[Ip-health] Nature: NIH asked to grant open license on HIV drug

Jamie Love james.love at keionline.org
Fri Nov 2 14:45:28 PDT 2012



NIH asked to grant open license on HIV drug

02 Nov 2012 | 22:05 GMT | Posted by Meredith Wadman | Category: Biology &
Biotechnology, Health and medicine, Industry, Policy

Should a sick American have to pay $9.18 for an anti-AIDS pill when a
Canadian is paying US $1.16 for the same tablet, and a New Zealander US

Four consumer and medical groups led by Washington, DC-based Knowledge
Ecology International are asking the US National Institutes of Health (NIH)
to say “No!” to that question. On 25 October, they petitioned the agency to
exercise a never-used legal privilege known as a ‘march in right’ to grant
open licenses to would-be makers of the protease inhibitor Norvir
(ritonavir), now marketed exclusively by Abbott Laboratories.

March in rights are part of the Bayh-Dole Act, a landmark 1980 US law that
aimed to spur the commercialization of government-funded inventions and
helped launch the biotechnology industry. The law says, in part, that the
NIH can ‘march in’ and force open licensing of an invention it funded when
the exclusive license-holder, in this case, Abbott, is not taking adequate
steps to “achieve practical application” of the invention. (See section 203
of the Bayh-Dole Act here.) The NIH funded Norvir’s discovery by a
scientist then at Abbott.

While that language covers the situation where a licensee simply sits on an
invention and doesn’t develop it, the law also defines “practical
application” to mean that the invention’s benefits are “to the extent
permitted by law or Government regulations available to the public on
reasonable terms.” (See section 201 of the Bayh-Dole Act here. )

“The question is: Is ritonavir being made available to the public on
reasonable terms? If you think it’s reasonable for Americans to pay more
than the rest of the planet for something we paid for as taxpayers, then
you would deny our petition,” says James Love, the director of Knowledge
Ecology International.

Greg Miley, the head of public affairs in Abbott’s US Pharmaceutical
Products Division, sent this statement by email:

 ”Abbott has not received formal notification from the National Institutes
of Health regarding a ritonavir march in petition. The price of Norvir has
remained unchanged for nearly a decade and Abbott has significant patient
assistance programs that provide access to Norvir for U.S. patients who
need this medicine. NIH rejected a similar march in petition request in
2004 related to Norvir on several grounds.”

Abbott increased the price of Norvir by 400% in 2003, prompting a huge
outcry. It has nonetheless kept to that pricing, except in the case of US
state and federal government health programmes like Medicare, for which it
kept the price as it was before the increase.

The full petition was submitted to NIH by Knowledge Ecology International,
the American Medical Students Association, the US. Public Interest Research
Group (PIRG) and the Universities Allied for Essential Medicines (UAEM).

The biomedical agency said it had no comment on an ongoing legal matter.
But it added in a statement: “We expect to have a response to the letter we
received, i.e. whether we have received sufficient information to proceed
[to march in], before the end of the year.”

It’s clear that the petitioners will have some convincing to do: in the 32
years that Bayh-Dole Act has been law, the NIH has been asked to exercise
march-in rights four times. It has declined all four requests.

For an excellent summary of those four petitions — including an explanation
of how the arguments in the 2004 petition on Norvir differ from the current
ones — see this Patent Docs blog by biotechnology patent lawyer Kevin

James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.

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