How Can You Patent Genes? Margaret Everett PSU

What are patents? b Exclusive rights to an invention b fixed period of time

What can be patented? b “any process, machine, manufacture, or composition of matter” [US patent statute][US patent statute] b an invention that is new, useful and non- obvious b 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” b US Supreme Court, Diamond v. Chakrabarty, 1980 b products of man v. products of nature b genetically engineered bacterium could be patented

Social and Cultural Implications b can life forms be owned? b Would the decision lead to commodification of higher life forms? b Should all forms of life be held ‘sacred’?

Harvard’s Oncomouse b 1984 patent application, granted in 1988 b genetically engineered mouse with high susceptibility to cancer b 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”“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. processproduct vs. process

John Moore’s spleen b 1988 California Supreme Court case b Does a patient retain ownership of body parts after removal from the body? b Can cell lines be patented? Who should profit?

John Moore’s spleen b treated for hairy cell leukemia at UCLA by Dr. Golde b spleen removed and preserved by Dr. Golde for research b spleen cells producing unique antibodies were patented and sold as MO cell line

John Moore’s spleen b Moore discovers patent and sues for ‘breach of fiduciary duty’ and ‘conversion’ b Can body parts be ‘stolen’? b Does a patient have a right to profit from their own body?

Court’s decision b Moore’s right to consent was violated b Moore does not retain ownership in his spleen cells b “socially important” medical research would be harmed b cell line belongs to scientists who created it in the lab

John Moore’s reaction b “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) b “like a rape”

Chief Justice Panelli b “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 b reinforced gene patents b patients have rights to informed consent, but cannot claim property interest in their bodies b property and patent rights go to those who “mix their labor” with biological material

Gene Patents b gene sequences are like any other chemical compound b by isolating them and replicating them in the lab, they exist in a form not found in nature b isolation and purification = inventive step

Benefits of patents b reward scientific advances b encourage research and investment, development of new drugs and therapies b bring new discoveries into the public domain

Opponents of gene patents b privatization of new discoveries inhibits research and new treatments “tragedy of the anticommons” (Heller and Eisenberg)“tragedy of the anticommons” (Heller and Eisenberg) b patents granted on sequences that have no known utility or function

Opponents b gene patents hurt patient care b American College of Medical Genetics: “Genes and their mutations are naturally occurring substances that should not be patented.” “Genes and their mutations are naturally occurring substances that should not be patented.” b limit access to testing services and threaten quality of testing

Computer sequencing b patents are for information rather than the compounds themselves b “discoveries” or “inventions”

Response to Opponents b 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.”“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 b 2001 b higher standard of ‘utility’: “specific, substantial, and credible” b 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? b Is the body something we own, or something we are? b Do gene patents change our view of life, of being human? b Why do some express a sentimental attachment to their body parts, even once removed? Organ transplant research, study of death rituals across culturesOrgan transplant research, study of death rituals across cultures