Replies to post #129195 on Biotech Values

[iwfal]

MNTA -

Claims 3 and 4 of the 466 patent cover a number of other subclasses to include both octasaccharides and hexasaccharides; claim 4 provides a table of allowable amounts.

Suggest you missed my point. '466 says, effectively, there are two gates:

1) A check on fraction-of-all-tetras-together, and on fraction-of-all-octas-together, and on ... (Note that for some reason Momenta is not actually asserting this particular claim)

THEN

2) A check on subfractions of the tetras. (This is the claim they are asserting.)

My question is whether it is possible to, for instance, substitute a different subanalysis for #2. E.g. check on subfractions of the octas instead of the tetras. Do I know that that would be adequate to show a batch meets Lovenox equivalency? No, but I'll bet there is some other kind of subfraction check (not in the patent) that would show equivalency - but it would take substantial time/$ to show that checking that particular subfraction in detail is adequate to show lovenox equivalency and then get FDA acceptance of that method.


PS For any patent attorneys out there - why is it that sometimes the enablement action is in the claim (as it is in claim 8 - where it says what to do with the batch if it passes) and sometimes it is buried in description (as it is for claim 4 - where the claim itself says measure and compare to the table, but then not what to do with the compared batch)?

[RockRat]

As far as I can tell there are two main issues in litigation over the TRO and PI. One is the construction of "a separation method," and the other, related but distinct, is "peak 9." Here, I'll peek at the second one.

It is true that Momenta never refers to a "1,6 anhydro ring" anywhere in the patent. Only since the patent issued has Momenta said that "Peak 9" is that non-naturally occurring sugar with a 1,6 anhydro ring. Amphastar is apparently admitting using the 1,6 anhydro ring, but is arguing that because Peak 9 is not identified as such in the patent, they are not infringing.

http://patimg2.uspto.gov/.piw?docid=07575886&SectionNum=2&IDKey=A649C3661820&HomeUrl=http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2%2526Sect2=HITOFF%2526p=1%2526u=%25252Fnetahtml%25252FPTO%25252Fsearch-bool.html%2526r=13%2526f=G%2526l=50%2526co1=AND%2526d=PTXT%2526s1=momenta.ASNM.%2526OS=AN/momenta%2526RS=AN/momenta

You're looking for figure 1a. Note the peaks are not numbered in order from left to right, rather in order of amplitude. Peak 9 is so labeled because it is the 9th highest peak. It would be nice to be able to read the labels on the axes. Fortunately, figure 1b is blowup at peak 1, and it does show them legibly. I think that's the only reason it's there. mAU stands for milli-Absorbance Unit or maybe mass absorbance unit. You know which in this context? HTe definition for either one is eluding me. The right axis is minutes.

There's a lot of semantic BS revolving around the complaint talking about Peak 9 as being a 1,6 anhydro ring sugar in the complaint, but not the patent. Further discovery involving just what size/charge ratio Amphastar is using could cut through that?

Regards, RockRat