Government Patent Use to Address the Rising Cost of Naloxone: 28 U.S.C. § 1498 and Evzio. Issue 2 (2018)

• Record Type: Journal Article
• Authors: Wang, Alex; Kesselheim, Aaron S.
• Editors: Ayres, Ian; Gluck, Abbe R.; Stith, Kate
• Is Part Of: Journal of law, medicine & ethics. Volume 46:Issue 2(2018)
• Page Start: 472
• Page End: 484
• Publication Date: 2018
• Subjects: Medical laws and legislation -- United States -- Periodicals; Medical care -- Law and legislation -- United States -- Periodicals; Medical ethics -- Periodicals; Jurisprudence -- Periodicals; Legislation, Medical -- Periodicals; Legislation, Nursing -- Periodicals; Ethics -- Periodicals; Forensic Medicine -- Periodicals; Nursing -- Periodicals; Medicine -- Periodicals; Societies -- Periodicals; Medical care -- Law and legislation; Medical ethics; Medical laws and legislation; United States; Periodicals; 344.73041
• DOI: 10.1177/1073110518782954
• Languages: English
• ISSNs: 1073-1105

Abstract

Abstract : The rising cost of the opioid antagonist and overdose reversal agent naloxone is an urgent public health problem. The recent and dramatic price increase of Evzio, a naloxone auto-injector produced by Kaléo, shows how pharmaceutical manufacturers entering the naloxone marketplace rely on market exclusivity guaranteed by the patent system to charge prices at what the market can bear, which can restrict access to life-saving medication. We argue that 28 U.S.C. § 1498, a section of the federal code that allows the government to use patent-protected products for its own purposes in exchange for reasonable compensation, could be used to procure generic naloxone auto-injectors, or at least bring Kaléo to the negotiating table. Precedent exists for the use of § 1498 to procure pharmaceuticals, and it could give meaning to the federal government's recent declaration of a public health emergency around the opioid epidemic, discourage new market entrants from charging exorbitant prices, and yield important public health benefits.