Yes but Hikma didn't just infringe on the skinny label, they also lied and withdrew pertinent information to the case from Judge Du in their court filing, etc. Am I wrong or what? Your comments are appreciated.
RMB, I'm going to ask you directly, what is the balance that Hatch Waxman claims to achieve? A skinny label takes the entire market. That isn't balance. FDA wants to protect ANDA labels from litigation. That pushes the scale even further away from balance. This could be what the Supreme Court wants to address. Sleven,
Regulatory Capture is a real thing. It's clear the (primarily foreign) Generic Industry spends big to get their allies into key FDA positions to push their agenda. Don't think for a minute the Courts are immune to this. All under the sales pitch of "cheaper drugs for Americans" to make it politically digestible for the voters.
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