Appeal No. 2002-1631 Page 6
Application No. 08/213,433
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. [5, 6]
Brana, 51 F3d at 1568, 34 USPQ2d at 1442-43 (citations omitted, footnotes added).
The court also expressed its “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 in the treatment of humans”
(quoting In re Krimmel, 292 F.2d 948, 953, 130 USPQ 215, 219 (CCPA 1961)). We
recognize that the claims in Brana were directed to chemical compounds taught to be
useful in treating cancer, but we believe that the contextual standard discussed in the
case is consistent with In re Wands, and is appropriately applied to the present claims
directed to methods of gene therapy.
Here, there is evidence of record that numerous gene therapy trials - some
involving vectors and protocols similar to those described in the present specification,
some involving genes encoding other nuclear proteins - were ongoing or approved at
the time of filing, despite the unpredictability of delivery and expression (see Exhibit B,
which accompanied appellants’ amendment of September 8, 1997 (paper no. 14)). We
regard these trials, ongoing or approved at the time of the invention, as evidence that
5 Phase I testing involves administration of a drug to a limited number of humans
in order to evaluate its safety. In Phase II testing, the drug is administered to a larger
population and its safety and potential efficacy under different dosage regimes are
determined.
6 Although the court in In re Brana discussed the issues raised in the appeal in
the context of utility under 35 U.S.C. § 101 and enablement under the first paragraph of
35 U.S.C. § 112, the rejection before the court was for lack of enablement.
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