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 24a
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.
Would you agree with the ruling to invalidate the patenting of the BRCA1 and BRCA2 genes? If you were asked to judge the patenting of the direct-to-consumer test for the BRCA1 and BRCA2 genes, how would you rule?

1
Understand the context: The BRCA1 and BRCA2 genes are naturally occurring genes associated with an increased risk of breast and ovarian cancer. The question revolves around the ethical and legal implications of patenting naturally occurring genes versus patenting a test developed to detect mutations in these genes.
Clarify the legal and ethical distinction: Genes that exist in nature are generally considered discoveries, not inventions, and thus are not patentable. However, a test or method developed to analyze these genes could be considered an invention and may be patentable if it meets the criteria of novelty, utility, and non-obviousness.
Evaluate the ruling on gene patenting: Judge Sweet's decision to invalidate the patent on the BRCA1 and BRCA2 genes aligns with the principle that natural phenomena cannot be patented. This ensures that access to genetic information remains open and not restricted by proprietary claims.
Consider the direct-to-consumer test: The patenting of the test for BRCA1 and BRCA2 mutations would depend on whether the test involves a novel and non-obvious method or technology. If the test is a unique invention that provides significant utility, it may be eligible for patent protection.
Formulate your judgment: If you were to judge the patenting of the direct-to-consumer test, you would need to assess whether the test meets the legal criteria for patentability while considering the broader implications for accessibility, innovation, and public health.

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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 practice of obtaining exclusive rights to specific genes or genetic sequences. This practice raises ethical and legal questions about ownership of natural biological materials. The ruling against Myriad Genetics highlighted the argument that naturally occurring genes should not be patented, as they are part of the human genome and exist in nature.
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BRCA1 and BRCA2 Genes
BRCA1 and BRCA2 are genes that produce proteins responsible for repairing damaged DNA. Mutations in these genes are linked to an increased risk of breast and ovarian cancer. Understanding the role of these genes is crucial for assessing the implications of genetic testing and the ethical considerations surrounding their patenting.
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Direct-to-Consumer Genetic Testing
Direct-to-consumer (DTC) genetic testing allows individuals to access genetic information without the need for a healthcare provider. This raises questions about the accuracy of tests, privacy concerns, and the potential for misinterpretation of results. Evaluating the patenting of DTC tests involves considering consumer rights, access to information, and the implications of genetic knowledge.
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Textbook Question
Describe how the Ames test screens for potential environmental mutagens. Why is it thought that a compound that tests positively in the Ames test may also be carcinogenic?
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