Appeal No. 2003-1170 Page 4
Application No. 08/817,192
We note that lack of conclusive evidence that a claimed invention provides
therapeutic or human efficacy does not necessarily mean that the claimed invention is
not enabled. As explained by our appellate reviewing court, “[u]sefulness 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.” In re
Brana, 51 F.3d 1560, 1568, 34 USPQ2d 1436, 1442 (Fed. Cir. 1995). In Brana, the
court observed that an invention need not have entered Phase II clinical trials in order
to be considered useful under the patent laws. Id., at 1568, 34 USPQ2d at 1442-1443.
In other words, a claimed invention may be considered useful or enabled under the
patent statutes at a time before the claimed invention is conclusively shown to have a
clinical or therapeutic effect.
Here, the examiner relies upon Orkin, Verma, and Galton to support his view that
the field of gene therapy in general is unpredictable. In our view these references do
not establish that the field of gene therapy is as unpredictable as the examiner believes.
For example, Verma states:
Although more than 200 clinical trials are currently underway
worldwide, with hundreds of patients enrolled, there is still no single
outcome that we can point to as a success story. To explore why this is
the case, we will use our own experience and other examples to look at
the many technical, logistical and, in some cases, conceptual hurdles that
need to be overcome before gene therapy becomes routine practice in
medicine.
As seen from Verma, gene therapy is not a “routine practice in medicine” even
though many clinical trials involving gene therapy have been conducted. However, a
claimed method need not be a “routine practice in medicine” in order for it to be
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