Patents, screening and privacy

1911

-Supreme court ruling adrenaline (Combo of epi and norepi) could be patented as and isolated and purified version of a substance in the human body

1923

Human insulin patented

1980: Diamond vs. Chakrabarty

-Establishes precedent for gene patenting
-paves way for the explosion of biotech patents
-by the end of 2000: ~20% of human genes patented

Arguments for

-Provides incentives for business to invest significant money in techniques
-Patents are temporary (less than 20 years); after that they enter public domain

Arguments against

-Gene are naturally occurring and natural occurring things cannot be patented
-Patenting can inhibit research into genetic disease by creating significant cost barriers
-Implication: To own a gene is to own a part of person

BRCA 1 & 2

-Both gene varients are associated with up to 5 times risk of breast cancer; 2 also increases risk of ovarian cancer
-Initial research done by U Berkeley & U Utah, myriad acquires patient for both genes
-Myraid test cost $4,000 (wrong 12% of the time)
-Any scientific research involving gene required permission from (and payment to) myraid

2013: Association for molecular pathology v. Myriad Genetics

-Court rules 9-0 against Myriad's central claim, effectively endind gene patents
-Left standing: patents on screening and testing process
-Left open: future patents on modified synthetic genes

Preventive and Information Genetic Screening Aim

-Determine risk of specific genetic diseases and determine responses

Infant Genetic Screening

1962: Test developed for PKU (phenylketonuria) which causes severe brain damage unless put on a special diet until age 6
-All 50 state now require test for at least 21 genetic disease (Sickle cell anemia)
-Ethical factors: parental autonomy, state paternalism, rights and dignity of child

Adult genetic screening

-Determine genetic risk for self
-Determine genetic risk for potential children
-Ancestry

PKU

1-25,000

MCAD

1-15,000

Galactosemia

1-34,000

Sickle Cell

-1-500 among African-Americans
-1-1,400 among Latino Americans

1972

Targeting reversed by National Sickle-cell Anemia control act

Genetic Screening and Race

-Sickle Cell anemia occurs in ~8% of African American pop.
-Occurs on other pops.
-Some states required AA to get screened when getting a drivers license
-Employers used sickle test to exclude African Americans.

Issues in heath testing

-Desirability of information when choices are limited
-Issues of accuracy
-2013: FDA requires approval process

Privacy Issues

-If my genes are in a database so are half of my brothers and parents
-Depending on privacy policy: firms may sell data.
-2018 Golden State Killer Case: Law enforcement can use genetic databases to identify criminal suspects