Method of Treatment Interpreted to Include a Pharmaceutical Formulation of the Claimed Compound

In a case turning on claim construction, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s ruling of infringement construing a claim directed to a treatment for bone reabsorption and urolithiasis to encompass the use of a pharmaceutical formulation of the active agent. Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 03-1168 (Fed. Cir. Oct. 30, 2003).
The drug Fosamax is marketed by Merck & Co. (Merck) and approved by the U.S. Food and Drug Administration (FDA) for the treatment of osteoporosis and Paget’s disease. The active agent of the product is formulated as a salt having the common name alendronate salt. The Merck patent in issue was U.S. Patent No. 4,621,077 (the `077 patent), which contained a single claim directed to a method of treating bone reabsorption and urolithiasis through the administration of the non-salt form of the compound, alendronic acid.