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HDGabor

12/29/19 10:29 PM

#237696 RE: jessellivermore #237693

JL-

Could Amarin bring in clinical experts who could testify that lack of information to duration was
Was so well known to clinicians that the information was not considered vital or even necessary

I hope not. Amarin should bring in clinical experts who could testify that the

full

label (inc. 13. Clinical trial) is relevant (not the "Indication and usage" only) … the label (any by the label the generics) encourage (suggest to) physicians to treat for more than 12 weeks.

Looks like the Judge see it positively (from Amarin aspect):
(i) "The Court finds this argument intuitively persuasive—chronic conditions require indefinite treatment."
(ii) More important, she cited other case: "See Sanofi v. Glenmark Pharm. Inc., USA, 204 F. Supp. 3d 665, 684 (D. Del. 2016), aff’d sub nom. Sanofi v. Watson Labs. Inc., 875 F.3d 636 (Fed. Cir. 2017) (finding after bench trial that the defendants’ labels induced infringement because of “the description of the long-term treatment involved in the ATHENA trial in Defendants’ labels, additional clues in the labels that suggest long-term treatment, and the experts’ testimony that prescribing physicians generally intend to treat patients with dronedarone for longer than 12 months[.]”)"

Best,
G

SocialBoom

12/29/19 11:42 PM

#237709 RE: jessellivermore #237693

As an adjunct to statins. Statins are a lifelong drug. There is no ambiguity.