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Issues for Today and Tomorrow Ownership Rights: Patents for Derivatives of the Human Body Larnita Pette May 19, 2009  (Upd...
<ul><li>Existing intellectual property laws favor those with the technology, the expertise, and the capital. All we have i...
How Did We Get Here? <ul><li>Diamond v. Chakrabarty  447 U.S. 303 (1980) an appeal from U.S. Court of Customs and Patent A...
Question of Ownership Rights <ul><li>Ownership of Source Material </li></ul><ul><ul><li>Donor </li></ul></ul><ul><ul><ul><...
Today’s Situation <ul><li>Result of Human Genome Project (1990 to 2003) </li></ul><ul><ul><li>20% of genes identified in h...
Strategies to Protect Donor Rights <ul><ul><li>Sweden has specific tissue-banking regulations with very strict consent req...
Recommendations <ul><li>Strict Regulation of Donor Informed Consent Rules </li></ul><ul><ul><li>Donors maintain an ownersh...
The Genetic Privacy Act  <ul><li>Each person who collects a DNA sample (e.g., blood, saliva, hair or other tissue) for the...
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Ownership Rights:: Patents for Derivatives of the Human Body

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Who owns your genes... It's complicated.

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  • Australia Whose DNA .pdf, Tonga &amp; Iceland, Biotech, Ownership and Consent Indigenous peoples and culturally appropriate informed consent and ownership of DNA. Genomic studies are also being undertaken with populations which do not identify themselves as indigenous peoples, such as the UK, Norfolk Island, Mormons and in Iceland. Such populations are sometimes targeted because they have well documented genealogical histories, making them valuable for tracing inherited diseases. In Iceland availability of genealogies date back centuries. Informed consent claimed through an act of parliament. decode a commercial firm. October 1999, Autogen Ltd announced an agreement in principle to form a strategic alliance with Merck Lipha, a subsidiary of Merck Kga A of Darmstadt, Germany the manufacturer of metformin the world’s top selling drug for the treatment of diabetes. Metformin holds 50% of the market for the treatment of Type 2 Diabetes in Australia.- introduced to the US market in 1996, where it became the #1 best seller. Object of Autogen/Merck Human Genetics Project is discovery of human genes involved in weight imbalance, Type 2 Diabetes and insulin resistance. Details of deal to share compensation with the Tongan people and the catch which caused Autogen to abandon research on TANIS gene
  • Who Owns Your Body The California Supreme Court agreed that Moore did have a claim for breach of fiduciary duty and lack of informed consent because Dr. Golde had failed to disclose the extent of his research and his economic interest in Moore’s cells. The court stated in its decision, that an adult of sound mind has the right to exercise control over his own body and, within that right, should have the power of deciding whether or not to submit to lawful medical treatment. For that power to be effective, the court stated, a patient’s consent must be informed consent. The Florida district court did find that Matalon and his group had unjustly benefited from the licensing fees negotiated under the commercial patent. However, the Florida court also ruled that the case involved no patient-physician relationship—because Dr. Matalon was not a treating physician to the Canavan patients or their families—and thus found no breach of duty of informed consent. The case of Washington University v. Catalona highlights the reality, that researchers themselves have limited rights over their own work, and provides a focal point by which to explore the question: How does informed consent grant a researcher the right to explore one’s biological materials in the name of science, and does it strip consenting patients of all interests in something that is uniquely their own? The district court found that WU had alone assumed the burden of all legal, regulatory, and compliance risks with respect to all research done in connection with the biorepository that Dr. Catalona had helped to create. The court found thus that WU had, at all times, exercised undisputed and exclusive possession over the samples in question, demonstrating prima facie evidence of ownership. The court ruled that the samples were donated to WU as gifts and donors had no ownership interest in those samples. Dr. Catalona appealed the decision.
  • Transcript of "Ownership Rights:: Patents for Derivatives of the Human Body "

    1. 1. Issues for Today and Tomorrow Ownership Rights: Patents for Derivatives of the Human Body Larnita Pette May 19, 2009 (Updated December 2011)
    2. 2. <ul><li>Existing intellectual property laws favor those with the technology, the expertise, and the capital. All we have is the raw material our blood. We should not sell our children’s blood so cheaply. </li></ul><ul><ul><ul><ul><ul><li>Lopeti Senituli, Director of Tongan Human Rights and Democracy Movement, Genomics, Society and Policy, Vol. 1 No. 1(2005), ISSN:1746-1554 p. 46 </li></ul></ul></ul></ul></ul>
    3. 3. How Did We Get Here? <ul><li>Diamond v. Chakrabarty 447 U.S. 303 (1980) an appeal from U.S. Court of Customs and Patent Appeals </li></ul><ul><ul><li>Diamond, Commissioner of Patents and Trademarks v. Chakrabarty, Microbiologist </li></ul></ul><ul><ul><li>Chakrabarty filed patent claim for human made, genetically engineered micro-organism capable of breaking down crude oil. </li></ul></ul><ul><ul><li>Court ruled that genetically modified bacteria were patentable. </li></ul></ul><ul><li>Moore v. The Regents of the University of California, et al. 51 Cal. 3d 120 (1990) </li></ul><ul><ul><li>Donors of biological materials do not have ownership rights in their biological materials. </li></ul></ul><ul><ul><li>Researchers who obtain patents on inventions derived from the biological materials, and reap economic benefits from the patents, are not liable for conversion. </li></ul></ul><ul><li>Greenberg et al. v. Miami Children’s Hospital Research Institute et al. (2003) Settled August 6, 2003 </li></ul><ul><ul><li>Donor has no property rights to tissue and genetic information derived from voluntarily donated, excised tissue. </li></ul></ul><ul><ul><li>Informed consent established regarding degree and licensing enrichment by researchers. </li></ul></ul><ul><li>Washington University v. Catalona , 490 F.3d 667 (8th Cir. (Mo.) 2006 </li></ul><ul><ul><li>Court ruled that Washington University controlled patient’s donated tissue; donors could not direct that the tissue be delivered to Catalona or to another university </li></ul></ul><ul><ul><li>Patients forfeited right to control donated tissue. </li></ul></ul><ul><ul><li>Control of tissue belonged to Washington University </li></ul></ul>
    4. 4. Question of Ownership Rights <ul><li>Ownership of Source Material </li></ul><ul><ul><li>Donor </li></ul></ul><ul><ul><ul><li>Informed Consent </li></ul></ul></ul><ul><ul><ul><li>Department of Health and Human Services Regulations, 45 C.F.R 46.116. </li></ul></ul></ul><ul><ul><ul><ul><li>Applicable regulations mandate that the basic elements of informed consent should include &quot;clear descriptions&quot; of: </li></ul></ul></ul></ul><ul><ul><ul><ul><li>The operation of the cell repository; </li></ul></ul></ul></ul><ul><ul><ul><ul><li>The specific types of research to be conducted; </li></ul></ul></ul></ul><ul><ul><ul><ul><li>The conditions under which data and specimens will be released to recipient-investigators; and </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Procedures for protecting the privacy of subjects and maintaining the confidentiality of data. </li></ul></ul></ul></ul><ul><li>Ownership of Gene Patents </li></ul><ul><ul><li>Creates Monopoly </li></ul></ul><ul><ul><ul><li>Single source for gene sequences. </li></ul></ul></ul><ul><ul><li>Restricts Peer Review </li></ul></ul><ul><ul><ul><li>License required to do research. </li></ul></ul></ul><ul><ul><ul><li>License costs can limit research </li></ul></ul></ul><ul><ul><ul><ul><li>SmithKline Beecham Clinical Laboratories (now GlaxoSmithKline) sent letters demanding licensing fees for use of the patented haemochromatosis gene to academic and commercial laboratories, 30% of those laboratories discontinued testing and/or ceased development of testing. </li></ul></ul></ul></ul>
    5. 5. Today’s Situation <ul><li>Result of Human Genome Project (1990 to 2003) </li></ul><ul><ul><li>20% of genes identified in human genome </li></ul></ul><ul><ul><li>4,382 genes of the 23,688 genes in database referenced in 4,270 patents by 1,156 assignees. </li></ul></ul><ul><ul><li>78% of gene patents are owned by for profit entities. </li></ul></ul><ul><ul><ul><li>15% of such patents are for inventions arising from Federally Funded Research </li></ul></ul></ul><ul><li>Some Consequences of Commercialization of Genetic Research. </li></ul><ul><ul><li>Limited research in: </li></ul></ul><ul><ul><ul><li>Alzheimer’s research </li></ul></ul></ul><ul><ul><ul><li>Diabetes research </li></ul></ul></ul><ul><ul><ul><li>Autism research </li></ul></ul></ul><ul><ul><ul><li>Breast Cancer (BRCA1 and BRCA 2 patents) </li></ul></ul></ul><ul><ul><ul><ul><li> </li></ul></ul></ul></ul>
    6. 6. Strategies to Protect Donor Rights <ul><ul><li>Sweden has specific tissue-banking regulations with very strict consent requirements. </li></ul></ul><ul><ul><li>Denmark allows individuals who gave required blood samples at birth to demand the return of their tissue samples. </li></ul></ul><ul><ul><li>Iceland requires that the source of the human tissue retain an interest in her tissue and maintain control over its future use. </li></ul></ul><ul><ul><li>In Australia, Autogen/Merck diabetes research, The Human Genetics Project, was discontinued by Tongan government after Autogen announced discovery of gene named TANIS. </li></ul></ul><ul><ul><ul><li>Autogen could reap increase in Venture Capital funding and share price as soon as agreement with Tonga was announced, while the Tongan people would receive royalties only if a pharmaceutical use for the diabetes research was developed from their blood. </li></ul></ul></ul>
    7. 7. Recommendations <ul><li>Strict Regulation of Donor Informed Consent Rules </li></ul><ul><ul><li>Donors maintain an ownership interest in their genetic material. </li></ul></ul><ul><ul><li>Researchers, Research Institutions and University Laboratories exemption from license fees. </li></ul></ul><ul><li>Congressional laws defining informed consent for donors </li></ul><ul><ul><li>Donors need clear understanding of the implications of informed consent when donating blood, tissue or organs. </li></ul></ul><ul><li>Court rulings on informed consent and restrictions on patentability of genes </li></ul><ul><ul><li>ACLU complaint filed May 12, 2009 </li></ul></ul><ul><ul><li>http://www.aclu.org/freespeech/gen/brca.html </li></ul></ul><ul><ul><li>On March 29, 2010, a New York federal court ruled that the patents on the BRCA1 and BRCA2 genes are invalid . </li></ul></ul><ul><ul><li>In April 2011, the U.S. Court of Appeals for the Federal Circuit heard Myriad's appeal of that ruling. </li></ul></ul><ul><ul><li>In July 2011, the appeals court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences. </li></ul></ul>
    8. 8. The Genetic Privacy Act <ul><li>Each person who collects a DNA sample (e.g., blood, saliva, hair or other tissue) for the purpose of performing genetic analysis is required to: </li></ul><ul><ul><li>provide specific information verbally prior to collection of the DNA sample; </li></ul></ul><ul><ul><li>provide a notice of rights and assurances prior to the collection of the DNA sample; </li></ul></ul><ul><ul><li>obtain written authorization which contains required information; </li></ul></ul><ul><ul><li>restrict access to DNA samples to persons authorized by the sample source; </li></ul></ul><ul><ul><li>abide by a sample source's instructions regarding the maintenance and destruction of DNA samples. </li></ul></ul><ul><li>The sample source has the right to: </li></ul><ul><ul><li>determine who may collect and analyze DNA; </li></ul></ul><ul><ul><li>determine the purposes for which a DNA sample can be analyzed; </li></ul></ul><ul><ul><li>know what information can reasonably be expected to be derived from the genetic analysis; </li></ul></ul><ul><ul><li>order the destruction of DNA samples; </li></ul></ul><ul><ul><li>delegate authority to another individual to order the destruction of the DNA sample after death; </li></ul></ul><ul><ul><li>refuse to permit the use of the DNA sample for research or commercial activities; and </li></ul></ul><ul><ul><li>inspect and obtain copies of records containing information derived from genetic analysis of the DNA sample. </li></ul></ul>The Final Report of &quot;Guidelines for Protecting Privacy of Information Stored in Genetic Data Banks&quot; funded by the Ethical, Legal & Social Implications of the Human Genome Project, Office of Energy Research, U.S. Department of Energy, No. DE-FG02-93ER61626. February 28, 1995
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