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tinkershaw

10/24/11 5:49 PM

#129235 RE: zipjet #129233

Yes, it looks like to me this puts a big dent in the PI argument. It also dramatically reduces the damages that MNTA could have potentially have claimed. And by doing so it also dramatically reduces Amphastar/Watson's risk if they decide to launch at risk, which at this point in time I believe they will given the reduced risk if the PI is not granted.

It also dramatically reduces the value of MNTA's enoxaparin IP, as keeping out a competitor now is worth in the $10s of millions per year and not hundreds of millions anymore with an AG.

All in all, a broadside hit, making this litigation less imperative, less valuable, less defining for MNTA. MNTA now has copaxone as its next big thing and enoxaparin should become baked in as a given at this point in time in regard to dramatically reduced revenues.

Talk about taking air out of the balloon. But there is no PI vs. an AG.

Tinker
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RockRat

10/24/11 5:51 PM

#129237 RE: zipjet #129233

Yeah, that's the only thing I can come up with. Given how much is under seal, I wonder what Sanofi knows as an expert in the field. How good a tell is this action of theirs on the outcome of the PI or, later of validity at trial? Brings to mind Peter's point that MNTA has not sued Sanofi for infringement. I privately poo-pooed the point at the time (on the theory that the FDA requires a higher standard of QC proof from the generics, requiring MNTA's IP), but it seems relevant given the timing here.

Regards, RockRat