STS midterm 1

Patent

Intellectual property protections for inventions

Buck versus Bell (Not very important)

• the supreme court ruled three generations of idiots is enough. This has never been overturned, it’s not active though.

• The same laws that force someone to get vaccinated can also enforce sterilization on people.

Henrietta Lacks versus Thermo fisher

Parties Involved:
Henrietta Lacks, a Black woman whose cancer cells were taken without consent at Johns Hopkins Hospital in 1951; Dr. George Gey, who cultured the cells; researchers and biotech companies that used the cells; and the Lacks family, who were unaware and uncompensated for decades.

Main Legal Question:
Do individuals have legal ownership or rights over their biological materials (like cells or tissues) once they are removed from their bodies, especially when those materials are used in research or for profit?

Decision and Reasoning:
Although Henrietta Lacks’s case did not go to the Supreme Court, the legal precedent was set in Moore v. Regents of the University of California (1990). The court ruled that individuals do not retain property rights over tissues once removed. However, the court emphasized the importance of informed consent for the use of human materials in research.

Significance to Law, Science, and Technology:
Legally, the case raised major bioethical concerns and helped push for stronger informed consent laws. Scientifically, HeLa cells became one of the most important tools in medical research, contributing to the polio vaccine, cancer treatments, genetic research, and more. Technologically, it sparked advancements in cell culture, biobanking, and genomics—while exposing gaps in regulations around the use of human tissues.

Moore V. Regents of the University of California

Parties Involved:

John Moore, a leukemia patient treated at UCLA Medical Center, and Dr. David Golde, his physician, along with the University of California system.

Main Legal Question:

Does a patient retain property rights over their biological materials (like cells or tissues) once removed from their body? Specifically, can Moore claim a share of profits from a patented cell line developed from his own spleen cells?

Decision and Reasoning:

The California Supreme Court ruled that Moore did not have property rights over his discarded cells or to any profits from the patented cell line.

The Court said Moore had relinquished his property when he signed the consent form allowing the hospital to discard the spleen.

It ruled that the patented cell line was a new invention, distinct from Moore’s original cells.

The Court emphasized that Moore’s rights were protected through informed consent, not through property law.

They reasoned that recognizing property rights in human tissues would harm scientific progress and research.

Significance to Law, Science, and Technology:

Law: Reinforced the legal principle that patients do not retain ownership of their tissues once removed, but emphasized the need for informed consent in research.

Science: Allowed researchers and institutions to develop patented biological products from human tissues without needing to share profits with donors.

Technology: Opened the door to commercial biotechnology innovations (like cell lines, biologics, etc.) while limiting patient control over materials derived from their own bodies.

What are some early methods of protecting intellectual property in agriculture, and how did they lead to formal IP laws?

Before formal IP laws, farmers and breeders used informal protections like proprietary breeding, animal registries, contracts (e.g., bull insemination agreements), and direct control (requiring their presence). These methods helped prevent unauthorized use of valuable animals like cows.
When it came to plants, ownership was trickier due to issues like seed dispersal and root cloning. In the early 1900s, asexual reproduction was seen as more controllable, leading to the idea of protecting a plant variety rather than a single plant. This movement, led by breeders like Luther Burbank, eventually pushed for formal IP protections in horticulture to combat widespread plant theft.

Ex Parte Latimer

Ex Parte Latimer was a court case where Latimer tried to patent the core of a pine needle, claiming it was a new invention once isolated. The court rejected his claim, establishing the “product of nature” doctrine, which says natural materials cannot be patented just because they’ve been discovered.
This decision made plant breeders realize they couldn’t rely on patents to protect their work. In response, they turned to informal protections like registries, contracts, and trademarks. After another case, Hoyt v. Lovett, blocked trademarking living products, plant breeders united and pushed for legal reform—leading to the Plant Patent Act of 1930, which allowed patents for asexually reproduced plants.

Plant Patent Act of 1936

The Plant Patent Act of 1930 allowed inventors to patent asexually reproduced plants (like grafts, cuttings, or clones), including mutants, hybrids, and cultivated discoveries—but not tuber-propagated plants (like potatoes) or wild plants.

This was the first legal recognition of ownership over living organisms in U.S. law. It marked a shift from Ex Parte Latimer, where natural products couldn’t be owned. Now, a breeder could exclude others from using or selling their plant variety.

The law required plant illustrations (submitted as "plant art") to help claim and protect the variety. It was a crucial step in giving companies legal tools to protect plant innovations—though it would take decades longer to figure out how to patent sexually reproducing plants.

What is a utility patent, and how is it different from a plant patent?

A utility patent protects new inventions or useful processes, machines, or compositions of matter—this is what people usually mean by “patent.”
A plant patent, by contrast, protects asexually reproduced plants (clones, cuttings, grafts). It gives the breeder exclusive rights to that plant variety, but does not apply to tubers or plants found in the wild.

What is a design patent, and how does it differ from other patents?

A design patent protects the ornamental appearance of a useful object—not how it works, just how it looks.
Unlike utility patents (which protect function) and plant patents (which protect asexually reproduced plants), design patents are focused only on visual design.

What are the requirements for a utility patent?

To get a utility patent, an invention must be:

1. Eligible (a process, machine, manufacture, or composition of matter)

2. New (not previously known)

3. Useful (must do something)

4. Non-obvious (not an obvious step to someone skilled in the field)

What is the Plant Variety Protection Act (PVPA) of 1970?

The PVPA of 1970 grants 20–25 years of exclusive rights to breeders of new, distinct, uniform, and stable sexually reproducing plants. It created the PVP certificate, complementing plant patents (for asexual reproduction) and utility patents (for inventions).They provide financial incentives for plant breeders by giving exclusive control over plant varieties. This ensures competitors can't steal their work—encouraging investment in innovation. However, patent systems can be abused and may lead to corporate control over public resources.

Diamond versus Chakrabarty

Parties Involved:

• Ananda Chakrabarty: A microbiologist who genetically engineered a bacterium capable of breaking down crude oil (used in oil spill cleanup).

• General Electric (GE): The assignee (owner of rights to the patent).

• Sidney Diamond: Commissioner of Patents and Trademarks, who represented the Patent Office in the case.

Main Legal Question:
Can a genetically modified living organism (a bacterium) be patented under 35 U.S.C. § 101, or is it an unpatentable “product of nature”?

Decision and Reasoning (U.S. Supreme Court, 1980):

• The Supreme Court ruled 5–4 in favor of Chakrabarty.

• It held that a “live, human-made microorganism” is patentable because it is a “manufacture” or “composition of matter” under §101.

• The Court rejected the idea that being alive disqualifies something from patent protection.

• Importantly, the Court said: “Anything under the sun that is made by man” can be patented, setting a broad precedent.

• Diamond argued Congress never intended for patents to apply to living things; the Court disagreed, stating Congress had left the scope intentionally broad.

Significance to Law, Science, and Technology:

• Law: Expanded patent eligibility to include genetically modified living organisms, redefining the scope of intellectual property.

• Science: Laid the foundation for the biotechnology industry, enabling the patenting of genetically engineered bacteria, plants, and even animals (like oncomice and knockout mice).

• Technology: Paved the way for gene patenting, synthetic biology, and biopharmaceutical innovation—but also raised deep ethical concerns about the commodification of life.

AMP versus Myriad

Parties Involved

Myriad Genetics: Biotech company that isolated and patented the BRCA1 and BRCA2 genes, which are linked to breast and ovarian cancer.

Association for Molecular Pathology (AMP): A coalition of scientists, medical professionals, and patients challenging Myriad’s gene patents.

ACLU: Represented AMP, framing the case as a civil liberties and access-to-healthcare issue.

Supreme Court of the United States: Final court that issued a unanimous ruling.

Main Legal Questions

Are isolated human genes patentable under 35 U.S.C. § 101?

Are diagnostic methods based on those genes patentable?

Decision and Reasoning (U.S. Supreme Court, 2013)

The Court unanimously ruled in favor of AMP:

Naturally occurring DNA sequences (like BRCA1/2) are products of nature and cannot be patented, even if isolated and purified.

However, synthetic DNA (cDNA), which is not naturally occurring, can be patented.

This overturned the earlier acceptance of gene patents, rejecting Myriad’s argument based on the "extraction and purification doctrine" (as seen in Parke-Davis v. Mulford).

Significance to Law, Science, and Technology

Law:

Reinforced the “product of nature” doctrine: DNA that exists in nature is not patentable, even when isolated.

Limited the scope of biotech patents, especially those involving the human genome.

Framed gene patenting as a civil rights issue, involving access to healthcare and body autonomy.

Science:

Made genetic testing more accessible by removing monopoly control over important cancer-related genes.

Encouraged collaboration and open research on the human genome.

Technology:

Distinguished between natural genes (unpatentable) and synthetic DNA/cDNA (patentable), influencing biotech innovation strategies.

Shifted focus from owning genes to owning tools and synthetic constructs for genetic research.

J.E.M. Ag Supply v. Pioneer Hi-Bred (2001)

Pioneer Hi-Bred International: A company that developed and patented genetically modified hybrid corn seeds.

J.E.M. Ag Supply: A business that bought and resold Pioneer’s patented seeds in violation of Pioneer’s licensing agreement.

Main Legal Question

Can plants be patented under utility patent law (35 U.S.C. § 101), or are they only protectable under specialized plant laws like the Plant Patent Act (1930) or the Plant Variety Protection Act (1970)?

Decision and Reasoning (U.S. Supreme Court, 2001)

The Court ruled in favor of Pioneer.

It held that utility patents can apply to plants, even though other forms of plant protection (like PVP certificates and plant patents) exist.

The Court cited Diamond v. Chakrabarty to affirm that genetically engineered or modified plants are eligible for utility patents.

The existence of other plant protections does not limit or invalidate the use of utility patents for plants.

Significance to Law, Science, and Technology

Law:

Affirmed the validity of utility patents for genetically modified seeds and plants, giving companies stronger control over how their seeds are used.

Confirmed that violating license restrictions, like replanting or reselling patented seeds, is legally punishable.

Science:

Supported biotech innovation in agriculture, encouraging companies to invest in genetically modified crops.

Created a system where ownership and control over life forms—even second-generation crops—could be enforced through patent law.

Technology & Ethics:

Raised concerns about unintentional infringement (e.g., if patented seeds accidentally sprout on someone’s land).

Fueled debates over corporate control of agriculture and farmers’ rights.

Scopes Trial (State of Tennessee v. John Scopes)

John Scopes: A Tennessee teacher who agreed to be the defendant in a test case to challenge the Butler Act.

ACLU (American Civil Liberties Union): Organized and supported Scopes’ defense to test the constitutionality of banning evolution in schools.

William Jennings Bryan: Former presidential candidate and fundamentalist Christian, argued for the prosecution and the authority of scripture.

Clarence Darrow: Famous defense attorney, agnostic, and advocate for science and evolution, represented Scopes.

Main Legal Question

Did John Scopes violate the Butler Act by teaching evolution in a Tennessee public school, and can a state prohibit the teaching of evolution in violation of the First Amendment?

Decision and Reasoning

Scopes was found guilty of violating the Butler Act, which banned teaching “that man descended from animals.”

The court upheld the law, stating that states can control school curricula, and that religious implications didn’t outweigh the state’s right to legislate education.

Scopes was fined, and although the Tennessee Supreme Court later overturned the verdict on a technicality, it did not overturn the law itself.

Significance to Law, Science, and Society

Law:

The trial raised—but did not resolve—First Amendment questions about freedom of speech and the separation of church and state.

Showcased how state laws can enforce religious beliefs in public education.

Science:

Sparked a national debate on evolution vs. creationism, fueling tension between scientific education and religious fundamentalism.

Society:

Became a media sensation, symbolizing the larger cultural clash between modernism and traditionalism in 1920s America.

Framed Scopes as a defender of academic freedom, though the trial was complicated by eugenics discourse and broader cultural fears.

EUGENICS OVERVIEW (EARLY 20TH CENTURY)

EUGENICS OVERVIEW (EARLY 20TH CENTURY)

• A social movement aimed at improving the human population by controlling reproduction.

• Two types:
  • Positive Eugenics (UK): Encourage reproduction of people with “desirable” traits.
  • Negative Eugenics (US): Prevent reproduction of people deemed “unfit.”

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KEY FIGURES AND INSTITUTIONS

• Francis Galton: Darwin’s cousin, coined the term eugenics, wrote Hereditary Genius. Believed humans could be bred like animals.

• Eugenics Record Office (New York):
  • Collected genetic, social, and moral data to map "desirable" vs. "undesirable" traits.
  • Framed issues like poverty and crime as genetic flaws, not social problems.

• Harry Laughlin:
  • Director of the Eugenics Record Office.
  • Lobbied for immigration restrictions and sterilization laws.
  • Provided “expert” testimony using flawed data.

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EUGENICS IN LAW AND POLICY

• Immigration Act of 1924:
  • Capped immigration at 165,000 per year.
  • 86% reserved for Northern & Western Europe.
  • 9% for Southern & Eastern Europe.
  • Banned all Japanese immigration.

• Sterilization Laws:
  • Based on Laughlin’s model law.
  • California (1909) led the nation—over 20,000 sterilized by 1963.
  • Sterilization often targeted poor, immigrant, or institutionalized people.
  • Practices inspired Nazi eugenics programs.

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EUGENICS IN CULTURE AND SOCIETY

• Contests and Propaganda:
  • “Fittest family” competitions.
  • Medals and awards for “good genes.”
  • Posters and public campaigns promoting selective breeding.
  • Framed reproduction as a civic duty.

• Educational Influence:
  • Civic biology textbooks promoted eugenics and linked social problems to heredity.
  • Taught that society should prevent “degenerate” populations from reproducing.

• Beliefs:
  • Prioritized nature over nurture.
  • Saw social ills as biologically inevitable.
  • Emphasized racial hierarchy—not just whiteness, but preservation of distinct European heritages.

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MARGARET SANGER AND BIRTH CONTROL

• Advocate for women’s reproductive autonomy.

• Founded American Birth Control League → Planned Parenthood.

• Criticized by eugenicists for promoting access to birth control across class lines.

• Eugenicists preferred sterilization over voluntary contraception.

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DECLINE OF EUGENICS

• Lost scientific credibility and public support after World War II, especially due to links to Nazi policies.

• U.S. sterilization programs continued into the 1970s despite global criticism.

Buck versus bell

Buck v. Bell was a U.S. Supreme Court case that upheld the constitutionality of forced sterilization laws for people deemed “unfit to reproduce.”

Carrie Buck, a young woman institutionalized in Virginia, was labeled as "feebleminded" and sterilized under Virginia's eugenics law.

The Court ruled 8–1 in favor of the state, with Justice Oliver Wendell Holmes writing the infamous line: “Three generations of imbeciles are enough.”

The decision legitimized eugenics-based sterilization, leading to over 60,000 forced sterilizations in the U.S.

Though never explicitly overturned, the case is now widely condemned as a human rights violation and a dark chapter in American constitutional law.

What was the Madrigal v. Quilligan case about, and what did it reveal about reproductive rights violations?

Madrigal v. Quilligan was a 1978 lawsuit brought by 10 Chicana women (including Dolores Madrigal and Consuelo Hermosillo) who were forcibly sterilized without informed consent at the Los Angeles County-USC Medical Center.

Consuelo Hermosillo was coerced into signing sterilization papers while in labor and in pain, under threat that her baby would die if she refused.

Dolores Madrigal was sterilized and falsely told her procedure was reversible and approved by her husband.

Although dozens of women reported coercion, only 10 pursued legal action. A whistleblower, Dr. Karen Benker, testified that doctors like Dr. Quilligan aimed to reduce non-white birth rates.

The court ultimately ruled against the women, dismissing Benker's testimony and framing the events as a "clash of cultures" rather than a civil rights violation.

The case exposed systemic racism, medical abuse, and violations of reproductive autonomy, particularly against Latinas.

What was Epperson v. Arkansas (1968), and why was it significant for education and constitutional law?

In Epperson v. Arkansas, Susan Epperson, a high school teacher and zoologist, challenged a 1928 Arkansas law that banned the teaching of human evolution, similar to Tennessee’s Butler Act.

Epperson sued, arguing the law violated her First and Fourteenth Amendment rights, especially free speech, academic freedom, and due process.

She won in state trial court, lost in state supreme court, and then took the case to the U.S. Supreme Court.

The Court ruled the law unconstitutional, stating it violated the Establishment Clause by favoring a religious viewpoint (creationism) over science.

Impact:

The decision struck down laws banning the teaching of evolution and affirmed that states cannot impose religious beliefs in public school science curricula.

It led to new strategies like “equal time” laws and the promotion of intelligent design, setting the stage for future legal battles over science education.