Replies to post #109881 on Biotech Values

[rkrw]

But they should have no idea if Teva did infringe other than if there were a whistleblower, perhaps Janet Woodcock :)

And this is all assuming mnta like characterization is required for approval, which they don't know.

[akasidney86]

The beauty of the strategy of patenting the tools used to prove sameness, and then pre-emptively suing to protect them is that it will force any other producer to show how they prove sameness and to prove that it is different. MNTA is simply saying 'if you're going to beat us, it won't be with our ball'.

From what I've read it would be possible, in the FDA ANDA process, for others to use the MNTA patented techniques in their proof of sameness (FDA wonks and patent atorneys correct if mis-stated). However, in the event that the FDA sameness hurdle was met with their tools and an approval granted, how it will be done in manufacturing remains protected regardless of manufacturing site (if they want to sell in the US), and MNTA with this suit is going scorched earth. Whether there are other roads to prove sameness remains to be seen. One thing is for sure, however; MNTA won't be beat with it's own inventions.