DOJ Opines that Genes Should Not Be Eligible for Patent Protection

In a surprising opinion, the United States Department of Justice (“DOJ”) recently said that genes should not be eligible for patent protection because they are found in nature. This opinion could have a huge impact on the medical and biotechnology fields.

This opinion was declared in friend-of-the-court brief by the DOJ in a case involving two human genes linked to breast and ovarian cancer. The DOJ’s opinion is surprising because it is contrary to the long standing practices of the United States Patent and Trademark Office (“USPTO”), the National Institutes of Health (“NIH”), and other various government agencies.

Under U.S. patent law, anyone who invents any new and useful process, machine, manufacture, or composition of matter, may obtain a patent on that subject matter. In 1980, the Supreme Court found that this includes man-made products of genetic engineering. Using this rationale, the USPTO has issued numerous patents on a wide range of engineered DNA molecules. In 2010, the Supreme Court determined that the boundary between eligible and non-eligible subject matter is defined by the principle that patent laws do not embrace laws of nature, physical phenomena, or abstract ideas. 

With this in mind, the DOJ asserted in its brief that certain compositions of matter whose value is derived from the information-encoding capacity of DNA qualify as human-made inventions eligible for patent protection, such as cDNAs, vectors, recombinant plasmids, chimeric proteins, vaccines, and genetically modified crops. However, genomic DNA that is isolated from the human body, without further alteration or manipulation, is not considered patent-eligible. The unique chemical base pairs that induce a human cell to express a certain protein is not a human-made invention. According to the DOJ, the chemical structure of native genes is a product of nature, and is no less a product of nature when that structure is “isolated” from its natural environment than “cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth”.

It is not clear whether the USPTO will change its policies in the face of this brief. However, the potential impact on the medical and biotechnology fields is daunting. Isolated DNA can be used to induce a human cell to create certain proteins linked to certain diseases, such as the protein BRCA1, which is linked to certain cancers. Researchers can study the structure and function of these proteins to determine how these proteins contribute to the disease at issue, and to determine if there are any drug treatment therapies that can inhibit the function of the protein, thereby treating the disease. 

If isolated DNA is not considered patentable, investors may be hesitate to fund expensive and time consuming research that does not provide a chance for the commercial reward of exclusive patent rights in the product of the research. Without funding for research that isolates DNA, there is a danger that one of the more successful ways to treat certain diseases, creating drug treatment therapies that target specific proteins within the body, will be severely hindered, if not eliminated. 

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