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“About” Means “Approximately,” Not “Exactly”

January 28, 2005

Decision icon Decision

Last Month at the Federal Circuit - February 2005

Judges: Gajarsa (author), Prost, and Rader (dissenting)

In Merck & Co. v. Teva Pharmaceuticals USA, Inc., No. 04-1005 (Fed. Cir. Jan. 28, 2005), the Federal Circuit vacated a judgment of the district court after construing the claim term “about” and found the asserted claims invalid and not infringed.

Merck & Company, Inc. (“Merck”) owns U.S. Patent No. 5,994,329 (“the ‘329 patent”). The ‘329 patent is directed to a method of treating and preventing osteoporosis through less than daily
administration of bisphosphonate compounds. Merck markets a product relating to the patent under the trade name Fosamax.

In late 2000, Teva amended its existing ANDA and sought approval to market generic versions of Merck’s once-weekly Fosamax supplement in 35 mg and 70 mg quantities. Merck subsequently filed suit against Teva, alleging that Teva’s ANDA filing was an act of infringement. The district court construed the claim terms “about 35 mg” and “about 70 mg” to mean exactly 35 and 70 mg, respectively. The district court had pointed to language in the specification of the ‘329 patent supporting its conclusion that the claim phrases “about” meant “exactly.” Based on that claim construction, the district court dismissed prior art that Teva alleged to invalidate the claims and enjoined commercial sale of Teva’s generic treatment.

The Federal Circuit reversed the claim construction and determined that the term “about” should be given its ordinary meaning of “approximately.” The Court concluded that the passage in the specification relied upon by the district court to support its limiting construction is ambiguous and failed to redefine “about” to mean “exactly” in clear enough terms to justify such a counterintuitive definition of “about.”

In light of that corrected claim construction, however, the Federal Circuit found reversible error in the district court’s obviousness analysis and found the asserted claims invalid for obviousness. The Court concluded that there was no great leap required of those skilled in the art to go from 40 or 80 mg once a week, as disclosed in the prior art, to a 35 or 70 mg pill once a week. Moreover, concerns over dosing amounts suggested lowering the weekly dosage from 80 to 70 mg and from 40 to 35 mg, just as Merck did.

Judge Rader dissented, concluding that the district court had correctly applied the “lexicographer rule.”