Mapping Our Future: The Impact of Gene Patents on Scientific Research and Health Care in the United States

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I. INTRODUCTION II. GENETICS 101: BASIC EDUCATIONAL FOUNDATION     A. Dissecting the Double Helix of Deoxyribonucleic Acid     B. The Human Genome Project     C. The HabMap Project     D. The Future of Genetic Research III. THE HISTORY OF THE U. S. PATENT SYSTEM AND THE EFFECT   OF THE LEAHY-SMITH AMERICA INVENTS ACT     A. Legislative History of the United States Patent System     B. The Common Law Approach to Gene Patents       1. The Impact of Diamond v. Chakrabarty       2. The Ongoing Debate of the Ass'n for Molecular Pathology         v. U.S. Patent & Trademark Office       3. Society's Split on Gene Patents           i. Monopolies           ii. The Effects on Science and Genetic Research           iii. Patenting an Aspect of Nature IV. LEAHY-SMITH AMERICA INVENTS ACT ("AIA")     A. Patent Processing       1. First-Inventor-to-File           i. Changes Made by the FITF System           ii. Exceptions to the FITF System       2. Submissions by Third Parties       3. Inventors Oath       4. Tax Strategies with Patent Applications       5. Human Organisms       6. Prioritized Examination       7. Faster Patent Processing       8. Derivation Proceedings     B. Post-Patent Proceedings and Review       1. Inter Partes Review       2. Post Grant Review       3. Supplemental Examination     C. Litigation       1. Defenses to Infringement Cases       2. Joinder of Parties in Infringement Litigation Cases       3. Venue       4. Advice of Counsel Defense       5. False Marketing Cases     D. The AIA's Answers for Gene Patents and Scientific Research V. THE IMPACTS OF GENE PATENTS ON SCIENTIFIC RESEARCH AND THE NEED   FOR LEGISLATIVE GUIDELINES     A. The Creation of a New Patent Category: Gene Patents     B. A Reduction in Patent Protection to Implement Collaboration     C. GenBank Database     D. Patent Pooling VI. CONCLUSION 


Kathy Hopkins was the eldest of seven children. She was a single mother, and the sole supporter of her son. In the spring of 2007, Kathy was diagnosed with stage four glioblastoma multiform ("GBM"). GBM is a compilation of small tumors within the glia or the precursors of the glia within the central nervous system. (1) This form of brain cancer is "the most aggressive of the glimoas." (2) Most individuals with GBM die in less than a year from the date of diagnosis. (3) Even with treatment, the life expectancy of individuals diagnosed with GBM only increases from two months to a year. (4) Kathy's tumor was inoperable. Her only options for treatment included chemotherapy and radiation. Determined that the medical community would discover a cure, Kathy chose to try every medical procedure available in hopes that she could defeat GBM. on April 1, 2009, two years after her diagnosis, at the age of 63, Kathy passed away surrounded by her loving family. (5)

Greg Knittel was the Classics' Chairman, Dean of Teachers, and founding soccer coach at St. Ignatius High School in Cleveland, Ohio. (6) Greg, fondly known by his students and the Ignatius community as "Doc," was forced to retire from St. Ignatius when he lost the ability to control his car on his drive into work. (7) Greg was suffering from amyotrophic lateral sclerosis ("ALS"). (8) The major cause(s) of ALS, also commonly referred to as Lou Gehrig's (9) disease, are unknown. (10) Ten percent of all ALS cases are genetically based. (11) ALS causes neurons (12) to slowly waste away and eventually die, resulting in "muscle weakening, twitching, and eventually the inability to move the arms, legs, and body." (13) This is caused by the inability of neurons to "send messages to [the] muscles" of the body after neurons have died. (14) Individuals with ALS typically die within three to five years after being diagnosed. (15) only about twenty five percent of individuals diagnosed with ALS live beyond five years. (16) On February 5, 2013 Greg "Doc" Knittel passed away surrounded by his loving family. (17)

Kathy and Greg are only two individuals, out of millions, who have suffered or who are currently suffering from incurable diseases. …