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Ch. 15 - Gene Mutation, DNA Repair, and Transposition
Chapter 15, Problem 24

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?

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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. The controversy arises from the question of whether naturally occurring genes, which are part of the human genome, can be patented. The ruling against Myriad Genetics highlighted that genes, as products of nature, should not be owned, raising ethical and legal implications for biotechnology and genetic research.
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Synthetic Biology

Synthetic biology is an interdisciplinary field that combines biology and engineering to design and construct new biological parts, devices, and systems. J. Craig Venter's work on creating a human-made life form exemplifies this field, as it involves manipulating genetic material to create organisms that do not exist in nature. The patentability of synthetic organisms raises questions about ownership and the implications of creating life.
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Legal Precedents in Biotechnology

Legal precedents in biotechnology refer to previous court decisions that influence future cases regarding the patenting of biological materials. The ruling on Myriad Genetics set a significant precedent by establishing that natural genes cannot be patented, which may affect how synthetic organisms are treated under patent law. Understanding these precedents is crucial for evaluating the potential outcomes of patent applications in the rapidly evolving field of genetics.
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Related Practice
Textbook Question
A fellow student considers the issues in Problem 22 and argues that there is a more straightforward, nongenetic experiment that could differentiate between the two types of mutations. The experiment requires no fancy genetics and would allow you to easily assay the products of the other SOS genes. Propose such an experiment.
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Textbook Question
In a bacterial culture in which all cells are unable to synthesize leucine (leu⁻), a potent mutagen is added, and the cells are allowed to undergo one round of replication. At that point, samples are taken, a series of dilutions are made, and the cells are plated on either minimal medium or minimal medium containing leucine. The first culture condition (minimal medium) allows the growth of only leu⁺ cells, while the second culture condition (minimal medium with leucine added) allows growth of all cells. The results of the experiment are as follows: Culture Condition Dilution Colonies Minimal medium 10⁻¹ 18 Minimal medium + leucine 10⁻⁷ 9 What is the rate of mutation at the locus associated with leucine biosynthesis?
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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?

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Textbook Question
Presented here are hypothetical findings from studies of heterokaryons formed from seven human xeroderma pigmentosum cell strains: XP1 XP2 XP3 XP4 XP5 XP6 XP7 XP1 - XP2 - - XP3 - - - XP4 + + + - XP5 + + + + - XP6 + + + + - - XP7 + + + + - - - Note: + = complementation; - = no complementation These data are measurements of the occurrence or nonoccurrence of unscheduled DNA synthesis in the fused heterokaryon. None of the strains alone shows any unscheduled DNA synthesis. Which strains fall into the same complementation groups? How many different groups are revealed based on these data? What can we conclude about the genetic basis of XP from these data?
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Textbook Question
Imagine yourself as one of the team of geneticists who launches a study of the genetic effects of high-energy radiation on the surviving Japanese population immediately following the atom bomb attacks at Hiroshima and Nagasaki in 1945. Demonstrate your insights into both chromosomal and gene mutation by outlining a short-term and long-term study that addresses these radiation effects. Be sure to include strategies for considering the effects on both somatic and germ-line tissues.
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Textbook Question
With the knowledge that radiation causes mutations, many assume that human-made forms of radiation are the major contributors to the mutational load in humans. What evidence suggests otherwise?
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