[Ip-health] Just when can NIH override a patent for a high-priced drug?

Kim Treanor kim.treanor at keionline.org
Fri Dec 1 13:16:40 PST 2017


Just when can NIH override a patent for a high-priced drug?
Ed Silverman in Stat News on 1 December 2017

Over the past two years, the National Institutes of Health has been pressed
by various lawmakers and advocacy groups to help alleviate the high cost of
medicines. Citing federal law, they have urged the agency to take action
when a prescription drug — one that was discovered with taxpayer dollars
and later licensed to a drug maker — was not considered affordable. So far,
though, the NIH has demurred.

On Thursday, NIH Director Francis Collins explained why. In testimony
before a House Energy  and Commerce subcommittee, he maintained federal law
does not provide any “levers to pull.”

“If you look at the language of the (law), it really intends to cover a
circumstance where a drug is simply not available to the public under any
circumstances and then NIH is entitled to step in,” he said. “This is a
little different. (A drug) is available, but at high cost. Our legal
experts don’t feel that the law actually puts us in a position to step in.”

But one group, which has worked closely with lawmakers to push the NIH,
argued Collins got it wrong.

“What Collins did is tell a congressional committee that NIH doesn’t have
authority to deal with excessive pricing — and that’s not true,” said Jamie
Love, who heads Knowledge Ecology International. “I believe he misled the
committee. The NIH has all sorts of leverage on the pricing problem.”


The notion has repeatedly emerged in the past two years as part of the
larger discussion about high prices for medicines and the extent to which
taxpayers should be asked to bankroll drug companies.


Whether the Trump administration will act is unclear. President Trump has
accused drug makers of “getting away with murder,” but his administration
has not moved to directly force the companies to change their practices.


Nonetheless, several lawmakers have continued to pursue march-in rights and
Knowledge Ecology International’s Love plans to lobby members of Congress
to press Collins on the issue. “This is a very important matter,” he said.
“His hands are not tied at all.”

Kim Treanor
Knowledge Ecology International
kim.treanor at keionline.org
tel.: +1.202.332.2670 <(202)%20332-2670>

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