E-DRUG: AZT patented? (cont)
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I certainly agree with those that say patents do indeed have to
do with indications, and as pointed out by several persons, AZT
is a case in point, where the compound itself was invented on
a government grant in 1964. However, it is also true that
laws regarding what can be patented vary from country to country,
and some countries are much more restrictive in terms of such
things as patenting indications or second uses.
Also, it is true that often patent owners do not file everywhere.
For example, many US government owned inventions have patents in
about 15 to 20 developed countries, but are off patent everywhere
else. This is the case, for example, for ddI. The best
advise is check with your own country, you might be surprised.
In the USA, the Glaxo patent was filed in 1985, approved in 1988,
and will expire in 2005.
Here is an interesting letter to the NYT about AZT written by
several US government officials and NIH funded researchers.
Jamie
<--------------begin letter--------------------------------->
New York Times, September 28, 1989
Credit Government Scientists With Developing Anti-AIDS Drug
To the Editor:
The Sept. 16 letter from T.E. Haigler Jr., president of the
Burroughs Wellcome Company, was astonishing in both substance and
tone. Mr. Haigler asserts that azidothymidine, or AZT, was
essentially discovered and developed entirely by Burroughs
Wellcome with no substantive role from Government scientists and
Government-supported research. This will be a surprise to the
many men and women who have devoted their lives to working for
the viral cancer program and developmental therapeutics program
of the National Institutes of Health over the last 25 years.
We (associated with the National Cancer Institute and Duke
University) make this statement as co-authors of the first
publications describing AZT as a drug for treatment of acquired
immune deficiency syndrome (Mitsuya, et al., Proceedings of the
National Academy of Sciences, 1985, and Yarchoan, et al., The
Lancet, 1986). There are few drugs now approved in this country
that owe more to Government-sponsored research. In the interest
of brevity, perhaps this point can be summarized most efficiently
by stating what Mr. Haigler's company did not do.
- The company did not perform the first synthesis of AZT. This
was done by Dr. Jerome Horowitz at the Michigan Cancer
Foundation in 1964, using a Government grant.
- The company did not conceive or provide the first
demonstration of an effect against animal retroviruses. This
was done by Wolfram Ostertag at the Max Planck Institute in
1974, using a mouse retrovirus in a test tube. Mr. Haigler's
implication that his staff discovered" the antiretroviral
potential of AZT in 1984 is noteworthy. What he did not say
was that his staff repeated the Ostertag mouse experiments.
You cannot discover" something published by someone else 10
years earlier.
- The company specifically did not develop or provide the first
application of the technology for determining whether a drug
like AZT can suppress live AIDS virus in human cells, nor did
it develop the technology to determine at what concentration
such an effect might be achieved in humans. Moreover, it was
not first to administer AZT to a human being with AIDS, nor
did it perform the first clinical pharmacology studies in
patients. It also did not perform the immunological and
virological studies necessary to infer that the drug might
work, and was therefore worth pursuing in further studies.
All of these were accomplished by the staff of the National
Cancer Institute working with staff at Duke University. These
scientists did not work for the Burroughs Wellcome Company. They
were doing investigator-initiated research, which required
resources and reprogramming from other important projects, in
response to a public health emergency.
Indeed, one of the key obstacles to the development of AZT was
that Burroughs Wellcome did not work with live AIDS virus nor
wish to receive samples from AIDS patients.
In a number of specific ways, Government scientists made it
possible to take a drug in the public domain with no medical use
and make it a practical reality as a new therapy for AIDS. It is
unlikely that any drug company could have found a better partner
than the Government in developing a new product. We believe that
the development of this drug in a record two years, start to
finish, would have been impossible without the substantive
commitment of Government scientists and Government technology. It
does not serve anyone's interests to nullify the importance of
Government-sponsored research in solving problems of American
public health.
HIROAKI MITSUYA, M.D.
KENT WEINHOLD
ROBERT YARCHOAN, M.D.
DANI BOLOGNESI
SAMUEL BRODER, M.D.
Bethesda, Md., Sept. 20, 1989
--
James Love / Director, Consumer Project on Technology
http://www.cptech.org / love@cptech.org
P.O. Box 19367, Washington, DC 20036
voice 202.387.8030 / fax 202.234.5176
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