Trade Alliance to Promote Prosperity Denounces Request for the Feds to Assert “March-In” Authority to Circumvent Prostate Cancer Drug Xtandi Patent Rights

U.S. Representatives Peter DeFazio (D-OR), Lloyd Doggett (D-TX), and several of their Democratic colleagues have made an egregious request to the federal government to subvert the patent rights protecting the drug Xtandi, which is used to treat prostate cancer.

The representatives sent a letter to Health and Human Services Secretary Xavier Becerra which says, in part, “We urge HHS to use march-in or government use rights to curtail the unreasonable price of the prostate cancer drug Xtandi…”

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 a “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 representatives’ letter focuses solely on price and makes no claim that Astellas Pharma, Inc., the company that markets the drug, has failed to commercialize the drug adequately or that the patent holder is failing to satisfy health or safety needs. Indeed, Xtandi is widely available to and affordable for the patients who need it. Moreover, 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 find miracle cures and therapies for diseases like cancer or to respond quickly to global health emergencies like the COVID-19 pandemic.

Misapplication of Bayh-Dole would disrupt the 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 representatives’ request for the federal government to assert march-in authority on Xtandi.