<<<because no judge in America would overrule the FDA on whether a drug is safe or not before said drug ever reaches the market.>>>
There is absolutely no reason for a TRO in this case absent the protection of the public. If a drug laced with cyanide is approved by the FDA the judge is not going to wait until it is distributed to tens of thousands of patients. The judge is going to protect the public and stop the distribution of the drug until the matter can be sorted out.
The innovator is going to do the same.
In this case, the innovator consented to not pursuing the TRO for a drug that it calls "dangerous" so that tens of thousands of patients can be victims of this dangerous generic medication. If a real and substantive safety concern is the issue, you pursue the TRO with great urgency, and not as a litigation tactic. Sanofi has lost any argument it has on this issue absent to something happening in the real world.
I come across issues like this all the time in the courtroom. Not as drug attorney but in my field of practice (which has nothing to do with IP or commercial litigation (although I use to conduct commercial litigation). The fact is, if things were so bad you would have sought the remedy to fix the problem up-front, or things simply were not so bad.
In this case, the actions speak for themselves. Neither the judge, the FDA, nor Sanofi think this generic is dangerous.
As for the statutory interpretation, that is another matter.
Tinker
AI
