Replies to post #113310 on Biotech Values

[ghmm]

When I went back over the most recent Momenta presentation (DB Biofest 12/15/10) this remark by Craig Wheeler stuck out:

Thanks to jbog for posting the transcript #msg-58235653

Of course, when we saw the FDA's Citizens' Petition Response, I was in one way thrilled, in one way very concerned [I am sure concern is to be taken in the "pleased" sense if that is possible :-)].
I was thrilled that they actually took advantage of our technology and approved a drug. And, business the other side of it is that there are many things buried in that petition. There are clearly -- are things that we own patents to, and therefore want to protect. So when we looked at that and saw that they were expecting those around manufacturing controls and release standards, and that Teva was out there saying, we're now manufacturing inventory for launch, it created an opportunity for us to actually assert those patents.

Though it could just be a CEO talking up his company I think there is a descent chance the courts could rule in Momenta's favor especially as others have implied the FDA unfairly used Momenta as the standard.

[biomaven0]

If Teva actually has a product on the verge of approval, that defense goes out the window anyways

I think you are missing my point. For me it is plausible that in their development process Teva used methodology that would infringe MNTA's patent. But because they did that ex-US, I'm not sure MNTA has any recourse. If for their production methodology they do not infringe, then there is at least an argument that the product is not made in a manner that infringes MNTA US patents, and so they can import it legally.

Process/use patents are always weaker than COM patents, and more often than not there are clever ways to circumvent them. I think the Teva language about development occurring outside the US hints at their angle of attack.

The other issue that may come into play here is the statutory exemption from patent infringement for activities leading to the development (but not sale) of a generic drug. This was meant to allow generic companies to start the process of copying a patented drug before its patent expired, but maybe it comes into play here too.

Peter