September 3, 1999 letter from Ralph Nader, James Love, Robert Weissman to Dr. Harold Varmus, Director of NIH, asking for NIH to give the World Health Organization, WHO, access to US government funded medical inventions.

September 3, 1999

Dr. Harold E. Varmus
Building 1, 126
National Institutes of Health
Bethesda, Maryland 20892

We are writing to ask that you enter into an agreement with the World Health Organization (WHO), giving the WHO the right to use health care patents that the US government has rights to under 35 USC Sec 202 (c)(4) of the Bayh-Dole Act or under 37 CFR 404.7, for government owned inventions.

Under the regulations concerning government owned inventions, the US government has an:

irrevocable, royalty-free right of the Government of the United States to practice and have practiced the invention on behalf of the United States and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement with the United States. 37CFR404.7(a)(2)(i)

With respect to government's rights in inventions funded by the US government through grants and contracts to Universities and small businesses under the Bayh-Dole Act, the US government has worldwide rights to practice or have practiced inventions on its behalf (37CFR401.14), and it may require that foreign governments or international organizations have the right to use inventions, under 37CFR401.5(d).

As you must know, the US government has rights to a large portfolio of health care inventions that were invented with public funds. These include inventions in many HIV/AIDS drugs, such as government-owned inventions on ddI, ddC and FddA, and university and contractor inventions such as d4T, 3TC and Ritonavir, as well as drugs to treat malaria and many other illnesses. The private pharmaceutical companies that have obtained exclusive rights to market these products charge prices that are excessive, and too expensive for many patients, including persons in the United States and Europe. Most seriously, the hardships are particularly difficult in developing countries, where countries do not have high enough national incomes to pay for expensive medicines.

In some cases poor countries can issue compulsory licenses to use these inventions, but not every country has the legal authority to issue such licenses, and many countries have small domestic markets without the economies of scale to make compulsory licensing economically feasible. The WHO, with new dynamic leadership, has expressed an interest in using these intellectual property rights. If the WHO uses efficient procurement programs, it can obtain production of these government funded inventions at a small fraction of current world prices. These lower prices would lead to expanded access to essential drugs and stretch public health budgets.

There are number of steps that can be taken by NIH to make these publicly funded inventions more widely available to poor consumers.

1. The NIH should enter into an agreement with the WHO that would permit the WHO to use US government intellectual property rights for public health initiatives. The NIH should specify the terms under with the WHO could use US government intellectual property rights, to ensure that the public interest is served.

2. In those cases where the US government can now give the WHO rights to health care inventions under 37CFR404.7 and 37CFR401.5, the WHO should be authorized to use those rights.

3. The US government should revise its grant and contract practices so that all new grants and contracts reference the WHO's rights to use patents, under 37CFR401.5.

4. The NIH should ask its general counsel to determine the scope of the NIH's rights to government funded university and small business inventions under 37CFR401.14, and to the extent appropriate, engage the WHO, US AID or other international organizations or US agencies to use these rights to expand treatment opportunities for the poor.

   This is a matter of extreme urgency. It is immoral for the US federal government to hoard its intellectual property rights to benefit a handful of commercial interests, particularly when the research was paid for by US taxpayers, and the drug companies are already reaping billions in profits from government funded inventions.

   We would like you meet with you and your staff to discuss this matter further.

   Sincerely,

   Ralph Nader

   James Love

   Robert Weissman

   cc: Leon Fuerth, Secretary Donna Shalala

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   October 19, 1999 letter from NIH Director, Dr. Harold Varmus to Ralph Nader, James Love and Robert Weissman responding to their request
   calling on the NIH to provide the World Health Organization, WHO, access to US government funded medical inventions.

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