Opinion ID: 809904
Heading Depth: 4
Heading Rank: 2

Heading: continuing the administration by orally

Text: administering, once monthly on a single day, a tablet comprising an amount of the pharmaceutically ac- ceptable salt of ibandronic acid that is equivalent to about 150 mg of ibandronic acid. ’634 patent, col.7 ll.23–39. According to the specification, treating osteoporosis with orally-administered ibandronate was known in the art. Id. col.1 ll.59–66, col.2 ll.10– 29. However, when administered orally on a continuous basis, ibandronate was known to cause skin irritations and result in digestive tract side effects. Id. To remedy those problems, the inventors discovered that a oncemonthly dose of 150 mg, among other infrequent dosing regimens, was effective at treating osteoporosis in postmenopausal women. Id. at col.2 ll.43–59, col.3 ll.13–24. In 2005, the United States Food and Drug Administration (“FDA”) approved once-monthly Boniva® to treat osteoporosis in post-menopausal women.