Actions in the US
"American consumers should not have to pay exorbitant prices for medicines our tax dollars helped invent. We have rights enshrined in law (known as "march-in rights") to ensure that taxpayer-funded medicines are available in a competitive market, and thereby affordable. In one particularly egregious example, Abbott Laboratories abused the monopoly granted to it by the National Institutes of Health for the HIV/AIDS drug ritonavir, arbitrarily raising the price of this taxpayer-funded drug by 400 percent and slowing innovation in the market for HIV/AIDS drugs. We should not permit such abuse, least of all in cases of medicines we paid for. And the law says we don't have to. The Secretary of Health and Human Services should respond affirmatively to the Knowledge Ecology International march-in request, and exercise her authority to protect American consumers from drug companies that would gouge us for pharmaceuticals developed with taxpayer dollars."
--Peter Maybarduk, Global Access to Medicines Director
"Licensing and competition could spur the development of new and improved ritonavir-based combination treatments against HIV/AIDS. If patent holders and the pharmaceutical industry will not negotiate, then health advocates will pursue compulsory measures to break their monopolies on lifesaving medicines."
-- Peter Maybarduk, Public Citizen
"When the U.S. government has funded the research that leads to the invention of a new drug, U.S. consumers should not pay more for that drug than do consumers in other high income countries. If the Obama administration approves our petition, U.S. citizens, as consumers, employers and taxpayers, will pay billions less for drugs invented on grants from the NIH and other federal agencies. If the Obama administration rejects our petition, we will continue to pay more, making our businesses less competitive in the global economy, when compared to other high income countries. Our petition thus raises two issues. 1. Given our budget deficits, why do we pay more than other high income countries for drugs invented on US government grants? 2. How can our businesses compete when they pay more than other high income countries for government funded medical inventions?"
-- James Love, Knowledge Ecology International
United States taxpayers helped fund the invention of ritonavir, one of the components of Kaletra, through a grant from the National Institutes of Health. Despite the taxpayer contribution to its development, Abbott charges exorbitant monopoly prices for Kaletra, and Abbott's anti-competitive tying practice has stymied the development of alternative ritonavir-based combination treatments by other pharmaceutical companies.
Under the Bayh-Dole Act, the US government retains certain rights to protect the public's interests with regard to government-funded inventions. In particular, the government retains a nonexclusive royalty-free license to practice the invention as well as "march-in" authority to require the patent holder or exclusive licensee to grant a license on reasonable terms under certain circumstances.
Knowledge Ecology International and other organizations will be asking the Department of Health and Human Services to issue a general policy that the government exercise its march-in rights where medical inventions are priced higher in the United States than in other high-income countries.
The march-in complaint will feature ritionavir, a drug invented on a government grant, but priced 3 to 8 times higher in the United States than in other high income countries. This will be at least the eighth time the federal government has been asked to use its government rights in patents on medical inventions since the Bayh-Dole Act was passed in 1980.
The price of ritonavir at drugstore.com is $9.18 per 100 mg tab. In Australia, the price is $1.30. In Ontario, Canada, the price is $1.45. In Denmark, the price is $2.79. In the Netherlands, $1.26. In Norway, a country with a per capita income of more than $84,000, the price is $1.29.
Other pharmaceutical products in KEI's march-in request include an antibiotic and drugs to treat brain disease, cancer, diabetes, heart disease, HIV/AIDS, hypoxic respiratory failure (HRF), kidney disease, macular degeneration, pain, epilepsy, and psychiatric illness.
- November 7, 2013- Knowledge Ecology International: NIH rejects March-In petition, also rejects proposed ruled on pricing of and access to government funded inventions
- November 2, 2012- Nature: NIH asked to grant open license on HIV drug (links to blogs.nature.com)
- How common is Federal Funding of patented inventions? (links to keionline.org)
- ACTION! Knowledge Ecology International: Four NGOs ask NIH to grant open licenses to ritonavir patents under Bayh-Dole March-in provisions (links to keionline.org)