Opinion ID: 4470746
Heading Depth: 2
Heading Rank: 1

Heading: Prior Art Dexmedetomidine

Text: Dexmedetomidine is a chemical compound that is effective as a sedative. ’106 patent col. 1 ll. 36–37. Dexmedetomidine was first developed and patented by Farmos Yhtyma Oy (“Farmos”) in the 1980s. Farmos was issued U.S. Patent 4,910,214, which disclosed the dexmedetomidine compound and its use as a sedative. 1 The other asserted claim was claim 8 of U.S. Patent 9,616,049, which the district court held would have been obvious and is not at issue in this appeal. HOSPIRA, INC. v. FRESENIUS KABI USA, LLC 3 In 1989, Farmos submitted an Investigational New Drug application (“the Farmos IND”) to the U.S. Food and Drug Administration (“FDA”) seeking approval to begin safety testing dexmedetomidine formulations in humans. Farmos conducted at least two human safety studies using intravenous administration of 20 µg/mL dexmedetomidine hydrochloride but subsequently abandoned its safety testing after the studies showed adverse effects. In 1994, Farmos’s successor granted Abbott Laboratories (Hospira’s predecessor-in-interest) an exclusive license to make, use, and sell dexmedetomidine for human use in the United States. In 1999, Abbott Laboratories received FDA approval to market a 100 µg/mL dexmedetomidine hydrochloride formulation known as “Precedex Concentrate.” Precedex Concentrate is supplied in 2 mL clear glass vials and 2 mL clear glass ampoules made from Type IA sulfurtreated glass sealed with coated rubber stoppers. The 100 µg/mL concentration of Precedex Concentrate is too strong to be directly administered to patients, and thus the label provides instructions for diluting the drug to a concentration of 4 µg/mL before intravenous administration. Dexmedetomidine is also available as a sedative for commercial veterinary use. In 2002, the European Medicines Evaluation Agency authorized use of a product called Dexdomitor, which is a ready-to-use 500 µg/mL formulation of dexmedetomidine hydrochloride. Dexdomitor is stored in a 10 mL glass vial sealed with a coated rubber stopper and has a two-year shelf life.