Replies to post #128022 on Biotech Values

[genisi]

I certainly agree with your view that exaggerating Section 271(e)(1) beyond the intent of the law would make the value of patents like Momenta's worth a lot less (using iwfal's words #msg-67816773). Still, from previous cases where utilizing patented techniques was allowed so long as it was related to gaining data for FDA approval for an ANDA, seems to me it is within the scope of Section 271(e)(1). Btw, Momenta will probably use the Bolar Provision in the Copaxone case (#msg-59195596).

[apljack]

MNTA: So one reading of this law is that Amphastar (or Teva) could freely infringe on MNTA's patent during the development process just so long as they don't infringe during the manufacturing process.

Don't know if anyone will know, but my response to this is that this begs the question of whether or not Amphastar needs to use the potentially protected molecule characterization process as part of their Quality Assurace in their production of aL. If they can get by with the FDA demonstrating that the manufacture does not need regular checks on production, then Peter's find is a broadside to MNTA's patent claims, IMO.

aj