"According to the document, TEVA has the burden of proof on infringement and at the trial MNTA/Sandoz will present evidence showing that their proposed GA [glatiramer acetate, i.e. Copaxone] product does not meet the asserted claims since it does not meet the molar ratio limitations (6:2:5:1) claimed in the patents and also does not use a "test reaction" as claimed in a manufacturing step. Further, since TEVA's patents claim that it is not possible to determine the molecular weight of individual polypeptides or their GA product, MNTA argues it is not possible for TEVA to prove infringement."
That last sentence is interesting. Could MNTA/Sandoz get approval w/o determining those molecular weights? If not, they are trying have it both ways, assuming they are able to. But if memory serves (don't have search on IHub), the tea leaves say the FDA might approve based on other criteria. What document is referred to in the first sentence (time to look at the relevant docket again?)? The implication is that MNTA reverse engineered the process (as opposed to completely characterizing the compound as they did with enoxaparin), then made some changes/improvements that skirt Teva's patents.
Can't remember what the consensus was regarding the success of the non-infringement approach, but I thought it was low. Now it seems as though it may be the strongest argument out there, and perhaps the easiest to show (as opposed to inequitable conduct, for example).
Apologies if this has been delved into by the board and I've simply forgotten. If that's the case, maybe I need to quit investing. But I don't remember us dissecting a document involving molar ratios and test reactions.
Regards, RockRat
