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TripleCutter

09/13/10 12:17 PM

#104059 RE: pollyvonwog #104053

This press release really got me thinking this morning. MNTA has many patents and pending patents around the analytics used to characterize heparins. This chain mapping one must be pretty important because I can't recall them doing a press release over a patent. What if there is no way to analytically characterize enox to FDA standard w out infringing on one of these patents? Teva could try to copy their science but would be infringing and couldn't get to market. Under this scenario the FDA could approve other generics but they couldn't get to market due to the IP.
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RockRat

09/13/10 3:14 PM

#104068 RE: pollyvonwog #104053

One thing that struck me in looking at this patent is that it seems to suffer from one of the defects that Momenta claims the Copaxone patents suffer from: indefiniteness due to the failure to adequately define a key term. Namely the same term of "average molecular weight." Anyone see this differently? The patent does address what Biomaven and I (and perhaps others) agree is a key hurdle for Teva: the fragment mapping criterion. To the extent this holds up, it could indeed make it tougher for Teva to manufacture without infringing. Not sure about obviousness and prior art here. The LC, MALDI, and NMR, techniques that are the instrumental backbone of this analysis are all known in the art (as PGS has pointed out); to what extent the applications described in this patent are novel, I have no idea. There is an embodiment in which it appears one of their proprietary enzymes is used in combination with readily available ones to digest a sample, and that could be a biggie. As for the algorithm used, it appears to be a long decision tree type thing used many times. Doubt that's novel. Has anyone else (hopefully someone with more training in this area) looked at these patents and made any conclusions?

Regards, RockRat