KEI requests that federal government use compulsory licenses on Kaléo held patents for devices used to administer opioid overdose reversal drug

KEI has submitted a request to Mr. James Carroll, Acting Director of the Office of National Drug Control Policy, and to Ms. Kellyanne Conway, Counselor to the President and appointed “opioid czar,” asking that the federal government use its authority under 28 U.S.C. § 1498(a), to authorize third parties to use patents held by kaléo Inc., in order to expand competition and lower prices for devices that are used to deliver naloxone to reverse an opioid overdose.

In a case similar to the Epipen, the drug, in this case, naloxone, is available as a generic, but an important device used to deliver the treatment is protected by several patents. Specifically, the letter to Carroll and Conway addresses a device sold under the brand name of Evzio by the company now known as kaléo Inc.. Kaléo lists 25 patents for Evzio in the FDA Orange Book. All 25 patents list two Virginia based twin brothers, Eric and Evan Edwards, among the inventors.

Evzio, the only auto-injector for naloxone, has increased in price over 500% since it was first entered on to the market, and a two pack now costs $4,500.[1}

The full request can be found here.

[1] Shefali Lthra, Kaiser Health News, The $4,500 injection to stop heroin overdoses, Washington Post, Shefali Luthra. January 27, 2017