"PS Pure speculation on my part - but one possible way to get around this patent might be to use a different subclass (or subclasses) as the proxy for enox status. E.g. perhaps using octasaccharides and hexasaccharides as an adequate proxy instead of tetra. But of course it would take substantial time to prove to the FDA that that new proxy was, in fact, adequate."
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. Claims 3 and 4 of the 466 patent are the only ones with the term "determining" in them and may be most pertinent for this case.
wc21
Claims 3 and 4:
3. The method of claim 2, wherein the method further comprises determining if the enoxaparin preparation has a fraction distribution profile of dodecasaccharides, decasaccharides, octasaccharides, hexasaccharides and tetrasaccharides, as shown in FIG. 2.
4. The method of claim 2, wherein the method further comprises determining if one or more fractions shown in the following tables are present or present in an amount shown in the following tables.
Distribution by Range A Range B Range C % Height of % Height of % Height of % Height of HPLC peaks HPLC peaks HPLC peaks HPLC peaks Tetrasaccharides 14.8 17.8 14.1 18.8 12.5 20.4 Hexasaccharides 21.2 23.9 20.8 23.9 19.7 24.9 Octasaccharides 21.6 22.7 21.5 22.8 21.1 23.3 Decasaccharides 19.8 21.2 19.7 21.5 19.1 22.0 Dodecasaccharides 17.6 19.3 17.3 19.6 16.5 20.3 Distribution by Range A Range B Range C % Area under % Area under % Area under % Area under HPLC curve HPLC curve HPLC curve HPLC curve Tetrasaccharides 9.8 12.3 9.1 12.5 8.0 13.7 Hexasaccharides 18.8 20.4 18.4 20.6 17.6 21.3 Octasaccharides 16.8 17.4 16.6 17.5 16.3 17.9 Decasaccharides 13.0 14.1 12.9 14.4 12.4 14.9 Dodecasaccharides and 34.0 38.8 33.4 39.9 31.3 42.0 higher size chains
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