Replies to post #100026 on Biotech Values

[bladerunner1717]

Rockrat,

What I'm saying is that the FDA relies on confidential information for comparative assessment, not the generic applicant. I'm going to figure that the FDA did something like that, and it will come out in deposition that they did not improperly reveal any trade secrets in the process.


The complaint does not say anything about "improperly reveal" trade secreets. That's not the crux of their argument; they are very sure and clever about that. Here's what the suit alleges as regards this point:




'Furthermore, Sanofi alleges that FDA's approval of Sandoz’s ANDA violated the Administrative Procedure Act (“APA”) and was improper under the FDC Act insofar as “FDA approved Sandoz's ANDA for a fully substitutable generic version of Lovenox notwithstanding the fact that the Agency required Sandoz to submit additional data and information demonstrating the safety and effectiveness of its product.” According to Sanofi, FDA disregarded FDC Act § 505(j)(2)(A), which concerns the required content of an ANDA and “specifically precludes FDA from requiring the submission of such [safety and effectiveness] information.” Moreover, requiring or considering such information as part of an ANDA “effectively allows the generic applicant to rely upon the pioneer's confidential commercial information in a manner not contemplated by the statute,” according to Sanofi.'


The point is not that the FDA revealed anything to applicant, but rather that the applicant has benefitted by the use of "...the pioneer's confidential commercial information in a manner not contemplated by the statute."

So the lawsuit doesn't claim that the FDA "stole" proprietary information and gave it to applicant, but rather that the FDA used (SNY's) proprietary information in such a way that it benefitted applicant and, at the same time, breached the FDA's own statutory injunctions.


Personally, I don't think SNY's argument will fly, BUT if the judge is so inclined to rule for SNY, then SNY's lawyers have provided ample ammunition for him to do so. (That's why they get paid $500/hr. LOLOL)


Bladerunner