NIH asked to give public health agencies use of government rights in patents

[James Love <love@cptech.org>]

This letter to NIH Director Dr. Harold Varmus asks the Clinton/
Gore administration to permit the World Health Organization 
and/or US public health agencies to use patents developed with 
US government support, in poor countries.   

     Jamie Love <love@cptech.org>

--------------------------------------------

                              Ralph Nader
                              P.O. Box 19312
                              Washington, DC 20036

                              James Love
                              Consumer Project on Technology
                              P.O. Box 19367
                              Washington, DC 20036
                              http://www.cptech.org

                              Robert Weissman
                              Essential Action
                              P.O. Box 19405
                              Washington, DC 20036
                              http://www.essentialaction.org/


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
     
-- 
James Love, Director, Consumer Project on Technology
I can be reached at love@cptech.org, by telephone 202.387.8030,
by fax at 202.234.5176. CPT web page is http://www.cptech.org