How Can You Patent Genes?

Download Report

Transcript How Can You Patent Genes?

How Can You Patent Genes?
Margaret Everett
PSU
What are patents?
 Exclusive rights to an invention
 fixed period of time
What can be patented?
 “any process, machine, manufacture, or
composition of matter”
• [US patent statute]
 an invention that is new, useful and non-
obvious
 gene patents usually for process (such as a
test) or composition of matter (specific
gene sequence)
“Anything under the sun
that is made by man”
 US Supreme Court, Diamond v. Chakrabarty,
1980
 products of man v. products of nature
 genetically engineered bacterium could be
patented
Social and Cultural
Implications
 can life forms be owned?
 Would the decision lead to
commodification of higher life forms?
 Should all forms of life be held ‘sacred’?
Harvard’s Oncomouse
 1984 patent application, granted in 1988
 genetically engineered mouse with high
susceptibility to cancer
 patent was for
• “any transgenic mammal, excluding human
beings, containing in all its cells an activated
oncogene that had been introduced into it - or
an ancestor - at an embryonic stage”
• product vs. process
John Moore’s spleen
 1988 California Supreme Court case
 Does a patient retain ownership of body
parts after removal from the body?
 Can cell lines be patented? Who should
profit?
John Moore’s spleen
 treated for hairy cell leukemia at UCLA by
Dr. Golde
 spleen removed and preserved by Dr. Golde
for research
 spleen cells producing unique antibodies
were patented and sold as MO cell line
John Moore’s spleen
 Moore discovers patent and sues for
‘breach of fiduciary duty’ and ‘conversion’
 Can body parts be ‘stolen’?
 Does a patient have a right to profit from
their own body?
Court’s decision
 Moore’s right to consent was violated
 Moore does not retain ownership in his
spleen cells
 “socially important” medical research
would be harmed
 cell line belongs to scientists who created
it in the lab
John Moore’s reaction
 “How does it feel to be patented? To learn,
all of a sudden, I was just a piece of
material?…There was a sense of betrayal…I
mean, they owned a part of me that I could
never recover.” (newspaper interview)
 “like a rape”
Chief Justice Panelli
 “Lymphokines, unlike a name or a face,
have the same molecular structure in every
human being and the same, important
functions in every human being’s immune
system…it is no more unique to Moore than
the number of vertebrae in the spine or the
chemical formula of hemoglobin.”
Effect of Moore v. Regents
 reinforced gene patents
 patients have rights to informed consent,
but cannot claim property interest in their
bodies
 property and patent rights go to those who
“mix their labor” with biological material
Gene Patents
 gene sequences are like any other
chemical compound
 by isolating them and replicating them in
the lab, they exist in a form not found in
nature
 isolation and purification = inventive step
Benefits of patents
 reward scientific advances
 encourage research and investment,
development of new drugs and therapies
 bring new discoveries into the public
domain
Opponents of gene patents
 privatization of new discoveries inhibits
research and new treatments
• “tragedy of the anticommons” (Heller and
Eisenberg)
 patents granted on sequences that have
no known utility or function
Opponents
 gene patents hurt patient care
 American College of Medical Genetics:
• “Genes and their mutations are naturally
occurring substances that should not be
patented.”
 limit access to testing services and
threaten quality of testing
Computer sequencing
 patents are for information rather than the
compounds themselves
 “discoveries” or “inventions”
Response to Opponents
 William Haseltine, CEO of Human Genome
Sciences:
• “The patent office does not reward
perspiration…They reward priority. They don’t
care if someone spent 20 years to find an
invention or 20 minutes.”
Revised Patent Office Policies
 2001
 higher standard of ‘utility’: “specific,
substantial, and credible”
 patient groups such as National Breast
Cancer Coalition and National Organization
for Rare Disorders continue to claim that
patents harm research
What’s anthropology got to do
with it?
 Is the body something we own, or
something we are?
 Do gene patents change our view of life, of
being human?
 Why do some express a sentimental
attachment to their body parts, even once
removed?
• Organ transplant research, study of death
rituals across cultures