Tech Transfer eNews Blog

NIH denies petition to lower cancer drug’s price using “march-in” rights

By Jesse Schwartz
Published: March 29th, 2023

The U.S. government has declined to force Pfizer and Astellas Pharma to reduce the price of their prostate cancer drug Xtandi.

The decision arrives seven years after the Union for Affordable Cancer Treatment filed a petition calling on the National Institutes of Health (NIH) to use its emergency “march-in” authority to lower the drug’s price. March-in rights, which have never been used, allow the government to grant additional licenses to third parties for products developed using federal funds if the original patent holder fails to make the products available to the public on reasonable terms.

A group of organizations with a focus on patents and innovation, including AUTM, have lobbied for the petition to be rejected, claiming that march-in rights would not be an effective means of making the drug less expensive, but would seriously erode the fabic of the U.S. innovation ecosystem.

According to AUTM, the Bayh-Dole Act specifies that march-in authority should only be used to alleviate health and safety needs that are not being reasonably satisfied, or when the benefits of a product are not reasonably accessible.

“This week’s denial of the Xtandi petition confirms what U.S. Administrations, both Democratic and Republican, and AUTM have long known: regulating pricing is not a proper use of the Bayh-Dole Act’s march-in rights — and misusing that provision would have a chilling effect on the innovation ecosystem on which we all rely,” says AUTM CEO Steve Susalka.

Astellas Pharma says NIH’s decision will protect public-private partnerships as “incubators of technological innovation.”

Source: Reuters

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