Momenta Pharmaceuticals, Inc. (MNTA)

[Mpower]

Mouton,

MNTA's intellectual property ("sweat of the brow") is being totally trampled on by the majority opinion. I'm very surprised at the interpretation that the court took in making their decision.

It is unfair that Amphastar (or anyone else for that matter) can "trespass" on MNTA's sophisticated characterization processes to validate sameness of their biologic products, all in the name of satisfying "FDA manufacturing and submission requirements." Way to support innovation!

This is one reason Wheeler stated that the ruling "has potentially wide ranging implications for all patent holders."

At some point, I believe the FDA will mandate a similar framework for establishing sameness for mC as it did for mL.

But I don't think we can rely on the TEVA orange book process patents as a mechanism to help establish sameness, in the same way Amphastar relied on MNTA's patents.