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 and a method for preventing the disease by administering "about 35 mg" of the compound weekly. In a Markman proceeding, the district court determined that the claim term "about" had been specifically defined by Merck and thus given a special meaning. In particular, the district court concluded that the term "about" was an attempt to take into account the different salt forms and formulations of alendronic acid in order to deliver the exact 35 or 70 mg of sodium alendronate. Teva's ANDA for 35 and 70 mg dosages was held to infringe.

The Federal Circuit disagreed, finding that the district court had construed the claim term "about" in a manner inconsistent with the specification since the patentee had failed to clearly redefine the term. The Federal Circuit concluded that the term "about" should be given its ordinary and accepted meaning of "approximately."

The panel then found that regardless of whether the term...