Hi all. I do not own MNTA, I have no affiliation with MNTA. Just doing research on this area. I'd like to understand why many folks here think MNTA will win on appeal and possibly get damages? Other than wishful thinking of course.
MNTA did to SNY what this Amph company is trying to do to MNTA. I don't understand why that is a problem. Now if Amph actually did do something like patent infringement, then Amph should be punished, but I haven't heard any information on that. In fact, I've heard that Amph actually filed its ANDA for this drug well before MNTA and have been waiting for FDA approval for a long time. If they had gotten it first, then they would have been the one with 180 exclusivity for a generic. If that's the case, where would the patent infringement be? If MNTA's only argument is that there will be financial harm to them if there is competition, then I don't understand that.
I'm looking into this because I like specialty pharma in general and I'm looking to buy in. MNTA is one I'm interested in.
My advice to you would be to look elsewhere unless you're prepared to do a lot of reading. The MNTA-SNY case could not be more different from the Amphastar-MNTA case. SNY had a patent on Enox. But the main patent expired, and MNTA(&NVS) convinced the courts that remaining patents were invalid. So they had a legal launch of Enox. Long ago, Ampha filed their Enox version with the FDA but couldn't get it approved. Then MNTA published a patent on how to characterize Enox well enough for FDA approval. That patent is new and still in effect. Ampha used the methods in that patent to get their Enox approved at the FDA. That is patent infringement, plain and simple. Details of MNTA's compaint and Ampha's defense are too much to go into, but if you read enough, you're likely to convince yourself that MNTA will probably win. If they do, they're entitled to damages from the patent infringer.