Biotech Values

[biomaven0]

expert insights

That's putting it much too strongly - I'm basically just using my intuition here as to both the legal situation and Teva's strategy. I'm sure one of the patent attorneys that post here could provide some actual expertise.

if ongoing validation uses mnta's processes ex-US for commercial product would you think that product when sold in the US would be deemed to infringe?

I would think that would infringe. You can't escape a US patent by simply manufacturing abroad in a way that would infringe if done here. So the key here would be that Teva would have to have found validation and quality control processes that do not infringe - I have no idea if that would be possible or not.

Here's some more on the broad patent exemption for R&D in this area:

http://www.buildingipvalue.com/06US_Can/131_134.htm

(Edit: Now that I think about it some more, the broad exemption for R&D activity actually undercuts my theory somewhat - given the exemption, why would it matter that the development activity took place ex-US?)