Appeal No. 2004-1761 Page 9
Application No. 10/044,807
pharmaceutical compositions that were disclosed to be useful in treating 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 most potent compounds . . ., analogous to the benefit provided by the showing of
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