In a reversal of a long time policy, the Federal government, on Fri. Oct. 29th, ruled that genes from humans and other organisms could not be patented because they are a part of nature.
The decision, declared in a friend-of-the-court brief filed by the Department of Justice, will have a major impact on the medical research and the biotechnology industry.
In the brief, the Department of Justice declared, “We acknowledge that this conclusion is contrary to the long-standing practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA.”
However, it is still unclear whether or not the patent office will implement the new policy.
Patents for isolating genes and DNA have been granted for decades. In fact, the Supreme Court, in 1980, upheld patents on living organisms.
The policy change follows a court decision made in April 2010, when the U.S. District Court for the Southern District of New York ruled that patents on the genes held by Myriad Genetics, a major biotechnology company, are invalid.
Many had predicted the court would throw out the suit. The genes in question were BRCA1 and BRCA2, which are associated with breast and ovarian cancer.
Myriad Genetics has held the patents on these two genes since the late 1990s.
The biotech company offers diagnostic tests to women, which allow them to determine whether or not they have the BRCA mutations in their DNA.
The tests cost more than $3,000. Before the court ruling, the patents prevented any competitors from offering the same test without paying a licensing fee to Myriad Genetics.
Prior to the court decision, it was estimated that over 20 percent of the human genome was patented by various pharmaceutical and biotech companies.
For a long time, these companies have argued that such patents are necessary in order to guarantee commercial profits and financial reward. In addition, the pharmaceutical companies argued that such patents are vital to the development of diagnostic tests, drugs and individualized patient treatments.
In a lawsuit filed by the Ravicher’s foundation, the American Civil Liberties Union, the American Medical Association, the American Society of Human Genetics and the March of Dimes Foundation, the plaintiffs argued that patents on human genes stymie research and prevent further expansion of medical research.
The ACLU argued that the use of gene patents dissuaded genome researchers from studying regions that were already claimed.
In a surprise decision, the district court ruled in favor of the ACLU. Since then, Myriad Genetics has filed an appeal, which has yet to be reviewed by the courts. The case will most likely end up in the Supreme Court before it is finally settled.
If the patent office were to implement the new policy change, it will most likely draw protests from some biotechnology companies.
In agreement with the court decision, the Department of Justice recognized that human genes are products of nature and, thus, cannot be patented.
“The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth,” said the brief.
The policy change, however, does not cover man-made manipulations of genes. Methods to create genetically modified crops and gene therapies can still be patented. However, the mere isolation of a gene, without alteration or modification, is not subject to patent under the new policy.
The hope is the policy change will promote further investigation in the human genome and lead to more scientific discoveries.
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