Opinion ID: 809904
Heading Depth: 3
Heading Rank: 1

Heading: A method for treating or inhibiting

Text: postmenopausal osteoporosis in a postmenopausal woman in need of treatment or inhibition of post- menopausal osteoporosis by admini- stration of a pharmaceutically acceptable salt of ibandronic acid, comprising:
pharmaceutically acceptable salt of HOFFMANN-LA ROCHE v. APOTEX 4 ibandronic acid by orally adminis- tering to the postmenopausal woman, on a single day, a first dose in the form of a tablet, wherein the tablet comprises an amount of the pharmaceutically acceptable salt of ibandronic acid that is equivalent to about 150 mg of ibandronic acid; and
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.