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

J Law Med Ethics. 2018 Jun;46(2):472-484. doi: 10.1177/1073110518782954.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Analgesics, Opioid / adverse effects
  • Drug Overdose / drug therapy
  • Health Services Accessibility / legislation & jurisprudence*
  • Humans
  • Naloxone / economics*
  • Naloxone / supply & distribution
  • Naloxone / therapeutic use
  • Narcotic Antagonists / economics*
  • Narcotic Antagonists / supply & distribution
  • Narcotic Antagonists / therapeutic use
  • Opioid-Related Disorders
  • Patents as Topic / legislation & jurisprudence*
  • Public Health
  • United States

Substances

  • Analgesics, Opioid
  • Narcotic Antagonists
  • Naloxone