Mapping our future: the impact of gene patents on scientific research and health care in the United States.

• Author: Lanning, Caitlin E.

1. 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 I. INTRODUCTION

   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. Scientists are in a race to discover new diagnostic technologies and treatments to bring an end to human anguish through the rapidly growing field of genetics. While cures are within the grasp of humanity's fingertips, current gene patent regulations act as roadblocks to uncovering such discoveries. Gene patents have long been a topic of debate, first with the discovery of DNA, and later with the Human Genome Project and the HapMap Project, which resulted in the discovery of the complete sequence of the human genome and further discoveries of gene sequences. (18)

   In September, 2011, the Senate passed H.R. 1249, the Leahy-Smith America Invents Act ("AIA"), which President Barrack Obama signed into law on September 16th. (19) The AIA is the largest transformation to U.S. patent law since 1952. (20) While the new legislation implements numerous, positive changes to the U.S. patent system, it fails to address any of the concerns raised by gene patent critics over the past few decades. (21) Gene patents should be categorized as patentable subject matter within the AIA, but under a separate patent category with specifically engineered regulations designed to promote scientific research and collaboration that will in turn foster quicker results in diagnostic technologies and treatments.

   Part I of this Note provides an educational background on genetics. Part II provides a background on the U.S. patent system, taking a historical look at patent legislation and case law, as well as the societal views surrounding gene patents. In general, this section analyzes the debate on whether genetic materials are patentable subject matter within the scope of 35 U.S.C. [section] 101. Part III lays a foundation of the AIA, and examines whether the new patent legislation properly regulates gene patents to stimulate and regulate scientific research and development. Part Iv analyzes the need for new regulations specifically designed for gene patents within the AIA, and proposes detailed guidelines to achieve stricter, more appropriate regulations for gene patents.

2. GENETICS 101: BASIC EDUCATIONAL FOUNDATION

   1. Dissecting the Double Helix of Deoxyribonucleic Acid

      An organism's complete set of deoxyribonucleic acid (DNA) (22) is known as its genome. (23) DNA is arranged in the nucleus of each cell within the human body. (24) Each nucleus contains two sets of chromosomes, one set given by each parent, for a total of forty-six chromosomes. (25) Each chromosome contains a single strand of DNA. (26) The DNA double helix is a linear arrangement of repeating nucleotides. (27) Nucleotides are composed of one sugar, one phosphate, and a nitrogenous base. (28) A nucleotide can contain one of four nitrogenous bases: adenine (A), guanine (G), cytosine (C), or thymine (T). (29) These bases pair up with one another, A with T, and C with G, to form base pairs. (30) The order of these base pairs "determines the information available for building and maintaining an organism, similar to the way in which letters of the alphabet appear in a certain order to form words and sentences." (31)

      A gene is "a specific sequence of nucleotides in DNA" found on a chromosome. (32) The specific sequence of nucleotides "determine[s] how, when, and where the body makes each of the many thousands of different proteins required for life." (33) "Genes make up less than [two] percent of human DNA." (34) The remaining DNA has important functions; however, those functions are still unknown. (35) It is speculated that those functions could "include regulating genes and maintaining the chromosome structure." (36) When a nitrogenous base changes within the nucleotide of a gene, disorders and diseases result. (37) For example, "cystic fibrosis (38) (chromosome 7) and sickle cell anemia (39) (chromosome 11) are caused by base sequence changes in a single gene." (40) Common diseases, such as cancer and diabetes, have complex causes that could be the result of base sequence changes on several genes encompassing several chromosomes. (41) In 1990, a project called the Human Genome (42) Project was orchestrated to learn more about the makeup of human DNA and genetic material. (43)

   2. The Human Genome Project

      The Human Genome Project ("HGP") was a collaborative, international research project aimed at producing a complete map of the human genome. (44) The project was expected to take fifteen years, but was completed in 2003.45 The HGP decoded the human genome in three ways. (46) First, it determined the sequence of all the nitrogenous bases that comprise DNA. (47) Second, it produced maps of gene locations and sections of chromosomes. (48) Third, it produced linkage maps to track inherited traits over generations. (49) The full genetic sequence of the human genome was completed in April 2003, which revealed about 20,500 human genes. (50) Knowledge regarding the make-up of DNA and the sequences that compose genes has and will continue to lead to revolutionary mechanisms in research, technology, diagnoses, treatments, and preventive measures in healthcare, and within medical fields. (51)

   3. The HabMap Project

      Concurrently with the HGP, the International HapMap (52) Consortium launched the International HapMap Project (HapMap Project) in 2002. (53) The HapMap Project was "aimed at speeding [up] the discovery of genes related to common illnesses [and diseases]." (54) Uncovering the genetic variations that lead to common diseases such as Alzheimer's, cancer, and diabetes is difficult because these disorders are caused by variations in multiple genes versus a single variation within one gene. (55) The variations in the nitrogenous bases within DNA are called single nucleotide polymorphisms (SNPs). (56) A set of SNPs found on the same chromosome is known as a haplotype. (57) The HapMap Project produced a public database of the SNPs and haplotypes that the project uncovered in order to share the results internationally with other scientists. (58) Scientists use SNPs and haplotypes to compare the genetic differences between healthy individuals and individuals with common diseases. (59) By looking at the...