[Ip-health] Stat News, Pharmalot: Obama administration rejects congressional push to override drug patents

Zack Struver zack.struver at keionline.org
Tue Mar 8 14:32:32 PST 2016


Obama administration rejects congressional push to override drug patents

MARCH 8, 2016

The Obama administration has rejected a request from dozens of
congressional Democrats to develop guidelines that would require drug
makers to license their patents and put a lid on “price gouging.”

Two months ago, the lawmakers wrote the National Institutes of Health to
note that the agency can issue so-called march-in rights, which refer to
overriding a patent. Under federal law, this allows an agency that funds
private research to require a drug maker to license its patent to another
party in order to “alleviate health and safety needs which are not being
reasonably satisfied” or when the benefits of a drug are not available on
“reasonable terms.”

The Affordable Drug Pricing Task Force, an ad hoc group of congressional
representatives, argued the NIH should be more aggressively granting
march-in rights in light of high medicines prices. This was just one of
several tactics lawmakers have pursued in recent months over the cost of
prescription drugs, including multiple hearings and an investigation into
pricing strategies used by Gilead Sciences for its expensive hepatitis C

But US Health and Human Services Secretary Sylvia Mathews Burwell wrote one
lawmaker last week that she does not believe a new guidance for march-in
rights is needed, because the law is already clear about when the NIH can
use its authority.

The NIH considers the use of a march-in right on a “case-by-case basis and
is prepared to use its authority” if the law permits such a move and would
“alleviate health or safety needs or address a situation where effective
steps are not being taken to achieve practical application of the
inventions,” Burwell wrote to Lloyd Doggett (D-Texas). Her March 2 letter
was released Monday by Doggett.

Burwell noted that the NIH had previously considered using its march-in
authority concerning drug pricing concerns in 2004 and 2013, but determined
the statutory requirements were not met. Two instances involved the Norvir
AIDS medicine that was marketed by Abbott Laboratories — now owned by
AbbVie — and another concerned the Xalatan glaucoma treatment sold by

Nonetheless, Burwell maintained the Obama administration is making moves to
address concerns about high drug prices. She pointed to a letter sent last
November to state Medicaid programs that they may be violating federal law
by restricting access to hepatitis C medicines, plus a recent forum on
pricing concerns and a guide to the most expensive drugs in the Medicare
Part D and B programs, among other things.

In response, Doggett issued a statement saying, “when Americans pay for
research that results in a pharmaceutical, that drug should be available at
a reasonable price. While establishing guidance to discourage widespread
price gouging is clearly justified, I am pleased that the Administration is
prepared to use existing authority on a case-by-case basis to address this

He went on to say, however, that the administration should act immediately
to exercise march-in rights concerning a prostate cancer drug. Two months
ago, several consumer advocacy groups asked the NIH to take this step
concerning Xtandi, which is sold by Astellas Pharma and has an average
wholesale price in the US of more than $129,000, about two to four times
more than what other high-income countries are paying.

The groups argued the Xtandi patent should be overridden because the drug
was developed at the University of California, Los Angeles, with help from
taxpayer dollars — specifically, NIH and Department of Defense grants. They
noted that a chief inventor of the drug was a UCLA professor and the
university later licensed the drug to Medivation, a biotech that eventually
struck a marketing deal with Astellas.

A spokesman for one of the advocacy groups, Knowledge Ecology
International, wrote us that the NIH expects to respond in a few months. We
asked the NIH for comment about the status of this request and will update
you accordingly.

Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428

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