The tiny silver lining in the CAFC loss in the m-enox case is that Teva's process patent for Copaxone shouldn't be any safer than Momenta's for enoxaparin. I would expect that, if approved, Momenta and other players with the ability to launch upon the expiration of the last 2014 CoM patent would do so.
I am not as positive as you are that the FDA will be more tight-fisted about the information they reveal when approving. I do not know what responsibility they have to respond to CPs that have already been denied (especially since part of the denial is a response, which we do not get to see prior to approval). I gather Sanofi's CP re enoxaparin was simply left in limbo for seven years until the FDA responded concurrent with approval. In other words, they hadn't denied it until that point, and even partially accepted it with respect to one claim regarding the 1-6 anhydro ring.
The whole situation is whacky. Safe Harbor in these types of cases -- which will keep coming -- will continue to be decided at the appellate level, and the decisions will depend on the composition of the panel of judges and the venue. Meanwhile, how the FDA responds to the relevant CPs would seem to greatly affect the ability of others to copy the process of the first player approved. The thought occurs to me that the FDA's four time denial of Teva's Copaxone CPs might be their strategy for allowing a modicum of IP protection for the first approved player. However, they started that pattern of denial well before the CAFC turned the Safe Harbor world upside down, so I don't put much stock in that notion.
What a mess. Holding my much reduced position if for no other reason than Momenta is simply due for good news by law of averages, a terrific investment thesis as you all know.
Regards, RockRat
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