Alex Wang is a J.D. candidate at Yale Law School. He holds a B.A. from NYU Abu Dhabi, and a second B.A. from the University of Oxford. Aaron S. Kesselheim, M.D., J.D., M.P.H., is an associate professor of medicine at Harvard Medical School and leads the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women's Hospital. He serves as an Irving S. Ribicoff Visiting Associate Professor of Law at Yale Law School and as a Distinguished Visitor at the Solomon Center for Health Law & Policy.
J Law Med Ethics. 2018 Jun;46(2):472-484. doi: 10.1177/1073110518782954.
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.
阿片类药物拮抗剂和过量逆转剂纳洛酮的成本不断上升，这是一个紧迫的公共卫生问题。最近，凯莱制药公司生产的纳洛酮自动注射器埃夫齐奥的价格大幅上涨，这表明进入纳洛酮市场的制药商如何依赖专利制度所保证的市场独占权来收取市场所能承受的价格，这可能会限制救命药物的获取。我们认为，美国法典第 28 编第 1498 节允许政府为自身目的使用受专利保护的产品，并支付合理补偿，可用于采购仿纳洛酮自动注射器，或者至少可以让凯莱制药坐到谈判桌前。该条规定之前曾被用于采购药品，这可能使联邦政府最近宣布的阿片类药物泛滥公共卫生紧急事件具有实际意义，阻止新的市场进入者收取过高的价格，并带来重要的公共卫生效益。
