[Ip-health] Biopharmadive: Sanders, other lawmakers urge NIH to consider patent override on cancer drug

Thiru Balasubramaniam thiru at keionline.org
Tue Mar 29 05:15:27 PDT 2016


By Ned Pagliarulo | March 28, 2016 print

Dive Brief:

Twelve lawmakers, including presidential candidate Bernie Sanders (I-VT),
sent a letter to the Department of Health and Human Services and the
National Institutes of Health strongly encouraging the agencies weigh using
their authority to override the patent on the drug Xtandi to lower its

Licensed by the Japanese drugmaker Astellas, the prostate cancer treatment
costs $129,000 a year before rebates in the U.S., compared to $39,000 in
Japan and $30,000 in Canada, according to the letter.

The lawmakers want the NIH to consider using its "march-in" rights, which
would allow the agency to license a patent drug to another company if
"action is necessary to alleviate health or safety needs." Democratic
lawmakers had previously asked the NIH to issue new guidelines on its use,
but the request was turned down by the government agency.

Dive Insight:

A week ago, eleven non-profit groups joined the Knowledge Ecology
International (KEI) and Union for Affordable Cancer Treatment (UACT) in
asking the NIH to lower the price of Xtandi using its march-in authority.
The lawmakers' letter attempts to put some legislative muscle behind the

Notably, Xtandi was developed in part through the use of federal funds. The
University of California, Los Angeles received grants from the Department
of Defense and the NIH to fund phase 1 and phase 2 trials, which were
eventually used as evidence in regulatory submission to the FDA. Medivation
currently licenses the rights to the drugs to Astellas.

"We do not think that charging U.S. residents more than anyone else in the
world meets the obligation to make the invention available to U.S.
residents on reasonable terms," the lawmakers wrote.

As an initial step, the letter asked for a public hearing to be held on
Xtandi to determine whether it meets the criteria for use of march-in
rights. The NIH held hearings on this authority for the drugs Norvir and
Xalatan in 2004, and again for Norvir in 2013.

Signatories to the letter also included Senators Al Franken (D-MN) and
Elizabeth Warren (D-MA), and Representatives Llyod Dogget (D-TX) and Elijah
Cummings (D-MD), among others.

Recommended Reading

Reuters: U.S. lawmakers want health agencies to lower prostate cancer drug

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