A greater than expected level of success “does nothing to undercut” a prima facie case of obviousness predicated on a finding of at least a reasonable expectation of success.
Background / Facts: The patents at issue here are directed to methods of treating osteoporosis through the once monthly administration of ibandronate, which is commercially available as the patentee’s once monthly Boniva®. The prior art discloses monthly dosing and that there is a reason to set that dose at the claimed 150 mg, but the patentee produced evidence that the 150 mg monthly dose was substantially more effective than the conventional 2.5 mg daily dose.
Issue(s): Whether a prima facie case of obviousness predicated on a finding of a reasonable expectation of success may be rebutted by a secondary showing that in fact greater than expected levels of success were achieved by the claimed invention.
Holding(s): No. “The evidence of superior efficacy does nothing to undercut the showing that there was a reasonable expectation of success with the 150 mg monthly dose, even if the level of success may have turned out to be somewhat greater than would have been expected.”