Biotech Values

[zipjet]

>>do u have the link to [a] message which discusses why the claim "copolymer of lower molecular weight is less toxic" is obvious?

>No one has addressed this directly, as far as I can recall.

As far as I know, it is a patent claim without a comparative clinical trial to prove the proposition. The level of evidence required by the patent office is far lower than that required by the FDA. The later-patented C with narrower mw range was not subject to clinical studies presented to FDA. TEVA could have done it but it would have been costly and offered some risk of FDA rejection.

TEVA has used two different systems (patenting and drug approval) with their different rules and standards to game the process. Why should a patent of the narrower mw C be allowed to block the wider range mw C (which was approved based on clinical studies)?

IMO the C-story is NOT really about patents. TEVA's patent ploy will fail. It is about getting FDA approval. Will FDA approve m-C?

ij