Appeal No. 2004-1040 Page 10
Application No. 09/770,643
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
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 claimed
compounds were disclosed to have higher antitumor activity than related compounds
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