Replies to post #125386 on Biotech Values

[biomaven0]

It sounds like you don't regard MNTA's IP as an impediment.

Any sort of process-type patent is always going to be easier to get around than a COM patent. There are also issues about what happens if the design of their drug happened outside the US (and potentially infringes), but the manufacture does not infringe. At the end of the day, a not unlikely outcome in my view would be that MNTA gets a modest royalty on the Teva product.

The Amphastar disclosures happened in their lawsuit against the FDA. They were referenced on this board at the time but I don't have a link handy.

Peter

[biomaven0]

>>which Amphastar disclosures are you referring to?

Their amended complaint:

http://208.78.96.220/Amphastar_4-25-11.pdf

In particular this paragraph:

46. On November 2, 2007, the FDA acknowledged, in a letter to Amphastar from the
Office of Generic Drugs, that Amphastar had met the FDA’s five “sameness” criteria and
therefore had demonstrated its enoxaparin’s sameness with Lovenox® in its ANDA.