Replies to post #99878 on Biotech Values

[DewDiligence]

1. Has MNTA/NVS actually been named as defendants in SNY's complaint?

No. SNY has no legal standing to sue NVS/MNTA because Lovenox is no longer protected by US patent or by Hatch-Waxman marketing exclusivity.

2. My general view, right or wrong, is that FDA really does not care about the financial repercussion toward various companies, so how robust of a defense might they expect to launch? I am hopeful that they want to protect the integrity of their process. Any thoughts?

I think you answered your own question: the FDA cares deeply about maintaining the scientific integrity of the drug-approval process.

3. If I am not mistaken, NVS sued the FDA a couple years ago relating to Omnitrope. How robust was the FDA's defense at that time?

The Omnitrope case was fundamentally different insofar as the FDA was sued for having taken no action whatsoever on NVS’ application.

4. I doubt very much that a federal court would consider an approval of a drug after 7 years of reviewing generic Lovenox ANDAs as arbitrary and capricious.

Quite so! SNY’s use of such language illustrates how ridiculous this lawsuit is.

Would anyone expect the FDA to point out any flaws in the submissions of TEVA and Amphastar to support the integrity of the FDA's process? Might this spell the death knell for TEVA's application if the FDA has to defend the superiority of the MNTA/NVS submission over the other applicants to show that it has neither been arbitrary nor capricious?

As much as I would like to see it happen, I don’t think the FDA will invoke this line of defense. The FDA ought to be able to win this case handily without the need to resort to such machinations. Regards, Dew

p.s. Thanks for the thought-provoking comments and questions, and welcome to the board!