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How Can You Patent How Can You Patent Genes?Genes?
Margaret EverettMargaret Everett
PSUPSU
What are patents?What are patents? Exclusive rights to an inventionExclusive rights to an invention fixed period of timefixed period of time
What can be What can be patented?patented?
““any process, machine, manufacture, any process, machine, manufacture, or composition of matter”or composition of matter”• [US patent statute][US patent statute]
an invention that is new, useful and an invention that is new, useful and non-obviousnon-obvious
gene patents usually for process gene patents usually for process (such as a test) or composition of (such as a test) or composition of matter (specific gene sequence)matter (specific gene sequence)
““Anything under the Anything under the sun that is made by sun that is made by man”man”
US Supreme Court, Diamond v. US Supreme Court, Diamond v. Chakrabarty, 1980Chakrabarty, 1980
products of man v. products of products of man v. products of naturenature
genetically engineered bacterium genetically engineered bacterium could be patentedcould be patented
Social and Cultural Social and Cultural ImplicationsImplications
can life forms be owned?can life forms be owned? Would the decision lead to Would the decision lead to
commodification of higher life commodification of higher life forms?forms?
Should all forms of life be held Should all forms of life be held ‘sacred’?‘sacred’?
Harvard’s Harvard’s OncomouseOncomouse
1984 patent application, granted in 19881984 patent application, granted in 1988 genetically engineered mouse with high genetically engineered mouse with high
susceptibility to cancersusceptibility to cancer patent was forpatent was for
• ““any transgenic mammal, excluding human any transgenic mammal, excluding human beings, containing in all its cells an activated beings, containing in all its cells an activated oncogene that had been introduced into it - oncogene that had been introduced into it - or an ancestor - at an embryonic stage”or an ancestor - at an embryonic stage”
• product vs. processproduct vs. process
John Moore’s spleenJohn Moore’s spleen 1988 California Supreme Court 1988 California Supreme Court
casecase Does a patient retain ownership of Does a patient retain ownership of
body parts after removal from the body parts after removal from the body?body?
Can cell lines be patented? Who Can cell lines be patented? Who should profit?should profit?
John Moore’s spleenJohn Moore’s spleen treated for hairy cell leukemia at treated for hairy cell leukemia at
UCLA by Dr. GoldeUCLA by Dr. Golde spleen removed and preserved by spleen removed and preserved by
Dr. Golde for researchDr. Golde for research spleen cells producing unique spleen cells producing unique
antibodies were patented and sold antibodies were patented and sold as MO cell lineas MO cell line
John Moore’s spleen John Moore’s spleen Moore discovers patent and sues Moore discovers patent and sues
for ‘breach of fiduciary duty’ and for ‘breach of fiduciary duty’ and ‘conversion’‘conversion’
Can body parts be ‘stolen’?Can body parts be ‘stolen’? Does a patient have a right to Does a patient have a right to
profit from their own body?profit from their own body?
Court’s decisionCourt’s decision
Moore’s right to consent was Moore’s right to consent was violatedviolated
Moore does not retain ownership in Moore does not retain ownership in his spleen cellshis spleen cells
““socially important” medical socially important” medical research would be harmedresearch would be harmed
cell line belongs to scientists who cell line belongs to scientists who created it in the labcreated it in the lab
John Moore’s reactionJohn Moore’s reaction
““How does it feel to be patented? How does it feel to be patented? To learn, all of a sudden, I was just To learn, all of a sudden, I was just a piece of material?…There was a a piece of material?…There was a sense of betrayal…I mean, they sense of betrayal…I mean, they owned a part of me that I could owned a part of me that I could never recover.” (newspaper never recover.” (newspaper interview)interview)
““like a rape”like a rape”
Chief Justice PanelliChief Justice Panelli
““Lymphokines, unlike a name or a Lymphokines, unlike a name or a face, have the same molecular face, have the same molecular structure in every human being and structure in every human being and the same, important functions in the same, important functions in every human being’s immune every human being’s immune system…it is no more unique to system…it is no more unique to Moore than the number of vertebrae Moore than the number of vertebrae in the spine or the chemical formula in the spine or the chemical formula of hemoglobin.”of hemoglobin.”
Effect of Moore v. RegentsEffect of Moore v. Regents
reinforced gene patentsreinforced gene patents patients have rights to informed patients have rights to informed
consent, but cannot claim property consent, but cannot claim property interest in their bodiesinterest in their bodies
property and patent rights go to property and patent rights go to those who “mix their labor” with those who “mix their labor” with biological materialbiological material
Gene PatentsGene Patents
gene sequences are like any other gene sequences are like any other chemical compoundchemical compound
by isolating them and replicating by isolating them and replicating them in the lab, they exist in a them in the lab, they exist in a form not found in natureform not found in nature
isolation and purification = isolation and purification = inventive stepinventive step
Benefits of patentsBenefits of patents
reward scientific advancesreward scientific advances encourage research and encourage research and
investment, development of new investment, development of new drugs and therapiesdrugs and therapies
bring new discoveries into the bring new discoveries into the public domainpublic domain
Opponents of gene Opponents of gene patentspatents
privatization of new discoveries privatization of new discoveries inhibits research and new inhibits research and new treatmentstreatments• ““tragedy of the anticommons” (Heller tragedy of the anticommons” (Heller
and Eisenberg)and Eisenberg) patents granted on sequences that patents granted on sequences that
have no known utility or functionhave no known utility or function
OpponentsOpponents
gene patents hurt patient caregene patents hurt patient care American College of Medical American College of Medical
Genetics:Genetics:• “ “Genes and their mutations are Genes and their mutations are
naturally occurring substances that naturally occurring substances that should not be patented.”should not be patented.”
limit access to testing services and limit access to testing services and threaten quality of testingthreaten quality of testing
Computer sequencingComputer sequencing
patents are for information rather patents are for information rather than the compounds themselvesthan the compounds themselves
““discoveries” or “inventions”discoveries” or “inventions”
Response to OpponentsResponse to Opponents
William Haseltine, CEO of Human William Haseltine, CEO of Human Genome Sciences:Genome Sciences:• ““The patent office does not reward The patent office does not reward
perspiration…They reward priority. perspiration…They reward priority. They don’t care if someone spent 20 They don’t care if someone spent 20 years to find an invention or 20 years to find an invention or 20 minutes.”minutes.”
Revised Patent Office Revised Patent Office PoliciesPolicies
20012001 higher standard of ‘utility’: higher standard of ‘utility’:
“specific, substantial, and credible”“specific, substantial, and credible” patient groups such as National patient groups such as National
Breast Cancer Coalition and Breast Cancer Coalition and National Organization for Rare National Organization for Rare Disorders continue to claim that Disorders continue to claim that patents harm researchpatents harm research
What’s anthropology got What’s anthropology got to do with it?to do with it?
Is the body something we own, or Is the body something we own, or something we are?something we are?
Do gene patents change our view of Do gene patents change our view of life, of being human?life, of being human?
Why do some express a sentimental Why do some express a sentimental attachment to their body parts, even attachment to their body parts, even once removed?once removed?• Organ transplant research, study of death Organ transplant research, study of death
rituals across culturesrituals across cultures