Biotech Values

[exwannabe]

Why is this finding obvious? could anybody who had read prior art on Copolymer or similar compounds have surmised, that lower mol weight always tends to be less toxic ?

Very possibly the FDA either considered it obvious, or considered it an insignificant change. Else why would they allow the change?

The argument for obviousness is this. The earlier invention already lowed the MW by removing much of the higher MW species. I would presume this was done for exactly the reason in the example rat study you note. If the higher MW weight species were causing AEs, then one would assume that a better job of removing them would be good.

Did the FDA accept the change because it was obvious that the change would be good as it removed unwanted contaminates?

Alternatively, the product is the same and all that happened was that they tightened up the process to make a more consistent product.

Did he FDA accept the change because there was no real change in the product?. If so though, then the CoM patents are likely double patenting.

So you have 2 very real possibilities that the info contained in the FDA documents will through serious doubt on the patents validity.

Come on man, throw us a bone and give us at least 5% and I will drop the issue

On a non-patent note, that the new MW was accepted by the FDA goes against TEVA's argument that Copaxone can not be duplicated because nobody knows what it is. "Obviously" the FDA did allow a change to it, with (presumably) far less documentation on it being the same than that which MNTA/Sandoz is providing.