Replies to post #104163 on Biotech Values

[genisi]

it's an invention relating to an in vitro bioassay for copaxone. so it covers PD. One argument TEVA makes for the need for trials is that there is no in vitro bioassay for copaxone like there is for lovenox (factor Xa and IIa activity)

To be accurate, Teva's arguments on that matter are :
"there are no pharmacodynamic (PD) markers known to reflect the immunomodulatory and neuroprotective effects of the drug, there are no pharmacokinetic (PK) or PK/PD correlations between glatiramer acetate levels in plasma and drug efficacy"
and also:
"there are no established PD markers for RRS,"

When writing a patent application one tries to make it as wide as possible since the paper suffers everything... PD is only mentioned in general in the summary, the claims are not directed to PD and in the examples they showed they tested only in cell line (not even from subjects) again with no mention of PD.