Appeal No. 2005-0792 Page 10
Application No. 09/750,373
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
an in vivo utility.” Id. On the facts of that case – successful in vitro testing
supplemented by similar in vitro and in vivo activities of structurally similar
compounds – the court held that in vitro activity was sufficient to meet the
requirements of § 101. See id.
The Federal Circuit confirmed in In re Brana, 51 F.3d 1560, 34 USPQ2d
1436 (Fed. Cir. 1995), that human testing is not necessary to establish utility for a
method of treatment. The invention claimed in Brana was a group of compounds
disclosed to have antitumor activity. See id. at 1562, 34 USPQ2d at 1437-38.
The specification disclosed that the claimed compounds had higher antitumor
activity than related compounds known to have antitumor activity, and the
applicants provided declaratory evidence of in vivo activity against tumors in a
mouse model. See id., 34 USPQ2d at 1438. The court held that these data
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