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Monday, March 30, 2020 7:30:53 PM
The idea that the 889 patent (V lowers Trigs but does not increase LDL) was obvious)...
That is preposterous..The PTO considered this issue and determined it was not obvious. The fact EPA could lower trigs and not raise LDL seemingly violated the Fiedewald Equation..Which was and is still held to be valid. Any violation or seeming violation of Friedewald could never be considered obvious.
History (which the judge does not know)...Involving Lovaza a mix of EPA and DHA...effectively lowered Trigs but received a CRL from FDA because it raised LDL..And so did every other drug which lowered trigs..So how could EPA's actions of lowering trigs and not raising LDL be considered "obvious.
If EPA's actions were obvious then why was Amarin required to run a Cardiovascular Outcomes Trial...Costing millions of dollars and running for over eight years..Guess the FDA did not think the result was obvious or maybe the judge feels everyone the FDA is stupid .
This judge was not present at the 2018 AHA annual scientific meeting where the audience of Cardiologists were polled before the REDUCE-IT results were presented and less than 10% of these experts thought Vascepa would be useful in treating their cardiac patients and after the results were present 94% of the doctors said they would treat their patients with Vascepa...Obvious...absolutely not...This judge opinion is way off.
This judge must have some ego to think she knows more about this drug than the patent office or the FDA..and a room full of cardiologists..
":>) JL
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