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genisi

10/31/11 1:11 PM

#129896 RE: jb_118 #129885

I'm way out of my depth here but under the 35 U.S.C. 271 (g)(1) saying "it is materially changed by subsequent processes", I think Teva (or others) can use the methods in part of the manufacturing process say from step A to C of the manufacturing process, in EU where there's no patent protection and then take the product which is not yet the final one and continue from there differently even in the US, the final product may be considered 'materially changed' and may not infringe on the US patent of the analyzing method. This is of course all mute until Teva or others will get an FDA approval, if they will. What I find interesting is why was that EU patent I've found withdrawn. Perhaps because generic Lovenox needs to go through clinical trials in EU.