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Supreme Court Rules ‘Naturally Occurring’ Human Genes Cannot Be Patented

Synthetic genes are fair game, however (June 13)

A unanimous Supreme Court has ruled that genes isolated from the human body are not patentable. The decision is seen as a victory for those awaiting more individualized, gene-based approaches to medical care.

The court’s ruling came after medical researchers and others challenged patents owned by or licensed to a Utah-based biotechnology company on two genes linked to breast and ovarian cancer.

Each human gene is encoded as deoxyribonucleic acid (DNA), which takes the shape of a “double helix.” Each cross-bar in that helix consists of two chemically joined nucleotides. Sequences of DNA nucleotides contain the information necessary to create strings of amino acids used to build proteins in the body. The nucleotides that code for amino acids are called exons, and those that do not are called introns.

The court noted that scientists can extract DNA from cells to isolate specific segments for study. However, they can also synthetically create exons-only strands of nucleotides known as composite DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening introns.

In the court’s opinion, a naturally occurring DNA segment is a product of nature and is not eligible for patent simply because it has been isolated, but cDNA is patent-eligible because it is not naturally occurring. The ruling pointed out that a laboratory technician “unquestionably creates something new when cDNA is made.”

According to Reuters, the biotech industry saw some good in the ruling, since the justices left intact not only patent protections on forms of DNA produced by scientists in laboratories, but also the processes used to carry out gene-based tests, such as cancer screenings.

Sources: Supreme Court; June 13, 2013; and Reuters; June 13, 2013.

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