Re: MNTA’s generic-Copaxone IP/Hatch-Waxman Safe Harbor
I encourage those interested in MNTA to listen to the 2-minute section of MNTA’s CC on Copaxone approval from 31:10 - 33:10 (in response to a question from Tom Shrader of Stifel).
It seems that MNTA has IP with respect to the reverse engineering of Copaxone that does not relate to ongoing submissions to the FDA by the sponsor of another generic product, thereby circumventing the Safe Harbor patent-infringement defense that Amphastar used in the Lovenox patent case.
Why might Copaxone patent litigation turn out differently from Lovenox?
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.
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