I listened to that stretch several times, and didn't really feel any differently about the need for ongoing submissions versus the situation with enoxaparin, notwithstanding the differences between the two (cell-based versus batch production). Note that we're talking about the totality of IP, not just patents but trade secrets.
He talked of parameters of time and temperature, and how variations would give you significant differences between batches. That to me sounds just like enoxaparin in that regard.
What is more heartening is the FDA's a) internal process for checking out other filers versions, and b) failure to give other filers the complete roadmap right off the bat in the CP response. Regarding a), Wheeler said somewhere else on the call that the FDA would allow each filer to use their own analytical/production resources and see if it matched with theirs. If not, tough titty, we're not going to help you. But if there's something in MOMENTA'S publicly available IP - in other words in their patents - that can be copied that allows a filer to achieve that standard, then I think the Safe Harbor card can again be played, because I heard nothing that steers me away from the need for ongoing submissions for the entire process. For these complex mixtures and for FOB's, if that was not, as Rader asserted, Congressional intent, I think it's going to take an actual Congressional fix. A tweak to the act. Unless Mnta's attorney's instead finally pull a rabbit out their hat and get a judicial precedent to this end in the final enoxparin litigation.
Not holding my breath about that. I think trade secrets and the "delicate balance" (believe that was Wheeler's phrase) in what is disclosed by the FDA in CP responses and communications with filers, coupled with the FDA's own analytical methods are a pretty good defense from Safe Harbor attacks. But not bulletproof (corporate espionage), or ideal.
You could yet be right, though. It's possible someone with more expertise than I could go through Momenta's Copaxone patents and find something essential that doesn't require ongoing submission. But my guess is that Momenta gave some trade secrets to the FDA for their "internally developed" testing methods.
Anyhow, I remain cautiously optimistic that Momenta will be the sole generic entrant for a good while. I am doubtful of Mylan's ability to tweak a flawed process into something usable. Thinking it might be harder than starting from scratch.
But really, all this stuff if pretty esoteric for us. You couldn't even throw a biotech patent attorney at this estate independently (i.e. with no help from scientists well versed in the production of complex mixtures) and get a reliable answer IMO.
Regards, RockRat
AI
