GENETIC MANIPULATION AND PATENTING OF GENES AND GMO S Uko Zylstra - - PowerPoint PPT Presentation

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GENETIC MANIPULATION AND PATENTING OF GENES AND GMO S Uko Zylstra - - PowerPoint PPT Presentation

GENETIC MANIPULATION AND PATENTING OF GENES AND GMO S Uko Zylstra Professor Emeritus Biology Department Calvin College ASA Conference July 26, 2014 Session overview Key court cases What is a gene? Rationale for genetic


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GENETIC MANIPULATION AND PATENTING OF GENES AND GMOS

Uko Zylstra Professor Emeritus Biology Department Calvin College

  • ASA Conference

July 26, 2014

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Session overview

Key court cases What is a gene? Rationale for genetic engineering (GE);

ethics of GE

Patenting of genes and life forms (GMOs): is

it necessary?

Ethics of “gene power”

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Supreme Court decisions related to biotechnology and patents

1980: Diamond v. Chakrabarty June 2013: Association for Molecular

Pathology v. Myriad Genetics

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Criteria for a patent

Useful Novel; did not previously exist Nonobvious

  • Requires some inventive step or action
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1980: Diamond v. Chakrabarty


Key issue is one of patenting a life form What was actually “created”? Did he really create an oil digesting

bacterium?

Formation of plasmids containing different oil digesting genes

isolated from different stains of oil digesting bacteria. Then mixing these plasmids (containing genes for an oil digesting enzyme) with a more hardy Pseudomonas bacterium that then took up the plasmid as bacteria are wont to do?

Decision was a 5-4 in favor of Chakrabarty (& GE) Chief Justice Warren Burger: “anything under the sun that is made

by man” could be patented

Thus: was the bacterium a ‘product of nature’ or a human

invention?

What does it mean to have a patent on a self replicating organism?

“Owning life”: owning a mule vs owning mule

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June 2013: Association for Molecular Pathology vs. Myriad Genetics


Key issue: can a human gene be patented?

  • Involved patents on BRCA1 and BRCA2 genes

Court decision: the genes are a product of nature and

thus could not be patented

But indicated that cDNA is not a “product of nature” Is cDNA really a ‘synthetic’ molecule and not a product of

nature? It’s sequence information is in the DNA transcribed into mRNA

  • Raises potential implications for patents on plant and

animal genes as well as for the numerous human genes already patented

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Why might patenting of genes and GMOs be a concern?

Do we really understand what is being

patented?

Can living beings be ‘reduced’ to genes or

DNA?

DNA as information – not just a molecule The motives of patenting is a separate issue

from engaging in genetic engineering itself

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What is a Gene?

Tendency for mechanistic – reductionist/materialist interpretations DNA as ‘blueprint’

  • In what way is DNA a blueprint?

Illustrative questions: Is there a gene for blue or brown eyes? Is there a gene for cystic fibrosis? Is there a gene for the shape of your nose?

  • “Genetic program” vs “Development program”

Is the ‘gene’ the subject (causal agent) or the object (of cell or development program)?

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‘Central dogma’ of molecular biology:

DNA RNA Protein

Is DNA really the blueprint for the organism? Arrows require enzymes (proteins) for action

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What is a Gene?

Central Dogma: “one gene – one protein” “Human cells carry nearly 24,000 genes that constitute the blueprint for the 100 trillion cells of our body (Sci Am, Feb 2006) But there are more than 24,000 proteins that can be synthesized during the course of an individual’s life Human inner ear gene can give rise to 576 different proteins

Neuron, 20(2): 165 (1998)

Three neuroexine category genes can give rise to 2258 polypeptides

Nature, 423: 939-948 (2003)

Thus we have more proteins than genes; therefore: A “gene” may be responsible for a whole range of proteins Many regulatory means may exist in the production of proteins

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What is a Gene?

Textbook Definition: A gene is the segment of DNA involved in producing a polypeptide chain; it includes regions preceding and following the coding region (leader and trailer) as well as intervening sequences (introns) between individual coding segments (exons).

  • B. Lewis: Genes VIII, 2004, glossary
  • How does alternative splicing providing for different polypeptides fit in

this definition? If genes are ‘causal agents’ how does location fit into that causal agency?

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What is a gene?

Genes have a context –an environment Thus, can a ‘gene’ really be ‘isolated’ from its

context or environment? “isolated from its natural state”

‘isolated genes’ are really ‘reduced’ genes DNA is not just a molecule; it’s information But information in cells/organisms is more than

simply DNA; contextual information

Genes/DNA are defined by relationships: “Genes-cell-organism-environment-community”

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A basic question

Can relationships be patented or “owned”? Analogy to factory farms where food company

‘owns’ the chickens or pigs; the farmer just grows the animals; this violates the relationship between farmer and animals

Also:

consider the relationship between employer and

employee; we consider slavery to be immoral

Consider parent and child relationship: parents

don’t ‘own’ children

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What does it mean to patent a gene or a DNA sequence?

Does it imply that all the interrelationships of

DNA with its environment is patented?

Regulatory relationships:

■ Extracellular signals ■ Signal transduction ■ Intracellular signals ■ Activation of transcription factors ■ Regulatory binding sites on DNA ■ Position effect in chromosome ■ Insertional mutagenesis is indication of context Can one patent a relation? What does that

mean?

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So, the basic question:

What is a GENE? If a gene can be patented, what is

patented?

If it is the cell (not the ‘inventor’) that

makes copies of DNA (genes), how does the patent apply to the copies?

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Rationale for genetic engineering (GE)

Pharmaceuticals Crops Animals

Pharma animals Increase growth (e.g. rBGH)

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Rationale for crop genetic engineering (GE)

Feed the world (9 billion human population in 2050) Increase yields More drought resistant crops More salt tolerant crops Improve nutrition (e.g. Golden Rice) 70 patents needed to be waived Reduce pesticide and herbicide use Reduce soil erosion (no-till agriculture) Increase profits

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What are concerns about GM crops?

Are they safe for human consumption? Possible allergens? Antibiotic resistance? Toxicity? Are they safe for environment? Pesticide resistance (refuge requirement) Harm beneficial insects Herbicide sprays are not always confined to HT crop Superweeds Contamination of non GMOs (e.g. canola) Affect on soil microorganisms

Food power (gene control (patents) ->> food control) Increase control in industrial food system)

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Are GMOs safe?

  • Multiple agencies: FDA, USDA, EPA

Framework of ‘deregulation” Different responsibilities No overall oversight Congressional failure to implement GAO recommendations for single agency Policies ‘drafted’ by industry (revolving door)

  • Testing of GMOs:

who is responsible? Transparency of testing? What are scientifically appropriate procedures for testing?

  • “substantial equivalence”

GRAS

■ argument that DNA is basically same in all organism, etc. ■ BT bacteria (and thus BT toxin) has been ingested with foods for decades

Double speak; if substantially equivalent, then what is basis for patent?

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Some case studies

Pusztai affair (Rowett Institute) Tested GE potato (1996 -Lectins) using toxicological protocol fed to rats; examined effects on intestinal mucosa (lesions) and

growth of mucosal epithelium

■ Non GE potato ■ Potato laced with lectin toxin (no effect) ■ GE potato (showed lesions and epithelial growth)

After prepublication relay of results on TV, subject to smear campaign

  • Starlink debacle

GE canola GE contamination of conventional canola (e.g. Percy Schmeizer

affair)

Transgenic contamination is not reversible GMOs infringe on freedom of farmer to choose crops to plant

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A central problem with present food system

concentration of power and control at

the various scales of food system

  • Privatization of relationships of genes

through patents, etc.; thus “owning” crops through owning seeds (e.g.: patent for roundup ready seeds by Monsanto – 98% of soybeans in US)

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World's Top Seed Companies

0% 5% 9% 14% 18%

Monsanto Syngenta Land O' Lakes Bayer

CR4=40%

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The Ethics of Food Power

Should a basic human need be under

the control of a few corporations?

  • Should a basic human need be limited in

access and distribution by a powerfully controlled market?

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The Ethics of Food Power

GE crops may have a good potential for addressing

increased food prodcution in a sustainable manner

But patenting of GE crops is a hindrance to reducing

global hunger

Patenting of GE crops serves to supoort and

increase industrial agriculture which has not served well in addressing issues of global hunger