Momenta Pharmaceuticals, Inc. (MNTA)

[investorgold2002]

MNTA's characterization patents on lovenox would block competitor

my point was due to claim 331 and supporting description 248 & 249 which was p8 which momenta identified for the 1st time

and since FDA in CP to response to aventis, states clearly the requirements for generic lovenox approval in
II)
"The resultant distribution of sequences of disaccharide units in enoxaparin is essentially both a function ofthe (1) sequences found "naturally" in heparin and"
III) Equivalence in Disaccharide Building Blocks, Fragment Mapping,

I believe the following claims will also be infringed among others when trying to prove the sameness criteria III)1. AND III)2.

claim 4. The method of claim 1 wherein the structural signature is determined by one or more methods chosen from the group consisting of MALDI-MS, ESI-MS, CE, HPLC, FPLC, fluorometry, ELISA, NMRUV, chromogenic assay, colorimetric assays, other spectroscopic techniques.

Also on claim
"2. The method of claim 1 wherein the structural signature is provided by determining one or more primary outputs chosen from the following: a. the presence or the amount of one or more component saccharides or disaccharides; b. the presence or the amount of one or more block components, wherein a block component is one made up of more than one saccharides or polysaccharide; c. the presence or amount of one or more saccharide-representative, wherein a saccharide-representative is a saccharide modified to enhance detectability; d. the presence or amount of an indicator of three dimensional structure or a parameter related to three dimensional structure; and e. the presence or amount of one or more modified saccharides, wherein a modified saccharide is one present in a starting material used to make a preparation but which is altered in the production of the preparation. "

It's interesting situation . FDA approves generics based on legislation created by congress so affordable drugs hit marketplace. But if you seriously think about approving complex generic based on structural characterization work (which ofcourse would be patented by the first generic maker), then forget about affordability. There will essentially be 2 players only for the most part. The sole generic that first did complete characterization and then the branded drug. Pricing impact would be minimal with just 2 players....kinda defeats the purpose of generics legislation when it was created by congress...And now they are going to adopt this approach for FOB...hmmmmmmm, interesting...

Dew, Tinkershaw, RockyRat - your thoughts ?