NOTE :: Scientific innovation is crucial to the prosperity, security, and health of a nation. During the founding years of the United States, political leaders realized the need for such innovation and created the patent law system 2 as a means of protecting American citizens. The major goals of the United States patent law system are to provide the public with cutting-edge scientific discoveries and to enlighten the public as to how these discoveries can benefit society.
In modern America, a substantial amount of patent protection is sought for inventions relating to the pharmaceutical industry. In recent decades, the pharmaceutical industry has expanded rapidly as researchers invent new and more effective drugs and products. The average life expectancy and quality of life of United States citizens has drastically increased in the past century, largely due to pharmaceutical innovation. Nonetheless, nearly sixty million people die each year, with many of these deaths caused by problems that pharmaceutical companies are striving to cure.
In the late 1970s, scientific researchers began to view genetic material as a means of developing treatment options for a variety of human diseases. Today, approximately two-thirds of the new drugs that hit the market have been influenced by genetic research, and genetic material has been linked to more than 850 human diseases. Additionally, biotechnology investors have indicated-with their pocketbooks-that they believe that the future of disease prevention and treatment is tied to genetic research. Despite the fact that pharmaceutical companies have invested billions of dollars for development of gene-related cures and treatments for human illnesses, the general public and the United States District Court for the Southern District of New York wish to rein in the intellectual property rights afforded to these companies. Furthermore, the United States Court of Appeals for the Federal Circuit (C.A.F.C.) is divided in regard to DNA patentability and has indicated that any change to DNA-patenting policy would be most effectively propagated legislatively.
In our society, there is a large disconnect between the supposed interests of the public and the pharmaceutical industry. In general, the public desires medical innovation but prefers to benefit from these medical advances at minimal cost. Meanwhile, the pharmaceutical industry is merely a business, and businesses are built on profit maximization. Because the pharmaceutical business is premised on seemingly altruistic purposes, the industry is an easy target for individuals who cannot afford its services. Due to the nature of the pharmaceutical industry, profit maximization benefits the general public. Therefore, decreasing pharmaceutical company profits necessarily has the unintended side effect of decreasing public health benefits. This complicated equilibrium has been convoluted further by the district court ruling, and the subsequent divided C.A.F.C. ruling, in the recent Myriad case.
This Note will explore the seemingly contradictory interests of the general public, the pharmaceutical industry, and the research community regarding human gene patents. Part I will look at the recent Myriad decisions in light of previous beliefs about the patentability of genetic material. Part II will examine the effect of gene patenting on scientific research and innovation. Parts III and IV will explore the effect of gene patents on both the general public and the pharmaceutical industry, and will seek to understand the belief dissonance between these two factions. Part V will consider how Congress has handled similar problems in the past through legislation, specifically in regards to plant patents and biological drugs. Part VI will discuss the possibility of finding a solution to the gene patent problem that satisfies the research community, the general public, and the pharmaceutical industry. Ultimately, this Note will analyze the success of prior legislation in order to propose a course of action that will appease all parties involved in the human gene patenting debate.
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