On November 18, 2014, the United States Court of Appeals for the Federal Circuit affirmed summary judgment that claims of U.S. Patents 7,192,938 and 7,718,634 directed to treating osteoporosis with once-monthly dosing of risedronate sodium were invalid for obviousness. The case arose after Plaintiffs Warner Chilcott and Hoffmann-La Roche sued the firm’s client Mylan Pharmaceuticals.  The case was filed in the United States District Court for the District of Delaware (Stark, J.) in a Hatch-Waxman patent infringement lawsuit concerning once-monthly Actonel®.

The Federal Circuit’s opinion detailed why the district court correctly granted summary judgment that obviousness had been proven by clear and convincing evidence. In particular, the Federal Circuit concluded that the “district court correctly determined that the cited prior art references disclosed or suggested each of [the claim] limitations and provided an express motivation to pursue the claimed monthly regimen and a reasonable expectation of success in doing so.” Furthermore, the Federal Circuit rejected Plaintiffs’ contention that a genuine dispute of material fact existed as to whether a skilled artisan would have reasonably expected once-monthly dosing of 150 mg of risedronate to be safe and effective. Thus, the district court’s judgment in favor of Mylan Pharmaceuticals was upheld.

Mylan Pharmaceuticals was represented by Richard Parke and Richard Kurz of Frommer Lawrence & Haug LLP, and Richard Herrmann and Mary Matterer of Morris James LLP.

To view the decision, please click here.

To view the Law360 article, please click here.