Appeal No. 2004-1346 Page 10
Application No. 08/971,338
acute myeloblastic leukemia. See id. at 1323, 206 USPQ at 886. The active
ingredients in the compositions were closely related to daunorubicin and
doxorubicin, both of which were “well recognized in the art as valuable for use in
cancer chemotherapy.” Id., 206 USPQ at 887. The applicant also submitted
declaratory evidence showing that eight of the claimed compositions were
effective in treating tumors in a mouse model, and one was effective in treating
humans. See id. at 1323-24, 206 USPQ at 887-88. The court noted that the
data derived from the mouse model were “relevant to the treatment of humans
and [were] not to be disregarded,” id. at 1327, 206 USPQ at 890, and held that
the evidence was sufficient to support the asserted therapeutic utility. See id. at
1327-28, 206 USPQ at 891.
The Federal Circuit held in Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739
(Fed. Cir. 1985), that in vivo testing (as in Jolles) was not necessarily required to
show utility in the pharmaceutical context. The Cross court stated that “[it] is
axiomatic that an invention cannot be considered ‘useful,’ in the sense that a
patent can be granted on it, unless substantial or practical utility for the invention
has been discovered and disclosed where such utility would not be obvious.” Id.
at 1044, 224 USPQ at 742 (citing Brenner v. Manson). The court “perceive[d] no
insurmountable difficulty, under appropriate circumstances, in finding that the
first link in the screening chain, in vitro testing, may establish a practical utility for
the compound in question.” Id. at 1051, 224 USPQ at 748. Successful in vitro
testing could provide an immediate benefit to the public, by “marshal[ling]
resources and direct[ing] the expenditure of effort to further in vivo testing of the
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