The United States Court of Appeals for the Federal Circuit, on April 11, 2014, affirmed summary judgment of invalidity of the asserted claims of U.S. Patent Nos. 7,718,634 (“the ’634 patent”) and 7,410,957 (“the ’957 patent”), which were directed to methods of treating osteoporosis by once-monthly oral administration of ibandronate sodium tablets. Plaintiffs Hoffmann-La Roche and Genentech had sued the firm’s client Mylan in the United States District Court for the District of New Jersey seeking to prevent the launch of a generic version of Boniva®. The District Court (Chesler, J.) ruled that the asserted claims of those two patents were invalid due to obviousness under 35 U.S.C. § 103.
In its precedential opinion, the Federal Circuit found that a monthly oral ibandronate treatment was taught by several prior art references. The court also noted that the claimed dosage of 150 mg was effectively taught by scaling up prior art dosages of 5 mg daily or 35 mg weekly in light of the “total dose concept,” namely, that the effect of ibandronate on bone formation was due to the cumulative dose for a time interval, not the size or frequency of individual doses. The Federal Circuit rejected Roche’s contention that the skilled artisan would have had safety concerns with a 150 mg dose.
As to secondary considerations, the Federal Circuit held that Roche’s claims of unexpected results were insufficient to overcome the prima facie showing of obviousness. While the majority observed that Roche provided evidence that a 150 mg dose had an unexpectedly high bioavailability in the body, it maintained that bioavailability was not a direct measure of efficacy and, regardless, did not change the reasonable expectation of success that one of ordinary skill in the art would have had before consideration of the bioavailability data. Thus, the Federal Circuit upheld the District Court’s decision in favor of Mylan.