Saturday, August 04, 2012 11:14:12 PM
The start of the thread was your claim that "These drugs have valid patents listed in the Orange Book. So, of course the FDA can't give final approval for an ANDA. "
This is indeed false. You did not say, "these drugs have patents which have been found valid by a court and that court has enjoined the FDA from approval prior to patent expiration and so the FDA cannot issue final approval." You claimed instead that a valid patent listed in the Orange book means the FDA can't give final approval. Indeed, you cited the 2004 Mylan case mentioned by poster Olsen as a perfect example, but in fact it is a perfect example of why your statement is false, since in that case, there was in fact a valid patent and in fact, the FDA issued a final approval.
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