Trade Alliance to Promote Prosperity Denounces Attorneys General Request for the Feds to Assert “March-In” Authority to Circumvent COVID-19 Potential Drug Patent Rights

Several states’ attorneys general have made an egregious request to the federal government to subvert the patent rights of Gilead Sciences, Inc., the manufacturer of Remdesivir, which has been fast-tracked by the U.S. Food and Drug Administration (FDA) and has shown promising results in reducing the risk of death and length of hospitalization for COVID-19 patients.

Remdesivir was invented more than a decade ago, identified as a broad-spectrum antiviral drug, that, in animal models, has demonstrated activity against viral pathogens MERS and SARS, which are structurally similar to COVID-19, but the drug is not currently approved anywhere globally for any use.

The attorneys general letter, sent to Health and Human Services Secretary Alex Azar, National Institutes of Health Director Francis Collins, and FDA Commissioner Stephen Hahn, says, in part, “…we respectfully urge the federal government to exercise its rights under the Bayh-Dole Act….”

The Bayh-Dole Act includes the right for the feds to “march in” on inventions, including pharmaceuticals, created with federal funds—under a narrow set of circumstances—and force patent holders to grant a license to “responsible applicant,” effectively negating patent protections. The two most common circumstances: 1) where effective steps have not been taken, or are not expected to be taken, within a reasonable period to commercialize the invention, or 2) the action is necessary to alleviate “health or safety needs not reasonably satisfied” by the patent holder or licensee.”

The attorneys general letter asserts that Gilead has not ensured a sufficient supply of the drug, which is false. Gilead has set the goal of producing over two million treatment courses by December 2020 and millions more in 2021. Moreover, the drug is appropriate for only a small fraction of the anticipated number of COVID-19 patients.

The attorneys general letter additionally focus on the price of Remdesivir, yet the National Institutes of Health has expressly stated and confirmed that the “extraordinary remedy of march-in is not an appropriate means of controlling prices.”

Misapplication of the Bayh-Dole Act’s provisions could have a serious chilling effect on public-private partnerships and could create a disincentive for scientists and drug companies to make the large and long-term investments required to respond quickly to global health emergencies like the COVID-19 pandemic.

No one can predict where the palliative therapies or the cure for COVID-19 will originate, but we know that the United States biopharmaceutical industry is well-positioned to help in their discovery because our country has aligned incentives to achieve the objective of providing the most innovative environment—including strong IP protections. Misapplication of Bayh-Dole would disrupt that innovative environment, ultimately to the detriment of Americans’ health.

The Trade Alliance to Promote Prosperity supports strong intellectual property protections for the scientists who routinely produce the miracle cures and therapies that American patients have come to enjoy and expect. That is why we, therefore, denounce the attorneys general request for the federal government to assert march-in authority on Remdesivir.