evaporate however seems to be a mechanistic trial. It’s objective is to determine how the drug works. Once you reach statistical significance you have your answer and that could happen at the interim analysis. Further plaque reduction with time will not add value to vascepa so what would be the value to run it to completion?
Well then everyone is on the same boat until at least Q2 with the exception of the DMC
Thanks and thanks HD as well.
Maybe, Once last event is in, management could be unblinded for the results on 60 and 80%. That would give them time to prepare launch and material for launch or even talk to potential 3rd party.
If you read carefully their public statements, they say that Amarin will be blinded until last event and it does not necessary means until the last 20% of the data is baked in.
Happy to hear others thoughts but that is my interpretation. If my interpretation is correct, amarin management will know sometime in January/February were we are and may start preparing the future of the company with very (I know they like this word) "robust" information.
According to the HC wainwright report on Feb 2016, we should be at higher than 20% RRR if trial is stopped beyond dec-2017
A posibility is that the onset of 60% that started in March was just that, the onset of aproximately that many events. Maybe 60% was reached in June?