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Two genes associated with breast cancer, BRCA1 and BRCA2, were discovered in 1994 and 1995, respectively, and shortly thereafter, were patented by Myriad Genetics, a company based in Utah. Under the patents, testing for mutations in these genes could only be performed by Myriad, at costs from $300 to $3,000. Myriad also patented the process of analyzing the results of such tests, preventing anyone who obtains the sequence of their BRCA genes by other means (which itself would probably be patent infringement) from interpreting the information.
The idea that genes can be patented has been a contentious issue from the beginning. Patents are not granted for products of nature, meaning that genes inside the body are not patentable, but biotech companies successfully argued that by removing a gene from the human body, purifying it, and then obtaining its DNA sequence, they created something not found in nature, and which is therefore a patentable invention. The U.S. Patent Office found the argument persuasive, but opponents argue that genes are parts of our bodies and can be identified but not invented. Biotech companies argue that without the protection offered by patents, they would have no incentive for research and development of diagnostic tests.
In Europe, patents for BRCA1 and BRCA2 were revoked in 2004 because they did not meet the standards for a patent. After more than a decade of legal disputes, the patents were partially restored in 2008 on a very restricted basis. In the United States, a lawsuit, focused on the patents for the BRCA genes, was filed in May 2009. The suit challenges the basic idea that genes are patentable. In November 2009, the judge ruled that the lawsuit can proceed, and the case is moving forward. In March 2010, a federal court invalidated Myriad Genetics’ patent on these genes. In August 2011, the U.S. Court of Appeals reversed the lower court’s decision and ruled that gene sequences isolated from cells are not a product of nature and are therefore patentable. The case went to the U.S. Supreme Court, which ordered the appeals court to reconsider the case. The Federal Appeals Court did not change its decision, and the case once again, went to the U.S. Supreme Court. A unanimous decision in June 2013 invalidated Myriad’s patents on the basis that isolating a gene from nature does not make it patentable. This is a landmark decision on gene patenting with widespread ramifications for the biotechnoloogy industry.
Will this decision reduce the incentives for companies to invest in new diagnostic tests that would be used by cancer victims or those with serious genetic disorders?
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Chapter 8 Solutions
Human Heredity: Principles and Issues (MindTap Course List)
- Although it is well known that X-rays cause mutations, they are routinely used to diagnose medical problems, including potential tumors, broken bones, and dental cavities. Why is this done? What precautions need to be taken?arrow_forwardOne unexpected result of the sequencing of the human genome was the finding that mutations in a single gene can be responsible for multiple distinct disorders. For example, mutations in the RET gene can cause two different types of multiple endocrine neoplasias, familial medullary thyroid carcinoma, and Hirschsprung disease. How do you think mutations in a single gene can have such diverse effects?arrow_forwardThe search for the BRCA1 breast cancer gene discussed in this chapter was widely publicized in the media (for example, Newsweek, December 6, 1993). Describe the steps taken by Mary-Claire King and her colleagues to clone this gene. How long did this process take?arrow_forward
- From your knowledge about DNA microarray, answer the following: If the expression microarray experiment was done with a normal sample and a suspected sample, after reading the color pattern resulted from the experiment it was recorded that “gene A22” is expressed in the suspected sample. The gene A22 is clinically linked to colon cancer. Answer the following: What is the expected color of the spot on the microarray which represents this gene? What is your interpretation of the suspected sample; is it a cancer sample or not and explain why?arrow_forwardWhat is the first step in quantifying the relative amounts of mRNA in different tissues? Would this method be useful in determining which immune system genes might be over-expressed in severe Covid cases? Why or why not? Could quantitative PCR, which uses a DNA-binding dye, to show how many copies of the target DNA sequence could be used to quantify the amount of mRNA in a cell? Would you expect that a metabolically active tissue such as the liver would show more cDNA copies in such a method, compared to less metabolically active tissues such as skin cells? One reason that the types and amounts of mRNAs are quantified in different tissue types is to compare which genes are activated and which are inactive. It used to be thought that any gene that was transcribed was automatically translated. The discovery of RNA-degrading systems shows that the real situation in cells is more complemented. Do you believe that a larger amount of mRNA of a given type, say for alpha hemoglobin in…arrow_forwardIn 2013 the actress Angelina Jolie elected to have prophylactic double-mastectomy surgery to prevent breast cancer based on a positive test for mutation of the BRCA1 gene. What are some potential positive and negative consequences of this high-profile example of acting on the results of a genetic test?arrow_forward
- Suppose a 10-year old patient has come to your office with a very rare disease. One so rare that only 100 people for the past 100 years have been diagnosed and nobody knows the gene or genes that are mutated in this disease. Describe the gene sequencing toold you would use to identify the mutated gene or genes in this hypothetical disease.arrow_forwarda. When gene probes, fi ngerprinting, and sequencing make it possible for you to know about genetic diseases in you or one of your children, would you wish to use this technology to fi nd out? b. What if it were used as a screen for employment or insurance? c. Most of us would agree to growth hormone therapy for a child with dwarfi sm, but how do we deal with parents who want to give growth hormones to their 8-year-old son so that he will be “better at sports”?arrow_forwardDo a few cells created by therapeutic cloning of your own somatic cells constitute life? If these cells do constitute life, do they have the same rights as a human being conceived naturally? If it were possible, should someone be allowed to grow his or her own therapeutic clone into an adult?arrow_forward
- In order to manufacture insulin for patients with diabetes, scientists create recombinant DNA by inserting a human insulin gene into bacterial DNA and have the bacteria produce human insulin. Based on what you have learned in this unit about gene expression, what must the scientists do to the DNA sequence of the human insulin gene BEFORE inserting it into the bacteria, in order to have them produce the same insulin sequence that humans would produce? Explain.arrow_forwardWhat are the biggest challenges that mutations pose to oncologists and cancer biologists who seek to find novel cures against cancers?arrow_forwardLet’s say, you want to deliver a gene into a cell and in your lab, there are lot of options available to do that. Describe five different options that you can use to deliver that gene.arrow_forward
Human Heredity: Principles and Issues (MindTap Co...BiologyISBN:9781305251052Author:Michael CummingsPublisher:Cengage Learning