title: 'Government Patent Use': A Legal Approach To Reducing Drug Spending.
abstract: The high cost of patent-protected brand-name drugs can strain budgets and curb the widespread use of new medicines. An example is the case of direct-acting antiviral drugs for the treatment of hepatitis C. While prices for these drugs have come down in recent months, they still create barriers to treatment. Additionally, prescribing restrictions imposed by insurers put patients at increased risk of medical complications and contribute to transmission of the hepatitis C virus. We propose that the federal government invoke its power under an existing "government patent use" law to reduce excessive prices for important patent-protected medicines. Using this law would permit the government to procure generic versions of patented drugs and in exchange pay the patent-holding companies reasonable royalties to compensate them for research and development. This would allow patients in federal programs, and perhaps beyond, to be treated with inexpensive generic medicines according to clinical need-meaning that many more patients could be reached for no more, and perhaps far less, money than is currently spent. Another benefit would be a reduction in the opportunity for companies to extract monopoly profits that far exceed their risk-adjusted costs of research and development.
authors.affiliation: Amy Kapczynski is a professor of law at Yale Law School, in New Haven, Connecticut.
authors.forename: Amy
authors.initials: A
authors.lastname: Kapczynski
authors.affiliation: Aaron S. Kesselheim (akesselheim@partners.org) is an associate professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, at Brigham and Women's Hospital, in Boston, Massachusetts.
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
mesh_terms: D016527:Drug Costs / Q000331:legislation & jurisprudence*; D055808:Drug Discovery / Q000191:economics; D004345:Drug Industry / Q000191:economics*; D016568:Drugs, Generic / Q000191:economics; D006076:Government; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence*
chemical_list: D016568:Drugs, Generic
keywords: Cost of Health Care; Legal/Regulatory Issues; Pharmaceuticals