For decades, genes have been eligible for patents and thus thousands of patents have been issued. The medicine and biotechnology industries have used such patents to make further advancements in the medical world. It has also been the traditional practice of both the Patent and Trademark Office and the National Institutes of Health to honor these patents. However, for the first time, the patentability of genes was addressed in court. In a decision made last Friday, the federal goverment said that genes should no longer be eligible for patents because “they are part of nature.”
A decision made by Judge Robert W. Sweet of the United States District Court in Manhattan in March prompted the government to reassess the pre-existing policy of granting patents for genes.
Myriad Genetics and the University of Utah Research Foundation had patents that covered the genes, BRCA1 and BRCA2, as well as the $3,000 cost of the actual analysis of those genes. Specifically, Myriad performed tests on women to determine whether or not BRCA1 or BRCA2 genes would lead to mutations that subject these women to breast and ovarian cancers.
But, the American Civil Liberties Union and the Public Patent Foundation, filed a lawsuit that challenged Myriad’s patents. The court ended in a surprise when the decision made by Judge Sweet declared the patents to be invalid.
The Los Angeles Times suggests that the judge had made his decision based on the fact that the “genes were important for the information they convey, and in that sense, an isolated gene was not really different from a gene in the body.”
Already there has been criticism of the government’s decision claiming that eliminating patents will hinder the health of individuals who need medicine specially made for them based on their genes. It would also impede the development of diagnostic tests and other drugs.
Such controversy surrounds the issue because for many years patents were never a problem. Edward Reines, a patent attorney who represents biotechnology companies expressed this concern by saying that “it’s major when the United States, in a filing, reverses decades of policies on an issue that everyone has been focused on for so long.”
On the other hand, the government stated that prohibiting patents would not leave a dramatic impact on the biotechnology industry because they would still be allowed to patent man-made manipulations to DNA.
Circumstances change over time and so should the policies surrounding the issue.
The government’s brief also said that “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.”
Genes are a part of us that cannot be controlled or chosen by a person. Although it is important to make attempts at controlling them, since they aren’t initially selected by people, they should not be available for patents.
Above all, genes are a product of nature. Patenting genes would be ‘locking up’ information that is essential for progress. It is never a good thing to tamper with nature and its evident that the government couldn’t agree more by making the decision to prohibit the patentability of genes.
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