NIH asked to grant open license on HIV drug : Nature News Blog

"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 $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 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.'  '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)... 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 Noonan."