So Rossman is "shooting down opinions" by others...To post his 100% fact...LOL...I would be a lot more impressed if he told me he was an active member of the FDA's CDER.
I have had one scheduled meeting with the FDA regarding a medical device. My partner and I sat at a conference table with representatives of the different intra-agency departments. These included medical, legal, compliance, safety and a couple more I do not remember. What I do remember was the obvious scarcely concealed hostility between the department heads.This was related to turf...How does this relate to Rossman ABSOLUTELY 100%..? Well..the H-W defines an NCE in terms of the FDAs APIs...an NCE being defined as a chemical entity that has no active moiety that has been approved by the FDA in any other application...This is determination of the NCE is made by the FDA's CDER committee. Their decisions can be more subjective than the strict definition provided bi H-W, but CDER is the sole determiner and my personal experience would leave me to doubt they bring in even outside members of FDA into the discussions, and certainly not the PTO...THis is MHO...The subjectivity would take in earlier decisions by the FDA...but the point is this is an FDA thing, and not a PTO thing...
Finally IMHO the NCE is not really very important anyway...
in regards to NCE, I believe once the NCE drama is behind us the concensus will be squarely behind you
The value of Amarin's patent portfolio is growing . We wil have 3 new patents issued over the next 3 weeks
On 11/20 408 will be issued
On 11/27 145 will be issued
On 12/4 - 150 will be issued
Also, 496 (cont. of 885) has already been allowed
the super patent 520 Anchor is follwoing same course as 889 with Dr. Bays weighing in with his affidavit on unexpected results - same examiner as 889 so I see thsi being allwoed within 2 months or less
we are in fantastic shape with 8 patents already and 28 more in the pipe