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Thursday, December 14, 2006 11:17:46 AM
kinda shows the integrity of DNA
(but thats what all big pharma do, so i do not blame them)
http://www.xs4all.nl/~surg3on
small part of it: (and it only gets better, they seem to have very very good arguments for 151)
INSMED’S ALLEGATIONS ARE SUPPORTED BY THE EVIDENCE
Plaintiffs’ argument that Insmed did not properly allege inequitable conduct is simply false.
Insmed properly asserted inequitable conduct alleging, inter alia, that Dr. Clark was under a duty of
candor to the PTO, and withheld material information—Growth Regulation paper Study 51—from the
PTO in violation of that duty. The particular facts about which Plaintiffs complain are not new bases of
inequitable conduct; rather, they further demonstrate that Study 5 was material.
Genentech repeatedly argued to the PTO that the complex of IGF-I/IGFBP-3 provided greater
anabolic growth compared to IGF-I when given by subcutaneous injection to obtain the ’151 patent.
Genentech compared two studies disclosed in the patent, an infusion experiment and a subcutaneous
injection experiment. The disclosed 7-day infusion study demonstrated greater growth by
administration of IGF-I alone after the third day of the experiment. Genentech relied on the day 5
results to form the comparison with the subcutaneous injection experiment that was only conducted for
3 days. The undisclosed experiment is relevant to materiality, in part, because undisclosed Study 5,
which tested the complex by subcutaneous injection for longer than 3 days, showed at best, equivalent
growth with IGF-I alone. Thus, the result of undisclosed Study 5 is directly contrary to the disclosed
results and is contrary to the arguments relied upon in support of the patentability of the claims.2
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