BioCentury
ARTICLE | Company News

Actavis, Apotex, Dr. Reddy's, Mylan, Orchid Chemicals & Pharmaceuticals, Roche musculoskeletal news

April 21, 2014 7:00 AM UTC

The U.S. Court of Appeals for the Federal Circuit reaffirmed a lower court's decision and found invalid claims related to once-monthly oral administration of Roche's Boniva ibandronate to treat osteoporosis. In Hoffmann-La Roche Inc. et al. vs. Apotex et al., the court upheld a 2012 ruling of the U.S. District Court for the District of New Jersey invalidating eight claims of U.S. Patent No. 7,718,634 and 10 claims of U.S. Patent No. 7,410,957. Roche argued that previous studies showing intermittent and daily ibandronate treatment were equally effective had focused on bone mass density (BMD) instead of reducing fracture risk. However, the court said BMD is a "powerful surrogate" for measuring fracture risk and thus the studies "established at least a reasonable expectation" of success of the once-monthly regimen. The court also found that the 150 mg dose of Boniva was obvious because previous studies showed that the efficacy of ibandronate depends on the total dose administered over a given period and not the amount administered at any single point in time. Thus, the court said it was reasonable to expect a once-monthly 150 mg dose would have similar efficacy to a daily 5 mg dose shown to be effective in previous studies...