Intellectual Property Blog

Can a Gene Be Patented?

April 21, 2013

By: Sharon Urias, Esq.

Can a company be granted a patent on the genes in the human body? This very controversial subject was heard by the Supreme Court on Monday, and, according to an article online at nbcnews.com, the majority of the justices who heard the arguments are likely to rule that a gene cannot be patented.

Myriad Genetics, a company based in Utah, does own patents on two parts of human genes known as BRCA 1 and BRCA 2, named for the first two letters of the words breast and cancer. Myriad discovered women with mutations in these two genes are at an 85 percent risk of getting breast cancer and a 50 percent risk of getting ovarian cancer.

After receiving the patents, Myriad now has a monopoly on performing all diagnostic tests related to BRCA 1 and BRCA 2.

Representing a group of scientists, doctors and cancer patients, the ACLU argued Myriad should not have been granted a patent on BRCA 1 and BRCA 2 because the company just removed something from the body that was already there, and therefore, it is a creation of nature and cannot be patented.

The ACLU also claims Myriad’s exclusive patent creates a monopoly that does not allow women the ability to seek another opinion and hinders other scientific laboratories from performing research on the patented genes, as well. Attorneys for the ACLU add that because of the monopoly on the testing for these two genes, Myriad can charge an unreasonable price for the test. If there was no patent protection, competition would make the test less expensive.

However, Myriad argues that a new chemical entity is made when removing the gene sequence from the body, and therefore the gene should be patentable. The company also stated these genetic materials “were never available to the world until Myriad’s scientists applied their inventive faculties to a previously undistinguished mass of genetic material.”

Myriad is not the only company to have been granted a patent on genetic material. The federal government has granted approximately 3,000 similar patents on genetic materials in the past thirty years.

Without this patent protection, argues Myriad, companies would be much less likely to spend the enormous amount of money required for researching and making genetic discoveries.

The outcome of this case does not look positive for Myriad, as President Obama’s administration urged the Supreme Court to “be deeply skeptical of Myriad’s broad claim of what can be patented,” and several of the justices stated during Monday’s oral arguments that “it would be one thing for a company to seek a patent on a test for breast cancer that was developed by analyzing a human gene, but it would be going too far to be awarded a patent on the gene itself.”

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