SNY's interpretation of the statute is joke, the moment the judge reads the statute he will laugh at SNY's argument. Sanofi's lawyers better watch out that they don't get hit with sanctions under Federal Rules of Civil Procedure Rule 11(b) ...
The Sanofi suit alleges that FDC Act § 505(j)(2)(A)“specifically precludes FDA from requiring the submission of such [safety and effectiveness] information." This is NOT true.
The language of 505(j)(2)(A) stipulates... "The Secretary may not require that an abbreviated application contain information in addition to that required by clauses 505(j)(2)(A)(i) through 505(j)(2)(A)(viii)."
But section (505(j)(2)(A)(iv) of the statute provides plenty of room for the FDA to request "information" it needs to help it assure bioequivalency.
(2)(A) An abbreviated application for a new drug shall contain— ... "(iv) information to show that the new drug is bioequivalent to the listed drug referred to in clause (i), except that if the application is filed pursuant to the approval of a petition filed under subparagraph (C), information to show that the active ingredients of the new drug are of the same pharmacological or therapeutic class as those of the listed drug referred to in clause (i) and the new drug can be expected to have the same therapeutic effect as the listed drug when administered to patients for a condition of use referred to in clause (i)"
We're starting to go in circles. Let me make sure I get your description of SNY's argument: because the FDA got additional data it should not have, it approved a drug it would not otherwise have approved. OK, not the intent of FDCA, but OK.
However, that subsection allows the FDA broad latitude to determine bioequivalence, as mPower points out in his citation of it. At the USP's 3rd Workshop on the Characterization of Heparin Products, it was proposed that a LMWH's immunogenic profile can be used to determine bioequivalence.
As such, the FDA can reasonably hold that their request was not for safety and efficacy data per se, but for bioequivalence data. Of course, the FDA requested the data way before Dr. Walenga presented her data . . . I can't find much reference to the concept prior to a couple of years ago, but that doesn't mean the concept was unknown to the FDA; the different immunogenicity profiles of LMWH and their generics (obviously these would be foreign ones approved by looser regulatory agencies) was well known. Certainly it was central in the contaminated heparin issue of '08, not TOO much after the FDA made the request . . . unless there is a smoking gun email or letter that says it was for safety & effectiveness. We only saw the PR, which made no mention of safety or effectiveness; the letter received by Momenta/Sandoz is not a public document at this juncture.
As for the argument that this data somehow effectively allowed the generic applicant to rely on SNY's pioneering confidential info, the FDA's response to the CP addresses that. I just don't see it unless the "chinese wall" broke down. And neither of us think that happened.
Obviously, I don't think SNY's argument will fly, either, but I believe it more strongly than you do because of the above. I don't think this is ample ammunition for a judge to rule their way.
Market Data 
Markets 
AI
