Here’s my somewhat convoluted conjecture about what is going on. In December, NVS/MNTA sued Teva for patent infringement based in part on Teva’s public assertions that FDA approval of Teva’s Lovenox was imminent. The lawsuit raised the stakes substantially by allowing NVS/MNTA to seek legal discovery about the details of Teva’s Lovenox ANDA.
To counter this tactic, Teva asked the FDA to issue some kind of formal response to Teva’s ANDA by the end of January. Now that the FDA’s response is a non-approval, Teva will tell the Judge presiding over the patent case that legal discovery is not warranted because the lawsuit is moot until the FDA is ready to approve Teva’s ANDA. This averts the considerable embarrassment and harm to Teva’s reputation that might have ensued from such discovery.
Finally, as the cherry on top of the ice cream sundae, Teva characterized the FDA-cited deficiencies in its Lovenox ANDA as “minor" in order to exert maximum pressure on MNTA.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
