Replies to post #107891 on Biotech Values

[jb_118]

But to the point of the analyst question, it didn't sound like it is his expectation that the trial will be in 2012.

What's the potential for an at-risk launch after 30-month stay ends?

[mouton29]

Re: Copaxone patent trial date. It was the second analyst who introduced 2012, which Bill Marth said was not unreasonable and even "fine." Here are the full two Q&A on the litigation. I would not have thought of 2012 after reading the first exchange, but then, I am not a litigator.

Ken Cacciatore

Maybe on the litigation front can you just give us an update of what's happening there following the summary motion in your favor. Can you talk about steps forward that you can take or are planning on taking?

Bill Marth

I think it will probably be helpful to kind of walk you through the process because I think there's maybe some misunderstandings out there. Because we have an excellent understanding of the litigation process and thus far we are really pleased at where this litigation process is going.

Mylan and Momenta have been essentially consolidated for all purposes and trial, so I think probably the best way to do it would be to take you through the anticipated flow. So Mylan's construction hearing will be on January 12, after which some period of time Judge Jones would issue the claims construction. We will then proceed to summary judgment.

Now the summary judgment is an undefined period, but it could be a substantial period of time as due course to go through summary judgment motions. After the summary judgments are ruled on it's about a 30-day process. Judge Jones will bring us in for pre-trial conferences. After that pre-trial conference she'll set a trial date. We will begin the trial. We expect it to be about a two-week trial and then Judge Jones will render a decision at the appropriate time. I mean that's pretty much the course. But we feel really good about where we're at right now.

... [Discussion of low dose formulation]

David Amssellem – Piper Jaffray

Just coming back to that Copaxone litigation, just so I'm clear, is it your expectation that the trial date will be sometime in 2012, and given the protracted process is it your view that the FDA will necessarily have any sense of urgency in terms of reviewing the filings from Momenta and Mylan?

Bill Marth

I think to say that the trial is in 2012, that is not unreasonable at all. That would be fine. With respect to how fast the FDA moves on approving their products, or processing their file, that's very difficult to say. That's something that happens within the FDA. But we know from our experience with enoxaparin that it took a very, very long time, and the FDA didn't get tremendously motivated until litigation was done.