Objective Criteria Fail to Overcome Prima Facia Obviousness

In a ruling that effectively shortens the period of patent protection for Merck & Co., Inc.’s (Merck) second-biggest seller in a decade, the U.S. Court of Appeals for the Federal Circuit reversed and vacated a lower court ruling and held that Merck’s U.S. Patent No. 5,994,329 (the `329 patent) is invalid as obvious over the prior art. Merck & Co., Inc, v. Teva Pharmaceuticals USA, Inc., Case No. 04-1105 (Fed. Cir., Jan. 28, 2005) (Gajarsa, J., Rader, J. dissenting).

Merck has U.S. Food and Drug Administration (FDA) approval to market a once-weekly dose of alendronate monosodium trihydrate, which it does under the trade name FOSAMAX. The `329 patent is listed in the FDA’s Orange Book for Merck’s FOSAMAX dosages of 35 mg and 70 mg. Teva filed an Abbreviated New Drug Application (ANDA) to market a generic version of FOSAMAX. Merck sued, alleging infringement of its `329 patent, which claims a method for treating osteoporosis by administering "about 70 mg" of the compound once weekly