Interference No. 103378
Reduction to Practice
Reduction to practice is a question of law, which is based on underlying
factual determinations. Estee Lauder, 129 F.3d at 592, 44 USPQ2d at
1613 . Proof of an actual reduction to practice of a compound requires a
showing of three elements: (i) production of a composition of matter satisfying the
limitations of the count, (ii) recognition of the composition of matter, and (iii)
recognition of a specific practical utility for the composition. Id. It is well settled
that a practical utility must be established for a novel compound before it can be
said to have been reduced to practice. Kawai v. Metlesics, 480 F.2d 880, 886,
178 USPQ 158, 163 (CCPA 1973). Whether a composition of matter must be
tested in order to establish a reduction to practice, and if so, what tests are
necessary, is a question which must be decided on the basis of the facts of the
particular case involved. Blicke v. Treves, 241 F.2d 718, 720-21, 112 USPQ
472, 475 (Fed. Cir. 1957). If no utility is specified in the count, evidence
establishing a substantial utility for any purpose is sufficient to prove reduction to
practice. Fujikawa v. Wattanasin, 93 F.2d 1559, 1563-64, 39 USPQ2d 1895,
1898-99 (Fed. Cir. 1996) ; Rey-Bellet v. Engelhardt, 493 F.2d 1380, 1383,
181 USPQ 453, 454 (CCPA 1974).
In the pharmaceutical arts, our reviewing court has long held that practical
utility may be shown by adequate evidence of any pharmacological activity. In
Fujikawa, 93 F.2d at 1564, 39 USPQ2d at 1899, it said:
It may be difficult to predict, however, whether a novel compound will
exhibit pharmacological activity, even when the behavior of analogous
compounds is known to those skilled in the art. Consequently, testing is
often required to establish practical utility. See e.g., Blicke, 241 F.2d at
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