How Can My Genes Be Patented?
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1 How Can My Genes Be Patented? Presented by: Jaydee Hanson, International Center for Technology Assessment Eric Hoffman, Friends of fthe Earth Karuna Jaggar, Breast Cancer Action
2 Goals of this Webinar Provide background info and context: BRCA gene patent Gene patents broadly What are they? Why do they matter? BCAction s position on the BRCA patent Info and update on the Myriad lawsuit How you can take action
3 BRCA 1 & 2 BRCA gene is in everyone BRCA mutations increase risk of breast and ovarian cancer Patents owned by Myriad Testing available through Myriad Limits of tests currently
4 What is a patent? A license granted by a government to an inventor.
5 What else is important to know? How long does a patent last? Normally 20 years Who issues patents? The US Patent & Trademark Office What standards are used? Novelty Not Natural Useful Not a discovery
6 The US Patent Office allows gene patents Under current Patent Office practice, it's possible to hold a patent on a piece of human DNA, otherwise known as a gene. Currently, over 4,000 genes have been patented.
7 Supreme Court ruling on bacteria patent led to gene patents 1980: Diamond v. Chakrabarty - The Supreme Court found in favor of Ananda Mohan Chakrabarty, who claimed to engineer a bacteria to eat oil. 2011: Thousands of gene patents Patents on gene testst Patents on copies of genes Patents on parts of genes
8 Why patent genes? Holding a patent on a human, plant or animal gene gives the holder control over commercial exploitation of that gene. i.e. diagnosis or therapy $$$
9 Can a Patent stop Research? Yes and No
10 Companies and Gene Patents Winners- Companies that discovered the gene Losers- Other companies that want to develop products that use knowledge of the gene, i.e. tests, drugs
11 Most Genetically Associated Diseases Have Multiple Genes or Genetic Variants Alzheimer's Heart Disease Asthma Diabetes Most Cancers MS
12 Multiple Sclerosis Study finds 29 variants The UK study compared DNA from 9,772 people with MS with that from 17,376 healthy people. Largest study of the disease. Photograph: Rex Features
13 Problems with Gene Patents
14 Limit Patient Access to Genetic Tests Prohibitively high costs for tests1 Not all health insurance providers (particularly l Medicaid) cover costs of patented tests2,3 Prevent second opinion testing4
15 Limit it Researchers Access to Genetic Information 53% of genetics labs stopped doing research due to concerns about patented genes5 49% of American Society of Human Genetics members limited research due to gene patents6 Significant decline in published material on patented genetic information7 Prevent more affordable and effective tests from being developed8
16 Profit-Driven Research Patents not needed for test development9 Patents provide economic incentive to find genetic correlations to disease Research driven towards what can be patented and profitable100 Shifts focus away from environmental factors of disease
17
18 Not Just Breast Cancer Gene Patents Other gene patents have stopped research and harmed patients11 Hemochromatosis (Mercator Genetics) Myotonic dystrophy (MIT, University of Wales) Canavan disease (Miami i Children s Hospital Research Institute) Huntington s disease (The General Hospital Corporation) Long QT syndrome (University of Utah)
19 Other Concerns Not just human genes are patented Thousands of plant, animal, bacteria, and viral genes have been patented Ex: SARS and Avian Flu virus patent races Bio-piracyi Religious concerns
20 BCAction opposes the BRCA patent We believe: Companies cannot own our genes Gene patents impede research & innovation Myriad s monopoly harms patients Restricted access to expensive genetic tests Inability to get 2 nd opinions Limitations it ti on current test t utility
21 ACLU Lawsuit ACLU representing 18 plaintiffs: Researchers Genetic counselors & clinicians Individual id women affected Breast cancer and women's health groups Professional associations BCAction is the only breast cancer organization named as a plaintiff!
22 Where are we now? March 2010: U.S. District Court rules genes to be unpatentable facts of nature. July 2011: Federal Court of Appeals overturned decision; Myriad's gene patents are valid. BCAction has been a plaintiff in this lawsuit since We will continue to inform members of opportunities to take action.
23 Liberate the Breast Cancer Genes ACLU video on ACLU and BCAction websites:
24 How you can take action! Orgs can submit amicus curiae briefs. Individuals can support legislation banning gene patents call your legislators. l Talk with others about the harms of gene patents. Become a BCAction member & support our work.
25 Works Cited 1. Stiglitz, Joseph, and John Sulston. "The Case Against Gene Patents." The Wall Street Journal. 7 Oct < 2. "Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests." Secretary's Advisory Committee on Genetics, Health, and Society, Apr < 3. Myriad Genetic Laboratories. BRCA1 and BRCA2 Prevalence Tables for Mutations Detected by Sequencing, the 5-site Rearrangement Panel (LRP) and the BRACAnalysis Large Rearrangement Test (BART ) in High Risk Patients. Available at: 4. ACLU Compl. 23, available at 5. Cho, Mildred K., Samantha Illangasekare, Meredith A. Weaver, Deborah G. Leonard, and Jon F. Merz. "Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services." Journal of Molecular Diagnostics 5.1 (2003): Issac Rabino, How Human Geneticists in U.S. View Commercialization of the Human Genome Project, 29 Nature Genetics (2001) 7. Fiona Murray, Scott Stern, Do Formal Intellectual Property Rights Hinder the Free Flow of Scientific Knowledge? An Empirical Test of the Anti-Commons Hypothesis, Prepared for the NBER Academic Science and Entrepreneurship Conference (June 2005). 8. Secretary s Advisory Committee on Genetics, Health, and Society, Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests, p (2010); Tom Walsh, et al., "Spectrum of Mutations in BRCA1, BRCA2, CHEK2, and TP53 in Families at High Risk of Breast Cancer," JAMA 295(12): (March 22, 2006). 9. Ibid 10. Patenting Genes - Stifling Research and Jeopardising Healthcare. Rep. GeneWatch UK & EcoNexus, Apr Web. < 11. Cho, Mildred d K., Samantha Illangasekare, Meredith A. Weaver, Deborah G. Leonard, and Jon F. Merz. "Effects of Patents t and Licenses on the Provision of Clinical Genetic Testing Services."
26 Breast Cancer Action More questions? Contact us! Toll-free: 877-2STOPBC Your support counts! If you ve been inspired i today, consider making a donation of $25 or more. Visit our website to donate now!
27 Breast Cancer Action Challenging Assumptions. Inspiring Change.
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