US government use

[James Love <love@cptech.org>]

I have posted many notes to this list on the issue of government
use rights, but I have had a few requests for additional 
information, so are a few notes.

The basic legal cites to look at are 35 USC 202 (c)(4),
from the Bayh Dole Act, which concerns US government rights
in inventions funded by the government, and 37 CFR 404.7,
on government owned inventions. 

Together these cover inventions where the US government owns 
the patent (ddI, ddC, fDDA, Paclitaxel clinical trial data, 
etc), and drugs that were invented on a government grant (d4T, 
some uses of 3TC, Ritonavir, etc).

The US government retains the right to have inventions practiced
by or "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."

I don't have a complete list of the drugs to which the US government
has these rights.  The US government can provide this information
to Congress.  It would include all US patents owned by the US
government, plus all patents owned by universities, non-profit
research institutions or businesses that obtained rights under
the US Bayh-Dole Act on government funded inventions.  

Secretary Shalala should be asked to provide a list of these 
inventions to the Congress, and the Department of Defense 
and the Department of Energy might also be asked, since both
institutions have extensive rights in biotech and pharmaceutical
inventions.  (The DOD with respect to drugs for Malaria, for
example).  

    Jamie


------------
From: http://www.cptech.org/ip/health/sa/mica-test.txt
     During this period, public health groups began to add a new
issue to the debate.  Under US technology transfer laws, the US
government retains broad "public use" rights on government funded
inventions, including many important AIDS drugs, such as ddI,
d4T, 3TC or Ritonavir, as well as other essential medicines.  The
relevant statutes and regulations are 35 USC 202 (c)(4) and 37
CFR 404.7.  According to these provisions, the US government
retains the rights 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.




-- 
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