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Re: dewophile post# 109735

Thursday, 12/02/2010 10:41:29 AM

Thursday, December 02, 2010 10:41:29 AM

Post# of 252867
>think this is MNTA's way of getting teva's capabilities in the public domain<

I'm not of that opinion.

MNTA knows from discussions with the FDA what the requirements are for a generic Lovenox, which are inevitably more detailed than the overview that the FDA has posted. In other words, the FDA has likely focused on some intermediates in the production process that are valid indicators of purity or activity. Further, some of these were likely derived from data submitted by MNTA based on processes that the company has patented.

In that light, MNTA need not know exactly what Teva is doing, but can simply conclude that *if* the FDA requires a valid reading of a specific intermediate and/or end-product in the development process (this they certainly know), and that since this intermediate was described by MNTA in their application to the FDA, and since MNTA has patents covering the synthesis and/or detection of this intermediate, they can reasonably make the case to sue for infringement.

I don't think this is as much a case of trying to get at Teva's technology, as it is an borderline show of contempt by MNTA with regards to Teva's tech. MNTA doesn't think Teva has the goods to have developed an alternate process.

This could have been part of a long game by MNTA / Teva wherein each were trying to get *their* patented and/or proprietary processes into the list of criteria that the FDA required for generic Lovenox. If so, we can surmise from the approval that, on balance, MNTA may have won that battle.
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