Compulsory licensing as limitations on remedies for infringement under 28 U.S.C. §1498: Patent and copyright

new: we have added a database of more than 1,000 federal court cases that cite 28 USC 1498 here:

The United States government can use any patented invention, copyright, or protection of plant variety, original design or semiconductor design, subject to providing compensation of the owner of the right, under 28 U.S.C. §1498.

Recently there has been renewed interest in using §1498 as a compulsory licensing mechanism for drug patents. Beginning in 2001, there have been at least four efforts to do this, the most recent involving patents on sofosbuvir (Sovaldi) based hepatitis C virus (HCV) treatments. In each case, the relevant agencies have expressed opposition to the use of §1498, partly on the grounds of the risks associated with compensation for the non-voluntary use.

KEI’s position has been that §1498 can and should be used as a tool to obtain less expensive versions of drugs (in some settings), including HCV drugs, but also that the statute was not designed for this use, and that (a) the Congress should consider amendments to §1498 so that it is better suited to dealing with cases of excessive drug pricing, or (b) modify the existing Bayh-Dole march-in statute to apply to non-government -funded inventions for biomedical technologies regulated by the FDA, or (c) to adopt a new compulsory licensing statute. In short, using §1498 can be better than the status quo, but going forward, a better legal basis for compulsory licensing is needed.

In 2015, Senator Bernie Sanders proposed a narrow but important amendment to §1498, in order to enable the Department of Veterans Affairs to use §1498 with more favorable terms for the government on the compensation to patent holders. Sen. Sanders’ proposal (see below) is worth reviewing for persons following this issue.

This page provides some background and context for the §1498 discussions.

For initial context see:

There have been a large number of cases where §1498 has been used, and links will be added as we develop this page. Below are a few important cases for medical technologies, where the use of §1498 was considered, but not used.

2001 – CIPRO case

2005/2006 – Tamiflu case

2006 – Avastin case

  • February 21, 2006 letter from Representative Dennis J. Kucinich to Secretary of the Secretary of the Department of Health and Human Services Mike Leavitt, asking for a compulsory license on the patents for the cancer drug Avastin, using 28 USC §1498.

Recent Proposals for use of §1498 on HCV Patents

Our main concern about the recent HCV proposals is that risks and challenges of setting compensation under 28 USC § 1498 are not always sufficiently explored. One exception is the 2015 proposal by Senator Sanders in the context of veterans.

2014 – Early discussions of using §1498 and other mechanisms for HCV drugs.

2015 – Veterans’ Affairs case involving HCV drugs.

2016-2017 – More commentary on HCV and §1498.

2018 – Proposals regard HCV and opioids

Selected blogs and articles