Biotech Values

[orangeone]

RE: 271 exemptions/"Momenta presentation (DB Biofest 12/15/10) this remark by Craig Wheeler stuck out"

WHeeler seems to state that M's IP will be needed in manufacturing controls. That will not be exempt under section 271 no matter what country in happens in.

I suppose Teva is saying that they do not use Momenta IP in manufacturing. I'm not sure to understand where the assertion comes from that CMC requires characterizing the product in these ways, where we could look to find this out? Is it in guidance documents from the FDA?