Merely confirming that extrapolations from known data are operational is not sufficient to preclude a conclusion of obviousness. Here, for example, a monthly dosing regimen in line with suggested but untested extrapolations from daily dosing regimens was found to be obvious even though lacking certainty. “[O]bviousness does not require absolute certainty or a guarantee of success.”
Background / Facts: The patents being asserted here are directed to methods of treating osteoporosis by orally administering a single, monthly dose of 150 mg of risedronate. The prior art contained no evidence of risedronate dosage testing above 50 mg, but suggested that, in setting the dose for a once-monthly regimen, one could extrapolate from a known effective daily dose to achieve an equivalent total dose over one month.
Issue(s): Whether a person of ordinary skill in the art would have reasonably expected that dosing 150 mg of risedronate once monthly would be safe and effective.
Holding(s): Yes. “As indicated, the FDA had approved a 5 mg daily dose of risedronate for the treatment of osteoporosis. Moreover, [the prior art] taught an equivalent once weekly dose of 35 mg of risedronate. [] Accordingly, a person skilled in the art looking to select a monthly oral dose of risedronate would have reasonably expected success in administering a dose of 150 mg (5 mg/day times 30 days/month). Indeed, the [patentee’s] own expert testified that risedronate was known to exhibit a linear bioavailability from 2.5 mg to 50 mg, and that linear scaling of risedronate to a higher dose was merely unknown. While it is true that, as of [the priority date], the highest single dose of risedronate that had actually been tested in a patient was 50 mg, obviousness does not require absolute certainty or a guarantee of success.”