Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

Re: Hatch-Waxman Safe Harbor /distinction between Lovenox and Copaxone

With Lovenox, there is variable animal feedstock, and hence you have to verify the batch production output indefinitely. The (purported) need for indefinite submissions to the FDA is what allowed Amphastar to succeed in Appellate Court by claiming non-infringement under the H-W Safe Harbor.

With Copaxone, on the other hand, there is no variable input element, so once you reverse-engineer TEVA’s (now also MNTA’s) production process, you’re done for all time and there is no need for ongoing submissions to the FDA.

Based on the interpretation of the Hatch-Waxman Safe Harbor taken by the CAFC, the above is a consequential distinction, IMO.