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