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Re: exwannabe post# 120763

Monday, 05/30/2011 6:16:23 PM

Monday, May 30, 2011 6:16:23 PM

Post# of 251581

The patent's range of average MW is 4-8.6 kD. The FDA label states 4.7-11 kD.



http://www.drugs.com/pro/copaxone.html

he active ingredient of Copaxone, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons.
I think originally when Copaxone NDA was filed it was prolly filed with specification of higher mol weight. But when the patents got issued, they prolly immediately got the label changed.
Anyway this is moot.

I still believe inequitable conduct has a very good chance. The 3 guys listed inventors on the patents DID NOT DISCLOSE STUDIES THAT CONTRADICTED VERY CLAIMS THAT THEY ARE TRYING TO PATENT....That satisfies both the "but for" materiality standard as well as "intent to deceive" standard. This cannot be about gross negligence when the prior art is from the inventors and when they had concluded in their own studies that "13-23kDA was safe and non-toxic to rats and humans"

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