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Wednesday, May 27, 2020 7:52:29 AM
IMO Amarin's strategy has argue unintended consequences. The generics' attack here is on the crucial weakness in the H-W legislation..And that is the patents..Obviousness is a subjective term..Regardless how the legal system tries to coral. It still remains subjective..Put very simply what Einstein might consider obvious an average person might not even comprehend..The legal definition of obviousness is based on a novel design for a plow. I think that says a lot about about obviousness and the law..
H-W needs to be amended and the nullification of patents in NDA cases needs to be removed..The USPTO's opinions on patent issues such as obviousness need to be decided once and for all at the time the patent is granted. Once in the Orange Book..The patent should no longer be challenged. For God's sakes we spend all this money on the Patent office and the FDA..Then we get one mentally challenged DC judge that can come in and blow the whole system up.
We need the system to go forward because we have not solved all the problems in medicine..We still have Alzheimer's and vascular disease is still an issue as I know from personal experience.Cancer, clinical depression to name a few..The drug industry is going to look on this Amarin debacle and the message is going to sink in..We have far to many drug trials and new drugs that fail at the FDA level..I remember reading success was only in the teens..
Drug innovation is the wildest form of gambling...The dice are loaded from the beginning...and if Du's opinion is upheld it is going to shake the entire foundation of the Drug industry and we are going into an "Ice Age" and no one is going to be bringing new drugs into the FDA "marketing process"..
All these fat ass BP execs are currently waiting on the sidelines of the Amarin Trial and thinking "glad this isn't me"...But a win here by the Duists is going to put everyone on alert..and taking "one in five" shots on new drugs and then having to worry about the crazy legal system..Giving their drugs to generics is going to be the end of the drug industry..A "Catastrophe"...
I say the problem is not in the drug industry..It is in the legal system..The legal system currently uses medical malpractice as its cash cow..Everyone who studies the problem understands that Med Mal is a scam..Medicine is defined by complexity and errors are essentially unavoidable..Even the serious and obvious ones..A good analogy is the game of golf..Golfers know the best strategy is the obvious one..down the middle..on the green and 2 putts..The problem is regardless of the fact professional golfers can make millions by doing just that..The best golfers in the world hit the ball out of bounds..miss the green..land in the water..and miss three foot putts...But when it happens to a clinician it could result in a huge malpractice suit..Numbers here on who gets sued...Its the clinicians that do the most operations, see the most patient..If you are a surgeon and don't want to get sued..Don't do any operations..
This Amarin case is no harmless event...This is Armageddon..BP better start reaching in its pockets and buying some influence and get rid of this stupid trial because it can pull them right down in the sand with Amarin...
":>) JL
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