Replies to post #7151 on Momenta Pharmaceuticals, Inc. (MNTA)

[iwfal]

Mylan has an Indian drug that is already sold in India. Unless Mylan is doing some rejiggering of the drug, then MNTA patents won't come into play.

Strongly suggest that this is very much missing the point of the enox demonstrated Momenta patent strategy - even if (and it is a very big if!!) Mylan is trying to get FDA approval on exactly the same drug as they sell in India Momenta's patents are entangled with the FDA need to prove 'sameness'. The ones they chose to enforce for Enox were not manufacturing patents - they were about a proxy that can be measured to prove sameness to the satisfaction of the FDA.

Momenta's strength, as evidenced by the events of their Enox approval before the earlier filers, and as evidenced by the events of the last week, is:

a) Understanding in great depth how to characterize a product - and prove it to the satisfaction of the FDA.

b) Finding a practical proxy (i.e. one that doesn't require running 5000 tests on each batch) to measure sameness on each batch. (and then the FDA takes that proxy and says to the other applicants - if you can measure this then you have produced an adequate generic).

IMO neither of these is substantially less likely just because Mylan was approved in India first.