Roche owns US Pat. No. 7,718,634 ("'634 patent") and manufactures Boniva® (osteoporosis medicine). Roche's '634 patent was directed to a method for treating osteoporosis by administering about 150 mg of pharmaceutically acceptable salt of ibandronic acid once monthly on a single day. Defendants were generic drug manufacturers who submitted ANDAs to the FDA for approval to engage in the manufactures and sale of generic versions of Boniva®. Roche moved for a preliminary injunction and defendants filed a motion for summary judgment of invalidity of the '634 patent. The district court found that the '634 patent was obvious over prior art.
During appeal, Roche attempted to argue that prior art taught away from once monthly dosing because it was widely believed as of the date of invention that a bisphosphonate regimen with a dose-free interval longer than one or two weeks would not be effective. Citing prior art providing competing explanations, the Federal Circuit disagreed with this argument.
In addition, Roche pointed out that the FDA approved a 2.5 mg daily dose of ibandronate instead of a 5 mg daily dose and argued that this FDA's finding taught away from further development of the 5 mg daily dose (equivalent to the 150 mg monthly dose). In regard to this argument, the Federal Circuit found that the FDA never made any finding contrary to the 5 mg daily dose, because it was never asked to approve that dose. Therefore, the Federal Circuit also disagreed with this argument.
Roche additionally proffered its MOBILE study (2005) results demonstrating that a patient group taking the 150 mg monthly dose showed more improvement in bone mineral density than a patient group taking the 2.5 mg daily dose and asserted unexpected results of the '634 patent. The Federal Circuit held that while this evidence would support a superior or efficacy of the 150 mg monthly dose, that improved efficacy does not rebut the strong showing that prior art disclosed monthly dosing and that a reason to set that dose at 150 mg.
Judge Newman, in her dissent opinion, criticized that the court's ruling of obviousness violates the principles of Graham and KSR. In addition, she pointed out that the majority opinion does not mention that the FDA refused to approve the 5 mg dose due to its toxic side effects.