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Great post. thanks HDG
Albeit correct, we have to read the text to put this in context, and in my opinion, Amarin's case is stronger (see below
On Commercial Success:
Amarin’s case:
“But the Court also found, as a factual matter supra in Section III.G.4(b), that Vascepa is a commercial success”
Teva’s case:
The district court found that Baraclude® achieved commercial success based on sales and market share, but it was “less dynam- ic” than BMS represented. J.A. 138. Baraclude®’s market share built up gradually over four years and it ultimately held onto the top spot for less than a year. Evidence also showed that two other competitors were able to gain market share more quickly at launch than Baraclude®. J.A. 54, 137. Even BMS’s internal documents viewed Baraclude®’s market performance as “sub optimal.” J.A. 136-38.
On long felt need
Amarin’s case:
The Court is persuaded that there was a long-felt need for a drug like Vascepa that could reduce TG levels without raising LDL-C levels, primarily because both sides’ experts testified that patients are more likely to comply with a prescribed treatment regime when they only have to take one pill, rather than two—and the Court relied on this evidence in finding a POSA would be motivated to combine the Lovaza PDR with the finding from Mori that EPA did not raise LDL-C levels.22 (See supra Section IV.B.2(a).) It is better to take one pill than two if taking that one pill will give you all the same benefit. Moreover, there is no real dispute that some patients may not be able to tolerate statins. (ECF No. 367 at 660-61.) Thus, the Asserted Claims represent an improvement—albeit a prima facie obvious one—over the prior art.
Teva’s case:
On long-felt need, three other drugs for treating hepa- titis B were invented before the filing date of entecavir. J.A. 147. These three drugs also gained FDA approval before entecavir. Finally, entecavir’s inventors did not know about its hepatitis B properties until four years after the filing date, and by then the first FDA-approved hepatitis B treatment was launched. J.A. 147-48. There- fore, we agree with the district court that the evidence of long-felt need is of limited value to BMS.
excellent, thanks!
After reading the full federal appeal ruling, the secondaries were extraordinarily weak so not sure anymore that that case is as comparable to amarin’s as I believed earlier. Actually I find the decision by the federal court easy to understand why they upheld the district court decision.
Actually i think that amarin secondaries are much stronger supported by the district court owns findings of fact (that will be given deference). Additionally the way that secondaries were weighted against each other is incorrect which was a concept also emphasized by this federal case appeal (albeit in that case the federal court did not find that the district court used that incorrect method despite plaintiff claiming it did, actually the district court use the word "mixed" to indicated that some secondaries gave more support than others....that is different from Amarin's case where, it was clear that the method used was not appropriate, in my view)
Additionally I agree with you as well that the Apo B issue was a clear missinterpretation by the district court that should even give us additional strength to the secondaries....So overall, I continue to think that Amarin has a decent chance at reversal. Judges assigned continue t be important though.
Never thought I would be reading so much law staff!!! :)
Can you please provide links?
Thanks
Jomama,
Again, fully agree with your post. I have now read the federal court appeal decision. I also agree with you also that Amarin's secondary looks way stronger and that the district court seemed to discount the strength of positive secondary considerations by using as a negative the others which is something we know is questionable and that it is also specifically mentioned in that federal ruling as not appropriate as well (in that ruling, the federal court did not think that the district court did the analysis in that way but instead was mentioning things that are more supportive of plaintiffs claims vs others that were less supportive.....in the words all secondary were fully taken as positive for the patent owner)
Thanks for your great contributions!
completely agree. However I understand now better than I did earlier that this case depends on the judges assigned to it.
Interestingly even the federal court did not find fault on weighting secondary consideration against each other....so not clear cut for me anymore that what occurred in our case was a clear error that could be central to a different result
what if they delay responses to EMEA so approval in Europe occurs in 2021?
If you hear the Jefferies call with the patent lawyer profesor he clearly stated that he does not think this case fits the guidelines for expedited cases.
The only way in my view to get this moving fast is that Amarin lawyers file their opening briefs as soon as possible. They have 60 days, but there is only a few issues at hand over here so I am hoping that they do it within 2-3 weeks. just to emphasize that this is what I am hoping, I don't know if that is a reasonable expectation but others with legal background can comment
this may sounds crazy, so happy to be told this would not work.
can Amarin do a deal with BP that includes co-selling in all the world now, with the option for first refusal to acquire Amarin next year? By then the valuation of Amarin would be more clear
There is no clarity on whether this could be brought up or not on appeal. From my perspective (not a lawyer), there is not reason why you could not. During appeal you only need to say something like:
respectfully we believe that judge conclusions that a significant differential effects reported between the EPA and control groups, a POSA would have attributed the reduction in Apo B to EPA is incorrect according to the evidence submitted [reference to paper as part of the evidence that was submitted during trial] that clearly states as a conclusion that 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. therefore it is not correct to state that there are intergroup differences and a POSA would not conclude otherwise
....no need to mention cropped table-3 at all
Here is what the judge says
thanks for confirming.
I find atypical that they are not answering back. I have never wrote IR myself but many posters have indicated in the past that they are very responsive. Has that been recent experience from others as well?
Anything that can be read out of it?
Agree, I would like to hear our legal expert's opinion. I believe the expert opinion was correct, it was the judge interpretation (comparing groups vs what I assume the expert said which is that there was a reduction vs baseline). To be honest, this is something that if it was not brought up to the expert attention by our lawyers, it should have been. Regardless, the way that the judge wrote her opinion does not likely reflect what the expert (I assume) said which is that there was a change with respect to baseline
exactly, I just found this difficult to believe. I hope legal experts in this board can weight in on this
This parts of the blog sounds incredible. So if I understand correctly Amarin cannot raise in its appeal that Dr. Heinecke interpretation fo the data is correct in terms of a change with respect with baseline but that the judge incorrectly attribute this to a change vs control arm?
Please someone with
I don't think that you are off. Apparently Pharma frequently request expedited process for patent cases. See below this is from a link that was shared earlier by money_man , so if that is the case, I would not be surprised at all if this one is expedited considering that it is the only drug that the appellant has and fully depend on it to survive.
here is the link again: https://www.wiley.law/alert-3389
here is something else that could be helpful:
Source (look under rule 27)
http://www.cafc.uscourts.gov/sites/default/files/rules-of-practice/ProposedRules/federal_circuit_rules_public_notice_dec_2015.pdf
MOTION TO EXPEDITE PROCEEDINGS. While motions to expedite proceedings are not
routinely granted, they may be filed in an appropriate case. A motion for expedited proceedings is
the procedural vehicle to request the court to accelerate consideration of an appeal or petition for
review, and should be filed immediately upon filing of an appeal or petition for review. Such a motion
is appropriate where the normal briefing and disposition schedule may adversely affect one of the
parties, such as appeals involving preliminary or permanent injunctions, or government contract bid
protests. A motion for expedited proceedings should be styled as an “Emergency Motion.” Unopposed
emergency motions should still include a brief review of the grounds for the motion, the specific relief
sought by way of a proposed briefing schedule, and the legal argument to support the motion, per
Rule 27(a)(4). A motion for expedited proceedings should also include as part of the relief sought a
request for an expedited briefing schedule for the motion.
thanks this was very helpful, so basically, the speed is also determined by the speed at which Amarin lawyers move with the appellant’s opening brief. Normally due in 60 days from appeal docketing but that could actually be filed anytime before and trigger the 40 days response time for the generics
Let's see how fast amarin get those document in. I don't see a good reason for them to take more than 2-3 weeks to do so (law savy posters, please comment on whether this is unrealistic), as I believe that the current case is very focused on a number of claims and issues.
What is the timeline to be expected on an hypothetical expedited appeal route?
Thanks M, do you or someone has a link or can explain us the guidelines over what would normally make it to the expedited appeal?
Is our case something that the federal court would consider worth taking up?
Thanks
I am with pharmadude and Cardiologymd on this one.
The difference now is that EPA (thanks to Amarin) has demonstrated benefit in cardiovascular disease. So regardless of the label, pharmacists could as far as I understand substitute for the generic regardless of the official label.
Look they are still substituting Vascepa for omega-3 which is even a more puzzling situation even today.
incredibly well stated, thanks Hamoa, could not agree more.
The best way to build the case in my mind is through the way that secondaries were used against Amarin. Kurabayashi and everything else should be used to further support Amarin's case, so by itself it may be weak but when all put together I believe Amarin has a decent case
Excellent. I think that means she understand the right way of interpreting the experiment
thanks MC, that is an excellent point and great find to clarify our current situation.
I agree with you that the only way of interpreting Kurabayashi as prior valid teaching in this case is if you have a difference between groups (as there are both taking estriol). This then weights in favor of Amarin as well in my mind
You can argue whether the Kurabayashi is valid considering that EPA was not given monotherapy but in combination with estriol (lipid modifying agent), but I agree that this would require Amarin making a strong case that is unclear to be successful given the district court's decision.
I believe however that the strategy for the appeal will be strongly based on the validity of the secondaries and whether the method the judge used to weight them with each other is appropiate. They way this was done shifted in my mind that burden of proof to Amarin when it should always have been in the generic. The way I understand it now, one successful secondary would have been sufficient to uphold the patent (and we got two of them).
It is not only the unmet need for statin intolerant, as she also agrees with....."It is better to take
15 one pill than two if taking that one pill will give you all the same benefit."
That by-itself is an invention. You take 1 single pill vs 2 pills:
-Benefits statin intolerants
-Eliminate side effects of the second pill (particularly in this case with the great safety of EPA)
The whole point is that this is definitely an invention that deserve to be patented and that it is not clear to me why this was given insufficient weight to maintain the patents
One part that I find incredible is that despite Amarin now having a new label (that includes CVD and that have additional layers of patents protecting it), legally, generics could still be allowed to sell the same molecule based on an initial and smaller indication.
Wouldn't the FDA then want to have the label for the generic-EPA equal to Vascepa? and if so, they would be listing the CVD benefit that would be infringing. I Know that obviously this is not case (otherwise we would not be where we are today) but can someone explain me why?
The patent office knew about Kurabayashi and still issued the patent. So I am not sure why defendants can make a convincing case that the patent officer ignored or did not acknowledge it. [Thanks to anyone that can explain that to me]
I find that final sentence however more interesting:
Exactly,
According to the Harvard lawyer, you can list as many secondaries as you want as they cannot harm the patent holder (or should not...as we learnt differently on this particular case) .
IN my opinion, I believe it is irrelevant whether they use the prima facie method or the correct method (all together). Once the secondary considerations are considered even if they are subsequent to looking at the prima facie first, Amarin has demonstrated that using EPA met two of the considerations (including commercial success). That in my mind should be sufficient maintain the patents
If I remember correctly, the fact that stradiols affect lipids was one of the reasons (among others) the patent officer did not include this as prior art for Apo B. Other can confirm
No worries, I really respect that he brings facts to this board which help us all to make the best possible decisions. Nobody can predict the outcome of this, as there are many things outside of Amarin's control (for instance the 3-judges panel). However I believe that the ruling has enough issues to make me believe that Amarin has a significant chance (could be 50/50 as the Harvard lawyer indicated) to restore their patents.
Exactly
Also, one single secondary going to Amarin should suffice to uphold the patent if I understood correctly what the Harvard lawyer and others said. So if that is correct, then this ruling has real issues.
About the 3 to 2 score, I will not even get into the gaps that I see on the other 3 points that she gave to generics as I see weaknesses as well. The above (one single secondary for Amarin) should be sufficient to prevent ruling to invalidate the patents.
Not only that, she accepts Kurabayashi study as valid (even when the patients were given a lipid modifying agent) as part of the obviousness case regarding ApoB, when it clearly this is both a group of patients below 500mg/dl and taking a confounding therapy and then rejects REDUCE-IT as insufficiently linked to the case on the secondary considerations because the patients on that group were below 500mg/dl and represent a different group (even when a small group of patients in reduce-it were above 500mg/dl)
So many issues on this ruling....