Biotech Values

[investorgold2002]

Due - Question

For Lovenox , I am just wondering , if momenta has demonstrated the structural sameness by identifying a signature component of Lovenox that would assure sameness and quality and patented that "structural signature"(identification and characterization), how else would another company be able to demonstrate structural sameness without infringing on momenta's patent ?

For eg, for copaxone, momenta says
"The invention is based, at least in part, on the identification and characterization of L-pyroGlutamic Acid (pyro-Glu) as a structural signature of glatiramer acetate (GA). Analysis of this signature component of GA is useful to assess product and process quality in the manufacture of GA."

So another company(mylan) that would want to make copaxone has to come up with another criteria for proving structural sameness to FDA I would think? or else they would infringe of momenta's patent

Same for TEVA on generic LOVENOX

let me know your thoughts...I think momenta's analytical methods that helps them identify structure is on to something big and is here in opportune time with pathway for follow on biologics to be released any time. Question is how easy or hard it is to use momenta's analytical methods to identify signature of these compounds. Is this a 5 year deal for each drug ? lovenox took many years i think