Apotex USA, Inc. v. Merck & Co., Inc.

Merck & Co., Inc. (Merck) (defendant) had an American and a Canadian patent on the compound for enalapril sodium, a blood-pressure medication. Although Merck had been manufacturing the medication compound under the name Vasotec since 1983, it did not hold a patent on the medication’s manufacturing process. Merck disclosed the medication’s ingredients in a French publication in 1988 and again in a Canadian publication in 1992. In 1991, Merck sued Apotex Canada in a Canadian court for allegedly infringing Merck’s Canadian patent for the compound. During the Canadian trial, a Merck witness provided a detailed description of Merck’s manufacturing process for the medication. Several days later, a scientist working for Apotex USA, Inc. (Apotex) (plaintiff) claimed to have invented the same manufacturing process. In 1996 and 1997, Apotex obtained two United States patents for the medication’s manufacturing process. Apotex then sued Merck in United States federal court, alleging that Merck’s production of Vasotec was infringing on Apotex’s manufacturing-process patents. Merck counterclaimed, alleging that Apotex’s patents were invalid. The district court granted summary judgment to Merck, ruling that Apotex’s patents were invalid under 35 U.S.C. § 102(g) because Merck had invented the manufacturing process first and had not abandoned, suppressed, or concealed it. Apotex appealed. On appeal, Apotex conceded that Merck had invented the medication’s manufacturing process first and had not abandoned it. However, Apotex argued that Merck had suppressed and concealed the manufacturing process by not filing a patent, by making insufficient public disclosures about it, and by misleading the Food and Drug Administration (FDA) by disclosing only some of the medication’s ingredients.