Ch. 22 - Applications of Genetic Engineering and Biotechnology

Klug - Concepts of Genetics 12th Edition

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Klug 12th Edition

Ch. 22 - Applications of Genetic Engineering and Biotechnology

Problem 24a

Chapter 22, Problem 24a

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?

Verified step by step guidance

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.

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.

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

Following the tragic shooting of 20 children at a school in Newtown, Connecticut, in 2012, Connecticut's state medical examiner requested a full genetic analysis of the killer's genome. What do you think investigators might be looking for? What might they expect to find? Might this analysis lead to an oversimplified analysis of the cause of the tragedy?

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Textbook Question

Private companies are offering personal DNA sequencing along with interpretation. What services do they offer? Do you think that these services should be regulated, and if so, in what way? Investigate one such company, 23andMe, at http://www.23andMe.com, before answering these questions.

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Textbook Question

Yeager, M., et al. [(2007) Nature Genetics 39:645–649] and Sladek, R., et al. [(2007) Nature 445:881–885] have used single-nucleotide polymorphisms (SNPs) in genome-wide association studies (GWAS) to identify novel risk loci for prostate cancer and Type 2 diabetes, respectively. Each study suggests that disease-risk genes can be identified that significantly contribute to the disease state. Given your understanding of such complex diseases, what would you determine as reasonable factors to consider when interpreting the results of GWAS?

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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.

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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Textbook Question

A number of mouse models for human cystic fibrosis (CF) exist. Each of these mouse strains is transgenic and bears a different specific CFTR gene mutation. The mutations are the same as those seen in several varieties of human CF. These transgenic CF mice are being used to study the range of different phenotypes that characterize CF in humans. They are also used as models to test potential CF drugs. Unfortunately, most transgenic mouse CF strains do not show one of the most characteristic symptoms of human CF, that of lung congestion. Can you think of a reason why mouse CF strains do not display this symptom of human CF?

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Textbook Question

Craig Venter and others have constructed synthetic copies of viral genomes. For example, the genome for poliovirus and the 1918 influenza strain responsible for the pandemic flu have been assembled this way. The United States currently has a moratorium on federal funding for 'gain-of-function' experiments which increase the virulence or transmission potential of viruses. What concerns might ethicists have about synthetic biology studies involving potential pandemic pathogens?

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