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22 February 2022Americas

Warren calls for government to seize Pfizer patents

US Senator Elizabeth Warren has urged the Department of Health and Human Services (HHS) to seize control of patents covering Pfizer’s prostate cancer drug Xtandi (enzalutamide).

In a  letter sent to HHS secretary Xavier Becerra on February 17, Warren—alongside Senator Angus King ad Congressman Lloyd Doggett—called on the government to move forward with the march-in petition submitted for Xtandi in November last year.

Established under the Bayh-Dole Act, march-in rights allow the government to grant licences to applicants for products developed with federal grants.

Warren said that Xtandi was developed at the University of California, Los Angeles and funded by the US Army and National Institutes of Health.

“Xtandi is not the only case where Americans are paying exorbitantly high prices for prescription drugs – there are legions of examples. But the Xtandi costs are particularly galling because the drug’s research and development were underwritten by American taxpayers,” said the lawmakers.

Back in 2019, two prostate cancer patients, Clare Melvin Love, a retired computer programmer and Vietnam veteran, and David Reed, a computer scientist, submitted a request to the US Army, asking them to use march-in or royalty-free rights in enzalutamide patents, according to non-governmental organisation Knowledge Ecology International’s  timeline.

Then, in April 2021, prostate cancer patient Robert Sachs filed a petition with the Department of Defense, asking to join the outstanding Love and Reed petition.

Later, in November, Love and Sachs, later joined by cancer patient Eric Sawyer, filed a petition with HHS, asking that HHS grant march-in rights.

According to Knowledge Ecology International, the average wholesale price for one Xtandi capsule in the US is $130. The price of the same capsule in Japan is just over $20.

“The drug is intended for long-term use, and a typical course of treatment involves four pills taken daily: over the course of a year, the cost of Xtandi in the US is nearly $160,000 higher than the drug’s price in Japan,” said Warren.

The lawmakers have asked Becerra to hold a public hearing on the Xtandi petition to allow petitioners and patent owners to present arguments and accompanying evidence on this case.

“Exercising the government’s march-in rights for Xtandi will dramatically lower the price of this life-saving drug for millions of Americans,” said the lawmakers. They added: “As the administration continues to stress the importance of lowering drug prices, we urge you to use existing executive authority to deliver meaningful relief to consumers.”

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