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tinkershaw

01/26/11 12:15 AM

#113310 RE: biomaven0 #113308

The gist of my comments was not that Teva does not have other defenses, but instead went to the point that Teva has dramatically changed their language in support of this one particular defense.

If Teva actually has a product on the verge of approval, that defense goes out the window anyways, so why change one's behavior so dramatically to support that defense? It has no real benefit to a firm that is on the verge of a commercial launch. It would seem that there would be no need to change one's behavior then to support that defense.

But instead, Teva has gone all out to do just that, to support a specific legal defense that has no merit, unless Teva has no commercial product that is imminently destined for commericial use, for the sole purpose of delaying any discovery that MNTA can conduct.

Once Teva gets approval, there is no question that MNTA can get all the discovery they want from Teva.

So it appears to me to be a very large change in behavior on the part of what was otherwise a very, best descriptive terms, cocky, and boastful management team, all of a sudden, to support this one legal defense that goes away anyways if they really have a product. Teva has no reason to change its behavior in regard to any of their other substantive defenses, and it could not have been easy to reign in managements comments. In fact, it probably took some very serious potential consequences to get this management team to reign in its comments to comport with this legal defense, and it did not take very long to get them to cooperate. I mean, how easy do you think it was to get Marth to chill on the comments and play along with the attorneys?

A lot of work, and a lot of lawyers having a face to face with management, for such little practical benefit, unless, well, there was really some important stuff that this legal defense could protect. As it cannot protect Teva once ANDA approval is given.

Tinker

genisi

01/26/11 11:45 AM

#113332 RE: biomaven0 #113308

What if their [Teva] research and tweaking of the process to manufacture the molecule made use of techniques that overlap MNTA's patent, but the end manufacturing process (including quality control) uses techniques that do not infringe? That would be my guess for one of their defenses.

That's my understanding of the § 271(e)(1) of the 35 U.S.C. namely the Bolar exception provision and I expect Momenta to use it as well for one of their defenses about Teva's molecular-weight markers related patents. There were several cases where the court ruled that the Bolar exception provision applied as long as the act of using a patented invention was reasonably related to gaining data for the FDA's regulatory approval.