Appeal No. 1999-1231 Page 5
Application No. 08/709,554
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 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. 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.
Brana, 51 F3d at 1568, 34 USPQ2d at 1442-43 (citations omitted). While the claims
involved in Brana were directed to chemical compounds taught to be useful in treating
cancer, we believe these principles can be applied to the present claims directed to
methods of gene therapy, especially in light of the examiner=s apparent holding that
gene therapy in general is non-enabled.
The references relied on by the examiner support his position that the future
course of gene therapy was uncertain at the time the present application was filed.
Nevertheless, these same references provide evidence that the field had reached that
stage of A[u]sefulness in patent law@ described in Brana. For example, in a 1995 article
discussing viral gene transfer systems, Günzburg cited Aover 140 human gene therapy
trials on the way to the clinic, with yet more planned.@ Page 417. Similarly, in a 1995
review article, Ledley listed A[m]ore than a dozen clinical trials [ ] currently underway
using nonviral systems for disease indications including cystic fibrosis and cancer.@
Page 1129.
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