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This. At best the study is suggestive of benefit, not clearly and convincingly obvious.
Most bothersome about Du's ruling is her failure to fully research proper patent analysis of obviousness, but she managed to unearth an additional study to fortify a ruling against Amarin. This after apparently declining to privately notify counsel before releasing the decision.
I'm glad to hear Amarin's legal team filed an appeal so quickly, before she could do any more immediate damage.
Our capacity to treat will have ramped up, and additional treatment regimens are identified. Covid would still knock you on your ass but new treatment protocols would drastically bring down the fatality rate. By Christmas of next year, at least one of the vaccine candidates will be successful. And free if Judge Du gets another promotion.
Hence the idiom "eating crow", which continues to gain relevance ;)
but that will take one yr.--but bltn--but but but
:P
eight-sure, but that's not what she did.
But you (the patent judge) always use secondary considerations when determining obviousness. Primary and secondary are supposed to be considered together, not a 1-2 step analysis. To refuse to look at any relevant evidence would be improper.
That is the procedural error I am referencing.
The burden wasn't on Amarin to prove non-obviousness, it was on Generics to prove obviousness. You are assuming the same procedural error Du seems to have made.
Question for any law-minded posters--how long between this decision, and it being "perfected" (ie. sealed) by the court?
lol
Now you can imagine this case going to appeal, appeal might rule in amrn's favor for procedural error and remanded for reconsideration, Judge Du finds a new way to pronounce "fish oil", another appeal... maybe adding up to 2-5 years of patent litigation, plausibly? Hikma and Reddy gonna hate how orange FDA's book is.
Amarin may just manage to litigate its way to exclusivity. Not ideal, but rough justice. Before this week I was wholeheartedly in favor of JT holding out for the golden BO. Now I feel like he should be ready to accept half of whatever target price he was wanting before. Most stocks are down big just for existing these days.
Are you?
How much is the annual tail value of branded V for current indications after 2030, all by itself? Current amrn market cap is under $2b.
I kinda like this approach: patent and litigate, patent and litigate. Probably not much more expensive than outright settling, and better discourages this copycat nonsense.
The POSA's at FDA didn't know EPA would have the desired effect. Which is why they required additional (expensive) clinical trials for approval.
An actual POSA wouldn't conclude from Mori due to extremely small sample sizes, and Mori's own comments favoring DHA rather than EPA.
That's not a great way to raise share price...
An offer of $8-10/share is always possible, and I'm sure has already happened. Whether it's accepted...
At a $4/share price, an offer of $10/share would be pretty "standard" m&a multiple of 2.5--to dismiss that as insane would be asinine ;)
I personally would hold out for (much) more because of depressed stock market, tail value of V's current labels in perpetuity, add'l indications, combos, etc. Oh and also that appeal chance.
It still speaks to nonobviousness of MARINE, because the quote states DHA "may represent a more favorable lipid profile than that seen after EPA supplementation". And if that's not non-obvious enough for you, remember - the burden of proof was on defendants to prove obviousness. Clearly and convincingly. Not the other way around. Judge Du seems to have forgotten that.
*sigh*
Time for me to buy more Amarin shares.
Now that Judge Du's fresh exciting take on patent law is in the books, settling isn't really an option.
JT, love him or hate him, has always been up front about maximizing company value to patients and investors. AMRN was never advertised nor executed as a quick play. I supported a decisive IP ruling before and support a no-holds appeal strategy now. Judge Du grossly misread the evidence, misapplied the level of proof, and disrupted patents with a new regime for prior art. BP has to be in JT's corner since they have more skin in the IP game. And other patent claims may be asserted (in a different jurisdiction). And the FDA is another matter. And, and... and if all else fails, then doom the bad actors by cozying up to Teva.
Until then, let's all appreciate that Judge Du thanks Amarin and us for our multi-billion wellness charity.
Awesome--thanks for shedding light on situation :)
Obvious. Thank you for being so noble though.
Yesterday's ruling was insane.
Ok I can't hold out any longer, I gotta post something.
I don't care if or how anyone wants to remove JT. But, maybe let's prioritize removing Judge Du from *her* job? FDA still hasn't finalized ANDA, though they likely will screw Amarin/us over. But there is a need for accountability.
In my totally lay opinion, Judge Du's primary reliance on Mori does not at all reflect the enourmous impact to patients, drug development, or $ billions in shareholder rights. Judge Du's interpretation of Mori is problematic for the following reasons:
The presumption is validity, burden of proof is to prove obviousness. Level of proof is clear and convincing. So, a competent unconflicted judge has to determine whether patents are clearly and convincingly obvious?
Mori has less than 20 data points for EPA, and less than 20 data points for DHA. Mori summarizes its own findings and other prior art, as indicative of "a more pronounced effect of DHA" for a "reduction in atherogenic risk". Not EPA. This is the simplest, most explicit conclusion you would draw from Mori. Judge Du whiffs here. Based on Mori's own conclusions, it was not clearly convincingly obvious, or even debatably obvious that EPA was the key. Rather such a conclusion directly contradicts Mori's own explicit statements on the DHA/EPA question. I was unable to find any comment indicating why Judge Du refused to engage Mori's statements that DHA was key to reduce atherogenic risk.
Mori shows an increase in LDL from EPA, but not statistically significant. This is not the same as stating no increase in LDL from EPA. A POSA would know better than to assume "EPA would not increase LCL-C [sic] levels" as this confuses the null hypothesis and brushes aside the small data set. Judge Du whiffs, can't even spell right, and is out of her depth pretending to think like a POSA.
Elsewhere in her opinion, Judge Du is comfortable drawing conclusions based on 92% DHA, but not 91% EPA. I was unable to find an explanation into whatever her thinking was on the apparent 92%/91% threshold.
This is just tunnel-visioning on Mori to the same magnitude Judge Du did, but actually reading it correctly. Given all the other literature then available, the FDA still saw fit to postpone approval of a NONobvious therapy pending multiple trials to collect substantial new data.
Yet Judge Du presumes to know better.