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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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_forwardScientists carried out a microarray analysis to compare the gene expression of normal pancreatic cells to that of cancer cells from a person with pancreatic cancer. The scientists labeled the cDNA from the normal pancreatic cells with green fluorescent nucleotides. They labeled the cDNA from the cancer cells with red fluorescent nucleotides. The two cDNAs were mixed and allowed to hybridize to a microarray. Less p53 activity is found in cancer pancreatic cells than normal cells. What color would the spot for the p53 gene be on the microarray? Red Green Yellow Blackarrow_forward2)You would expect liver cells and muscle cells to have the same gene expression. a)True b)Falsearrow_forward
- A graduate student who has not taken BIOL 519 thinks they have discovered a new oncogene that could cause breast cancer. The student transfects cells with this oncogene and finds that the cells proliferate uncontrollably. The student next designs a PCR assay that will detect the presence of the oncogene in cancerous breast tissue. The student sets up the assay and analyzes the presence of the oncogene in normal and tumor issue samples (See data below). The student is disappointed to see that the potential oncogene is present at similar levels in both the normal and tumor tissue. Therefore, the student concludes that this gene is not an oncogene. Do you agree with this conclusion? Justify your answer (5-6 senetences max).arrow_forwardA graduate student who has not taken BIOL 519 thinks they have discovered a new oncogene that could cause breast cancer. The student transfects cells with this oncogene and finds that the cells proliferate uncontrollably. The student next designs a PCR assay that will detect the presence of the oncogene in cancerous breast tissue. The student sets up the assay and analyzes the presence of the oncogene in normal and tumor issue samples (See data below). The student is disappointed to see that the potential oncogene is present at similar levels in both the normal and tumor tissue. Therefore, the student concludes that this gene is not an oncogene. Do you agree with this conclusion? Justify your answer (5-6 senetences max). Oncogene? GADPH Normal Tumor 1 Tumor 2 Tumor 3arrow_forwardDolly is the first mammal to have been successfully cloned from an adult cell Which of the following statement/s is/are most relevant to the birth of Dolly? I. It suggests that human could be cloned. II. It proves that specialized cells could be used to create an exact copy of the animal they came from. III. It improves the production of milk, meat, and other products from livestock. IV. It proves that animals could be cloned to have gene mutations that help scientists study diseases that develop in the animals. A. II only B. I and II C. III, and IV D. II, III, and IV Which of the following statements best explain the significance of mitosis and ? A. Both mitosis and meiosis produce diploid cells which responsible for the continuity of life. B. Many single-celled organisms rely on mitosis and meiosis as their primary means of asexual reproduction C. replication, cells have another interesting choice, whether they want to make an identical copy, or do they want to make four half-copies…arrow_forward
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- Mutations in the CFTR gene result in cystic fibrosis in humans, a conditions in which abnormal secretions are present in the lungs, pancreas, and sweat glands. The gene was mapped to a 500-kb region on chromosome 7 containing 3 candidate genes. a)Using your knowledge of the disease symptoms, how would you distinguish between the candidate genes to decide which is most likely to encode the CFTR gene? b)How would you prove that your chosen candidate is the CFTR gene?arrow_forwardAnswer the two parts of the question. a) Explain what gene therapy involves.b) Discuss how gene therapy can be used to treat/cure or prevent a disease and include in your answer any current challenges associated with its use.arrow_forwardIdentical (monozygotic) twins have identical genomes. In one pair of identical twins, they inherit a dominant, disease-causing allele from one of their biological parents. However, one twin has symptoms of the genetic disease while the other does not. This is likely an example of… 1.) RNA interference 2.) pleiotropy 3.) DNA methylation 4.) alternative splicing 5.) incomplete penetrancearrow_forward
- Human Heredity: Principles and Issues (MindTap Co...BiologyISBN:9781305251052Author:Michael CummingsPublisher:Cengage Learning