AI
Friday, February 18, 2011 1:48:28 PM
it sounds like MNTA is going to work around these patents with alternate methods of measuring molecular weight. from the Q4 cc:
Duane Nash – Wedbush Securities
Good morning and thanks for taking the questions. Craig during the claim construction hearing for Copaxone, I believe your attorneys commented that your version of Copaxone mainly to be reformulated. Is that correct, if so could you clarify how long that may take?
Craig Wheeler
So first, I will assure you that our partner [ph] is not mean to be reformulated so and as of our attorney said that then I would want to what they were talking about but there were series of patents that have asserted here that we have – have to defend in the court but we have no reformulation required at all.
Rick Shea
Duane, let me just add, the Teva has a patents called a Gad patents where – which are used, it’s nothing is used to measure molecule weight. And so what was indicated in the course was that we needed or that we intended to use a different method for measuring molecule a weight, and so that would simply, had nothing to do with change in formulation.
it sounds as if MNTA needs to submit an amendment. the fact management does not think this will be rate limiting in approval tells me copaxone approval is at the earliest a late 2011 event
Duane Nash – Wedbush Securities
And, using a different method, would there be any FDA implications where you have to modify the filing in any way or -
Craig Wheeler
All of our methods have to be into our application.
Duane Nash – Wedbush Securities
So, changing this method would it incur any significant delay.
Craig Wheeler
We don't believe so.
