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Federal Circuit Invalidates Fosamax Patent
In Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005), the Federal Circuit reversed a lower court's ruling, and found that claims 23 and 37 of U.S. Patent 5,994,329 (the '329 patent) were invalid for obviousness. The '329 patent discloses a method of treating and preventing osteoporosis through less-than-daily administration of bisphosphonate compounds. This patent is listed in the Orange Book as covering Merck's Fosamax drug, which had sales of $3.2 billion in 2004.
In 2000, Teva amended an existing ANDA and sought FDA approval to market a generic version of Fosamax in 35 mg and 70 mg quantities. The '329 patent claims a method for treating and preventing osteoporosis by orally administering “about” 35 mg or 70 mg of alendronate monosodium trihydrate once-weekly. The district court found that Merck had acted as its own lexicographer and had redefined the ordinary meaning of “about” 35/70 mg to mean the equivalent of 35/70 mg.
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