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Patents Concerning Coronavirus Treatments

March 26, 2020
Post by Gregory Lars Gunnerson

28 U.S.C 1498 allows the government to use or authorize others to use any invention “described in and covered by a patent of the United States.” If such authorization is granted, patent owners can sue the United States, but only for reasonable compensation. Patent owners are not able to seek injunctions against private entities working for the United States government.

In 2009, the United States Department of the Treasury used this section to purchase software without regard to patents held by Advanced Software Design Corporation. Interpretation of the statute was expanded to give immunity from liability to private companies as well as persons who are performing work on behalf of the government. In other words, when the government invokes Section 1498, the government becomes the defendant in a patent infringement lawsuit, saving the public from the risk of an injunction that would cut off the public’s access to desperately-needed inventions.

Long before the current crisis, scholars in the pharmaceutical field have advocated for the government to use Section 1498 to enhance access and reduce drug prices. In fact, one similar situation concerning direct-acting antivirals arose in 2016. In a May 18, 2016 letter to the United States Department of Veterans Affairs, Senator Bernie Sanders (I-VT) suggested that the Secretary “utilize federal law, specifically 28 USC § 1498, to break the patents on these drugs to authorize third parties to manufacture or import them for government use” through section 1498 to “address the funding shortfall that has resulted from the high demand for, and high cost of, direct-acting antivirals.”

 

By July 2017, Louisiana’s Department of Health sought government patent use as a strategy to make Sofosbuvir, manufactured by Gilead Sciences, more available to the public. Sofosbuvir is a highly effective treatment for Hepatitis C which costs $84,000 for a treatment in 2016. Gilead’s CEO John Martin was questioned by the US Congress on the prohibitive pricing. The FDA recently granted Gilead “orphan status” for Remdesivir, Gilead’s experimental coronavirus treatment, which would have shielded Gilead from generic competition for longer than other prescription medicines. Orphan drugs are among the most expensive in the United States. Facing public backlash, Gilead has since asked the FDA rescind its request for orphan status.

It remains to be seen whether the United States government will invoke 28 U.S.C. § 1498 to issue compulsory licenses on patents that stand in the way of treating coronavirus. If you are the owner of one of these patents, rest assured that you are entitled to “reasonable compensation”.

Gregory “Lars” Gunnerson is a Patent Attorney in the Mechanical and Electrical Patent Practice Groups at McKee, Voorhees & Sease, PLC. For additional information please visitwww.ipmvs.com or contact Lars directly via email at gregory.gunnerson@ipmvs.com .


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