Virginia
August 2012

Source: ISB News Report August 2012
By Philip Jones

For decades, biotech inventors and company officials have assumed that DNA molecules can be patented. This is not a wild assumption. The US Patent and Trademark Office routinely issues “gene patents,” and federal court judges support patent claims to DNA molecules. These decisions reflect a principle of US patent law: Products of nature are not eligible for patent protection unless an inventor introduced a change that results in the creation of a fundamentally new product, one that possesses markedly different characteristics. Isolated DNA molecules are not products of nature, or at least that was the perception that supported the biotech industry.

In May 2009, the American Civil Liberties Union and the Public Patent Foundation challenged this notion. On behalf of the Association for Molecular Pathology and other groups, they sued the USPTO, Myriad Genetics, and Directors of the University of Utah Research Foundation, asserting that the patenting of human genes violates US patent law. Specifically, the plaintiffs alleged the invalidity of Myriad’s patent claims to molecules with nucleotide sequences of the BRCA1 and BRCA2 genes, two genes linked to susceptibility for breast cancer. About one year later, US District Judge Robert W. Sweet issued his decision; he agreed with the plaintiffs. The judge acknowledged that an isolated DNA molecule differs chemically from a DNA segment in a chromosome that resides within a cell. But that’s not enough. “In light of DNA’s unique qualities as a physical embodiment of information,” Judge Sweet declared, “none of the structural and functional differences between native BRCA1/2 and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA ‘markedly different.’”

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Website: http://www.isb.vt.edu

Published: August 28, 2012