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Friday, May 22, 2020 10:26:44 AM
Thanks
I wanted the other deep dive minds on this board to have ALL the data I could muster so in all of us chewing the cud we can can find a way out of the darkness that has befallen Amarin land.
++The papers by Mori are all there in the time period 1999-2002 : what they show is a lack of consistent directionality of LDL direction when TG’s are lowered by EPA vs. DHA. That coupled with the population studied ( marginal to mildly elevated Triglycerides) can lead an intelligent person to conclude that nothing can be concluded and demand better data in a larger study set in the right range of triglyceride elevation, with men and women: in short the MARINE trial which followed. This contextual representation of the Mori ‘no change in LDL’ argument for obviousness is a good way to represent to CAFC.
++Where IS this prima facie obviousness that Du saw in using the first three Graham factors? The same “overwhelming obviousness” that she felt was so compelling that NO secondary indicia could overcome it ... well it fails scientific examination at every level...and beggars the imagination!
++The irony is that while everyone at the Du court was blathering on about LDL the real gold in the data is the ApoB effects ( specifically EPA reduction thereof) since it is this that encapsulates the atherogenic risk of the elevated triglycerides. Happily the Du misreading of the Kurabayashi data is ( if admissible in oral arguments) a gem. It exposes clear errors of understanding, interpretation of essential statistics and leaves a powerful argument intact: the USPTO examiner cited, read and digested the Kurabayashi paper. In view of these unique hitherto un obvious effects of Vascepa on both LDL neutrality and ApoB lowering, patent was granted for TG> 500 mg/ dl. This scientific rationale for granting patent was summarily discarded.. Du did not have cause to do so.
Only a Judge like Du, could say Mori data represented “obviousness”, misread Kurayabashi, and then commit sequential legal idiocy by switching burdens of proof and trading off graham factors. Lets hope that what one Judge can foul up three other cognoscenti may not?
HK
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