Replies to post #121952 on Biotech Values

[zipjet]

Sorry to be repetitive on this I have still not heard obviousness defense on the claim "lower mol weight is less toxic" . 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 ?

Obviousness is not my top argument.

But here goes. It is "obvious" that when a drug is a complex mixture that refining selection of the components in some fashion could improve the resulting product. It does not matter whether that is lower mw, higher mw, combinations of selected ranges, or some other screening factor. Thus, incremental improvements are to be expected and are obvious.

Absent a dramatic and unexpected result, refinement of the selection of the drug by whatever criteria is likely to improve the result and thus obvious and another patent should not issue or should be invalid.

I would certainly give a different answer if some tweaking of the drug resulted in dramatic reductions in toxicity or dramatic improvements in effectiveness. BUT that is clearly NOT what happened with C.

ij

[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.

[DewDiligence]

In the handicapping of the Copaxone patent case on this board, posters have been treating obviousness and double patenting as a single argument for the sake of simplicity, although they are not exactly the same thing.

If you think Teva’s Orange Book patents are non-obvious, perhaps you should ask yourself whether they constitute a significant discovery relative to Teva’s older, expired patents. In mulling this question, consider the fact that no commercial product was developed as a direct consequence of the newer patents.