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NIH asked to grant open licence on HIV drug

Should a sick person in the United States have to pay US$9.18 for an anti-AIDS pill when a Canadian is paying $1.16 for the same tablet, and a New Zealander $1.15?

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 licences 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 to 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.

That language covers the situation where a licensee simply sits on an invention and doesn’t develop it, but 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).

“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 e-mail:

“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 such as 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 NIH said that it had no comment on an ongoing legal matter. But it added in a statement: “We expect to respond to the letter we received by the end of the year about whether there is sufficient information that would warrant the exercise of march-in rights.”

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 post by biotechnology patent lawyer Kevin Noonan.




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