Government Patent Use to Promote Public Health in the United States: Overcoming Nonpatent Exclusivities

ABSTRACT

GOVERNMENT PATENT USE One way to facilitate public access to high-cost medications is through government patent use.1 Given sovereign immunity-a legal doctrine immunizing the government from being sued without its consent-the federal government and its agents, such as generic drug manufacturers, have the ability to make or use patented inventions without the permission of the patent holder;in other words, protected by sovereign immunity, the federal government could use inventors' US patents without legal consequence (US patent rights do not apply overseas). [...]nonpatent exclusivities generally prohibit the approval of competing products only if they rely on data generated by another manufacturer. [...]the government or any third party could submit full new drug applications with original data.1,2 This strategy would not be able to circumvent Orphan Drug Act exclusivity for rare disease drugs because that act blocks the FDA from approving the "same drug" for the same disease or condition if it is a generic;however, because full trials would be needed, it might be feasible to pursue approval of a chemically distinct but therapeutically identical drug. [...]many agency actions are judicially reviewable under the Administrative Procedure Act (1946, Pub L No. 79-404)-a statute that waives the federal government's sovereign immunity. Fourth, Congress could amend the Federal Food, Drug, and Cosmetic Act (1938, Pub L No. 75-717) and the Public Health Service Act (1944, Pub L No. 78-410) to carve out exceptions to existing nonpatent exclusivities for government use.1,8 Although an exception exists for biologics the Public Health Service prepares when the biologic is unavailable from the license holder,9 this kind of authority could be expanded in terms of both to whom and to what it applies as well as under what conditions.