Biotech Values

[RockRat]

>>TEVA/MNTA: Wouldn't the product presumably have to enter US jurisdiction in order for the FDA to prosecute the Teva aNDA? Doesn't matter where, just "if" the FDA had a sample?<<

Momenta's patents issued pretty recently. So the the samples provided to the FDA up to that date of issuance to prosecute the ANDA are grandfathered in. As to subsequent samples, I have no idea. It is still not a commercial product, but if Teva is using an infringed process to gain approval . . .

And this t-enox stockpile that Rick Shea refers to . . . does he have any idea when it was made? If made before the date of issuance of the patents, would it not also be exempt from prosecution? Answer to my own question here is that it is the date of sale, not manufacture, that matters, per 35 U.S.C. 271(g). So no, the stockpile is not grandfathered.

It is unlikely that, if Teva is using a Momenta patented process, it can use a subsequent process to materially modify their product and still have an equivalent enoxaparin. But that is the subject of the discovery phase, if we get to that point.

>>On another front, wouldn't data on an infringed product, provided to the U.S. FDA, qualify as de facto infringed product?<<

Interesting question, since, as has been noted, the process is the product to a huge degree in the case of enoxaparin. Or rather, data about the process is hard to separate from the process itself. It's kind of fuzzy & abstract, probably a tough angle to litigate . . .

Bottom line is that I don't think Teva has actually infringed yet. This strikes me as a warning shot; I think Teva may actually have grounds for dismissal. But Momenta can file if & when Teva gets t-enox approval and launches. I seem to recall Sanofi took a few days before taking legal action, which I thought strange. Would have expected them to be better prepared. Momenta and Sandoz are clearly not going to make that mistake, and the threat of a lawsuit over infringement and an at risk launch is what this is really about.

By filing this suit, even though it is likely to be dismissed, Momenta and Sandoz are telling Teva that a) we're not gonna let you guys sell anything before we slap an injunction on ya, and b) we'll be looking for treble damages if you dare try it.

Pretty much as Peter said earlier, but with the added threat of really prompt action.

Regards, RockRat