Weekly Policy Bulletin - March 31, 2010
On Monday, March 29, a federal judge issued a summary judgment ruling in Association for Molecular Pathology v. USPTO and Myriad Genetics that invalidates certain patents related to the breast and ovarian cancer genes BRCA1 and BRCA2. Genetic Alliance filed an amicus curiae brief opposing positions taken by the plaintiffs, not just because we disagree with the plaintiffs' factual and legal positions, but more importantly, because we believe the remedies demanded by plaintiffs would undermine genetic and biotechnological research breakthroughs urgently needed by patients. Although this case will work its way through appeals courts, this decision has far-reaching implications for future patenting of human genes and genetic medicine.
Read a helpful summary of the judge's decision and a discussion of the practical outcome of this ruling from the Genomics Law Report.
Please join Genetic Alliance tomorrow, Thursday, April 1 from 12:00pm - 1:00pm EDT, for a free webinar that will explain the basics of the law regarding gene patenting. Although patents have been granted on thousands of isolated and purified human genes, the practice of gene patenting remains ill understood and fraught with controversy. Professor John Conley of the University of North Carolina School of Law will review the understanding of genetics on which the patentability of genes has been based, discuss the most significant cases establishing gene patentability, review current developments, and offer some predictions about future directions. Ann Waldo, Senior Counsel at Genetic Alliance, will moderate the discussion. We invite you to hear Professor Conley shed light on this heated and complicated topic.
The 2010 Annual Conference of the National Library of Medicine (NLM) and the Friends of the National Library of Medicine (FNLM) will host its Annual Conference on Tuesday, April 6 and Wednesday, April 7 at the National Institutes of Health in Bethesda, MD. The focus of the meeting will be "The ePatient: Digital and Genomic Technologies for Personalized Health Care," and it will feature sessions highlighting hot topics in the fields of comparative effectiveness and innovation, health information technology through the lenses of connectivity, vendors, and decision support, social networks for health research, biomarkers in research and clinical care, and telemedicine. The meeting aims to underscore critical considerations and opportunities for patient care in the intersection of genomic, digital, and wireless technologies.
The Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) recently released two videos in a new series of educational trainings developed by the Division of Education and Development that focus on the HHS regulations for the protection of human subjects in research. The recently launched videos address 1) the research use of human biological specimens, and 2) the reviewing and reporting of unanticipated problems and adverse events. Both films are best suited for individuals with previous knowledge of the HHS regulations, but all videos can be reproduced, shared, or incorporated into training materials. Educational films to be released soon include Institutional Review Board (IRB) membership, general informed consent requirements, and IRB records. View the HHS website for more information
Edited by: Molly Brenner, Andria Cornell, and Sharon F. Terry
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