OncoLog Volume 47, Number 01, January 2002

Preserving and Restoring the Ability to Swallow in Patients with Head and Neck Cancer Requires a Team Approach Modified Barium Swallow Helps Speech Pathologists Determine What Patients Are Able to Eat House Call: Common Cancers, Common Symptoms Portal Vein Embolization Offers More Pateints an Opportunity for Potentially Curative Hepatic Resectionhttps://openworks.mdanderson.org/oncolog/1102/thumbnail.jp

OncoLog Volume 45, Number 02, February 2000

National Cooperation Leads to New Standard of Treatment for Cervical Cancer House Call: Stress and Cancer: What\u27s the Connection? Researchers Study Hormone Intervention Therapy to Prevent Treatment-Induced Sterility Protocols: Cervical Cancer Clinical Trials Regular Pap Smears Still Key to Preventing Cervical Cancerhttps://openworks.mdanderson.org/oncolog/1082/thumbnail.jp

OncoLog Volume 46, Number 07/08, July/August 2001

Chemoprevention Researchers Look for Ways to Halt the Process of Carcinogenesis House Call: HPV and Cancer: What Every Woman--and Man--Should Know Chemoprevention Trial Targets Former Smokers DiaLog: Serving International Clients, by Wendeline Jongenberger, MBA, Director, International Programs Protocols: Chemoprevention Clinical Trialshttps://openworks.mdanderson.org/oncolog/1094/thumbnail.jp

OncoLog Volume 47, Number 10, October 2002

A Natural Progression: M. D. Anderson Cancer Center Promotes the Study and Integration of Complementary Therapies New AJCC Staging System for Hepatocellular Carcinoma Reflects Patient Prognosis After Surgical Resection DiaLog: Complementary Medicine: Research, Education, and Communication, by Stephen P. Tomasovic, PhD, Professor of Molecular and Cellular Oncology and Vice President for Educational Programs House Call: Making the Cancer Journey Easierhttps://openworks.mdanderson.org/oncolog/1110/thumbnail.jp

OncoLog Volume 48, Number 10, October 2003

\u27Hitting Bladder Cancer on All Fronts\u27: Researchers Focus on Improving Therapies and Identifying Biomarkers Restoring Erectile Function in Patients Treated for Prostate Cancer: Efforts across Disciplines Address Physical, Psychological, and Emotional Factors Related to Sexual Potency House Call: Note to Self: Get Screened for Colon Cancer DiaLog: Sexual Function and Prostate Cancer: The Importance of Realistic Expectations, by Leslie R. Schover, PhD, Professor, Department of Behavioral Sciencehttps://openworks.mdanderson.org/oncolog/1123/thumbnail.jp

OncoLog Volume 45, Number 09, September 2000

Multidisciplinary Care Improves Treatment, Enhances Quality of Life for Patients with Colorectal Cancer DiaLog: Treating Cancer with a Team Approach, by David L. Callender, MD, Senior Vice President and Chief Medical Officer Cervical Cancer Prevention: Could Spectroscopy Steal the Spot light ? Virtual Colonoscopy a Potential Screening Reality Protocols: Clinical Trials for Colorectal Cancer Compass: Clinical Practice Guidelines House Call: Sharing Personal Stories: Books Written by People with Cancerhttps://openworks.mdanderson.org/oncolog/1088/thumbnail.jp

OncoLog Volume 47, Number 11, November 2002

Diagnosis Based on Nonsurgical Biopsy: A Cooperative Effort Benign Care: Young Patients with a Variety of Noncancerous Conditions Find Treatment at M.D. Anderson Cancer Center Cognitive Interventions Are Crucial for Many Patients with Neurofibromatosis FNA Clinic Streamlines Biopsy Diagnosis of Palpable Lesions Is This Going to Hurt? , by Frank A. Morello Jr., MD, Assistant Professor, Section of Vascular and Interventional Radiology House Call: Answers to Common Questions about the Use of Radioisotopes for Diagnosishttps://openworks.mdanderson.org/oncolog/1111/thumbnail.jp

University of Texas / M.D. Anderson Cancer Center Newsletter

Monthly report discussing cancer care and research to inform physicians

Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year\u27s end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court\u27s decision. A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians\u27 offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product\u27s distinction from the DNA found in nature. In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders