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Genes are Unpatentable, New York Court Concludes

Daily Journal
05/13/10

Genes, as products of nature, are not protectable under patent law, ruled a New York federal court, in the case of Association for Molecular Pathology v. USPTO.  The court, in a 152 page opinion, concluded that seven patents on two genes linked to cancer were invalid.

Patients groups, scientists and the American Civil Liberties Union challenged seven patents issued by the U.S. Patent and Trademark Office (USPTO) to Myriad Genetics and the University of Utah Research Foundation (collectively "Myriad") for the so-called "BRCA genes."  These genes have been identified as linked to breast and ovarian cancer and thus have significant value for medical research purposes.  Broadly speaking, the patents fell into two categories: "composition of matter claims" for isolated DNA containing BRCA gene sequences; and "method claims" for comparing BRCA gene sequences to identify the presence of mutations correlating with a predisposition to cancer.  The plaintiffs alleged that Myriad's patents hindered the ability of cancer patients to receive the highest-quality breast cancer genetic testing and impeded the development of improvements to BRCA genetic testing.  Additionally, the plaintiffs maintained that gene patents generally impede research aimed at identifying the role of particular genes in medical conditions.

The trial court rendered summary judgment in favor of plaintiffs, determining that both isolated human genes and the comparison of their sequences were unpatentable subject matter under the Patent Act (35 U.S.C. Section 101).  The court began by citing to two well-established principles regarding the scope of patent protection: "scientific principles and laws of nature...have existed throughout time...and, as a consequence, ought not to be the subject of exclusive rights to any one person"; and "products of nature" are not patentable.

Turning specifically to the composition patents, the court relied upon precedent holding that "products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product," and that "purification of a natural compound, without more, is insufficient to render a product of nature patentable."  Applying these principles, the court held that isolated DNA was not sufficiently distinct from native DNA found within human cells to render the former within the scope of patentable subject matter.  The court rejected Myriad's argument that isolated DNA should be treated identically to other biochemical compounds for the purpose of assessing patentability (i.e., by examining its chemical composition).  Rather, the court held that DNA is unique from other chemical compounds, given its dual role as both a chemical compound and a carrier of biological information.  As such, "DNA...therefore serves as the physical embodiment of a law of nature - those that define the construction of the human body."  According to the court, when isolated DNA is assessed within this conceptual framework, the differences between native and isolated DNA were legally immaterial, since in both forms the information-coding sequences of the DNA were identical.

The court also concluded that Myriad's method patents were invalid, based upon the principle that "abstract intellectual concepts are not patentable."  Specifically, the court held that methods of "comparing" or "analyzing" gene sequences were not patentable, absent the identification of a specific process of comparison or analysis.  According to the court, Myriad's method patents failed to identify a specific process of comparison or analysis, and were therefore not protectable under the Patent Act.

The Molecular Pathology case has significant implications.  About 20 percent of human genes have patents associated with them (4,382 of the 23,688 identified).  A total of 53,664 DNA-related patents have been granted by the USPTO.  Multibillion-dollar industries have been built atop the intellectual property rights these patents grant.  According to Wikipedia, four of the top 10 biotechnology companies in the U.S. are headquartered in California.

As more and more correlations have been discovered between individual genes and diseases with hereditary components (such as cancer), a burgeoning market for genetic testing has developed, in order to identify and treat at-risk individuals.  Many companies and laboratories have therefore invested in developing predictive or diagnostic tests for diseases.  Under the current law, when a business or individual is granted a patent for an individual gene, the intellectual property rights associated with the patent extend to the use of genetic tests to determine gene carriers.  In other words, the patent owner has the de facto right to control the market for any diagnostic tests associated with the patented gene.

The Molecular Pathology decision unsettles the market for the development of drugs based on owning the rights to certain genes.  While the ruling is non-binding as to patents other than those at issue, if other courts follow the lead of the Southern District of New York, the validity of over 4,000 patents on human genes could potentially be called into question.  Proponents of the ruling maintain that a wholesale bar on human gene patents will reduce health care costs and increase patient freedom.  By contrast, those in the biotech industry contend that such a bar will undermine the viability of the market for predictive and diagnostic genetic testing, slowing the pace of medical innovation and ultimately harming patients.  Absent a reversal by the U.S. Court of Appeals, the Molecular Pathology holding will invariably be utilized by parties seeking to invalidate DNA patents, and its reasoning is likely to be adopted by other trial courts.  The question of whether isolated DNA is patentable is unlikely to be resolved any time soon.
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