Table of contents
- 1. Introduction to Genetics51m
- 2. Mendel's Laws of Inheritance3h 37m
- 3. Extensions to Mendelian Inheritance2h 41m
- 4. Genetic Mapping and Linkage2h 28m
- 5. Genetics of Bacteria and Viruses1h 21m
- 6. Chromosomal Variation1h 48m
- 7. DNA and Chromosome Structure56m
- 8. DNA Replication1h 10m
- 9. Mitosis and Meiosis1h 34m
- 10. Transcription1h 0m
- 11. Translation58m
- 12. Gene Regulation in Prokaryotes1h 19m
- 13. Gene Regulation in Eukaryotes44m
- 14. Genetic Control of Development44m
- 15. Genomes and Genomics1h 50m
- 16. Transposable Elements47m
- 17. Mutation, Repair, and Recombination1h 6m
- 18. Molecular Genetic Tools19m
- 19. Cancer Genetics29m
- 20. Quantitative Genetics1h 26m
- 21. Population Genetics50m
- 22. Evolutionary Genetics29m
17. Mutation, Repair, and Recombination
Induced Mutations
Problem 24b
Textbook Question
In 2010, a U.S. District Judge ruled to invalidate Myriad Genetics' patents on the BRCA1 and BRCA2 genes. Judge Sweet noted that since the genes are part of the natural world, they are not patentable. Myriad Genetics also holds patents on the development of a direct-to-consumer test for the BRCA1 and BRCA2 genes.
J. Craig Venter has filed a patent application for his 'first-ever human-made life form.' This patent is designed to cover the genome of M. genitalium. Would your ruling for Venter's 'organism' be different from the judge's ruling on patenting of the BRCA1 and BRCA2 genes?

1
Understand the key difference between the BRCA1 and BRCA2 genes and the genome of M. genitalium. The BRCA1 and BRCA2 genes are naturally occurring sequences in humans, while the genome of M. genitalium in this case is described as 'human-made,' implying it was artificially synthesized or engineered.
Review the legal and ethical principles surrounding patent law. In general, naturally occurring substances, such as genes found in nature, are not patentable. However, inventions or creations that are not naturally occurring, such as synthetic or engineered organisms, may be eligible for patents.
Consider the implications of Judge Sweet's ruling. The decision to invalidate Myriad Genetics' patents was based on the principle that genes found in nature cannot be patented because they are discoveries, not inventions. This principle would not necessarily apply to a synthetic genome, as it is not naturally occurring.
Evaluate the criteria for patent eligibility. For Venter's 'human-made life form,' the genome must meet the requirements of being novel, non-obvious, and useful. If the genome of M. genitalium was entirely synthesized and meets these criteria, it could be considered patentable.
Conclude by comparing the two cases. The BRCA1 and BRCA2 genes are part of the natural world and were ruled unpatentable, while Venter's synthetic genome, being an artificial creation, could potentially be ruled patentable under current patent laws. The ruling would likely differ based on the distinction between natural and synthetic entities.

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Key Concepts
Here are the essential concepts you must grasp in order to answer the question correctly.
Gene Patenting
Gene patenting refers to the legal ability to claim ownership over specific genes and their sequences. The controversy arises from the balance between incentivizing innovation in genetic research and the ethical implications of owning parts of the human genome. The ruling against Myriad Genetics highlighted that naturally occurring genes cannot be patented, as they exist in nature and are not inventions.
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Synthetic Biology
Synthetic biology is an interdisciplinary field that involves designing and constructing new biological parts, devices, and systems. It also includes the modification of existing natural biological systems for useful purposes. The patent application by J. Craig Venter for a human-made organism represents a significant aspect of synthetic biology, where the creation of novel life forms raises questions about ownership and the nature of biological inventions.
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Natural vs. Artificial Distinction
The distinction between natural and artificial is crucial in patent law, particularly in genetics. Natural entities, such as genes found in the human body, are generally not patentable, while artificial creations, like genetically engineered organisms, may be eligible for patents. This distinction influences legal rulings and ethical considerations regarding what constitutes an invention versus a discovery in the realm of genetics.
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Textbook Question
Contrast and compare the mutagenic effects of deaminating agents, alkylating agents, and base analogs.
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