Abstract

     Advances in genetics and molecular biology have changed our views on what life means and what a human being is. They will ultimately reshape the interpretation of terms such as “reproduction, individuality, history, freedom and subjectivity.” For the past several decades, emerging frontiers of biotechnology have grown dramatically and continue to offer innovative methods to detect, diagnose, and treat diseases. Recently, much of the attention of the biotechnology industry has been focused on the Human Genome Project, which has a primary goal of producing a roadmap of the human genome. The potential being delivered by this gene map is immense, as the knowledge on gene sequences can serve as a starting point for scientists to understand the functions of genes and how alterations in gene’ structure and function may affect a disease state. Genomics has not only become a “vast scientific” venture but also a “commercial enterprise.” Both public and private sectors have entered into this arena to search for new and better ways to prepare vaccinations, cure diseases, and relieve the suffering caused by debilitating conditions. In the meantime, researchers have sought for and obtained patents to protect their knowledge of human genes. The World Health Organization has reported that an increasing number of patent applications have been filed to claim inventions related to gene sequences. These patent applications and granted patents have generated considerable discussion and debate on the acceptability of gene patenting.
     Generally, in order to obtain a patent, an invention must be a patentable subject matter that is novel, non-obvious, and useful, and must comply with the written disclosure requirements in 35 U.S.C. §112. Under current U.S. patent law, a deoxyribonucleic acid (“DNA”) sequence is a patentable subject matter as a composition of matter or an article of manufacture. However, naturally occurring genes are not eligible for a patent; therefore, to be patentable, a DNA molecule must be “isolated and purified” from its natural state. Similar to all other inventions, inventions directed to DNA sequences also need to fulfill all statutory requirements under U.S. patent law.
     The U.S. economy has become increasingly dependent on technological innovations. The patent system has worked well for more than 200 years to foster innovation and its commercial development. As for other areas of inventions, patent protection for DNA sequences will be needed to provide incentives to invent and discover, and to secure new capital for growth.
     On the other hand, patenting DNA sequences is not free of problems. Because of the unique nature of DNA sequences, DNA technology has fundamentally changed the way that biological and medical research is conducted. The term, “invention,” has acquired a new meaning, and patents on DNA sequences are intrinsically different from traditional mechanical patents. As discoveries of new genes and knowledge gained from genomic research continue to have substantial impact on development of drugs and therapeutics for humans, people have stronger feelings about DNA sequence patents. Some researchers, physicians, non-profit organizations and religious groups have opposed patenting DNA sequences. They believe that granting patent rights on DNA sequences will lead to “private appropriation of the genetic commons.” Furthermore, patents have been issued to cover short  DNA fragments, such as expressed sequence tags (“EST”) and single nucleotide polymorphisms (“SNP”), as well as large fragments that contain genes of medical interest. Sometimes, the patented small fragments turn out to be part of the gene covered by the patent claiming the larger fragment. Under the current system, both patents can co-exist. However, “the second patent holder may have to obtain licenses from . . . the primary patent holder but is not prevented form obtaining the second patent.” While the law allows multiple patents to be granted on the same sequence, certain groups fear that this trend will lead to more litigation. Additionally, others argue allowing DNA patents will result in higher expenses in obtaining licenses to conduct research, more costly products, and heavier burdens on the healthcare system. For example, Myriad Genetics, a U.S. company, holds patents on BRCA1 and BRCA2 genes, which indicates susceptibility to breast cancer. It charges $2,680.00 for each diagnostic test. Healthcare professionals are worried that women at risk for breast cancer will be adversely affected by Myriad’s monopoly. Furthermore, while recognizing that patents protect the intellectual property and efforts of the inventors, many have expressed concerns that exclusive rights granted to the inventors of gene patents may block public access to important information, which in turn will impede genetic research, inhibit technology development, and ultimately produce an adverse effect on public health.
     In order to maintain a balance among the competing interests with regard to patenting DNA sequences, changes are needed to avoid the pitfalls in the current system. Modifications to the current system will ensure that gene patents continue to serve their intended purpose of promoting science and exchange of information, while further ensuring that exclusive property rights on sequences do not impede the research and development of new technologies.
     This paper argues that some of  the concerns posed by patenting DNA sequences can be addressed through changes made by the United States Patent and Trademark Office (“USPTO”). First, the U.S. has recently revised its examination guidelines for the utility requirement and written description requirement. The new heightened guidelines will work to eliminate ineligible claims, improve the quality of DNA sequence patents, and reduce the likelihood that a patent may be challenged by a third party. Also, the inter partes re-examination procedure can serve as an inexpensive alternative to full litigation in challenging a patent. Furthermore, this paper will propose solution-oriented reform structures, which are necessary to improve the current system. A patent pool can be used as a powerful tool to make obtaining a license much easier. Additionally, legislative changes including compulsory licensing schemes and research exemptions will ensure that the granting of DNA patents does not affect scientific research. Ultimately, a fundamental reform of the patent law may serve as the true gatekeeper in guarding against invalid patents.