Appeal No. 2001-1150 Page 5
Application No. 09/767,764
different dosage regimens. See 21 C.F.R. § 312.21(b). FDA
approval, however, is not a prerequisite for finding a compound
useful within the meaning of the patent laws. . . . . Usefulness in
patent law, and in particular the context of pharmaceutical
inventions, necessarily includes the expectation of further research
and development. The stage at which an invention in this field
becomes useful is well before it is ready to be administered to
humans. Were we to require Phase II testing in order to prove
utility, the associated costs would prevent many companies from
obtaining patent protection on promising new inventions, thereby
eliminating an incentive to pursue, through research and
development, potential cures in many crucial areas such as the
treatment of cancer.
In re Brana, 51 F.3d, 1560, 1568 34 USPQ2d 1436, 1442-43 (Fed. Cir. 1995)
(citations omitted).
In this case, the inventor has presented data from Phase I clinical studies
in humans. See Klimas Declaration, Paper No. 5, ¶ 11. Moreover, as noted by
the examiner, most of the patients demonstrated some type of improvement
upon receiving treatment. See Examiner’s Answer, page 5 (“Upon treatment,
patients reported little improvement (page 12, line 1), modest improvement (page
14, line 3), marked improvement after one week, but only 50% showed
improvement overall (page 16, line 3; page 18, line 2; page 20, line 3; page 22,
line 3.”). There is no need for the inventor to demonstrate that the treatment will
be efficacious in every patient exhibiting CFS, i.e., a “magic bullet” for the
treatment of CFS. See, e.g. Brana, 51 F.3d at 1568, 34 USPQ2d at 1442 (“We
hold as we do because it is our firm conviction that one who has taught the
public that a compound exhibits some desirable pharmaceutical property in a
standard experimental animal has made a significant and useful contribution to
the art, even though it may eventually appear that the compound is without value
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