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Re: Whalatane post# 37833

Wednesday, 11/05/2014 5:20:53 AM

Wednesday, November 05, 2014 5:20:53 AM

Post# of 429566
Hi Kiwi,

AMRN vs AZN

Issue: '662 patent. The patent require that treatment not "increase[e] LDL-C by more than 20%"

AZN argument #1: The commercial launch of Epanova has not occured and is not imminent and "real life" LDL-C data could be different than during the study ... no comment ...

AZN argument #2: Epanova label fall outside the claimed range based on non-placebo adjusted data (2g - 21%, 4g - 26%) - BS. The patent makes clear that the measurement of LDL-C in a patient as claimed in the patient is against a baseline (non-placebo adjusted data) or a placebo arm. Epanova, against the placebo arm: 2g - 13%, 4g - 15%.

Best,
G
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