Replies to post #278728 on Amarin Corp Plc (AMRN)

[mrmainstreet]

HDG, given Singer's brief, the amicus briefs, the recent JAMA paper from Bhatt, and your own analysis of Du's decision, how would you assign probabilities to the following:

1. Case affirmed
2. Case remanded
3. Case overturned

Thanks for your insights.

[alm2]

Brilliant HDG ... simply precisely and clearly sets out the absurdity of Du decision
Alm

[MateoPaisa]

Excellent observations/post

[Laurent Maldague]

Excellent overview. This was my impression too after reading the patent documents on PAIR. Basically, the PTO was fully aware of Mori but granted the LDL-C point based on unmet need. PTO basically decided prima facie obviousness was sort of a rabbit hole for the LDL-C issue, and used long felt unmet need as the decisive test. The justification for reversing this weighing seems purely based on a whim, and without any new prior art/facts, is definitely out of line with presumption of validity for the PTO.

The Apo-B point ,too, is well qualified by the PTO. I believe the examiner stated prior art "is either silent" or does not teach of statistically sig reduction, which is a tacit reference to Kurabayashi. On this point, our smoking gun is of course Judge Du's by now infamous "statistically significant differential effects".

I honestly don't think this appeal needs to be any more complicated than this. But I suppose throwing in the procedural error couldn't hurt. I hope the Federal Circuit sees that the intense battleground for LDL-C prima facie obviousness is just affirmation of the examiner's view of that it's a pointless direction.

[The Irishman]

HDGabor...

Quite intriguing. It’s been sent. Incredible...

Be well

[HinduKush]

Quote of the DAY...maybe Raf should pins this gem to the top to remind us all what this is all about philosophically, scientifically, medically, and financially:

.... Thus, it is not permissible to use hindsight after viewing the claimed
invention to determine questions of obviousness or to rely at all on the teachings of the
claimed invention in determining whether one of ordinary skill in the art would find the
invention obvious. See, e.g., Millennium Pharm., Inc. v. Sandoz Inc., 862 F.3d 1356, 1367
(Fed. Cir. 2017) (“The inventor’s own path itself never leads to a conclusion of
obviousness; that is hindsight. What matters is the path that the person of ordinary skill in
the art would have followed, as evidenced by the pertinent prior art.”) (quoting Otsuka
Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1296 (Fed. Cir. 2012)).

Judge DU stated goals bench order 3/30

Comparisons are odorous (Much Ado about Nothing, Shakespeare)

[HinduKush]

Absolutely HDG

However Applicant was able to overcome the above 103 obviousness rejection by showing
1- Unexpected results and
2- Long felt unmet medical need
1. is Apo-B reduction
2. is no-increase of LDL-C

This is why Kurabayashi and the serial statisticals errors matter....and it was discussed extensively by Judge Du--so ripe for Appeal discussion.

Quote:
The Court is persuaded that there was a long-felt need for a drug like Vascepa ... Thus, the Asserted Claims represent an improvement — albeit a prima facie obvious one — over the prior art. And this secondary consideration therefore weighs slightly in favor of finding the Asserted Claims nonobvious.
Secondary considerations are to avoid hindsight. An existing Long-felt need (confirmed by commercial success despite existing, cheaper alternative; generic Lovaza) has to nil the prima facie obviousness determination ... does not vica versa - as Judge did - PFO weaken the LFN. The Judge did not consider the fact that nobody made this type of drug, everybody tried to develop an EPA / DHA mix (e.g. Epanova) ... despite Mori "teaching / suggestion" ...

Judge Du failed both Science and Logic classes...most of the last part HDG quoted from her judgement reads like a dyslexic took a coke hit and then put pen to paper...