Patents prevent anyone but the patent-holder from manufacturing, using, or distributing discoveries and inventions for twenty years from the date of filing. In order to be patentable, an invention needs to be useful, non-obvious, and represent an original design or process rather than an abstract concept or item commonly found in nature. Patents related to genetics received their first legal test in 1980, when the U.S. Patent and Trademark Office (USPTO) granted protection to a genetically engineered bacterium that consumed oil and was useful in cleaning oil spills. The legality of this patent was affirmed in Diamond v. Chakrabarty, where the Supreme Court observed that although “[t]he laws of nature, physical phenomena, and abstract ideas” were not patentable subject matter under § 101, the claimed invention in the case was distinguished from nature as “a product of human ingenuity having a distinctive name, character and use.” The Court held that although the invention comprised a living thing, the patentee had produced a new bacterium with “markedly different characteristics” from the original. The bacterium was, therefore, “not nature’s handiwork but [the patentee’s] own.” Although Chakrabarty settled the question of whether manufactured genes can receive patent protection, it did not address the patentability of naturally occurring genes. In the absence of such definitive legal guidance, the USPTO routinely issues patents on human deoxyribonucleic acid (DNA) sequences, reasoning that the material has been purified from its natural form through human intervention and is thus sufficiently “touched by man” to be beyond the scope of nature. From 1980 to 2009, the USPTO issued between 3,000 and 5,000 patents on human genes, encompassing nearly 20% of the human genome. In addition, the USPTO has issued nearly 50,000 patents involving human genetic material, yet the fundamental validity of such patents has never been reviewed until now. In March 2010, a district court decision in New York brought attention to the role of gene patents in the advancement of biomedical research. In Association for Molecular Pathology v. United States Patent and Trademark Office (“AMP”), the Southern District of New York enforced a strict standard for subject matter patentability by invalidating seven patents relating to the human breast cancer genes BRCA1 and BRCA2 (collectively “BRCA”). The court reasoned that not only were the coding sequences and mutations of BRCA results of natural phenomena but that, the purified forms of BRCA maintain essentially the same structures and functions as their natural forms and therefore fall outside the scope of patent law protection. Although the decision primarily addressed the patent’s subject matter, the court also noted the possible social implications resulting from how patents affect access and innovation in biomedical research. Contrary to concerns raised by the plaintiffs in AMP, empirical studies indicate that gene patents do not impede access to biomedical research data or play a significant role in influencing the topics of research that scientists choose to pursue. These results suggest that while gene patents do not impede innovation, they may not be necessary for it either, at least at the foundational level. Some scholars still maintain, however, that patent protection is necessary to ensure adequate funding for further research, development, and marketing of their innovations. This Note focuses on the role of patent law in encouraging or discouraging innovation in the field of biomedical research. Specifically, this Note analyzes the policy justifications underlying gene patents and explores whether these justifications validly apply to the patenting of the BRCA gene. Part I establishes a basic understanding of patents, genes, and gene patents. Part II provides greater detail regarding the arguments and holding in the AMP case. Part III introduces the traditional rationales for patent protection and applies them to gene patents. Part IV considers the concerns surrounding gene patents and whether these concerns are realistic given the results of empirical studies on the relationship between patents and biomedical research. Part IV also examines whether the district court’s holding in AMP is consistent with the policy goals behind intellectual property rights and the reality of the industry. Finally, this Note concludes that, in general, patents do not impede upon innovation. However, the broad issuance of composition claims, such as those held by Myriad in AMP, may block research in areas of study that the patent holder is not pursuing (such as therapeutics). This Note suggests that this issue could be resolved by narrowing the focus of the patent claim to the application of the gene composition, rather than the composition on its own.
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Open Access
Aug 25, 2012
Mee-Sun Lee + 2
