Momenta Pharmaceuticals, Inc. (MNTA)

[GrthzGd]

However if AW launch in Q42011 as in the PR, then wouldn't that invalidate your conjecture ?

Yes, though AW's ability to do that will be litigated in the injunction phase, so I doubt it will come to that.

Isn't the key to whole mystery of AW a-enox approval ... whether Amphastar can reproduce Lovenox without somehow using Mnta IP?

No, it's only the key to AW's liability under MNTA's patents. As you state below, I don't think the FDA cares one way or another vis a' vis its approval. However if--as MNTA has stated many times--the FDA echoed the substance of MNTA's technology in its published "roadmap," it does seem likely that the FDA may have forced AW into violating them.

And like you say, only they know the answer to that. We don't know that and to some degree MNTA does not know that .

Yes, but see my answer above.

The same logic applies to m-copax. The FDA can/will grant approval to m-copax once they are satisfied with whatever make them happy. Whether MNTA lose their shirt in court or not does not concern them, nor does that legal consideration should enter into their decision to approve or not approve.

Yes, my view is that the FDA issued its roadmap without regard to whether forcing MNTA's competitors to follow that route would cause them to be liable for patent infringement--the FDA obviously felt that it was the best route from a scientific standpoint. Perhaps this factor could be argued by the defense to oppose multiple damages, along the lines of, "We were only doing what we were told."

Thank you for the comments.