Unexpected results cannot rebut showing that treatment was obvious to try

Federal Circuit affirms summary judgment of obviousness in favor of generic drug companies. The patents claimed using one monthly 150 mg dose of ibandronic acid to treat or inhibit osteoporosis.

Hoffman-La Roche Inc. v. Apotex Inc., ___ F.3d ___ (Fed. Cir. Apr. 11, 2014) (Newman, Lourie, BRYSON) (D.N.J.: Chesler) (4 of 5 stars)

Obviousness: The Federal Circuit held that monthly dosing was obvious to try based on several prior art references that disclosed monthly dosing of ibandronic acid or related phosphonates. The court rejected Roche's argument that the art taught away from monthly dosing because Roche relied on a speculative article that was undermined by other prior art. The Federal Circuit also held that a 150 mg dose was obvious to try because prior art disclosed a 5 mg daily dose and showed that longer-interval doses could be calculated by multiplying the daily dose by the days between doses. Finally, the Federal Circuit held that evidence of higher side effects associated with the 5 mg daily dose did not establish a genuine safety concern or teach away from extrapolating from that dosage.

Unexpected Results: The Federal Circuit also held that unexpected results of a monthly 150 mg dose, including nonlinear bioavailability and unexpected efficacy relative to a 2.5 mg daily dose could not "rebut the prima facie showing of obviousness," reasoning that "evidence of superior efficacy does nothing to undercut the showing that there was a reasonable expectation of success with the 150 mg monthly dose." Slip op. at 17.

In dissent, Judge Newman argued that the majority ignored the holding in KSR "that a patent challenger must 'identify a reason that would have prompted a person of ordinary skill in the relevant field' to arrive at the patented invention. 550 U.S. at 418." Dissent slip op. at 5. She also criticized the majority's conclusion that the method was "obvious to try," arguing that "[t]he extensive experimentation with other regimens and dosages demonstrates that this selection was not obvious to try." Dissent slip op. at 13.