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sstyles

10/03/20 12:37 AM

#302762 RE: amarininvestor #302761

I suggest you read the ruling as opposed to guessing. It's all there.

Teva argued that it could not be liable for induced
infringement because it had deliberately omitted, or
“carved out” from its 2007 label, reference to congestive
heart failure.
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anfla

10/03/20 2:18 AM

#302768 RE: amarininvestor #302761

They ruled for infringement even before the 2011 label change
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oneragman

10/03/20 8:27 AM

#302790 RE: amarininvestor #302761

amarininvestor, I may be wrong, but I believe the label has to be the same per FDA regulations, this is why I stated they would be infringing. As you quoted:
In 2011 the FDA required Teva to amend its carvedilol
label to be “identical in content to the approved [GSK
Coreg®] labeling (including the package insert and any
patient package insert and/or Medication Guide that may
be required).” Dist. Ct. Op. at 587. Teva amended its label
to include the indication for treatment of heart failure, as
required by the FDA. Dist. Ct. Op. at 587.