Appeal No. 94-2100
Application 07/902,109
(CCPA 1961). In concluding that similar in vivo tests were
adequate proof of utility the court in In re Krimmel stated:
We hold as we do because it is our firm conviction that
one 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 in the
treatment of humans.
And
FDA approval, however, is not a prerequisite for
finding a compound useful within the meaning of patent
laws. Scott, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120.
Usefulness in patent law, and in particular in 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.
Here, we find that the appellant has provided evidence that
the screening assays which were employed to test the claimed
compositions were performed using standard experimental animal
models. See the Molchan publication. We note that Molchan
recognizes that the scopolamine model has limitations, however,
contrary to the examiner’s assertion, we do not find that such
acknowledgment in any way suggests that the models be discarded
or the results obtained therefrom, disregarded. Rather, the
Molchan studies indicate that the effects of scopolamine are age
dependent. We direct attention to the concluding statements on
p. 224 of Molchan (first complete paragraph) that
7
Page: Previous 1 2 3 4 5 6 7 8 9 Next
Last modified: November 3, 2007