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 engineering (GE); ethics of GE � Patenting of genes and life forms (GMOs): is it necessary? � Ethics of “gene power”
Supreme Court decisions related to biotechnology and patents � 1980: Diamond v. Chakrabarty � June 2013: Association for Molecular Pathology v. Myriad Genetics
Criteria for a patent � Useful � Novel; did not previously exist � Nonobvious � � Requires some inventive step or action
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
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
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
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)?
‘Central dogma’ of molecular biology: DNA RNA Protein Is DNA really the blueprint for the organism? Arrows require enzymes (proteins) for action
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
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?
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”
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
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?
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?
Rationale for genetic engineering (GE) � Pharmaceuticals � Crops � Animals � Pharma animals � Increase growth (e.g. rBGH)
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
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)
� � � 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?
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
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)
World's Top Seed Companies 18% CR4=40% 14% 9% 5% 0% Monsanto Syngenta Land O' Lakes Bayer
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?
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
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