mannitol-containing liquid formulation lost 27% of its IU/ml
after three weeks at 50°C while the sucrose stabilized liquid
formulation lost 36% over the same time period at the same
temperature (Appeal Brief, page 3).
25. We are unsure as to how counsel arrived at the
27% and 36% figures for the data in the three week column of
Table 14. As best we can tell, the percentages should be 26.5%
for sucrose and 18.4 for mannitol:
Sucrose (9194 - 6757)/9194 = 0.265 = 26.5%
Mannitol (8548 - 6977)/8548 = 0.184 = 18.4%
We assume that applicants would maintain that the lower the
percentage, the better the result. However, as we have noted
earlier, we are unable, on this record, to make a finding as to
whether the results are due to (1) sucrose v. mannitol or (2) the
amount of sucrose v. the amount of mannitol or (3) both.
Moreover, we note that after a 3-week period the IU/ml for
sucrose (6757) is not all that different than the IU/ml for
mannitol (6977).
26. Still further according to counsel, Table 15 shows
that the mannitol liquid formulation lost 24% measured in IU/ml
after 6 weeks at 40°C whereas the sucrose liquid formulation lost
32.5% over the same time period at the same temperature (Appeal
Brief, page 3).
27. We have no idea where the 24% and 32.5% figures
come from. As best we can tell, if one starts with T = 0, then
the percentages should be:
- 8 -
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next
Last modified: November 3, 2007