Replies to post #128106 on Biotech Values

[exwannabe]

To continue your analogy:

Amphastar uses techniques that infringe MNTA's patents to demonstrate sameness, and using these techniques, they get approval. But they also show that if they monitor their 7 (non-infringing) elves closely, they always have sameness, and going forward they manufacture using these 7 elves only.

Possibly, but very unclear and I personally doubt it would fly. The problem is that you now gave a second level of indirection in establishing "sameness". I suspect the FDA would want to see some level of QA that directly establishes the sameness of the product.

[iwfal]

MNTA -

But they also show that if they monitor their 7 (non-infringing) elves closely, they always have sameness, and going forward they manufacture using these 7 elves only.

I.e translated into real world - that the FDA allows generics to use the same kind of (lack of) process rigor as the original manufacturer. Agreed that, as I've said before, if(!!) the FDA allows the generic to use only the same kind of process rigor as the originator then Momenta patents are worth a lot less.


However I think this is very very unlikely - the FDA has a long history of being (justifiably IMO) retentive about a change in manufacturing even by the original manufacturer trying to duplicate their original elves. (Because they don't really know it is the same elves.)

PS As for prognostication - I agree there are a lot of pieces we just do not know and thus the distribution is large. But based upon Momenta's demonstrated expertise and the FDA's retentitiveness I'd give 50 pct odds of greater than 10% royalties and more than a 1 year delay of launch.

[mcbio]

My guess is this gets settled at some point with a high single-digit royalty.

If it's only going to be a high single-digit royalty, then MNTA should roll the dice on landing a permanent injunction. That's too little in return (single-digit royalty) in exchange for foregoing what would be huge upside for MNTA if they were to win a PI against Amphastar.

[DewDiligence]

I'm basing my prediction [of a high-single-digit royalty rate] on the fact that...generally process-type patents don't hold up at all (there is typically some way to circumvent them)…

What are you basing the above assertion on? In fact, US generic-drug litigation pertaining to process patents is extremely rare.

Almost all US generic-drug patent litigation pertains to composition-of-matter patents, formulation patents, or method-of-use patents. Process patents are not allowed in the FDA’s Orange Book, so the rare generic-drug litigation concerning such patents falls outside the scope of the Hatch-Waxman framework.