Appeal No. 2003-2017 Page 12
Application No. 09/802,116
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 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 were sufficient to satisfy
§ 101; usefulness in patent law does not require that the invention be ready to be
administered to humans. See id. at 1567, 34 USPQ2d at 1442.
Several lessons can be drawn from Brenner and its progeny. First,
§ 101’s requirement that an invention be “useful” is not to be given its broadest
reach, such that little or nothing of a chemical nature would be found to lack
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