Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

The nub of TEVA's argument is that the Federal Circuit reviewed the lower court decision that the 808 patent was not indefinite "de novo", that is, they did not "defer" to the findings of the lower court as they generally would for factual matters, being of the view that the question is a legal one. The standard of review for claims of indefiniteness is one that has been, and is being litigated in the Federal Circuit, indeed, one of the arguments adduced by Mylan/Momenta legal team is that the Supreme Court should wait for the full panel of the Federal Circuit to review the question, as they are scheduled to do.

Based on the above, if the USSC accepts Teva’s application, it appears that the worst-case scenario for NVS/MNTA/(MYL) would be USSC’s remanding the case to the CAFC with new instructions rather than having USSC re-establish the validity of the ‘808 patent. Under this remand scenario, NVS/MNTA might still decide to launch “at risk” (assuming FDA approval has been obtained).